Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Diverticular Disease Patients

Project Abstract Current surgical treatment guidelines for diverticulitis have been updated to favor reconstruction over Hartman’s Pouch, typically with an associated protective temporary ostomy. Thus, the use of temporary ostomies for the management surgical diverticular disease is becoming common and necessary, but has major drawbacks and costs, including high morbidity (>50%), high healthcare costs ($7.8 billion in the US), and significant reductions in patient well-being/quality of life. Importantly, it is reported that 16-50% of “temporary” ostomies are not reversed, leaving many patients with life-long stomas. Ostomy care, associated complications, and reversal surgery represent a heavy added burden to patients. There exists an unmet clinical need for a better alternative to temporary ostomies for diverticulitis surgery patients while still protecting patients from the potentially life- threatening complications of an anastomotic leak. To directly address this need, Averto Medical has developed a minimally invasive medical device that is safe, reliable, and easily reversible as an alternative for temporary colonic protection. This innovative and proprietary technology directly addresses safety and reliability issues faced by previous attempts demonstrating avoidance in the majority of temporary ostomies for rectal cancer surgery – our beachhead indication - with potential future impacts on other indications (e.g. other colon cancers, inflammatory bowel disease, and acute bowel injury). We have tested our device in benchtop models, chronic survival animal models, and human clinical trials in rectal cancer patients outside the US. These studies demonstrate that the device is safe, easy to use, functions as intended, and well-tolerated by patients. In order to expand beyond our initial indication of rectal cancer, our next step in development is to treat subacute/elective (Aim 1) and acute, complicated (Aim 2) diverticulitis patients in a US-based clinical trial. Successful completion of these Aims will allow Averto to assess the safety of the device in this new indication and develop more refined clinical treatment protocols. Furthermore, these data will provide essential information on how the technology integrates with emergency/urgent surgery and other specific practice differences found in this patient population. The successful completion of these Aims will allow for the foundational work required for a larger indication- specific RCT and market adoption.