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DOBI Medical International Announces Registration Statement Deemed Effective

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Mahwah, NJ, September 27,  2004 – DOBI Medical International, Inc. (DBMI.OB) announced today that a registration statement on Form SB-2 filed September 14, 2004 with the U.S. Securities and Exchange Commission covering the resale of 58,030,920 shares by certain stockholders was deemed effective by the U.S. Securities and Exchange Commission at 9:00 a.m. today.
Of the 58,030,920 shares registered, 29,286,754 are currently issued and outstanding. DOBI Medical also registered 19,294,219 shares issuable in connection with the exercise of warrants; 6,000,002 shares issuable if the second tranche of its December 2003 private placement closes, 2,580,667 shares issuable in connection with the conversion of its series A preferred stock, and 869,278 shares in connection with the payment of dividends on its series A convertible preferred shares.
Of the 29,286,754 shares issued and outstanding, approximately 15,652,000 are held by DOBI Medical’s directors and executive officers as well as certain other significant stockholders who previously agreed to lock-up arrangements. These lock-ups generally preclude those individuals from selling any shares of stock for a period of two years, subject to the achievement of certain milestones by DOBI Medical. The remaining issued and outstanding shares now registered are held by other investors. Pursuant to previously agreed lock-up arrangements, approximately 2,896,000 shares held by investors are now eligible for resale under this registration statement. Approximately 671,000 shares of common stock will become eligible for resale each month for the next three months. Thereafter, approximately 1,342,000 shares per month will become eligible for resale until all investor shares are unlocked.
DOBI Medical will receive proceeds only from the sale of shares issuable if the second tranche of the December 2003 private placement closes. The Company will not receive any of the proceeds from any shareholders who may sell their shares, except by those who may exercise warrants.

Phillip C. Thomas, Chief Executive Officer of DOBI Medical stated, “This event marks a significant milestone for our company and shareholders. We continue to make steady progress toward the full implementation of our business plan, including commencing our final PMA clinical trials necessary for FDA acceptance of our PMA application. We are also looking forward to selling and shipping our first production ComfortScan systems in the international market later this year. Our team of dedicated employees is working extremely hard to achieve these results which I am confident will, in time, translate into increasing shareholder value.”

About DOBI Medical International, Inc.

DOBI Medical is a developmental 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. The company's first application of the technology is the ComfortScan™ system, a gentle, non-invasive, non-ionizing, dynamic 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 not readily available today. The ComfortScan system is limited by U.S. law to investigational use within the United States. This product is not yet commercially available in the U.S. and its future availability in the U.S. cannot be assured.


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, our Second Quarter Report 2004 on Form 10-QSB, and our Registration Statement on Form SB-2 declared effective September 27, 2004, all of which may be accessed from our website at 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.



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For further information:
Please contact: Michael Jorgensen, Chief Financial Officer

DOBI Medical International
1200 MacArthur Blvd.
Mahwah, New Jersey 07430
Voice: (201) 760 6464
Fax: (201) 760 8860


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