Lymphovenous Anastomosis and Lymph Node Transfer Performed with Medical Microinstruments’ Symani® Surgical System at the Renowned University Hospital Zurich

System acquired to enhance hospital’s lymphatic’s program

Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today the University Hospital Zurich (USZ), Division of Plastic and Hand Surgery, successfully completed its first case using the Symani® Surgical System. Prof. Nicole Lindenblatt, M.D. performed a lymph node transfer and lymphovenous anastomosis (LVA), a novel and challenging supermicrosurgical procedure intended to improve the patient's lymphedema by allowing outflow of lymphatic fluid through residual lymphatic channels.

“Empowering surgeons with additional precision and dexterity through robotics has tremendous potential to evolve how effectively we treat a range of conditions,” said Mark Toland, Chief Executive Officer of MMI. “Prof. Lindenblatt’s procedure marks a milestone in improving treatment for lymphedema, a disease state with lengthy and burdensome effects on patients. As additional hospitals adopt the Symani Surgical System, supermicrosurgical techniques will offer patients new treatment possibilities that are too small to effectively address by hand.”

The University Hospital Zurich, the No. 2-ranked hospital in Switzerland and No. 12 hospital in the world according to a recent poll in Newsweek, installed the Symani Surgical System in July to enhance its lymphatic surgery program. About 250 million people in the world suffer from some form of lymphedema, which is characterized by excess lymphatic fluid causing swelling in the arms or legs.

The Symani Surgical System is designed to repair small anatomical structures such as blood vessels, nerves and lymphatic ducts that may be as small as 0.3mm in diameter. The Symani Surgical System has been shown to reduce the occurrence of thrombosis by 50 percent in preclinical studies by mitigating hand tremor and scaling movements up to 20X. The Symani Surgical System received CE Mark in 2019 and is intended for free-flap reconstructions, replantations, congenital malformations, peripheral nerve repairs, lymphatic surgeries and more.

To learn more about MMI and the Symani Surgical System, please visit: www.mmimicro.com.

About MMI

Medical Microinstruments S.p.A. (MMI) was founded in 2015 near Pisa, Italy to enhance surgical performance through the development of a robotic system that enables surgeons to achieve better outcomes in microsurgery. The Symani Surgical System combines proprietary innovations including the world’s smallest wristed microinstruments as well as tremor-reducing and motion-scaling technologies. Together, these powerful capabilities allow more surgeons to successfully perform microsurgery while expanding the field of supermicrosurgery. MMI is backed by international medtech investors including Andera Partners, Panakes Partners, Fountain Healthcare Partners and Sambatech.

About University Hospital Zurich

The University Hospital Zurich (USZ) is internationally renowned for its achievements in university medicine, nursing, research and teaching. More than 42,000 inpatients and over 600,000 outpatient consultations per year testify to the great trust placed in the USZ and its approximately 8,500 employees. Thanks to the interdisciplinary cooperation of more than 40 clinics and institutes as well as the proximity to the University and ETH Zurich, the University Hospital Zurich offers its patients the broad experience of its specialists and up-to-date therapies.

Media Contact:

Matter Health for MMI
Dan Ventresca
617-874-5488
mmi@matternow.com
www.matternow.com

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

• Independent Data Monitoring Committee authorized proceeding to Phase 2 at highest dose level tested following review of clinical safety data from the Phase 1 dose escalation

• Phase 2 clinical data readouts on safety and efficacy of XC001 anticipated in 2022

• Company plans to commence study startup of XC001 as an adjunct to CABG in 2H21, and clinical studies in additional cardiovascular indications are under discussion

• Progress highlights potential of gene therapy in cardiovascular disease
  

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced the completion of the Phase 1 dose-escalation component of its Phase 1/2 clinical trial (EXACT) of XC001 (encoberminogene rezmadenovec), its lead investigational gene therapy candidate for patients with refractory angina who have no further treatment options.

Following a review of clinical data from the Phase 1 dose escalation component of the study, the Independent Data Monitoring Committee (IDMC) authorized proceeding to the Phase 2 component of the study at the highest dose tested. Since the IDMC authorization, three patients have been dosed in the Phase 2 expansion cohort. This progress highlights the potential for gene therapy to go beyond rare diseases and to address larger patient populations with significant unmet needs, such as chronic cardiovascular diseases.

XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21. The company also plans other clinical studies in additional cardiovascular indications, including heart failure caused by ischemic heart disease and as adjunctive therapy to percutaneous coronary intervention.

“Patients with refractory angina are forced to live with the ongoing burden of a disease that limits their activities on a daily basis due to chest pain,” said Thomas Povsic, M.D., Ph.D., Duke University cardiologist and National Principal Investigator for the EXACT study. “With a unique mechanism of action that restores blood flow to the heart via the creation of new blood vessels, XC001 represents a novel therapeutic approach for patients who have exhausted other medical and surgical options. It is very exciting to now move forward with exploring XC001’s potential in the Phase 2 portion of EXACT as a one-time therapy for patients with refractory angina.”

“In our mission to deliver safe and effective gene therapies that transform the lives of people with cardiovascular disease, we are excited to achieve this important milestone and advance into the Phase 2 portion of our study,” said Al Gianchetti, President and Chief Executive Officer of XyloCor Therapeutics. “XC001 has enormous potential to significantly improve the lives of patients with refractory angina. We are grateful for the support of patients and their families, as well as the EXACT trial investigators as we continue to study the safety and efficacy of XC001 and look forward to reporting results in 2022.”

About XC001

XC001 (encoberminogene rezmadenovec) is a novel, investigational gene therapy designed to stimulate the growth of new blood vessels in the heart, in order to bypass diseased vessels and improve coronary blood flow. XC001 delivers the gene for vascular endothelial growth factor (VEGF), a naturally occurring protein, in targeted myocardial cells, thus stimulating the creation of new blood vessels via a process called angiogenesis. XC001 employs a proprietary multi-isoform VEGF expression cassette that has been optimized to maximize expression of VEGF. XC001 has been granted Fast Track designation by the FDA for study in refractory angina. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina, in 2020.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm, dose-escalation trial. 12 subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by an experienced cardiac surgeon. The EXACT Trial is being conducted at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor

XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

Medical Microinstruments Announces First Commercial Installation of the Symani® Surgical System

University Hospital Salzburg solidifies standing as leader in microsurgery by being first to commit to robotic-assisted platform

Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today the University Hospital Salzburg, part of the Salzburg State Hospitals (SALK), is the world’s first hospital to implement the Symani® Surgical System for commercial use in its robotic microsurgery programs. A leading hospital in the DACH region and one of the largest hospitals in Austria, SALK will specifically leverage Symani to further enhance its capabilities in oral and maxillofacial surgery.

“University Hospital Salzburg has demonstrated a sincere desire to further improve patient care through robotic-assisted surgeries and is an ideal partner for launching our Symani Surgical System commercially,” said Mark Toland, Chief Executive Officer of MMI. “Innovation in microsurgery has been lacking over the last decades but it is clearly an ideal field for surgical robotics as the procedures are complex and require extreme precision. SALK is a visionary teaching institution that is keen to apply technology to microsurgical techniques and unlock the possibilities of supermicrosurgery with Symani.”

The Symani Surgical System and its NanoWrist Instrumentation were designed to augment a physician’s capabilities during microsurgical procedures by reducing tremor and scaling movements up to 20X. It can repair anatomical structures such as blood vessels, nerves and lymphatics that may be as small as 0.2mm in diameter. Specific procedures that may benefit from enhanced precision include free-flap reconstructions, replantations, congenital malformations, peripheral nerve repairs and lymphatic surgeries. Lymphedema marks one disease state with an acute need for improved treatment options, as it impacts nearly 250 million people worldwide who often suffer from long periods of treatment with limited effectiveness.

“SALK’s mission is to offer patients the highest level of care available today, which is why pioneering robotic microsurgery is so important to us,” said Prof. Alexander Gaggl, M.D., Department of Oral and Maxillofacial Surgery at the University Hospital Salzburg. “From the moment we evaluated the Symani Surgical System, we knew that robotic microsurgery was the future, and we began to imagine how we could expand our capabilities through the system and its NanoWrist instruments.”

SALK intends to participate in MMI’s post-market study to validate the intended clinical benefits of the Symani Surgical System.

