• Bone Biologics (Thousand Oaks, California) said it has successfully completed the initial primate trials validating the efficacy of the proprietary bone growth regeneration UCB-1 (NELL-1) protein in spinal fusion surgery. 100% fusion was obtained in a 3-month period. No cystic lesion was observed. The successful primate surgical outcomes used the DBX demineralized bone matrix (scaffold) produced by the Musculoskeletal Transplant Foundation (MTF). MTF is a non-profit service organization dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families.

• Celerus Diagnostics (Carpinteria, California) has introduced new products for use on the Celerus Wave System, a solution to deliver precise, standardized IHC results in 15 minutes. Some of the new products are the D10, a cell surface antigen also known as CALLA (common acute lymphoblastic leukemia antigen), is expressed on a variety of cell types, including immature and germinal center B cells, as well as lymphoblastic leukemia cells; the CD34, a marker of lymphatic and vascular endothelium (antibodies to CD34 can be used to study tumors of endothelial origin and CD34 also is a useful marker for quantifying micro-vascular density in a variety of other tumor types); and Tyrosinase, a copper-glycoenzyme involved in the synthesis of melanin pigments. The melanin pigments can serve as markers for cells of melanocytic lineage, including malignant melanomas.

• Curexo Technology (Sacramento, California) said it has submitted a premarket notification 510(k) application to the FDA for U.S. market clearance of its Robodoc Surgical System for total knee arthroplasty. The Robodoc Surgical System includes two components; Orthodoc, a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the Robodoc Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries.

• Kensey Nash (Exton, Pennsylvania) said it has submitted an Investigational Device Exemption (IDE) application to the FDA to study the use of the company's unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will use the company's Cartilage Repair Device (CRD), which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions. The CRD is a composite of several bioresorbable biomaterials, using collagen technology, and beta-tricalcium phosphate mineral suspended in a synthetic polymer Porous Tissue Matrix (PTM). This device architecture is designed to repair damaged articular cartilage in the knee or other articulating joints.

• Meta Biomed (Horsham, Pennsylvania) reported the launch of BoneMedik-S and BoneMedik-DM, a biocompatible bone graft substitute based on natural coral. Meta Biomed says that the natural coral-based hydroxyapatite provides framework to promote strong and faster regeneration and healing. It is of the highest product quality and most compatible with the human bone structure, the company said.

• Oridion Systems (Needham, Massachusetts) reported FDA clearance for the Capnostream 20 Monitor with Integrated Pulmonary Index. The Integrated Pulmonary Index uses sophisticated algorithms to integrate the real time measures and interactions of four complex parameters – end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) into a single index value. The result is displayed on a scale from 1-10, where 10 indicates optimal pulmonary status. The company claims that by using the Integrated Pulmonary Index, clinicians can quickly and easily assess a patient's ventilation status and monitor a patient's changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.

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