BondEase® Topical Skin Adhesive
BondEase® product is a biocompatible, topical skin adhesive that combines methylidene malonate polymer technology with an ergonomic, user-friendly delivery device to provide a compelling set of differentiating benefits to clinicians and patients compared with existing products.
- Designed to provide clinicians with a high level of comfort and control during adhesive application
- Wound closure can be accomplished uniformly in a single layer
- Fast drying time after the adhesive sets, allowing rapid completion of procedure
- Generates minimal heat during polymerization
- Transparent tip allows clear visualization of adhesive delivery
- Internal initiation of the adhesive allows for uniform performance and prevents tip clogging
- Device design lowers risk of injury to the user by eliminating direct contact with glass components of the device
BondEase® Topical Skin Adhesive technology is the subject of U.S. and foreign-issued patents as well as pending patent applications worldwide.
Testing and Regulatory Pathway
OptMed has performed extensive in vitro and in vivo animal studies in accordance with the FDA guidance on topical skin adhesives and with the requirements of ISO 10993 "Biological Evaluation of Medical Devices."
OptMed has conducted extensive in vitro
and in vivo animal studies to demonstrate the equivalence of BondEase® Topical Skin Adhesive with cyanoacrylate-based skin adhesives on the market. Above: Porcine skin model.
Current Clinical Status
In September 2012, OptMed initiated a multicenter, prospective, open-label, randomized clinical study to evaluate BondEase® Topical Skin Adhesive.
In May 2013, OptMed submitted to the FDA the results of the first 30 patients enrolled and followed in the first phase of the trial.
In December 2013, OptMed completed the enrollment and follow up of an additional 132 patients for the second phase of the trial.
For more information on the trial, please visit the BondEase® Topical Skin Adhesive study listing on www.clinicaltrials.gov