To learn more about MMI and the Symani Surgical System, visit www.mmimicro.com.

About MMI

Medical Microinstruments S.p.A. (MMI) was founded in 2015 near Pisa, Italy to enhance surgical performance through the development of a robotic system that enables surgeons to achieve better outcomes in microsurgery. The Symani Surgical System combines proprietary innovations including the world’s smallest wristed microinstruments as well as tremor-reducing and motion-scaling technologies. Together, these powerful capabilities allow more surgeons to successfully perform microsurgery while expanding the field of supermicrosurgery. MMI is backed by international medtech investors including Andera Partners, Panakes Partners, Fountain Healthcare Partners and Sambatech.

About University Hospital Salzburg

The Salzburg State Hospitals are the leading health care provider and employer in the State of Salzburg. The 6,570 employees treat 83,700 in-patients and 9,300 day-patients every year. The Salzburg State Hospital Group manages four hospitals: the University Hospital Salzburg in the City of Salzburg and the State Hospitals in Hallein, St. Veit and Tamsweg.

Contacts

Media:
Matter Health for MMI
Dan Ventresca
617-874-5488
mmi@matternow.com
www.matternow.com

Vivasure Medical Announces Development of Sutureless Venous Closure Device for Use in Percutaneous Transcatheter Procedures

• Investigational PerQseal Blue designed to be the world’s first and only fully absorbable device for large-bore venous closure

• Development program funded by €2.5 million grant awarded by the European Innovation Council Accelerator

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced its development program for PerQseal® Blue, the company’s new investigational product. PerQseal Blue is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). The PerQseal Blue technology is based on PerQseal, the company’s vascular closure device approved in Europe for use in femoral arteries.

The PerQseal Blue development program was first initiated in 2020 and is funded in part by a €2.5 million grant awarded by the European Innovation Council Accelerator (EIC). The EIC was part of the European Commission’s Horizon 2020 program and supports innovative entrepreneurs, small companies and scientists planning to expand internationally. Vivasure Medical was one of only 36 companies to receive a grant award from the EIC, which reviewed 1,852 applications from EU-based companies. Horizon 2020 is the largest EU research and innovation program, with nearly €80 billion of funding available over seven years.

“As transcatheter procedures for mitral and tricuspid valve treatment become increasingly common, there is a growing need for new venous closure options. These minimally invasive procedures require much larger punctures which often result in vascular complications,” said Dr. Azeem Latib, M.D., Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York. “Based on my experience using PerQseal for large-bore arteries in percutaneous endovascular procedures, I am optimistic for the potential of PerQseal Blue to provide a simple and safe option for venous closure that does not leave behind any sutures, metal implants, or collagen.”

Currently, there are no sutureless options for venous closure following TMVR or TTVR procedures. PerQseal Blue has the potential to be the first sutureless, fully absorbable synthetic implant for large-bore venous closure following these catheter-based procedures. Leveraging Vivasure Medical’s PerQseal technology, PerQseal Blue consists of an intravascular patch designed to seal the vessel from the inside, returning the vein to its natural state.

“We’re thrilled to introduce PerQseal Blue to our product development portfolio as a potential new option specifically for large-bore venous closure following percutaneous cardiovascular procedures,” said Andrew Glass, CEO of Vivasure Medical. “We plan to advance our venous program to the clinical stage in 2022 with the initiation of a study to evaluate and optimize PerQseal Blue.”

PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures that require large-bore arterial vessel access, including TAVR, thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). Frontier V, a European multicenter study, was recently initiated to evaluate Vivasure Medical’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial closure.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal Blue development program has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 946304.

Neuromod research reveals that more than three in four UK tinnitus sufferers have never received treatment for their condition

• Neuromod launches ground-breaking Lenire tinnitus treatment device to more than seven million tinnitus sufferers in the UK

• Lenire tinnitus treatment device now available from The Tinnitus Clinic practices in seven UK cities

New research from Irish medical device company, Neuromod Devices Ltd, has found that more than three quarters of people suffering from tinnitus in the United Kingdom have never received any treatment for their condition. The poll also revealed that 67% of UK tinnitus sufferers don't feel adequately informed about their condition.

This news comes as Neuromod Devices has launched its tinnitus treatment device, Lenire® in the UK, where it is estimated that seven million people suffer from tinnitus – commonly referred to as 'ringing in the ears'.

The research, which polled 251 people with tinnitus across the UK, found that 76.1% of respondents have never used any form of tinnitus treatment. It also revealed that 67.7% of those polled don't feel adequately informed about tinnitus. This translated as 12.7% of respondents who didn't feel informed at all about their condition; 22.3% feeling somewhat uninformed and 31.5% who were unsure about how informed they were about their tinnitus.

The poll also asked respondents about their awareness of treatment options open to tinnitus patients and found that 28.3% of respondents didn't feel informed at all about their options and a further 30.3 said they were 'somewhat uninformed'.

Speaking on research, Dr Ross O'Neill, CEO of Neuromod Devices said: "Our poll shows that there is a clear gulf in knowledge of tinnitus treatments in those suffering from this debilitating condition. This may stem from the fact that so many people with tinnitus never seek any form of treatment for it. Recent research has told us that tinnitus is a symptom of long-COVID and we now know that the COVID-19 pandemic has taken a toll on people who have tinnitus."

"In addition, a recent study led by Anglia Ruskin University, Cambridge, found that 46% of tinnitus sufferers in the UK reported a worsening of their tinnitus during the COVID-19 pandemic[i]. With Lenire, our goal is to improve the quality of life of those suffering from tinnitus and this is what motivates us to bring this treatment to as many people as we can. The results of large-scale clinical trials, involving more than 500 participants, are very positive, as are the real-world outcomes for our patients in Europe so this is a very exciting time for the company."

The Lenire tinnitus treatment device is available to people with tinnitus through The Tinnitus Clinic's network of seven locations across the UK or online via the company's Neuromod Medical tinnitus telemedicine service.

The Tinnitus Clinic's audiologists will provide Lenire to patients, as well as devising and monitoring their tinnitus treatment plans using the device. The Tinnitus Clinic is the leading provider of the latest evidence-based tinnitus treatments in the UK, with clinics in London, Bristol, Leeds, Leicester, Manchester, Newcastle, and Stirling.

Neuromod specialises in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation tinnitus device which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms.

Tinnitus affects between 10 and 15% of the global population and the British Tinnitus Association estimates that more than seven million people suffer from this condition in the UK alone[ii].

Dr Ross O'Neill continued: "I am absolutely delighted to launch Lenire in the United Kingdom and to begin treating tinnitus patients with the device. Interest in Lenire from the UK has been strong, so in order to best serve those with tinnitus in the UK, it is important to provide patients with the best treatment option for them, whether that's an in-clinic assessment or one they can do online via telemedicine. This is why working with The Tinnitus Clinic is a great fit for us. The Tinnitus Clinic and Neuromod share the goal of providing evidence-based and clinically proven treatments to those afflicted by tinnitus. I look forward to working with their accomplished team".

Mark Williams, Chief Audiologist for the Tinnitus Clinic said: "We are delighted to be partnering with Neuromod to introduce Lenire to the UK. It is a novel, but evidence-based treatment which we are pleased to be providing alongside the suite of treatments which are currently available from the service."

Patients in the United Kingdom can also opt to have tinnitus assessments online via Neuromod's telemedicine service, which launched earlier this year and has had over 1,000 people use the service to date. The service is delivered through Neuromod Medical, a centre of excellence for tinnitus care, based at the Hermitage Medical Clinic in Dublin, Ireland, and aims to provide patients with quick access to tinnitus care, without waiting lists.

With this service patients can get assessed, fitted for the Lenire device and complete follow up appointments with their healthcare professional via a video call from the comfort of their own homes, using a mobile device or home computer.

Neuromod has been advancing the commercialisation of Lenire across Europe having opened its German office in Forchheim, Bavaria last year. Since then, the company has made Lenire available to patients in Germany by taking on 57 partners who make the device and its treatment plan available in 96 clinics throughout Germany. Neuromod also has three partner clinics in Austria.

The company, which raised €10.5 million in an oversubscribed Series B financing round late last year, has been scaling manufacturing of the Lenire device to meet demand in Europe. This funding has also seen the employee numbers at the company grow by more than 50% in six months. which is being used to expand European commercialisation and scale-up manufacturing of the Lenire device to meet demand.

