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

  • 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.

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.

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