SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES AND EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
May 5, 1998
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-12850 13-3152648
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Numbers) Identification No.)
200 N. Westlake Blvd., Suite 202
Westlake Village, CA 91362
(Address of Principal Executive Offices)
(805) 381-2700
(Registrant's Telephone Number)
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Item 5. OTHER EVENTS
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Reference is made to the press release of Registrant, issued on May 5,
1998, which contains information meeting the requirements of this Item 5, and
which is incorporated herein by this reference. A copy of the press release is
attached to this Form 8-K as Exhibit 99.1.
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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 hereunto duly authorized.
May 7, 1998 Dental/Medical Diagnostic Systems, Inc.
By: /s/ Ronald E. Wittman
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Ronald E. Wittman
Vice President and Chief Financial Officer
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EXHIBIT INDEX
EXHIBITS
99.1 Press Release dated May 5, 1998
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Exhibit 99.1
FOR IMMEDIATE RELEASE
CONTACT: Stephen D. Axelrod, CFA
Nancy S.L. Block
Robert H. Gurevitch, Chairman & CEO Susan T. Bolen (Media)
Ronald E. Wittman, Vice President & CFO WOLFE AXELROD ASSOCIATES
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. (212) 370-4500
(805) 381-2700; (805) 374-1966 (Fax) (212) 370-4505 (Fax)
e-mail:[email protected] e-mail:[email protected]
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. ANNOUNCES DELAY
IN SHIPMENT OF APOLLO 9500 Trademark TOOTH WHITENING AND COMPOSITE
CURING SYSTEM
WESTLAKE VILLAGE, CA. MAY 5, 1998 - DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
(NASDAQ:DMDS, DMDSW) announced today that Ion Laser Technology, Inc. (ASE:ILT)
cannot deliver the Apollo 9500 Trademark, a tooth whitening and composite
curing system, as required in DMDS's agreement with ILT.
DMDS's agreement with ILT allows the Company exclusive distribution to the
dental market in the United States and Canada of the FDA-approved Apollo 9500
unit. Because ILT cannot deliver the Apollo 9500 in a timely manner, DMDS will
pursue all its other options and intends to file for 510(k) notification from
the United States Food and Drug Administration (FDA) for its Apollo 95E in the
next two weeks which would permit the Company to market its product in the U.S.
upon notification from the FDA. DMDS is working with experts who have
significant experience in obtaining 510(k) notification and was recently able
to obtain such notification for its TeliCam Intraoral Camera in 67 days after
filing.
DMDS began internationally marketing the Apollo 95E, a tooth whitening and
composite curing system, at the end of March 1998. The Apollo 95E, which has
many of the attributes of the Apollo 9500, cures composites in 1-3 seconds and
whitens teeth in under one hour in the dentist's office. The Apollo 95E has
been enthusiastically received in the international dental community. The
Company has received orders for 800 units of the Apollo 95E and has shipped in
excess of 300 units.
The development of the Apollo 95E tooth whitening and composite curing System
was funded by DMDS and produced at its European operation for the international
market. Designed by Dr. Francois Duret, a world renowned innovator and
developer of high technology dental devices, who is the General Manager and
Director of Research & Development of DMDS's French operation. The Apollo 95E
is sold internationally through distributors and is believed by the Company to
be the world's fastest composite curing and whitening system commercially
available.
Robert Gurevitch, CEO and Chairman of the Dental/Medical Diagnostic
Systems, Inc., stated, "Obviously, we are not pleased by this development but
we are fortunate that in the Apollo 95E we have a unit that is equal to the
Apollo 9500 in features, can be produced at a much lower price, and is
currently in production. The Apollo 95E weighs slightly over 14 pounds, has a
small footprint, and is easily portable. If for whatever reason the Apollo
9500 is unavailable, then we believe that the Apollo 95E will prove to be an
excellent replacement. By initiating the 510(k) notification process
immediately, the impact on our future sales will be minimized while the long
term opportunity will be still as attractive as ever."
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. designs, develops, manufactures and
sells high technology dental equipment. One of the Company's products is an
intraoral camera system known as the TeliCam System and a dental office
networking system known as InTELInet. The Company has independently developed
its own technology for a teeth whitening and curing system, the Apollo 95E
Trademark, which is presently being manufactured for markets outside the United
States and Canada. In a separate agreement, the Company is supporting the
development of a state-of-the-art digital dental X-ray system which is expected
to be marketed in late 1998.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS. This press release includes
"forward-looking statements" within the meaning of Section 27A of the
Securities Act of 1933 ("Securities Act") and Section 21E of the Exchange Act
of 1934 (the "Exchange Act"). Although the Company believes that the
expectations reflected in such forward-looking statements are reasonable at
this time, it can give no assurance that such expectations will prove to have
been correct. Forward-looking statements in this press release include the
Company's statements that (or to the effect that) (i) the Company will file for
a 510K notification with the Food and Drug Administration ("FDA") within the
next two weeks, (ii) that the Company could receive a 510k notification from
the FDA without undue delays, (iii) that the Company expects to introduce the
Apollo 95E in the United States and Canada to replace the Apollo 9500, and (iv)
that the Apollo 95E will prove to be a satisfactory replacement for the Apollo
9500. These and other forward-looking statements involve numerous risks and
uncertainties. The process of obtaining required regulatory clearances or
approvals can be time-consuming and expensive, and compliance with the FDA's
regulatory requirements can be burdensome. Moreover, there can be no assurance
that the required regulatory clearances will be obtained, and those obtained
may include significant limitations on the uses of the product in question.
Also, the success of the Apollo 95E and its adequacy as a replacement for the
Apollo 9500 are subject to risks and uncertainties including (i) the ability of
the Company to forecast market trends and preferences and adapt the Apollo 95E
to market requirements, (ii) the ability of the Company to develop and
implement a manufacturing capability for the Apollo 95E in the United States,
and (iii) the rapid technological change that is a characteristic of the dental
device market may render existing products, or products under development,
obsolete or unmarketable. As a result of these factors and other important
risks and uncertainties described in the Company's most recently filed Form
10KSB report which should be read in conjunction herewith, copies of which are
available from the Company's Investor Relations Department, actual results may
differ materially from those contemplated by the forward-looking statements
set forth herein. The Company expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any statement
herein or to reflect any change in the Company's expectations or any change in
events, conditions or circumstances on which any such statement is based.
