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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/