• Arbios Systems (Waltham, Massachusetts), which is developing liver assist products for treatment of liver failure, reported that the FDA has allowed the expansion of its clinical sites and increased the number of patients in its investigational device exemption feasibility clinical trial for its Sepet liver assist device. Under the revised protocol, Arbios can include up to four clinical trial sites and to up to 20 liver failure patients with encephalopathy. The company also reported that the University of California at San Diego Medical Center will serve as an additional clinical site in the trial. The goal of the current trial is to assess the safety of the Sepet liver assist device, as well as its potential 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.

• BioLok International (Deerfield Beach, Florida), a manufacturer of dental implant technology, reported receiving FDA 510(k) clearance to market BoneGen-TR, a nano-composite, time-release calcium sulfate product used for bone regeneration, augmentation, and as a soft tissue barrier in implantology, periodontology, endodontics and oral surgery. BoneGen-TR is ready for limited distribution in the U.S. for clinical evaluation and will be available for mass distribution this summer. A large multicenter, multinational clinical study to enhance the product's marketability will be conducted in April, and U.S. clinical studies will also be started.

• BioMimetic Therapeutics (Franklin, Tennessee) reported that it has initiated three clinical trials to evaluate GEM OS1 Bone Graft for use in foot and ankle fusion procedures and the treatment of unstable distal radius fractures. GEM OS1 is a bio-active drug/device product that combines a tissue growth factor, recombinant human Platelet-Derived Growth Factor (rhPDGF), one of the principal wound healing stimulators in the body, with a synthetic bone matrix, Beta-tricalcium phosphate (Beta-TCP). BioMimetic is leveraging the same combination drug-device technology for orthopedic applications as it used in its FDA-approved product, GEM 21S Growth-factor Enhanced Matrix for the treatment of periodontally related defects and gingival recession. BioMimetic is developing GEM OS1 for use in open surgical treatment of fractures and bone fusions where the use of bone graft is indicated. GEM OS1 is designed to be placed directly into an open surgical site to stimulate bone regeneration. The combination of rhPDGF and Beta-TCP is key to the product's overall effectiveness, the company said.

• BSD Medical (Salt Lake City), a developer of microwave/radio frequency systems used in the treatment of cancer, reported that it has sent to the FDA a premarket approval application for the company's BSD-2000 cancer treatment system. The BSD-2000 delivers precision-focused radio frequency energy in cancerous tumors, and was developed particularly to allow treatment access for cancer located deep in the body. The company said its submission was expanded considerably to include testing for system enhancements to the BSD-2000, and therefore contains all of the upgrades envisioned for the commercial version of the BSD-2000.

• Cardinal Health (Dublin, Ohio) reported the launch of Impress Scan, a web-based, hosted instrument management system, at the 53rd annual AORN Congress in Washington. Part of Cardinal Health's V. Mueller offering, Impress Scan allows hospitals and free-standing surgery centers to track surgical instruments and sets anywhere in the work cycle. According to the company, the real-time program makes it easier to maintain instrumentation, streamline processing, increase productivity and decrease instrument replacement costs. The system helps drive standardization of instrument sets and tracks all aspects of instrument repairs and sterilization history. Barcode technology allows staff members to scan sets, peel packs and individual instruments to case carts, operating rooms and patients. The V. Mueller catalog database, with more than 15,000 products, is provided with the tracking system. Impress Scan also has numerous reports that help measure employee and department productivity. Also at AORN, Cardinal Health unveiled Protegrity Blue, a surgical glove designed to be worn as a single glove or for use as an underglove when double gloving. Cardinal Health's new gloves are one of the thinnest latex gloves on the market and deliver heightened tactile sensitivity. They feature a smooth grip for ease of double gloving and have a blue tint for easy differentiation from standard Protegrity gloves.

• CeraPedics (Lakewood, Colorado), which is developing a line of bone substitute products and implant coatings that employ its small peptide P-15 technology to facilitate bone formation in orthopedic procedures, said that it has initiated a U.S. clinical trial of its first P-15-based bone graft substitute, P-15 Putty, with the enrollment of the first patient at the Center for Spinal Disorders (Thornton, Colorado). This multicenter clinical study involves up to 204 patients and will be conducted under the company's approved investigational device exemption application which compares P-15 Putty to local autogenous bone in a structural allograft ring for the treatment of anterior cervical discectomy and fusion.

• Clearant (Los Angeles), the developer of the Clearant Process for pathogen inactivation, reported that Clearant-branded ready-to-use pre-mixed radioprotectant solution is now available for sale and use with the Clearant Process and Clearant Sterilization Service for tissue allograft implants. Previously, Clearant tissue bank customers were required to prepare the solution of radioprotectants necessary for sterilization of tissue implants under the patented conditions of the Clearant Process by purchasing each one of the four individual radioprotectants separately from reagent suppliers.

