Vivasure Announces Positive Results of PATCH IDE Pivotal Study Indicating Safety and Efficacy of PerQseal® Large Hole Closure Device

• Data from U.S. IDE PATCH Pivotal Study presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference will support a pre-market approval submission to the FDA

• Results demonstrate Vivasure’s PerQseal® Closure Device achieved closure with very low rates of major vascular complications and rapid times to hemostasis

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced initial positive results from its U.S. IDE PATCH Pivotal Study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System, at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual conference in Washington, D.C.

The Vivasure PerQseal® Closure Device System (PerQSeal) is the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures, and is an alternative to the use of suture- or collagen-based closure devices. It is used for large hole arterial access and is needed for a variety of procedures including transcatheter aortic valve replacement (TAVR) and numerous other large hole cardiovascular procedures. The goal of the device is to reduce vascular complications while simplifying the closure.

Vivasure’s U.S. IDE PATCH Clinical Study, a multi-center, single-arm, pivotal study, enrolled over 145 patients across 17 U.S. and European investigational sites and evaluated the safety and efficacy of PerQseal when used to achieve hemostasis of common femoral arteriotomies created by 12 to 22F sheaths (arteriotomies up to 26F) in subjects undergoing percutaneous catheter-based interventional procedures.

Data presented at TCT show an impressively low 0.8% Valve Academic Research Consortium 3 (VARC-3) major complication rate at discharge in 124 patients included in the study’s primary intention-to-treat analysis. Times to hemostasis following percutaneous procedures were rapid, with a median time of zero minutes.

“Complications from large hole vascular closure remain vexing, impacting patients and requiring additional time and resources. As interventionalists, we need new technologies to improve both outcomes and procedural efficiency,” said William A. Gray, MD, principal investigator of the PATCH study and system chief in the division of cardiovascular disease at Main Line Health, Philadelphia. “The PATCH study results presented today show real promise for the PerQseal technology and positions it to meaningfully improve patient care.”

“We are addressing an unmet need in the market by delivering the first sutureless, fully absorbable synthetic implement for large-bore vessel punctures that, for the first time, delivers a minimally invasive approach to conventional venous closure,” explained Andrew Glass, CEO, Vivasure Medical. “The results from our U.S. pivotal study, as well as the previous PerQseal studies, indicate that the PerQseal System is safe and effective for patients around the globe.”

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® is not available for sale in the United States.

Mainstay Medical Announces New ICD-10 Diagnosis Code for Multifidus Dysfunction

Mainstay Medical today announced that the United States Centers for Disease Control and Prevention (CDC) has designated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code specifically for multifidus dysfunction in the low back. The new diagnosis code – M62.85: dysfunction of the multifidus muscles, lumbar region – went into effect on October 1, 2024.

In response to an acute injury in the low back, the brain typically reduces the neural drive that activates the multifidus muscle, resulting in reduced multifidus activity. Because the multifidus muscle is a primary stabilizer of the lumbar spine, this inhibition can lead to joint instability and overload, exacerbating the problem and contributing to chronic low back pain (CLBP). The ReActiv8® Restorative Neurostimulation™ system is designed to provide electrical stimulation to the nerves activating the multifidus muscle, aid in restoring its function and facilitate recovery from CLBP. ReActiv8 is the only FDA-approved treatment for the management of intractable CLBP associated with multifidus muscle dysfunction.

“The CDC has recognized multifidus muscle dysfunction as a prominent cause of CLBP and is now providing clinicians a clearer pathway to specifically diagnose this condition. Multifidus dysfunction is a highly specific disease state that does not respond to palliative forms of stimulation, and we are excited that this new code provides for clear reflection of the underlying disease state,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

NEUROMARK® Treatment for Chronic Rhinitis Yields Significant Clinical Improvements

• PARAGON Study Shows NEUROMARK® Treatment Benefits Allergic and Nonallergic Rhinitis Patients

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced the publication of positive six-month results from the PARAGON clinical study in Ear, Nose & Throat Journal. The study demonstrates that treatment with Neurent Medical's NEUROMARK® System, a radiofrequency ablation device indicated for chronic rhinitis, led to significant improvements in rhinitis symptoms, ear symptoms, and quality of life.

The PARAGON Study, a prospective, multicenter, singe-arm trial, enrolled 80 participants. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). Subgroup analyses were performed for participants with allergic and nonallergic rhinitis.

Key Efficacy Findings:

• The primary endpoint was met with a statistically significant improvement from baseline to 6 months in the rTNSS (p < .0001).

• 91% or participants achieved the minimal clinically important difference (MCID) of ≥1 point improvement in the rTNSS at 6 months.

• The ETDQ-7 score, which measures ear pressure, ear pain, clogged ears, ear problems with cold/sinusitis, crackling/popping, ringing in ears, and muffled hearing, was significantly improved at 6 months (p < .0001).

• The total NOSE score and all 5 subscores were significantly improved at all time points (p < .0001).

• The overall mini-RQLQ score and all domain scores demonstrated significant improvement at all follow-ups (p < .0001).

• Both allergic and nonallergic subgroups showed significant improvement in all outcome measures (rTNSS, ETDQ-7, NOSE, and mini-RQLQ) (p < .001), with no significant differences between subgroups.

Lead investigator, Dr. Greg Davis said, "This study provides significant evidence that the NEUROMARK System dramatically improves the symptoms of chronic rhinitis, especially runny nose and nasal congestion." He continued, "In addition, one of the exciting benefits of NEUROMARK, is that this procedure improves ear symptoms associated with Eustachian tube dysfunction. This is the first study to show that neuromodulation of the posterior nasal nerve improves these symptoms. I am proud of the research team and co-investigators, and look forward to seeing our long-term data in the future."

"We are very pleased with the results from the PARAGON study, which underscore the effectiveness of our NEUROMARK System in providing significant relief for patients suffering from chronic rhinitis, including patients with both allergic and nonallergic rhinitis" said Brian Shields, CEO of Neurent Medical. "This data reinforces our commitment to developing innovative, minimally invasive solutions that enhance patients' quality of life and address the growing need for more effective treatments for chronic sinonasal diseases."

