The majority of the 30 million U.S. patients who report back pain each year usually resolve the problem with conservative treatments or just good old-fashioned rest — or a combination therof. But roughly 4.5 million fail these types of treatments and only 500,000 will commit to surgery.

The bad news extrapolated from this data: a population of around 4 million people who have to live with some type of chronic back pain. The good news: help possibly on the way in the form of a new spine stabilization device.

The FDA, under its Investigational Device Exemption protocol, has granted Applied Spine Technologies (AST; New Haven, Connecticut) permission to commence a multi-center, randomized, controlled clinical trial comparing posterior dynamic stabilization using the company’s Stabilimax NZ dynamic spine stabilization system to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis. The study will enroll 266 Stabilimax NZ patients and 133 control patients at 20 sites across the U.S.

The premise of the Stabilimax NZ — the NZ for “neutral zone” — is that painful spine motion increases in the injured spine, and this abnormal motion is most pronounced in what is termed the neutral zone. The company defines this zone as an “area of laxity” in the center portion of the spine’s range of motion, and says that as age increases the laxity in this area results in a range of problems.

“The device shrinks the neutral zone to normal, but allows for a free range of motion,” Thomas Wood, AST’s president/CEO told Biomedical Business & Technology. “It adds stability without eliminating motion with a therapy which is less invasive than fusion or disk replacement. It is laterally inserted between the muscle plains and then anchored in place through pedicle fixation.” The device requires no bone graft, site preparation, or harvesting from the patient.

To correct this, the Stabilimax uses a dual-spring mechanism with a feature that maximizes stiffness and support in the neutral zone, where the spine needs it most, thus serving to return the neutral zone to its normal, limited range, according to the company. The device uses traditional pedicle screw vertical anchors; but, unlike other implant systems, they are attached to the bone using two flexible joints. The “give” allowed by the dual springs creates proper spine stabilization (with limited range of motion), and also reduces stress on the pedicle screws, decreasing the potential for screw failure. By eliminating abnormal motion, the design of Stabilimax NZ is intended to alleviate abnormal loading on surrounding muscles and tissues.

The company reports that in Europe, a clinical trial of Stabilimax NZ is already underway, and Rudolf Bertagnoli, MD, one of the most experienced motion-preservation spine surgeons in the world, has thus far implanted patients successfully.

Of note, Wood told BB&T that Stabilimax NZ has just recently received CE-mark approval.

AST says it expects the U.S. trial to last at least 18 months, given the number of patients enrolled in the study, before any endpoints — decreased pain and increase in motion — are tabulated. Then there is the usual two-year follow-up period before any filing with the FDA will be considered.

“It is well-known that fusion implants promote adjacent level disease, while fusion techniques promote spine fusion disease,” said spine surgeon Hansen Yuan, MD, chairman of AST’s scientific advisory board. “What’s exciting about AST’s Stabilimax NZ implantation via a minimally invasive technique is that it avoids both of the main complications of fusion.”

The company was founded in February 2004 with Series A funding of $4 million from Oxford Bioscience Partners and BioVentures Investors. About a year ago it closed on a $15 million Series B round of financing led by InterWest Partners, with De Novo Ventures also participating. Wood told BB&T that AST “hopes to raise $25 million” over the next few years.

Elsewhere in the product pipeline:

• Adlyfe (Rockville, Maryland) has reported securing a U.S. patent for technology covering a method for the early detection of more than 40 amyloid diseases. The company’s goal is to utilize this method as a platform for a diagnostic test for Alzheimer’s disease (AD) within the next two to three years. Founded in 2003, Adlyfe originally focused on a test for another disease involving misfolded proteins, Creutzfeldt-Jacob disease, or the human version of what is known as “Mad Cow” disease. However, CEO Alan Rudolph, PhD, told CDU that the company “shifted its focus to Alzheimer’s as the target” because, “undoubtedly, the diseases that are listed in the patent announcement today are significantly more prevalent than the prion diseases in the UK.”

Advanced BioHealing (La Jolla, California) said it has begun shipping the bioengineered tissue product Dermagraft, approved by the FDA as a treatment for full-thickness diabetic foot ulcers. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. It is supplied frozen in a clear bag containing one piece of approximately 2 x 3 inches for a single-use application. The product is approved for marketing in the U.S. and also a number of other countries. Advanced BioHealing specializes in the science of regenerative medicine.

