According to a 1999 article in the journal Diabetes Care, the typical patient between the ages of 40 and 65 who suffered from a foot ulcer in the mid-1990s incurred almost $28,000 in medical costs alone, making this a profoundly expensive condition. Add in time missed from work and the cost of treating these lesions is staggering.

An article in the January 2007 edition of Diabetes Care reports the results of a trial of an infrared thermal probe designed to predict the occurrence of foot ulcers, and the results suggest that this low-tech device may yield large returns on investment. Xilas Medical (San Antonio), maker of the TempTouch home infrared thermal probe, closed the trial roughly a year ago, and the device has been commercially available since last March, when it won FDA 510(k) clearance. Commercial results are now arriving.

Designed to detect impending foot ulcers by picking up the increased temperatures characteristic of the inflammation that precedes the onset of ulcers, the TempTouch is selling briskly to institutions, Xilas said, and it expects to see sales to individual patients climb and in the future match institutional sales.

The trial showed that consistent use of the device cut the incidence of foot ulcers to 8.5%, a huge drop from the approximately 30% observed in the two control groups in the study. Among the inclusion criteria was a previous history of diabetic foot ulceration, and the 173 enrollees undertook standard therapy, structured foot examination, or enhanced therapy with the study article.

The sponsor provided each subject with therapeutic footwear, diabetic foot education, and regular foot care, and those in the study arm recorded the temperature measurements from six identical sites on each foot. The reason for checking the same spot on each foot is that temperatures do not remain constant, and the temperature difference is the only reliable way to detect a hyper-thermal state. The protocol deemed any differences in temperature that exceeded 4 F (2.2 C) as indicative of an impending ulcer.

Larry Lavery, MD, professor of surgery at the Texas A&M University Health Science Center (College Station), said that he found the results “very compelling.” Lavery, the lead author of the article, wrote that rates of ulcer recurrence “can be as high as 58% to 83% within 12 months” of the first such event.

“It is not unusual for these problems to require radical surgical procedures if gangrene and infection persists, as evidenced by the 90,000-plus amputations that take place each year in the United States alone,” Lavery said. He pointed out that diabetic neuropathy often makes it nearly impossible for patients to feel the inflammation that precedes ulceration, and that a thermal sensor gives patients “a way to participate in their own preventive care.”

Don Lawson, CEO of Xilas, told Biomedical Business & Technology that the predicate for the TempTouch is the Dermatemp, made by Exergen (Watertown, Massachusetts). He said that the temperature difference between feet is a very reliable sign that “you have a hot spot, but without such a device, patients they may not know that they have a problem until they have an open wound” because of neuropathy. He said that a lot of the available data suggests that inflammation usually precedes the opening of a wound by 10 to 20 days.

At present, the TempTouch is available only by prescription, but that situation might not hold permanently. “When we submitted our 510(k), we elected to set it up as an Rx device because we felt that it’s important that an individual interacts with their physician regarding their condition. We want them to stay in touch with their doctors,” Lawson said.

Lawson acknowledged as much but said that the device is accurate to within one degree Fahrenheit. The test of both feet is designed to close any error gap as well as errors of interpretation.”Feet are cooler in the morning, and no two people have the same foot temperature,” he pointed out

To date, Xilas has sold about 10,000 units, most to disease management customers operating in Texas, Tennessee and New York. “We found a nice niche with disease management companies,” said Lawson. “Once they’ve learned about the device, they incorporate it into their protocols” for overall reduction of cost of care of diabetes.

Onward to Europe for Xilas, Lawson said. “We’re getting the CE mark, and we’ll have that in early 2007, but we’re going to stay focused on the U.S. for now. We may start to look for [European] distributors in a year or two.”

Elsewhere in the product pipeline.

