• IYIA Technologies (San Marcos, California) reported preliminary results from a clinical trial using IYIA’s wound treatment system, O2Misly (O-Mis-ly), a new method to treat slow-healing diabetic foot ulcers. O2Misly provides oxygen infused under tension in a closed chamber blended with a mist, which also delivers an antimicrobial to the affected area. Only patients that had failed current standard of care treatment were allowed to enter into the study. In the study, 75.5% of patients treated with MislyT were healed within 12 weeks, compared to 24.2% treated via standard care therapies; 100% of patients treated 20 weeks with MislyT were healed compared to 30.9% treated via standard care.

• Nephros (New York) reported positive results of a recent pilot clinical study confirming that its end stage renal disease (ESRD) therapy, Mid-Dilution Hemodiafiltration (HDF), is an effective alternative to standard HDF, offering superior clearance of certain toxins from the blood and improving quality of life for patients with ESRD. The study, headed by Guillermina Barril, MD, was conducted at the Hospital Universitario de la Princesa in Madrid, Spain and the Hospital Clinico Universitario de Granada in Granada, Spain. As a result of the findings, Barril said that Mid-Dilution HDF therapy is an effective alternative to standard HDF. Nephros develops products for the End-Stage Renal Disease (ESRD) patient. The company also markets a line of water filtration products, the Dual Stage Ultrafilter (DSU).

Researchers at Pulmonary Associates (Phoenix) reported the start of the AIR2 (Asthma Interventional Research) international, multi-center clinical trial to explore an investigational asthma treatment. Conducted at the John C. Lincoln North Mountain Hospital (Phoenix), the study focuses on a procedure called bronchial thermoplasty. This procedure uses thermal energy to heat the airway and reduces the amount of smooth muscle that contributes to the constriction during an asthma attack. Early patient data from trials outside the U.S. suggest it may hold promise for moderate and severe asthmatic patients, the company said.

• Specialty Laboratories (Valencia, California) reported the launch of HCV Liver Fibrosis GenotypR, a genomic clinical test to predict progression to liver fibrosis or cirrhosis for hepatitis C virus patients. This test identifies the patient’s genomic signature of seven single nucleotide polymorphisms to provide a cirrhosis risk score, which rates the relative risk of progression to liver fibrosis or cirrhosis, the company said. Specialty Laboratories provides advanced clinical tests to diagnose disease.

• Spectranetics (Colorado Springs, Colorado) reported that it has received FDA clearance to market its Turbo elite product line for the treatment of blockages within leg arteries. The Turbo product line is designed for improved pushability, trackability, and ablation capability as a result of an improved outer jacket and inner guidewire lumen, and additional laser fibers in most sizes, the company said. Spectranetics makes single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its excimer laser system.

• Visicu (Baltimore) has been granted a reexamination certificate for patent No. 6,804,656 by the U.S. Patent and Trademark Office for its “System and Method for Providing Continuous, Expert Network Critical Care Services from a Remote Location,” which represents its eICU program. A reexamination of the patent claims was requested in January 2005 by a third party desiring to implement their own solution and citing references that required further consideration by the Patent Office. During the re-examination process, minor amendments to the claims were made that were consistent with the eICU Program. The eICU Program features a centrally located, remote monitoring system equipped with high fidelity telemedicine and early warning intervention software. Visicu is the first company to receive such U.S. patent protection and the first to bring remote critical care (eICU centers) to the marketplace. Visicu says the eICU is used at over 30 health systems, representing approximately 5,000 beds. Visicu is a healthcare information technology and clinical solutions company focused on transforming the delivery of critical care through its eICU program.

• Xenomics (New York) has introduced a test for the detection of NPM gene mutations, a recently discovered genetic marker for Acute Myeloid Leukemia (AML). This genetic marker for AML, discovered by Drs. Cristina Mecucci and Brunangelo Falini, collaborators at the Institute of Hematology at the University of Perugia (Perugia, Italy) and licensed by Xenomics, is designed to provide diagnostic accuracy, prognosis, and monitoring of the disease, the company said. Xenomics is focused on the development of DNA-based tests using transrenal DNA. Its technology uses simple urine specimens and is being applied to various applications, including detection and monitoring of infectious diseases, tumor detection and therapeutic monitoring, stem cell transplantation monitoring, and prenatal genetic testing.

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