• ATS Medical (Minneapolis) reported submitting its request for an Investigational Device Exemption for its 3f Enable Aortic Bioprosthesis to the FDA for review, the next step in the process necessary to begin U.S. clinical trials. The ATS 3f Enable Aortic Bioprosthesis is the company's second tissue valve product to market. The company calls it a "first of its kind prosthesis" designed to eliminate the time-consuming procedure of placing and tying the 12-20 or more sutures necessary to implant current valve replacements. A flexible Nitinol frame has been integrated with the companies' initial tissue valve offering, the ATS 3f Aortic Bioprosthesis. During an open chest procedure and after removal of the diseased valve, the ATS 3f Enable Aortic Bioprosthesis is folded into a reduced geometry and diameter that is positioned in the native valve annulus with a proprietary delivery system. Upon deployment, the Nitinol frame and valve expand within the annulus applying a continuous radial force that effectively implants the valve without the need for sutures. Overall procedure time and specifically, cardio-pulmonary bypass time can be significantly reduced.

Inovio Biomedical (San Diego) reported that the Journal of Virology has published a scientific paper prepared by Inovio's development partner, Wyeth (Madison, New Jersey), regarding results from a non-human primate study of an investigational DNA vaccine against HIV delivered using Inovio Biomedical's electroporation technology. The paper summarized results of a research project lead by Michael Egan, PhD, a principle research scientist at Wyeth Vaccine Research. The scientific paper concluded that in vivo electroporation appears safe and can dramatically improve the delivery and immunogenicity of a multi-vector, multi-antigen pDNA vaccine in non-human primates. It also suggested that the data "have important implications for the design and development of an efficacious therapeutic vaccine for the treatment of HIV-1 infection." Inovio said it is focused on commercializing its Selective Electrochemical Tumor Ablation therapy and development of multiple DNA vaccines using its delivery platform for gene-based treatments.

Oculus Innovative Sciences (Petaluma, California) reported receiving Institutional Review Board (IRB) approval from six sites within the U.S. to participate in its Phase II clinical trial evaluating the preliminary safety and efficacy of topical Dermacyn Wound Care vs. systemic oral antibiotics for the treatment of mild diabetic foot infections. Dermacyn is a solution containing oxychlorine compounds manufactured using Oculus' Microcyn Technology. The primary endpoint of the trial will be clinical cure or improvement of infection. Oculus expects results from the study in 3Q07, followed by the initiation of two larger, pivotal Phase III trials. The randomized, open-label three-arm study will enroll 60 total patients at up to 13 U.S. sites. Patients will be randomized 3:1 to receive Dermacyn, Dermacyn in combination with the oral antibiotic levofloxacin, or saline plus levofloxacin. The twenty patients in each arm will be treated over ten days, each time their wound dressing is reapplied. After 10 days, patients will stop treatment and return two weeks later for a follow-up assessment. Oculus makes Microcyn Technology-based products intended to help prevent and treat infections in chronic and acute wounds.

Wright Medical Group (Arlington, Tennessee) reported the launch of its Carolina Jones Fracture System for foot and ankle surgery. The system is the latest addition to Wright's line of reconstructive products for foot and ankle procedures. It is the first major product designed specifically for treatment of Jones fractures of the fifth metatarsal of the foot, the company said.

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