Haifa /PRNewswire/ - Sealantis, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received CE Marking approval ("CE") for its Seal-G ® Surgical Sealant ("Seal-G"), the first and only alginate sealant designed specifically to help reduce leaks after gastrointestinal ("GI") procedures. The CE will allow to market the product in the Europe and additional other countries.
Seal-G helps prevent anastomotic leaks - a serious complication that occurs in 5-15 % of patients undergoing GI surgery. One third of the post-surgical mortality after colorectal surgery is attributed to leaks and it is considered by GI surgeons as the most devastating complication. In addition to its clinical outcome, this serious complication can cause up to a five-fold increase in patient management costs. Seal-G Surgical Sealant reinforces the anastomosis during the initial post-surgery period, when the development of leaks is most likely to occur.
"The Seal-G CE marking approval represents a key milestone on our journey to commercialize the Sealantis platform technology," said Avi Kerbs, Sealantis Chairman and Teuza fund CEO. "We look forward to making Seal-G available to patients and surgeons in Europe, China and globally.
"The CE marking approval for Seal-G is a major achievement for our team" said Tomer Fuchs, Sealantis CEO. "This approval clearly indicates that Seal-G and our supporting quality system met the essential requirements for product safety, performance and usability, in compliance with growing rigorous requirements set by the EU regulations."
Sealantis is a leader in the development and manufacturing of tissue adhesives and sealants intended to improve the recovery of patients following surgery. The Sealantis Algae-mimetic technology platform, developed at the Technion, is a protein-free plant based technology, which provides excellent adhesion in a wet surgical field and is easy to use and handle. Sealantis' flagship product, Seal-G is designed to reinforce the suture or staple-line in GI surgery. Seal-G has a CE marking for sale in the EU. In the US, Seal-G is not approved by FDA and is not yet available for sale. The company's future products include absorbable hemostatic sealant and a Dural sealant for neurosurgery. Sealantis pipeline products are in development and have not yet been approved for sale in the US or in any other market.
SOURCE: SealantisCopyright 2018 PR Newswire. All Rights Reserved