ProCyte Seeks FDA Clearance For New Wound Care Product
Company Seeks Clearance to Market Unique Polymer-based Wound Dressing
KIRKLAND, Wash., July 8 /PRNewswire/ -- ProCyte Corporation (Nasdaq: PRCY) today said
that it has filed a 510(k) pre-market notification with the United States Food and Drug
Administration for clearance to market the company's OsmoCyte(TM) Ultra Pillow Wound
Dressing.
"This is the first in a line of unique polymer-based wound care products that we hope to
introduce," said Joseph Ashley, ProCyte's president and chief executive officer. "Together with
ProCyte's recently launched premiere copper-based wound care product Iamin(R) Hydrating Gel
-- we expect to build a significant new wound care products line using a proprietary hydropolymer
technology."
OsmoCyte(TM) Ultra Pillow Wound Dressing is a cushion-like mesh which encapsulates highly
absorbent polymer-formed granules. The mesh allows excess wound moisture, or exudate, to pass
through it and into the granules contained inside. The granules absorb up to twenty times their
weight in wound exudate. The dressing may then be safely and easily removed by the health care
provider.
OsmoCyte(TM) Ultra is intended for the care of a variety of exudating chronic and acute wounds,
including infected and non-infected wounds. It is intended for use in such wounds as diabetic
ulcers, pressure sores, and venous stasis ulcers. In addition to the product's important absorptive
properties, it provides a cushioning environment for wounds, which frequently occur on pressure
points or weight-bearing parts of the body. The dressing will come in a range of sizes and
configurations.
OsmoCyte(TM) Ultra will bring user-responsive innovation to a competitive class of wound care
products. According to published sources, the estimated annual cost of patient wound care, based
on products currently used, dressing changes and re-bandaging two to three times a week, may
range from $1.9 to $2.5 billion in the U.S. alone. OsmoCyte(TM) Ultra is expected to provide
important use and cost advantages over existing products.
The underlying polymer technology that forms the granules has a built-in intelligence that can be
chemically manipulated to provide a broad range of wound care products which are highly
responsive to patient and care giver needs while addressing a variety of wound types and exudate
levels. ProCyte is presently developing manufacturing processes for the commercial launch of its
planned polymer-based product line.
ProCyte is a development-stage healthcare company that, in addition to its medically responsive
and innovative wound care products focus, is pursuing commercialization of its patented family of
copper-based compounds for potential treatments of inflammatory bowel disease, wound healing
and hair loss.
The discussion in this release regarding the company's expectations for its wound care products
line contains forward looking statements that involve risk and uncertainties, including commercial
manufacturing challenges and other risks detailed from time to time in the company's readily
available SEC reports, including the Form 10Q for the quarter ended March 31, 1996. Actual
results may differ materially.
/CONTACT: Karen L. Hedine, Vice President of ProCyte Corporation, 206-820-4548/ |