The NEUROMARK® System is a groundbreaking, minimally invasive treatment option designed to target the underlying drivers of chronic rhinitis. With these promising clinical outcomes, Neurent Medical continues to pave the way for non-surgical interventions in sinonasal care.

For more information about the PARAGON study the full publication can be accessed online at: https://journals.sagepub.com/doi/epub/10.1177/01455613241285134

About the NEUROMARK® System

The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radio frequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The system is engineered to gently apply controlled low-power RF energy to target regions of the nasal cavity to disrupt the parasympathetic nerve signals in order to reduce the inflammatory response, thereby reducing core symptoms such as congestion and rhinorrhea.

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neurentmedical.com.

Lenire Controlled Clinical Trial Results Published in Nature Communications

• FDA approval for the groundbreaking tinnitus treatment device, Lenire, was granted in March 2023 based on the success of the device’s large-scale controlled clinical trial, TENT-A3.1

• TENT-A3 demonstrated that Lenire is more effective at providing relief from bothersome tinnitus than sound therapy alone, which was the trial’s control.

• No device-related serious adverse events were detected during TENT-A3.1

• 88.6% of participants stated they would recommend Lenire to treat tinnitus.1

• Lenire is available through specialized clinics in the United States of America and Europe. Further details about Lenire® can be found at www.lenire.com.

Nature Communications has published the peer-reviewed results of Neuromod Devices’ TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial for the first and only FDA-Approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper titled: Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial, were central to Lenire’s successful De Novo US FDA Grant approval.

Published TENT-A3 Paper: Nature Communications

Lenire is a bimodal neuromodulation device which has been shown to provide relief from tinnitus that can sustain for at least 12-months after treatment in large-scale clinical trials.2,3 Lenire’s bimodal neuromodulation pairs mild electrical pulses to the tongue through an intra-oral component called the Tonguetip® with auditory stimulation through headphones.

TENT-A3 – Lenire Controlled Clinical Trial Design

TENT-A3, Neuromod’s third large-scale clinical trial for Lenire, was a controlled trial. The controlled trial was conducted as part of Lenire’s De Novo submission to the US FDA at three independent sites between March and October 2022 with 112 enrolled participants.

TENT-A3 compared Lenire’s bimodal neuromodulation mechanism to sound therapy. The trial was designed and executed with guidance from the US FDA. Participants were given six weeks of sound-only stimulation as a control condition, followed by six weeks of bimodal treatment where tongue stimulation was added to the sound component.

As part of Lenire’s successful De Novo submission, Neuromod was required to demonstrate that Lenire’s bimodal neuromodulation provided additional clinically significant benefit for tinnitus when compared to sound-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to sound-only stimulation for the majority of patients with moderate or worse tinnitus.

TENT-A3 Clinical Trial Results

Clinical trial data from Lenire’s De Novo submission further showed that 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.5,7

The majority of participants with moderate or worse tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.1,5

Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated at least 25 million Americans6 are currently living with the condition. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 2023.4

“Tinnitus is the largest unmet need in hearing healthcare,” said Neuromod Founding CEO, Dr. Ross O’Neill Ph.D., “Historically, tinnitus patients have been disappointed and frustrated by products that are neither backed by compelling clinical evidence, nor cleared by regulatory authorities. With the success of TENT-A3 and the first-of-its-kind De Novo FDA-Approval, Lenire is the only tinnitus treatment backed by multiple large-scale clinical trials and approved by the US Food and Drug Administration.”

Lenire – A Category-Defining Tinnitus Intervention

In addition to the majority of participants benefitting from bimodal neuromodulation, 82.4% were compliant to bimodal treatment and 88.6% responded that they would recommend Lenire as a tinnitus treatment1.

“Lenire’s FDA Approval combined with the rigorous design of the device’s controlled clinical trial were compelling factors when choosing to add Lenire to the treatment options at my clinic. said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University. “Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results.”

The positive efficacy, compliance, and safety findings for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire’s successful De Novo submission to the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire proved to be inherently safe with zero device-related serious adverse events1. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.2,3

“The TENT-A3 controlled clinical trial was properly designed with expert guidance from the US FDA.” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D., “This interactive collaboration enabled the success of Lenire’s De Novo FDA approval, which has further established Lenire as a category-defining tinnitus intervention.”

References and Notes

1. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)

2. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

3. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

4. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/

5. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories. https://www.nidcd.nih.gov/health/tinnitus

6. https://www.nidcd.nih.gov/health/tinnitus

7. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)

MMI Completes World’s First Robotic Preclinical Study in Neurosurgery with Symani® Surgical System

First-of-its-kind procedure a breakthrough in expanding robotic capability to complex neurosurgical care

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced the completion of a preclinical study that demonstrated the feasibility of the Symani® Surgical System in neurosurgical procedures. Adnan Siddiqui, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of the Jacobs Institute and Vice Chair and Professor of Neurosurgery in the Jacobs School of Medicine and Biomedical Sciences, successfully repaired a blood vessel in the brain in an animal model using the Symani Surgical System, the first such robotic-assisted microsurgery demonstration in the brain.

“Dr. Siddiqui’s breakthrough demonstration showed the benefits of robotic precision and control when operating on brain tissue,” said Mark Toland, CEO of MMI. “The robotic platform allowed him to perform extremely delicate maneuvers deep in the skull cavity that would not have been possible with the human hand alone. The success of this procedure opens the possibility of expanding Symani’s reach into neurosurgery, a field of medicine that involves the most fragile anatomy and has yet to benefit from robotic-assisted microsurgical capabilities.”

The study aimed to both collect feedback on Symani from a highly experienced neurosurgeon and assess the feasibility of the platform as a tool to treat neurological conditions. It was performed at the Jacobs Institute, a nonprofit medical device innovation center located in Buffalo, N.Y., which aims to accelerate the development of next-generation technologies in vascular medicine.