Lenire is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENT (Ear, Nose and Throat) surgeons.

The device has been used in large-scale clinical trials, the most recent of which, involving 326 participants, delivered dramatic improvements in patients' tinnitus symptoms[iii]. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.[iv]

For more information please contact:

Robert Magee
Senior Communications Manager,
Neuromod Devices
robert.magee@neuromoddevices.com / +353 87 670 6826

About Neuromod Devices Limited

Founded in 2010, Neuromod Devices Ltd is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod's tinnitus treatment device, Lenire is currently available in Ireland and throughout Europe. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details on Lenire including a list of providers can be found at www.lenire.com.

About The Tinnitus Clinic Ltd

The Tinnitus Clinic is an independent audiological practice specialising in tinnitus treatment and management and providing hearing aid consultations and fitting.

The clinics offer a highly personalised service and a commitment to audiological best practices for tinnitus treatment and hearing loss from centres in Harley Street, London, and across the UK. Tinnitus Clinic is one of the few private audiology clinics that has been registered by the Care Quality Commission in the UK. Further details can be found at www.thetinnitusclinic.co.uk

References

[i] Beukes et al., DOI=10.3389/fpubh.2020.592878

[ii] British Tinnitus Association - https://www.tinnitus.org.uk/blog/more-people-living-with-tinnitus-than-previously-thought

[iii] As measured by Tinnitus Handicap Inventory score

[iv] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Medical Microinstruments’ Symani Surgical System Saves Patient’s Arm from Amputation

Highly complex, innovative reconstruction procedure part of post-market study

Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, announced today that MMI’s Symani  Surgical System was successfully used at Careggi University Hospital Florence by Prof. Marco Innocenti and his team in a complex, post-traumatic limb reconstruction that saved a patient’s arm from amputation. The case is the first enrolled patient in MMI’s post-market study.

Prof. Marco Innocenti, M.D., the head of reconstructive surgery and microsurgery at Careggi University Hospital in Florence, performed the procedure which involved a young adult who suffered a motorcycle accident. After eight months of unsuccessful surgeries and bone fixation attempts, the patient received a recommendation for amputation. Dr. Innocenti was made aware of the case and determined the patient was a candidate for a free-flap reconstruction, which involved transferring a piece of bone and its vessels from the lower leg to the patient’s forearm. The robotic-assisted procedure successfully restored blood flow to the area despite severe damage and extensive scar tissue inside the arm.

“Robotic-assisted technology is a revolutionary tool for microsurgery, because it allows physicians to complete procedures that are difficult or impossible with the human hand,” said Dr. Innocenti. “By increasing our precision, we can reconnect submillimeter vessels and nerves that enable reconstruction even after severe trauma. I am confident our post-market study will show significant advantages to improving patient outcomes, as the patient in the motorcycle accident would have lost her arm without robotic-assisted microsurgery.”

The patient marked the first enrolled in the post-market study. It was also the first time Dr. Innocenti performed a free-flap reconstruction with the fibula bone using the Symani Surgical System.

“By evolving surgical intervention from a manual process to one that leverages robotic technology, we can open the door to procedures that have never been done before,” said Mark Toland, chief executive officer of MMI. “Dr. Innocenti’s accomplishment in this case is an extremely exciting piece of validation for our technology that will contribute to our data collection for our growing global regulatory strategy.”

The Symani Surgical System received CE Mark in 2019 and can enhance free-flap reconstructions, replantations, congenital malformations, peripheral nerve repairs and lymphatic surgeries. The platform minimizes hand tremor and scales physician movements (7-20x), reducing the occurrence of thrombosis by 50 percent in preclinical studies. Its NanoWrist  instruments are the world's smallest wristed surgical instrumentation and create seven degrees of freedom for optimal dexterity inside of minimally invasive incisions.

The MMI post-market study at the University of Florence Careggi Hospital is registered at www.clinicaltrials.gov. To learn more about MMI and the Symani Surgical System, please visit: www.mmimicro.com.

About MMI

Medical Microinstruments S.p.A. (MMI) was founded in 2015 near Pisa, Italy to enhance surgical performance through the development of a robotic system that enables surgeons to achieve better outcomes in microsurgery. The Symani Surgical System combines proprietary innovations including the world’s smallest wristed microinstruments as well as tremor-reducing and motion-scaling technologies. Together, these powerful capabilities allow more surgeons to successfully perform microsurgery while expanding the field of supermicrosurgery. MMI is backed by international medtech investors including Andera Partners, Panakes Partners, Fountain Healthcare Partners and Sambatech.

###

For more information, contact:

Matter for MMI
Dan Ventresca
617-874-5488

Inotrem Receives Approval to Expand Nangibotide Clinical Trial in Critically Ill COVID-19 Patients and Receives Additional Public Funding of €45 Million

• Inotrem’s phase 2/3 clinical trial “ESSENTIAL” will enroll up to 730 patients in Europe to demonstrate the safety and efficacy of nangibotide to treat critically ill COVID-19 patients with respiratory failure.

• Recent preclinical studies have strengthened the body of evidence for targeting the TREM-1 pathway which is activated in a subset of patients suffering from severe COVID-19.

Inotrem S.A., a biotechnology company specializing in the development of immunotherapies targeting the TREM-1 pathway, announces that it has obtained authorization to pursue the clinical development of nangibotide up to registration in COVID-19 patients from both the French and Belgian competent authorities.

As part of this program, Inotrem receives additional 45 million euros in public funding under the "Capacity Building" Call for Expression of Interest, operated on behalf of the French government by Bpifrance, the French national investment bank, as part of the Programme d’investissements d’avenir (PIA) and the France Recovery Plan, bringing French state support for the project to a total of 52,5 million euros. This public funding will support Inotrem’s clinical program including the phase 2/3 study “ESSENTIAL” which aims to demonstrate the efficacy and safety of nangibotide in treating patients in respiratory distress with severe forms of COVID-19.

The primary endpoint is evaluation of the impact of nangibotide on the progression of disease in patients receiving ventilatory support due to COVID-19 as well as on the severity of the respiratory failure, duration of mechanical ventilation, length of stay in intensive care and mortality. In “ESSENTIAL”, a Phase 2/3 clinical program, up to 730 patients will be enrolled initially in France and Belgium and, possibly in other European countries. Pre-defined interim analyses will be conducted by an independent Data Monitoring Board to test futility and to allow for the study design to be adapted as necessary. “ESSNTIAL” is the continuation of a 60 patients phase 2a evaluating the safety and efficacy of nangibotide in patients suffering from severe COVID-19. In July 2020, the CoviTREM-1 consortium, which includes the Nancy and Limoges university hospitals and Inotrem, obtained public funding of 7,5 million euros under the “PSPC-COVID” call for projects, operated on behalf of the French government by Bpifrance

New pre-clinical studies with nangibotide have demonstrated that the administration of nangibotide in murine models infected with SARS-CoV-2 was associated with a decrease in inflammatory mediators and an improvement of clinical signs, in particular respiratory function, and survival. Inotrem also confirmed in 3 different and independent cohorts that sTREM-1, a marker of the activation of the TREM-1 biological pathway, is associated with both severity and mortality in critically ill COVID-19 patients.

Leveraging the results of these preclinical studies and the implications for the role of the TREM-1 pathway in COVID-19, Inotrem has filed additional patents to cover nangibotide use in severe forms of COVID-19 as well as the use of sTREM-1 as a biomarker and companion diagnostic. This significantly strengthens Inotrem’s already broad patent estate.

Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder said :“We are eager to pursue the development of nangibotide in these severe forms of COVID-19. Nangibotide is a TREM-1 inhibitor which has already demonstrated a trend towards efficacy in septic shock patients and has the potential to modulate the dysregulated immune response in critically ill COVID-19 patients. With this large clinical study, we can demonstrate efficacy for nangibotide in a further indication with the goals of reducing the duration of hospitalization and mortality.”

Sven Zimmerman, CEO of Inotrem, also declared: “The size of the financial support awarded to us as part of the French government’s initiative against COVID-19 is a testimony to the relevance of targeting the TREM-1 pathway with nangibotide in these severely ill patients. We are delighted by the confidence placed in our technology and our team. Everyone at Inotrem is fully committed to deliver on this ambitious program alongside nangibotide’s ongoing Phase 2b trial in septic shock patients.”

