Aspero Medical completes animal clinical study and announces the formation of Clinical Advisory Board
We are very encouraged by the results from this clinical evaluation, said Dr. Steven Edmundowicz, Aspero Medical Chief Clinical Officer.
Boulder, Colorado, Dec. 29, 2020 (GLOBE NEWSWIRE) -- Aspero Medical, a medical device startup focused on developing new products for the field of gastroenterology recently completed the company’s first enteroscopy and colonoscopy animal clinical study. The study was performed to compare currently available smooth silicone balloons with Aspero Medical’s micro-textured balloon on the Ancora balloon overtube.
In the study, a smooth silicone balloon was utilized as the control against the Aspero Medical micro-textured balloon to assess safety of the Ancora design on intestinal mucosa. Histopathological evaluation of small intestine following the procedures revealed minimal histologic changes. Overall, findings were generally minimal or absent in all examined sections of small intestine, independent of the treatment. No differences in intestinal integrity were observed between areas where a smooth silicone balloon was used and comparative sections where the Aspero Medical balloon was used.
“We are very encouraged by the results from this clinical evaluation, said Dr. Steven Edmundowicz, Aspero Medical Chief Clinical Officer. “This clinical data provides yet further evidence to advance the development and introduction of a next generation single balloon overtube for GI endoscopy procedures.”
Balloon endoscopy has become the standard of care in the drive to diagnose and treat small bowel disease. Unlike the Aspero Medical balloon, which is characterized by the addition of a proprietary gripping PillarTM micro-texture, current balloons are smooth and round, making them prone to slippage. Ineffective balloons are estimated to result in over $100 million in increased annual healthcare costs annually due to incomplete or lengthened procedures.
“We are very pleased that this study has shown no difference in intestinal integrity when using the Ancora product,” said Mark Rentschler, CEO for Aspero Medical. “This study validates our core performance assumptions related to the PillarTM micro-texture technology developed by Aspero Medical. These results will enable the company to proceed full speed to finalize the design and move to commercialization.”
The company has also recently established a clinical advisory board (CAB) that is chaired by Dr. Edmundowicz. Joining the CAB will be John Vargo, M.D., M.P.H. and Andrew Ross, M.D. Dr. Vargo is the Head, Section of Advanced Endoscopy, Department of Gastroenterology and Hepatology, Digestive Disease Institute and Director, Endoscopic Research and Innovation Digestive Disease and Surgery Institute at Cleveland Clinic. Dr. Ross is the Interim Executive Director of the Digestive Disease Institute, Virginia Mason Medical Center in Seattle, WA. Dr. Vargo also served as president of the American Society for Gastrointestinal Endoscopy, 2019-2020.
“We are very pleased to have both Dr. Vargo and Dr. Ross join the clinical advisory board for Aspero Medical and assist the company in further evaluating the technology,” said Rentschler. “Both are outstanding leaders in the field of gastroenterology and their shared expertise will enable our team to fine tune the development of the next generation balloon overtube.”
The clinical advisory board will meet on a quarterly basis to monitor and evaluate continued development progress with the Aspero Medical product portfolio. The Board will be responsible for providing clinical perspective and partnering to develop future clinical investigational review of the company’s technology.
“We continue to be impressed Aspero Medical team’s progress,” said Mike Freeman, Innosphere Ventures general partner. “It is outstanding to see Dr. Vargo and Dr. Ross join the company’s clinical advisory board as well as the very positive clinical results from the recent study. Their positive momentum continues to build for a significant commercial launch in the near term.” Aspero Medial received initial equity funding through Innosphere Ventures.
MEDIA CONTACTS:
Mark Rentschler, CEO, Aspero Medical
(720) 315-5165 | [email protected]
James Willett, Aspero Medical Board of Directors
[email protected]
Attachments
Emily Wilson Innosphere Ventures 9702954481 [email protected] Mark Rentschler, CEO Aspero Medical (720) 315-5165 [email protected]