NEW YORK (December 17, 2012)--- OptMed Inc., a specialty healthcare product development company, announced the completion of its required 30 patient enrollment for the first phase of a multicenter, prospective, open-label, randomized clinical study to evaluate BondEase™ Topical Skin Adhesive. The study is being conducted under the Investigational Device Exemption (“IDE”) regulation from the Food and Drug Administration (the “FDA”). BondEase™ is a biocompatible, topical skin adhesive that OptMed believes combines polymer technology with an ergonomic, user-friendly delivery device expected to provide a compelling set of differentiating benefits to clinicians and patients, compared with existing products.
The first phase of the trial required the enrollment of thirty patients. OptMed currently believes the 30 patients’ follow-up data will be submitted to the FDA, for clearance to initiate the second phase of the clinical study, during the first quarter of 2013.
“We believe BondEase™ Topical Skin Adhesive represents a significant step in the development of a high-performance medical and surgical adhesive, and subject to, among other factors, successful medical and regulatory review and required clearance, such a product could move quickly to commercialization,” said Alain Klapholz, OptMed’s founder and director.
OptMed currently believes that its clinical trial may be completed during the third quarter of 2013. BondEase™ Topical Skin Adhesive has been designed to combine ease of use with performance and to attempt to provide physicians with an attractive alternative to other surgical adhesives.
Biosurgical adhesives have emerged as important complements to sutures and staples to achieve rapid wound closure, reduce surgical time and costs, protect from infections, and improve cosmetic results. These products are used widely in the emergency and operating room settings. Since the introduction of the first surgical adhesive in 1999, annual sales in the category have grown to an estimated $650 million worldwide in 2010 and are projected to grow by 15% annually to reach estimated sales of $1.7 billion by 2017 (MedMarket Diligence Report, February 2012).
OptMed is a development-stage medical device company headquartered in New York City. OptMed is developing specialty healthcare products with an initial focus on an innovative line of surgical, biocompatible adhesives. OptMed has also initiated the development of products based on the local delivery of diazepam (the generic form of the widely used drug, Valium®) for the treatment of disorders such as overactive bladder (OAB) and urolithiasis (kidney stones).
For more information, please visit www.optmed.com
