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NYSTAR award jump starts partnership behind vibrational therapy device

Ken McLeod, chair of the bioengineering department, has been awarded a $537,000 New York State Office of Science, Technology and Academic Research (NYSTAR) grant to partner with Juvent Research to bring a circulation-stimulating medical device to market.

Juvent Research will provide a match to the NYSTAR grant, bringing the total funding for the project to $1.1 million.

The device — the Juvent1000cs, which improves blood flow in patients and will hopefully prevent various forms of chronic illness, including osteoporosis and heart disease — is close to final FDA approval. It works by stimulating the sole of the foot to trigger receptors that send nerve impulses to the spine, which causes muscle fibers in the calf to contract and pump blood and lymphatic fluid back to the heart. The resulting improved blood and lymphatic circulation will help prevent conditions such as deep vein thrombosis and pulmonary embolism from developing.

According to McLeod, calf muscles serve as a “second heart,” and are essential to maintaining good health. In addition, by using this “second heart,” the primary heart doesn’t have to carry the full load, which can lead to early heart failure, he said.

The device is under review by the FDA for short-term effects of poor skeletal muscle pump activity. “We expect approval from the FDA in the next few months,” said McLeod. “Then we need to ramp up manufacturing and distribution, so, while the product may come on the market this calendar year, it’s more likely to be early next year.”

However, there are also long-term effects, such as osteoporosis and Type 2 diabetes, which are believed to be linked to “second heart” failure, he said. The NYSTAR grant will allow his group to investigate the extent to which skeletal muscle pump stimulation can reduce or eliminate these conditions. John Moroney, president and CEO of Juvent, Inc., said the technology for the Juvent1000cs is already embraced by the medical community and there are ways it could serve people that haven’t been thought of yet. “We’ll be doing specific studies like the one with Ken right now on diabetes,” he said. “This is a wonderful technology with lots of applications — and it’s simple. No drugs, no refills — just results.”

The next step in McLeod’s process is to get the necessary approvals for the human studies, buy some equipment, hire staff and get organized to start the required studies.

The NYSTAR award is part of more than $2.7 million in NYSTAR funding announced recently by Gov. George E. Pataki. The grants are meant to assist academic research institutions to work with New York State companies to bring high-tech innovations from the research lab to the marketplace and to spur the creation of new jobs and new companies in the state in a variety of high-tech fields.

“New York State has become one of the world’s most attractive locations for technology-driven businesses,” Pataki said. “Our colleges and universities are hard at work conducting research that will lead to the development of new state-of-the-art technol-ogies. By setting up a process to transfer these cutting-edge technologies from an academic setting to the business world, we will spark the creation of even more high-tech companies, jobs and products.

“The economy is driven by innovation, and therefore it is essential that New York remains at the forefront of high-tech innovation and development,” he said. “Through our nationally-recognized Centers of Excellence program and other key high-tech initiatives such as our technology transfer programs, our state continues to lead the way. As we do, we remain on track to meet our aggressive goal of creating one million new jobs in New York State by the end of the decade.”

Russell W. Bessette, executive director of NYSTAR, reinforced the benefits of supporting research such as McLeod’s. “The high-tech initiatives that Gov. Pataki has launched are already reaping major benefits,” he said. “This program, and others like it, will strengthen the types of research and development in New York State that will lead to the creation of new technology and companies in the state.”

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