Diabetic Neuropathy Study Using Anodyne Therapy Published in Diabetes Care Demonstrates Reversal of Symptoms

Anodyne® Therapy announces the publication of its second peer-reviewed clinical study to demonstrate restoration of sensation in the feet of patients with diabetes with peripheral neuropathy. This landmark study, conducted at the Joslin Diabetes Center at Morton Plant Hospital in Clearwater, Florida, appeared in the January 2004 issue of Diabetes Care (the Professional Journal of the American Diabetes Association) and is titled, “Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with Diabetic Peripheral Neuropathy; A Randomized, Double Blind, Placebo Controlled Study.” The study showed that after 12 45-minute treatments, there was a 46 percent improvement in sensation, and pain decreased by 45 percent. Additionally, 70 percent of patients reported an improvement in balance and less fear of falling.

Neuropathy is nerve damage often associated with diabetes and other chronic diseases. Symptoms include numbness and/or pain in the feet, legs, and hands. Neuropathy from some causes like diabetes is usually considered to be progressive and irreversible and is a major contributing factor to chronic foot wounds, over 60,000 amputations per year, and falls. The cost of diabetic neuropathy alone to the United States healthcare system has been reported to exceed $37 billion per year.

Anodyne Therapy treatments are currently available at outpatient facilities, hospitals, nursing homes, physician offices, and home health agencies nationwide. Products are also available for convenient home use. For more information, visit www.anodynetherapy.com.

HydroCision Sells Advanced Wound Business to Smith & Nephew

HydroCision Inc. announces that its VersaJet surgical debridement product has been acquired by the advanced wound management business of Smith & Nephew plc to add to Smith & Nephew’s growing range of advanced wound bed preparation products.

VersaJet is a specialized fluid jet instrument enabling surgeons to easily remove damaged tissue and contaminants from surgical, traumatic, and chronic wounds in a precise and safe manner. Approved for use in the US, Canada, and the European Union, VersaJet was launched in January 2003.

Smith & Nephew will acquire the VersaJet product line for $5m in cash up front and additional consideration payable upon reaching future development and sales milestones. Smith & Nephew expects 2004 sales of the product to reach $2–3m.
For more information about Smith & Nephew, visit www.smith-nephew.com. More information on HydroCision is available at www.hydrocision.com.

Diapulse Wins Medicare Approval

Diapulse Corporation of America announces that Centers for Medicare and Medicaid Services (CMS) granted approval for coverage of the Diapulse Wound Treatment System in a Decision Memorandum issued December 22, 2003.

Under CMS guidelines, the company submitted a Formal Request for Reconsideration outlining an error in a decision that had become effective April 1, 2003 that omitted Diapulse from Medicare coverage for treatment of chronic wounds.

Over a 17-month period, David M. Ross, Vice President of Diapulse Corporation of America, met with CMS and supplied information that was instrumental in convincing CMS to reverse a previous national non-coverage policy decision. Medicare will now provide coverage for Diapulse in hospitals, nursing homes, and physician offices when the National Coverage Determination is published.

Diapulse produces non-thermal pulsed electromagnetic energy that can effectively treat through bandages and surgical dressings to reduce swelling and pain. The system is prescribed by physicians and has been successful as an adjunct in healing wounds. In many cases, it has helped to prevent amputations of limbs. Research published in medical journals around the world has proved its safety and effectiveness.

The company also intends to supply additional information and request CMS to provide coverage for patients at home. Diapulse has treated thousands of wounds on patients confined to home, and the company has received accreditation by the Joint Commission on Accreditation of Healthcare Organizations for high quality and standards in home care.

For more information on Diapulse Corporation of America, visit www.diapulse.com.

RegeneRx Completes $2.3 Million Private Placement; Capital Will Fund Initiation of Phase 2 Clinical Trials

RegeneRx Biopharmaceuticals, Inc. announces that it successfully completed a $2.3 million private placement of its common stock. Participants in the transaction included Defiante Farmaceutica, Lda., a wholly-owned subsidiary of Sigma-Tau Group, headquartered in Rome (Italy), and a number of other outside investors. On January 22, 2004, RegeneRx announced an exclusive European licensing deal with Defiante related to development of RegeneRx’s novel wound healing drug, TB4, for certain fields of use.

Under the terms of the deal, the investors purchased approximately 2,400,000 shares of RegeneRx common stock at $.95 per share and received warrants to purchase up to 600,000 additional shares of common stock at $1.50 per share, exercisable for 30 months. The capital will be used to fund phase 2 clinical trials to test TB4 for the treatment of chronic dermal wounds and for general operating purposes. There were no placement fees associated with the transaction.

TB4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. TB4 represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. A key mechanism of action is TB4’s ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. It has been the subject of a significant amount of research at the National Institutes of Health (NIH) and a number of other academic institutions and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of conditions.

RegeneRx is a biopharmaceutical company developing TB4 as a platform technology for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the NIH. The company holds several patents related to the technology and has numerous world-wide patent applications pending. RegeneRx successfully completed phase 1 human clinical trials with TB4 for the treatment of chronic dermal wounds and expects phase 2 trials to begin in the second quarter of 2004.

For more information, visit www.regenerx.com.