FDA Approves EndoClot® Hemostat to Manage GI Bleeding

Feb. 23, 2021 13:00 UTC

FDA Approves EndoClot® Hemostat to Manage GI Bleeding

A Unique Product to Rapidly and Reliably Control Bleeding During GI Procedures

 

SANTA CLARA, Calif.--(BUSINESS WIRE)-- EndoClot Plus, Inc. (EPI) announced the U.S. Food and Drug Administration (FDA) has approved EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS), an innovative product that assists Gastroenterologists to stop bleeding rapidly and reliably. EndoClot® PHS is expected to be commercially available in the United States by May 2021.

EndoClot® PHS is a single use device including a starch-based powder hemostat that is applied directly to the bleeding site through a flexible endoscope. The patented Absorbable Modified Polymer (AMP®) powder can quickly concentrate the blood to accelerate the normal physiological clotting process.

A gelled matrix forms when the AMP® powder contacts blood or fluid in the GI tract to provide a mechanical barrier to further control bleeding. EndoClot® PHS is a nonthermal, nontraumatic method for achieving hemostasis with GI bleeds.

“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,” said Steve Heniges, President of EPI. Heniges further stated, “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”.

EndoClot Plus utilizes its biomaterial expertise to develop customized polymer based 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.

For more information about EndoClot® PHS and other products, please visit http://endoclot.com/

About EndoClot Plus

EndoClot Plus, Inc. is a privately held medical device company in Santa Clara, California. In collaboration with endoscopists and biomaterial scientists, EPI develops platforms and technologies to improve treatment for GI patients and to assist gastroenterologists.

EndoClot Plus Co., Ltd. located in Suzhou, China is the manufacturer of the EndoClot® product lines including EndoClot® PHS, EndoClot® Adhesive and EndoClot® Submucosal Injection System.

Contacts

For additional information, including distribution and licensing inquiries, please contact
Stephen Heniges
(408) 980-9125
stephen@endoclot.com
www.endoclot.com

 
 

Source: EndoClot Plus, Inc.

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