Neuromod launches Ótologie to provide specialist care service for tinnitus patients

Irish medical device company, Neuromod Devices Ltd, has launched Ótologie, a specialist healthcare service for people living with tinnitus. This new service will enable tinnitus patients, in Ireland and throughout Europe, to avoid waiting lists and give them immediate access to treatment for tinnitus.

The establishment of Ótologie follows a successful pilot of a telehealth service for tinnitus patients by Neuromod and the publication of analysis by the Irish Hospital Consultants Association which found that approximately 77,000 patients were on waiting lists for public ENT services. Through engagement with consultant ENTs, Neuromod estimates up to 15,000 of these are tinnitus patients.

In 2021, Neuromod piloted a telehealth service to treat tinnitus patients in Ireland and throughout Europe. This pilot complemented Neuromod’s in-person treatment services at its clinic in Dublin, allowing patients to attend appointments and proceed with treatment at the clinic or via video call according to their preference.

Due to the success of the pilot, which allowed patients to progress to treatment within days of contacting the service and avoid waiting lists for public ENT appointments, Neuromod established Ótologie to provide quick access to tinnitus care from qualified healthcare professionals who can prescribe a range of proven treatments including Lenire, Cognitive Behavioural Therapy (CBT), and hearing aids.

The service streamlines the typical healthcare journey for tinnitus patients, offering them next day appointments which they can attend online or in-clinic. Neuromod’s clinic, located at the Hermitage clinic in Dublin, has been renamed from Neuromod Medical to Ótologie in preparation for the launch of the service.

Tinnitus, a condition commonly known as ‘ringing in the ears’, affects between 10 and 15% of the global population and could affect up to 500,000 people in Ireland.

However, in a recent study more than 60% of GPs reported that they do not follow routine criteria for onward referral of tinnitus patients and expressed a need for more access to specialist resources for these patients, demonstrating the need for specialist care services for tinnitus, such as Ótologie, which people seeking treatment can contact directly or be referred to by their current physician.

Speaking on the launch of Ótologie, Dr Ross O’Neill, CEO of Neuromod Devices said: “Waiting lists for tinnitus patients are not only stressful for the patients themselves but they are also a burden on the health system. From publicly available figures and our engagement with the healthcare system we estimate that today, there are 15,000 people suffering from tinnitus on a waiting list to access specialist public ENT care.”

“Furthermore, recent research has shown that waiting times for an ENT referral can be up to four years in some parts of Ireland. This study also highlighted the distress these lengthy waiting lists put on people living with tinnitus. It also showed that GPs and ENTs alike acknowledged the need for better access to ENT or audiology services for tinnitus. With Ótologie, our vision is to tackle this significant healthcare challenge by enabling patients to get started with treatment as soon as possible from anywhere in the country or indeed Europe. Our long-term aim is to create the first globally recognised approach to tinnitus care and management.”

Ótologie’s team of audiologists and therapists, specifically trained in treating tinnitus, have extensive experience treating patients with evidence-based treatments. Following clinical best practices, they assess each patient and recommend a personalised treatment plan from options which include the Lenire tinnitus treatment device; Tinnitus Therapy (a form of Cognitive Behavioural Therapy or CBT); or hearing aids suitable for people with tinnitus.

Ótologie’s Head of Tinnitus Care, audiologist Anita Sayers said: “Our experience, since we opened the Neuromod Medical clinic in 2019, from talking to our patients is that there is a lot of frustration in the lack of a clearly defined tinnitus patient pathway in Ireland, as well as the lack of clinically effective treatment options for people living with this condition.”

She continued: “People who live with tinnitus are looking for credible, expert advice and treatment plans to help them manage the impact that bothersome tinnitus has on their day-to-day life. With Ótologie, our goal is to build a patient centered service to provide groundbreaking and evidence-based tinnitus treatments, coupled with the empathy that patients need to feel supported at every stage of their tinnitus journey. We are really excited to be able to expand our services and tinnitus care offerings, all under the new Ótologie name.”

The launch of Ótologie follows Neuromod’s establishment of its US subsidiary, Neuromod USA Inc. To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US.

This funding has been led by Fountain Healthcare Partners, an international life science focussed venture capital fund which invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit.

Ótologie’s treatment options for tinnitus

• Lenire - Lenire, a non-invasive bimodal neuromodulation device, has been proven in large-scale clinical trials to soothe the symptoms of tinnitus. Lenire delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes, or neuroplasticity, in the brain to treat tinnitus.

• Tinnitus Therapy - Tinnitus Therapy is a form of psychotherapy which aims to change a patient’s perception of their tinnitus and minimise its impact on their life.

