Eleven finalists selected for $100K pediatric medical device competition

WASHINGTON – Eleven finalists will pitch their pediatric medical device innovation during the annual “Make Your Medical Device Pitch for Kids!” competition at the Sixth Annual Pediatric Device Innovation Symposium. Hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. This year’s competition focuses on pediatric cardiovascular devices, an area of significant need where advancements can make life-saving differences in the care of children.

The symposium is set for Sunday, Sept. 23, 2018 in Philadelphia, Pennsylvania. Up to four prizes of $25,000 each are awarded to the winning presentations and each awardee receives consultation services from the Sheikh Zayed Institute’s innovation resource network.

Winners receive financial support and advisory services that help bring pediatric medical devices to market faster by bridging the gap that often follows the prototyping phase in the device development life cycle. 

Selected from a field of 45 submissions received from across the U.S. and internationally, finalists are: 

• Bardy Diagnostics, Seattle, Washington - a single patient use, continuous recording ambulatory ECG monitor that records for up to 7 days and is useable for all pediatric patients
• CardioSounds, Ann Arbor, Michigan -- non-invasive blood pressure monitor for continuous and accurate collection of blood pressure data 
• Circadiance, Pittsburgh, Pennsylvania – next generation cardiorespiratory monitor with Wi-Fi-enabled communication for use in hospital or home care to monitor breathing, heartrate and blood oxygen level in pre-term infants 
• Design Mentor, Inc., Pelham, New Hampshire – extracorporeal blood pump for short-term cardiopulmonary support of pediatric open-heart surgery patients requiring full or partial cardiopulmonary bypass
• Draper, Cambridge, Massachusetts – a pediatric valve designed for children, birth to age 6, that passively expands to a two-fold change in valve diameter to accommodate child growth
• EspeRare Foundation, Geneva, Switzerland -- a telemetry flow control technology platform for remote adjustment and precise control of pulmonary artery (PA) blood flow and PA blood pressure in congenital heart diseases
• Flow Forward Medical, Inc., Fairway, Kansas -- Pediatric arteriovenous fistula (AVF) eligibility system to improve hemodialysis treatment using AVF for children with end-stage renal disease
• NuPulseCV, Raleigh, North Carolina – a minimally invasive, long-term mechanical circulatory support device for pediatric patients with cardiac dysfunction 
• PECA Labs, Pittsburgh, Pennsylvania -   a novel expandable cardiovascular conduit that uses a minimally-invasive balloon catheter to allow for pediatric growth to reduce surgeries
• PolyVascular Corporation, Houston, Texas -- a minimally-invasive pediatric pulmonary valve replacement approach for young children with congenital heart disease  
• PyrAmes, Inc., Cupertino, California - lightweight wireless device to continuously and noninvasively monitor blood pressure of neonates in real time 

“There is a profound need for cardiovascular devices made specifically for children, especially the younger subpopulations of children under 18 years of age, where an estimated 1 million children nationally currently live with a congenital heart defect and about 40,000 births annually are affected,” said Kolaleh Eskandanian, Ph.D., vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. “Given the significant need, we decided to focus this year’s competition on cardiovascular innovation with the emphasis on also making novel devices available sooner for younger kids.  We are grateful to all innovators who applied and are committed to continuing a dialogue with them as well as providing consultation services where we can.”

Each finalist will have five minutes to present their innovation to the judging panel, which includes: 

• Susan Alpert, M.D., of SFA Consulting, a former director of the Food and Drug Administration (FDA)  Office of Device Evaluation and former senior vice president and chief regulatory officer of Medtronic;
• Vivian Emmely de Ruijter, MD, a pediatric surgery fellow at Stanford University Pediatric Health Technology Incubator;
• James R. Love, partner, the law firm of Oblon;
• Matt Maltese, PhD, director of Biomechanics Research for the Department of Anesthesiology & Critical Care Medicine at Children's Hospital of Philadelphia;
• John Parker, managing director at Springhood Ventures, L.L.C.; 
• Jacqueline Phillips, M.D., senior director, Pediatric Product Development, Johnson & Johnson;
• Kyp Sirinakis, managing partner, Epidarex Capital;
• Eric Stone, CEO and co-founder, Velano Vascular, Inc.; and
• Kathryn Zavala, PhD, vice president of operations and business development, MedTech Innovator. 

The pitch competition is one feature of the day-long annual symposium devoted to the challenge of bringing more and better medical devices to market to serve the needs of children. Again this year, the nation’s leading pediatric innovation symposium is a joint effort with The MedTech Conference powered by AdvaMed. The pediatric symposium brings together medical device innovators, investors, researchers, clinicians and policy makers. This year’s theme is “Using Real World Evidence to Drive Pediatric Innovation,” recognizing the recently issued finalized guidance from the FDA for medical device developers’ use of real world evidence (RWE) and real world data (RWD) to gain FDA approval for medical devices.  

Program highlights include a keynote address by Hemant Virkar, president and CEO of Digital Infuzion, Inc. on how real world evidence can shape the regulatory pathway for devices.  A live podcast of “BioTalk with Rich Bendis” will feature an interview with Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, FDA , hosted by Richard Bendis, president and CEO of BioHealth Innovation, Inc. 

For the symposium agenda and registration, visit pediatric-device-symposium.org. 

Media contact: Debbie Asrate | 202-476-4500