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.

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.

Neurent Medical Announces New CPT Code® for Chronic Rhinitis Treatment Offering Significant Symptom Improvements

CMS Assignment Empowers ENT Physicians and Offers Relief to Millions of Chronic Rhinitis Patients

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced a significant milestone for the chronic rhinitis market. The Centers for Medicare and Medicaid Services (CMS) has recently assigned a Category I Current Procedural Terminology (CPT®) reimbursement code for a breakthrough minimally invasive procedure designed to address the symptoms of patients suffering from chronic rhinitis.

Effective January 1, 2024, the assigned payment for CPT code 31242 for endoscopic destruction of the posterior nasal nerve (PNN) using radiofrequency ablation will be instated for use with Neurent Medical's NEUROMARK® System. The new code describes the procedure performed by otolaryngologists or ear, nose, and throat (ENT) physicians when disrupting overactive nerves that drive chronic rhinitis symptoms.

Marc G. Dubin, MD, FACS, a nationally recognized subspecialist in sinus and nasal disease expressed his enthusiasm for this upcoming assignment, stating, "The establishment of this CPT code is a significant milestone for physicians who treat chronic rhinitis patients with ablation of the posterior nasal nerves as we are now able to provide patients lasting relief and address chronic runny nose, post-nasal drip, and congestion more effectively." He continued, "I have been fortunate to use the NEUROMARK System throughout its development and with its demonstrated safety and efficacy in the recently published CLARITY study, I am eager to have this treatment option readily available to my chronic rhinitis patients who have had limited options for long term treatment to-date."

It is estimated that several million chronic rhinitis patients are seen by ENT doctors annually in the United States. The condition affects approximately one in four Americans1. Chronic rhinitis patients endure sinonasal discomfort characterized by persistent congestion, rhinorrhea (runny nose), sneezing, and nasal itching due to inflammation and swelling mucosal membrane in the nose. The high prevalence of chronic rhinitis and its negative impact on day-to-day life, including sleep, cognitive function, mood, and ultimately on performance at work or school, make chronic rhinitis a global public health issue2.

Currently available treatments have been shown to be effective in interrupting posterior nasal nerves (PNN). However, not all patients have adequate resolution of their symptoms. One hypothesis for this lack of improvement is inadequate treatment of nerves due to natural anatomic variations that are not addressed by current devices3.

The NEUROMARK System offers ENTs a novel and unique flexible leaflet design to help achieve precise placement across the PNN and accessory pathways. The proprietary Smart Algorithms monitor the treatment of targeted tissue to ensure it is delivered adequately to the intended area. The system can comfortably accommodate a range of anatomies. Microlesions disrupt the PNN pathway while maintaining mucosal and vascular integrity.

The significance of this milestone is further emphasized by Neurent Medical's CEO, Brian Shields, who commented, "The assignment of the CPT Code marks the next chapter of evolution and growth for Neurent Medical. We are extremely proud to be at the forefront of innovation, introducing a sustainable treatment option for patients who are suffering with chronic rhinitis." He added, "The NEUROMARK System uses a proprietary algorithm and biofeedback to tailor treatment for each individual patient. This achievement reflects our commitment to enhancing patient outcomes and our partnership with clinical investigators and the otolaryngology community as a whole."

The NEUROMARK System received U.S. Food and Drug Administration (FDA) 510(k) clearance in October 2021 and Neurent Medical announced the limited market release of the system in February 2023.

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 algorithmic control, physicians can 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 the US office located in Braintree, MA. For more information visit www.neurentmedical.com.

1 Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34. PMID: 17153005.

2 Vandenplas O, Vinnikov D, Blanc PD, et al. Impact of Rhinitis on Work Productivi.: A Systematic Review. J Allergy Clin Immunol Pract. 2018;6(4):1274-1286.e9. doi:10.1016/j.jaip.2017.09.002

3 Fan T, Chandna M, Gorelik D, et al. Correlation between middle turbinate insertion in relation to sphenopalatine foramen and failure rates of cryotherapy and radiofrequency treatment for chronic rhinitis. Int Forum Allergy Rhinol. 2023;13(1):88-91. doi:10.1002/alr.23058

New Data show NEUROMARK® Chronic Rhinitis Treatment Offers Significant Symptom Improvements

Results from the CLARITY Study Show the NEUROMARK® System Provides Safe and Effective Treatment for Patients with Chronic Rhinitis

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sinonasal diseases, today announced three-month data from the CLARITY study, a prospective, single-arm, multicenter safety and efficacy study of its NEUROMARK® System for patients with chronic rhinitis. These data, published in Laryngoscope Investigative Otolaryngology, show that patients receiving the NEUROMARK therapy demonstrated significant improvement in rhinorrhea and nasal congestion symptoms at 3 months.

Approximately one in four Americans have chronic rhinitis1, a condition that results in persistent congestion, rhinorrhea (runny nose), sneezing, and nasal itching caused by inflammation and swelling of the mucosal membrane in the nose. NEUROMARK’s unique device and intelligent technology platform enable otolaryngologists to treat chronic rhinitis with precision and control, which in turn allows for an enhanced patient experience from treatment through recovery.

