SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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): January 11, 1999
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-12850 13-3152648
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) 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
Reference is made to the press release of Registrant, issued on January 11,
1999, 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.
January 12, 1999 Dental/Medical Diagnostic Systems, Inc.
By: /S/ STEPHEN ROSS
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Stephen F. Ross
Chief Financial Officer
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EXHIBIT INDEX
EXHIBITS
99.1 Press Release dated January 11, 1999
EXHIBIT 99.1
FOR IMMEDIATE RELEASE
CONTACT:
Stephen D. Axelrod, CFA
Robert H. Gurevitch, President & CEO Nancy S. L. Block
Stephen F. Ross, Vice President & CFO Susan T. Bolen (Media)
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. WOLFE AXELROD ASSOCIATES
(805)381-2700; (805)374-1966(fax) (212)370-4500;(212)370-4505(fax)
e-mail: [email protected] e-mail: [email protected]
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. ANNOUNCES
FILING FOR 510(k) NOTIFICATION FOR DIGITAL X-RAY SYSTEM
WESTLAKE VILLAGE, CA., JANUARY 12, 1999 -- DENTAL/MEDICAL DIAGNOSTIC SYSTEMS,
INC., (NASDAQ: DMDS, DMDSW) today announced that it has submitted its filing for
510(k) notification with the United States Food and Drug Administration (FDA)
pursuant to Section 510(k) of the federal Food, Drug and Cosmetic Act for its
new state-of-the-art digital radiography system. While the Company cannot be
assured of obtaining 510(k) notification, the Company and its regulatory experts
believe that if the Company is able to obtain 510(k) notification for the
digital radiography systems, such 510(k) notification should require
approximately sixty to ninety days.
The Company believes that DMDS' digital radiography system offers superior image
quality to digital X-ray systems currently available in the market, is expected
to be offered at an attractive price point, and will use sensors that will be
available in three sizes, all thinner and more comfortable than those offered by
the current market leaders. Digital radiography systems permit real-time dental
X-ray images that can be stored and recalled when needed and can be
electronically delivered to insurance providers. At the same time, it eliminates
the need for film and reduces radiation by up to 90%.
The Company today announced that Dr. Jack Preston, a member of its Board of
Directors, has accepted a full time position as Executive Vice President in
charge of digital radiography systems. Dr. Preston has 40 years of experience
practicing dentistry and is affiliated with the prestigious University of
Southern California School of Dentistry as a tenured professor and Chairman of
the Department of Oral and Maxillofacial Imaging. In light of Dr. Preston's
extensive background and expertise in digital radiography systems, his decision
to join DMD highlights the Company's preeminent status within the dental
community.
Robert H. Gurevitch, Chairman and CEO of Dental/Medical Diagnostic Systems,
Inc., stated, "We are looking forward to having Dr. Preston help to bring our
digital radiography system to the dental market. We believe the acceptance rate
of this product is rapidly increasing and our unit will represent a substantial
technical improvement over other digital radiography systems currently
available. The extremely positive review of our digital radiography system by
professional dental experts supports our enthusiasm for this product, and we
plan to launch it internationally, possibly as soon as the end of the first
quarter. Marketing this device domestically will begin as soon as FDA
notification pursuant to a 510(k) filing is granted."
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-MORE-
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. designs, develops, manufactures and
sells high technology dental equipment. Currently, the Company sells an
intraoral camera system known as the TeliCam System and a dental office
networking system known as inTELInet. The Company has developed its own
technology for a tooth whitening and curing system, the Apollo 95E, that began
shipping outside the United States and Canada in the first quarter and
domestically in Q3, 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 SECURITIES 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
COULD RECEIVE A 510(k) NOTIFICATION FROM THE FDA WITHOUT UNDUE DELAYS, (II) THE
COMPANY PLANS TO LAUNCH ITS ADVANCED DIGITAL X-RAY SYSTEM INTERNATIONALLY
POSSIBLY AS SOON AS THE FIRST QUARTER OF 1999 AND DOMESTICALLY IF, AND WHEN,
510(k) NOTIFICATION IS RECEIVED FROM THE FDA, AND (III) THE ADVANCED DIGITAL
X-RAY SYSTEM WILL BE OFFERED AT AN ATTRACTIVE PRICE POINT. 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 ON A TIMELY BASIS OR AT ALL, AND THOSE OBTAINED MAY
INCLUDE SIGNIFICANT LIMITATIONS ON THE USES OF THE PRODUCT IN QUESTION. ALSO,
THE SUCCESS OF THE DIGITAL RADIOGRAPHY SYSTEM DEPENDS UPON, AMONG OTHER THINGS,
THE ABILITY OF THE COMPANY TO (I) FORECAST MARKET TRENDS AND PREFERENCES AND
ADAPT THE DIGITAL RADIOGRAPHY SYSTEM TO MARKET REQUIREMENTS, (II) DEVELOP AND
IMPLEMENT A MANUFACTURING CAPABILITY FOR THE DIGITAL RADIOGRAPHY SYSTEM IN THE
UNITED STATES AND INTERNATIONALLY AND (III) CONTEND WITH THE POSSIBLE ADVERSE
EFFECT OF BUGS AND DESIGN FLAWS INHERENT IN NEWLY INTRODUCED TECHNOLOGIES. AS A
RESULT OF THESE FACTORS AND OTHER IMPORTANT RISKS AND UNCERTAINTIES DESCRIBED IN
THE COMPANY'S MOST RECENTLY FILED FORM 10KSB REPORT AND SUBSEQUENT FORM 10QSB
REPORTS 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.
