Somnera® is a privately held sleep solutions and connected health innovator. The company’s new treatment for Obstructive Sleep Apnea (OSA), secured its first FDA clearance in 2018, followed by the clearance of its commercial-ready Somnera System in June 2020. The Somnera® System is small, lightweight, and easy to use, ushering in a new era of sleep for OSA patients. Somnera’s technology is cloud-connected, taking advantage of the latest advances in cloud-based data analytics, patient engagement, and automated reorder/subscription models. Somnera holds six issued US patents, has completed two randomized clinical studies, and is now launching the Somnera System in the United States. Somnera’s dedicated and experienced management team is poised to capture share in the $35B available market for better OSA therapies and provide outstanding return to its shareholders.
John joined SOMNERA as President and CEO in 2016, and is a 30 year veteran of the Medical Device Industry. John has held leadership roles in nearly every function, from sales to operations, where he has led numerous products and businesses through development and transformative growth. Prior to joining SOMNERA, John was the Chief Operating Officer of USGI Medical, where he led the development and commercialization of a breakthrough non-invasive surgery platform. He has held senior executive and management roles for several medical device manufacturers such as B. Braun Aesculap, Applied Medical, and U.S. Surgical. John also serves as Chairman and Co-Founder of Retraction Ltd., a Hong Kong-based innovator in minimally invasive surgery. John is named on over 20 US and foreign patents, and earned his MBA with honors from the University of Virginia’s Darden School of Business. Recently, he won OCTANe’s “Elevator Pitch” contest representing Somnera as a LaunchPad finalist in 2017, and was selected to be the Master of Ceremonies at the 2019 Medical Technology Innovation Forum (MTIF), Orange County’s largest annual Medtech meeting.
Mary Lou has over 30 years of experience and has successfully guided five startups through US approval. Prior to joining SOMNERA, she served as the Vice President of Regulatory, Clinical & Quality at four startup companies: Reshape Medical, USGI Medical, SenoRx and Focal. Her regulatory and clinical experience also includes senior management positions with cardiovascular and surgical device manufacturers. Mary Lou has designed and successfully executed numerous clinical studies used to support PMA approvals and 510(k) clearances. From 2001 to 2005, she served as the industry representative on the FDA Obstetrics and Gynecology Devices Advisory Panel. Mary Lou led Somnera through the rigorous FDA de novo request process in 2017, which was granted in just five months. Recently, Mary Lou secured 510(k) clearance of the Somnera System in just 112 days. Ms. Mooney holds an MS in Biomedical Science from Drexel University and a BA in Biology from La Salle University.
Tracy Maahs is responsible for Somnera’s manufacturing scale-up, operations and engineering. Tracy is a proven leader in Engineering and Operations Management. With nearly 30 years of experience, Tracy has held executive positions in general management, operations and R&D. Tracy has led the development of disruptive technologies in interventional cardiology, orthopedics and endoluminal surgery. Before joining SOMNERA, Tracy was the Chief Operating Officer at USGI Medical, where he led the development and manufacturing scale-up of a revolutionary endoscopic surgery platform, now one of the most successful non-invasive treatments for obesity in Europe. Tracy held senior R&D and product development roles at Volcano Corporation, Embol-X, Arthrocare and Heart Rhythm Technologies. He earned his BSME from Kettering University and is named in over 75 US and foreign patents.
OUR BOARD AND ADVISORS
Otto is the Executive Director and CEO of Vincent Medical Group, a Hong Kong based respiratory company and the largest shareholder in SOMNERA. Otto joined Vincent Medical in February 2000 and is primarily responsible for overseeing the corporate management and formulating the business and product development strategies of the Group. Before joining Vincent Medical, Otto worked in the audit division of H. L. Leung & Co, Certified Public Accountants from January 1991 to December 1992. He also held various accounting positions in Deloitte Touche Tohmatsu from January 1993 to April 1996.Otto earned a Bachelor’s degree in Commerce from Murdoch University, Australia in August 1990. He further obtained a Master’s degree in Science in Chinese Business Studies from the Hong Kong Polytechnic University in November 2010. He was the vice chairman of the Hong Kong Medical and Healthcare Device Industries Association from 2015 to 2016. He is also an associate member of the Hong Kong Institute of Certified Public Accountants.
