VivoMetrics (Ventura, California), developer of the LifeShirt, has expanded its efforts in diagnostics and early assessment of health risk into the military sector and associated high-stress arenas that firefighters and first responders often face. Through its newly developed VivoMetrics Government Services unit, VivoMetrics has acquired a contract with the U.S. Army Research Institute of Environmental Medicine (USARIEM; Natick, Massachusetts) to supply key respiratory components of its LifeShirt technology for integration into the Army's Warfighter Physiological Status Monitor-Initial Capability (WPSM-IC) program.

The focus of this effort, says Andy Behar, chief operating officer of VivoMetrics and president of the Government Services business, is "getting critical life signs data during actual high-stress situations. That's a huge benefit. The Army is taking our standard LifeShirt technology and putting it on people in these environments." Such an approach, he told The BBI Newsletter, offers "a great advantage over what [the military] is doing now, which is basically nothing."

He underlines the fact that VivoMetrics won't be supplying to the Army its LifeShirt a garment for measuring physiological vital signs, most often for instance, to monitor human reaction to drugs in clinical trials and FDA-cleared in 2002 but will instead be supplying the underlying technology, called respiratory inductive plethysmography (RIP). VivoMetrics acquired that technology from Non-Invasive Monitoring Systems (North Bay Village, Florida) in 1999. The technology then was incorporated into a fabric made into a vest-like shirt for continuous measurement of a vital signs, not just in a physician's office, but as a person is ambulatory, moving, working, playing.

The technology to be adapted by the Army, Behar says, will consist of "bands that go around the chest and the chips and circuit boards that make it all work." The technology will likely be integrated into some sort of uniform "that's similar but different from the LifeShirt," Behar says, with an emphasis on collecting heart and temperature monitoring, plus additional data points and "parameters that they need for the war fighter." Worn by soldiers in training and combat operations, the WPSM-IC technology will be designed to enable medics to remotely locate soldiers, assess their health status and begin triage for medical attention, and do it immediately, a key point of the application, according to Behar.

The central purpose, he said, is to avoid pushing soldiers or firefighters or others performing hazardous duties beyond their limits, determining when they should be pulled back and rested, and then returned to the fray, rather than losing them to heat stroke, dehydration or other trauma conditions. "A person could be fighting a fire on a Navy vessel or at a factory," Behar said, "throwing themselves at the problem with great passion." Fueled by adrenaline and their programmed reaction to such situations, "They don't realize they many be suffering from heat stress." And pulling them back from combat vs. bullets, fire, long hours of sleeplessness or other intense stress could mean saving their health and even their lives, enabling them to fight another day.

"Basically we've spent a lot of years and a lot of science and energy validating this technology and looking at every kind of disease state post-traumatic stress disorder, asthma and COPD, all the different disease states you can see in cardiopulmonary traces," Behar says. And he emphasizes the technology's ability "to get an extraordinarily high resolution picture of a person's health and in real time, that's the big difference."

Rather than capturing all the data points enabled by the LifeShirt, he says the Army wants "more macro-analysis points," with these sent wirelessly via "a black box on every person."

Behar says that the LifeShirt technology already has been tested in mountain climbs, including up Mt. Everest, worn in Indy cars and in a variety of other extreme environments, but the Army testing offers a new level of validation for VivoMetrics. "Now the world will say, 'Okay, the Army must have kicked the heck out of this thing.' That validation is very significant for us, so that, for instance, fire departments are going to look at us differently knowing that soldiers have worn this and the Army has tested it."

He said the Army contract now opens a large new vista for the technology. "We think we're just starting out with this contract. Now we're taking to the first responder world and these different groups hungry for information. With the data we can provide, we can make them more efficient, help everything they do, keep them healthy and alive."

Medtronic, Genzyme in cardio j-v

In an agreement that bolsters the growing trend toward medical device/biotechnology combination products, device giant Medtronic (Minneapolis, Minnesota) and Genzyme (Cambridge, Massachusetts), a large biotech company that focuses on rare genetic diseases as well as other disorders, have formed a joint venture to accelerate the development of new treatments for some of the most intractable forms of cardiovascular disease. The new venture, to be named MG Biotherapeutics, will combine Medtronic's skill in creating devices that deliver targeted therapies and Genzyme's research in seeking biological approaches to treating disease, initially developing products for cardiac repair and the treatment of heart disease. The new operation will employ about 50 people in three locations.

Scott Papillon, senior public relations manager for Medtronic, said the collaboration reflects an increasing interest from his company in developing therapies that combine drugs and medical devices. "We feel that is where the industry is heading," he told The BBI Newsletter, "this convergence of the two, biotech and med-tech, and even information technology as well." Papillon noted that the two companies have been in discussions for close to five years. He added that Genzyme "has been seeking to partner for some time with a company that has strong skills like we have in delivery [platforms], and we've been seeking solutions for many of the disease markets that we are in, so it was a natural marriage."

A key component to the new j-v platform, according to Papillon, was Medtronic's acquisition last September of TransVascular (Palo Alto, California), developer of the FDA-approved CrossPoint TransAccess Catheter System, which is indicated to facilitate the positioning and placement of catheters within the peripheral vasculature. The system, approved in the U.S. in 2002, has the ability to deliver therapeutic agents including cells, genes and drugs to precise locations within the vascular architecture.