• Angiotech Pharmaceuticals (Vancouver, British Columbia) reportedU.S. launch of its Quill Self-Retaining System (SRS) for tissue approximation. Using a barbed design, Angiotech said that the Quill SRS, using a barbed design, offers an “elegant “timesaving option for surgeons, which eliminates the need for knots while providing improved tissue approximation. In addition to other benefits, Angiotech believes that the Quill SRS could reduce procedure times, resulting in cost-savings in the OR and shorter operation times. The Quill SRS could be of even greater benefit to the surgeon or physician whenever knots can be challenging to tie, such as in endoscopic procedures. Angiotech produces wound closure products for tissue approximation and ligation.

• Applied Biosystems (Foster City, California), a business of Applera, reported a new instrument system for conducting genetic and genomic analysis experiments using real-time PCR (polymerase chain reaction) technology. The StepOne Real-Time PCR System was developed in response to the growing market of researchers interested in lower throughput applications of real-time PCR. Real-time PCR is a laboratory method used to simultaneously detect and determine the amount of nucleic acids present in samples. This kind of data helps life scientists to more precisely assess how changes in the amounts of key DNA or RNA sequences contribute to the development of disease or how they relate to biological processes in plant and animal cells. Applera consists of two operating groups. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services.

• Artes Medical (San Diego) reported its first shipment of ArteFill to trained physicians. Artes says that ArteFill is “the first and only non-resorbable injectable filler for the correction of wrinkles, or nasolabial folds and featuring the use of microspheres that are not absorbed by the body and therefore providing permanent support for long-lasting wrinkle correction in one to two treatments. ArteFill was approved by the FDA in October 2006, based on data from a 12-month controlled, randomized, double-masked, multi-center U.S. clinical trial, which compared outcomes for patients treated with ArteFill with those of patients treated with the leading bovine collagen-based filler. At the six-month evaluation, the primary efficacy evaluation period for the clinical trial, the wrinkle correction in patients treated with ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment status. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.

• AtriCure (West Chester, Ohio) reported receiving FDA 510(k) clearance for its Isolator Synergy Bipolar Ablation System for the ablation of soft tissue. The device is not yet cleared for the ablation of cardiac tissue. The system incorporates two pulsing pairs of electrodes in the jaws of the clamp, which the company believes will allow physicians to ensure full thickness ablation of thicker and more diseased tissues and create more durable lines of block. Pre-clinical studies using the system have demonstrated that the lesions are shaped like columns for durability and that the ablation lines are consistently transmural in thicker tissues, which the company believes will result in superior patient outcomes. AtriCure manufactures of surgical devices.

• BioMimetic Therapeutics (Franklin, Tennessee) reported positive results from its pilot clinical study evaluating the safety and clinical utility of GEM OS1 Bone Graft for the treatment of distal radius (wrist) fractures. In the randomized, controlled study evaluating distal radius fractures treated with external fixation vs. external fixation augmented with GEM OS1, patients treated with GEM OS1 demonstrated faster bone healing at the fracture site as measured by CT scans. The company also reported that it has initiated patient enrollment in a pilot study evaluating its second orthopedic product candidate, GEM OS2 Injectable Bone Graft, for the closed treatment of distal radius fractures. GEM OS1 is indicated for use in open surgical procedures while GEM OS2 is indicated primarily for minimally invasive, percutaneous administration to a fracture site without surgical intervention. BioMimetic makes bio-active drug-device combination products for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications.

• Carl Zeiss Meditec (Dublin, California) reported FDA clearance for the laser keratome applications of its Visumax femtosecond laser system and that it received the clearance sooner than expected. The company had projected the clearance would be granted in the second half of 2007. The Visumax system is designed to provide smooth and precise flap cutting capabilities for refractive laser surgery. A femtosecond is an interim of a quadrillionth of a second. Carl Zeiss said the technology, combined with its MEL 80 excimer laser, delivers “excellent clinical outcomes” coupled with the potential for a “unique optimized workflow for refractive surgeons and improved comfort for their patients.” Using a pivoting patient bed and an integrated data management system, the refractive surgeon will be able to complete a full refractive procedure without the need to move the patient or to perform redundant data entries, Zeiss said. Alternatively, either platform may be used separately and/or in conjunction with other laser systems, but without the full system integration benefits.

