Lithotripsy testing potential falls

Sonic Technologies had high hopes for its lithotripsy testingbusiness when it received a National Institutes of Health researchgrant last year to fund the development of a lithotripsy hydrophone(SCAN 4/11/90). But those hopes have been tempered by the generaldownturn in lithotripsy market prospects over the last year anda half.

ST, based in Horsham, PA, is a subsidiary of mobile ultrasoundprovider American Medical Imaging.

The firm did develop a specialized measurement device to gaugethe pressure of lithotripter shock waves, but it no longer expectsthis business to be larger than its primary diagnostic ultrasoundtesting 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 necessarilybad news for Sonic Technologies. The company provides testingservices and regulatory advice for companies seeking market approvalof their ultrasound and lithotripsy machines. While some equipmentvendors, such as Medstone, have retreated from the regulatoryprocess for biliary lithotripters, others continue to plug away,Schafer said.

ST also expects continued business from the quality assuranceprograms it provides to the existing installed base of renal lithotripters,he said.

The ST lithotripter hydrophone works on the same principleas its diagnostic ultrasound hydrophone except that it has a disposablefilm. Rather than throwing away the entire hydrophone when thelithotripter shocks wear it down, the film can be replaced.

The firm also has a patented technique for monitoring the lithotripsyhydrophone and indicating when replacement is necessary, Schafersaid.

Most of the new lithotripsy FDA approval efforts ST is workingwith involve low-cost renal units. Vendors are targeting the private-officeurology market with systems that will sell for $200,000 to $300,000.These lithotripters would undercut the price of existing systemssold by Dornier and others, while opening up a new market of urologistswho want to bring their kidney stone blasting business in-house,Schafer said.