FDA Authorizes Fresca Medical to Market the CURVE™ System to Treat Sleep Apnea

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  • FRESCA Medical

    FRESCA is a next-generation respiratory medical device and technology company dedicated to making treatment for Obstructive Sleep Apnea comfortable to the millions of people who suffer from these conditions.

  • FRESCA Medical

    A New Type of Treatment for Obstructive Sleep Apnea

  • FRESCA Medical

    Reclaim Your Night™

Our Story

FRESCA Medical, Inc. addresses the $7 Billion Global Therapeutic Obstructive Sleep Apnea (OSA) market with a patient-friendly and ergonomically-elegant solution. FRESCA is developing a new option for the treatment of OSA, low-flow Positive Airway Pressure with the potential to usher in a new age of treatment to millions of sufferers. The company has completed clinical studies, developed a robust intellectual property portfolio, established manufacturing and distribution partnerships, and is preparing to launch in the US, China, Japan and Europe after regulatory approvals are secured.

Our Team

  • John Cox

    President and CEO

  • Jim Downes

    Chief Financial Officer (fractional)

  • Mary Lou Mooney

    Vice President – Clinical, Regulatory and Quality Affairs


  • Rich Ewers

    Director of Research and Development

  • Nirav Patel

    Manager, Systems Engineering

  • Ed McCarthy

    Director of Business Development

John Cox

President and CEO

John joined FRESCA Medical as President and CEO in 2016, and is a 29 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 FRESCA, 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.

Jim Downes

Chief Financial Officer (fractional)

Jim has over 30 years of experience in finance and accounting. Highlights of Jim's career include 10+ years at Plante Moran CPA's as a CPA and corporate auditor. He served as Vice President and CFO of Urban Science, where he was responsible for finance, human resources, IT, and international expansion. The company won the Ernst and Young Entrepreneur of the Year award. He later spent time at KPMG in their Capital Markets Group (Mergers and Acquisitions) and as a Certified Turnaround Professional (CTP) working with distressed companies during the Great Recession. Currently Jim works with Signature Analytics as a fractional CFO for a select group of emerging growth companies in various industries, including life sciences.

Mary Lou Mooney

Vice President – Clinical, Regulatory and Quality Affairs

Mary Lou has over 30 years of experience and has successfully guided five startups through US approval. Prior to joining FRESCA, Ms. Mooney served as the Vice President of Regulatory, Clinical & Quality at three startup companies: Reshape Medical, USGI Medical, and SenoRx. Her regulatory and clinical experience also includes senior management positions with cardiovascular and surgical device manufacturers. From 2001 to 2005, she served as the industry representative on the FDA Obstetrics and Gynecology Devices Advisory Panel. Ms. Mooney holds an MS in Biomedical Science from Drexel University and a BA in Biology from La Salle University.

Rich Ewers

Director of Research and Development

Rich is the architect of the commercial SmartValve™ technology that is the key to the FRESCA value proposition. He has 20 years of medical device experience and is named on over 100 patents and applications. Rich is a mechanical engineering expert with extensive experience in developing and protecting intellectual property. Before joining FRESCA, Rich held several senior director roles at Voyage Medical, USGI Medical, and Applied Medical. Rich has played an integral part in the development of many innovative medical devices, such as the Gel Port, which was awarded the Laparoscopic Innovation of the Year by the Society of Laparoscopic Surgeons. Rich holds a Bachelor of Science in Mechanical Engineering from California State University Long Beach.

Nirav Patel

Manager, Systems Engineering

Nirav is a Systems Engineering expert with over 15 years of experience in the development of respiratory medical devices. He is leading the development of the commercial flow generator for the FRESCA positive airway pressure system. Prior to joining FRESCA, Nirav has held senior engineering positions with medical device companies such as Fresenius Medical Care, Karl Storz, Philips, and Covidien. Nirav holds a Bachelor of Science degree in Instrumentation and Control Engineering at Dharmsinh Desai Institute of Technology and a Master's of Science in Electrical Engineering at the University of Southern California. He also received an EMC Certificate in System Design from the Missouri University of Science and Technology.

