MEDICAL
The Food and Drug Administration’s Gastroenterology and Urology panel has unanimously recommended FDA approval of Medstone International’s “dry” technology for disintegrating kidney stones without surgery or requiring patients to be immersed in water.
As a result, Errol Payne, chief executive officer of the 3-year-old Costa Mesa company, said he hopes to obtain a final FDA go-ahead to market the technology nationally within 90 days. He anticipates that FDA approval will enable Medstone to “double or triple” its business. In the privately held company’s last fiscal year, ended Oct. 31, it posted $7 million in revenue and $1.5 million in earnings, Payne said.
Payne said the company in its last fiscal year generated revenue from exporting its “lithotripter,” called the Medstone 1050 ST system, to Japan and by selling contracts for the same machinery at five trial facilities in the United States, including Hoag in Newport Beach.
He said Medstone’s stiffest competition in lithotripter manufacturing comes from a German firm called Dornier, a subsidiary of Daimler-Benz AG, which developed an acoustical shock wave treatment for kidney stones as an outgrowth of aerospace technology.
Payne said he believes the Medstone technology has an advantage over Dornier’s because, unlike Dornier’s, it does not require a patient to sit in water. Instead, the shock waves that crush the kidney stone are transmitted through fluid contained in a tube and placed in contact with the patient’s back.
The lithotripter treatment is much cheaper than surgery and does away with post-operative recuperation periods, Payne said.
In addition to the profits from its lithotripters, which retail for more than $1 million each, Payne said Medstone receives a fee for each procedure as part of its contract with hospitals and outpatient surgical centers that buy the equipment. In turn, Medstone provides engineering support to maintain and update the machinery. Yet another source of continuous revenue to the company, he said, comes from the sale of fluids and other disposable medical supplies used in operating the lithotripters.