• Hearing Aids for Tinnitus - Hearing loss is one of the most common causes of tinnitus and improving a patients hearing can improve their symptoms. Ótologie offers a range of hearing aids, and ongoing support.

About Ótologie

Ótologie is an effective, patient-centred service that provides ground-breaking tinnitus care to improve the lives of people living with this condition every day and it has been established to address the growing healthcare need for people with tinnitus.

Its specialist audiologists and psychotherapists, have extensive experience treating tinnitus patients with the latest evidence-based treatments. They follow clinical best practices to assess each patient and recommend a personalised treatment plan from treatment options such as of Lenire, tinnitus therapy (CBT), or hearing aids for tinnitus. Combining these treatment options and the company’s technology-led platform, which offers next day appointments, Ótologie’s vision is to create the first globally recognised approach to tinnitus care and management. For more information visit www.otologie.com.

References

*(i) 15,000 waiting list number is based on a 20% estimation of a recent study by the IHCA, stating there were 77,000 people on ENT waiting lists as of November 2021 - https://www.ihca.ie/news-and-publications/77000-people-on-ent-waiting-lists-some-waiting-up-to-five-years-%E2%80%94-cancer-diagnoses-could-be-missed-says-surgeon

*(ii) Kilroy, Naomi & Refaie, Amr. (2020). Tinnitus management in Ireland: a pilot study of general practitioners. Irish Journal of Medical Science (1971 -). 189. 1-11. 10.1007/s11845-020-02222-6.**

Mainstay Medical Announces Publication of Two-Year Patient Outcomes Data from ReActiv8-B Clinical Trial Demonstrating Long-Term Efficacy of ReActiv8® Restorative Neurostimulation™

Data shows compelling efficacy and safety, as well as improvement on all key measures of pain and disability as compared to the one-year study results

Mainstay Medical Holdings plc today announced the publication of the two-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, confirm the efficacy and safety of ReActiv8 Restorative Neurostimulation, and also demonstrate compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.

On virtually all key efficacy measures, the 2-year data showed improvements over the data from the patients’ 1-year visits. Of note:

Outcome measure 2-year result (N = 156) 1-year result (N = 176)

Patients reporting pain intensity (VAS score) reduced by 50% or more from baseline 71% 64%
Patients reporting a greater than 20-point reduction in Oswestry Disability Index 61% 57%
Patients reporting VAS score < 2.5 65% 52%
Patients taking opioids at baseline that voluntarily eliminated or reduced opioid use 60% 48%

Dr. Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, and Assistant Professor of Anaesthesia, Harvard Medical School, said, “The recently published data from the ReActiv8-B clinical trial showed clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received two years of neurostimulation. Pain scores in patients have decreased substantially from an average of 7.3 to 2.4 and are sustained for the duration of 2 years and longer with ongoing data collection. These long-term data are extremely important and encouraging given the chronic and refractory nature of this condition.”

“These impressive results represent an important milestone for Mainstay, as the profound improvements in patient outcomes we observed from baseline to 1 year to 2 years validate the restorative nature of the therapy and represent a new paradigm among treatments available to patients with intractable chronic low back pain,” said Jason Hannon, CEO of Mainstay Medical. “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, evidence which continues to expand through multiple clinical trials.”

The full publication can be downloaded free of charge at https://www.sciencedirect.com/science/article/pii/S1094715921063868. The ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.

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 United Kingdom, and the United States.

About the ReActiv8-B Clinical Trial

The ReActiv8-B clinical trial is an international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the FDA. A total of 204 patients with chronic low back pain refractory to physical therapy and medical management were implanted with ReActiv8 at leading clinical sites in the U.S., Europe and Australia and randomized 1:1 to therapy or control. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit episodic contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed over to receive levels of electrical stimulation similar to those in the treatment group.

Clinical trial funded by Mainstay Medical. Dr. Chris Gilligan, Principal Investigator of the trial, is a consultant of Mainstay Medical. Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

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 Appointment of Jeffrey Dunn and Eric Major to its Board of Directors

Mainstay Medical Holdings plc today announced the appointment of two new independent members to the company’s board of directors, Jeffrey Dunn and Eric Major. These appointments bring Mainstay’s total board membership to seven.

“We are pleased to welcome these two transformational business leaders as new independent directors on the Board,” said David Brabazon, Chairman of the Mainstay Board of Directors. “Their deep experience will be invaluable to Mainstay as we grow our business and pursue our mission to serve patients with intractable chronic low back pain.”