Ed McCarthy

Director of Business Development

Ed has over 20 years of business development, marketing and sales experience in the medical device and healthcare industries. Before joining FRESCA, he was the Director of International Business Development for USGI Medical. Ed has also held Executive Management positions with providers of Assisted Living, Skilled Nursing and Memory Care such as Emeritus and The Ensign Group. He completed his undergraduate studies at California State University, Chico and he earned his MBA at the Marshall School of Business at the University of Southern California.

Our Board and Advisors

  • Otto To

    Board Member

  • Matthew Weil

    Board Member

  • George Wallace

    Co-Founder and Advisor (Board Observer)

  • Andrew Cragg, MD

    Co-Founder and Advisor (Board Observer)

  • Alan Schwartz, MD

    Advisor

  • Mark Goetting, MD

    Advisor

  • John Trusheim, MD

    Advisor

  • Gary Zammit, PhD

    Advisor

Otto To

Board Member

Otto is the Executive Director and CEO of Vincent Medical Group, a Hong Kong based respiratory company and the largest shareholder in FRESCA Medical. 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.

Matthew Weil

Board Member

Matthew joined Christopher Weil & Company, Inc. in January 2009 after nearly two decades litigating intellectual property matters, principally patents. He is a Registered Investment Advisor Representative in a firm of investors, managers, and advisors. Matthew serves as General Counsel for CWC Asset Advisors, Inc. Before joining CWC, he was a partner in the law firm of McDermott Will & Emery LLP. He was a past President of the Orange County Patent Law Association and a current Director of the Preuss School UCSD and the Patricia & Christopher Weil Family Foundation and a trustee of the San Diego Repertory Theatre. He has served on the boards of several medical device companies. Matthew earned a BA in History and Russian Language from the University of California, Davis, a Masters in Political Science from Columbia University, and a J.D. from University of California, Berkeley, School of Law.

George Wallace

Co-Founder and Advisor (Board Observer)

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.

Alan Schwartz, MD

Advisor

Dr. Schwartz is a professor of medicine at the Johns Hopkins University School of Medicine. His areas of clinical expertise include pulmonary disease and critical care medicine. Dr. Schwartz directs the Johns Hopkins Sleep Disorders Center at Bayview Campus, the Sleep Medicine Fellowship Program and the Center for Interdisciplinary Sleep Research and Education with its Sleep Core Research Laboratory and Scoring Hub (Johns Hopkins Bayview Medical campus). His research interests include obesity and sleep apnea pathogenesis, nocturnal hypoxemia in COPD, and obesity and neural control in sleep-disordered breathing. He has served on the American Thoracic Society Program Committee and currently serves on the Planning Committee for the Sleep and Respiratory Neurobiology Assembly. He was recognized by the Department of Medicine with a Levine Excellence in Mentoring Award in 2011. He earned his M.D. from Johns Hopkins, completed his residency in internal medicine at Mount Sinai Medical Center and performed a fellowship in pulmonary, critical care and sleep medicine at Johns Hopkins.

Andrew Cragg, MD

Co-Founder and Advisor (Board Observer)

Andy is one of the co-founders of FRESCA 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 FRESCA technology from its concept to a commercial product. He brings a depth of clinical and research experience to the team. 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.

Mark Goetting, MD

Advisor

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.

John Trusheim, MD

Advisor

Dr. Trusheim served as an investigator for one of the early feasibility studies that demonstrated the effectiveness of the FRESCA 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

Advisor

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?

Snoring

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.

Gasping

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.

Sleepiness

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 CURVE™ Positive Airway Pressure System

The CURVE™ 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).

Contact us

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FRESCA Medical

1291 Puerta Del Sol, Suite #200
San Clemente, CA 92673

info@frescamed.com