“Symani offered added control that allowed me to access and repair a vein just under 1 millimeter in diameter, with clips spaced 4 millimeters apart,” said Dr. Siddiqui. “It required techniques that would be extraordinarily difficult for most micro-neurosurgeons to replicate without robotic assistance, using sutures so small they are barely visible to the naked eye. Based on this excellent initial experience, I have no doubt Symani could be highly effective during a wide range of complex neurosurgical procedures with the development of additional microsurgical tools. In fact, I believe it is ready for superficial temporal to middle cerebral artery bypass surgery today.”

The Symani Surgical System is designed to provide enhanced precision and control for the anastomosis and suturing of microscopic vessels with the thinnest available sutures. With the world’s smallest surgical robotic wrist, called NanoWrist®, Symani enables surgeons to replicate the natural movements of the human hand at the micro scale. It also features motion-scaling technology that reduces the hand’s scale of movement by as much as 20x, giving surgeons more freedom to operate on microscopic anatomy.

Surgeons have leveraged the Symani Surgical System in over 1,000 cases globally and more than two dozen publications highlight positive clinical outcomes. It is designed to help restore quality of life for patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the Symani Surgical System in April 2024, making it the only commercially available platform in the U.S. for reconstructive microsurgery. It is available for commercial use in Europe and parts of Asia Pacific.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe and APAC, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

About the Jacobs Institute

The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next-generation technologies for vascular and neurologic diseases through collisions of physicians, engineers, entrepreneurs, and industry. The JI’s vision is to improve the treatment of vascular and neurologic disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University of Buffalo (UB), Kaleida Health, and industry to be a fitting tribute to the work and memory of Lawrence D. Jacobs, MD. Additionally, the JI’s i2R, or Idea to Reality Center, is taking ideas for vascular and neurologic medical devices and moving them through the proof-of-concept process. Finally, the JI also increases physician and industry knowledge of vascular and neurologic diseases through clinical education programs.

Contacts

Media:
Dan Ventresca
Matter Health for MMI
MMI@matternow.com

Investor Relations:
Lisa Croke
Lisa.Croke@mmimicro.com

Mainstay Medical Announces Receipt of European and Australian Approvals of MRI Labeling on ReActiv8® Restorative Neurostimulation System

MRI clearances received in connection with certification of conformity with EU and UK Medical Device Regulations

Mainstay Medical Holdings plc today announced that it has received regulatory approvals in the European Union, the United Kingdom and Australia for full-body MR conditional labeling for the ReActiv8® Restorative Neurostimulation system. As a result, all current and future ReActiv8 patients in Europe and Australia implanted with the commercially available 45 cm leads have the ability to undergo 1.5T full-body scans. Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory.

The MRI approvals were achieved in connection with Mainstay receiving certificates issued by its Notified Body confirming conformity with the Medical Device Regulations (MDR) of both the European Union and the United Kingdom.

“These MRI approvals will allow us to significantly broaden access to ReActiv8 for patients in Europe and Australia who may require (or develop the need for) MRI imaging post-implantation, complementing our earlier approval of MRI labeling in the United States,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “In addition, we are proud of our continued commitment to patient safety and product quality, as shown by our being among the first in the neuromodulation field to achieve MDR certification for Europe and the UK.”

Customer information emails will be sent, and MRI Guidelines and related information will be available, next week.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

XyloCor Therapeutics and SmartCella Enter into License Agreement for Use of the Extroducer Infusion Catheter System to Administer Novel Gene Therapy XC001 to the Heart

• The Extroducer® Infusion Catheter System ® enables local delivery of XC001 to the heart without the need for surgery.

• XC001 has achieved positive Phase 1/2 results in the EXACT Trial validating its transformative potential for treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality-of-life.

XyloCor Therapeutics, Inc. (“XyloCor”), a clinical stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, and SmartWise, a unit of SmartCella Holding AB (“SmartCella”), have entered into a licensing agreement under which XyloCor has rights to the Extroducer® Infusion Catheter System ®, a first-in-class endovascular device designed to deliver advanced therapies directly into the heart. XyloCor plans to deploy the Extroducer to support catheter-based endocardial delivery of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in future clinical studies and commercial use.

“This agreement with SmartCella will enable XyloCor to build upon its robust foundation of efficacy and safety data for XC001 by offering the potential for improved safety and ease of delivery without surgery via this novel catheter,” said Al Gianchetti, President and CEO of XyloCor. “Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina. It also opens up the potential to develop XC001 earlier in the coronary artery disease progression for even larger patient groups.”

XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple isoforms of vascular endothelial growth factor (VEGF). With the use of the Extroducer catheter, XyloCor can offer patients a better delivery option for local administration of XC001 directly to the heart, that is less invasive and eliminates potential risks associated with surgical administration.

“We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” said Timothy D. Henry MD, Interventional Cardiologist and Director of the Lindner Center, The Christ Hospital, Cincinnati, Ohio. “Preclinical models provide strong evidence that this approach will maintain, or even improve the efficacy when compared to surgical delivery and it should lower the risk of complications that may arise from surgical administration. I am looking forward to initiating the Phase 2b trial of XC001 in patients with refractory angina using this innovative administration approach.”

The recently published EXACT Phase 1/2 trial assessed the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina – a debilitating and chronic condition that impacts over one million people in the United States and is growing in prevalence. In the EXACT trial, 42 patients with class II-IV angina were treated with XC001 directly administered to the heart following minimally invasive surgical access. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements of exercise duration, and angina frequency, due to a decrease in ischemic burden, as measured by Positron Emission Tomography (PET) imaging. Notably, six months after treatment 43% of patients had no chest pain with ordinary activities and 58% reported no angina episodes at 12-month clinical follow up. XC001 was well tolerated in the patient population and there were no serious adverse events related to the drug. The Phase 2b trial will be a randomized double-blinded study assessing the safety and efficacy of XC001 administered via the Extroducer® Delivery Catheter in coronary artery disease patients with refractory angina.