• AngioDynamics (Queensbury, New York) has received FDA 510(k) clearance for Oncobionic to market irreversible electroporation (IRE), a technology indicated for surgical ablation of soft tissue, including cardiac and smooth muscle. As previously disclosed, AngioDynamics will acquire Oncobionic upon successful human use of its IRE technology, for which testing is expected to begin in mid-2007. IRE uses needles and image guidance similar to existing thermal ablation technologies, but instead of “cooking” or “freezing” the targeted tissue, IRE disrupts the cell membrane, thereby destroying the targeted cells. In IRE, needle electrodes are placed through the skin by image guidance in the center or at the edge of the targeted tissue. A certain electrical field is then generated within the electrode array, causing permanent nanoscale defects (pores) in the cell membranes. The impaired cells are left in the body to be removed by the body’s natural immune system. AngioDynamics manufactures devices to treat peripheral vascular diseases and other non-coronary diseases.

• Aspect Medical Systems (Norwood, Massachusetts) updated the status of the Biomarkers for Rapid Identification of Treatment Effectiveness (BRITE) major depression trial, scheduled for completion by the end of 1Q07. The goal of the study is to determine the accuracy of using Aspect’s brain assessment technology to predict the effectiveness of antidepressant medications. The study will also attempt to determine an alternative treatment for subjects who show a poor response to a selective serotonin reuptake inhibitor (SSRI) and to expand the company’s database to allow further optimization of Aspect’s technology. Aspect Medical Systems is a brain monitoring technology company. The company says its bispectral index technology has been used to assess more than 17.4 million patients.

• ATS Medical (Minneapolis) said it received a notice of allowance from the U.S. Patent and Trademark Office for a key patent application on its anti-coagulation and demineralization of conductive medical devices technology. It said it expects this patent to be issued in early 2007. The ATS technology is used in conjunction with implantable medical devices to minimize blood/platelet interaction with the device. ATS provides products and services focused on cardiac surgery.

• Baxa (Englewood, Colorado) reported the release of its new 2 mL Exacta-Med Oral Dispenser, saying such dispensers play a vital role in preventing wrong-route administration of non-IV fluid drugs. It noted that oral dispensers and accessories are recommended by the Institute for Safe Medication Practice for use in oral and enteral fluid drug delivery.

• Cambridge Heart (Bedford, Massachusetts) reported the publication of a study in the Journal of the American College of Cardiology assessing the utility of Microvolt T-Wave Alternans (MTWA) in predicting risk of sudden death among patients who have previously suffered a heart attack but have preserved cardiac function. This group of patients is outside of the MADIT II and SCDHeFT populations as the study included only patients with a left ventricular ejection fraction (LVEF) greater than or equal to 0.40, while the two studies involved LVEF less than or equal to 0.30 and LVEF less than or equal to 0.35 patients respectively. The results indicate that the MTWA test, using the Cambridge Heart Spectral Analytic Method during low heart rate exercise, identifies those patients who are at elevated risk for sudden cardiac death and therefore may benefit from implantation of a defibrillator. The study was a large cohort study enrolling 1,041 post-MI patients at eight medical centers in Japan. All patients had an LVEF greater than or equa to 0.40, and the average LVEF was 0.55. Microvolt TWA testing was performed 48 to 66 days after acute MI, and 10 other risk variables were also evaluated. Cambridge Heart develops products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest.

• Cardiac Science (Bothell, Washington) said it has begun shipments of the Powerheart G3 Plus, a CPR-enhanced addition to its Pow toerheart automated external defibrillator (AED) that is designed for the public access defibrillation market. The G3 Plus is designed for public places such as schools, shopping malls, private homes (with a doctor’s prescription) and corporate offices. Its Rescue Coach voice prompts guide the less experienced rescuer through the steps of cardio-pulmonary resuscitation and defibrillation with calm, direct and comprehensive instructions. Cardiac Science makes a family of advanced diagnostic and therapeutic cardiology devices and systems.

• Researchers at Cincinnati Children’s Hospital Medical Center (Cincinnati) have reported that they have developed the first gene chip to use in the early diagnosis of at least five hereditary liver diseases, to detect genetic causes of jaundice in children and adults and potentially to lead to personalized treatment options. The “jaundice chip” uses a new technology that rapidly and accurately discloses the composition of several genes known to cause liver disease in children and adults. Jaundice is a yellowing of the eyes and skin caused by impairment in bile flow from the liver to the intestine.