• Cook Medical (Miami) reports that the Zilver PTX Paclitaxel-Eluting Stent trial results demonstrated no stent fractures. Cook said that the major adverse event rate was equivalent to conventional balloon angioplasty treatment at its six-month follow-up point. To reduce or prevent restenosis, the Zilver PTX stent is coated with Paclitaxel, a drug approved for clinical use as an anti-cancer agent. Paclitaxel-coated coronary stents are approved for use in the U.S. to reduce the risk of restenosis of the coronary arteries. Cook produces medical therapies in the fields of radiology, cardiology, urology, endovascular therapy, women’s health, critical care medicine, surgery and soft tissue repair, gastroenterology, bone access, oncology and cellular and genetic treatments.

• Cytori Therapeutics (San Diego) received FDA 510(k) clearance for its adipose tissue processing system with related Celase tissue processing reagent. This system with the Celase reagent is intended for use in plastic and reconstructive, thoracic, gastrointestinal, urological orthopedic, and other surgeries when processing fat or soft tissue is desired. The specific claims for the adipose processing system, Cytori’s Lipoplasty System with Celase Reagent, are as follows: The Cytori adipose processing system is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue is required and intended for use within Cytori’s adipose tissue processing system. Cytori Therapeutics is developing and seeks to commercialize stem and regenerative cell therapies for cardiovascular disease, reconstructive surgery and many other serious chronic and life-threatening conditions

• DePuy Spine (Raynham, Massachusetts), a business of Johnson & Johnson (New Brunswick, New Jersey), reported the launch of the Expedium 6.35, a titanium and stainless steel screw and rod system designed to simplify the correction of spinal deformities and treatment for degenerative disc disease. The system’s screws are designed with a double-lead thread pattern allowing surgeons to advance the screws twice as fast as standard screws. The system includes screw options, open and closed hook patterns, multiple rod-to-rod connection options and lateral connectors, and it also offers new spinal deformity instruments and implants that can aide in vertebral body de-rotation.

• Electro Optical Sciences (EOS; Irvington, New York) reported that it has initiated a pivotal trial for MelaFind, its noninvasive, point-of-care device to assist in the early diagnosis of melanoma, which accounts for 80% of all deaths due to skin cancer. The first patients have been enrolled in the study, and the company said it expects to submit the premarket approval application to the FDA for review in the second half of this year.

• ev3 (Plymouth, Minnesota) said it will enter the carotid artery stent market with FDA approval of its Prot g RX carotid stent. The company said that the stent, when used in conjunction with its SpidRX embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. The SpideRX was cleared by the FDA for use in the carotid artery in February 2006. The FDA approval was supported by the (Carotid Revascularization with ev3, Arterial Technology Evolution (CREATE) trial demonstrating the safety and effectiveness of the Prot g stent and the Spider embolic protection device when used together to treat carotid artery disease patients at risk for stroke and also at high-risk for adverse events from surgery. CREATE enrolled 419 patients in 31 centers in a prospective, non-randomized study. The results of the trial compared favorably with performance criteria that were based on the results of previous carotid stenting trials.

• FlowCardia (Sunnyvale, California) reported receiving FDA 510(k) clearance of the Crosser 14 chronic total occlusion (CTO) recanalization system. The Crosser 14 is designed to facilitate the placement of guidewires beyond CTOs in coronary arteries. This endovascular catheter is delivered using standard guidewires to the site of a chronic total occlusion in the coronary arteries. The CROSSER utilizes high-frequency vibration to facilitate guidewire crossing of CTOs allowing for subsequent balloon angioplasty and stent placement. This cath-lab based, minimally invasive approach to CTO recanalization can eliminate the need for potentially traumatic coronary artery bypass graft surgery. FlowCardia is a company developing endovascular devices for coronary and peripheral CTO recanalization.

• Generic Medical Devices (GMD; Gig Harbor, Washington) reported CE-marking and a EC-Declaration of Conformity (EC-DoC) indicating compliance with health and safety requirements set out in applicable European Directives and allowing the company to place the GMD universal circumcision clamp on the market in all European Union countries, as well as other countries that accept this certification. In January, GMD reported FDA 510(k) clearance to market the circumcision clamp. The GMD Universal Circumcision Clamp is a medical device intended for use in circumcision procedures generally performed on newborns and less frequently on older males. Generic Medical makes surgical devices marketed, it says, “at generic prices.”