The CLARITY Study enrolled thirty-six participants and all completed follow-ups at one and three months. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total Nasal Symptom Score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated.

The data demonstrated the following benefits of NEUROMARK’s posterior nasal nerve (PNN) ablation procedure at 3 months post procedure:

• The mean VAS NSS scores for rhinorrhea and nasal congestion significantly improved from baseline (both p<0.0001), achieving a mean percent change of 53% and 55%, respectively.

• Total rTNSS scores and all individual items demonstrated significant improvement (all p<0.001).

• Percent responder rate (≥30% reduction from baseline in total rTNSS) was 78%.

• Total mean mini RQLQ scores and all subdomains improved significantly (p<0.0001).

• 89% of participants reported a minimal clinically important difference (MCID) of ≥0.4 point improvement in the mini RQLQ score.

• No serious adverse events occurred during the study, and there were no reports of epistaxis or headaches.
  

“People living with chronic rhinitis have had limited options when traditional therapies fail. Other therapies on the market don’t always adequately address symptoms for every patient,” said Douglas D. Reh, MD, FARS, Otolaryngology Specialist at ENT Associates and the study’s principal investigator. “The data showed statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post NEUROMARK procedure.”

NEUROMARK is designed to gently apply controlled low-power radio frequency (RF) energy to target regions of the nasal cavity, disrupting the parasympathetic nerve signals that can trigger an inflammatory response. This unique system offers ENTs a novel and unique leaflet design to help deliver precision neurolysis of posterior nasal nerves, with the intelligence and flexibility to comfortably accommodate a range of anatomies.

“We’re encouraged by the three-month CLARITY data demonstrating the safety, efficacy and relief from chronic rhinitis symptoms that can be achieved with NEUROMARK,” said Neurent Medical CEO Brian Shields. “I’m grateful to Dr. Reh and each of the study’s investigators for adding to the growing body of clinical evidence supporting PNN for these patients.”

The NEUROMARK System has received U.S. Food and Drug Administration (FDA) clearance and Neurent Medical announced the limited market release of the system in February 2023.

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 algorithmic control, physicians can 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. For more information visit www.neurentmedical.com.

1 Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34. PMID: 17153005.

Neurent Medical Announces Limited Market Release of NEUROMARK® System to Treat Chronic Rhinitis

NEUROMARK received new Category I CPT code and support from AAO position statement

Neurent Medical, a company pioneering innovative non-surgical interventions to treat chronic inflammatory sino-nasal diseases, today announced its NEUROMARK® Rhinitis Neurolysis Therapy (RNT) is now commercially available in limited U.S. markets. Commercialization comes as the American Medical Association (AMA) issued a new Category I Current Procedural Terminology (CPT®) code for posterior nasal nerve ablation (PNN) procedures, which includes NEUROMARK, to treat chronic rhinitis. The code will go into effect in January 2024. Furthermore, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) endorses this procedure.

Approximately one in four Americans suffer from chronic rhinitis, which can result in irritating symptoms including rhinorrhea (runny nose), persistent congestion, swelling of the mucosal membrane in the nose, and sneezing and nasal itching caused by inflammation. NEUROMARK’s unique device and intelligent technology platform enable Otolaryngologists to treat chronic rhinitis patients with precision and control and enhance the patient experience from treatment through recovery.

“Our goal is to provide an easy-to-operate, smart treatment that provides clinicians with more precise control and confidence, and patients with a safe, comfortable experience,” said Brian Shields, CEO of Neurent Medical. “The new CPT code underscores the value of this technology as we further grow our commercial presence in the U.S. and work to make NEUROMARK more accessible to the millions of patients living with chronic rhinitis today.”

NEUROMARK is designed to gently apply controlled low-power radio frequency (RF) energy to target regions of the nasal cavity, disrupting the parasympathetic nerve signals that can trigger an inflammatory response. This unique system offers ENTs a novel and unique leaflet design to help deliver precision neurolysis of posterior nasal nerves, with the intelligence and flexibility to comfortably accommodate a range of anatomies.

The recent endorsement of PNN by the AAO-HNS, a specialty society representing almost 12,000 ENT surgeons, further validates Neurent Medical’s long-term future in the treatment of chronic rhinitis.

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 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 Chronic Rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland. For more information visit www.neurentmedical.com.

Neurent Medical Receives FDA Clearance for NEUROMARK™, a Novel Multi-Point Nerve Disruption Treatment for Chronic Rhinitis

Proprietary NEUROMARK™ system is the first in-office treatment indicated to disrupt symptom-causing nerve tissue for Chronic Rhinitis patients.

Neurent Medical, a company pioneering innovative treatments for chronic inflammatory sino-nasal diseases, today announced Food and Drug Administration (FDA) clearance of its proprietary NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT). The clearance gives clinicians access to an in-office treatment designed to create lesions to disrupt the posterior nasal nerves, for patients with chronic rhinitis.