“The collaboration underscores the transformative potential of the Extroducer in delivering XC001 therapy for patients with refractory angina. A great example of a powerful combination of delivery system and drug therapy representing a substantial advancement in treatment options. The collaboration with such a distinguished partner as XyloCor marks a significant milestone for our global expansion efforts and will also enable us to further explore and harness the future capabilities of the Extroducer, ultimately expanding the benefits to a greater number of patients in need,“ said Niklas Prager, CEO of SmartCella.

Terms of the agreement include a global license to XyloCor for use of the Extroducer for the administration of XC001 and provide for SmartCella to supply catheters to XyloCor in clinical trials and commercial use in exchange for an upfront payment, clinical, regulatory and commercial milestones and a royalty on sales. Total deal value amounts to approximately USD 130 million and mid-single digit royalties.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About Extroducer® Infusion Catheter System

The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of modalities for solid tumor treatment, genetic disorders and tissue repair, to name but a few. Using standard equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022.

About XyloCor

XyloCor Therapeutics, Inc. 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 whom 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, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

About SmartCella

SmartCella, founded in 2014, is an innovative biotechnology company based in Stockholm, Sweden. SmartCella’s vision is to combine first-in-class delivery platforms with cutting-edge cell and mRNA therapies to unleash the full potential of targeted therapies. The company has three main business units, Smartwise, SmartCella Solutions and ProCella. For more information, visit www.smartcella.com.

MMI Builds Global Momentum with Multiple Distribution Agreements and Regulatory Approvals

Expansion includes fastest-growing market for microsurgical procedures and opportunity for considerable advancement, improved patient treatment options

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced milestones across two continents that increase the global reach of the Symani® Surgical System.

The company announced:

• It reached an exclusive distribution agreement with Gunze Medical Limited, a leading developer and manufacturer of medical devices in Japan. The agreement signals a step toward commercializing Symani across Japan, upon regulatory approval, and will eventually enable hospitals there to expand their open surgical programs to include microsurgery and supermicrosurgery procedures.

• The Symani Surgical System has now received regulatory approvals in 35 countries around the world, most recently securing approvals in Hong Kong, Malaysia, New Zealand and Taiwan. They mark Symani’s latest regulatory milestones following the U.S. Food and Drug Administration authorizing the system for commercial use in April.

• It has expanded commercialization efforts in Europe by partnering with the Synektik Group, a leading integrator of innovative medical solutions that covers six countries across Eastern Europe. The agreement marks the next stage in bolstering Synektik’s standing as a top distributor of robotic medical systems in the region.

“The demand for innovative, less invasive, highly precise surgical options is increasing around the world, particularly in Asia, where microsurgery and reconstructive surgery both have long histories,” said Mark Toland, CEO of MMI. “Our recent regulatory approvals in multiple countries, and growing relationships with distributors in key markets, have enabled us to accelerate our timeline for global expansion. Each new milestone represents another step toward expanding patient access to highly advanced microsurgical capabilities around the world.”

The Symani Surgical System uniquely addresses the scale and complexities of microsurgery and supermicrosurgery, such as the anastomosis and suturing of small anatomical structures like blood and lymphatic vessels, during open surgical procedures. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can help restore quality of life for more patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

“Our partnership with MMI will facilitate the Symani Surgical System’s expansion into Japan,” said Shojiro Matsuda, President of Gunze Medical Limited. “We are deeply committed to expanding patient access to robotic-assisted microsurgery and believe Symani’s proven clinical success will complement our relationships with care provider organizations with expertise in plastic and reconstructive surgery.”

Asia-Pacific represents the fastest growing microsurgery market in the world, and Taiwan specifically is a hub of microsurgical innovation that attracts surgeons from around the globe. MMI has already signed a distributor agreement in the country to support its regulatory approval there and details are being finalized on the heels of the authorization.

“MMI’s mission to expand patient access to highly specialized microsurgical options perfectly aligns with our own as we help to further enable robotic capabilities across Poland and Eastern Europe,” said Cezary Kozanecki, founder and CEO of Synektik. “Symani has introduced a new level of capability and enabled surgeons to perform exceptionally precise procedures that include lymphedema repair, head and neck cancer-related reconstruction, and autologous breast reconstruction. Our health system partners have already expressed significant interest in expanding their open surgery capabilities to include procedures they haven’t been able to previously perform.”

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe and APAC, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

Contacts

Media:
Dan Ventresca
Matter Health for MMI
MMI@matternow.com

Investor Relations:
Lisa Croke
Lisa.Croke@mmimicro.com

Neuromod's FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus

• Lenire, the first and only tinnitus treatment device of its kind approved by the FDA, is now an option for 2.9 million veterans living with tinnitus through Veterans Affairs.5

• Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government.

• The General Services Administration Federal Supply Schedule 65 II Medical Equipment and Supply Contract will also make Lenire an option for patients receiving care through the Department of Defense (DoD), the Bureau of Prisons, Indian Health Services, and Public Health Services.

Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making the Lenire tinnitus device a treatment option for the 2.9 million US Veterans living with tinnitus5 through the Department of Veterans Affairs (VA).
The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services.
Lenire is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.
General Services Administration's decision to award the FSS contract was based on Neuromod Devices' clinical trial success, commercial sales practices, financial performance, and additional clinical capability factors.

Tinnitus, which is commonly known as "ringing in the ears," is a complex neurological condition afflicting an estimated ten percent of all adults.4 It causes a perception of sound when there is no external source. If left untreated, tinnitus severity can have a significant impact on a person's quality of life.

Tinnitus has been the number one service-connected disability compensated for by the VA since 1955. More than 2.9 million veterans received more than $5 billion in compensation in 2023.5 Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus.5

"Tinnitus is the number one service-connected disability," said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations. "The number of veterans with tinnitus is growing at a double-digit rate annually. Neuromod's FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology. Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care."

