Averto Medical's ColoSeal™ Gets FDA Breakthrough Designation

Averto Medical, a medical device company at the forefront of gastrointestinal healthcare innovations, has achieved a noteworthy milestone. The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to their ColoSeal™ Intraluminal Colonic Diversion (ICD) System, a pivotal recognition for this clinical-stage company. This accolade highlights the potential of ColoSeal™ to revolutionize colorectal surgery by removing the necessity for temporary ostomies, which are often required post-surgery.

The FDA's Breakthrough Device Program aims to accelerate the development and evaluation of medical devices that present significant improvements over existing solutions for treating life-threatening or debilitating conditions. This designation provides Averto Medical with prioritized interactions with the FDA and an expedited review process, enabling quicker access to this cutting-edge technology for patients and the healthcare community.

Grace Carlson, Vice-President of Clinical and Regulatory Affairs at Averto Medical, expressed excitement over this development, emphasizing its importance in recognizing the transformative potential of ColoSeal™. She highlighted the company’s dedication to enhancing patient outcomes, improving quality of life, and reducing healthcare costs through advanced technology.

In the pursuit of bringing ColoSeal™ to market, Averto Medical secured $30.5 million in a Series A financing round in May 2024. This round was spearheaded by Cormorant Asset Management and included contributions from Venrock Healthcare Capital Partners, LifeSci Venture Partners, CVF, among others. The funds raised are being directed towards advancing the clinical trials necessary for regulatory approval of the ColoSeal™ system. In addition, the company received a $1.8 million grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) in September 2024, further supporting the clinical evaluation of this innovative system.

Kenton Fong, CEO of Averto Medical, underscored the company's commitment to pushing the boundaries of gastrointestinal care innovation. He emphasized the excitement surrounding the FDA designation, which highlights the company's unique technology in a market with substantial demand for alternatives to ostomies.

The ColoSeal™ ICD system offers a minimally invasive solution to temporary ostomies, aiming to promote better patient recovery and minimize complications traditionally associated with colorectal surgeries. By introducing this novel approach, Averto Medical aims to fulfill unmet needs within colorectal surgery and elevate the standard of care provided to patients.

Averto Medical is dedicated to developing pioneering medical solutions targeting gastrointestinal diseases. The company's mission is focused on enhancing patient outcomes by creating minimally invasive devices that address pressing clinical demands in gastrointestinal healthcare.

This significant FDA recognition places Averto Medical at the leading edge of innovation in gastrointestinal treatment, positioning them to potentially transform the landscape of colorectal surgical procedures. The company’s efforts continue to focus on bringing this promising technology to fruition, thereby offering improved care options for patients dealing with complex gastrointestinal conditions.