BondEase™ Topical Skin Adhesive, OptMed’s first clinical indication, has received 510(k) marketing clearance from FDA.

Alternative to surgical sutures and staples

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

Fast drying time after the adhesive sets, allowing rapid completion of procedure

Generates minimal heat during polymerization

Device design lowers risk of injury to the user by eliminating direct contact with glass components of the device

The BondEase technology is the subject of domestic and foreign issued patents and pending patent applications worldwide.

In-Vitro and Clinical Testing

OptMed 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 equivalence of BondEase™ topical skin adhesive with cyanoacrylate-based skin adhesives on the market. Above: Porcine skin model.

Clinical Trials

BondEase® Topical Skin Adhesive was evaluated in a prospective, randomised clinical study compared to conventional wound closure devices in the same manner as Dermabond®, our predicate device. Types of wounds included traumatic lacerations and surgical incisions with and without deep dermal sutures.

159

patients were
treated

105

patients receiving BondEase®

54

patients receiving conventional wound closure device(s) (sutures)

1.  The primary endpoint of the study was the incidence of 100% apposition of wound edges 10 days after wound closure which showed that BondEase® 100% closure rate was 77.1% versus 80.4 % for the conventional wound closure devices (CWCD) group.

2.  The secondary efficacy endpoint was the incidence of wounds with an optimal cosmetic outcome at 28 days; The results for cosmesis showed that the proportion of subjects treated with BondEase® had an optimal cosmetic outcome that was 5% greater than that of the CWCD group.

The trial showed:
- The use of BondEase® is equivalent to sutures
- Investigators found that the use of BondEase® was either good or excellent for all performance categories in nearly all subjects.
- The use of BondEase® is safe for the closure of traumatic lacerations and surgical incisions.
- There were no infections at the study wound site or signs of infection with BondEase®.
The signs of inflammation reported with BondEase® were minimal

BondEase™ topical skin adhesive is positioned to deliver solid and reliable performance :

SPEED AND COVERAGE

- Fast drying time
- More adhesive

RELIABILITY

- Consistent polymerisation
- High flexibility on skin
- High strength

TOLERABILITY

- Odorless
- Low exotherm

COMFORT & CONTROL

- Ergonomic
- Great control of application

[1] Biocompatible Poly(Methylidene Malonate)-Made Materials for Pharmaceutical and Biomedical Applications. European Journal of Pharmaceutics and Biopharmaceutics; March 2008