LinkMed (Stockholm, Sweden) said that its portfolio company AbSorber AB, launched its first product, XM-One at the end of 2006. AbSorber's next product — an ABO diagnostic test — is expected to launch in 2008. AbSorber's new test measures the concentration of blood group A and B antibodies. The product is based on beads (magnetic nanoparticles) carrying synthetic blood group A and B antigens. By adding patient sera to the beads, the presence of blood group antibodies can be measured by flow cytometry. The test would provide doctors with a more reliable basis for decision-making, thereby facilitating greater transplantation success, according to the company. LinkMed develops new life science companies.

Aspect Medical Systems (Newton, Massachusetts) reported initiation of two studies being conducted with the Cleveland Clinic (Cleveland, Ohio) to investigate the impact of anesthetic management techniques on patient outcomes. The first study seeks to determine if avoidance of deep anesthesia, administration of steroids and control of blood sugar levels improves outcomes in patients undergoing major vascular surgery. The second study will test the hypothesis that avoiding deep general anesthesia reduces cancer recurrence rates in women undergoing surgery for breast cancer. Both studies will use the company's BIS monitoring system to assess depth of anesthesia. Using a sensor placed on the patient's forehead, BIS monitoring translates information from the electroencephalogram into a single number that represents each patient's level of consciousness. The BIS value ranges from 100 (indicating an awake patient) to zero (indicating absence of brain activity).

Cardica (Redwood City, California) reported completing enrollment of about 220 patients in a pivotal clinical trial in U.S. and Europe to evaluate safety/efficacy of its PAS-Port Proximal Anastomosis System during coronary artery bypass graft (CABG) surgery. The PAS-Port system, commercially available in Japan and Europe, creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during bypass procedures, Cardica said. The trial is being conducted in the U.S. under an Investigational Device Exemption. Two venous bypass grafts were randomly selected in each patient to be connected to the aorta using either the PAS-Port device or the conventional hand-sewn technique. Patients will receive a follow-up angiogram nine months after their procedure to determine patency (degree of openness of the vein graft) of both PAS-Port and control grafts. If the results of this trial are favorable, the company plans to submit a 510(k) application for the PAS-Port system to the FDA in early 2008. The PAS-Port system is designed to allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in about two minutes, with little or no injury to the bypass graft vessel or the aorta. Cardica makes automated anastomosis systems for coronary artery bypass graft (CABG) surgery.

CryoCath Technologies (Montreal) said it has received FDA approval to expand its pivotal Investigational Device Exemption STOP AF trial for Arctic Front to the full cohort of patients in all 20 centers. The trial is designed to demonstrate Arctic Front's clinical and therapeutic effectiveness in treating paroxysmal Atrial Fibrillation (AF) when compared to traditional medical therapy. CryoCath develops cryotherapy products to treat cardiovascular disease.

Inovio Biomedical (San Diego) reported that the Journal of Virology has published a scientific paper prepared by Inovio's development partner, Wyeth (Madison, New Jersey), regarding results from a non-human primate study of an investigational DNA vaccine against HIV delivered using Inovio Biomedical's electroporation technology. The paper summarized results of a research project lead by Michael Egan, PhD, a principle research scientist at Wyeth Vaccine Research. The scientific paper concluded that in vivo electroporation appears safe and can dramatically improve the delivery and immunogenicity of a multi-vector, multi-antigen pDNA vaccine in non-human primates. It also suggested that the data "have important implications for the design and development of an efficacious therapeutic vaccine for the treatment of HIV-1 infection." Inovio said it is focused on commercializing its Selective Electrochemical Tumor Ablation therapy and development of multiple DNA vaccines using its delivery platform for gene-based treatments.

Synova Healthcare Group (Media, Pennsylvania) said it plans to officially re-launch the Today Sponge female contraceptive at the upcoming American College of Obstetricians and Gynecologists (ACOG; Washington) meeting May 5 - 9 in San Diego. According to Synova, the Today Sponge was once the most well-known over-the-counter form of female birth control. It was also the first product to combine a spermicide and a barrier contraceptive in one product, the company said. The Today Sponge is an effective, non-hormonal contraceptive that offers 24-hour protection without the potential side effects and long-term commitment associated with hormonal methods, Synova noted. The female birth control option is available without a prescription to women (in its previous packaging) through retailers across the U.S. and Canada. Synova develops healthcare products related to contraception, vaginal health, menopause management, fertility planning, obstetrics and personal care.

Wright Medical Group (Arlington, Tennessee) reported the commercial launch of its Carolina Jones Fracture System for foot and ankle surgery. The system is the latest addition to Wright's market-leading line of reconstructive products for foot and ankle procedures. The Carolina system is the first major product designed specifically for treatment of Jones fractures of the fifth metatarsal of the foot, the company said. Jones fractures can be a disabling injury, and are common in young, athletic patients and geriatric patients. Wright makes reconstructive joint devices and biologics.

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