Approximately one in four Americans suffer from chronic rhinitis1, a condition that results in persistent congestion, rhinorrhea (runny nose), sneezing and nasal itching caused by inflammation and swelling of the mucosal membrane in the nose. NEUROMARK™ RNT is designed with a unique flexible electrode array geometry to access and disrupt hard-to-reach posterior nasal nerves in a single placement.

“The FDA clearance of NEUROMARK™ RNT means otolaryngologists can now offer precise care to patients with chronic rhinitis, while avoiding the trial and error that often goes into treating this condition” said Marc Dubin MD, Scientific Advisor for Neurent Medical. “The truth is, medications, sprays and other intranasal procedures are often either ineffective or only offer short-term relief for patients suffering with chronic rhinitis. I look forward to being able to offer them an exciting new treatment option conveniently administered in a single in-office visit.”

NEUROMARK™ system is a novel multi-point nerve disruption treatment for chronic rhinitis. The system’s unique design, biofeedback monitoring features and advanced algorithmic controls enable the physician to simultaneously disrupt multiple nerve branches with a high degree of anatomical precision, safety, and patient comfort.

“It is well documented1 that chronic rhinitis can significantly decrease the quality of life for patients by adversely impacting their sleep quality, daily activity, mental health and overall wellbeing” said Neurent Medical CEO Brian Shields. “NEUROMARK™ addresses the limitations of other treatments and uses advanced technology to do so safely, gently and with ease. The market need is immense and underserved, and we are excited to bring our initial product offering to the market, providing symptom relief to as many patients as possible. We are equally as excited to continue our product pipeline development to address other sino-nasal inflammatory conditions and realize the full potential of the NEUROMARK™ platform.”

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 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 Chronic Rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland. For more information visit www.neurentmedical.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.

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.

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Medical Device Company, Neurent Medical Closes €9.3m Series A Financing

Galway, Ireland – Neurent Medical Limited, an Irish medical device company specialising in the treatment of rhinitis, announces that it has raised €9.3m ($11m) in a Series A financing round led by Fountain Healthcare Partners with participation from Atlantic Bridge Capital, the Western Development Commission, Enterprise Ireland and a syndicate of Irish and US Medical Device veterans. This funding will be used to advance product development, carry out clinical trials and prepare for US commercialisation of the device. As part of the Series A financing, Justin Lynch of Fountain Healthcare Partners will join the Board of Directors of Neurent Medical. Existing independent Non-Executive Director Mark Fletcher (former President of Medtronic’s ENT business) will be retained on the board with Brian Shields and David Townley.

Rhinitis is reported to affect 30% of the population. It is associated with direct healthcare costs of up to $15bn per year in the US. Rhinitis has a proven major impact on quality of life, cognitive function and decision-making and is associated with decreased work productivity and absenteeism. Neurent Medical is developing a novel therapy that will offer allergic and non-allergic rhinitis patients an alternative, minimally invasive, and more readily accessible treatment to alleviate the two primary symptoms of rhinitis, rhinorrhoea and nasal obstruction. Neurent Medical’s therapy will enable ENT surgeons to treat rhinitis patients in an ENT office setting using only local anaesthesia, removing the complications and costs associated with existing surgical procedures. The potential market is as high as $2bn upon full commercialisation following successful clinical trial completion.

Commenting on their investment in Neurent Medical, Justin Lynch, Partner at Fountain Healthcare Partners said, “A substantial portion of the rhinitis patient population are candidates for surgical treatments but currently the surgical treatments are sub-optimal, provide only temporary relief and really only address the symptoms of nasal obstruction and do little or nothing for rhinorrhoea. Neurent Medical with its novel therapy, is seeking to improve outcomes, lower complications with extended duration of relief of both rhinitis symptoms, rhinorrhoea and nasal obstruction.  We are investing in Neurent to help build a credible and sustainable business with great growth potential”. 

Neurent Medical Chief Executive Brian Shields commented, “We are delighted to announce this investment, which will help us to advance our product development and ultimately get our technology in the hands of ENT surgeons. Fountain Healthcare Partners, along with other members of our investment syndicate, bring huge experience to Neurent Medical and have a proven track record in the industry. We would also like to take the opportunity to thank Enterprise Ireland for their continued support over the past number of years”

Neurent Medical expects to create up to 25 new positions in the company  as a result of this investment. This includes a series of both senior management and technical/functional hires over the coming months to fulfil the Research & Development, Quality and Regulatory Assurance and Manufacturing functions of the company. 
 
 

About Neurent Medical Ltd
Neurent Medical Ltd is a privately held, venture backed, Galway (Ireland) based medical device company in the Ear, Nose and Throat market.  The company designs and develops products for treating inflammatory diseases of the nasal cavities. The initial product offering reduces the primary symptoms of rhinitis, congestion and rhinorrhoea. Neurent Medical was by established by Brian Shields and David Townley as a spin-out from the National University of Ireland, Galway. www.neurentmedical.com
 
About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 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. For more information, please visit www.fh-partners.com.