George is a veteran corporate executive and founder of many successful companies. He currently is managing general partner for Intersect Partners LLC, which was formed as a research incubator and investment vehicle dedicated to advancing and founding disruptive medical device companies. Intersect Partners also founded, among others, MindFrame and Altura Interventional, a company dedicated to the treatment of aneurysms. Prior to Intersect Partners, George cofounded and managed four companies: Sub-Q, Micro Therapeutics, TranS1, and ReShape Medical. He also served as general manager of the Applied Vascular and Urology Divisions of Applied Medical Resources, Vice President of Marketing and Sales for Vaser, and held various positions at Edwards Laboratories. George holds a BS in Marketing from Arizona State University.
Andy is one of the co-founders of SOMNERA and a serial entrepreneur and inventor with over 200 patents to his name. Andy has founded over a dozen companies with his inventions and is an expert at the intersection of clinical science and technology development. Andy has been instrumental in the development of the SOMNERA technology from its concept to a commercial product. He brings a depth of clinical and research experience to the team and advises SOMNERA’s scientific projects and programs. He is a Researcher at the Minneapolis Heart Foundation, an Interventional Radiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital and a Clinical Professor of Radiology at the University of Minnesota. He attended Medical School and conducted his Residency and Fellowship at the University of Minnesota.
Dr. Goetting is a clinical associate professor in the Department of Pediatric and Adolescent Medicine and the Department of Medicine at the Western Michigan University, Homer Stryker M.D. School of Medicine. He is Board Certified in neurology, pediatrics, sleep medicine, obesity medicine and lifestyle medicine. Dr. Goetting earned his medical degree in 1980 from Michigan State University College of Human Medicine and completed postgraduate training at the University of Michigan and Henry Ford Hospital. Dr. Goetting is a member of the Bronson Healthcare Group and is the immediate past president of the Michigan Academy of Sleep Medicine. He directs the sleep medicine program and is active in medical education and research.
Dr. Trusheim served as an investigator for one of the early feasibility studies that demonstrated the effectiveness of the SOMNERA technology. His specialties include Psychiatry, Neurology and Sleep Medicine. Dr. Trusheim is an assistant clinical professor at the University of Minnesota Medical School and medical director of neuro-oncology at the Virginia Piper Cancer Institute. In addition, Dr. Trusheim is medical director of the Givens Brain Tumor Center at Abbott Northwestern hospital. He received his medical degree from University of Missouri-Columbia School of Medicine and conducted his residency and Fellowships at the University of Minnesota. Dr. Trusheim has been in clinical practice for more than 20 years.
Gary Zammit, PhD, is a scientist and the President & CEO of Clinilabs, Inc. He is also the Executive Director of the Sleep Disorders Institute in NY, and a Clinical Associate Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai, NY. Dr. Zammit is a widely recognized key opinion leader in the field, an award-winning entrepreneur, a contributor to FDA workshops, and an advisor to the senior management of pharmaceutical and medical device companies. He has authored more than 180 original publications and two books, and has served as a reviewer and editor for well-known medical journals.
HOW DO I KNOW IF I HAVE OBSTRUCTIVE SLEEP APNEA?
One of the most common signs of obstructive sleep apnea is loud and chronic (ongoing) snoring. Pauses may occur in the snoring. Choking or gasping may follow the pauses. The snoring usually is loudest when you sleep on your back; it might be less noisy when you turn on your side.
You're asleep when the snoring or gasping happens. You likely won't know that you're having problems breathing or be able to judge how severe the problem is. A family member or bed partner often will notice these problems before you do.
Another common sign of sleep apnea is fighting sleepiness during the day, at work, or while driving. You may find yourself rapidly falling asleep during the quiet moments of the day when you're not active. You may also develop memory, learning or concentration problems.
INDICATIONS FOR USE: THE SOMNERA® SYSTEM POSITIVE AIRWAY PRESSURE SYSTEM
The Somnera Positive Airway Pressure System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea. The system includes a dedicated flow generator and a patient interface, and is intended for use in the home environment. This system is to be used by adult patients weighing more than 66 lbs (30 kg).