(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
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
"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.
SOURCE EnzySurge Ltd