“As our business evolves and we continue to focus on commercial growth, broadening the industry expertise on our Board will help the company strategically and operationally,” said Jason Hannon, Mainstay’s Chief Executive Officer and Board member. “Both Jeff and Eric have strong track records of success leading medical device companies focused on back pain from the launch phase through maturity. They bring decades of leadership in key areas, such as commercial and reimbursement strategy, new product development and operations, that will be valuable to us as we continue to grow our ReActiv8 business in the U.S. and abroad.”

Mr. Dunn currently serves as the Executive Chairman of the Board of Directors of SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy. Mr. Dunn co-founded the company and served as its President, Chief Executive Officer and Chairman of the Board of Directors from 2008 until April 2021. Mr. Dunn led the company through the launch and market growth of the iFuse proprietary minimally invasive surgical implant system as well as the company’s 2018 Nasdaq IPO, taking the company from inception to its current market cap of over $700 million. Prior to joining SI BONE, Mr. Dunn held multiple Chief Executive Officer positions in various other companies since 1994. Mr. Dunn received a B.A. from Colgate University and an M.B.A. from Babson College.

Mr. Major has more than 25 years of experience in the spine device industry as an entrepreneur, executive, chairman, and board member. In 2004 Mr. Major co-founded K2M Group Holding, Inc., a global leader in complex spine and minimally invasive medical device solutions, and led the company to $300 million in annual revenue and a Nasdaq IPO in 2014. K2M was acquired by Stryker Corporation for $1.4 billion in 2018, after which Mr. Major served as president of Stryker’s spine division until June 2021. Prior to starting K2M, in 1998 Eric co-founded American OsteoMedix Corporation, a global minimally invasive spine company that was acquired by Interpore Cross (now part of Zimmer Biomet). Mr. Major holds a B.S. from James Madison University.

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.

Priothera Appoints Elisabeth Kueenburg M.D., as Chief Medical Officer

Dr. Kueenburg, former Clinical Development Lead at Celgene, a Bristol Myers Squibb Company, to advance clinical development of mocravimod in Acute Myeloid Leukemia patients undergoing allogeneic hematopoietic stem cell transplant.

Priothera Limited, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, announces the appointment of Elisabeth Kueenburg, M.D., as Chief Medical Officer. Dr. Kueenburg will lead the advancement of mocravimod into Phase 2b/3 clinical trials as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving hematopoietic stem cell transplantation (HSCT), and expansion of Priothera’s pipeline.

“The breadth of knowledge Elisabeth has gained working at Celgene, alongside her extensive clinical experience, makes her a crucial addition to our team,” said Florent Gros, Co-Founder and CEO of Priothera. “We are delighted to welcome Elisabeth during this exciting time as we look to progress mocravimod, into a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia receiving hematopoietic stem cell transplantation. The study is expected to begin in 2022.”

“I am pleased to join Priothera at such an important stage of its development,” said Dr. Kueenburg. “Mocravimod has the potential to address the significant unmet need of AML patients undergoing HSCT. I look forward to guiding mocravimod and future programs into the clinic and making an important contribution to Priothera’s future success.”

Dr. Kueenburg brings significant drug development and medical affairs experience from her years at Celgene where she most recently served as Clinical Development Lead. At Celgene she developed deep clinical development and medical affairs expertise, providing strategic insight and overseeing the coordination of multiple clinical trials, in the area of hematology and specifically in multiple myeloma. Furthermore, Dr. Kueenburg has supported the successful global launch of Celgene’s Revlimid.

Prior to her numerous roles at Celgene, Dr. Kueenburg spent more than 15 years in clinical practice and academic research specializing in oncology and hematology.

Dr. Kueenburg gained her Doctor of Medicine from the University of Vienna in Austria

About Priothera

Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues and not being immunosuppressants, thereby allowing for inhibition of graft-versus-host-disease (GvHD) while enhancing graft-versus-leukemia benefits in patients receiving HSCT. Headquartered in Dublin, Ireland, Priothera was founded in 2020 by an experienced team of drug development and biotech experts.

Founding investors are Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.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.

Inotrem appoints Dr. Gregory Meiffren as Project Director for its Antibody-based R&D Program Targeting Chronic Inflammatory Diseases

Inotrem, an advanced clinical stage biotech company specialized in immunotherapies targeting the TREM-1 pathway, announced today the appointment of Dr. Gregory Meiffren as Project Director for its Antibody-based R&D Program. The creation of this position comes at a time of significant growth for Inotrem as it is accelerating the expansion of its drug portfolio. The Antibody-based R&D Program will seek to develop new and promising alternatives for the treatment of chronic inflammatory diseases by modulating the activity of the TREM-1 pathway over extended periods of time. Dr. Meiffren will report to Dr. Margarita Salcedo Magguilli, Inotrem’s Chief Development Officer.