• Greatbatch (Clarence, New York) reported the release of a new, non-proprietary model of its medium-rate implantable “Q” series battery. The battery provides a shape factor and capacity that can be readily utilized by many medical device manufacturers with little or no modification-significantly reducing the development time for new implantable devices. Greatbatch Q is presently the primary battery of choice for meeting neurostimulation, drug-infusion, and cardiac-pacing device requirements, Greatbatch said .

• iCAD (Nashua, New Hampshire) reported the availability of the TotalLook version 8.0, the latest version of its film digitizer, providing women’s healthcare centers with workflow and connectivity-related benefits supporting the transition from film to digital mammography by enabling comparative image review on a single digital review workstation. The digitizer also compresses the image size while maintaining image quality. iCAD is a provider of computer-aided detection solutions for cancer detection.

• Inovio Biomedical (San Diego) reported that the US Patent and Trademark Office issued to Genetronics, Inovio’s wholly-owned subsidiary, US Patent number 7,171,264, titled “Intradermal Delivery of Active Agents by Needle-Free Injection and Electroporation.” This patent adds to Inovio’s patent estate relating to the delivery of genes and drugs to a variety of tissues. It claims a method of delivering biological material, including DNA vaccines, to skin using a needle-free method of electroporation. Electroporation uses brief, controlled electrical pulses to dramatically increase cellular uptake of a useful biopharmaceutical. Inovio Biomedical specializes in tumor ablation therapy and development of multiple DNA vaccines.

IRIS International (Chatsworth, California) reported that its IRIS Molecular Diagnostics subsidiary has filed an FDA 510(k) application for its ultra-sensitive prostate-specific antigen (PSA) test. The technology utilized to develop the ultra-sensitive PSA test was compared to a commercially available test and compared well across the assay range with improved sensitivity at low concentrations. The PSA is to be used for monitoring prostate cancer patients following therapy. The underlying technology for the PSA test is a proprietary protein diagnostics platform called nucleic acid detection immunoassay, an ultra-sensitive method for the detection of proteins using nucleic acid-labeled antibodies and the polymerase chain reaction many times more sensitive than conventional immunoassays. The assay is capable of being performed on instruments already in place in large laboratories, the company said.

• Kimberly-Clark Health Care (Roswell, Georgia) reported the launch of Kimberly-Clark InteguSeal Microbial Sealant (InteguSeal Microbial Sealant), a microbial barrier designed to reduce the risk of skin flora contamination throughout a surgical procedure. The sealant uses a proprietary formulation to seal and immobilize pathogens to help protect against migration into an incision hair-content or amount or types of flora present. Joanne Bauer, president of Kimberly-Clark Health Care, said, “The appropriate use of medical products during surgical procedures can help to prevent healthcare associated infections and ultimately lower costs incurred by facilities.”

Life Spine (Hoffman Estates, Illinois) reported receiving FDA 510(k) clearance to Pilot, arod and post pedicle screw system allowing for quick one step lockup.featuring an open and cannulated screw design, the surgeon is able to self-guide, self-tap, and self-drill the screws, eliminating time consuming steps from the procedure. The system is top-loading, and can be quickly assembled outside the body, and then placed in-situ via the all-in-one drill guides. The system can be locked up inline, allowing for an open or an minimally invasive approach. In-situ compression and distraction can be done directly with the bone screw drill guides.

• LifeNet (Virginia Beach, Virginia) introduced the VertiGraft VG2 TLIF spine specialty allograft for lumbar fusion surgery to treat lower back pain. VG2 spine specialty allografts feature composite cortical-cancellous- cortical construction so every allograft spacer has inherent osteoconductivity. The VertiGraft VG2 TLIF has a unique geometry that facilitates a streamlined straight-in, oblique surgical technique. It is a machined allograft composite made to promote fusion by providing both the biomechanical strength of cortical bone and the osteoconductive matrix of cancellous bone. LifeNet is a biomedical tissue banking system and a non-profit organ and tissue donation agency.

