IRVINE, Calif.--(BUSINESS WIRE)--Neomend, Inc., a leading innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company’s Progel® Adhesion Barrier (AB) product.
Progel® AB is a hydrogel adhesion barrier sealant that can be sprayed onto general visceral organs during surgery to help prevent post-operative adhesions. Progel® AB sealant can be used in open as well as laparascopic abdominal or pelvic surgical procedures. According to a MedMarket Diligence LLC report prepared for the company, more than one million of these types of surgeries are performed in Europe each year. According to a MedMarket Diligence LLC report prepared for the company, the world market for surgical sealants, glues and wound closure products is valued at over $7 billion.
“This additional CE Mark positions Neomend to substantially grow its revenue in the European Union as we seek to expand our distribution channel there,” said David Renzi, the company’s President and CEO. “Post-operative adhesions are the number one complication of any surgery. They not only can cause pain and discomfort to the patient but can necessitate additional surgeries. This important milestone will enable us to help surgeons in Europe more effectively help prevent complications caused by adhesions.”
“Progel® AB sealant adheres well to varying organs and tissues, and it has a great amount of elasticity that allows it to maintain this high level of adherence after application,” Renzi added.
Progel® AB sealant is the latest in a line of hydrogel sealants to be commercialized by Neomend that will include cardiovascular, dural and colorectal applications. The first commercial product from this platform technology in the United States was Progel® Pleural Air Sealant, which has been used in the treatment of more than 27,000 patients since the product received FDA approval in January 2010. Progel® Pleural Air Leak Sealant is also the only commercially available and FDA approved pleural air leak sealant in the United States. As the only sealant designed specifically for sealing lung air leaks Progel® Pleural Air Leak Sealant has compelling clinical results that show a significant reduction in post-operative air leaks and a reduction in inpatient length of stay.
A second product, Progel® Platinum Surgical Sealant, is a recombinant version of the pleural air sealant which received the CE mark in January 2011 and was launched in the European Union in June of last year. Progel® Platinum Surgical Sealant is a hydrogel polymer consisting of two components: a biocompatible synthetic protein of recombinant albumin (Albucult®*) and a cross-linking component of polyethylene glycol (PEG). Albucult® rAlbumin USP-NF is a product of Novozymes Biopharma UK Ltd. and Novozymes Biopharma DK A/S.
The Progel® technology platform is a resorbable hydrogel with a unique molecular structure that undergoes a proprietary process to form strong, flexible bonds that promote adherence to tissue surfaces. These special bonds can be chemically engineered to remain intact and provide strength during the critical phases of healing until the molecules are resorbed by the patient’s body.
About Neomend, Inc.
Neomend, based in Irvine, Calif., is a leading innovator in sealant and adhesion-prevention products for the surgical marketplace focused on the design, development and commercialization of innovative surgical sealants and adhesion prevention products derived from the Progel® technology platform. These products are designed to enhance existing standards of care and inspire confidence in surgical technique; to provide uncomplicated solutions that improve each patient’s healthcare experience and to reduce cost-of-care in hospitals and medical facilities worldwide. The Company holds 29 issued patents in chemical composition and delivery applicators. For more information, visit www.Neomend.com or call 949.916.1630.
About Progel® Technology Platform
The Progel® technology platform is a resorbable hydrogel with a unique, accessible molecular structure that makes it ideal for development of novel medical devices like surgical sealants and adhesion barriers. The first commercial product from this platform technology in the U.S., Progel® Pleural Air Sealant, received FDA approval in January, 2010 and is the only commercially available and FDA approved pleural air leak sealant in the U.S. As the only approved sealant designed specifically for sealing lung air leaks Progel® Pleural Air Leak Sealant has compelling clinical results that show a significant reduction in post-operative air leaks and a reduction in inpatient length of stay. Additional products including Progel® Platinum Surgical Sealant and Progel AB have received CE marks and are currently distributed in Europe.