Aliso Viejo-based medical device maker Medstone International Inc. is stepping up marketing of its kidney stone break-up machine for a new purpose: removing gallstones in a way that allows people to keep their gallbladders and without incisions.
David Feigal Jr., head of the Food and Drug Administration’s Center for Devices and Radiological Health, recently gave Medstone initial approval to market its shockwave lithotripsy device for gallstone removal, pending post-approval effectiveness studies. The therapy, which combines Medstone’s equipment with Novartis AG’s Actigall medication, breaks up the gallstones so that the body can expel them.
So far, Medstone is the only U.S. company that has FDA approval for the treatment, according to David Radlinski, the company’s chairman and chief executive.
“I don’t think anybody will get approval for another five years,” he said.
Medstone shares got a boost from the approval in early September, spiking from around 6 to 9. They’ve since pulled back to around 7. In the second quarter, the company saw sales slip 8% to $6.5 million from a year ago. Net income dropped 14% to $554,988.
The move into gallstone treatment is part of a diversification bid by Medstone. In June, company officials issued a four-point plan aimed at boosting revenue and expanding in areas with greater market potential. Along with gallstones, Medstone hopes to increase its market share for kidney stone lithotripsy procedures and expand its urological product offerings. The company also is looking to invest in start-up companies.
The national cost for operations and hospitalization for gallstone disease is more than $5 billion a year, according to figures from the National Institutes of Health. But Radlinski said he doesn’t yet have a specific dollar estimate on the machine’s market potential for gallstone removal.
“The good part is that the market is extremely large,” he said.
Radlinski said an estimated 7 million of around 25 million people with gallstone disease could fit the treatment’s eligibility criteria.
The treatment is aimed at gallstone disease patients who either aren’t surgery candidates or refuse to have the operation. He said a typical gallstone patient is “40 years old, fertile, female and full-figured.” The National Institutes of Health reports gallstone disease causes 500,000 Americans, two-thirds of them women, to have their gallbladders removed every year.
Medstone plans to continue its existing strategy of selling and marketing the equipment, which costs around $375,000, to hospitals, outpatient surgery centers and physician groups, Radlinski said. The company also will continue using equipment-loaded trucks that travel to individual hospitals on a per-procedure basis, he said.
Medstone plans to go to the U.S. Health Care Financing Administration to get a billing code for health insurance, Radlinski said.
The company plans to open two training centers, one on the West Coast and one on the East Coast, up and running within a month. Surgeons and gastrointestinal specialists are the most likely doctors to be trained.
Medstone spent about a decade trying to gain FDA approval to use shockwave lithotripsy for gallstone treatment. The company did a study on the subject in the late 1980s that was rejected by federal regulators because of the lack of a “control” group to compare results against, Radlinski said.
Several years later, he said, Novartis agreed to share data with Medstone concerning gallstone treatment with Actigall. Studies were then done on two groups of patients, one with the medication alone and the other with medication and lithotripsy.
Some two years ago, an FDA panel voted 8-1 to recommend approval of Medstone’s gallstone application, Radlinski said. But it took personal action by the FDA’s Feigal to get final approval. n
