Sonic Technologies had high hopes for its lithotripsy testing business when it received a National Institutes of Health research grant last year to fund the development of a lithotripsy hydrophone (SCAN 4/11/90). But those hopes have been tempered by the general downturn in lithotripsy market prospects over the last year and a half.
ST, based in Horsham, PA, is a subsidiary of mobile ultrasound provider American Medical Imaging.
The firm did develop a specialized measurement device to gauge the pressure of lithotripter shock waves, but it no longer expects this business to be larger than its primary diagnostic ultrasound testing business. There appears to be a brighter future, however, in testing and quality assurance for related therapies under development, such as ultrasound angioplasty, said vice president Mark Schafer.
Delays at the Food and Drug Administration are not necessarily bad news for Sonic Technologies. The company provides testing services and regulatory advice for companies seeking market approval of their ultrasound and lithotripsy machines. While some equipment vendors, such as Medstone, have retreated from the regulatory process for biliary lithotripters, others continue to plug away, Schafer said.
ST also expects continued business from the quality assurance programs it provides to the existing installed base of renal lithotripters, he said.
The ST lithotripter hydrophone works on the same principle as its diagnostic ultrasound hydrophone except that it has a disposable film. Rather than throwing away the entire hydrophone when the lithotripter shocks wear it down, the film can be replaced.
The firm also has a patented technique for monitoring the lithotripsy hydrophone and indicating when replacement is necessary, Schafer said.
Most of the new lithotripsy FDA approval efforts ST is working with involve low-cost renal units. Vendors are targeting the private-office urology market with systems that will sell for $200,000 to $300,000. These lithotripters would undercut the price of existing systems sold by Dornier and others, while opening up a new market of urologists who want to bring their kidney stone blasting business in-house, Schafer said.
