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OptMed Inc., a medical device manufacturer, announced that it has received marketing clearance from the FDA for its BondEase® topical skin adhesive intended for the closure of surgical incisions and lacerations as an alternative to sutures and staples. BondEase is a biocompatible, topical skin adhesive that combines a novel polymer technology with a user-friendly delivery device.
“FDA clearance of BondEase represents a significant advance for OptMed and its ability to move innovative medical products through clinical development and the regulatory process. We believe, the news provides an excellent foundation for the continued development of BondEase for additional medical indications and global markets,” said Dr. Ervin Braun, Chief Executive Officer of OptMed.
BondEase is applied directly to the wound with a patented delivery system that affords ease of use and rapid drying times. The solution is odor-free and has key product advantages in busy surgical settings and emergency room environments and has no contraindication for sensitivity to formaldehyde.
“The approval was the result of a rigorous product development and clinical trial program in combination with a good working relationship with the FDA,” said Dr. James Quinn, Professor of Emergency Medicine at Stanford University. “BondEase presents an excellent alternative for surgeons and patients seeking an effective, safe technology for treating surgical incisions and lacerations.”
Biosurgical adhesives are rapidly emerging as important alternatives to sutures and staples to achieve rapid wound closure, reduce surgical treatment time and costs, protect from infections, and improve cosmetic results. These products are used widely in the emergency and operating room settings. The global market for high-strength medical adhesives is forecasted to show strong growth over the next several years.
OptMed is also developing its adhesive technology for several additional indications, including the treatment of acute wounds in other indications that include skin tears of the elderly, as well as chronic wound treatment. The company believes these represent substantially underserved, medical and commercial opportunities in a number of global markets. OptMed anticipates that its product will be made available to medical professionals in late 2016.
For Further Information
More on the wound closure market in the U.S. can be found in the report series published by iData entitled U.S. Market for Wound and Tissue Management. This report covers the U.S. markets for wound closure, static compression therapy, dynamic compression therapy, advanced dressing, moist dressing, antimicrobial dressing, interactive dressing, non-adherent contact layers, traditional wound dressing, hemostats, tissue sealants, anti-adhesions, and negative pressure wound therapy.
The iData series on the market for wound and tissue management devices covers the U.S., Brazil, China, India, Japan, South Korea, Australia, and 15 countries in Europe. Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.
About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.
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