Leto Medical’s™ Continent Ostomy System – A Preclinical Update of a Novel Electrical Stimulation Device to Restore Continence Control to Individuals with Colostomy

Jaime Cavallo, MD, John Minasi, MD, James Schneider, MBA, Seung Hyuk Baik, MD, Alyssa Fajardo, MD, Logan McKenna, BS, Michael Talcott, DVM, James Fleshman, MD. Leto Medical, LLC (Fernandina Beach, FL) and Washington University School of Medicine in St. Louis, Division of General Surgery – Colon & Rectal and Division of Comparative Medicine (St. Louis, MO)

1. Objective:
Leto Medical’s™ Continent Ostomy System (COS) is a system of products based on an innovative electrical stimulation device that will restore continence control to individuals with a colostomy.
2. Description of the technology:
The COS electrical stimulation device will actively control the terminal segment of the colon and prevent the elimination of feces caused by normal colonic motility. In addition to the stimulation device, the COS will have a disposable ostomy sealing device that will capture and deodorize any “passive” drainage (typically, small amounts of feces and mucus) that may occur not as a result of colonic activity but as a result of passive drainage from effects like gravity and changes in intra-abdominal pressure
The product iteration of the electrical stimulation device currently being tested in preclinical studies includes:
3 pairs of leads implanted in the colon wall from the serosal side; a proximal sensing lead pair and 2 pairs of more distally positioned stimulating leads
• A smart phone-sized external pulse generator (EPG) connected to the leads and carried in the pocket of a protective vest
• A programmer that allows for wireless programming of and data collection from the EPG
When active, the EPG delivers electrical stimuli to the distal two pairs of electrodes in a sequentially retrograde fashion. Stimuli can be delivered per a programmable schedule, as a response to intrinsic triggers, or as a combination of the two. Fecal evacuation occurs naturally when the system is inactive.
3. Preliminary results:
Multiple rounds of acute animal experiments have been completed. The data from these experiments has been used to develop the animal model for a survival study, to refine the design of the leads and EPG specific to this model, and to identify the initial sensing and stimulation parameters to be tested in a survival animal study.
The survival animal study is currently in progress at the time of this submission.
4. Future directions:
The means of managing a colostomy has remained virtually the same for decades. The aim of the COS is to restore continence control to individuals with a colostomy. Continued progress and validation will lead to clinical trials.

Session: Emerging Technology
Program Number: ET007

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