Thursday, May 25, 2006

MicroLight Gains First FDA Biostim Approval

This article, written by Kathy Kincade the editor of MLR, was published in Medical Laser Report in March 2002. It is a fitting conclusion to our series on biostimulation.

MicroLight Gains First FDA Biostim Approval

Kathy Kincade
Editor, Medical Laser Report

It took 11 years and more than $4 million, but Michael Barbour has finally seen his low-energy therapeutic laser technology make it to “the show.” The FDA granted clearance to MicroLight (Missouri City, TX), Barbour’s latest commercial venture to market the ML830 diode-laser instrument for the treatment of carpal tunnel syndrome (CTS). This is the first time the FDA has given the “thumbs up” to a laser based device for low-level laser therapy (LLLT), also known as “biostimulation.”

The 830-nm ML830 is battery operated and comprise three laser diodes, each delivering 30 mW of energy peripherally located around a red light-emitting diode. Barbour first began pursuing the technology for non-surgical treatment of CTS in the early 1990s when he was head of a company called Lasermedics. In 1993, Lasermedics sponsored a preliminary clinical study involving 100 employees at General Motors and found that those individuals treated with the laser showed significant improvement in certain hand functions, compared to those treated with a dummy laser or with physiotherapy. A subsequent randomized double-blind trial involving 173 patients at Baylor College of Medicine (Houston, TX) and two other sites showed an 80% success rate and further demonstrated the efficacy of the device in relieving pain and improving functionality for individuals suffering from CTS.

In 1997, Lasermedics was revamped and renamed Henley Healthcare, with the intention of expanding its product portfolio into nonlaser products and accessories used to control acute and chronic pain. Barbour continued to serve as president and CEO, and in mid-1999, the company began submitting preliminary clinical data from the MicroLight trials to the FDA in support of its anticipated premarket approval application. But one year later, Barbour was gone, and in April 2001, Henley terminated all of its U.S. employees following foreclosure by creditors on Henley’s U.S. assets. Those assets – including the MicroLight technology – were subsequently sold to a third party in Seattle for $900,000 as part of the company’s efforts to repay some of its debts. That’s when Barbour decided to try his hand again with MicroLight.

“I was able to purchase the technology at a reasonable price and was willing to invest the time, energy, and money necessary to see it through the FDA process,” said Barbour, who founded MicroLight in October 2001, and serves as president of the two-man operation.

Barbour expects the first MicroLight CTS device to be on the market by mid-year. The product is currently being assembled by an OEM supplier in Denmark, but Barbour’s strategy is to join forces with a much larger medical-device company that can handle volume manufacturing and move the ML830 into the U.S. marketplace through a well-established sales and distribution network. In addition, MicroLight holds a method patent that covers the use of this technology in soft tissue “from head to toe,” according to Barbour.

Market Potential

Having the first FDA-approved biostimulation product — and a method patent covering use of the technology in soft tissue “from head to toe,” according to Barbour – should make MicroLight very attractive to any number of large medical-device companies. According to Irving Arons of Spectrum Consulting (Peabody, MA), the market for the ML830 in the treatment of CTS alone could reach $480 million to $600 million in the United States over the next few years. This projection represents the sale of 60,000-100,000 laser biostimulation devices selling at an initial average price of $8000-$10,000. The potential market for CTS treatment alone includes physical therapists, anestheologists, neurosurgeons, orthopedic surgeons, and hand surgeons. More than 1 million Americans develop CTS symptoms each year, and more than 200,000 surgical procedures are performed to treat CTS at an annual cost of more than $10 billion.

But CTS is only the first of what should be a broad spectrum of applications for the ML830 and similar devices. Ongoing research in LLLT covers a wide range of applications, including dentistry, where studies in Switzerland and Russia have shown that LLLT encourages wound healing in the mouth; pain alleviation and modulation, with studies in Ireland indicating that there may be a way to determine LLLT’s effect on pain receptors; and bone and nerve regeneration. Other studies have focused on the interaction of light with biological systems and determining the molecular mechanisms underlying the anecdotal and clinical results that have been reported.

“What we know about this technology is that it is using light in a non-heat fashion to have an anti-inflammatory response in tissue,” Barbour said. “Clinicians say they see applications in arthritis, wound healing, and other soft-tissue indications – even, in the next few years, internal anti-inflammatory responses via an endoscope.”

Eventually, Barbour envisions the technology making its way into any number of consumer-based applications where it functions in a more autonomous capacity. “When someone goes to put a tennis-elbow brace or a knee brace on, the brace could have an anti-inflammatory sensor in it,” he said. “This technology could probably go where magnets have gone, but with clearer science behind it.”