About Inotrem

Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors.

www.inotrem.com

About TREM-1 pathway

TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction.

About Nangibotide

Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.

About ESSENTIAL study:

The Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients with ventiLatory support, is a randomized, double-blind, placebo-controlled confirmatory study with adaptive features that will be performed in Europe. This is a pivotal study and it is expected that based on its results, nangibotide could be registered in this indication. The first part of the study (i.e.: 60 patients) has been already finalized and assessed by an independent data monitoring committee with excellent safety results. The study will recruit up to 730 patients in up to 40 sites. Several interim and futility analyses are foreseen as part of the adaptive design of the study.

About Bpifrance

Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra-financial services (training, consultancy...) to help entrepreneurs meet their challenges (innovation, export…).

For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr

Follow us on Twitter: @Bpifrance

NeRRe Therapeutics raises £20 million in a Series B2 financing round

• New funds to evaluate orvepitant as a treatment for the disabling chronic cough associated with idiopathic pulmonary fibrosis (IPF).

• New investor Columbus Venture Partners joins existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, and the UK Government’s Future Fund.

NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional £20 million in a Series B2 financing round.

Having demonstrated proof of efficacy in patients with refractory or unexplained chronic cough[i], NeRRe will now continue the clinical development of orvepitant in chronic cough caused by IPF, a rare type of interstitial lung disease[ii]. A dominant symptom of this severe progressive fibrotic pulmonary disease, in a high proportion of these terminally ill patients, is an uncontrolled, persistent, and disabling cough.

The chronic cough can markedly reduce quality of life, is often refractory to medical therapy and there are no approved treatments for it[iii]. Idiopathic pulmonary fibrosis is recognised as an orphan disease in both Europe and the US.

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Columbus Venture Partners and existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and the UK Government’s Future Fund. The proceeds from the financing round will primarily be used to fund the Phase 2 clinical development of orvepitant as a treatment for chronic cough associated with IPF. Preparation for the start of the Phase 2 trial is underway.

Dr. Mary Kerr, CEO of NeRRe Therapeutics, said: “After demonstrating that orvepitant reduces the burden of chronic cough in one population, we are delighted to have received the financial support to further advance this promising asset for patients suffering from chronic cough associated with IPF. I am also pleased to welcome Columbus Venture Partners to the syndicate and would like to thank our existing investors for their continued support of the NeRRe team, and this exciting first in class asset.”

Toby Maher Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles said: “IPF is a rare, progressive, and fatal form of interstitial lung disease in which cough can be a dominant and distressing feature. A treatment that improves this chronic cough would substantially improve the quality of life of many IPF patients.”

Javier Garcia, General Partner and Founder of Columbus Venture Partners, said: “We have been impressed by NeRRe’s clear strategy and focus on chronic cough associated with IPF, a condition of high unmet medical need and we look forward to supporting the company as it fully uncovers the multiple benefits that orvepitant can provide to these patients.”

About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a clinical-stage company developing orvepitant, a neurokinin(NK)-1 receptor antagonist, as a first in class, once daily breakthrough treatment for cough hypersensitivity disorders. Having demonstrated proof of efficacy in patients with refractory or unexplained cough, NeRRe will now continue development in chronic cough caused by the rare and terminal lung disease idiopathic pulmonary fibrosis (IPF). A dominant feature of this severe progressive respiratory disease in a high proportion of patients is an uncontrolled and persistent cough which is disabling for these terminally ill patients. The cough is often refractory to medical therapy and there are no approved treatments for it. IPF has been designated an orphan disease in both Europe and the USA. Preparations for the start of the Phase 2 trial to evaluate orvepitant as a treatment for disabling chronic cough associated with IPF are currently underway.

About Columbus

Columbus Venture Partners is a Spanish independent venture capital that brings a unique approach for investing in outstanding early-stage and high growth opportunities in the life science industry of Spain. Columbus has $275M under management through three funds. Our team includes solid and internationally experienced investment professionals with a deep scientific, medical and business development background combined with a proven experience in building and investing in companies to accelerate their commercialization. The combination of industry possibilities and investment experience will provide Limited Partner investors in the Fund a level of professionality and deep expertise that is essential for success in this field.

For more information, refer to www.columbusvp.com

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the UK, the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, refer to: www.adventls.com

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science focused venture capital fund with EUR 300 million (USD 354 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. fh-partners.com

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio)pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 69 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

For more information, please visit: www.forbion.com

About OrbiMed

OrbiMed is a leading healthcare investment firm, with approximately $19 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya and other key global markets.

For more information, please visit: www.OrbiMed.com

About the Future Fund

The Future Fund was established to support the UK’s innovative businesses currently affected by Covid-19. These businesses have been unable to access other government business support programmes, such as CBILS, because they are either pre-revenue or pre-profit and typically rely on equity investment. The Future Fund provided eligible companies with convertible loans, on the condition that private investors at least match the government’s commitment. The convertible loans are designed to convert into equity at the next qualifying funding round. The Future Fund is developed by the government and delivered by the British Business Bank.

For more information, please contact:

Mary Kerr, CEO of NeRRe Therapeutics
Tel: +44 1438 906960
Email: info@nerretherapeutics.com

Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
Nerretherapeutics@conslium-comms.com

[i] Smith J, Ballantyne E, Kerr M, Mcgarvey L, Morice A, Sher M, Trower M & Pawsey S. The neurokinin-1 receptor antagonist orvepitant improves chronic cough symptoms: results from a Phase 2b trial European Respiratory Journal 2019 54: PA600; DOI: 10.1183/13993003. 0

[ii] Orphanet – portal for rare diseases and orphan drugs. IPF entry: ORPHA:2032

[iii] Van Manen MJ, Birring SS, Vancheri C, Cottin V, Renzoni EA, Russell AM & Wijsenbeek MS. Cough in idiopathic pulmonary fibrosis. Eur Respir Rev 2016; 25: 278-286.

Vigeland CL, Hughes AH & Horton MR. Etiology and treatment of cough in idiopathic pulmonary fibrosis. Respiratory Medicine 2017; 123: 98-104

Mainstay Medical Announces Limited Commercial Launch of ReActiv8® in the U.S.

Official launch includes new website and marketing resources to support physician and patient education

Mainstay Medical Holdings plc (the “Company”) today announced the limited commercial launch in the U.S. of ReActiv8, its implantable Restorative Neurostimulation™ system to treat intractable chronic low back pain. The ReActiv8 system will be available in the U.S. through ReActiv8-certified physicians commencing in the summer of 2021.

“We are delighted to commercially launch ReActiv8 in the U.S. and make this innovative Restorative Neurostimulation therapy available to Americans suffering from intractable chronic low back pain. Supported by more than 10 years of clinical research, ReActiv8 is the only proven neurostimulation system to address mechanical intractable low back pain. Physicians will finally have access to a therapy to treat these patients beyond temporary treatments designed to merely mask the pain for a limited time,” said Jason Hannon, CEO of Mainstay Medical. “We are launching in a limited fashion to ensure we provide proper education to physicians and assist them in selecting the appropriate patients. We look forward to expanding the availability of ReActiv8 across the U.S. over the coming months and building on the momentum we have gained in Europe and Australia to continue to improve the quality of patients’ lives.”

To support the U.S. commercial launch, Mainstay Medical has launched a new corporate website centered around patient and physician education. The new company website can be accessed at: https://www.mainstaymedical.com. In addition to the new website, the Company has introduced updated tools, guidance, and training materials to assist in identifying prospective patients for ReActiv8 therapy, educating physicians on the ReActiv8 system and becoming ReActiv8-certified, and helping patients access ReActiv8 in the U.S. Specific resources include physician training protocols and modules on ReActiv8, educational and marketing collateral, and informative videos that support and further physician education, patient identification, and appropriate product use.

“We are equipping ReActiv8-certified physicians with robust tools and information to enable proper patient identification and education. We expect that these resources will facilitate the identification of strong candidates for ReActiv8 and drive compelling patient outcomes,” added Mr. Hannon.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing an innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

About ReActiv8®

ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy (including pain medications and physical therapy) and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. Stimulation of this nerve that supplies the multifidus muscle elicits contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Prostheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved and the Company commercially launched the ReActiv8 system in the summer of 2021.

