Pulse Electromagnetic Wound Therapy

Ivivi Technologies was founded to develop the field of non-invasive electrotherapies, based on pulsed electromagnetic fields, for the treatment of acute and chronic disorders. The company has existing technology in the marketplace, in wound care and cosmetic surgery, as well as an aggressive research and development program incorporating the full range of scientific, clinical and engineering components necessary to become the pre-eminent company in the field of electrotherapeutics.

The currently marketed technology, SofPulse™, is a non-invasive pulsed magnetic field device, FDA-cleared for the treatment of pain and edema in soft tissue. The technology was approved in July 2004 by the Centers for Medicare and Medicaid Services for use with chronic wounds, such as Stage III and IV pressure ulcers, diabetic, arterial or venous stasis ulcers. The technology employs pulsed magnetic fields to induce micro-currents into injured tissues, the same technology successfully used in the $650 million bone-growth stimulator market. SofPulse is essentially a superior, alternative delivery system for electrical stimulation, a modality well-established to be effective, but to date, with limited acceptance. Because of the way in which the signal is provided to the body, SofPulse is non-disruptive to wound care protocols, has little effect on healthy tissue, no side effects, no overdose dangers and has few warnings, precautions and no contraindications.

The original SofPulse delivered over 600,000 treatments, primarily in skilled nursing facilities, for pressure ulcers without adverse events in the mid 1990s. AHCPR (Health and Human Resources) recognized in 1994 that this modality was the “only adjunctive [wound] therapy with sufficient supporting evidence to warrant recommendation,” and an updated review in 1998 moved the evidence rating from “B” to “A.” In 2001, the American Society of Plastic Surgeons issued a position paper endorsing the use of SofPulse post-surgically after a randomized, controlled prospective trial demonstrated a 40% increase in healing. A body of published scientific evidence explains the mechanisms and characterizes the efficacy of the therapy. Ivivi Technologies has established a Center of Excellence at Montefiore Hospital in New York and supports an ongoing research program. Published studies include demonstrating 500% improvements in angiogenesis and unparalleled surgical flap survival with this therapy. Recently completed and presented studies on the newest generation of Ivivi Technologies patented signals showed a 58% increase in healing in a surgical incision model.

The technology is simple and effective. It treats directly through clothing, dressings, eschar, casts and virtually any other material. Simply position the lightweight, conformable applicator at the site, and press “Start.” The timer ends the treatment automatically after 15 minutes. This treatment is conducted twice per day. There is no disruption of the current standard of care, no burden to staff and no pain or inconvenience to the patient.

Ivivi Technologies maintains an aggressive program of clinical and engineering research and development. Pictured below is the SofPulse unit, 9 lbs, with a single patient use applicator coil.

This safer, lighter, and more effective signal generator is coupled with a new generation of lightweight, conformable applicators, molded from implantable medical grade silicon and available in a variety of sizes. These applicators are single patient use, and are purchased once for each patients duration of therapy.

Ivivi Technologies non-invasive electrotherapies summary:

• CMS National Coverage Determination (wound healing) as of July, 2004
• FDA-cleared since 1991 for treatment of pain and edema in soft tissue
• Safe: over 600,000 treatments without adverse events or side effects
• Treats directly through clothing, dressing, casts, eschar, etc. without any special preparation of injured area or wound bed
• Seamlessly integrates into current standard of care
• Simple, unattended “point and shoot” use with single patient use applicator.
• Significantly less expensive and vastly more economical to use than alternative solutions for treating chronic or acute wounds.
• Fully-supported clinical research facility publishing significant results in medical journals
• Aggressive R & D efforts supported by Ivivi Technologies’ engineering laboratory
• Suite of patents and pending patents securing broad intellectual property rights