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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported) SEPTEMBER 4, 1997
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MEDSTONE INTERNATIONAL, INC.
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(Exact Name of Issuer as Specified in Charter)
DELAWARE
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(State or Other Jurisdiction of Incorporation)
0-16752 66-0439440
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(Commission File Number) (I.R.S. Employer Identification No.)
100 COLUMBIA, SUITE 100, ALISO VIEJO, CA 92656
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(Address of Principal Executive Offices)
(714) 448-7700
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(Registrants's Telephone Number, Including Area Code)
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS.
1) PMA Submission for Non-invasive Gallstone Treatment
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On September 4, 1997, the Company announced that it has submitted an
application for a pre-market approval (PMA) with the U.S. Food & Drug
Administration (FDA) to treat gallstones using the Company's non-invasive
lithotripter in conjunction with Actigall(R), a gallstone dissolution medication
from Novartis Pharmaceuticals Corporation.
The submission is based on an analysis of clinical trials for Actigall
monotheraphy and separate clinical trials for combination therapy with
lithotripter and Actigall. An analysis of these separate trials indicates that
the combination therapy of a device and drug can speed up clearance of the
gallstones and result in higher success rates when compared to drug therapy
alone.
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EXHIBITS
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NUMBER DESCRIPTION PAGE NO.
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<C> <S> <C>
99.1 Press Release 5
"Medstone Submits PMA for Non-Invasive Gallstone
Treatment"
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
MEDSTONE INTERNATIONAL, INC.
Dated: September 4, 1997 By: \s\ Mark Selawski
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Mark Selawski
Chief Financial Officer
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE PRESS RELEASE
September 4, 1997
Contact: MEDSTONE INTERNATIONAL, INC.
David V. Radlinski
Chairman and Chief Executive Officer
(714) 448-7700 Ext. 235
MEDSTONE SUBMITS PMA FOR NON-INVASIVE GALLSTONE TREATMENT
ALISO VIEJO, California, September 4, 1997 -- Medstone International,
Inc. (NASDAQ: MEDS) today announced that it has submitted an application for a
pre-market approval (PMA) with the U.S. Food & Drug Administration (FDA) to
treat gallstones using the Company's non-invasive lithotripter in conjunction
with Actigall(R) (ursodiol USP), a gallstone dissolution medication from
Novartis Pharmaceuticals Corporation (East Hanover, NJ).
The submission is based on an analysis of clinical trials for Actigall
monotheraphy and separate clinical trials for combination therapy with
lithotripter and Actigall. An analysis of these separate trials indicates that
the combination therapy of a device and drug can speed up clearance of the
gallstones and result in higher success rates when compared to drug therapy
alone.
"Should the Medstone STS be approved to treat gallstones, it will be the
only lithotripter approved in the U.S. to treat both renal stones and gallstones
on the same equipment. This means a higher utilization of the Medstone machines
already in the field and a comparative advantage in the competition for new
sales," said David Radlinski, Medstone Chairman and CEO.
An estimated 20 million Americans have gallstones of which 2.3 million
are symptomatic resulting in approximately 421,000 surgeries each year. This
compares to an estimated 1.5 million Americans with kidney stones resulting in
approximately 180,000 extracorporeal shockwave lithotripsy procedures each year.
The filing with the FDA contains the request that the Medstone STS, in
combination with Actigall therapy be indicated for use in fragmenting and
eliminating symptomatic, radiolucent, non-calcified gallstones less than 20 mm
in maximum diameter. It is estimated that approximately 1.2 million Americans
are in this group.
Actigall is ursodiol USP (ursodeoxycholic acid), a naturally occurring
bile acid. The medication was cleared for marketing in 1987 to treat patients
with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest
diameter in whom elective cholecystectomy would be undertaken except for the
presence of increased surgical risk, or for those patients who refuse surgery.
In 1996, it was cleared to prevent gallstones in obese patients experiencing
rapid weight loss. The most common side effects observed in trials with Actigall
were constipation, diarrhea and headache.
Medstone, as the only vertically integrated extracorporeal shockwave
therapy ("ESWT") company, is focused on providing cost effective lithotripsy for
the treatment of renal stones and expanding the application of ESWT to other
diseases such as gallstones and non-healing bone fractures. (See our web site on
the Internet http://www.medstone.com).
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