• Light Sciences Oncology (Seattle) reported the treatment of the first patient in its Phase II trial for gli to demonstrate the safety of light infusion therapy (Litx) with increasing light doses in the treatment of primary or recurrent glioma, including glioblastoma and astrocytoma. Litx uses light-emitting diodes (LEDs) to activate LS11 (talaporfin sodium). An activated LS11 molecule results in the production of singlet oxygen molecules, which can kill target tissues with minimal side effects through vascular closure and apoptosis, or “programmed cell death.” Constant illumination can activate each molecule of LS11 many times, resulting in a continuous supply of singlet oxygen molecules. The Litx device contains a tiny array of LEDs at the end of a very narrow, flexible catheter-like conductor. Administering physicians insert the LED array into a tumor after intravenous injection of LS11. Emitting red light at a discrete frequency, intensity, and time period, the device activates LS11 in a prescribed “kill zone” around the LED array. Light Sciences Oncology helps to provide treatment to cancer patients.

• MedicAlert (Turlock, California) will launch a pilot project to test the use of radio frequency identification detection (RFID) in improving access to student health information. MedicAlert is working with Advanced Micro Devices, Siemens IT Solutions and Services and California State University, Stanislaus, to demonstrate the effective application and use of RFID technology. The 90-day pilot is expected to start March 1, 2007 and it is estimated that about 200 students will participate in the project. Students participating in the pilot will be provided with a one-year free subscription to MedicAlert membership and a special plastic RFID enabled ID Card. The RFID circuit on the card will only contain the student’s unique member identification number linked to their personal health record securely stored at the MedicAlert repository. Each time a student enters the student health center a secure kiosk will print out a personal health summary record of the student’s medical information that has been stored in the MedicAlert repository. The summary can then be added to the “face sheet” or to the student’s medical record to be used as additional or supplemental information for the clinical visit. MedicAlert is a provider of personal health records.

• Menssana Research (Fort Lee, New Jersey) said it has developed a new breath test that has been reported to detect lung cancer in its early stage. Michael Phillips, MD, CEO of Menssana, said, “We developed a breathalyzer that is one billion times more sensitive than those the police use to measure alcohol in the breath. It detects around 200 different chemicals in a person’s breath, and some of these chemicals are markers of cancer. A breath test has great advantages over most other medical tests — it is completely safe, painless and non-invasive. All you have to do is breathe gently into a tube for two minutes. There are no potentially dangerous X-rays to worry about, and it will certainly be a lot less expensive than chest imaging.” The breath test will not be available in the U.S. until approved by the FDA, but may be available sooner in the European Union. Menssana Research is currently developing breath tests to detect several other diseases in their early stages, including pulmonary tuberculosis, breast cancer, and ischemic heart disease.

• Molecular Devices (Sunnyvale, California) reported the introduction of the Arcturus laser capture microdissection instrument. The instrument uses Molecular Devices’ LCM technology and, combined with the system’s automated image archiving, enables researchers to maintain sample custody at all times. Molecular Devices is a supplier of bioanalytical measurement systems that accelerate and improve drug discovery and other life sciences research.

N Spine (San Diego) reported that it has received FDA clearance of its Nfix II dynamic pedicle screw and rod system for stabilization of the lumbar spine as an adjunct to fusion. The product is now available in the U.S. Outside of the U.S., early clinical results with the company’s NFlex controlled motion system have been very favorable. NFlex is the first product to market that controls shear motion, while allowing a more physiologic level of flexion, extension and lateral bending. N Spine is a privately held spinal implant company.

• Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) reports the publication of a new peer-reviewed report in the Journal of Clinical Laboratory Analysis providing further positive data on the accuracy and utility of the company’s urinary AlzheimAlert test. AlzheimAlert is Nymox’s urine-based diagnostic aid for Alzheimer’s disease. The test has the CE mark, and is also available to physicians in the U.S. Nymox is a biopharmaceutical company specializing in the research and development of therapeutics and diagnostics for the aging population.

• Orthovita (Malvern, Pennsylvania) reported FDA approval of its pre-market approval supplement for the Cellpaker plasma collection system, used in conjunction with its Vitagel surgical hemostat product. Vitagel is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Vitagel stimulates hemostasis and healing through multiple mechanisms, amplifying the patient’s own biology. Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products.