Dr. Meiffren will lead the development of Inotrem’s first-in-class therapeutic antibody-based drug program. He will coordinate the design, execution, and all development activities of the company’s second asset, next to nangibotide, from a preclinical stage to a clinical stage product. This second asset to target the TREM-1 pathway is meant to address chronic inflammatory conditions with high unmet needs.

Dr. Meiffren brings a solid experience in international project development from discovery to phase 3 ready asset, with a demonstrated talent for coordinating multidisciplinary teams. Prior to joining Inotrem, he spent 12 years at Adocia, a clinical-stage biotechnology company specialized in the treatment of metabolic diseases, where he was Director of Biology, Pharmacokinetics and Clinical Development, and the global project leader for the two most advanced projects of the company. He successfully led several collaborations with major international pharmaceutical groups. He started his career at the French public scientific institute, Inserm. Dr. Meiffren obtained a PhD in immunology and cell biology from Ecole Normale Supérieure of Lyon in 2007. He is the inventor of 5 patent families and published a dozen of articles in major scientific publications.

Dr. Margarita Salcedo Magguilli says: “We are thrilled to welcome Gregory to lead our new antibody-based R&D program. With his knowledge and experience, I am confident that Inotrem will continue to expand its drug portfolio and develop a new class of assets to treat chronic inflammatory diseases”.

Dr. Gregory Meiffren says: “I am delighted to join Inotrem whose accomplishments in the field of immunotherapy have been extraordinary. Using a new therapeutic modality targeting the TREM-1 pathway, it has rapidly advanced the clinical development of its first compound on several acute inflammatory indications. I am looking forward to the development of a new drug and bring innovative therapeutic solutions to the millions of patients suffering from chronic inflammatory syndromes without access to a satisfying treatment”.

About Inotrem

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

About TREM-1 pathway

TREM-1 pathway is central to innate immune reaction. In the critical care setting, TREM-1 is responsible for an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock, severe forms of COVID-19 and acute myocardial infarction. The TREM-1 pathway is also engaged in the pathophysiology of chronic inflammatory processes, fibrotic diseases and immuno-oncology.

Neuromod appoints Teri Minard to lead introduction of tinnitus treatment medical device to US Veterans

Tinnitus is US Veteran Association’s largest and fastest growing cause of service-connected disability

Neuromod Devices Ltd, the medical device company which specialises in neuromodulation technologies, has announced the appointment of Ms. Teri Minard as Director, Government Sales of its recently established US entity, Neuromod USA Inc.

As Director of Government Sales, Ms. Minard will oversee Neuromod’s efforts to introduce its interventions for tinnitus into the public hearing healthcare ecosystem by partnering with relevant government organisations. Neuromod’s initial area of focus will be to provide tinnitus interventions for US Veterans by building relationships with the Department of Veteran Affairs, the Department of Defense, and other key government stakeholders.

Tinnitus is believed to affect between 10 and 15% of the global population. In the United States it is estimated that almost 50 million people suffer from this neurological condition(i), commonly referred to as ‘ringing in the ears’. Of these, roughly 20 million people struggle with burdensome chronic tinnitus(ii). According to the United States Department of Veteran Affairs, more than two million U.S. Veterans receive disability payments for service-connected tinnitus. This unmet clinical need makes tinnitus the department’s largest and fastest growing cause of service-connected disability(iii).

Ms. Minard joins Neuromod from the multinational conglomerate, 3M where she had an extensive career driving business growth with global responsibilities for strategic planning, business development, and sales and marketing. Her appointment comes as Neuromod prepares to enter the US market with its proprietary medical device for tinnitus treatment, pending the granting of approval from the Food and Drug Administration.

Speaking on the appointment of Ms. Minard, Mr. Eric Timm, CEO of Neuromod USA commented: “Teri is an entrepreneur at heart and has a proven track record of building businesses across a variety of industries. Teri’s role is important to our ambition of meeting the needs of Veterans living with tinnitus in the USA and I’m very much looking forward to working with her as she leads the development of our services in this area.”

Ms. Minard holds a Master’s degree of Business Administration and Management from Pepperdine Graziadio Business School and Arizona State University, and is a Certified Six Sigma Master Black Belt.

Speaking on her appointment, Ms. Minard said: “Neuromod’s vision to introduce an evidence-based neuromodulation treatment has the required ambition to resolve the unmet clinical need that tinnitus presents for Veterans in the USA. I’m looking forward to working with the wider Neuromod team to make that vision a reality.”

