• Nephros (New York), which is developing products designed to improve the quality of life for the End Stage Renal Disease (ESRD) patient, said that it has provided a 510(k) submission for its OLpur HD190 to the FDA. The OLpur HD190 is a high flux filter designed for use in a variety of ESRD therapies, including dialysis and hemodiafiltration (HDF). Submission of form 510(k) is the first step for Nephros in the regulatory process to gain approval for its ESRD therapies in the U.S. CEO Norman Barta said, "The OLpur HD190 high flux filter for example shares similar components with our core OLpur MD190 filter, and we believe this 510(k) filing will serve to lay the groundwork and help accelerate approval for the Olpur MD190 in the U.S." The company's OLpur MD190 hemodiafilter is an advanced cartridge designed specifically for use in HDF therapy.

• Protein Polymer Technologies (PPTI; San Diego) reported the development of a new surgical sealant designed to prevent air and fluid leaks following lung, gastrointestinal and cardiovascular surgery. Following the completion of required preclinical testing, the company said it intends to seek approval for an investigational device exemption with the FDA in order to conduct clinical trials in humans. PPTI's surgical sealant is applied following closure of tissues with sutures or staples. Using a simple dual-syringe applicator, the sealant is sprayed over the surgical incision. In less than a minute, a tough yet flexible barrier – strongly adherent to the tissue being repaired is formed. As the tissue heals, the sealant gradually resorbs. Ease of use, strength, flexibility and resorption are the key product features required for the targeted applications. PPTI is focused on developing products to improve medical and surgical outcomes.

• Purkinje (St. Louis) said results of a second controlled study of the Purkinje (formerly known as Wellinx) electronic prescribing system were presented last week at the eHealth Initiative's HIT Summit West in San Francisco. The results of a controlled trial in which WellPoint measured the impact of the Purkinje ePrescribing system on generic prescribing rates as well as prescription costs during a nine-month study period. The 26 physicians in the study group increased generic prescribing rates 3.7% relative to a control group of 86 physicians. The cost per prescription for the study group was 10.1% lower than that of the control group. Wellinx, known for its evidence-based electronic prescribing service, recently merged with Purkinje, a leading electronic medical records provider.

• Quark Biotech (Fremont, California) reported findings from a study that suggest that the hypoxia inducible gene RTP801 may serve an important mechanistic role in the development of experimental chordial neovascularization (CNV), the principal cause of vision loss in patients with age-related macular degeneration (AMD). The study, led by Dr. Jayakrishna Ambati of University of Kentucky, provides scientific rationale for further preclinical and clinical studies of RTP801 in AMD and will be presented later this month at the Ocular Angiogenesis conference in Cambridge, Massachusetts. " The targeted disruption of RTP801 inhibits experimental CNV, which ultimately may help to inhibit vision loss," Ambati said. The data reveals that in an animal model of CNV, disruption of RT801 expression through siRNA, reduced CNV by almost 58% compared to the control. In addition, in RTP801-knockout mice, CNV was inhibited by 32%.

• Restore Medical (St. Paul, Minnesota), a provider of medical technologies to address sleep-disordered breathing, reported that its Pillar Procedure is now available internationally. As part of its global expansion, Restore Medical said it has signed partnerships with Bedtime Medical (Shanghai, China) and Medicare Health Products (Hong Kong). Initial product shipments have been made to each of these distributors in support of anticipated 1Q05 launches. In the coming year additional distributors will be added in Asia, Europe and South America. The company said the Pillar Procedure has received strong acceptance in the U.S. since its clearance by the FDA in late 2004 as a first-line implantable treatment for mild-to-moderate obstructive sleep apnea.

• Sontra Medical (Franklin, Massachusetts) reported that rapid dermal anesthesia was achieved using SonoPrep ultrasonic skin permeation followed by two minutes of active drug transport with iontophoresis, a needle-free method of delivering drugs through the skin using low-level electrical current. In this randomized, prospective internally controlled clinical study, 30 patients received three different types of treatments on their forearm with 2% topical lidocaine. Needle-stick pain was evaluated using the Visual Analogue Scale. The study evaluated SonoPrep ultrasonic skin pretreatment or a placebo skin pretreatment followed by two minutes of iontophoresis, compared to 10 minutes of iontophoresis alone. Pain scores from the SonoPrep treatment followed by two minutes of iontophoresis were equivalent to the 10-minute iontophoresis treatment. In this study, Sontra used an Iomed Phoresor Iontophoretic Drug Delivery System and 2% topical lidocaine with 1-10,000 epinephrine. SonoPrep pretreatment followed by 2% lidocaine application and two minutes of iontophoresis provided equivalent pain relief to 2% lidocaine applied over intact skin with 10 minutes of iontophoresis. SonoPrep also enabled iontophoresis to be applied with only 1 milliamp electric current compared to 4 milliamps employed when iontophoresis was used alone.

• Vital Images (Minneapolis), a provider of enterprise-wide advanced visualization software, has launched Vitrea 2, Version 3.7, the company's latest software for 2D, 3D and 4D visualization analysis. The new release features Cardiac Functional Analysis (CFA) and Computed Tomography (CT) Lung options developed by Vital Images. In addition, Version 3.7 includes enhancements to InnerviewGI, the company's CT colon software. Version 3.7, geared to enhance workflow and productivity, is now available for shipment.