Hydron Technologies, Inc. Adds Clinical and Regulatory Consultants, Plans to Seek FDA Approval for Wound Care Oxygenation Techno
February 10 2004 - 10:15AM
PR Newswire (US)
Hydron Technologies, Inc. Adds Clinical and Regulatory Consultants,
Plans to Seek FDA Approval for Wound Care Oxygenation Technology
POMPANO BEACH, Fla., Feb. 10 /PRNewswire-FirstCall/ -- Hydron
Technologies, Inc. (BULLETIN BOARD: HTEC) announced it has added
expert clinical and regulatory consultants and will pursue approval
from the FDA to allow the use of its oxygenation technology for a
number of medical applications. Hydron has developed and received a
U.S. patent for the method of oxygenating skin and tissue
topically, using microbubbles of pure oxygen suspended in fluid.
This technology has important medical applications for improving
medical treatments and quality of life for burn victims, chronic
wound care, radiation induced injury, decubitus and pressure ulcers
(bed sores), skin grafts and frostbite. Hydron has added two
senior-level consultants to help structure the volumes of
supporting materials and experimental results required by the FDA
for approval of the new technology: Dr. Len Rosenberg -- Managing
partner at eP2Consulting, Inc., a consulting firm focused on
strategic clinical and regulatory solutions in the drug and device
development space for small to mid-size bio-pharmaceutical
companies. Dr. Judy Gordon -- Managing partner at ClinReg
Consulting Services, Inc., a clinical and regulatory consulting
group primarily focusing in device development. Dr. Gordon has
successfully attained FDA approval for more than 10 original PMAs
for Class III devices. According to Richard Banakus, Hydron
Technologies' CEO, "We believe the company has a significant
innovation to offer to the medical community. Hydron's technology
delivers the oxygen partial pressure of full hyperbaric treatments
to the surface of the skin in a simple, convenient liquid form,
while also avoiding the expense of hyperbaric chambers. Ultimately
this technology should allow for treatment of patients at home."
According to Dr. Rosenberg, "Within the FDA, it is not the use of
oxygen that is regulated, rather, the FDA regulates the devices and
means by which the oxygen is delivered to tissue. The mechanism of
oxygen's role in wound healing is well understood and there are a
number of indications where oxygen is a significant adjunct to a
wide variety of wound healing applications. Hydron's
microbubble-laden fluids have been shown to penetrate tissue to
depths in experimental models that should provide significant
patient benefits." Dr. Gordon stated, "I am pleased to be working
on a project that has the potential to expand oxygen therapy for
wounds, making it more convenient and accessible to a significantly
broader range of patients." Banakus added, "Hydron recently
completed a private placement offering, raising $1.1 million, to
accelerate itsresearch and development program surrounding this
technology. Now, with the addition of these new consultants and the
development of a plan to approach the FDA, Hydron is furthering its
shift into becoming a medical technology company." Hydron
Technologies, Inc. is expanding its research and development of
products and medical applications associated with its proprietary
tissue oxygenation technology. The Company also markets skin care
products through Hydron's direct-to-consumer catalog and on the
Internet at http://www.hydron.com/. Catalogs are available by
calling 1-800-4-HYDRON (1-800-449-3766). Except for historical
information, all of the expectations and assumptions contained in
the foregoing are forward-looking statements involving risks and
uncertainties. For additional information regarding the risks
associated with the Company's business, refer to Hydron
Technologies, Inc. reports filed with the SEC. DATASOURCE: Hydron
Technologies, Inc. CONTACT: Terrence S. McGrath, Chief Operating
Officer, Hydron Technologies, +1-954-861-6416, or Web site:
http://www.hydron.com/
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