• Arbios Systems (Waltham, Massachusetts), a medical device and cell-based therapy company developing liver support products, said it presented interim safety and patient outcome results of its feasibility clinical trial of the Sepet Liver Assist Device, which demonstrated that all patients treated with the device tolerated the therapy well and met the clinical endpoint for improvement of hepatic encephalopathy. The presentation was given at the Rodman & Renshaw Techvest 3rd Annual Global Healthcare Conference in Monaco. The primary goals of the Sepet clinical feasibility trial are to assess preliminary safety, tolerability and efficacy of the device. In addition, data are being collected to assess the potential of Sepet to serve as a blood purifier to facilitate recovery from liver failure and encephalopathy, to support liver regeneration, and, if a patient is eligible for liver transplantation, to help keep the patient alive until a donor organ becomes available for transplantation.

• Focus Surgery (Indianapolis) reported that a clinical study for locally recurrent prostate cancer following radiation failure with High Intensity Focused Ultrasound (HIFU) using the Sonablate 500 is now enrolling patients at the London Health Sciences Centre (London, Ontario). The purpose of the study is to determine the ability of HIFU to destroy prostate cancer tissue in patients with local recurrence after radiation failure. Developed by Focus Surgery and manufactured by Misonix (Farmingdale, New York), the Sonablate 500 is the only HIFU device in Canada that can treat prostates with height dimensions greater than 25 mm and does not require a preliminary transurethral resection of the prostate, a surgical procedure.

• Impliant (Milford, Connecticut), a developer of spine arthroplasty alternatives to fusion surgery, reported that data from the clinical trial of its TOPS system, a mobile posterior device, was presented at the Spine Arthroplasty Society Meeting in Montreal. Outcome data on twenty patients included one-year follow-up data on five spine arthroplasty patients, who received the TOPS system for treatment of facet arthosis, spondylolisthesis, and spinal stenosis. Among the group that received the TOPS dystem implant, scores on various scales indicated positive patient outcomes. On the Visual Analogue Scale, the average group score dropped from 8.6 preoperative to 1.4 at the one-year postoperative visit; and on the Oswestry Score, the average group score dropped from 55 preoperative to 17 at the one-year postoperative visit. In addition, an independent radiologist confirmed that there was no screw loosening, no advancement of spondylolisthesis, and no loss of disc height.

• Nexa Orthopedics (San Diego), which makes products for reconstructive surgery of the extremities, reported that it has received FDA 510(k) clearance for its pyrolytic carbon Carpometacarpal Implant (CMI). The CMI is designed to relieve basal thumb joint pain associated with arthritis while improving the thumb's range of motion and biomechanical function. The CMI is intended to replace the proximal end of the first metacarpal for treatment of rheumatoid arthritis, traumatic arthritis, osteoarthritis, post-fracture deformation or bone loss. Nexa will officially launch the CMI in the U.S. in September at the American Society for Surgery of the Hand conference.

• Paradigm Spine (New York) said spine surgeons Dieter Adelt, MD and Rudolf Bertagnoli, MD, reported results of separate studies of the company's coflex spinal implant at the annual Spine Arthroplasty Society meeting in Montreal. The investigational device is a U-shaped titanium alloy surgical implant indicated for use in patients with moderate to severe spinal stenosis, with neural element compromise, resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to L5. Adelt, a neurosurgeon at the Ostseeklinik (Damp, Germany), implanted 240 patients with the coflex interspinous device. His study evaluated 200, or 83%, of the patients. Spinal stenosis was found in 76% of the study group. Of these, Adelt said that 143 (86%) experienced relief in severe low back pain sufficient to significantly increase their walking distance. Bertagnoli, a surgeon at the ProSpine Centers (Straubing/Bogen, Germany), presented results of a 12-month follow up on 46 patients treated with the coflex interspinous implant. The patients had been diagnosed with secondary spinal canal stenosis, either with or without hypertrophic facet joints. A total of 60 devices were implanted. He reported that the results showed consistent reductions in six- and 12-month post-operative disability and pain scores compared with preoperative scores.

• Quanta Technologies (Tucson, Arizona), a distributor of medical laser technologies, reported the introduction of the sterile QlickSmart system. QlickSmart is the first single-handed solution for scalpel blade removal, the company said. The QlickSmart system works with most conventional scalpels. Users direct the blade into a mounted cartridge with one hand, listen for the click, and then pull out the scalpel, avoiding exposure to cuts and contaminants while removing blades.

• Regeneration Technologies (Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants, said it officially launched its Adjustable Bone Tendon Bone (BTB), the first in a new line of assembled tendon implants, at the Arthroscopy Association of North America annual meeting in Hollywood, Florida. The adjustable implants provide surgeons with an equivalent alternative to natural bone tendon bone grafts in strength and biocompatibility. The Adjustable BTB offers the flexibility of soft tissue grafts with bone tendon bone fixation. Features include pre-drilled suture holes and a pre-attached bone block for quick preparation. Surgeons can size the Adjustable BTB to fit any joint aperture. The Adjustable BTB is delivered to surgeons sterilized through RTI's BioCleanse process and is covered by multiple U.S. and international patents pending.

• Siemens Medical Solutions (Malvern, Pennsylvania) said it showcased its portfolio of electronic health record (EHR) solutions at the 2006 Towards the Electronic Patient Record conference in Baltimore. The company demonstrated healthcare information technology (IT) solutions that can assist providers in realizing an interoperable EHR, while supporting initiatives such as patient safety and satisfaction, medical error reduction, improved quality of care, cost reduction and industry standards. Solutions include the Soarian Disease Management, which facilitates collaborative care between clinicians and patients with chronic illnesses; the Soarian Community Access, which enables healthcare providers to securely connect with patients and other members of the healthcare community; and the NextGen EMR (electronic medical record), which in collaboration with NextGen Healthcare (Horsham, Pennsylvania) addresses the healthcare IT needs of the physician practice market.

• Synthetic Blood International (Costa Mesa, California) reported treatment of the fourth patient in its eight-patient Phase II proof-of-concept Oxycyte study in traumatic brain injury. Cerebral oxygen tension following Oxycyte administration was significantly increased in this patient, consistent with the results in the first three patients. In the open label, Phase II pilot study being conducted at Virginia Commonwealth University (Richmond), Oxycyte is administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9. The primary purpose of this study is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury. The study will further assess the safety of Oxycyte when given by intravenous infusion.

• Wright Medical Group (Arlington, Tennessee), a global orthopedics company, reported the launch of its next generation of OdysseyDistal Cut First (DCF) instruments for minimally invasive total knee replacement procedures. The instruments are reduced in size for minimally invasive surgery (MIS). The multi-function design requires fewer intraoperative steps than traditional instruments for increased surgical efficiency. The instrumentation's reduced size avoids damage to the surrounding soft tissues. These features work together to offer increased surgical efficiency, the company said. The OdysseyDCF MIS instruments are designed for use with Wright's Advance series of knee products, designed to provide more natural joint function.