More than 500,000 Americans have some type of stoma, an abdominal opening where waste from the small or large intestine is routed following surgery, according to data attributed to the United Ostomy Associations of America. The reasons vary, from bowel cancer, inflammatory bowel disease to trauma. John Accardi, an entrepreneur and cancer survivor, frustrated by a lack of options for ostomy pouches, has collaborated with a chemist to develop a smaller, more compact design for the colostomy bag.
Lewcardia, founded by Accardi and Frank Lewis, is raising $5,000 on crowdfunding website Medstartr to develop prototypes of its ostomy pouch called Ostomy Freedom. It also wants to hear from users of its devices about comfort, reliability and effectiveness. The team would also use the funding to ship these kits to physicians and nurses. Ultimately, it wants to publish the results of its trial program online and in a peer-reviewed journal. It’s a class 1 medical device so it doesn’t require FDA clearance.
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The kit uses a 3-D scanner to produce customized devices, as stoma size can vary. Users download a companion app, point the phone at their stoma and it automatically uploads the images to a 3D printer for customized production.
The device uses lightweight durable non-allergenic plastics and carbon fiber that form a stabilizing sleeve around the length of the stoma and a convex barrier-ring around its base. It’s designed to prevent leakage.
So far Lewcardia has raised about one quarter of its goal. To contribute or find out about the device check out this link.