ROSH HA'AYIN, Israel, December 15 EnzySurge Ltd.(EnzySurge), a provider of innovative solutions for the advanced chronicwound management market, announced today that it has received clearance fromthe U.S. Food and Drug Administration (FDA) to market its newSilverStream(TM) solution for prescription use. The FDA also clearedDermaSept, 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 continuousstreaming of fresh therapeutic solutions, such as SilverStream, over thewound bed. The treatment provides constant removal of foreign material,exudate, micro-organisms and debris while creating negative pressure over thewound.
SilverStream may be either applied directly onto the wound or by thedisposable DermaStream(R) device. According to Dr. Noa Hadar and Prof. AmihayFreeman who led the development, SilverStream is a hypertonic solution thatcontains very low concentration of preservative silver ions. "SilverStreamhas demonstrated remarkable capabilities by in-vitro testing inhibiting thegrowth of drug-resistant clinical bacterial strains, yeast and fungi uponcontact in-vitro", stated Freeman.
SilverStream is intended for use under the supervision of a healthcareprofessional for management and moisturizing of wounds such as stage I-IVpressure 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 uniqueproduct", says Amir Shiner Chief Executive Officer of EnzySurge. "We believethat SilverStream is a powerful wound management solution and will be asignificant addition to the DermaStream(R) product line, which is intended tobecome the wound management system of choice. We are poised to launchingSilverStream to market in 2010 with our U.S. partner, the VirginiaBiosciences Commercialization Center."
The treatment of chronic wounds (such as diabetic, pressure and venousulcers) is expensive, laborious and requires ongoing application andmonitoring by a skilled caregiver. The global market for chronic woundproducts amounted $3.2 billion in 2008 and is expected grows to $4.1 billionby 2011.
"The recent achievements of EnzySurge and especially this FDA approvalfor SilverStream, represent significant opportunities for EnzySurge in theglobal wound care market in the near future", says Shiner.
About EnzySurge Ltd.
EnzySurge Ltd. is a developer and provider of innovative solutions forthe treatment and management of chronic wounds. EnzySurge's DermaStream(R)platform offers a new and unique wound treatment modality by continuouslystreaming a fresh supply of advanced therapeutic solutions to a controlledwound environment. DermaStream is designed to deliver effective, affordableand easy-to-use wound treatment throughout all phases of chronic woundtreatment from debridement, through regeneration to wound closure. TheEnzySurge product line is intended for use in hospitals, clinics and for homecare.For further details: Amir Shiner, CEO Mobile: +972-54-3030294 Tel: +972-3-6227600 http://www.dermastream.com
SOURCE EnzySurge Ltd