• Cordis Endovascular (Miami, Florida) reported the launch of two products in the treatment of blocked lower-leg arteries: the Frontrunner XP CTO Catheter and the Outback LTD Re-Entry Catheter. These devices safely place guidewires in narrowed or blocked arteries during minimally invasive procedures that remove blockages and reestablish blood flow. Cordis Endovascular, a division of Cordis (Miami Lakes), is a developer of interventional and diagnostic products including nitinol and stainless steel stents, vena cava filters, balloon catheters and accessories.

• CoreValve (Irvine, California) said its Revalving system was used to percutaneously implant its porcine pericardial tissue bioprostheses over the severely diseased aortic heart valves of four consecutive high-risk patients: two at the Helios Heart Center (HHC; Siegburg, Germany) and two at the University of Leipzig Heart Center (Germany). CoreValve said each of the ReValving procedures were performed without the necessity of a surgical cut-down for catheter access, without the use of extracorporeal bypass, and without any other cardiac assistance or even rapid pacing. CoreValve has developed a delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery.

• CytoCore (Chicago) reported the start of clinical trials in support of its EndoScan, a non-invasive uterine cancer screening method expected to become a standard gynecological wellness test available worldwide, according to the company. Phase I trials should be complete in six months; Phase II trials will begin immediately, with a product market release anticipated during 2008, the company said. CytoCore develops cost-effective cancer screening systems, which can be used in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers.

• Fluidigm (South San Francisco) said it has launched a new platform for gene expression analysis that runs TaqMan assays on nanofluidic chips, known as BioMark dynamic arrays. The BioMark system delivers higher throughput than 384-microwell plate systems, and at reduced running costs. These include researchers in diagnostics and drug development who seek to validate molecular markers against thousands to tens of thousands of patient samples. Whereas such studies require thousands of microwell plates and multiple robotic systems, the same studies can now be accomplished with a few hundred chips, a single BioMark system, and in a matter of days. Fluidigm develops and distributes systems based on the properties of integrated fluidic circuits (IFCs) to control fluids on a nanovolume scale.

• Genzyme (Cambridge, Massachusetts) reported commercial availability of a new laboratory test designed to help identify non-small cell lung cancer (NSCLC) patients who may not respond to targeted therapies. Genzyme’s KRAS Mutation Analysis is meant to help identify NSCLC patients who test positive for specific KRAS mutations. Mutations in the KRAS gene have been associated with resistance to certain drugs used in treating this deadly form of cancer, including the tyrosine kinase inhibitors (TKIs) Tarceva and IRESSA. Genzyme Genetics offers “extensive diagnostic testing services,” the company said.

• Iapyx Medical (San Diego) has introduced its Iso-Line Suction Wand Holster System, an infection control product designed to isolate suction wands to minimize the transmission of pathogenic organisms (viruses, bacteria, and fungi) in a hospital setting. According to a study published in the American Journal of Infection Control, 80% of oral suction wands can be contaminated with highly pathogenic bacteria and fungi which can contribute to serious hospital-acquired infections. Typically, these wands are placed under the patient’s pillow or on other hospital equipment increasing the risk of infection to both patients and healthcare workers. The Iso-Line is mounted onto the patient’s bedrail, hospital stand or ventilator, and includes a rigid disposable holster that isolates the suction wand from surface contact, thereby reducing the transmission of infectious pathogens. The holster is designed with a secretion reservoir that allows blood and mucus to drain away from the tip of the suction wand. Iapyx Medical produces single-use medical devices designed to combat hospital-acquired infections.

