Averto Medical announced today that its ColoSeal™ Intraluminal Colonic Diversion (ICD) System has received Breakthrough Device Designation from the U.S. Food and Drug Administration, marking a significant advancement in minimally invasive gastrointestinal care. The novel device aims to eliminate the need for temporary ostomies in patients undergoing colorectal surgery.
The FDA's designation acknowledges ColoSeal's potential to provide substantially improved treatment options for life-threatening or irreversibly debilitating conditions. This status grants Averto Medical priority access to FDA interactions and an accelerated review process, potentially expediting the device's path to market.
Clinical Impact and Market Potential
"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."
The ColoSeal ICD system represents a technological breakthrough in gastrointestinal care, offering a minimally invasive alternative to traditional temporary ostomies. The innovation addresses a critical need in colorectal surgery, potentially reducing complications and improving patient recovery experiences.
Financial Backing and Research Support
The company's development efforts are well-funded, having secured $30.5 million in an oversubscribed Series A financing round in May 2024. The funding round was led by Cormorant Asset Management, with participation from notable investors including Venrock Healthcare Capital Partners, LifeSci Venture Partners, and CVF.
Further validating the technology's potential, Averto Medical received a $1.8 million grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in September 2024. These funds will support the ongoing clinical evaluation of the ColoSeal system.
Strategic Vision and Market Opportunity
Kenton Fong, Chief Executive Officer of Averto Medical, emphasized the company's strategic position: "At Averto Medical, our mission is to push the boundaries of innovation in gastrointestinal care. 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 company is now focused on advancing clinical testing of the ColoSeal system toward regulatory approvals, with the breakthrough designation expected to streamline this process. As a privately held, clinical-stage medical technology company, Averto Medical continues to develop innovative solutions addressing unmet needs in gastrointestinal care, potentially transforming the standard of care for colorectal surgery patients.