Lenire's bimodal neuromodulation works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip®.
In March 2023, Lenire became the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework. FDA Approval was granted based on the success of Lenire's controlled large-scale clinical trial, TENT-A3.
That trial confirmed Lenire was clinically superior to sound-only stimulation. 70.5% patients with moderate or worse tinnitus who did not report clinically significant improvement in their tinnitus from six weeks of sound-only, reported clinically significant tinnitus improvement following six weeks of treatment with Lenire.3 The majority of patients with moderate or worse tinnitus who benefitted from six weeks of sound-only stimulation experienced additional benefit from a further six weeks of treatment with Lenire.3, 6
Nearly 89 percent of clinical trial participants would recommend Lenire to treat tinnitus.6

About Neuromod Devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. 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.
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 large-scale clinical trials.1,2,6
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.
Further details about Lenire® including a list of providers can be found at www.lenire.com.

References & Notes

1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

3. Neuromod Devices Ltd., Lenire (CR-201) Clinician's Manual, (2023)

4. https://www.nidcd.nih.gov/health/tinnitus

5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/

6. TENT-A3 trial data in preparation for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1

Neurent Medical Announces Publication of Positive Long-Term Results from Study on Chronic Rhinitis Treatment

Recent study confirms safety and efficacy of NEUROMARK® for chronic rhinitis

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced the publication of positive 12-month results from the CLARITY clinical trial in Laryngoscope Investigative Otolaryngology. This study demonstrates that treatment with Neurent Medical’s radiofrequency (RF) ablation device, the NEUROMARK® system, is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up.

Key Findings:

• Symptom Reduction: All 5 Visual Analog Scale Nasal Symptom Score (VAS NSS) items demonstrated significant improvement (p<.0001) over baseline at all 3 time points (6, 9, and 12 months). The reflective Total Nasal Symptom Score (rTNSS) improved from baseline at all 3 time points (p<.0001). A total of 91% of participants achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point for the rTNSS at 12 months.

• Clinical Safety: The procedure showed a consistent safety profile, with no serious adverse events related to the RF ablation device observed throughout the study.

• Quality of Life Improvement: The total mean mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) significantly improved from baseline at all 3 time points (p<.0001). A total of 86% of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ at 12 months.
  

Brian Shields, CEO of Neurent Medical, overviewed the significance of these findings, “This publication further validates the efficacy of our algorithm-driven patented technology for the treatment of chronic rhinitis. The publication of our device’s long-term efficacy and safety data in Laryngoscope Investigative Otolaryngology reaffirms our commitment to building strong clinical evidence to support the continued adoption of our innovative solutions that significantly improve outcomes and patient quality of life.”

Lead investigator Dr. Douglas D. Reh added, “The CLARITY study results provide compelling evidence of sustained symptom relief and enhanced quality of life for patients suffering from chronic rhinitis. This important research better elucidates the neurovascular component of chronic rhinitis and underscores the potential of Neurent Medical’s RF ablation device as a transformative treatment option with durable relief.”

The publication of this study further represents a noteworthy advancement in the field of sinonasal treatment options. The long-term data presented in the CLARITY study not only informs healthcare providers’ treatment decisions but also paves the way for future potential payor coverage considerations. As Neurent Medical continues to innovate, the company remains committed to improving the standard of care for chronic rhinitis patients nationwide.

The full publication may be accessed online here: https://onlinelibrary.wiley.com/doi/epdf/10.1002/lio2.1286

About the NEUROMARK® System

The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radio frequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The system is engineered to gently apply controlled low-power Radio Frequency (RF) energy to target regions of the nasal cavity to disrupt the parasympathetic nerve signals in order to reduce the inflammatory response, thereby reducing core symptoms such as congestion and rhinorrhea.

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sinonasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK® technology with a unique design and advanced smart algorithmic control, allows physicians to precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate chronic rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland, with US HQ in Braintree, MA. For more information visit www.neurentmedical.com.

XyloCor Therapeutics Positive EXACT Phase 2 Data for XC001 Simultaneously Presented at SCAI 2024 Scientific Sessions and Published in Circulation: Cardiovascular Interventions

• Positive Phase 2 EXACT Trial results validate transformative potential of novel gene therapy XC001 for treatment of refractory angina and support continued clinical development

• Novel therapeutic approach aims to fill significant unmet medical need for patients with refractory angina who have exhausted available treatment options and have a debilitating quality-of-life

XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented final results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions, May 2-4, 2024 in Long Beach, CA. These encouraging results supporting XC001’s safety and efficacy potential are being simultaneously published in Circulation: Cardiovascular Interventions.

The EXACT trial assessed the use of one-time gene therapy with XC001 as a new therapeutic approach in refractory angina – a debilitating and chronic condition that impacts over one million people in the United States and is growing in prevalence. XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor (VEGF) isoforms. In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through minimally-invasive transepicardial delivery (direct administration to the heart).

“The results of the EXACT trial suggest that angiogenic gene therapy with XC001 has the potential to improve cardiovascular outcomes for refractory angina patients without revascularization or other treatment options,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and Kenta Nakamura, M.D., Assistant Professor at the University of Washington, lead authors of the EXACT study results. “There is significant need for novel therapies for this serious and disabling condition and we hope that the clinically meaningful evidence emerging from the EXACT trial is the catalyst for continued development that will further validate the potential of this innovative gene therapy for patients.”

The Phase 2 results validated the transformative disease modifying potential of XC001 to reduce ischemia and improve the quality-of-life for cardiac patients who have no treatment options. The results demonstrated that treatment with XC001 can be safely administered and achieve durable clinical improvements including: increases in exercise duration, decrease in ischemic burden as measured by Positron Emission Tomography (PET) imaging, and a reduction in angina frequency. Notably, 93% of patients in the trial entered the trial with chest paint so severe that it markedly limited daily activities and six months after treatment 43% of patients had no chest pain with ordinary activities. VEGF gene therapy with XC001 was well tolerated in the patient population and there were no serious adverse events related to the drug or unexpected serious adverse events related to XC001 administration.

“The results from the EXACT trial represent a promising moment for people with refractory angina and the cardiovascular community as we drive forward toward our goal to deliver a long overdue new treatment option,” said Al Gianchetti, President and CEO of XyloCor. “We are preparing our next clinical trial to advance the development of XC001 and further unlock its transformative medical potential for patients and their families.”

