• Cyberonics (Houston) said it has made a proposal to the FDA to amend the protocol of its post-market dosing study (D-21) in depression patients treated with VNS Therapy. Based on a reassessment of the study power and size following FDA's approval of an amendment to the data analysis originally specified in the study protocol, the company proposes to reduce the number of study subjects from 460 to 330, while still maintaining appropriate study power. Cyberonics makes the Vagus Nerve Stimulation (VNS) Therapy system, which is FDA-approved for the treatments of refractory epilepsy and treatment-resistant depression. The VNS uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve.

• Nomir Medical Technologies (Waltham, Massachusetts) said the FDA has granted a second clearance of the company's Noveon system. With this clearance, the device may now be used during procedures of the skin, subcutaneous tissues and nasal passages, for applications in podiatry, dermatology, plastic surgery, and otolaryngology. The Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery. Nomir has completed two IRB human studies with Noveon against methicillin-resistant Staphylococcus aureus carriage and infection in the nose. Based on positive data from these studies, Nomir is initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.

• Osteotech (Eatontown, New Jersey) said it has initiated a pivotal clinical trial for its DuraTech BioRegeneration Matrix. The first five patients in this 60-patient trial have already been enrolled. During the study's initial cranial surgical procedures, the patients' dura mater (the tough, outermost membrane surrounding the brain and spinal cord) was successfully repaired by surgeons using the DuraTech BioRegeneration Matrix. Using Osteotech's collagen technology, DuraTech is an engineered nano-structure human collagen material that provides a porous scaffold for rapid cellular in-growth to facilitate healing. The DuraTech BioRegeneration Matrix is the lead product in Osteotech's collagen platform and is designed to be used to repair the dura mater, a fibrous membrane that protects the brain and the spinal cord, when the dura mater has been compromised due to injury or surgery. Osteotech's collagen technology platform is supported by three pending patent applications.

• Vital Therapies (San Diego) said patient enrollment has begun for a randomized, controlled, multi-center, Phase II clinical trial that will study the company's Extracorporeal Liver Assist Device (ELAD) as a treatment for patients with acute liver failure (ALF) under three protocols. ELAD is a bedside system whose central component is four cartridges containing 440 grams of immortalized human liver cells and 32,000 hollow fibers. The patient's plasma flows inside of the hollow fibers to allow two-way transfer of metabolites. During ELAD therapy, the cells metabolize toxins and synthesize proteins and other liver specific products essential for life.