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8® is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by their CLBP and the resulting days lost from work, disability benefits, and health resource utilization, exert a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstaymedical.com.

Neurent Medical Expands Leadership Team to Support Advancement of In-Office Chronic Rhinitis Treatment

New Hires Bring Significant ENT and Industry Experience

Neurent Medical, a company pioneering innovative treatments for chronic inflammatory sino-nasal diseases, today announced expansions of its leadership team. The hires bring deep medical device industry and ear, nose and throat-specific experience to the company that will support commercial advancement of Neurent’s proprietary NEUROMARK™ technology, an innovative in-office treatment for chronic rhinitis.

Key hires include:

• Declan Daly, Chief Financial Officer – Declan brings a wealth of financial leadership to Neurent Medical. As Chief Financial Officer of INAMED Corporation (NASDAQ: IMDC, acquired by Allergan plc) and Fibrocell Science Inc. (NYSE MKT: FCSC), he managed a $3.2 billion M&A transaction and raised in excess of $250 million in financing.

• Prasad Nalluri, Vice President of Strategic Marketing – Prasad has more than two decades of experience in commercializing ground-breaking ENT technologies, from pre-clinical stage through product launch and growth phases. He has held senior leadership roles in global marketing at large multinational organizations including Medtronic plc (NYSE: MDT) and Smith & Nephew plc (NYSE: SNN), and at ENT startups ENTrigue Surgical Inc. and Aerin Medical Inc.

• Brent Shreiner, Vice President of Sales – Brent brings extensive expertise in sales leadership serving the ENT industry and has been integral to the success of several medical device startups. Much of Brent’s recent experience consists of building and managing high-performing sales teams in the fast-growing ENT office channel. Brent previously held senior leadership roles with Arrinex Inc. (acquired by Stryker Corp.), Spirox Inc. (acquired by Entellus Medical Inc.), Intersect ENT Inc. (NASDAQ: XENT) and Access Closure Inc. (acquired by Cardinal Health Inc.).

Additional team members have recently joined the Neurent Medical leadership team to support the advancement of NEUROMARK and Neurent Medical’s rich R&D pipeline. These new team members will be integral to executing on the company’s vision to transform the treatment of inflammatory sino-nasal diseases.

“There are two vital components to a successful business: an innovative solution to an unmet need, and a motivated team that is focused on fulfilling that need,” said Brian Shields, CEO and co-founder of Neurent Medical. “Our technology carries potential to improve the quality of life for patients suffering from chronic rhinitis, and we are making significant strides in cultivating a team that will bring our innovation into the hands of clinicians. Declan, Prasad, Brent and the entire team at Neurent Medical are real change-makers in the industry, and I couldn’t be more honored to have some of the brightest industry experts supporting our mission.”

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sino-nasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK™ technology is the world’s first multi-point nerve disruption therapy for rhinitis. With a unique design and advanced algorithmic control, physicians can precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland. For more information visit www.neurentmedical.com.

Inotrem adds a new strategic asset to its immunotherapy anti-TREM-1 drug pipeline

Inotrem announces start of development and the filing of a patent for its new anti-TREM-1 monoclonal antibody to target chronic inflammatory diseases

Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today that it has filed a patent to protect a new therapeutic modality against TREM-1, a monoclonal antibody.

The filing of this monoclonal antibody patent is a significant milestone for Inotrem’s strategic development as it represents the company’s second asset, next to nangibotide, and a further diversification of its drug portfolio. Moreover, by modulating the activity of the TREM-1 pathway over extended periods of time, this therapeutic modality offers a new and promising alternative for the treatment of chronic inflammatory diseases.

TREM-1 is an immunoreceptor initially discovered for its role in the pathophysiology of acute inflammatory syndromes and in particular septic shock. Since its inception in 2013, Inotrem has introduced the therapeutic peptide nangibotide into the clinics for acute inflammatory syndromes secondary to severe infections. Two Phase IIB clinical trials are currently ongoing in septic shock and COVID-19 patients. Since its discovery in 2000, an increasing number of research work indicated the implication of the therapeutic target TREM-1 in not only acute inflammatory diseases but also in the development of chronic inflammation. Pioneering these approaches, Inotrem initiated in 2019 a proprietary research and discovery program to identify a new modality against TREM-1 in the form of a therapeutic monoclonal antibody, with pharmacological properties suitable for the management of chronic indications.

“Inotrem’s research team’s exceptional commitment is at the core of today’s success. Adding a monoclonal antibody to our therapeutic modalities targeting the TREM-1 pathway now allows us to expand our development efforts beyond the current acute indications to also address chronic inflammatory syndromes with a high unmet medical need” said Marc Derive, co-founder and Chief Scientific Officer of Inotrem.

“Today’s announcement constitutes a key advancement for Inotrem. This new patent application demonstrates the company’s ability to deploy its vision and strategy. Through its proprietary technology platform addressing inflammatory diseases, it has the potential to develop treatments in a wide number of inflammatory indications, both acute and now chronic, for which there are today no or limited specific treatment. We are looking forward to the clinical development progress of this new asset, with preclinical development slated to start later this year”, said Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder

Chronic inflammatory diseases are inflammatory-driven diseases of the digestive system, joints, skin, respiratory system, kidneys, and various other organs. Most of them have no cure, and new biologics have recently reached the market to target inflammation. But there are still a high number of non-responders to these innovative drugs, and therefore a very significant unmet medical need.

About Inotrem

Inotrem S.A. is an advanced clinical stage biotech company specialized in immunotherapy for inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with potential applications in a number of therapeutic indications such as septic shock and COVID-19. In parallel, Inotrem has launched a program to develop new therapeutic modalities targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. S bastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors. For more information please visit: www.inotrem.com

About TREM-1 pathway

TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction.

Media contact for Inotrem

Anne REIN
S&I
anne.rein@strategiesimage.com
+33 6 03 35 92 05

Inotrem announces positive outcome of interim futility analysis for its Phase IIB ASTONISH trial in septic shock patients to demonstrate nangibotide efficacy

• Independent Data Monitoring Committee recommends continuation of the trial with no changes.

• This milestone triggers the payment of the second tranche of €17M of the Series B financing.

Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today that the ASTONISH Independent Data Monitoring Committee (IDMC) completed the planned safety and efficacy assessment for futility of the company’s ongoing Phase IIB ASTONISH trial in septic shock patients.

The ASTONISH Phase IIB study aims at demonstrating safety and clinical efficacy of nangibotide in septic shock patients. It is a global, multicentric study conducted in 48 centers. Four hundred and fifty patients are planned to be enrolled in this study. The study compares the effect of nangibotide at two different doses versus standard of care. The futility analysis has been conducted on the first 225 patients enrolled. The primary endpoint for futility analysis was the delta SOFA score between the treatment groups and the standard of care/placebo group at day 5. A delta of 1 to 1.5 was observed in a previous Phase IIa trial in a subpopulation of septic shock patients with high concentration of soluble TREM-1, a mechanism-based biomarker. In addition, the ASTONISH study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment.

The IDMC’s decision marks a significant milestone for Inotrem’s development as it triggers the payment of the second tranche of 17 M€ of the Series B financing raised in 2020 from top-tier international investors.

“We are pleased with the IDMC's recommendation to continue the ASTONISH trial as it advances our understanding of the safety, tolerability and efficacy of nangibotide, our lead drug candidate, for septic shock patients. It is an important step toward establishing a potential new treatment for septic shock, a severe and often fatal condition for which there are currently no specific targeted therapies”, said Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder.

“We look forward to sharing updates from the ASTONISH trial in the coming months. The payment of this €17M tranche strengthens our strategic ability to move towards the completion of our the septic shock program as well as the active development of our drug pipeline in chronic inflammatory conditions”, said Sven Zimmermann, CEO of Inotrem.