Details regarding the SCAI 2024 scientific session is as follows:

Title: VEGF Gene Therapy Improves Exercise Time, Ischemia, and Symptoms in Patients with Refractory Angina: Results of the Phase II EXACT Trial

Lead Presenter: Kenta Nakamura, M.D., Associate Professor at the University of Washington

Date and Time: Thursday, May 2, 2024; 9:31-9:38 AM PT

Location: Long Beach Convention Center, 104A, First Level

An additional press release from SCAI on the Phase 2 EXACT Trial results and poster session is available here.

The Circulation: Cardiovascular Interventions full article titled “Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial” is available here.

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one‑time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open‑label, single‑arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 1011 vp, the highest tested dose). In the EXACT trial, this investigational gene therapy was administered directly to the heart muscle through a mini‑thoracotomy by a cardiac surgeon.

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.

About XyloCor

XyloCor Therapeutics, Inc. 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 whom 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, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations:

A. Brian Davis, XyloCor Therapeutics, Inc.
brian.davis@xylocor.com
610-541-2056

Media Contact:

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

Vivasure Medical Announces First Large Hole Venous Patient Treated with PerQseal Elite Vascular Closure System

Investigational technology designed for patients undergoing emerging large bore percutaneous catheter-based venous interventional procedures

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The first successful implant was completed by Prof. Nicolas Van Mieghem, M.D. Ph.D., Clinical Director of Interventional Cardiology at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, The Netherlands, as part of the company’s ELITE Venous Clinical Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of the vascular closure system.

Leveraging Vivasure Medical’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.

“Current venous closure methods are not indicated for large hole venous access applications like Transcatheter Edge-to-Edge repair (TEER), TMVR and TTVR. As these procedures become more common, there’s a need for closure options that can effectively address these emerging clinical applications,” said Prof. Nicolas Van Mieghem, principal investigator of the ELITE Study. “I’m looking forward to further study the PerQseal ELITE technology for venous closure and assess its performance for patients.”

The PerQseal Elite vascular closure system is placed from inside the vein, making deployment simpler and more controlled than conventional closure techniques and returning the vein to its natural state without leaving materials like collagen, metal implants or sutures behind, as commonly seen in other closure technologies.

“Cardiovascular procedures have increasingly adopted minimally invasive approaches, but conventional venous closure techniques have presented risks for vascular complications,” said Andrew Glass, chief executive officer of Vivasure Medical. “We’re encouraged by the early progress we’ve seen in clinical studies of the Elite vascular closure system to address this unmet need. I’m grateful to Prof. Van Mieghem for treating the first patient in this study and look forward to following the outcomes from other patients in this study.”

Vivasure’s Elite Venous Clinical Study will enroll up to 97 patients at up to 12 European investigational sites. Completion of the study is expected this year, and results will support CE mark and pre-market approval submissions.

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® is not available for sale in the United States.

MMI Receives FDA Authorization to Commercialize Symani® Surgical System in the U.S.

De Novo Classification builds on proven clinical success and expands global access to new category of treatments

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that its Symani® Surgical System is now commercially available in the United States. The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the robotic system for soft tissue manipulation to perform microsurgery, a highly specialized technique that involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair.

The FDA authorization makes the Symani Surgical System the only commercially available platform in the U.S. for reconstructive microsurgery. The technology is positioned to open the field of microsurgery to new surgeons by quickly developing their skills, as well as to empower skilled microsurgeons to confidently expand into supermicrosurgery, creating a novel category of treatments that the human hand cannot perform without robotic assistance.

“The U.S. is facing a potentially dire shortage of physicians, and that shortage acutely impacts specialized fields of medicine, such as microsurgery,” said Mark Toland, CEO of MMI. “With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema. Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat.”

Specific techniques used in microsurgery include reconnecting small anatomical structures, such as blood and lymphatic vessels, during open surgical procedures. Supermicrosurgery involves reconstruction or repair of even smaller vessels, typically less than 1mm in diameter, and fewer than 600 surgeons worldwide perform supermicrosurgery today.

The Symani Surgical System provides advanced solutions for a range of open surgeries, including post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair.

“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” said Dr. L. Scott Levin, co-CMO of MMI. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance. The authorization from the FDA helps to solve a critical unmet need and will help surgeons perform a new category of complex open surgeries enabled by transformative technology.”

The Symani Surgical System offers surgeons entirely new capabilities because it features the world’s smallest surgical robotic wrist, called NanoWrist®. The unique design enables surgeons to replicate the natural movements of the human hand at the micro scale, which encourages a flatter learning curve in the training process. The articulated wrist features seven degrees of freedom that match the human wrist, tremor filtration and motion scaling, ultimately increasing precision and control.

Surgeons have leveraged the Symani Surgical System in nearly 1,000 clinical cases in the European Union and in thousands of preclinical cases around the world. The Symani Surgical System is available for commercial use in Europe and parts of Asia Pacific. MMI plans to immediately launch the technology in the U.S.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair and lymphatic repair. In Europe, it also addresses peripheral nerve repair. The Symani System is authorized for use in the U.S. by the FDA and is a CE Marked medical device in Europe. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioS

Corteria Pharmaceuticals announces initiation of Phase 1 study to evaluate CRF2 agonist COR-1167 for treatment of worsening heart failure

Corteria Pharmaceuticals (‘Corteria’), a clinical-stage biopharmaceutical company focused on the development of transformative therapies for heart failure and obesity, today announces the initiation of its Phase 1 study to evaluate the company’s first-in-class corticotropin-releasing hormone receptor 2 (CRF2) agonist, COR-1167, for the treatment of Worsening Heart Failure (WHF).

COR-1167 is a once-daily subcutaneous CRF2 agonist that has demonstrated substantial protective effects and functional improvement in the heart, vasculature and kidneys in multiple animal models of heart failure. Its unique mechanism of action offers a novel opportunity for treating WHF with the goal of alleviating cardiac congestion by restoring and maintaining stable cardiovascular and renal function.

