Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients

PROJECT SUMMARY/ABSTRACT Ostomy surgery for intestinal diseases are performed in around 130,000 patients annually in the US. Although currently fundamental to colorectal disease care, ostomies are associated with profound negative impacts on the quality of life of patients, high morbidity (around 50%), and high healthcare costs. Despite advances in the diagnosis and treatment, colorectal cancer remains the third most common cancer with about 30-40% of cases involving the rectum. Currently, most rectal cancer patients are treated surgically, and most will undergo temporary ostomy creation. Ostomy care, associated complications, and reversal surgery represent a heavy added burden to patients who must already undergo difficult cancer treatment. There exists a medical need for a technology that can safely eliminate this burden by replacing the important function of an ostomy without the negative consequences. Savage Medical has developed a technology that replaces the need for a temporary ostomy with a proprietary minimally-invasive medical device that is safe, reliable, easily reversible. This technology allows for only the small percent of patients who develop severe leaks to safely undergo delayed ostomy surgery while sparing the vast majority of rectal cancer patients from requiring an ostomy. Savage Medical estimates that around 90% of temporary ostomies for rectal cancer surgery can be safely avoided with this new technology. Successful implementation of this technology would dramatically change how rectal cancer patients are treated and has the potential to be used in a variety of both surgical and non-surgical colorectal diseases where temporary protection of the colon from fecal flow is important to prevent severe infection or expedite healing. This represents a combined total accessible worldwide market of >$10 billion. Eliminating the need for a temporary ostomy would on average save around $65K per patient treated, resulting in a potential impact of up to around $7.8 Billion on healthcare expenditures annually in the US. Although not all temporary ostomies can be eliminated, the impact on both the individual patient and US healthcare system are potentially tremendous. Savage Medical has successfully completed all the FDA required testing and animal studies to demonstrate safety and effectiveness, and the device has had early clinical success in human clinical trials. The clinical trial proposed here will allow Savage Medical to further refine clinical protocols, access use factors, and complete the final commercial design while providing valuable clinical data on both safety and efficacy for regulatory approval and fundraising. Savage Medical has assembled a highly experienced team of leading colorectal surgeons and clinical trial specialists to perform the proposed human study at some of the most prestigious and well-regarded hospitals in the country. The Principle Investigator has personally organized and led over twelve GCP clinical trials both in the US and abroad including a large 14 center randomized-control trial. The core clinical trial team has a combined experience of over 90 years executing FDA-regulatory clinical trials. Completion of this project will allow Savage Medical to raise the private capital necessary for funding a future pivotal randomized- controlled trial, gain FDA regulatory clearance, and begin commercial treatment of patients.