• I-Flow (Lake Forest, California) said that a landmark meta-analysis confirming the efficacy of continuous wound catheters delivering local anesthetic, including On-Q, for post surgical analgesia (pain relief) was published in the December 2006 Journal of the American College of Surgeons. The study encompassed 44 different randomized clinical trials which included 2,141 patients across a wide range of surgical procedures. On-Q is a device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it automatically through a tiny, specially designed tube (catheter) to provide even distribution of local anesthetic over a wider area, according to the company. I-Flow makes drug delivery systems and services designed to provide life enhancing, cost effective solutions for pain relief.

• Illumina (San Diego) reports that the next BeadChip in its Infinium product family will profile more than 1 million genetic variants. The Human 1M BeadChip combines a level of content for both whole-genome (WG) and copy number variation (CNV) analysis, along with additional unique, high-value genomic regions of interest - all on a single microarray chip. Illumina also announced that it plans to introduce the Human 450S BeadChip, which will enable customers using Illumina’s HumanHap550 BeadChip to further extend their genetic studies to include the 1 million content level. The Human 1M and Human 450S BeadChips will be powered by Illumina’s Infinium Assay. Both products are expected to enter the market by the close of the second quarter, 2007. Illumina makes tools for the large-scale analysis of genetic variation and function.

• Immunicon (Huntingdon Valley, Pennsylvania) reported the availability of the EasyCount System, a fluorescent microscopy-based imaging system designed to accurately count dead and live nucleated cells and automatically calculate cell viability, in a single test. The researcher can perform up to six tests at a time using the EasyCount Slide Multi-Well Slide provided with the EasyCount ViaSure Kit and the instrument reports total and live cell counts and viability calculation in less than one minute per test, the company said. Immunicon said it will target research laboratories and industrial accounts including bioprocessing facilities in the pharmaceutical, biotechnology and diagnostics sectors, where rapid, accurate cell counting is valued highly by users. Immunicon is developing cell- and molecular-based human diagnostic and life science research products, and is providing certain analytical services to pharmaceutical and biotechnology companies to assist them in developing new therapeutic agents, with an initial focus on cancer disease management.

• Medicsight (London) reported the publication in the December 2006 issue of Gastroenterology of a study that showed Medicsight CAD (computer-aided detection) significantly improved reader interpretation of CT colonography. The study investigated the effect of CAD assistance on the performance of 10 readers who were ‘non-expert’ in the interpretation of CT colonography. Each participant read 107 CT colonography cases: 60 patients had 142 polyps and the remaining 47 had normal colons. The cases were first read without the assistance of CAD and then two months later the studies were read with the assistance of CAD. The study found that readers detected significantly more polyps with CAD than without. Medicsight plc, a subsidiary of Medicsight, is an investment company that focuses solely on the dynamic and consolidating HCIT sector.

• Results of a two-year follow-up study show that about two-thirds of Meniere’s disease patients who are unresponsive to traditional medical treatment experience a “significant, long-term reduction” in vertigo frequency using a Medtronic (Minneapolis) device specifically designed for this purpose, called the Meniett Low-Pressure Pulse Generator. The study results, the latest of a series of studies undertaken on the device, were published in the December issue of the Archives of Otolaryngology-Head and Neck Surgery. Medtronic said that about 2.6 million people in the U.S. and Europe have the disease, which originates with excess fluid in the ear. The primary symptom of the disease is vertigo — which can be debilitating to the point of people being unable to work or conduct other everyday activities. Medtronic acquired the device from a Swedish company, and it secured FDA approval for the product in December 2001. The Meniett device and treatment, which is self-administered, is designed to deliver low-pressure air pulses through a tube, which remains in the ear, and is then connected to an earpiece placed in the outer ear. The tube in the inner ear is surgically implanted.

• MIV Therapeutics (MIVT; Atlanta) said a comparative animal study of two of its novel polymer-free drug-eluting stent coating technologies has concluded with positive results. The study compared stents coated with MIVT’s polymer-free drug-eluting technologies to Johnson & Johnson (New Brunswick, New Jersey) Cypher stent. The study demonstrated that both of MIVT’s polymer-free, Sirolimus eluting coatings are at least as good as Johnson & Johnson’s Cypher Stent, MIVT said. MIVT is developing a next-generation line of advanced biocompatible coatings for passive and drug-eluting applications on cardiovascular stents and a range of other implantable devices. The company’s ultra-thin coating formulation is designed to protect surrounding tissue from potentially harmful interactions with bare metallic stents.