The Phase 1 trial is a randomized placebo-controlled study with the primary objective of assessing the safety and tolerability of COR-1167 in both healthy volunteers and patients with chronic heart failure.

“The advancement of our lead CRF2 agonist into the clinic is a significant milestone in our mission to bring novel treatments to patients experiencing the debilitating effects of worsening heart failure,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “The preclinical data for COR-1167 is very promising and we are excited to determine its therapeutic potential in patients.”

Prof. Adriaan Voors, professor of cardiology at the University Medical Centre Groningen (Netherlands) and principal investigator of the study, emphasized that: “the initiation of this Phase 1 study with COR-1167, a CRF2 agonist, both in healthy volunteers and patients with heart failure is an important step in potentially reducing the burden of heart failure, especially for patients who experience worsening signs and symptoms despite being treated with currently recommended therapies.”

The company anticipates completing the Phase 1 study in the first half of 2025, to be followed by the initiation of a Phase 2 study in this indication.

About Worsening Heart Failure

The clinical course of heart failure is characterized by periods of clinical stability being frequently interrupted by episodes of worsening symptoms and signs, defined as Worsening Heart Failure (WHF). Given the central role of congestion in WHF, loop diuretics are the standard of care treatment. However, while effective acutely, these do not improve rehospitalization rates or patient outcomes. Therefore, WHF remains a critically important unmet medical need that continues to have a major impact on quality of life and imposes a major economic burden on the global healthcare system.

About Corteria Pharmaceuticals

Corteria Pharmaceuticals is a clinical-stage biopharmaceutical company developing first-in-class medicines for the treatment of heart failure and obesity. In addition to its lead daily CRF2 agonist, COR-1167, the company is advancing a long-acting CRF2 agonist for the chronic treatment of right heart failure and obesity, as well as an Arginine VasoPressin (AVP) neutralizing monoclonal antibody for the treatment of acute heart failure with hyponatremia. Worldwide, more than 60 million people live with heart failure and more than one billion with obesity, resulting in substantial morbidity and mortality.

Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up

Groundbreaking ReActiv8-B study supports the long-term efficacy, safety and durability of ReActiv8® Restorative NeurostimulationTM for the treatment of intractable Chronic Low Back Pain

Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction.

The publication is available here: https://www.sciencedirect.com/science/article/pii/S1094715924000552

The ReActiv8-B study saw multiple patients have their implants removed for resolution of back pain. These removals for success suggest a restorative mechanism, and the therapy shows no evidence of the loss of efficacy commonly observed with palliative treatments.

Dr. Chris Gilligan, Chief Medical Officer and Chief Quality Officer at Robert Wood Johnson University Hospital, stated: “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”

Jason Hannon, CEO of Mainstay Medical, stated: "We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

Mainstay Medical Announces Publication of Clinical Results Comparing Older Patients and Younger Patients

Efficacy of ReActiv8® Restorative Neurostimulation™ shows no statistically or clinically meaningful differences between older and younger patient populations.

Mainstay Medical Holdings plc today announced the publication of a pooled analysis of three different clinical studies that evaluated the safety and efficacy of ReActiv8 therapy after two years in patients of various ages. The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor when utilizing ReActiv8 to treat intractable mechanical chronic low back pain patients with multifidus dysfunction.

The publication can be found here: https://rapm.bmj.com/content/early/2024/03/08/rapm-2023-105032

There were no statistically significant or clinically meaningful differences between the groups in the magnitude or durability of response across pain, disability, or health-related quality of life measures. A summary of some of the data from the analysis for patients at two years of ReActiv8 therapy is as follows:

Dr Simon Thomson MBBS FFPMRCA, Consultant Lead at the Pain and Neuromodulation Centre, Mid and South Essex University Hospitals NHS, Essex, UK and the London Clinic, former President of International Neuromodulation Society (INS), stated: “Restorative Neurostimulation has proven to be a unique therapy that delivers consistent results in randomized, controlled and real-world studies. Until now it was unknown if age was a factor in predicting long-term outcomes. This pooled analysis demonstrates that properly selected patients can benefit from this therapy, irrespective of age.”

Jason Hannon, CEO of Mainstay Medical, stated: “High quality clinical evidence sets us apart in this industry. We study, learn, and demonstrate outcomes in patient populations before we suggest ReActiv8 is beneficial to a particular group of patients. This is how we partner with clinicians to deliver the best possible, and most durable, treatments for their patients. With these exciting results demonstrating the value of ReActiv8 across all studied age groups, we can now confidently support identification of older patients who are likely to benefit from the therapy. We look forward to continuing to partner with physicians to help chronic low back pain patients of all ages, and to growing the global body of peer-reviewed evidence supporting the ability of ReActiv8 to provide positive long-term outcomes.”

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

Mainstay Medical Announces US$125 Million Equity Financing Transaction

Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8® Restorative NeuromodulationTM System

Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.

The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors.

“A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical. “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”

“We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare, who also joins the Mainstay Medical Board of Directors. “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising.”

Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

MMI Raises $110 Million in Series C Financing

Largest ever investment in microsurgery will further MMI’s mission to transform open surgery with robotic technology

MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that it has raised $110 million in Series C financing. The round, led by Fidelity Management & Research Company, marks the largest ever investment in microsurgery innovation.

The funds will support commercialization of the Symani® Surgical System in high-growth markets and continued investment in studies that generate clinical evidence and enable indication expansion. Investments will also accelerate advanced technology capabilities and enable MMI to scale its operational capabilities globally.

MMI and its existing investors, all of whom contributed to the Series C financing, see considerable opportunity for rapid growth. The company projects the market for eligible robotic microsurgical procedures will grow from 3 million to 22 million annually by 2028, driven primarily by technological advancements and indication expansion.

“Against a backdrop of plateauing investments in medical robotics, this support builds on our confidence in a new, less invasive solution for open surgery, a significant market that can benefit from the smallest wristed microinstruments,” said Mark Toland, CEO of MMI. “Our Symani Surgical System is uniquely positioned to expand patient access to care by accelerating the number of surgeons able to perform complex, delicate procedures. With the support of our investors, we will continue to advance our technology through a growing body of clinical evidence and expanded hospital partnerships.”

