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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) APRIL 30, 1998
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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)
(949) 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) FDA's Gastroenterology and Urology Device Advisory Panel has
recommended conditional approval of the Medstone's submission to treat
gallstones.
On April 30, 1998, the Company announced that FDA's Gastroenterology and
Urology Device Advisory Panel has recommended conditional approval of the
Medstone's submission to treat gallstones using the Company's lithotripter, in
combination with Actigall, a drug used to dissolve gallstones. The condition to
approval is that Medstone performs a post-approval study of the outcome and
quality of life improvements for five years after treatment for a limited
quantity of patients.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits
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NUMBER EXHIBIT
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99.1 Press Release - Medstone Receives Recommendation for Approval
from FDA Panel for Treatment of Gallstones.
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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: May 20, 1998 By: /s/ Mark Selawski
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Mark Selawski
Chief Financial Officer
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EXHIBITS
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NUMBER DESCRIPTION PAGE NO.
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99.1 Press Release - Medstone Receives Recommendation for Approval
from FDA Panel for Treatment of Gallstones 2
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE PRESS RELEASE
April 30, 1998
Contact: MEDSTONE INTERNATIONAL, INC.
David V. Radlinski
Chairman and Chief Executive Officer
(714) 448-7700 Ext. 235
MEDSTONE RECEIVES RECOMMENDATION FOR APPROVAL
FROM FDA PANEL FOR TREATMENT OF GALLSTONES
ALISO VIEJO, California, April 30, 1998 --- Medstone International, Inc.
(NASDAQ: MEDS) has been notified that the FDA's Gastroenterology and Urology
Device Advisory Panel has recommended conditional approval of the Medstone's
submission to treat gallstones using the Company's lithotripter, in combination
with Actigall, a drug used to dissolve gallstones. The condition to approval is
that Medstone performs a post-approval study.
"The recommendation for approval is another step along the approval trail.
This step was taken after many years of hard work by a group of talented people.
We believe this combined therapy will be a valuable tool for the physicians in
treating certain patients with gallstones," said David V. Radlinski, Chairman
and Chief Executive Officer.
Medstone, as the only vertically integrated extracorporeal shockwave
therapy ("ESWT") company, is focused on providing cost effective lithotripsy for
treatment of various diseases.
This press release contains forward-looking information. The forward-looking
statements are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements may be
significantly impacted by certain risks and uncertainties described herein and
in the Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission for the year ended December 31, 1997.
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