July 2005

Thirty years ago, only 2% of hospital-acquired Staphylococcus aureus infections in intensive care units were resistant to antibiotics, but today physicians are seeing rates of approximately 60%.
“The rapid emergence of MRSA is an increasing public health problem, especially among hospitalized patients where skin and soft tissue infections caused by MRSA can be fatal,” said Dr. Weigelt. “Zyvox has been shown to have excellent skin and tissue penetration, which I believe is important when treating complicated SSTIs to ensure the treatment reaches the infection site. Zyvox is a critical option for patients with risk factors for MRSA, such as an acute illness, a compromised immune system, or previous antibiotic use.”
In the intent-to-treat (ITT) population, Zyvox had clinical cure rates of 92.2% versus 88.5% for patients on vancomycin. In the MRSA subgroup (microbiologically evaluable population), patients treated with Zyvox had better microbiologic cure rates of 88.6% compared with 66.9% for patients on vancomycin. In the ITT population, patients in the Zyvox group had fewer days of IV therapy than those in the vancomycin group (4.0 ± 2.6 days vs. 9.0 ± 5.3 days, respectively). The overall mean treatment duration was significantly longer in the Zyvox group versus the vancomycin group (11.8 ± 4.9 days vs. 10.9 ± 5.3, respectively).
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Anodyne Therapy Receives Regulatory Approval from Health Canada for Treatment of Peripheral Neuropathy

Anodyne Therapy LLC (Tampa, Fla) announces that it has received regulatory approval from Health Canada to market its Anodyne Therapy Systems in Canada. Approved Canadian labeling, based on submission of published clinical studies, includes temporary reduction in disturbances in skin sensation, increases in balance, and reduction in fall risk (when used adjunctively with physical therapy) due to diabetic and other peripheral neuropathies.
Peripheral neuropathy is nerve damage associated with diabetes and other chronic conditions. Symptoms include numbness and/or pain in the feet, legs, and hands. Complications of this devastating condition are reported to cost the US healthcare system in excess of $37 billion annually and include wounds that do not heal for months or years, lower-extremity amputations, reduced mobility, and increased risk of falls. While drugs are sometimes effective for the pain associated with diabetic peripheral neuropathy, no drug or medical device had previously been shown to increase sensation or improve balance once it has been diminished or lost due to peripheral neuropathy.
Anodyne Therapy treatments are currently available nationwide at more than 3,200 outpatient therapy facilities, hospitals, nursing homes, physician offices, and home health agencies to improve functional outcomes for patients suffering from peripheral neuropathy, chronic pain, and a broad range of other health problems. Products are also available for convenient home use.
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Ortec Set to Initiate 60-Patient Confirmatory Trial for Venous Leg Ulcer Approval

Ortec International, Inc. announces that it has come to an agreement with the US Food and Drug Administration (FDA) on the parameters of a 60-patient confirmatory trial evaluating OrCel® in the treatment of venous ulcers and has submitted a final version of the study protocol to the FDA. Upon Ortec receiving formal approval of the clinical protocol from the FDA, Ortec will initiate patient enrollment upon completion of all the preliminary steps required to initiate the 8 clinical sites participating in the study. Patient enrollment is expected to begin at the end of July.
The confirmatory trial is being conducted by Ortec at the recommendation of the FDA based on its review of Ortec’s Pre-Market Approval (PMA) application.

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