FDA OKs Aspero Medical’s enteroscopy device

BOULDER — Aspero Medical Inc., a University of Colorado Boulder spinoff and Innosphere Ventures Fund portfolio company, has received clearance from the federal Food and Drug Administration to market and sell its Ancora-SB balloon overtube for use during small bowel enteroscopy procedures.

The company had received a $310,000 grant in 2020 through the Small Business Investment Research program from the National Institutes of Health to develop the device, and it secured a patent for it in 2021.

“We are incredibly pleased to receive FDA 510(k) clearance for the Ancora-SB device, and look forward to seeing the anticipated clinical benefits,” Mark Rentschler, Aspero Medical’s CEO, said in a prepared statement. “We believe this novel balloon design will have a significant impact for both caregivers and patients.”

Enteroscopy is a procedure to examine the small intestine, which is more than 20 feet long but just an inch wide. 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 health care costs annually because of 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, Aspero’s chief medical officer. “We look forward to ensuring that the Ancora-SB is available for all cases where the innovative design can make a difference.”

The device was initially developed in part through grant funding from the state of Colorado’s Office of Economic Development and International Trade.

Aspero Medical plans to expand the Ancora platform as additional products are brought to market in the near future.

“There are significant limitations with 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, general partner at Fort Collins-based Innosphere Ventures Fund. “We look forward to continuing to support the company and the ongoing product development efforts.”

Rentschler, a professor of mechanical engineering at CU Boulder, and Edmundowic, a professor and medical director of the Digestive Health Center at the University of Colorado Anschutz Medical Center in Aurora, founded Aspero in 2018 with help from initial equity funding through Innosphere Ventures.

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