FDA grants marketing approval for EnzySurge's new SilverStream solution for prescription use

Dec 15 2009

EnzySurge Ltd. (EnzySurge), a provider of innovative solutions for the advanced chronic wound management market, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its new SilverStream(TM) solution for prescription use. The FDA also cleared DermaSept, an Over-the-Counter version of the SilverStream product.

EnzySurge is the developer of the DermaStream(R) product line. DermaStream is a line of woundcare devices that allows for the continuous streaming of fresh therapeutic solutions, such as SilverStream, over the wound bed. The treatment provides constant removal of foreign material, exudate, micro-organisms and debris while creating negative pressure over the wound.

SilverStream may be either applied directly onto the wound or by the disposable DermaStream(R) device. According to Dr. Noa Hadar and Prof. Amihay Freeman who led the development, SilverStream is a hypertonic solution that contains very low concentration of preservative silver ions. "SilverStream has demonstrated remarkable capabilities by in-vitro testing inhibiting the growth of drug-resistant clinical bacterial strains, yeast and fungi upon contact in-vitro", stated Freeman.

SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations. DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.

"We are extremely pleased to receive FDA clearance for this unique product", says Amir Shiner Chief Executive Officer of EnzySurge. "We believe that SilverStream is a powerful wound management solution and will be a significant addition to the DermaStream(R) product line, which is intended to become the wound management system of choice. We are poised to launching SilverStream to market in 2010 with our U.S. partner, the Virginia Biosciences Commercialization Center."

The treatment of chronic wounds (such as diabetic, pressure and venous ulcers) is expensive, laborious and requires ongoing application and monitoring by a skilled caregiver. The global market for chronic wound products amounted $3.2 billion in 2008 and is expected grows to $4.1 billion by 2011.

"The recent achievements of EnzySurge and especially this FDA approval for SilverStream, represent significant opportunities for EnzySurge in the global wound care market in the near future", says Shiner.