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Juvent Brings Its Vibrations To the US Market

By John Greenwald | Source: All Business

For more than two decades the scientists behind Juvent, a medical-device maker in Somerset, have been developing a nondrug treatment for osteoporosis. The disease, marked by fragile and easily broken bones, afflicts more than 10 million Americans - about one third of whom can't tolerate drugs for the condition.

Next month Juvent will introduce a gentle vibrating platform called the Juvent 1000 that is based on this research to the US market - but, ironically, not as an osteoporosis treatment. Instead, the $2,500 device that resembles a wide bathroom scale will be billed as an exercise machine for strengthening muscles, stimulating circulation and improving balance and coordination.

The Juvent 1000 is currently available in Canada, Europe, Australia and New Zealand, where governments have OK'd it as a safe and effective treatment for osteoporosis. And the National Aeronautics and Space Administration plans to install the device on the International Space Station next year to help counter the bone loss that astronauts experience in zero gravity.

But gaining Food and Drug Administration approval to sell the Juvent 1000 as an osteoporosis treatment calls for a much lengthier process than other governments require. So the Juvent device is about to begin a two-year clinical trial under the aegis of the Harvard Medical School and Hebrew SeniorLife in Boston to win the FDA's go-ahead.

Meanwhile, Juvent has watched from the sidelines with mounting frustration as the makers of bone-jarring vibrating exercise machines with names like Power Plate, TurboSonic and Galileo have used websites and other marketing materials to tout their devices to a US audience as providing benefits that can include relief from osteoporosis - even though none of the devices have FDA approval to treat the condition. Several companies have altered their sites after receiving warning letters from Juvent.

The FDA has taken a low profile with regard to manufacturers of exercise equipment that they say can be used to treat osteoporosis. When asked about its policy, the agency said in a statement, "No kind of powered exercise equipment has been cleared or approved by FDA for the treatment of osteoporosis as a medical device. While there has been no recent enforcement actions by FDA for such products, FDA does have the regulatory authority and can investigate for violation of the Food Drug and Cosmetic Act."

Companies are targeting osteoporosis because the prize for a nondrug treatment is a chance at a vast and untapped market. According to the US Surgeon General, 34 million Americans are at risk of developing osteoporosis, in addition to the 10 million who already have it. The disease becomes increasingly prevalent with age; eight out of 10 sufferers are women.

The world's osteoporosis patients spend an estimated $5 billion to $10 billion a year on medications, many of which can have serious side effects. Among those reported for two of the most widely used drugs - Fosamax from Merck and Actonel from Aventis and Procter & Gamble Pharmaceuticals - are osteonecrosis of the jaw, a wasting condition that is also called jaw death.

Juvent COO Roger Talish estimates that his company's revenue could zoom from about $1 million today to $100 million within the next five years as international sales take off and the FDA approves the Juvent 1000 for osteoporosis. "There's a huge demand for this," says Talish.

Investors have pumped about $14 million into Juvent. Last April the company was voted "the Venture Capitalists' Choice" at the New Jersey Technology Council's annual Venture Fair. Juvent earlier this year became one of the first two beneficiaries of the New Jersey Economic Development Authority's new Techniuum program, which gave the company $1 million in low-interest financing.

The Juvent machine works by generating high-frequency, low-magnitude vibrations that travel up the skeleton of the person standing on it. The mud vibrations mimic the bone-forming effect that the patient's muscles - particularly those in the calf - had when he or she was younger. "We trick the skeleton into thinking that a 75-year-old's muscles are really a 35-year-old's," says Clinton Rubin, a principal developer of the Juvent 1000.

Rubin, who chairs the department of biomedical engineering at the State University of New York (SUNY) at Stony Brook, began work on the vibrating technology in the early 1980s. He and fellow SUNY researcher Kenneth McLeod were with a Piscataway company called Exogen when British medical-device maker Smith & Nephew acquired it. In 2002 the scientists joined with investors led by John Moroney of Landmark Financial in New York City to acquire the vibrating-platform technology from Smith & Nephew. They launched Juvent to bring it to market.

Under Moroney, a native of Ireland, the company opened a manufacturing plant in Ireland and over the past year has won approvals to market the Juvent 1000 as an osteoporosis treatment outside the United States.