• OXIS International (Foster City, California) said that it has identified a new predictive diagnostic lipoprotein biomarker that has the ability to detect early cardiovascular disease. Traditional biomarkers, such as serum LDL levels, have limited predictive power, with as little as 12% of future heart attack victims identified by LDL screening in some studies. Additionally, the first sign of cardiac disease may be sudden cardiac death (SCD), which is seen in up to 30% of heart attack victims according to some estimates. Oxis believes that early detection may be able to prevent SCD through identification of at-risk individuals. This pioneering approach may be of great value in helping to prevent the estimated 600,000 SCD deaths annually in the U.S. and Europe. OXIS is a biopharmaceutical company focused on commercializing predictive biomarkers, clinical assays and nutraceutical and therapeutic products. The Oxis portfolio of predictive biomarkers includes assays for four different human peroxidase enzymes, as well as multiple assays designed to detect both specific and nonspecific oxidative damage at the level of protein, lipids and DNA.

• Paradigm Medical (Salt Lake City) reported receiving FDA approval to market a new generation of ultrasound devices, developed through collaboration with MEDA, a Chinese developer and manufacturer of ultrasound devices. The devices include the P2000 A-Scan (used to measure axial length of the eye); P2200 Pachymeter (used for measuring corneal thickness); P2500 A-Scan/Pachymeter (a combination of the two stand-alone devices); P2700 AB/Scan (an ultrasound imaging device for detecting abnormalities within the eye); and P37-II (a more advanced AB/Scan used to provide portability for ophthalmology veterinary applications).Paradigm Medical produces ultrasound devices for the ophthalmic and medical industries.

• Ravgen (Columbia, Maryland) reported that a study of its methods for using genetic markers on fetal DNA recovered from maternal blood was published in The Lancet. The study, with accompanying commentary, was completed based on the company’s method of looking at common genetic variants in the human genome, called single nucleotide polymorphisms (SNPs) to determine potential chromosomal abnormalities in the fetus. Ravgen hopes to use that technology in a noninvasive blood test for prenatal diagnosis of disease.

• Roche Diagnostics (Basel, Switzerland) and Caliper Life Sciences (Hopkinton, Massachusetts) reported a joint product offering that combines Caliper’s Twister II Microplate Handler and Roche’s LightCycler 480 Real-Time PCR system. The integrated product provides a solution for laboratories to complete high-throughput screening with increased automation capability and walk-away time. The companies also have agreed to co-market and promote the joint solution into the life science research market. The Twister II is a plug-and-play bench-top plate handler with a walk-away capacity to stack and load up to 200 standard microplates. When integrated with the LightCycler 480 system, it doubles the throughput screening capacity for detection of nucleic acids and genotyping. Roche Diagnostics offers a portfolio and supplies testing products and services to researchers, physicians, patients, hospitals and laboratories. Caliper is a provider of drug discovery and life sciences research solutions.

• Royal Philips Electronics (Andover, Massachusetts) reported the release of its new vital signs monitor, the SureSigns VS3, designed for use both in and out of the hospital. The monitor is suitable for general care wards, emergency departments, outpatient surgery and urgent care centers.

Separately, Philips reported commercial release of Philips EP navigator, an imaging tool that will support clinicians in the treatment of complex cardiac rhythm disorders. EP Navigator combines pre–interventional 3D CT images of a patients’ cardiac anatomy with live X-ray fluoroscopy catheter position information in a single image. This allows physicians to navigate more easily through the heart during complex procedures and enables them to work with greater confidence, in a more intuitive way. Royal Philips Electronics makes medical diagnostic imaging and patient monitoring systems, energy efficient lighting solutions, personal care and home appliances, as well as consumer electronics.

• Scient’x USA (Maitland, Florida) reported the receipt of 510 (k)learance to market its Isobar LP low profile pedicle screw system. The Isobar LP offers a top-loading tulip head design with an inner locking set screw to offer more space in the construct. The screws feature a self-tapping design and are available in a variety of diameters and lengths for thoracic, lumbar and sacral areas. This pedicle screw system works in conjunction with the other components in the Isobar TTL system, including the EASYS Crosslink and Dynamic TTL-Rod, which provides controlled micro motion in compression, distraction, flexion, extension, and rotation. Scient’x makes spinal implant technologies.

• Signalife (Greenville, South Carolina) reported completing the development of a prototype device to be used for objective evaluation of electrocardiogram and intracardiac (ECG/IC) data recorders. This mechanism for evaluating all ECG systems will provide physicians, hospitals, and other end users with valuable information regarding the clinical efficacy of various ECG systems across the market, which will allow them to better evaluate their future purchasing decisions. Signalife is a life sciences company focused on the monitoring and detection of disease through biomedical signal monitoring. It uses its signal technology to design and develop medical devices that simplify and reduce the costs of diagnostic testing and patient monitoring in an ambulatory setting.

