Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, announce that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its ColoSeal™ Intraluminal Colonic Diversion (ICD) System. 

This designation underscores the potential of ColoSeal™ to significantly improve outcomes for patients undergoing colorectal surgery by eliminating the need for a temporary ostomy.

The FDA's Breakthrough Device Program is designed to expedite the development and review of medical devices that offer substantial advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. With this designation, Averto Medical will benefit from prioritized FDA interactions and a streamlined review process, facilitating timely access to this innovative solution for patients and healthcare providers.

"Receiving the Breakthrough Device Designation from the FDA is a significant milestone," said Grace Carlson, Vice-President of Clinical and Regulatory Affairs at Averto Medical. "This recognition highlights the transformative potential of ColoSeal™ in colorectal surgery. We are committed to advancing this technology to improve patient outcomes, quality of life, and healthcare costs."

In May 2024, Averto Medical announced the successful closing of an oversubscribed $30.5 million Series A financing round, led by Cormorant Asset Management, with participation from Venrock Healthcare Capital Partners, LifeSci Venture Partners, CVF, and other investors. This funding is being utilized to advance the clinical testing of the ColoSeal™ system towards regulatory approvals. Additionally, Averto was 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 clinical evaluation of the ColoSeal™ system.

"At Averto Medical, our mission is to push the boundaries of innovation in gastrointestinal care," said Kenton Fong, Chief Executive Officer 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."

The ColoSeal™ ICD is designed to provide a minimally invasive alternative to temporary ostomies, aiming to enhance patient recovery and reduce complications associated with traditional surgical methods. By offering a novel approach to gastrointestinal care, Averto Medical seeks to address unmet needs in colorectal surgery and improve the standard of care for patients.