• Nikon Instruments (Melville, New York) has introduced the BioStation CT, a fully integrated, self- contained cell culture observation device and monitoring system designed to allow users with minimal microscopy experience to conduct live cell imaging locally or by remote operation over a public or private network. The BioStation CT provides a system for managing, observing and recording cell growth, morphology, and protein expression in culture by providing consistent environmental control of temperature, humidity and gas concentration. The system allows numerous researchers to perform multiple experiments with the same instrument within the same period. Major applications for the Nikon BioStation CT include clinical medicine to determine the optimum selection of anticancer drug combinations; re-generative medicine for stem cell culturing and cell differentiation; biotechnology based drug development and toxicology studies; drug discovery safety testing; biotechnology research involving genome and proteome initiatives; and traditional bioscience research using multi-channel fluorescence and time lapse image recording. Nikon Instruments develops optical technology. Its product line includes microscopy equipment, digital imaging, precision measuring and semiconductor wafer-handling equipment.

• Ophthonix (San Diego) reported receiving its 14th patent, including the diagnostic capabilities of the Z-View Aberrometer to profile the high-order aberrations of a patient’s eye with a proprietary algorithm. The high-order profile is used to manufacture the iZon High Resolution Lens, giving the patient high definition vision. The patent also covers the use of the high-order profile to generate a simulation of the high definition vision quality provided by the iZon Lens, for use by the practitioner in explaining the iZon Lens benefits to the patient. Ophthonix is an ophthalmic company marketing technology that enables patients to see with fully optimized vision.

• Quest Diagnostics (Lyndhurst, New Jersey) reported that it has introduced its newly developed test, the breast cancer gene expression ratio, to help in predicting the risk of disease recurrence in women with estrogen receptor (ER)-positive, lymph node-negative breast cancer. Quest said it developed the test based on licensed gene-expression profiling technology from AviaraDx (Carlsbad, California), a molecular cancer profiling company. “Until recently, a patient’s breast cancer prognosis depended on limited variables, such as tumor size and grade, patient age, lymph node involvement and hormone-receptor status,” said Richard Bender, MD, Quest Diagnostics’ medical director for oncology. “With this measurement, we now have more information to help predict the likelihood of disease recurrence in patients with ER-positive, node-negative breast cancers. Physicians and patients will want to consider this new information when deciding on treatment options.” Quest Diagnostics provides diagnostic testing, information and services.

• Signalife (Greenville, South Carolina), reported development of a cardiac vest system and that it will soon be seeking FDA clearance. Described as looking somewhat like a sports bra, the cardiac vest, which has been featured in a late 2006 NBC “Today Show” segment, has been “extensively” used in testing in the Champ Car World Series open cockpit racing, the company notes. During those tests, the ECG signals allowed physicians to evaluate data previously unavailable when captured in the very harsh environment of a race car. The Signalife vest features electrodes about the size of a quarter embedded in a cloth fabric designed to provide an improved level of comfort.

• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of an insulation material for cardiac leads used with pacemakers and implantable cardioverter defibrillators (ICDs). Optim lead insulation is the first silicone-polyurethane co-polymer material created specifically for cardiac lead use, the company said. The new Optim insulation is designed for long-term reliability, while providing physicians with better flexibility and handling to facilitate device implantation. Optim insulation is a new hybrid insulation material, blending the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. St. Jude Medical is introducing Optim lead insulation on two of its newest leads, the Riata ST Optim ICD lead and the Tendril ST Optim pacing lead. A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device. St. Jude Medical is focused on cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.