• StatSure Diagnostic Systems (Framingham, Massachusetts) reported that its oral-fluid collection device was successfully used by the National Highway Traffic Safety Administration (NHTSA), for a pilot test program (DOT HS 810 704) titled: Pilot Test of New Roadside Methodology for Impaired Driving. The company anticipates that its collection device will be incorporated as part of the next NHTSA roadside survey. StatSure makes rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases, as well as oral-fluid collection devices. • Thermage (Hayward, California) introduced the ThermaCool NXT, a system for non-invasive skin tightening and contouring. Advances to the technology include a streamlined operating system which speeds treatment times; a lighter more ergonomic handpiece with remote controls; and a sleek new design with a smaller footprint that takes up 50% less floor space than its predecessor. Thermage develops capacitive radio frequency technologies.

• Thermo Fisher Scientific (Palm Springs, California) reported showcasing a spectrum of laboratory automation capabilities at LabAutomation 2007 designed to improve workflow efficiency and data reproducibility in two key areas of lab automation and drug discovery research: cell growth and analysis, and protein crystallization. Also featured will be a number of other technologies, including the Thermo Scientific Matrix PlateMate automated liquid-handler that can be integrated into other robotic systems, including the CataLyst Express robot. Thermo Fisher develops analytical instruments, laboratory equipment, software, services, consumables and reagents for integrated laboratory workflow.

• ThermoGenesis (Rancho Cordova, California) reported submitting a 510(k) application for its AutoXpress System (AXP). The AXP automates the isolation and capture of stem cells from umbilical cord blood in a functionally closed system. GE Healthcare (Waukesha, Wisconsin), the exclusive distribution partner for the AXP, began selling the product commercially in March 2006. The submission requests clearance for the AXP for processing cord blood stem cells and claims substantial equivalence to other devices used for this purpose. The submission covers the complete AXP System including the AXP hardware device, docking station, disposable bag processing set, and XpressTRAK software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP). ThermoGenesis makes automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products.

• Sirtex (Lake Forest, Illinois) reported its support of a clinical study evaluating the safety of SIR-Spheres microspheres when administered with bevacizumab, an anti-angiogenic agent, and chemotherapy as a first-line treatment for patients with colorectal cancer that has metastasized to the liver. The FAST trial will evaluate the concurrent administration of either FOLFOX6 or FOLFIRI and bevacizumab with selective internal radiation therapy (SIRT) using SIR-Spheres approved by the FDA for the treatment of unresectable metastatic liver tumors from primary colorectal cancer together with adjuvant intra-hepatic artery chemotherapy of floxuridine. Sirtex is a developer of cancer therapies.

• U.S. Spinal Technologies (d.b.a. US Spine; Boca Raton, Florida) reported completing the first surgeries using its Preference 2 Spine System, featuring Helical Flange Technology. Christo Koulisis, MD, and Scott Webb, MD, were the first surgeons to use the system clinically. “This is a great system, and I would recommend this to any surgeon using pedicle screws as a treatment option,” stated Koulisis. Preference 2 marks the debut of Helical Flange technology into the low-profile system, giving it strength and rigidity, without the risk of tulip-splay or cross threading. Helical Flange interlocks the tulip and the rod blocker, containing any spreading forces that threaten to compromise the interconnect between polyaxial screws and rods. US Spine is a middle-stage company developing advanced spinal implant systems.

• Varian Medical Systems (Palo Alto, California) has received FDA 510(k) clearance for patient position monitoring capabilities that have been added to the company’s RPM respiratory gating system, used to synchronize imaging and radiation therapy treatment with a patient’s respiratory cycle. The new feature detects any motion that compromises the accuracy of the treatment. The system works by placing a reflective marker box on the patient’s chest or abdomen and monitoring its motion using special cameras positioned in the treatment room. It then analyzes the marker block motion in all three dimensions as it moves up and down, forward and back, and side to side. A new display on the system’s console immediately alerts the radiation therapist if the patient moves and should be repositioned. Varian Medical Systems provides medical technology for treating cancer and other medical conditions with radiotherapy, brachytherapy, and radiosurgery.