Ms. Minard is the latest addition to Neuromod USA’s leadership team. The organisation was established earlier in 2021 as a wholly owned subsidiary of Neuromod Devices Ltd. In September the organisation announced the appointment of Mr. Eric Timm, an experience hearing healthcare executive, as CEO of Neuromod USA. In August, the company announced the formation of its leadership team with the hiring of three executives with previous hearing healthcare experience. Stephanie Glowacki joined the organization as Chief Financial Officer, Dr. Tish Ramirez (AuD) as Chief Commercial Officer, and Holly Dean as Director, Commercial Sales.

Neuromod specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US.

This funding has been led by Fountain Healthcare Partners, an international life science focussed venture capital fund which invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms(iv). 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field(v).

References:

(i) American Tinnitus Association, (https://www.ata.org/understanding-facts)

(ii) U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey

(iii) USVA Annual Benefits Report 2019

(iv) As measured by Tinnitus Handicap Inventory score

Syndesi Therapeutics announces commencement of dosing in clinical trial of SDI-118 in elderly subjects with cognitive impairment

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, announces that dosing has commenced in the first clinical trial in the next phase of development of its lead compound, SDI-118.

The double-blind, placebo-controlled, parallel group study will evaluate the safety, tolerability, and pharmacodynamics of SDI-118 in elderly male and female participants with cognitive decline. Eligibility for enrollment in the study includes self-reported and companion-confirmed decline in memory, as well as a below average performance on a delayed word recall test as an objective measurement of cognitive deficit. The study includes fMRI imaging, both at rest and during cognitive tasks, as a biomarker of drug effect, as well as a battery of cognitive tests conducted at baseline and following approximately two weeks dosing with SDI-118 or placebo. The design of the study was the subject of a presentation at the recent European College of Neuropsychopharmacology (ECNP) annual conference (1), held 2-5 October 2021

Subjects are currently being enrolled at St Pancras Clinical Research in London, with additional sites in Germany to be initiated shortly.

Commenting on the initiation of the study, Jonathan Savidge CEO of Syndesi said “We are very excited to get this proof of principle study with SDI-118 underway to explore the potential of this novel synaptic mechanism to mitigate cognitive impairment due to underlying synaptic loss.”

Torsten Madsen, Syndesi’s CMO added “We are incorporating fMRI both before and after treatment in all subjects to translate preclinical results and build on findings from fMRI measures in a prior clinical study. Together with the battery of cognitive tests, this will provide a wealth of information on this novel synaptic mechanism to optimize the late stage development program”

(1) See: https://www.ecnp.eu/Congress2021/ECNPcongress/programme/Programme#!abstractdetails/0000469100

About Syndesi Therapeutics SA

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

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

Neuromod appoints Eric Timm as US Chief Executive Officer

• Timm to lead recently established U.S. team

• Neuromod USA Inc. established in anticipation of FDA approval for Neuromod's tinnitus treatment device

Neuromod Devices Ltd, the medical device company which specialises in neuromodulation technologies, has announced the appointment of Mr. Eric Timm as Chief Executive Officer of its recently established US entity, Neuromod USA Inc., effective from 1st October 2021.

Mr. Timm's appointment to lead the U.S. business comes as Neuromod prepares to enter the U.S. market with its proprietary medical device for tinnitus treatment, pending approval from the Food and Drug Administration.

Mr. Timm has significant experience, with leadership positions in medical devices and hearing aid companies spanning more than 35 years. He joins Neuromod from WS Audiology, one of the biggest hearing aid manufacturers in the world, where he was President and Chief Executive Officer of the company's U.S. wholesale business.

Before that, he was CEO of Sivantos USA when it merged with Widex to become WS Audiology. He had previously been Chief Operating Officer of Sivantos USA. In addition, Eric has held general management, sales, marketing and corporate strategy leadership positions at Phonak, Cardinal Health, Bristol-Myers Squibb and 3M.

In August, Neuromod announced the hiring of three experienced hearing healthcare executives to form Neuromod USA's leadership team and prepare for entry to the US market. Stephanie Glowacki joined the organization as Chief Financial Officer, Dr. Tish Ramirez (AuD) as Chief Commercial Officer, and Holly Dean as Director, Commercial Sales.

Working with the leadership team, Mr. Timm will be responsible for the development of the organization's strategy to work with the private and public hearing healthcare ecosystem to bring Neuromod's interventions for tinnitus to US patients.

Tinnitus is believed to affect between 10 and 15% of the global population. In the United States it is estimated that almost 50 million people suffer from this neurological condition[i], commonly referred to as 'ringing in the ears'. Of these, roughly 20 million people struggle with burdensome chronic tinnitus[ii]. According to the United States Department of Veteran Affairs, more than two million U.S. Veterans receive disability payments for service-connected tinnitus. This unmet clinical need makes tinnitus the department's largest and fastest growing cause of service-connected disability[iii].