The Symani Surgical System is a first-of-its-kind robotic technology that uniquely addresses the scale and complexities of microsurgery and supermicrosurgery. By allowing surgeons to replicate the natural movements of the human hand at the micro scale, it can expand treatment options for patients in need of soft tissue, open surgical procedures, such as free flap reconstructions, lymphatic surgery, and trauma replantations. It is designed to help restore quality of life for more patients, accelerate the number of surgeons able to push the boundaries of complex procedures for delicate anatomy, and enable hospitals to expand their open surgical programs.

MMI has raised over $200 million in funding to date. In 2022, it closed a Series B financing round to propel growth. The funding was allocated to help expand indications and support ongoing commercialization efforts for the Symani Surgical System in Europe, where it received CE mark in 2019, accelerate plans to commercialize in the U.S. and Asia-Pacific, and advance clinical research.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

About MMI

MMI (Medical Microinstruments, Inc.) is on a mission to advance robotic technology that pushes the limits of soft tissue open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. The company was founded in 2015 near Pisa, Italy, and its proprietary Symani® Surgical System combines the world’s smallest wristed microinstruments with tremor-reducing and motion-scaling technologies to address significant unmet patient needs across the globe. This first-of-its-kind surgical robotic platform for open, soft tissue micro-level surgery can help address microvascular repair, lymphatic repair, and peripheral nerve repair. The Symani System is CE Marked for commercial use in Europe. In the United States, the system is not approved or cleared for commercial use. MMI is backed by global investors including Fidelity Management & Research Company, Andera Partners, BioStar, Deerfield Management, Fountain Healthcare Partners, Panakès Partners, RA Capital, Sambatech, and Wellington Partners.

Mainstay Medical Announces Receipt of FDA Approval for MRI Labeling on ReActiv8® Restorative Neurostimulation SystemTM

U.S. patients implanted with ReActiv8 now eligible for full-body MRI scans

Mainstay Medical Holdings plc today announced that the U.S. Food and Drug Administration (FDA) has approved full-body MRI conditional labeling for the ReActiv8® Restorative Neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the current 45 cm commercially-available leads.

The approval provides patients implanted with ReActiv8 the ability to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in the ReActiv8 FDA MRI Guidelines manual.

“This approval expands the existing safety profile of ReActiv8, broadening access to patients who may need (or develop the need) for MRI imaging after implant,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “The ReActiv8 MRI labeling is one of the most comprehensive among neurostimulation devices approved for chronic low back pain, with full-body imaging at 1.5T at normal operating mode (maximum specific absorption rate (SAR) of 3.2 W/kg for the head and 2.0 W/kg for the rest of the body). We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

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

Inotrem Successfully Reaches Agreement with the FDA for a Phase 3 Registration Trial for Nangibotide in Septic Shock

• Novel biomarker-guided Phase 3 registration trial in septic shock with an enrichment strategy-based patient selection.

• Historic paradigm shift in Primary endpoint: from all causes of mortality at Day 29 to proportion of patients alive and free of organ support at Day 29
  

Inotrem, an advanced clinical stage biotech company specializing in immunotherapies for acute and chronic inflammatory syndromes, today announced the outcome of its regulatory interactions with the US Food and Drug Administration (FDA) to finalize the design of a single Phase 3 registration trial (ACCURATE) for nangibotide in septic shock. The ACCURATE trial design is built upon Phase 2 (ASTONISH) data that confirmed nangibotide’s strong efficacy and safety profile. The FDA accepts Inotrem’s innovative biomarker-driven precision medicine approach.

The ACCURATE study will be centered on patients with high risk of mortality and morbidity as defined by a high concentration of the blood based sTREM-1 biomarker representing about 50 percent of the septic shock patients. This unique biomarker-guided approach allows for a single Phase 3 registration trial with a manageable number of subjects. The overall size of ACCURATE will be about 1,300 patients, with a primary analysis group of 900 patients. The primary endpoint of ACCURATE will be the proportion of patients alive and free of organ support at Day 29. ACCURATE will run globally and enroll patients in about 100 sites in the Americas, Europe and Japan.

Inotrem is collaborating with Roche Diagnostics since 2017 to develop a sTREM-1 assay on the Elecsys/COBAS platform to identify patients that are both more at risk and more likely to benefit from nangibotide treatment. All sTREM-1 measurements in ACCURATE will be carried out on the Roche platform paving the way for the test to be available as a companion diagnostic at the time of nangibotide approval.

“Inotrem is now in a leading position to conduct a single Phase 3 registration trial in a prospectively defined population of septic shock patients that are at high risk of morbidity and mortality. Our innovative, biomarker-guided strategy along with a new patient-related primary endpoint gives us the best possible chance of success in this challenging indication,” said Margarita Salcedo-Magguilli, Chief Development Officer of Inotrem.

“The successful End of Phase 2 meeting with the FDA is a testament to the dedication and expertise of our team. We are energized by the support and guidance from the FDA which will enable us to accelerate the development of nangibotide and, ultimately, bring a potentially transformative treatment to septic shock patients in need of new alternatives," added Sven Zimmermann, Chief Executive Officer of Inotrem.

Septic shock is the ultimate complication of sepsis and constitutes a high unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated: it is the main cause of death in intensive care units. There is currently no specific therapy approved for this indication. Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway to restore appropriate inflammatory response, vascular function and improve post septic shock survival. Based on its scientific leadership on TREM-1, next to acute inflammatory syndromes, the company has expanded its TREM-1 franchise into chronic inflammatory diseases.

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, nangibotide, with potential applications in life-threatening immune dysregulations caused by severe infections such as septic shock and severe forms of COVID-19. In parallel, Inotrem has also launched an antibody-based 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. Inotrem is part of the French Tech 120, a government program dedicated to support the development of fast-growing startups. www.inotrem.com

Contacts

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