FDA Clears the Provant Therapy System for Use by Patients with Metallic Implants

Clinicians can now treat the post-operative pain from joint replacements and spinal fusions

Scottsdale, Arizona, December 13, 2013 —

Regenesis Biomedical Inc., today announced that FDA has approved the removal of the contraindication for use of the Company’s Provant Therapy System in patients with metallic implants in the area of treatment. The decision was made after the FDA reviewed additional data and research demonstrating that the use of Provant’s Pulsed Electromagnetic Therapy (PEMT) did not put such patients at risk.

“The positive effects of using our non-thermal PEMT Therapy to treat patients with persistent post operative pain have been reported by both doctors and patients,” commented Scott S. Brooks, President and Chief Executive Officer of Regenesis Biomedical. “The FDA’s decision to approve the removal of this contraindication for the Provant System allows many more patients to benefit from Provant Therapy.”

Mr. Brooks continued, “The clinical literature reports a significant unmet need for effective pain therapies in patients undergoing orthopedic surgery. A recent case series shows Provant Therapy may be beneficial for treating Failed Back Surgery Syndrome (FBSS) patients as a means to avoid more invasive and expensive therapies. This decision by the FDA expands the number of patients who might benefit from Provant Therapy. We are now actively engaging orthopedic, podiatric, primary care, and rehabilitation clinicians to educate them on the benefits of Provant Therapy for resolution of postoperative pain. Provant is a non-narcotic, non-invasive and safe option for patients in need.”

Each year about 1.1 million patients have hip, knee, shoulder and elbow replacements, 350,000 have a spinal fusion, and 600,000 require metal implants. Substantial pain following surgery is prevalent; for example, 32% of knee replacement patients experience ongoing pain. Common metal implant procedures that result in post-operative pain include knee and hip replacements, spinal fusion, and bone fracture internal fixation.

About Regenesis Biomedical

Regenesis Biomedical, Inc. is a privately held medical technology company focused on the research, design, manufacture, and sale of energy-based medical products and services that alleviate pain, restore health, and improve quality of life. Regenesis developed, patented, and now markets the Provant Therapy System. Our customers include health care facilities, acute care hospitals, long-term acute care hospitals, skilled nursing facilities, rehabilitation centers, home health care agencies, and outpatient clinics.

About the Provant® Therapy System

Provant uses pulsed electromagnetic energy to facilitate reduction of the pain and edema associated with post-operative, superficial soft tissues. Provant relieves pain two ways: through anti-nociceptive analgesia by inducing endogenous opioids, and by regulating inflammatory mediators.

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SOURCE: Regenesis Biomedical Inc.