• Archus Orthopedics (Redmond, Washington) reported that the FDA has conditionally approved an investigational device exemption for its Total Facet Arthroplasty System (TFAS). The TFAS is a spinal implant designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS replaces the degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. Archus said it will conduct a prospective, randomized pivotal clinical trial comparing TFAS to spinal fusion achieved using posterior, pedicle screw instrumentation. The approval allows the company to enroll patients at up to 20 sites throughout the U.S. Patients will be followed for two years. The company said that enrollment in the trial will likely begin within the next two to three months. The TFAS device is CE-marked in Europe.

• Cybernet Medical (Ann Arbor, Michigan), a developer of biometric monitoring technologies for outpatient care, said its MedStar Disease Management Data Collection System now offers enhanced Internet video capabilities and web-based management tools for improving the monitoring of homebound chronic disease patients with wound care needs. The MedStar system, used to remotely collect and transmit a patient's physiological data, supports the high-resolution camera output that is especially beneficial in wound care management programs. Through MedStar, chronic disease patients – including those in harder-to-reach rural areas – can receive regular contact with a healthcare provider. The MedStar device collects data directly from measurement tools such as blood pressure cuffs and glucose monitors and transmits it to a collection server over a standard telephone line. The MedStar's compatible videophones can also transmit reliable, high quality images over regular phone lines or the Internet. For healthcare providers, MedStar now offers web-based wound care management tools such as a measurement device that visually assesses the healing process via successive digital images.

• Israel Pluristem Life Systems (Haifa, Israel), a developer of stem cells from umbilical cord blood, reported receiving a notice of allowance from the U.S. Patent and Trademark Office for "Method of producing undifferentiated hematopoietic stem cells using a stationary phase plug flow bioreactor." The patent covers Pluristem's concept of creating a 3-D bone-like environment that supports stem cell expansion without differentiation. The patent allowance also protects the concept and the mechanism of action of the PluriX bioreactor. Pluristem's technology mimics the 3-D human bone marrow environment in order to achieve significant stem cell replication without the use of artificial substances.

• LifePoint (Ontario, California), a provider of non-invasive drug diagnostic technologies, said it believes it is reaching the goal of resolving the "aspiration"-related technical difficulties experienced with its Impact system, a rapid saliva-based testing, screening and drug monitoring device. The company reported making a number of improvements in the system over the last several weeks and running more than 400 tests in a number of external drug court and rehabilitation centers with better than a 95% success rate. LifePoint said it also has begun shipping the more "optimized" aspiration units to its current customer base and that it has decided to sub-license its exclusive rights to saliva-testing technology acquired from the U.S. Navy, which forms the platform for the Impact system. This strategy is in addition to completing other "fixes" now underway with its current Impact system that are designed to enhance its marketplace capability, the company said. "We believe that we have now largely resolved one operational issue and intend to resolve as quickly as possible the one or two remaining operational problems being experienced with the existing Impact system," said CEO Richard Wadley.

• Proneuron Biotechnologies (Los Angeles) reported receiving a European patent for ProCord (autologous incubated macrophages) for the treatment of acute spinal cord injury by the European Patent Office. European patent No. EP 0952772 B1, for the use of mononuclear phagocytes to promote axonal regeneration, was granted to Yeda Research and Development Co. Ltd. (Rehovot, Israel) from which Proneuron Biotechnologies has an exclusive license. ProCord was previously patented in the U.S. under three U.S. patents, and received an orphan drug designation by the FDA in September 2004. Proneuron is currently engaged in a Phase II international, multi-center, randomized controlled study of ProCord.

• Spacelabs Medical (Issaquah, Washington) reported its release of the UltraviewSL Dual Capnography Module. The new module, combining both mainstream and sidestream technology, is designed to accommodate a range of patient needs and provide clinicians with comprehensive information about patient respiratory status and adequacy of ventilation. The Dual Capnography Module is compatible with Spacelabs UltraviewSL, Ultraview and PCMS bedside monitors and is suitable for adult, pediatric and infants. The less-invasive sidestream CO2 monitoring capability with traditional mainstream monitoring enables the clinician to measure EtCO2, respiration rate and minimum inspired CO2 with support for apnea alarms. The Dual Capnography Module incorporates both Capnostat III mainstream and LoFloTM sidestream technology from Respironics Novametrix.