• Gel-Del Technologies (St. Paul, Minnesota) said it has received FDA approval for clinical trials of CosmetaLife, a dermal filler injection that the company says holds potential to be a more effective treatment for deep lines and wrinkles. Gel-Del began clinical trials of CosmetaLife, a gel-particle product for injection to correct wrinkles, at four of six planned U.S. sites this fall and expects to conclude the trials in 2007. Gel-Del hopes to introduce the product to the cosmetic augmentation market by 2008. The material is also being developed for blood vessel grafts, cardiovascular stent coatings, cellular/bone scaffolds, fillers and drug delivery with other uses planned. Gel-Del Technologies makes biomaterial products that mimic the body’s tissue using revolutionary and patented protein-based fabrication techniques.

• Genzyme (Cambridge, Massachusetts) reported commercial availability of a new laboratory test designed to help identify non-small cell lung cancer (NSCLC) patients who may not respond to targeted therapies. Genzyme’s KRAS Mutation Analysis is meant to help identify NSCLC patients who test positive for specific KRAS mutations. Mutations in the KRAS gene have been associated with resistance to certain drugs used in treating this deadly form of cancer, including the tyrosine kinase inhibitors (TKIs) Tarceva and IRESSA. Genzyme Genetics offers extensive diagnostic testing services, the company said.

• Immunicon (Huntingdon Valley, Pennsylvania) reported the availability of the EasyCount System, a fluorescent microscopy-based imaging system designed to accurately count dead and live nucleated cells and automatically calculates cell viability, in a single test. The researcher can perform up to six tests at a time using the EasyCount Slide Multi-Well Slide provided with the EasyCount ViaSure Kit and the instrument reports total and live cell counts and viability calculation in less than one minute per test, the company said. Immunicon said it will target research laboratories and industrial accounts including bioprocessing facilities in the pharmaceutical, biotechnology and diagnostics sectors, where rapid, accurate cell counting is valued highly by users. Immunicon is developing cell- and molecular-based human diagnostic and life science research products, and is providing certain analytical services to pharmaceutical and biotechnology companies to assist them in developing new therapeutic agents, with an initial focus on cancer disease management.

• Neuro Kinetics (NKI, Pittsburgh) said it has been awarded patent number 7,119,471 from the U.S. Patent and Trademark Office for the design of its Barany (rotary) chair’s motor. The Barany chair is the motion stimulus component of NKI’s diagnostic systems used clinically for balance, neurologic and vertigo testing in hospitals and other healthcare facilities, and for advanced research by universities, government agencies and others, the company said. The motor design incorporates advanced digital technologies, fiber optics, optical encoders and unique cooling, slip ring and bearing designs, as well as other advanced technologies employed to enable precise control of the chairs, which in turn produces more accurate test results, according to NKI. Neuro Kinetics makes diagnostic equipment used world wide.

• Paracor Medical (Sunnyvale, California) said it has started enrolling participants in its pivotal clinical trial of HeartNet therapy, designated PEERLESS-HF (Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure). The HeartNet implant, an elastic structure delivered in a minimally invasive thoracotomy procedure in about one hour, is designed to provide support to the walls of the heart’s pumping chambers, the ventricles. This elastic support is intended to augment the function of the heart, and to potentially attenuate or reverse the negative remodeling associated with the advanced stages of heart failure. The HeartNet device has been studied in both U.S. and international safety and feasibility trials, the results of which support the progression to a randomized, controlled clinical study where the impact of the therapy in treated patients will be compared to the results in patients who continue with optimal therapy dictated by current recommended practice guidelines. More than 45 patients have been treated to-date in the safety and feasibility trials. Paracor plans to enroll patients at up to 30 U. S. centers, under an investigational device exemption that has been reviewed and approved by the FDA.

No Comments