For Immediate Release: September 29, 2014
Contact: Dale Peterson, PhD, founder DRP Biomedical, (760) 607-6460, DRPBiomed@gmail.com
Breakthrough Medical Device Clears FDA Hurdle
NephroFlow® Designed to Help Millions Stricken with Loss of Kidney Function
CARLSBAD, CA-Today DRP Biomedical Inc. is applauding a U.S. Food and Drug Administration (FDA) decision to regulate its breakthrough technology to treat acute kidney injury as a medical device rather than as a drug.
“This is a very important FDA determination because it will further streamline the final development and testing of NephroFlow, a medical device designed to prevent permanent kidney damage or death for four million patients in the United States each year,” said Dale Peterson, Ph.D., the inventor and founder of DRP Biomedical.
Acute kidney injury (AKI) is a sudden loss of kidney function which has severe short and long term consequences. It is a relatively common clinical condition that results in death for a large number of people. There are over 4 million new cases of AKI each year in the US. Of those 900,000 are classified as severe cases, resulting in 190,000 deaths.
NephroFlow is a solution containing a drag-reducing polymer (DRP) that is given intravenously to mechanically increase blood flow in kidneys. This is a novel approach designed to cut the death rate in patients with acute kidney injury, which has no other effective treatment currently. Most cases of AKI are acquired in the hospital as a result of complications from other illnesses or interventions. The most common causes are infection, low blood volume (due to trauma, dehydration or surgery), or side effects of other drugs.
“Existing data show dramatic effects of drag-reducing polymers and DRP Biomedical’s early work shows promise in treating AKI in animals.” Peterson explained.
In pilot animal studies of severe AKI using NephroFlow, results showed improved kidney function within 24 hours. At the end of the 3-day experiment, the treatment had cut the death rate in half and improved the recovery rate 5-fold. The FDA’s decision to regulate NephroFlow as a device could lead to human studies in two years.
More information about NephroFlow and DRP Biomedical can be found at:
NephroFlow® is a registered trademark of DRP Biomedical Inc.
DRP Biomedical Team
Dale Peterson, PhD, the inventor and founder is working with a team of 5 experts serving as advisors in new business development, clin/reg, product development, marketing, and strategy roles. Dr. Peterson has successfully commercialized 17 medical devices including combination and PMA products such as the first clinical cell culture system (Stericell), the first clinical stem cell isolation system (CellPro), the first automated food pathogen identification instrument (RiboPrinter), and BioFiber products made from a new resorbable polymer. He holds 19 issued US patents in 8 disciplines. He has helped build three start-up companies (CellPro, Intent, Microvascular Tissues), successful joint ventures (Stericell, DePuy-Dupont Orthopedics, Qualicon), and participated in three IPO’s (CellPro, DePuy, Tornier). Dale has also worked for DuPont, Boehringer-Mannheim, J&J, and the Vertical Group.
Sterling Johnson spent the first 20 years of his career with Elanco and Eli Lilly in sales, marketing, new business development and management functions around the world. He left Lilly to become VP of Business Development of the Liposome Company and later founded and was CEO of Escalon Medical Inc. (ESMC). In addition to Escalon he has served as CEO of three start-up firms, run business development operations for clients, founded 4 companies, and served on numerous boards. It is estimated that he has negotiated over 150 JV, licensing, and M&A transactions. He is an investor and a member of the Board of Directors of DRP Biomedical.
Kevin Ohashi, PhD, is the co-founder of 7 MedTech start-ups. He has launched 11 medical devices and has consulted for a number of medical device companies in the areas of biomaterials, surgical sealants, stent technologies, and surgical instrumentation (pulmonary, vascular, ENT, orthopaedic, and cardiovascular). Kevin earned a BSc from the University of California at San Diego, an S.M. from Harvard-MIT Division of Health, Science and Technology, an MBA from MIT Sloan School of Management and a M.S. and Ph.D. from Stanford University. He is also on the Board of Directors.
Lael Pickett is a regulatory expert who has been extremely successful in gaining regulatory approvals in the US and Europe for devices, biologics, and combination products. She managed compliance issues for more than 20 years at 3M and has held leadership roles in regulatory affairs at Boston Scientific, Medtronic and Tornier. Lael also brings an outstanding network of experts who have held key positions at the FDA.
Dr. Joseph Bonventre MD/PhD holds appointments as Chief of both the Renal Division and the Founding Chief of the Biomedical Engineering Division at a large academic medical center. He runs a large, productive research lab focused on kidney injury, repair, and signal transduction and has over 300 peer-reviewed publications and 150 invited book chapters and reviews. He is past president of the American Society for Nephrology and received two MERIT awards from the NIH. He served as director of the Harvard-MIT Health Sciences and Technology program for 10 years and was the founding head of the Kidney Group and is now on the Executive Committee of the Harvard Stem Cell Institute. He is also the co-founder of two companies and an advisor to a number of other pharmaceutical and biotechnology companies. In addition to his BS with distinction in Engineering Physics from Cornell, Dr. Bonventre holds MD and PhD degrees in biophysics from Harvard University and honorary degrees from Mt. Saint Mary’s College and from the Norwegian Institute of Science and Technology.