Aspero Medical, a CU spin-out company co-founded by Professor Mark Rentschler, has received clearance from the Food and Drug Administration (FDA) to market and sell the Ancora-SB small bowel balloon overtube that incorporates the company’s patented Pillar micro-texture balloon technology. The Ancora-SB device is used for small bowel enteroscopy procedures.
“We are incredibly pleased to receive FDA 510(k) clearance for the Ancora-SB device, and look forward to seeing the anticipated clinical benefits,” said Dr. Rentschler, Aspero Medical CEO. “We believe this novel balloon design will have a significant impact for both caregivers and patients.”
Balloon endoscopy has become the standard of care in the drive to diagnose and treat small bowel disease. Unlike the Aspero Medical Pillar balloon, which is characterized by the addition of a proprietary gripping micro-texture, current balloons are smooth and round, making them prone to slippage. Ineffective balloons are estimated to result in significantly increased annual healthcare costs annually due to incomplete or lengthened procedures.
“The ever-increasing number of patients suffering with small bowel disease requires that we look to develop innovative diagnostic and treatment options, including devices like the Ancora-SB which is designed to enable more efficient small bowel enteroscopy procedures,” said Dr. Steven Edmundowicz, Chief Medical Officer for Aspero Medical. “We look forward to ensuring that the Ancora-SB is available for all cases where the innovative design can make a difference.”
Ancora-SB, a next-generation balloon overtube for GI endoscopy procedures, was initially developed in part through grant funding from the State of Colorado’s Office of Economic Development and International Trade and through National Institutes of Health (NIH) SBIR grant funding. Aspero Medical is continuing to innovate in GI endoscopy, and plans to expand the Ancora platform as additional products are brought to market in the near future.
“There are significant limitations with current technology used in gastrointestinal endoscopy procedures, but Aspero has developed an alternative that will potentially improve performance of certain procedures, save time for practitioners and patients, and improve patient outcomes,” said Mike Freeman, Innosphere Ventures general partner. “We look forward to continuing to support the company and the ongoing product development efforts.”