EndoClot® SIA Receives FDA Clearance

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EndoClot® SIA is the first starch-derived submucosal injection system cleared in the U.S. market for endoscopic removal of polyps, adenomas, early-stage cancers, and other gastrointestinal mucosal lesions. Starch-based polysaccharide has a long history of clinical applications with an excellent safety profile. A specially designed spiral injection syringe is included in the single-use kit for ease of delivering the solution.

“EndoClot® SIA enables longer-lasting and higher mucosal elevation with clearer margins than saline and therefore enables more precise and effective removal of the lesion,” said Steve Heniges, President of EPI. “It also increases the safety cushion by creating a greater margin between the mucosa to be resected and the muscle layer to be protected due to the viscosity of the solution. This is very important as it reduces complications and enables the Gastroenterologist to remove the lesions efficiently.”

EPI will utilize its established distribution network along with new strategic partners to bring this innovative product to the GI Endoscopy market.

EndoClot Plus is focused on utilizing its polymer expertise to develop customized medical devices to meet GI clinical needs. With its innovative technology platforms, EndoClot Plus aims to become the leading company in creating new biomaterial therapeutic solutions for GI Endoscopy.

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