• ChronoTherapeutics (Trenton, New Jersey), a developer of tailored, chrono-pharmacological drug delivery, unveiled the fully operational, stand-alone fifth-generation prototype of its ChronoDose system. ChronoDose is a miniaturized and automated, fully programmable, non-invasive drug delivery device. ChronoDose is worn like a wristwatch and programmed like an alarm clock, to accurately and automatically deliver predefined-sized doses to coincide with peak disease symptoms. Initial applications target depression, pain management, attention deficit disorder, addiction management, cardiovascular disease, urinary incontinence and migraines. The ChronoDose incorporates the company's AccuFuse technology, and features a micro-modulated dispensing device, microprocessor, drug reservoir, power source, LCD and programming buttons.

• Nektar Therapeutics (San Carlos, California) reported that the FDA has granted orphan drug designation to the first amphotericin B inhalation powder for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy. Nektar developed the amphotericin B inhalation powder to target the lungs directly with this potent, broad spectrum, fungicidal “gold standard“ antifungal drug. Using a small proprietary pocket size inhaler, the company has conducted two Phase I trials and has long-term toxicity studies under way to support the planned pivotal trials early next year. Nektar scientists will present data from the first of two ongoing studies at the 2nd Advances Against Aspergillosis conference this week in Athens, Greece, and at Focus on Fungal Infections 16, next month in Las Vegas. Pivotal trials are on target to begin in early 2007.

• Possis Medical (Minneapolis) reported the recent publication of a clinical study that included its AngioJet Rheo-lytic Thrombectomy Catheter System. The study evaluated clinical outcomes in high-risk acute coronary syndrome patients whose initial treatment with thrombolytic drugs had failed, and who therefore required urgent, rescue percutaneous catheter-based intervention (PCI). More than 200 patients were included in the study, which appears in the February issue of Catheterization and Cardiovascular Interventions. Of these, 21% received AngioJet treatment as part of the rescue PCI. The authors concluded that “angiographic and clinical success was high with low bleeding complications and low in-hospital mortality.“ Dr. Ray Matthews, who conducted the study with colleagues at Good Samaritan Hospital and the UCLA Medical Center (Los Angeles), will participate in a roundtable discussion of AngioJet coronary thrombectomy, hosted by Possis Medical, during the March meeting of the American College of Cardiology in Atlanta.

• Respirics' (Raleigh, North Carolina) MD Turbo, a breath-activated device for use with metered dose inhalers, will be launched by Accentia Biopharmaceuticals (Tampa, Florida), Accentia reported. TEAMM Pharmaceuticals, the specialty pharmaceutical division of Accentia, will market the device beginning in 2Q06. Handheld and battery-powered, the FDA-approved MD Turbo can be used with most inhalers. Designed to more reliably deliver a specific amount of medication to the user's lungs, MD Turbo coordinates the activation of the canister with the user's breathing in, and includes an electronic dose counter that shows how much medication is left in the canister.

SenoRx (Aliso Viejo, California), which makes minimally invasive devices for the diagnosis and treatment of breast cancer, reported that it has made available a new 7-Gauge size probe for its recently launched breast biopsy device, EnCor. EnCor probes were previously only available in a 10-gauge size. According to the company, EnCor is the first fully programmable, automated, multi-modality, modular breast biopsy system available, and is the first that offers the benefits of both open and closed tissue collection.

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