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EXHIBIT 99.1
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NEWS RELEASE
CONTACT:
Fern Lazar/David Carey Michael Jorgensen
President Chief Financial Officer
Lazar Partners Ltd. DOBI Medical International, Inc.
420 Lexington Avenue, Suite 442 201-760-6464
New York, NY 10170 Fax: 201-760-8860
212-867-1762 Phone www.dobimedical.com.
212-867-0856 Fax Trading Symbol: DBMI.OB
www.lazarpartners.com
DOBI MEDICAL INTERNATIONAL REPORTS
THIRD QUARTER, 2004 RESULTS
MAHWAH, NJ, NOVEMBER 4, 2004 - DOBI Medical International, Inc. (DBMI.OB)
announced today its financial results for the third fiscal quarter of 2004,
ended September 30, 2004. The net loss for the third quarter of 2004 was
approximately $2.6 million, or $.07 per share, compared with a net loss of
approximately $1.3 million, or $.07 per share, in the comparable quarter last
year. For the first nine months of fiscal 2004, the net loss was approximately
$5.6 million, or $.15 per share, compared with a net loss of approximately $3.6
million, or $.19 per share, in the comparable nine month period last year. The
third fiscal quarter results include $.75 million, or $.02 per share, in deemed
and accrued dividends associated with the Company's Series A Preferred Share
offering, which was completed during the third quarter.
Phillip C. Thomas, DOBI Medical's Chief Executive Officer commented, "We are
ramping up our manufacturing and international sales activities in accordance
with our established plans which accounts for much of the rise in operating
expenses compared to last year. The company is at an inflection point as we
transition from being strictly an R&D company to a more comprehensive commercial
enterprise, with our initial focus being international business development and
manufacturing. We have also been preparing to begin our final step in the FDA
PMA approval process, which has increased our operating expenses. Taken
together, we continue to be on plan and remain committed to our published
guidance."
During the third quarter, DOBI Medical signed distributorship agreements with
distributors in Italy, Russia, and Canada in addition to other distribution
agreements announced earlier in the year. Additionally, the Company held its
first annual International Symposium in Optical Breast Imaging at Cernobbio,
Italy in September.
On July 30, 2004, the Company completed the sale of its Series A Preferred
Shares, generating approximately $5.16 million in gross proceeds. These funds
are in addition to the $3 million second tranche as part of the December 2003
private placement which the Company believes will become available in the fourth
quarter as it achieves the milestones of selling its first 10
production and revenue producing ComfortScan systems and collecting the first 20
scans in its PMA clinical trial.
On September 27, the registration statement filed by the Company on form SB-2
with the U.S. Securities and Exchange Commission was declared effective. That
registration statement registered all shares issued and issuable in connection
with the company's reverse merger and private placement transaction closed in
December, 2003, and the shares issuable in connection with the Company's Series
A Preferred Share offering completed in July, 2004.
DOBI MEDICAL INTERNATIONAL, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Period from
September 7,
Three months ended Nine months ended 1999 (inception)
September 30, September 30, to September 30,
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2004 2003 2004 2003 2004
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Research and development expenses $527,371 $ 273,414 $1,497,352 $851,471 $8,399,606
General and administrative expenses 566,195 507,081 1,558,986 1,082,992 5,926,212
Clinical program expenses 235,311 90,273 512,064 251,418 2,228,134
Sales and marketing expenses 568,752 84,852 1,281,182 318,633 3,051,725
Interest expense 2,632 370,901 6,772 1,078,301 2,172,428
Interest income (4,478) (48) (8,968) (330) (190,193)
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Net loss (1,895,783) (1,326,473) (4,847,388) (3,582,485) (21,587,912)
Deemed dividend on preferred stock (645,167) - (645,167) - (645,167)
Preferred Stock Dividends (103,227) - (103,227) - (103,227)
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Net loss applicable to common stock $(2,644,177) $(1,326,473) $(5,595,782) $(3,582,485) $(22,336,306)
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Basic and diluted loss per common $(0.07) $(0.07) $(0.15) $(0.19)
share
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Weighted average common shares,
basic and diluted 37,737,073 18,802,410 37,670,271 18,801,021
===============================================================
The unaudited financial information included in this document is intended only
as a summary provided for your convenience, and should be read in conjunction
with the complete consolidated financial statements of the Company (including
the Notes thereto, which set forth important information) contained in its
Reports on Form 10-KSB/A and 10-QSB filed by the Company with the Securities and
Exchange Commission (SEC). All SEC reports are available
on the public EDGAR electronic filing system maintained by the SEC or accessed
through the Company's website, www.dobimedical.com.
ABOUT DOBI MEDICAL INTERNATIONAL, INC.
DOBI Medical is a development stage medical imaging company working to create a
new means for the improved diagnosis of cancer through the detection of abnormal
vascularization ("angiogenesis") associated with tumors. DOBI Medical
International's first application of the technology is the ComfortScan system, a
gentle, non-invasive, and non-ionizing, optical imaging system designed to
assist physicians in the detection and management of breast cancer. The
ComfortScan system is intended to achieve this by providing new,
physiology-based imagery of abnormal vascularization in the breast that are not
readily available today. The ComfortScan system is an investigational device and
is not commercially available in the United States.
CAUTIONARY STATEMENT FOR FORWARD-LOOKING STATEMENTS
Statements contained in this press release may contain information that includes
or is based upon certain "forward-looking statements" relating to our business.
These forward-looking statements represent management's current judgment and
assumptions, and can be identified by the fact that they do not relate strictly
to historical or current facts. Forward-looking statements are frequently
accompanied by the use of such words as "anticipates," "plans," "believes,"
"expects," "projects," "intends," and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties, and other factors,
including without limitation, those relating to our ability to timely and
successfully complete our patient clinical trials; our ability to timely and
successfully complete and submit our premarket approval application to the FDA;
the timely and final approval by the FDA of our ComfortScan system as a adjunct
to mammography, which approval in the U.S. cannot be assured; our ability to
secure the additional financing adequate to execute our business plan; the
success of product development and research efforts; our ability to timely meet
U. S. and foreign government laws and industry standards; our ability to meet
U.S. and foreign medical device quality regulation standards required to
maintain our CE Mark, ISO, UL and FDA export certifications; our ability to
timely deliver our products into international markets; the acceptance and use
of our ComfortScan system by physicians, imaging clinics, and patients; our
ability to meet the performance milestones and obtain the funding to close on
the second tranche of the private placement completed in December, 2003; and our
ability to obtain third party reimbursement from U.S. and foreign government and
private payers.
Any one of these or other risks, uncertainties, other factors, or any inaccurate
assumptions may cause actual results to be materially different from those
described herein or elsewhere by us. We caution readers not to place undue
reliance on any such forward-looking statements, which speak only as of the date
they were made. Certain of these risks, uncertainties, and other factors are
described in greater detail in our filings from time to time with the Securities
and Exchange Commission, which we strongly urge you to read and consider,
including our 2003 Annual Report on Form 10-KSB/A and our Registration Statement
on Form SB-2 declared effective September 27, 2004, all of which may be accessed
from our website at www.dobimedical.com. Subsequent written and oral
forward-looking statements attributable to us or to persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements set forth
above and elsewhere in our reports filed with the Securities and Exchange
Commission. We expressly disclaim any intent or obligation to update any
forward-looking statements.