Averto Medical Gains FDA Breakthrough Nod for ColoSeal Colonic Diversion

Averto Medical, a clinical-stage company focused on minimally invasive gastrointestinal (GI) care, has been granted U.S. Food and Drug Administration (FDA) breakthrough status for its ColoSeal intraluminal colonic diversion system.

ColoSeal aims to improve outcomes for patients undergoing colorectal surgery by removing the need for a temporary ostomy. Its goal is to enhance patient recovery and reduce complications that are associated with traditional surgical methods.

Last May, Averto Medical closed an oversubscribed $30.5 million Series A financing round. The funding is being used to advance ColoSeal’s clinical testing and advance it toward regulatory approvals. The company was also awarded a $1.8 million grant from the National Cancer Institute  (NCI) of the National Institutes of Health (NIH) in September 2024 to further support ColoSeal’s clinical evaluation.

Breakthrough device status expedites development and review of medical devices that provide significant advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. Averto Medical will benefit from prioritized FDA interactions and a streamlined review process.

“At Averto Medical, our mission is to push the boundaries of innovation in gastrointestinal care,” said Kenton Fong, CEO of Averto Medical. “This FDA designation highlights our highly differentiated technology in a white-space market where there is strong demand from both patients and providers for an ostomy replacement solution.”