• CytoCore (Chicago), with its recent product licenses, said it has developed the InPath System NG, consisting of the e2 Collector, the CVX/GCI Assay, the Automated Image Proteomic System (AIPS) automated microscopy platform, and a new drug delivery system. The company said each of the four components of the InPath System will improve the current methods used with the Pap test to collect and analyze cells. According to the company, the e2 Collector improves the cell collection and therefore the accuracy of the Pap test; the CVX/CGI Assay should increase the accuracy of identifying potentially dangerous cells; the AIPS platform will scan and locate the marked cells for cytologist thereby improving the screening accuracy; and the Drug Delivery System will give the physician for the first time a choice on how to respond to the abnormal Pap test. The components, which can be used separately or in combination, will be available in late summer.

• Dilon Technologies (Newport News, Virginia), manufacturer of the Dilon 6800 Gamma Camera, said results of two clinical studies at the annual meeting of the National Consortium of Breast Centers in Las Vegas demonstrate the value of breast-specific gamma imaging (BSGI) in the identification of two hard-to-detect cancers: ductal carcinoma in-situ (DCIS) and invasive lobular carcinoma (ILC). BSGI is a nuclear medicine procedure that images the metabolic activity of breast lesions through radiotracer uptake, specifically imaged using a high-resolution, small field-of-view, anatomic-specific gamma camera, the Dilon 6800. In the first study, the authors concluded that BSGI has a higher sensitivity in detecting DCIS than MRI, even when the cancer is less than 1 cm in size. In another study on detection of ILC using the Dilon 6800, the authors concluded that BSGI is a highly sensitive imaging modality in detecting ILC, a cancer that is often difficult to detect mammographically, with ultrasound or with physical examination.

• Hitachi America (Tarrytown, New York), a subsidiary of Hitachi, said that it has obtained FDA 510(k) clearance for its ProBeat Proton Beam Therapy System. ProBeat is a proton beam irradiation system designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Hitachi's first U.S. ProBeat system is in its final stages of construction at the University of Texas M. D. Anderson Cancer Center Proton Therapy Center (Houston).

• InSightec (Haifa, Israel) said that it has completed treatment of the final patient in a postmarketing study to evaluate the efficacy of its ExAblate 2000 in treating uterine fibroids in African-American women. This study is an element of the FDA's commercial approval for ExAblate in October 2004, initiated to confirm the efficacy of the treatment in African American women, as they tend to have more severe uterine fibroids. In addition to the 30 African-American patients treated in the preapproval study 75 patients were treated in this postmarket study focused on African-American women, and will be followed up for a period of 36 months. The company said the study will produce some of the first data of its kind regarding the non-invasive treatment management of uterine fibroids of this high risk segment of population with the ExAblate system. The ExAblate 2000 used MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate tissue. MR thermal feedback, provided by the system, allows the physician to control and adjust the treatment in real time.

• IRIS International (Chatsworth, California), a manufacturer of automated IVD urinalysis systems and medical devices used in hospitals and clinical reference laboratories worldwide, said it unveiled its new iChem 100 Urine Chemistry Analyzer at the Clinical Laboratory Management Association ThinkLab '06 conference in Charlotte, North Carolina. The iChem100 analyzer, its associated iChem Urine Chemistry Strip and the visual read vChem Urine Chemistry Strips product lines, were introduced to nearly 3,500 laboratory professionals who attended the exhibition at the Charlotte Convention Center. The iChem100 is a semi-automated, benchtop instrument designed for small clinical laboratories testing up to 50 samples per day, which include small hospitals, outpatient clinics, alternate care facilities, nursing homes and large physician offices.

• Matritech (Newton, Massachusetts), a developer of protein-based diagnostic products for the early detection of cancer, said data on its point-of-care NMP22 BladderChek Test were presented at the Society for Gynecologic Investigation meeting in Toronto, showing that it detected 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for bladder cancer. The NMP22 BladderChek Test was also positive for seven conditions that required biopsy for diagnosis. The clinicians noted that the test has the potential to be an effective screening tool in identifying aggressive lesions early and improving prognosis in women at risk for bladder cancer. The NMP22 BladderChek Test detects elevated levels of the NMP22 protein marker in a single urine sample. The noninvasive assay is the only in-office test approved by the FDA for the diagnosis of bladder cancer.

• Nanogen (San Diego), a developer of advanced diagnostic products, reported that it has expanded its molecular reagent product portfolio with analyte specific reagents (ASRs) designed to detect 23 wild type and mutation sequences associated with cystic fibrosis. The U.S. launch of the product took place at last week's American College of Medical Genetics meeting in San Diego. The new CFTR ASR products are part of the company's NGEN brand of reagents for molecular applications. Assays using NGEN CFTR ASRs, once validated by the laboratory, can be used as a clinical diagnostic test. The products will be CE marked in Europe for in vitro diagnostics and will be available in the U.S. as ASRs for which analytical and performance characteristics are not established.

