Averto Medical's ColoSeal™ Achieves FDA Breakthrough Device Designation

Averto Medical's Breakthrough in Colorectal Surgery

Averto Medical, a clinical-stage company specializing in minimally invasive gastrointestinal care, has exciting news: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to their innovative product, ColoSeal™ Intraluminal Colonic Diversion System. This major recognition signifies a pivotal advancement in patient care during colorectal surgery.

What is ColoSeal™?

Designed to enhance surgical outcomes, the ColoSeal™ system aims to provide surgeons with a novel alternative that can eliminate the need for temporary ostomies, which are often associated with several post-operative complications. This minimally invasive approach is set to improve recovery time and overall quality of life for patients after surgery.

The FDA's Breakthrough Device Program is specifically tailored to facilitate the development and review of medical devices that show significant advantages over traditional treatment methods for life-threatening or severely debilitating conditions. By earning this designation, Averto Medical can expect expedited communication with the FDA and a streamlined approval process, allowing them to bring this much-anticipated solution to market more quickly.

Significant Milestones for Averto Medical

Grace Carlson, the company's Vice-President of Clinical and Regulatory Affairs, expressed the significance of this achievement: "Receiving the Breakthrough Device Designation from the FDA is a significant milestone! 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 alignment with their ambitious development plans, Averto Medical successfully closed a hefty $30.5 million Series A financing round in May 2024, led by prominent investors including Cormorant Asset Management. With these funds, the company is set to push forward with clinical trials culminating in regulatory approvals. Moreover, in September 2024, Averto Medical secured a $1.8 million grant from the National Cancer Institute (NCI), further supporting the development of the ColoSeal™ system.

A Vision for the Future

Kenton Fong, Averto Medical's CEO, articulated the company’s vision: "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 ColoSeal™ ICD, which employs cutting-edge technology, is set to revolutionize the standards of care in colorectal surgery, addressing the unmet needs of patients and healthcare providers. Its ability to reduce complications associated with traditional surgical options presents a promising solution that is anticipated to reshape current practices.

As Averto Medical continues its development journey, the implications for healthcare professionals and patients alike are immense. With the potential to significantly improve the post-operative experience, the ColoSeal™ system could well mark a new chapter in gastrointestinal surgery.

For those interested in the advancements made by Averto Medical, further information can be accessed on their official website at www.avertomed.com. The company remains committed to pioneering improvements in the treatment of gastrointestinal diseases through innovation and comprehensive care strategies.

Conclusion

The breakthrough achieved by Averto Medical serves as a reminder of the importance of innovative medical technologies in enhancing patient outcomes. With the FDA's accelerated pathway to approval, the hope is that ColoSeal™ will soon be widely available, improving the surgical experience for countless patients undergoing colorectal procedures.