• Dermisonics (Irvine, California), focused on the development of a painless, needle-free drug-delivery technology, reported that it has received a notice of allowance from the U.S. Patent and Trademark Office on its second U-Strip patent application, concerning an ultrasonic drug delivery system. The U-Strip system employs an unusual form of sonic energy to facilitate the expansion of the pores of the skin, enlarging the pores to the point where large molecule drugs can be deposited into the dermis, and from there into the bloodstream of the patient. A previously granted patent covered the design of the Patch-Cap coupled with ultrasonic substance delivery. This second application focuses upon the use of an alternating sonic transmission instead of the use of conventional ultrasound. The alternating waveform, a sawtooth wave to square wave, expands the skin pores without perforating the skin and without burning the tissue or denaturing the drug.

• Fluke Biomedical (Everett, Washington), a manufacturer of biomedical test and simulation products and a provider of imaging and oncology quality assurance solutions for regulatory compliance, said that it has released the DPM2 Plus Digital Universal Pressure Meter, designed to measure the positive and negative pressures of medical devices in either liquid or gaseous form to assist in repair and quality control. When coupled with the optional Parabolic Flow Adapter accessory, the displayed pressure can be interpreted, using the look-up-table supplied with the parabolic flow adapter to determine flow from medical devices.

• Impliant (Milford, Connecticut), a developer of spine arthroplasty alternatives to fusion surgery, reported that its wholly owned subsidiary, Impliant Ltd., has received CE-mark approval for its TOPS system. Impliant said it plans to make the system available outside of the U.S. on a controlled basis to centers that want to work directly with the company. The TOPS System, a mobile posterior device, is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis, and spondylolisthesis.

• Maxxon (Mount Pleasant, South Carolina), a manufacturer of safety-engineered medical devices, reported the results of an optimum retraction activation force user/lab study for its Maxxon 3 cc Vacuum Operated Retractable Safety Syringe (ReVac) plunger. The study was conducted by the company's joint venture partner, Globe Med Tech (GMT; Houston), to simulate the actual clinical testing required by FDA and to ensure the activation force is comfortable for various healthcare professionals. GMT has initiated the next phase, manufacturing the 5,000-piece sample for FDA application and customers' evaluation. GMT estimates the sterilized samples will be ready in four to six weeks and about two to three months to complete all biocompatibility and clinical testing after samples are ready. The company said its next major milestone is to obtain FDA 510(k) registration.

• MD Scientific (Charlotte, North Carolina) reported FDA clearance to market its EndoTool Glucose Management System, an intravenous insulin-dose calculator designed for critical care applications where tight blood glucose control is desirable. The software leads to prompt control of the glucose level and has a hypoglycemia incidence of less than 0.1% of total calculated doses administered. The company said the software is HIPPA compliant, provides printed and digital records, is user friendly and reduces physician work load.

• Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) said that results from clinical studies of the company's AlzheimAlert test were presented at the recent International Meeting on Affective, Behavioral and Cognitive Disorders in the Elderly in Bologna, Italy. In the reported studies, more than 90% of cases of probable Alzheimer's disease (AD) tested positive in the test, with a specificity of 90%. The studies showed that adjunctive use of the AlzheimAlert test adds significantly to both the positive predictive value and the negative predictive value of the clinical diagnosis of Alzheimer's disease. All of the findings reached statistical significance. The AlzheimAlert test is a urine-based diagnostic aid for AD, and the company said it is the only proven accurate non-invasive AD test technology available.

• Orthovita (Malvern, Pennsylvania), a developer of orthopedic biomaterials, reported that it has obtained premarket approval (PMA) from the FDA to market its Vitagel surgical hemostat manufactured at its Malvern facility. Orthovita has already manufactured three lots of Vitagel at its facility and will begin shipping and selling this product immediately. Vitagel is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Vitagel is approved for use only in conjunction with the Cellpaker plasma collection system. Orthovita has been distributing Vitagel and Cellpaker since January 2005 under a distribution agreement with Angiotech BioMaterials.

• SuperArray Bioscience (Frederick, Maryland), which provides products and services designed for the analysis of gene expression associated with specific biological pathways or disease states, reported the availability of an improved method for isolating RNA from Formalin-Fixed Paraffin-Embedded (FFPE) samples of sufficient quality and quantity for microarray-based gene expression analysis. The company said that the method increases percent positive calls on high-density microarrays over other available kits and methods by reversing more of the cross-links introduced by the archiving process. The ArrayGrade FFPE RNA Isolation Kit and Service now bring these profiling capabilities to even more areas of biological research, including cancer and pathology.

• Uroplasty (Minnetonka, Minnesota) reported its first approval for its next-generation Urgent PC Neuromodulation System, a minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. The Therapeutic Products Directorate of Health Canada approved the company's amended license to sell the Urgent PC in Canada. Regulatory clearances from European and U.S. agencies are pending. Uroplasty said it redesigned the Urgent PC stimulator to include enhanced controls, visual and auditory signals of operational status, and an ergonomic device shape.

• Vascular Solutions (Minneapolis) reported that it has received conditional approval from the FDA of its investigational device exemption to begin a clinical study of the use of its Thrombin-VSI as a component in the company's existing hemostatic devices. The clinical study will evaluate the performance of Thrombin-VSI in comparison to the company's original source of thrombin in use with its Diagnostic Duett Pro sealing device. The clinical study is also expected to satisfy the clinical requirements necessary for the qualification of the use of Thrombin-VSI in the company's existing D-Stat Dry, D-Stat Radial, ThrombiGel and D-Stat Flowable hemostats. The study is expected to commence in the third quarter at up to 10 centers in U.S.

No Comments