# A Novel Device Alternative to Temporary Diverting Ostomies after Rectal Cancer Surgery

> **NIH NIH R43** · AVERTO MEDICAL INC · 2021 · $298,509

## Abstract

PROJECT SUMMARY/ABSTRACT
Colorectal cancer is the third most common cancer with about 30-40% of cases involving the rectum.
Rectal cancer is typically treated with neoadjuvant therapy and surgical resection. However, anastomotic
leaks can occur in up 10-18% of patients after resection with an associated high mortality due to severe
abdominal sepsis. Currently, diverting ostomies are typically placed above the anastomosis to mitigate
the severe consequences of an anastomotic leak, but temporary ostomies themselves are highly morbid,
have significant risk of mortality, are expensive to the healthcare system, and drastically impact patient’s
quality of life. Because the majority of patients do not develop severe anastomotic leaks, most patients
who receive temporary ostomies end up not actually requiring them. There exists a medical need to
provide protection to an anastomosis to prevent the severe consequences of leaks without the morbidity
of a temporary ostomy. Savage Medical has developed an intraluminal fecal diversion device that utilizes
a novel anchoring mechanism that is safe, reliable, easily reversible, and eliminates the need for
temporary ostomy surgery for most rectal cancer patients. This technology allows for only those small
percent of patients who develop severe leaks to undergo ostomy surgery while sparing the vast majority
of rectal cancer patients from requiring an ostomy. Eliminating the need for a temporary ostomies would
on average save over $25K per patient in direct surgical costs (ostomy surgery and reversal surgery) and
eliminate $8.5K per patient in annual ostomy maintenance costs. The quality of life for patients who would
avoid ostomies due to this technology would also be profoundly improved during their cancer treatment.
This proposed project is to perform design verification testing and large animal validation testing in an
anastomotic leak model for this novel medical device.

## Key facts

- **NIH application ID:** 10152724
- **Project number:** 1R43CA246987-01A1
- **Recipient organization:** AVERTO MEDICAL INC
- **Principal Investigator:** Kenton Dodyan Fong
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $298,509
- **Award type:** 1
- **Project period:** 2021-08-10 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10152724

## Citation

> US National Institutes of Health, RePORTER application 10152724, A Novel Device Alternative to Temporary Diverting Ostomies after Rectal Cancer Surgery (1R43CA246987-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10152724. Licensed CC0.

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