The company intends to commercialise the product in the US by May 2021
EndoClot Plus has received the US Food and Drug Administration (FDA) approval for its Polysaccharide Haemostatic System (EndoClot PHS) to help gastroenterologists rapidly stop bleeding during procedures.
EndoClot PHS is a single use device that includes a starch-based powder haemostat intended to be applied directly to the bleeding site through a flexible endoscope.
The company’s patented Absorbable Modified Polymer (AMP) powder is capable of rapidly concentrating the blood to advance the normal physiological clotting process.
After the AMP powder contacts blood or fluid in the GI tract, a gelled matrix is formed to provide a mechanical barrier to further control bleeding.
EPI president Steve Heniges said: “The FDA clearance of EndoClot PHS represents a significant milestone in advancing the care of the GI patient.
“This technology will drive a paradigm shift in the treatment of upper and lower GI bleeding as we have already seen outside the U.S. for many years.
“Since 2011, when EPI was the first to launch a powder hemostat for GI endoscopic applications in Europe, EndoClot PHS has proven to be an effective technique to treat GI bleeding especially for those lesions located in hard-to-reach areas and where the source of the bleeding is not easily identifiable.”
The company said that its EndoClot PHS is a nonthermal, nontraumatic method for achieving hemostasis with GI bleeds. It intends to commercialise the product in the US by May 2021.
EndoClot Plus is a privately held medical device company engaged in developing platforms and technologies to improve treatment for GI patients, through collaboration with endoscopists and biomaterial scientists.
The company leverages its expertise biomaterials to develop customised polymer based medical devices that address the GI clinical needs.
EndoClot Plus has operations in Suzhou, China, where it manufactures products including EndoClot PHS, EndoClot Adhesive and EndoClot Submucosal Injection System.