Septic shock is the ultimate complication of sepsis and currently constitutes a high unmet medical need. It represents a significant economic burden for the European healthcare system. Recent works have also emphasized the health economic impact of long term patients’ outcomes; indeed 30% of septic shock survivors are re-hospitalized in the three months following a first shock and between 20% and 30% have long term morbidities at twelve months. The incidence of septic shock is bound to increase as the population ages, leading to a rise in ICU admissions. Elderly patients are predisposed to septic shock due to existing co-morbidities, repeated and prolonged hospitalizations, reduced immunity, functional limitations and as well as the effects of aging itself. Europe is therefore poised to see a continuous rise in septic shock in the coming decades. We estimate that by 2025 the incidence of septic shock in Europe will be as high as 500,000 cases leading to 150,000 deaths per year. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic treatment. Inotrem’s solution is based on a novel approach of immunomodulation which targets the TREM-1 pathway: a crucial mediator of the septic shock and has the potential to become the first mechanism-based treatment for septic shock.

About Inotrem

Inotrem S.A. is an advanced clinical stage biotech company specialized in immunotherapy for inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with potential applications in a number of therapeutic indications such as septic shock and COVID-19. In parallel, Inotrem has launched a program to develop new therapeutic modalities targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors. For more information please visit: www.inotrem.com

Media contact for Inotrem

Anne REIN
S&I
anne.rein@strategiesimage.com
+33 6 03 35 92 05

Vivasure Medical Begins Clinical Evaluation of Next-Generation PerQseal+ Device

Vivasure Medical® today announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal®+, the next generation of the company’s PerQseal® device.

The patient was enrolled by Dr. Fernando Gatto, head of cardiac catheter labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany and investigator of the study. The study will evaluate the company’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies.

The company’s PerQseal device is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), that require large-bore vessel access. The enhanced PerQseal+ device is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore closure.

“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” said Dr. Gatto. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”

“The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large bore closure,” said Dr. Christian Frerker, head of structural heart disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, and principal investigator of the Frontier V study. “This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”

“Enrolling the first patient in the Frontier V study is an exciting milestone in Vivasure’s mission to ensure success for percutaneous cardiovascular therapies,” said Andrew Glass, CEO of Vivasure. “The original PerQseal device has been well-received by clinicians since it became available in Europe because it helps address the complications and risks associated with access-site management for large-bore procedures. The enhanced PerQseal+ device promises to build on that success by enabling even better patient outcomes.”

Inotrem bolsters leadership team with the appointment of Sven Zimmermann as new CEO

Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today the appointment of Sven Zimmermann as Chief Executive Officer, effective April 19th, 2021. Sven brings an extensive leadership experience in biotech companies’ financial and corporate strategy.

Jean-Jacques Garaud, who co-founded Inotrem and successfully led the company over the last 6 years, will continue to play a key role in the development of the company as Executive VP, Head of Scientific and Medical Affairs.

Prior to joining Inotrem, Sven served as Chief Financial Officer at MetrioPharm, a Swiss biopharmaceutical company. He benefits from a wide-ranging international experience in corporate finance, M&A and private and public fund raisings. He has been involved in several recent exits such as Novimmune’s asset sale to Swedish Orphan Biovitrum, Auris Medical’s IPO on Nasdaq as well as the acquisition of PregLem by Gedeon Richter. Prior to this, Sven worked for UBS Investment Bank and holds a PhD in molecular biology from the University of Zurich.

“We are excited that Sven is coming onboard. He brings a broad set of experiences in the development of advanced clinical biotech companies. With his successful financial and corporate strategy track record, and his deep understanding of the immunomodulation field, he has the ideal profile to lead Inotrem’s next phase of strategic growth,” says Thierry Hercend, Chairman of the Board of Directors at Inotrem.

“I am delighted to have been given the opportunity to lead Inotrem through its next growth phase. Its concept of immunomodulation targeting the TREM-1 pathway to control unbalanced inflammatory responses is very innovative and allows for potential treatments for many indications. I am also looking forward to work with Jean-Jacques Garaud as a visionary co-founder and Inotrem’s talented team to bring targeted therapeutic solutions to patients with inflammatory diseases, both acute as well as chronic,” says Sven Zimmermann.

“Over the past few years, the team has accomplished a remarkable work. Thanks to its dedication, the company achieved numerous milestones and successfully diversified its portfolio focused on the role of the TREM-1 pathway in innate and also adaptive immunity. Today, Inotrem is in an extremely favorable position as it engages its next stage of growth focusing on product development and making regulatory advances. I look forward to contributing to Inotrem’s continued success” says Jean-Jacques Garaud.

Based in Paris with a Research Center in Nancy, Inotrem today employs 20 people with the support of leading European and North American investors. Its lead product candidate, nangibotide, currently undergoes two Phase II clinical trials. One is the Phase IIb ASTONISH trial 450 in Patients with Septic Shock being performed in 50 clinical sites in Europe and the US. The second Phase II trial with nangibotide targets the severe forms of COVID-19 in initially 60 patients in 7 sites globally. The latter was declared “National Priority Research” by the French government. In addition, Inotrem is also developing an antibody program for chronic inflammatory diseases and immuno-oncology applications. Moreover, the company has secured a strategic licensing agreement with Roche Diagnostic for a companion diagnostics test to stratify septic shock patients. Inotrem was recently chosen for the second year in a row, to join the French Tech 120, a government program dedicated to support the development of fast-growing startups.

About Inotrem

Inotrem S.A. is an advanced clinical stage biotech company specialized in immunotherapy for inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with potential applications in a number of therapeutic indications such as septic shock and COVID-19. In parallel, Inotrem has launched a program to develop new therapeutic modalities targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors.

For more information please visit: www.inotrem.com

Media contact for Inotrem

Anne REIN
Strategies & Image (S&I)
anne.rein@strategiesimage.com
+33 6 03 35 92 05

XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease

• Company closes additional $22.6 million in new financing 

• Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery 

XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for the significant unmet patient needs in advanced coronary artery disease, today announced the closing of an additional $22.6 million financing. Fountain Healthcare Partners led the oversubscribed financing joined by new investors Longwood Fund and Lumira Ventures. All existing institutional investors including Sofinnova Investments and LSP (Life Sciences Partners) participated in the financing. The additional financing builds upon XyloCor’s 2018 Series A financing round, bringing total investment in the company to $41.9 million to date. XyloCor’s lead product candidate, XC001, is an investigational gene therapy currently being studied in a Phase 1/2 clinical trial (EXACT) for patients with refractory angina, a chronic condition for which there are no treatment options.

The financing will enable XyloCor to expand its clinical development program for XC001, including the initiation of a new trial of XC001 as a potential adjunctive therapy to augment the effectiveness of coronary artery bypass graft surgery (CABG). XyloCor is at the forefront of scientific research and clinical study in the application of gene therapy to address vast unmet treatment needs in large patient populations with cardiovascular disease. In both its initial potential indication in refractory angina, and as an adjunctive therapy for patients undergoing CABG, XC001 represents a novel therapeutic approach.

“We greatly appreciate the recognition by Fountain Healthcare Partners, Longwood Fund, and Lumira Ventures of the value we have created since our initial funding and in XC001’s enormous potential for improving the lives of patients with advanced coronary disease,” said Al Gianchetti, president and chief executive officer of XyloCor Therapeutics. “With the support of our investors, we can build on the progress we have made since our initial funding to pursue, with a sense of urgency, new clinical indications where XC001 has promise for addressing unmet medical needs.”

“XyloCor has created significant value with XC001 with the progress the team has achieved on clinical and CMC milestones. Based on our experience, excellence on both fronts is critical to success in the gene therapy field,” said Aidan King, managing partner and co-founder, Fountain Healthcare Partners, who also joined XyloCor’s board of directors. “We are gratified that this additional capital accelerates XC001’s development and expands its potential impact to the significant unmet need among CABG patients who are at high risk for incomplete revascularization.”

Board of Directors Additions

Joining Mr. King as a member of the XyloCor board of directors is Daniel Hétu, M.D., managing director, Lumira Ventures, and Perry Nisen, M.D., Ph.D., executive partner, Sofinnova Investments. Alan Colowick, M.D., MPH, will now serve an independent board member of XyloCor.

About XC001

XC001 is an investigational gene therapy designed to promote the growth of new blood vessels in the heart, with these new blood vessels bypassing diseased blood vessels and improving blood flow in the heart. XC001 deposits the gene for vascular endothelial growth factor (VEGF) in targeted heart cells. VEGF is a naturally occurring protein and it is believed that XC001 enables the heart cells to produce more VEGF, thus stimulating the creation of new blood vessels, a process called angiogenesis. XC001 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for study in refractory angina. An Investigational New Drug (IND) application for XC001 is open with the FDA. XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina in 2020.