• Vascular Solutions (Minneapolis) reported receiving FDA 510(k) clearance for its new 023 version of its Twin-pass dual access catheter. The original Twin-Pass catheter was launched in early 2006 as a two-lumen catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature. The 023 version features a larger 0.023” lumen that allows the Twin-Pass 023 catheter to measure intra-arterial pressures and deliver specialty guidewires into the distal vasculature. Vascular Solutions said it plans to launch the Twin-Pass 023 catheter through its direct U.S. sales force immediately. Vascular Solutions produces solutions for clinical opportunities within interventional radiology and interventional cardiology.

• Visiogen (Irvine, California), said it has received FDA approval to expand its Phase III U.S. clinical trial for its Synchrony dual optic accommodating intraocular lens. Already approved for use throughout the European Union, the Synchrony system is being studied in a multi-center trial in the U.S. to evaluate safety and effectiveness and the potential for near and intermediate vision. The Synchrony system, intended for use in cataract and refractive patients, incorporates a dual optic lens with a pre-loaded injector. The entire system is self-contained and ready for use without the need for lens handling. The dual optic lens can be inserted through a 3.6 mm–3.8 mm clear-corneal incision. The single-piece silicone lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5-mm high power anterior optic and a 6-mm negative power posterior optic; the spring action moves the front optic and changes the eye’s focus from near to far. This combination of positive- and negative-powered optics is customized for each patient, Visiogen said. To date, the Synchrony lens has been implanted in over 400 patients worldwide.

• VQ OrthoCare (Irvine, California) reported launch of its new Catalyst line of off-the-shelf ligament knee braces. The braces are available in three configurations to accommodate individual patient anatomies and activity levels. The launch also marks the debut of VQ OrthoCare’s It Fits Technology — a design that enables each knee brace to accommodate individual patient anatomies. This technology allows for a continuous custom fit and ligament protection by automatically adapting to anatomical changes patients may experience and leading to improved patient compliance, more positive patient outcomes and increased levels of patient satisfaction. VQ OrthoCare is a provider of medical solutions for bone, joint, and soft tissue conditions.

• Ximedica (Providence, Rhode Island) reported the launch of the ThermoSuit System, a non-invasive, cooling system designed to rapidly reduce core body temperature of a clinically indicated patient to between 32 degrees C and 34 degrees C. The ThermoSuit reduces a patient’s core temperature by applying direct liquid contact. A thin film of ice water is continuously pumped around the patient’s body until the temperature reaches a preset limit, at which point, the fluid is automatically removed by the system. Ximedica is a contract design and manufacturing company.

• Zimmer Holdings (Warsaw Indiana) and ISTO Technologies (St. Louis) reported that the clinical trial is now underway for Neocartilage, a tissue-engineered graft under investigation for the restoration of cartilage defects, reestablishment of joint function and relief of pain in the knee. The product will be marketed as DeNovo ET. The product is a living tissue graft grown from juvenile chondrocytes (cartilage cells) using ISTO’s cell-based platform technology. Studies have demonstrated that juvenile chondrocytes produce cartilage significantly better than their adult counterparts. Cartilage works as a low friction articulating surface to protect joints from wear and tear experienced during motion. Cartilage is known to have limited capacity to heal on its own. Most joint replacements are performed as a result of the effects of osteoarthritis. Zimmer makes reconstructive and spinal implants, trauma and related orthopedic surgical products. ISTO Technologies is an orthobiologic company focused on developing products for sports medicine and spinal therapy.

Zoll Medical (Chelmsford, Massachusetts) reported receiving FDA clearance for its ZOLL E Series with Real CPR Help technology. Zoll’s Real CPR Help allows rescuers to instantly see and hear how well they are performing the rate and depth of CPR chest compressions. With this clearance, the company said that the E Series becomes its first advanced pre-hospital device to provide this instantaneous feedback. “Typical professional defibrillators on the market today only provide generic, ancillary support to rescuers when it comes to CPR performance,” said Richard A. Packer, president/CEO of Zoll. “These devices merely tell rescuers to start CPR at the appropriate moment during a resuscitation attempt. Zoll’s Real CPR Help technology can provide rescuers with assistance beyond merely prompting them to start CPR, so they are better equipped to improve their CPR performance and help cardiac arrest patients when it matters most.” Zoll develops technologies that provide human resuscitation.