Speaking on the appointment of Mr. Timm, Dr Ross O'Neill, CEO of Neuromod Devices commented: "Eric is a highly regarded executive that has operated at the highest levels in the hearing industry so we are delighted to have him on board to lead Neuromod's operation in the United States of America. In anticipation of FDA approval, we are developing our infrastructure to give ourselves the fastest start to meeting the needs of people living with tinnitus in the USA, a population that has been chronically underserved when it comes to patient care. Eric's vast experience and leadership will be instrumental for Neuromod in this exciting and pivotal time and I very much look forward to working with him."

Mr. Timm holds an MBA from the University of Wisconsin-Madison and a BA from Gustavus Adolphus College. He has also participated in post-graduate development studies with the faculty of INSEAD, the Kellogg Graduate School of Management at Northwestern University, as well as civilian training in warnings intelligence and countermeasures planning from the United States Defense Intelligence College.

Mr. Eric Timm said: "Neuromod is a unique company and its vision, to deliver treatments that reduce the suffering of patients underserved by existing clinical treatment options, is equally ambitious and inspiring. The company's Lenire tinnitus treatment device is backed by science which is pushing tinnitus care forward and is empowering patients and caregivers in Europe to successfully treat their condition. It's estimated that 50 million people in the USA suffer from tinnitus. Tinnitus is a serious medical condition and it deserves a serious, evidence-based treatment option."

Neuromod USA Inc. is a wholly owned subsidiary of Neuromod Devices Ltd. The company specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. To date Neuromod has raised more than €26 million in venture financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation's FDA submission process in the US.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austriaand Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients' tinnitus symptoms[iv]. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.[v]

For more information please contact:

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

References:

[i] American Tinnitus Association, (hhttps://www.ata.org/understanding-facts)
[ii] U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey
[iii] USVA Annual Benefits Report 2019
[iv] As measured by Tinnitus Handicap Inventory score
[v] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Calypso Biotech announces first patient with Celiac Disease dosed in anti-Interleukin-15 (IL-15) monoclonal antibody CALY-002 Phase 1b Trial, and extension of Series A to €28M

• Single ascending dose administration of CALY-002 to Healthy Volunteers successfully completed

• Dr Jos G.A. Houbiers MD, PhD joins Calypso Biotech as Chief Medical Officer

• Fountain Healthcare Partners join existing investors to extend Series A financing

• Proceeds to accelerate development of CALY-002 for auto-immune diseases including Celiac Disease, Eosinophilic Esophagitis and Dermatology

Calypso Biotech, a leader in the development of Interleukin-15 (IL-15) targeted therapies, announces today completion of dosing of first Celiac Disease patient in the Phase 1 clinical trial of CALY-002, a novel humanized monoclonal antibody neutralizing IL-15. The ongoing clinical study of CALY-002 includes a single ascending dose in Healthy Volunteers, now successfully completed, as well as ascending dosing of cohorts of patients with Celiac Disease and Eosinophilic Esophagitis, two indications with significant unmet medical need where IL-15 plays a critical role.

The company is now expanding the senior clinical management to reflect this important transition to clinical evaluation. Dr Jos G.A. Houbiers MD, PhD joined Calypso Biotech as Chief Medical Officer on June 1st. Dr Houbiers brings to Calypso Biotech over 25 years of experience in pharmaceutical clinical development from large pharma companies and from biotech, where he has implemented medical and clinical development strategies, creative trial design and comprehensive medical safety monitoring across therapeutic areas, including immunology, urology and pain. He most recently served as Chief Medical Officer at Summit Therapeutics. Dr. Houbiers received his MD from Leiden University Medical Center and PhD (immunology) and MSc in medicine from Leiden University

Reflecting this exciting clinical progression, Calypso Biotech raised an additional €8M to the 2019 Series A round, bringing its total Series A financing to €28M from new and returning investors. Fountain HealthCare Partners joins renowned syndicate of Gilde Healthcare, Inkef Capital, Johnson & Johnson Innovation - JJDC, Inc. (JJDC), and the company’s founding investor M Ventures. Dr. Ena Prosser from Fountain’s Dublin (Ireland) office has also joined the Board of Calypso Biotech. The additional proceeds of the Series A will be used to accelerate the development of CALY-002 in the core gastroenterology indications, further de-risk the asset, and develop a solid translational package to support the development of CALY-002 in additional auto-immune disease indications.

