Healthcare Industry News:  BioniCare Medical Technologies 

Devices FDA

 News Release - June 14, 2006

FDA Issues Clarification of Classification for BioniCare Technology

New Classification: 'Transcutaneous Electrical Stimulator for Arthritis'

SPARKS, Md., June 14 (HSMN NewsFeed) -- Today, the FDA issued documents making official changes in response to BioniCare's request for a clarification of classification for their proprietary BioniCare pulsed electrical stimulator technology. The new classification will be "Transcutaneous Electrical Stimulator for Arthritis" (T.E.S.A). BioniCare has a distinct FDA labeling for both osteoarthritis (OA) of the knee and rheumatoid arthritis (RA) of the hand based on the clinical studies, however it had been classified as a TENS based on the similar safety profile. The FDA revised all clearances for BioniCare. This change in product code will apply retroactively to all commercially available products from BioniCare: OA Knee Device and RA Hand Device. This news comes just a few months after Medicare created a new product code effective in January 2006, E0762, as a result of BioniCare's application submission last year.

According to Thomas Zizic, MD, President & CEO of BioniCare, this news comes at a time when the organization has been building significant momentum. "We have passed so many milestones over the last few years that this news from the FDA is one more level of confirmation that this technology is solidifying a place in the treatment algorithm for patients suffering from osteoarthritis. At the core of this announcement is our ongoing commitment to evidence based medicine (E.B.M.). Since our commercial launch, we have committed ourselves to numerous clinical trials that are now providing additional outcomes for both physicians and insurance providers, and will continue to do so. Several new peer reviewed publications will be coming out in the next few months providing further evidence not only of the long-term clinical benefits of the BioniCare Knee Device, but also more evidence demonstrating the cost benefits to the healthcare system."

The BioniCare Knee Device: A Product with an Uncommon Clinical Profile of Safety and Efficacy

The BioniCare Knee Device works through low amplitude electrical stimulation, and is the first and only non-drug, non-invasive treatment option available for OA of the knee. In one four-year study conducted at Johns Hopkins University, 62% of candidates for total knee replacement were able to defer surgery; this was true for only 7% of patients in a control group. In addition, no patient has suffered a serious adverse event using the BioniCare Knee Device. Its benefits include the following:

* Targeted, durable relief of pain and associated symptoms

* Substantial improvement over baseline anti-inflammatory medications

* Excellent safety profile

* High patient acceptability

* Ease of use

About BioniCare Medical Technologies, Inc.

BioniCare Medical Technologies, Inc. develops and markets devices to meet the growing needs of more than 70 million Americans who suffer from the painful complications of arthritis and related musculoskeletal diseases. Through application of its patented technology, BioniCare is dedicated to the discovery of non-invasive devices for the regeneration of musculoskeletal soft tissues to significantly improve the quality of patients' lives.

For more information about the company and the benefits of BioniCare's non-invasive, non-drug option for treating OA and RA, please visit http://www.bionicare.com.


Source: BioniCare Medical Technologies

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