While specific financial terms were not disclosed, the companies said they would share 50-50 both the research costs and the profit if a treatment is successfully developed. The companies expect to enter a late-stage clinical trial in early 2008.

The first goal of the new venture is the continuation of clinical trials in using cell therapy to repair damaged heart tissue. Genzyme is conducting its Myoblast Autologous Graft in Ischemic Cardiomyopathy (MAGIC) Phase II clinical trials in Europe, and the company has been studying whether skeletal muscle cells can help repair damaged heart tissue. These cells, called myoblasts, are harvested from a patient who is about to undergo heart bypass surgery. The cells are cultivated in a laboratory, and then injected back into a damaged portion of the patient's heart during surgery. This clinical trial is using myoblasts because heart cells involved in growing new heart tissue called cardiomyocytes have little ability to regenerate in adults, the companies said. Researchers want to know if this therapy can reverse heart damage or at least halt further damage to the heart muscle.

The Phase II clinical trial, which is currently being conducted in Europe with partial funding from Assistance Publique-Hopitaux de Paris, will enroll up to 300 patients. This trial builds upon the work of Genzyme's European principal investigator, Philippe Menasche, MD, PhD, of Hopital Bichat (Paris), who was among the first to test whether autologous cell therapy could be used to stop or reverse the damage done to the heart muscle by a heart attack. The trial has enrolled patients in France, and is currently expanding to sites in Belgium, the UK, Italy, Germany and Switzerland.

Because cardiomyocytes have limited regenerative ability in adults, the heart has minimal potential to heal itself after a heart attack occurs. Investigators in the Phase II trial harvest a patient's myoblast cells prior to bypass surgery through a small biopsy in the leg. These cells are multiplied many-fold in the laboratory over roughly 21 days using patented cell-culture techniques. The investigators then inject the cells into a damaged region of the heart during a coronary artery bypass operation. Investigators are examining the safety of this procedure and are monitoring a range of outcomes designed to provide a meaningful indication of potential efficacy.

While the Phase II trial progresses, the companies will work to develop a catheter-based system to deliver cells to the heart using Medtronic's TransAccess system. This device has shown potential in pre-clinical studies to effectively deliver autologous cells to damaged areas of the heart. Medtronic and Genzyme said they believe that catheter-based delivery could make cell therapy treatments less invasive, enabling access to the heart through a patient's vascular system. They also believe this may greatly increase the number of patients who could benefit from cardiac cell therapy.

In addition to these efforts, the companies said they will pursue a longer-range joint research program focused on potential next-generation cell therapy approaches, including the use of genetically modified cells, allogeneic cells (cells from a donor or cell bank), and advanced biomaterials designed to enhance cellular engraftment and survival. Medtronic noted that it already has a long and successful history of combining chemical compounds or biologics with medical devices to achieve improved therapeutic results. Some notable examples are steroid-eluting leads for pacemakers and defibrillators, bioactive coatings for heart valves and heparin-coated components used in open-heart surgery. More recent examples include an investigative drug-coated coronary stent, drug infusion systems and Infuse Bone Graft, a morphogenic protein used in conjunction with spinal instrumentation. Infuse was approved in May by the FDA for the treatment of acute, open fractures of the tibial shaft.

Genzyme, which already markets a cell therapy product called Carticel that helps repair damaged cartilage tissue in the knee and Epicel, a cell therapy for treating patients with severe burns, sees this new transaction as part of an ongoing effort to expand into markets with large commercial potential, and this vascular application would be the biggest one for the company to date.

Veridex maps growth via oncology diagnostics

Although the company was formed in 2001, cancer diagnostics firm Veridex (Raritan, New Jersey) made its official coming-out at last month's American Society of Clinical Oncology meeting in New Orleans, Louisiana. Veridex was formed by Johnson & Johnson (J&J; New Brunswick, New Jersey). However, as David Atkins, PhD, Veridex general manager of molecular diagnostics, said, "the ideas were percolating in 2000."

"The company was formed to really address an unmet need in the field of oncology diagnostics," Mark Myslinski, general manager, told BBI. "Oncology diagnostics hasn't changed substantially in the last 25 years or so, so there was clearly an area of opportunity." He added: "Secondly, that opportunity was magnified by the advent of new diagnostic technologies, specifically molecular and cellular technologies."

The company initially is developing two complementary product platforms: CellSearch assays that identify, enumerate and characterize circulating tumor cells using whole blood, and GeneSearch assays, which use molecular technology "to diagnose, stage and more accurately characterize tumors."

CellSearch had its beginnings in a collaboration in 2000 with Immunicon (Huntingdon Valley, Pennsylvania). Immunicon's technology, combined with assays from Veridex, comprise the CellSearch System, recently cleared by the FDA for prediction of "progression-free and overall survival" in patients with metastatic breast cancer. The CellSearch system is designed to detect and enumerate circulating tumor cells in peripheral blood. "What differentiates it from anything that came before is [that] it's fully automated, which has always been a problem in trying to find very rare cells in blood," Robert McCormack, PhD, general manager of cellular diagnostics at Veridex, said. The first indication for the platform is metastatic breast cancer. The company also is going to be working to translate the results it has had with metastastic breast cancer to other cancers, McCormack said.

The second platform, the GeneSearch system, is based on genetic findings. With this system, Veridex offers an intra-operative assay for sentinel lymph node testing during breast cancer surgery. A second category of products is to attempt to derive information by looking at the genome regarding prognosis for colon cancer and breast cancer.

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