Alain Vicari, CEO of Calypso Biotech, commented: “We are delighted to welcome Dr Jos Houbiers to the team and to announce the extension of the Series A syndicate with Fountain Healthcare Partners. This further validates our ability to attract high-quality investors, and bodes well for our future fundraising campaign. These funds will accelerate the development of CALY-002 and bring us one step closer to propose a new treatment paradigm for auto-immune diseases to patients in need.”

About Calypso Biotech BV

Calypso Biotech BV is a private biotechnology company focused on the research and development of novel biologics to address unmet medical need in immunological diseases, with a unique expertise in IL-15 biology. IL- 15 controls immune pathways critically involved in disease onset and maintenance, as well as tissue destruction, in addition to its broad effect on inflammation. Calypso’s approach offers significant advantages over traditional cytokine interventional therapies, and could provide for unprecedented long lasting disease-modifying effects in multiple auto-immune diseases. Calypso Biotech is a spin-off by the healthcare business of Merck KGaA and is headquartered in Amsterdam, The Netherlands, with offices and laboratories in Geneva, Switzerland. The Company raised their initial Series A funding in 2018 with Gilde Healthcare, Inkef Capital, Johnson & Johnson Innovation - JJDC, Inc. (JJDC), and the company’s founding investor M Venture; Fountain Healthcare Partners joined this syndicate in 2021. For more information see www.calypsobiotech.com

Neuromod Establishes U.S. Presence, Adds Local Leadership

Neuromod Devices Ltd, the Irish medical device company specialising in the treatment of tinnitus, has announced the establishment of Neuromod USA Inc., a subsidiary headquartered in Oak Brook, Illinois.

Three executives with significant experience in the hearing health industry have been appointed to Neuromod USA’s leadership team as the organization prepares to enter the US market with its medical device for tinnitus treatment, pending approval from the Food and Drug Administration.

Stephanie Glowacki joins the organization as Chief Financial Officer. In this role she is responsible for the creation and management of Neuromod USA’s operating infrastructure, including finance, human resources and operations. Stephanie joins from WS Audiology where she held positions in finance, sales operations and as chief of staff to the wholesale Chief Executive Officer. Prior to that, she held positions of increasing responsibility in sales operations and corporate finance at Sivantos, Phonak, Tellabs and Andersen Consulting/Accenture. Stephanie holds a BA degree in economics and business from Hanover College.

Dr. Tish Ramirez (AuD) has joined the US organization as Chief Commercial Officer. In this position she is responsible for customers, interactions with consumers, as well as offering, launching, and introducing products to meet Neuromod USA’s strategic commercial objectives. Before Neuromod, Tish was vice president of clinical education and product management for WSAudiology. Prior to this, she held roles in clinical education, sales management and as a clinical audiologist at Sivantos/Siemens, Phonak and CIGNA Healthcare. Tish holds a doctorate degree in Audiology from A.T. Still University, an MS from Arizona State University and a BS degree from the University of Arizona.

Holly Dean joins Neuromod USA as Director, Commercial Sales. In this role she oversees Neuromod USA’s sales activities to private practices. Holly comes to the organization from WS Audiology where she held the position of Director of National Accounts. In that role, she led a team that provided substantial growth within the buying groups, third party, insurance and medical channels. Before WSAudiology, Holly held positions of increasing responsibility in sales leadership and territory management at Sivantos, Phonak and Sunovian Pharmaceuticals. Holly holds a BS degree from Louisiana State University.

Collectively, Neuromod USA’s leadership team will lead the development of the organization’s strategy to work with the private and public hearing healthcare ecosystem to bring Neuromod’s interventions for tinnitus to patients in the US.

Tinnitus is believed to affect between 10 and 15% of the global population and is commonly described as ‘ringing in the ears’. In the United States, tinnitus remains a significant healthcare need as it’s estimated that almost 50 million people suffer from this neurological condition . Of these, roughly 20 million people struggle with burdensome chronic tinnitus .

According to the United States Department of Veteran Affairs, more than two million US Veterans receive disability payments for service-connected tinnitus. This unmet clinic need makes tinnitus the department’s largest and fastest growing cause of service-connected disability.

Dr. Ross O’Neill, Founder and Chief Executive Officer at Neuromod Devices Ltd. commented on the recent developments in the US, saying “In order to give ourselves the fastest start to meet the needs of the estimated 50 million people in the USA with tinnitus, we are developing our US infrastructure. I am personally energized by the quality of talent joining the company and look forward to working with them on addressing the needs of the world’s largest tinnitus market.”

