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DOBI MEDICAL INTERNATIONAL RECEIVES RENEWED
ISO CERTIFICATION AND CE MARK CERTIFICATIONS

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CE Certification Allows Shipment of DOBI Medical’s ComfortScan ™ System to European Union Countries Planned for Q4, 2004

Mahwah, NJ, May 11, 2004 - DOBI Medical International, Inc. (OTCBB:DBMI.OB) announced today that the Company has received renewed European Union Community ISO 9001:2000 and CE Mark certifications in addition to a new ISO 13485 certification that pertains specifically to manufacturers of medical devices. The above ISO certifications, awarded by RWTUV, a European Union certifying registrar, are in recognition of the Company’s adherence to the highest, most recent and up to date comprehensive quality standards in the design and manufacturing of its ComfortScan system at its Mahwah, New Jersey facility.
In order to qualify for the certifications, DOBI Medical International passed a substantive review by RWTUV of its complete Quality System processes and technical file, which demonstrates adherence to the European Union Medical Device Directive. The receipt of ISO 13485 represents DOBI Medical’s compliance with the newest ISO standards for medical device manufacturers.

In the course of this comprehensive audit of DOBI Medical’s design and manufacturing processes, the Company determined that it is in compliance with the Good Manufacturing Processes (GMP) and 21 CFR 820 regulations established by the U.S. FDA. Compliance with these mandates is necessary for the manufacture of DOBI Medical’s ComfortScan system in the U.S. after the Company receives final FDA approval for the device.
The renewal of the ComfortScan system’s Registered CE Mark allows the shipment of the Company’s ComfortScan system to European Union countries, currently planned for the fourth quarter of 2004, subject in some cases to compliance with the local regulations of the European Union countries.

“DOBI Medical International receipt of its necessary ISO certifications and registered CE Mark demonstrates that we are on par with other high-quality medical device manufacturers and adhere to the same stringent quality standards established to govern the design, manufacturing, and sales process”, said Phillip C. Thomas, Chief Executive Officer of DOBI Medical International, “It is a critical step for us in the process of commercializing the ComfortScan system.”

About DOBI Medical International, Inc.
DOBI Medical International 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 non-invasive, non-ionizing, and pain-free 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.

CAUTIONARY STATEMENT PURSUANT TO SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements contained in this press release may contain information that includes or is based upon certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act 1995 relating to the business of DOBI Medical. 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 “anticipate”, “plans”, “believes”, “expects”, “project”, “intends”, or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties, including uncertainties relating to our ability to secure additional financing; success of product development efforts; our ability to timely meet federal, local and foreign government and industry regulations and standards; timely and successful completion of our patient clinical trials and submission of our premarket approval application to the FDA; final approval of our ComfortScan system by the FDA; delays in the manufacturing process caused by our inabilities or the inabilities of our subcontractors to timely meet our specifications; our ability to establish international and domestic distribution networks, our ability to timely export our products to international markets; acceptance and use of our ComfortScan system by physicians, imaging clinics, and patients; our ability to obtain third party payer reimbursement; and our ability to compete on price and quality. Any one of these or other risks and uncertainties may cause actual results to be materially different from those described herein or elsewhere by us. Certain of these risks and uncertainties are or will be described in greater detail in our filings from time to time with the Securities and Exchange Commission, which we strongly urge you to read, including our 2003 Annual Report on Form 10-KSB filed on February 18, 2004. 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 and risk factors 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: Phillip C. Thomas, Chief Executive Officer
201-760-6464
pct@igaot.pt

DOBI Medical International
1200 MacArthur Blvd.
Mahwah, New Jersey 07430
Voice: (201) 760 6464
Fax: (201) 760 8860
e-mail: information@igaot.pt

 
 


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