• Regeneration Technologies (Alachua, Florida), a processor of orthopedic, cardiovascular and other biologic implants, reported the official launch of its Sterling xenograft line of implants as well as BioSet DBM at the American Association of Orthopaedic Surgeons annual meeting in Chicago. The new Sterling product line, which includes the interference screws and cancellous chips and cubes, is available immediately through RTI's direct distribution representatives. Sterling Biological Matrix provides surgeons an expanded supply of safe, sterile tissue that is a natural alternative to autograft, allograft and synthetic resorbable materials. BioSet DBM consists of demineralized bone matrix (DBM) in a purified gelatin carrier, with bone chips added to the BioSet IC version. BioSet is available in various sizes and forms and is used as a bone void filler in many types of surgical procedures.

• Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the Bioraptor Suture Anchor for arthroscopic repair of the hip joint at the American Association of Orthopaedic Surgeons' annual meeting in Chicago. Smith & Nephew said is the first company to introduce a labral repair device for the hip. The Bioraptor Suture Anchor was originally introduced in Smith & Nephew Endoscopy's shoulder line. The tiny anchor, threaded with Ultrabraid Suture, is implanted into the bone of the cup of the hip joint. This enables the surgeon to close the tear or tighten the labral tissue as required.

• Stryker Orthopaedics (Mahwah, New Jersey) said it showcased its Triathlon Knee System, which was designed to better meet the needs of women, at last week's American Academy of Orthopaedic Surgeons meeting in Chicago. The Triathlon Knee is designed with a wide-range of sizing options that closely match the anatomies of both women and men. For women, the smaller sized implants have a more narrow design, helping to improve fit and function for the female bone structure. The system also offers 150 degrees of flexion. Orthopaedic surgeons are reporting patient outcomes that have shown the Triathlon Knee System offers 12 to 15 degrees of greater range in motion one year after surgery. Stryker's new X3 polyethylene is an advanced bearing surface technology for knees that has demonstrated up to 79% less wear compared to conventional polyethylenes in laboratory testing.

• Verimetrix (Clayton, Missouri) reported the introduction of Veriscan, the first automated endoscope leak testing technology. Veriscan transforms the critical leak testing procedure during endoscope reprocessing into a precise, repeatable and documented process that reduces total repair costs by about 50% while lowering cross-patient infection risk. Veriscan's pneumatic, sensor and microprocessing technology automatically detect leaks with greater accuracy – 98% detection accuracy vs. about 65% for current methods. Additionally, the device also detects the presence of fluid within the endoscope. A unique feature to the Veriscan is the ability to automatically record each leak test and retrieve it on command via the LCD display, printing or downloading to a computer, allowing medical institutions to analyze endoscope damage, track procedure activity, and ensure every endoscope is properly leak tested.

• VirtualScopics (Rochester, New York), a developer of image-related biomarker solutions, reported that it presented four co-authored papers at last week's meeting of the Orthopaedic Research Society in Chicago. The first presentation was a canine study that demonstrated the potential of MRI as a non-invasive tool to accurately detect cartilage degradation associated with osteoarthritis in early stages of the disease. The second presentation showed the ability of CT scans to detect the migration of hip implants without prior knowledge of the implant design and without surgical intervention. The third presentation demonstrated that MRI can be useful in supplementing arthroscopy and subjective scoring of the severity of chondromalacia of the knee. The last presentation demonstrated the accuracy of MRI in detecting and measuring various biomarkers.

• WaveLight Laser Technologies (Erlangen, Germany), which is developing products in the fields of ophthalmology and aesthetics, said six-month study results comparing outcomes of wavefront-optimized and wavefront-guided treatments with the Allegretto Wave excimer laser were presented at the American Society of Cataract and Refractive Surgery meeting in San Francisco. The study validated that both groups performed similarly for uncorrected visual acuity (UCVA), manifest refractive spheroequivalent and postoperative UCVA vs. preoperative best spectacle visual acuity. The company said the Allegretto Wave is the first refractive laser to receive concurrent approvals for the treatment of myopia up to -12 diopters with astigmatism of up to -6 diopters and hyperopia up to +6 diopters with astigmatism of up to +5 diopters, not exceeding a mean spherical equivalent of +6 diopters.

• Zimmer Holdings (Warsaw, Indiana) demonstrated at the American Association of Orthopaedic Surgeons' meeting in Chicago the first knee replacement system designed specifically to address the anatomy of a woman's knee. The Gender Solutions Knee Femoral Implant is based on Zimmer's flagship brand, the NexGen Complete Knee Solution. The Gender Solutions implant will first be available in Zimmer's flex design, which enables patients to achieve high degrees of flexion. The company said it hopes to receive regulatory clearance to begin marketing the implants with specific claims regarding women patients in the second half of this year.