Neuromod specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has shown in large-scale clinical trials to reduce the symptoms of tinnitus. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. In October 2020, Neuromod announced it raised €10.5 million in an oversubscribed Series B financing round to fund ongoing expansion of the availability of Lenire in Europe and the organization’s FDA submission process in the US for the approval for Lenire.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the highly regarded journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms . 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.

References

i American Tinnitus Association, (https://www.ata.org/understanding-facts)
ii U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey
iii As measured by Tinnitus Handicap Inventory score
iv Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Neuromod appoints US hearing aid industry expert and audiologist, Susan Whichard to company board

Neuromod Devices Ltd, the Irish medical device company, has announced the appointment of Ms. Susan Whichard as a non-executive board member of the company.

Ms. Whichard has more than 30 years’ experience in the hearing industry, having worked as both a business executive and a practicing healthcare professional, as a clinical audiologist. Her appointment comes as Neuromod plans continued expansion of the availability of Lenire, its tinnitus treatment device across Europe and in the U.S., pending FDA approval.

A United States native, Ms. Whichard started her career as a clinical audiologist and established her own private practice. Later, she went on to represent her fellow professionals when she was appointed as President of the Academy of Doctors of Audiology (ADA), formerly the Academy of Dispensing Audiologists, from 1992-1994. The Academy dedicated to the advancement of practitioner excellence, high ethical standards, professional autonomy and sound business practices in the provision of quality audiologic care.

Following this, she became Vice President of Marketing and Product Development at GN Resound. Ms. Whichard went on to become Vice President of Marketing at InSound Medical, a start-up company that developed Lyric; the world’s first and only 24/7, invisible hearing aid.

In 2010, InSound Medical was acquired by Sonova, in a deal worth $175 million and following the acquisition, Susan joined hearing aid company, Phonak US (part of the Sonova group) as its Vice President for Business Development and Industry Relations. In 2018, she started a consulting business focused on start-up innovation in hearing and healthcare.

Speaking on the appointment of Ms. Whichard to the board, Dr Ross O’Neill, CEO of Neuromod Devices commented: “I am delighted to announce the appointment of Susan Whichard as a non-executive board member of Neuromod Devices Ltd. Susan brings a wealth of hearing aid industry experience to the table, having worked at the coalface as an audiologist and in leadership positions in some of the largest hearing aid companies in the world. Her guidance will be important in this exciting and pivotal time for Neuromod as we prepare to enter the U.S market, pending FDA approval, and as we continue to expand our commercialisation and availability of Lenire in Europe.”

Ms. Susan Whichard said: “Neuromod is one of the most exciting companies in the hearing space and in Lenire, the company has developed an excellent device, backed up by robust clinical research and data, which brings hope for millions of people with tinnitus across the world. I am excited to be in this position to advise this company which has so much potential.”

Neuromod specialises in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. Tinnitus is believed to affect between 10 and 15% of the global population.

Lenire is a non-invasive medical device that uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was recently published as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms. 86.2%(i) of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements (ii). This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.

(i) As measured by Tinnitus Handicap Inventory score
(ii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

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

System acquired to enhance hospital’s lymphatic’s program

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

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

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

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

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

About MMI

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

About University Hospital Zurich

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

Media Contact:

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

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

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

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

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

• Progress highlights potential of gene therapy in cardiovascular disease
  

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

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

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

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

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

About XC001

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

About the EXACT Study

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

About Chronic Refractory Angina

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

About XyloCor

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

Media Contact

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

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

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

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

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

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

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

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

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

About MMI

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

About University Hospital Salzburg

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

Contacts

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

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

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

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

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

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

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

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

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

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

About Vivasure Medical

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For more information please contact:

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

About Neuromod Devices Limited

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

About Lenire

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

About The Tinnitus Clinic Ltd

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

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

References

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

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

[iii] As measured by Tinnitus Handicap Inventory score

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

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

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

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

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

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

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

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

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

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

About MMI

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

###

For more information, contact:

Matter for MMI
Dan Ventresca
617-874-5488

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

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

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

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

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

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

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

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

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

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

About Inotrem

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

www.inotrem.com

About TREM-1 pathway

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

About Nangibotide

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

About ESSENTIAL study:

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

About Bpifrance

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

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

Follow us on Twitter: @Bpifrance

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

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

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

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

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

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

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

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

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

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

About NeRRe Therapeutics (www.nerretherapeutics.com)

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

About Columbus

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

For more information, refer to www.columbusvp.com

About Advent Life Sciences

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

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

About Fountain Healthcare Partners

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

About Forbion

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

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

About OrbiMed

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

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

About the Future Fund

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

For more information, please contact:

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

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

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

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

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

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