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EnzySurge Obtains FDA Clearance For New Wound Management Solution

To market its SilverStream solution for prescription use

EnzySurge has received clearance from the FDA to market its new SilverStream solution for prescription use. The FDA has also cleared DermaSept, an over-the-counter version of the SilverStream product.

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 device. According to Dr. Noa Hadar and Prof. Amihay Freeman who led the development, SilverStream is a hypertonic solution that contains low concentration of preservative silver ions.

The company claims that SilverStream is intended for use under the supervision of a healthcare professional for management and moisturising 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 moisturising of minor cuts, minor burns, abrasions and irritated areas.

Amir Shiner, chief executive officer of EnzySurge, said: “We are pleased to receive FDA clearance for this product. We believe that SilverStream is a powerful wound management solution and will be a significant addition to the DermaStream 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 US partner, the Virginia Biosciences commercialisation 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 to grow to $4.1 billion by 2011.