First Patient Enrollment into Aspero Medical NIH-Funded StudyFederal grant dollars extended to improve patient outcomes and procedure times
05 Feb 2024
Phase 2
Boulder, Colorado, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Aspero Medical, an Innosphere Venture Portfolio Company and medical device startup focused on design and development of innovative technology to improve gastrointestinal (GI) endoscopy procedures, had previously received clearance from the Food and Drug Administration (FDA) to market and sell the Ancora-SB small bowel balloon overtube which incorporates the company’s patented Pillar micro-texture balloon technology. Ancora-SB is indicated for use during small bowel enteroscopy procedures.
Aspero Medical was also awarded a National Institutes of Health (NIH) SBIR Phase II grant of $1.9 million to complete a double-blinded, multi-centered, randomized controlled trial (RCT), titled “Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures.” The purpose of the study is to demonstrate superiority over current standards of care and assess the potential to expand indications for use. The study will be specific to the middle third of small bowel for balloon enteroscopy and completion is expected by end of 2024. The first patient of this study was enrolled last week.
Balloon enteroscopy has become the standard of care in the drive to diagnose and treat small bowel disease. Unlike the Ancora-SB balloon made by Aspero Medical, 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 Ancora-SB (see image below) is characterized by the addition of a proprietary gripping micro-texture which reduces the potential for slippage and incomplete procedures, thereby potentially reducing procedure times and improving patient outcomes.
“We are beyond excited to have the first patient enrolled in the NIH-funded RCT. This marks the first step toward demonstrating the effectiveness of the Ancora-SB overtube as a reliable platform for the diagnosis and treatment of small bowel disease” said study principal investigator Vladimir Kushnir, MD, Professor of Medicine and Director of Interventional Endoscopy at Washington University in St Louis School of Medicine.
About Aspero Medical:
Aspero Medical’s patented Pillar micro-texture balloon technology was developed to improve gastrointestinal endoscopy procedure performance and outcomes. Aspero Medical was founded in 2018 by Mark Rentschler, PhD, PE, Professor of Mechanical Engineering at the University of Colorado Boulder, and Steven Edmundowicz, MD, Professor and Medical Director of the Digestive Health Center at the University of Colorado Anschutz Medical Center, and received initial equity funding through Innosphere Ventures, Fort Collins, Colorado.
About the NIH:
Ancora-SB research has been supported by the National Institute Of Diabetes And Digestive And Kidney Diseases of the National Institutes of Health under Award Numbers R43DK126504 and R44 DK126504. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Innosphere Ventures:
Innosphere Ventures accelerates the success of science and technology-based startup and emerging companies and operates a sed stage venture capital fund. As Colorado’s leading incubation program and commercialization expert, Innosphere’s program focuses on ensuring companies are investor-ready, connecting founders with experienced advisors and early hires, making introductions to corporate partners, exit planning, and accelerating top line revenue growth. Innosphere has been supporting Colorado startups for over 20 years and is a non-profit 501(c)(3) organization with a strong mission to create jobs and grow Colorado’s entrepreneurship ecosystem.
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About Aspero Medical
The Ancora-SB small bowel balloon overtube
Mark Rentschler, CEO, Aspero Medical
Aspero Medical
(303) 834-7885
mark.rentschler@asperomedical.com
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