ArthroCare(R) Sports Medicine To Tackle Diabetic Foot Ulcers

Main Category: Diabetes
Article Date: 28 Mar 2008 - 15:00 PDT

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As part of ArthroCare Sports Medicine's recent entry into the Foot and Ankle arena, ArthroCare(R) Corp. (Nasdaq: ARTC) announced today that it has launched early stage clinical and pre-clinical research work for treating diabetic foot ulcers and is encouraged by preliminary results reported by physicians.

There are an estimated 18 million Americans living with diabetes today and each year at least 5% of that population develops foot ulcers as an effect of the disease. The Centers for Medicare and Medicaid Services (CMS) report that up to 30% of those suffering from diabetic foot ulcers eventually require amputation and that even for those whose ulcers heal, there is a 66% recurrence rate in that patient population. Indeed, such ulcers are far and away the most common condition leading to lower extremity amputations in the world today.

With hospitalization and amputation often being the only options for patients, ArthroCare's Sports Medicine division is working with surgeons to develop less invasive, more effective alternatives.

"Our findings treating diabetic foot ulcers with ArthroCare's technology thus far are quite promising," said J. Brian Warne, DPM of the Samaritan Foot & Ankle Center in San Jose. "For example, one 48-year old type 1 diabetic male patient we treated last year had an 18 month history of non-healing foot ulceration. The patient had been treated both conservatively and surgically in the past for this wound, but all treatment up to now had been unsuccessful. Thirteen weeks after a debridement procedure we performed with ArthroCare technology, this patient's wound was fully closed. It has now been five months and this patient has had no reoccurrence of the wound. While this is just one patient example, of course, it is a very promising result we look forward to achieving with many additional subjects."

"We're very encouraged by Dr. Warne's early findings thus far," said Jack Giroux, president of ArthroCare Sports Medicine. "We're constantly exploring new applications for our technology that can help surgeons achieve superior outcomes and we think we may have something very special here that could potentially provide a large patient population with relief. Furthermore, Foot and Ankle and Podiatric surgeons fit very well within our current call patterns, where today we are actively selling our Topaz and Opus product lines for tendon treatment and tendon fixation."

ArthroCare's platform technology is indicated for soft tissue debridement in arthroscopic and orthopedic applications, which includes treating diabetic foot ulcers among other soft tissue conditions. ArthroCare is evaluating pathways to expand product indications to include diabetic foot ulcers as a specific treatment methodology and will work with FDA for specific product labeling. Giroux added that ArthroCare Sports Medicine has also completed a research protocol for a patient case series study in conjunction with Georgetown University Medical Center to further investigate diabetic foot ulcer treatment options using ArthroCare's unique Coblation technology. ArthroCare expects IRB approval within the next month.

About ArthroCare

Founded in 1993, ArthroCare Corp. is a highly innovative, multi-business medical device company that develops, manufactures and markets minimally invasive surgical products. With these products, ArthroCare targets a multi-billion dollar market opportunity across several medical specialties, significantly improving existing surgical procedures and enabling new, minimally invasive procedures. Many of ArthroCare's products are based on its patented Coblation technology, which uses low-temperature radiofrequency energy to gently and precisely dissolve rather than burn soft tissue - minimizing damage to healthy tissue. Used in more than four million surgeries worldwide, Coblation-based devices have been developed and marketed for sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and gynecologic procedures. ArthroCare also has added a number of novel technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.

Safe Harbor Statements

Except for historical information, this press release includes forward-looking statements. These statements include, but are not limited to, the company's stated business outlook for fiscal 2008, continued strength of the company's fundamental position, the strength of the company's technology, the company's belief that strategic moves will enhance achievement of the company's long term potential, the potential and expected rate of growth of new businesses, continued success of product diversification efforts, and other statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to the uncertainty of success of the company's non-arthroscopic products, competitive risk, uncertainty of the success of strategic business alliances, uncertainty over reimbursement, need for governmental clearances or approvals before selling products, the uncertainty of protecting the company's patent position, and any changes in financial results from completion of year-end audit activities. These and other risks and uncertainties are detailed from time to time in the company's Securities and Exchange Commission filings, including ArthroCare's Form 10-K for the year ended Dec. 31, 2007. Forward-looking statements are indicated by words or phrases such as "anticipates," "estimates," "projects," "believes," "intends," "expects," and similar words and phrases. Actual results may differ materially from management expectations.

http://www.arthrocare.com