• Genetronics Biomedical (San Diego) and the H. Lee Moffitt Cancer Center (Tampa, Florida) reported initiation of a Phase I clinical trial that is using Genetronics' MedPulser System to deliver plasmid DNA to tumors with the aim of treating malignant melanoma. The trial is measuring the safety of Genetronics' electroporation system to deliver plasmid DNA into tumor cells to mount an immune response. In this Phase I study, plasmid DNA encoding a cytokine is delivered directly to tumors in patients with malignant melanoma using the MedPulser, thus enabling the entry and uptake of plasmid DNA into the tumor cells, leading to cytokine production and inducing an immune response to eliminate the cancer. The MedPulser, enhancing local cellular uptake of useful biopharmaceuticals, has received the CE mark, and Genetronics said it would launch the product in Europe this year. The company also is conducting multi-center, premarketing, observational studies in Europe to study the MedPulser to treat newly diagnosed, primary and recurrent, head and neck cancers, as well as skin cancers.

• Innovative Biosensors (IBI; College Park, Maryland) reported the launch of a rapid and ultra-sensitive test for the detection of E. coli O157:H7 contamination in foods. The E. coli O157:H7 detection system enables meat processors to test for the pathogen in less than five minutes. The system is based on Canary, a biosensor technology developed at the Massachusetts Institute of Technology (Cambridge, Massachusetts) and exclusively licensed to IBI. The assay protocol is simple, requiring minimal training and easy-to-use instrumentation. The company said the E. coli O157:H7 detection system is the first in a series of upcoming IBI products for rapid pathogen detection.

• Light BioScience (Virginia Beach, Virginia) reported that the FDA has cleared GentleWaves Light Emitting Diode (LED) Photomodulation System for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The company said GentleWaves is the first and only LED device to receive marketing approval for a medical claim associated with cosmetic improvement of aging and sun-damaged skin. GentleWaves uses specially coded arrays of light emitting diodes to modulate the activity of living cells. Unlike other techniques used for skin rejuvenation, GentleWaves' core technology delivers very low-intensity, non-thermal light energy to stimulate collagen and reverse the appearance of photoaging.

• Wright Medical Group (Arlington, Tennessee) reported that a reimbursement “J“ code has been assigned for its GraftJacket Ulcer Repair Matrix, a treatment for chronic wounds often associated with diabetes. Under the new code, Medicare will provide reimbursement for the use of the GraftJacket Matrix to treat diabetic foot ulcers and other lower extremity wounds in the physician office setting. The new reimbursement status complements the “C“ code granted in November by the Centers for Medicare & Medicaid Services (Baltimore), now making Wright's GraftJacket Ulcer Repair Matrix reimbursable by Medicare in hospital outpatient departments, wound care centers and physicians' offices. Wright said it is working with payers at the local level to ensure smooth claims processing. The GraftJacket Matrix accelerates tissue regeneration at deep levels of the wound, while protecting the wound surface with a scaffold that actually converts into functional host tissue.

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