The EXACT Trial

The EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial. Approximately 12 subjects (n=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion phase of the trial with 21 additional subjects at the highest tolerated dose. The trial is designed to assess the safety and efficacy of XC001. The investigational gene therapy will be administered directly to the muscle tissue of the heart by an experienced cardiac surgeon. The EXACT Trial was initiated in 2020 and is ongoing at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

Chronic angina pectoris occurs when the heart muscle does not receive as much oxygen as it needs for the amount of work it is performing, and this often results in chest pain. This is usually due to coronary artery disease. Patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and CABG have refractory angina and currently have no treatment options. These patients often become sedentary because of their symptoms, which in turn can exacerbate comorbidities and severely impact quality of life causing further deterioration of their health status. An estimated one million people suffer from refractory angina in the United States.

About Coronary Artery Bypass Graft Surgery (CABG)

CABG is a procedure used to treat coronary artery disease – the narrowing or blockage of the blood vessels that supply oxygen and nutrients to the heart muscle. During CABG, a healthy artery or vein from the body is connected, or grafted, to the blocked coronary artery. The grafted artery or vein bypasses the blocked portion of the coronary artery. This creates a new passage, and oxygen-rich blood is routed around the blockage to the heart muscle. Approximately 500,000 CABG procedures are performed annually in the United States, in which an estimated one-third of patients are at risk for incomplete coronary revascularization, often resulting in persistent angina. An adjunctive treatment to CABG, such as gene therapy with XC001, may reduce the incidence of incomplete revascularization.

About XyloCor

XyloCor Therapeutics is a biopharmaceutical company focused on the development of novel gene therapy for unmet needs in advanced coronary artery disease. In the United States, coronary artery disease is a leading cause of death and disability. The company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor also has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact:

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

Mainstay Medical Announces Commercial Launch of ReActiv8® in Australia

Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced the commercial launch in Australia of ReActiv8®, its implantable neurostimulation system to treat chronic low back pain.

“Launching ReActiv8, our Restorative Neurostimulation therapy, commercially in Australia is a significant milestone for our global commercial expansion. Several top Australian physicians have been part of our clinical studies since inception and are among the most experienced globally in selecting and treating patients with ReActiv8. We are excited to make ReActiv8 commercially available to Australian physicians and their patients suffering from mechanical chronic low back pain,” said Jason Hannon, CEO of Mainstay.

The first commercial ReActiv8 implant in Australia was conducted by Associate Professor Bruce Mitchell, Sports and Interventional Pain Physician and Director of Metro Pain Group in Melbourne, Australia.

“Having been involved in both the ReActiv8-A and -B Clinical Trials, I am excited to be able to expand this restorative therapy to other patients in my practice. The launch in Australia is a great milestone for ReActiv8 and, ultimately, the patients that suffer from chronic mechanical low back pain who now have a new treatment option,” said Associate Professor Bruce Mitchell.

About ReActiv8

ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. Stimulation of this nerve that supplies the multifidus muscle elicits contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

The ReActiv8 Restorative Neurostimulation therapy has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved and the Company plans to commercially launch in early 2021.

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety, and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry, and governments.

About Mainstay

Mainstay is a medical device company focused on commercializing an innovative implantable Restorative Neurostimulation system, ReActiv8®, for people with disabling mechanical chronic low back pain (“CLBP”). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstay-medical.com

Mainstay Medical Announces US$108 Million Equity Financing Transaction

Funding to support U.S. commercial launch and global expansion

Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced the closing of an equity financing in which it raised gross proceeds of US$108 million. Mainstay intends to use the funds to support the company’s commercial launch of ReActiv8® in the U.S., continued expansion in Europe and Australia, additional post-market clinical studies and research, and general operations.

The financing was co-led by new investors Ally Bridge Group and Sofinnova Partners, through its Crossover Fund, and also included a large, global medical device company. Key existing investors who participated in the financing include Sofinnova Partners (Capital Fund), KCK Group and Fountain Healthcare Partners.

Jason Hannon, CEO of Mainstay, commented: “A financing of this magnitude, supported by such a quality global investor group, is testament to the confidence in the commercial opportunity for ReActiv8. We are now strongly capitalized to execute on our corporate objectives in 2021 and beyond, including the launch of ReActiv8 in the U.S. market and acceleration of our commercialization efforts in Europe and Australia.”

“This is an exciting time for Mainstay as they bring to market a restorative therapeutic option for patients suffering from disabling chronic low back pain,” said Charles Chon, Partner and Managing Director at Ally Bridge Group, who also joins the Mainstay Medical Board of Directors. “We commend the Company on all the progress it has achieved to-date and look forward to supporting it going forward.”

Cédric Moreau, Partner at Sofinnova Partners, who also joins the Company’s Board of Directors, commented: “We are thrilled to co-lead such a strong syndicate of investors in fuelling Mainstay’s commercial acceleration to make its first-in-class neurostimulation technology available in the U.S. and more extensively worldwide.”

An extraordinary general meeting of Mainstay shareholders was held on 9 February 2021 to approve the financing and related matters. At the EGM, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

About Mainstay

Mainstay is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling mechanical Chronic Low Back Pain (“CLBP”). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States, Australia, Germany and the Netherlands.

About ReActiv8

ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the multifidus muscle to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved and the Company plans to commercially launch in early 2021.

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s plans to commercialize ReActiv8 in the United States, the U.K., Australia and elsewhere; the commercial performance of ReActiv8; and the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration and other commercial performance.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance, and actual results may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if future results and developments are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements, including, without limitation, the successful launch and commercialization of ReActiv8, general economic and business conditions, global medical device market conditions, industry trends, competition, the availability and cost of capital, changes in law or regulation, changes in taxation regimes, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, and political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Syndesi Therapeutics Announces Positive Results From Two Additional Phase I Studies Of Its Novel SV2A modulator SDI-118

Provides strong support for the initiation of further clinical trials in cognitive impairment

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, announces results from two Phase I studies of its lead compound SDI-118, supporting further development of this promising molecule.

Results from a multiple ascending dose study demonstrated SDI-118 was safe and well tolerated over 14 days dosing in both young and elderly male and female participants. The highest dose tested is calculated to result in greater than 95% SV2A occupancy. Furthermore, the compound showed a very favourable pharmacokinetic profile and is suitable for once-daily dosing.

The second Phase I study investigated the effects of single doses of SDI-118 on electroencephalogram (EEG) recordings of brain activity in healthy young volunteers. The compound produced a unique profile of changes in quantitative EEG relative frequency power, consistent with the novel mechanism of action. These functional data complement the PET target engagement data generated in the first-in-human clinical study previously conducted. SDI-118 was also shown to be safe and well tolerated in this study.

The company is now preparing two further clinical studies of SDI-118 in two groups of subjects. One study will recruit participants in remission from major depressive disorder reporting cognitive impairment. The second study will recruit elderly subjects with evidence of cognitive decline. Both studies will employ fMRI imaging in addition to cognitive testing to explore the effect of SDI-118 on the cognitive deficits seen in these populations. These studies are planned to commence during H1 2021.

Commenting on the Phase I results and further clinical development plan for SDI-118, Jonathan Savidge CEO of Syndesi said “These clinical study results are very promising and provide an excellent basis for the further development of SDI-118. We look forward to commencing the two proof-of-principle clinical studies in different populations of subjects reporting a cognitive deficit with the aim to explore the therapeutic potential of SDI-118 as broadly as possible.”

About Syndesi Therapeutics

Syndesi Therapeutics is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. Synaptic dysfunction, with the consequent disruption of connectivity between brain regions, underlies cognitive impairment seen in multiple CNS disorders, including Alzheimer’s Disease and schizophrenia. There is a major unmet need for new therapies that can improve cognitive function across these various CNS disorders. Unlike other therapeutic approaches, our unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A) which plays a central role in regulating synaptic transmission. The lead molecule, SDI-118, has successfully completed three Phase I studies including PET target engagement and biomarker measures.

The company is financed by a syndicate of international and Belgian investors: Novo Holdings, Fountain Healthcare, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. The Phase I program has been supported in part by funding from the Walloon Region.

