Adhezion Biomedical Receives FDA Marketing Clearance For SurgiSeal™ Topical Skin Adhesive New Topical Skin Adhesive Is Cleared For U.S. Launch

Main Category: Dermatology
Also Included In: Medical Devices / Diagnostics
Article Date: 08 Jan 2009 - 8:00 PST

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Adhezion Biomedical LLC, a medical device manufacturer, announced that the FDA has provided marketing clearance for its SurgiSeal (2-octyl cyanoacrylate) topical skin adhesive. SurgiSeal is the first and only 2-octyl cyanoacrylate that does not require an activator. It is indicated for use in surgical and emergency applications.

Cyanoacrylate medical adhesives are designed to save time during wound closure, provide a flexible, water-resistant, microbial barrier coating, and eliminates the need for suture removal. 2-octyl cyanoacrylate formulas feature greater breaking strength and broader use in clinical applications than existing n-butyl-2-cyanoacrylates.i

Dr. Danie Hoffman, a plastic and reconstructive surgeon who has been using SurgiSeal since its international launch, states, "SurgiSeal does an excellent job of sealing the wound, and its applicator provides very easy, controlled use. It will save staff time in attending to lacerations."

Confirms Pete Molinaro, CEO of Adhezion Biomedical, "SurgiSeal's patented OctylFlex monomer process can be used in a wide array of topical product applications, addressing skin lacerations, incisions and plastic surgery. It meets the needs of surgeons and patients seeking less disruptive, more natural healing solutions that are both durable and versatile."

"This clearance to market SurgiSeal represents a significant milestone for the commercialization of our proprietary cyanoacrylate technology. We are pleased to expand our efforts in the U.S. with the introduction of this key product from our Surgical Solutions Platform," says Manuel Rodriguez, Sales and Marketing VP for Adhezion.

About Adhezion Biomedical, LLC

Adhezion Biomedical is a privately held medical device company based in Wyomissing, PA. Adhezion is committed to developing and manufacturing adhesive and microbial sealant products that are both highly differentiated and proprietary. To learn more, visit http://www.adhezion.com.

i Schwade, Nathan D. eMedicine. 2007. WebMD. 17 September 2007.

Adhezion Biomedical, LLC