• Thoratec (Pleasanton, California) said it has completed the submission of its Pre-Market Approval (PMA) seeking bridge-to-transplantation (BTT) approval for its HeartMate II LVAS (left ventricular assist system) by filing the clinical summary and draft final labeling module. The PMA filing is based on data from 133 BTT patients representing more than 57 years of cumulative support. Days of support ranged from 1-568 days. The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. Thoratec makes products to treat cardiovascular disease and advanced stage heart failure.

• Tm Bioscience (Toronto) reported results from clinical testing of the ID-Tag RVP regarding the H5 subtype of the influenza A virus, the focus of the current pandemic threat being monitored through the World Health Organization (Geneva). Results confirm the ability of the ID-Tag RVP to detect the bird flu virus in all positive clinical samples tested (0% false-negative rate for H5). Additionally, the majority of patient samples tested by the ID-Tag RVP across both the European and North American arms of the clinical trial were probed for Influenza A-H5. There were no false-positive results observed in any of these samples. The ID-Tag RVP is a test that, in a single patient sample, simultaneously probes up to 20 distinct viral sequences that represent more than 95% of all circulating respiratory viruses. The ID-Tag RVP has been designed to enable, through a single test on a patient sample, discrimination of the H5 subtype of influenza A from the subtypes generally seen in the human population (H1, and H3). It also discriminates influenza A from a panel of respiratory viruses, including those with similar clinical presentations. Tm Bioscience develops DNA-based tests for genetic disorders, drug metabolism and various infectious diseases.

• Vascular Solutions (Minneapolis) said it received FDA approval of its PMA Supplement for the added indication for the use of the D-Stat Flowable hemostat for the reduction in the incidence of clinically significant hematomas in the implantation of a pulse generator (pacemaker or ICD) in anticoagulated patients. The D-Stat Flowable hemostat is a thick, yet flowable, suspension of collagen, thrombin and diluent that was originally approved for topical application in 2002. The flowable consistency of the D-Stat Flowable allows it to coat the pocket created in the prepectoral area during the implantation of the pulse generator component of pacemaker and implantable cardioverter defibrillator (ICD) implants. Particularly with patients on anticoagulant medications such as heparin and coumadin, the prepectoral pocket can bleed for a substantial period following the implantation, resulting in a pocket hematoma which can lead to infection or require surgical evacuation. Approval of the additional indication was supported by the Pocket Protector clinical study — a prospective, randomized, multi-center clinical study to assess the safety and effectiveness of the D-Stat Flowable hemostat in the prepectoral pocket during the implantation of a pulse generator (pacemaker or ICD) in an anticoagulated population.

• Viasys (Conshohocken, Pennsylvania) reported receiving FDA 510(k) clearance for its Sonara and Sonara/tek digital Transcranial Doppler (TCD) systems. Viasys introduced both TCD systems at the Medica Healthcare meeting in D sseldorf, Germany. TCD is a noninvasive method of measuring blood flow velocities in the arteries of the brain using ultrasound Doppler technology. Sonara and Sonara/tek systems were developed with a new digital data acquisition approach designed to provide higher-resolution data than previously available. Sonara is an integrated system, while the Sonara/tek is a Doppler module that allows connectivity to a PC or our current TCD products for an affordable choice without compromising high-end features.

• Viasys Respiratory Care (also Conshohocken), a subsidiary of Viasys Healthcare, received FDA clearance to market its PulmoLife spirometry screener, a device used to assess lung function via spirometry

• Vital Therapies (VTI; San Diego), a company seeking to develop the first “bioartificial” liver, reported that completing interim analysis of the first 45 patients enrolled in its pivotal trial of its ELAD (Extracorporeal Liver Assist Device) System in China. The trial, which is studying the liver assist device in patients with chronic liver disease, indicates statistical significance with the endpoint of transplant-free survival. Terry Winters, CEO and chairman of VTI, said the company will submit the results of its trial in China to the FDA to recive permission to begin a Phase III trial in the U.S. later this year. ELAD is designed to augment the metabolic functions of a patient’s liver, thereby enabling a bridge to transplant or recovery.