Mainstay Medical Announces Key Strategic Hires to Drive Global Commercial Expansion

Appointments to support upcoming commercial launch of ReActiv8® in the U.S. and foster further growth in Europe and Australia

Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced recent senior leadership additions as part of its global commercial strategy. These include: Elias Tu as Vice President of U.S. Sales; Derek Matteo as Vice President of Marketing; James Knibbs as Vice President of UK, Ireland, and Australia; Boris Deutschmann as Country Manager for Germany; Chip Moebus as Vice President of Reimbursement and Market Access; Richard Herman as Vice President of Operations; and Celia Reyes as Vice President of Human Resources.

“We continue to demonstrate the clinical value ReActiv8 brings to patients and are preparing to expand the availability of this compelling therapy in multiple countries. Each of these individuals brings incredible leadership and experience to help build our commercial capabilities, expand in our existing markets, and launch in the U.S.,” commented Jason Hannon, CEO of Mainstay. “Each of them is experienced in bringing disruptive new technologies to the market and will help us deliver ReActiv8 to patients suffering from mechanical chronic low back pain and the physicians treating this condition. Collectively they complement the existing strong leadership we already have and will leverage the deep history of clinical and scientific leadership we’ve developed.”

Appointee Biographies:

Prior to his new role at Mainstay, Elias Tu served as global commercial leader in the neurology division at Philips Healthcare. He also has over 13 years of sales experience at LivaNova, a medical device company specializing in devices used for cardiac surgery and neuromodulation. From 2016 to 2019, Mr. Tu served as Vice President of Sales for Neuromodulation in North America at LivaNova where he attained $350 million in annual sales.

Since 2008, Derek Matteo has led Global Marketing and Global Commercial Development teams in the Orthopedic and Spine healthcare industry. Most recently while at NuVasive, he served as Vice President of Global Technology Commercialization, scaling new innovations in the United States, Latin America, Europe, Australia, and across Asia.

James Knibbs brings extensive experience in sales leadership in implantable devices. He was a Territory Sales Manager at Stryker Instruments, followed by several roles over approximately nine years at Nevro. At Nevro, he rose from Business Development Manager for North UK to UK Country Manager, and ended his time there as Senior Area Director for Western Europe.

Boris Deutschmann possesses over 10 years of experience in the Neuromodulation sector. Previously, he worked at Nevro for over six years, spending the latter part of his time there as Country Manager for Germany and Austria.

Chip Moebus has been in the health care industry for over 20 years serving in multiple roles ranging from field sales leadership to leading teams focused on managed markets and health economics at both Medtronic and Senseonics. Before joining Mainstay Medical, he was part of the senior leadership team at Senseonics where he led commercial and Medicare coverage and payment strategy and execution for the first implantable continuous glucose monitor in the US market.

With over 20 years of field experience in operations management, Richard Herman contributes broad expertise that will be essential for the expansion of operational activities at Mainstay. Previously, he served as Vice President of Global Operational Excellence at Smith & Nephew, a British multinational medical device company. Mr. Herman previously held the position of Senior Director Lean Enterprise of Global Operations at Alere, Inc., a global manufacturer of rapid point-of-care diagnostic tests.

Celia Reyes possesses extensive global Human Resources experience and knowledge in the Life Sciences industry. She served as Executive Human Resources Director at Acadia Pharmaceuticals, Inc., and previously worked as Executive Vice President of Human Resources at Biotix Holdings Inc., as well as other key human resources positions at Millipore Sigma, Roche, and Solvay Pharmaceuticals.

About Mainstay Medical Holdings

Mainstay Medical Holdings is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling mechanical Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

About ReActiv8

ReActiv8 is an active implantable medical device designed to treat adults with intractable chronic low back pain associated with dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low back, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery. ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the multifidus muscle to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved and the Company plans to commercially launch in early 2021.

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com.

Contacts

PR and IR Enquiries:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Email: mainstay@fticonsulting.com

The Ruth Group
Annika Parrish
Tel: +1 (720) 412-9042
Email: aparrish@theruthgroup.com

Neurent Medical Closes $25 Million Series B Funding to Advance Innovative Chronic Rhinitis Treatment

Company Prepares for Commercialization of Revolutionary In-Office Therapy

Galway, Ireland – Neurent Medical, a company pioneering innovative treatments for chronic inflammatory sino-nasal diseases, today announced it has closed a $25 million Series B financing. The round was led by new investor LSP, from its LSP HEF-2 fund, and co-led by Atlantic Bridge, investing from its Growth Fund IV. Fountain Healthcare Partners also participated as a returning investor with strong participation in the round.

The financing will support the expansion of the company’s clinical and commercial operations as it prepares for U.S. Food and Drug Administration (FDA) clearance and U.S. commercialization of its proprietary NEUROMARK™ Rhinitis Neurolysis Therapy™, an innovative in-office treatment for chronic rhinitis.

Approximately one in four Americans suffer from chronic rhinitis, a common condition that results in persistent symptoms including congestion, rhinorrhea, sneezing and nasal itching. Chronic rhinitis significantly decreases quality of life and can have an adverse effect on sleep quality, mood and daily activities.

The traditional rhinitis patient journey is often full of frustration due to limited treatment options. Many chronic rhinitis patients are treated with a combination of continuously prescribed medications including steroid sprays, decongestant sprays, and oral or nasal antihistamines, with varying and limited effectiveness. In addition to the significant expense, excessive use of these remedies can cause issues such as damage to nasal and bodily tissues, medication dependencies and exacerbated symptoms. Invasive surgical procedures and existing in-office interventions provide mixed outcomes for patients, along with the potential for post-operative complications and pain.

Neurent Medical’s proprietary Rhinitis Neurolysis Therapy is a revolutionary treatment option for chronic rhinitis designed to comfortably and safely disrupt hyperactive parasympathetic nerves that drive the underlying inflammation. The NEUROMARK™ System’s unique design, biofeedback monitoring features and advanced algorithmic controls enable the physician to simultaneously treat multiple nerve branches with a high degree of precision, safety and patient comfort.

“We are grateful for the financial support of this group of highly regarded investors, which will enable us to transition to an international commercial-stage company,” said Neurent Medical CEO and Co-Founder Brian Shields. “Our technology has the potential to provide an effective, safe and comfortable in-office treatment solution to alleviate the burdensome symptoms of chronic rhinitis, and we are excited that this funding brings us a step closer to offering it to clinicians and patients.”

“We are dedicated to nurturing and growing companies with the potential to have a meaningful impact on society, and Neurent Medical is aligned with this mission,” said Drew Burdon, Investment Manager at LSP. “The company, with its strong team and pioneering technology, is well-placed to succeed in making a significant difference for the millions of people suffering with chronic rhinitis.”

As part of this transaction Drew Burdon of LSP and Gerry Maguire, General Partner, Atlantic Bridge, will join Neurent Medical’s Board of Directors.

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sino-nasal diseases by targeting and safely disrupting hyperactive parasympathetic nerves that drive underlying inflammation. Its proprietary NEUROMARK™ Rhinitis Neurolysis Therapy™

is the world’s first multi-point nerve disruption therapy for rhinitis. With a unique design and advanced algorithmic control, physicians can precisely target and safely treat multiple underlying nerve branches in a single procedure to alleviate symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland. For more information visit www.neurentmedical.com.

About LSP

LSP is one of the largest European investment firms providing financing for life sciences and health care companies. LSP’s management has raised over €2 billion ($2.3 billion) and developed more than 120 companies since it started to invest in 1988. With offices in Amsterdam, Munich, and Boston, LSP currently has the possibility to invest from three funds, each having a distinctive investment scope and a dedicated team: LSP 6 invests in private early- to late-stage drug development and medical technology companies; LSP HEF 2 focuses on private late-stage medical technology companies with a health and economic benefit; and LSP Public targets public healthcare companies. Among LSP’s signature deals are argenx, Crucell, KuDOS, Movetis, Neuravi, Okairos, Prosensa, Qiagen and Zealand Pharma. In addition, LSP is an active contributor to the life sciences industry through roles as founder and board member of the Oncode Institute, initiator of the Dutch Venture Initiative (DVI), as well as board member of European venture capital associations, technology transfer institutes and government bodies. For more information: lspvc.com.

Media Contact

Health+Commerce
Jessica Stebing
260.336.6202
jstebing@healthandcommerce.com