• Baxter Healthcare (Deerfield, Illinois) reported receiving FDA approval for its V-Link Luer-activated device (LAD) with VitalShield protective coating. V-Link with VitalShield is the first needleless IV connector containing an antimicrobial coating. This new device has been shown to kill 99.9% of specific common pathogens (infection- causing microorganisms) known to cause catheter-related blood stream infections, including the highly treatment-resistant bacteria called methicillin-resistant Staphylococcus aureus, or MRSA. The U.S. Centers for Disease Control and Prevention recently reported that MRSA infections cause an estimated 18,650 deaths a year in the U.S., more deaths in the U.S. per year than HIV/AIDS. V-Link is coated on both inner and outer surfaces with a proprietary silver technology, called VitalShield. Silver is a well-known antimicrobial agent, and this specially designed formulation has been shown to be effective against a broad spectrum of microorganisms. The silver antimicrobial agent helps prevent the contamination and growth of these pathogens within the V-Link device. The antimicrobial agent is not intended to be used as a treatment for existing infections. Baxter is the principal U.S. operating subsidiary of Baxter International. Baxter International, through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma.

• Monogram Biosciences (South San Francisco) said that the California ADAP program under the California Office of AIDS has established coverage and reimbursement for its Trofile Assay. This coverage will be administered by the Public Health Service Bureau, the California ADAP program’s pharmacy benefit manager. Monogram introduced Trofile in August, upon FDA approval of Pfizer’s Selzentry (maraviroc), and since then, roughly 2,000 tests have been requested. Some 1,200 tests have been performed, of which about 400 have been for clients and payers for whom reimbursement arrangements are in place, and for which revenue is recorded. Monogram makes products to guide and improve treatment of serious infectious diseases and cancer.

• Nephrocor (Glen Allen, Virginia) reported the availability of RenalVysion, the non-invasive urine-based test for early diagnosis of kidney disease. RenalVysion identifies and measures urinary sediment findings not detected in routine urinalysis. These highly specific results allow anatomic localization of injury in the kidney and the severity of disease. RenalVysion incorporates technology that has up to 91% accuracy in diagnosis according to comparative studies with kidney biopsies for glomerular disease. Nephrocor is an anatomic pathology laboratory exclusively serving nephrologists throughout the U.S.

• Novasys Medical (Newark, California) said that six-month data from its post-market, prospective open label study to evaluate the long-term durability of the Renessa treatment for stress urinary incontinence (SUI) in women was presented at the Western Section meeting of the American Urological Association. The FDA-cleared Renessa system includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing collagen in the tissue. Upon healing, the treated tissue is firmer, resulting in increased resistance to involuntary leakage at times of increased abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating leaks. The Renessa treatment can be performed in the convenience of a physician’s office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. Novasys makes therapies for women’s health.