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

> **NIH NIH R44** · AVERTO MEDICAL INC · 2024 · $838,162

## Abstract

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 tr...

## Key facts

- **NIH application ID:** 11007069
- **Project number:** 1R44CA287615-01A1
- **Recipient organization:** AVERTO MEDICAL INC
- **Principal Investigator:** Kenton Dodyan Fong
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $838,162
- **Award type:** 1
- **Project period:** 2024-09-20 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007069

## Citation

> US National Institutes of Health, RePORTER application 11007069, Safety and Efficacy Trial of the ColoSeal ICD System for the Treatment of Rectal Cancer Patients (1R44CA287615-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11007069. Licensed CC0.

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