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DOBI Medical International Releases Clinical Paper on ComfortScan™ System Research Studies

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Preliminary Results from Two Data Interpretation Methods for the ComfortScan™ System

Mahwah, NJ, September 16, 2004 – DOBI Medical International, Inc. (DBMI.OB) released a paper today compiling the results from company sponsored research studies at four clinical sites over a 10-month period. The purpose of the studies was to evaluate the possibility of breast cancer in women who had suspicious mammograms. As a result, the findings from these studies suggest that the ComfortScan™ system could be effective in delineating malignant from benign tissue in the breast and thus improve breast cancer diagnosis efforts.
“These promising results underscore the potential role the ComfortScan™ system can play in identifying suspicious breast lesions when used in conjunction with other diagnostic methods,” said Phillip C. Thomas, DOBI Medical’s Chief Executive Officer.
A total of 245 scans were acquired with prototype ComfortScan systems from March 2003 to January 2004. The scans were collected from women who had a suspicious finding on their mammograms and were being further evaluated for possible breast cancer. The scans were collected at clinical sites from four countries (Italy, France, Spain and United States).
Patient results were screened to adjust for current hardware and software upgrades and for the most recent physician reading and interpretation rules. The 68 remaining scans, which reflected the current improvements to the device, were then audited to ensure that appropriate clinical information was available. The 68 scans were then interpreted in a blinded read using two methods: a manual physician reading approach followed by an advanced computer assisted reading technique.
Using the manual reading approach, the sensitivity (the measure of the number of patients who truly have cancer who test positive) obtained by the blinded reader was 98 percent and the specificity (the number of patients who do not have the disease and tested negative) was 63 percent.
A second, computer-aided interpretation technique was developed and tested. This method relied on a computerized mapping of regions that have suspicious temporal waveforms. The physician manually positioned a cursor over a preliminary area of suspicion mapped by the computer. Based on a predetermined level-of-suspicion threshold, a “malignancy” score was obtained from the computer. This computer-aided method is less operator dependent for reader interpretation and is expected to require less training and expertise than the manual method.
The sensitivity and specificity obtained by this method were comparable to the manual method at 92% and 63% respectively. DOBI Medical anticipates that the computer-assisted method will continue to improve in both sensitivity and specificity as new cases are used to further refine the system’s ability to identify suspicious areas. This should decrease operator variability and improve the consistency of results of the ComfortScan system in the future.
“Reducing operator variability and image review time are major goals for us because of the high volume of cases and significant workflow issues associated with breast disease diagnosis,” said Denis O’Connor, Senior Vice President for Sales, Marketing and Service. “A recent study published by the Agency for Healthcare Research and Quality showed that in mammography, radiologists varied widely in their diagnostic interpretations and recommendations for additional screens and biopsies. It is our goal that the ComfortScan software will aid technicians in providing consistent, accurate and more direct readings.”
The clinical research paper has been posted on the company website and may be accessed at igaot.pt under the “Clinical” tab.
 

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, while it is not possible to predict or identify all such risks, uncertainties, and other factors, 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 and commercial availability in the U.S. cannot be assured; (note: other medical device imaging companies have recently experienced delays in seeking FDA final approval);
• 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 United States and foreign government regulations, and related industry regulations and standards;
• delays in the manufacturing process caused by our inabilities or the inabilities of our subcontractors to timely meet our specifications;
• our ability to establish and maintain international and domestic distribution networks;
• our ability to meet the quality standards and requirement to maintain our CE Mark and ISO certifications, and successfully pass periodic FDA inspections of our facilities and the ComfortScan system;
• our ability to successful verify and validate our manufacturing processes and the ComfortScan system and its various hardware and software components in accordance with current good manufacturing practices and federal quality system regulations;
• our ability to be granted licenses from the FDA to export the ComfortScan system to certain international markets;
• our ability to timely ship and export our products to certain international markets;
• the acceptance and use of our ComfortScan system by physicians, imaging clinics, and patients both in international and domestic markets;
• existing or new competitors developing superior diagnostic imaging technologies;
• our ability to meet the performance milestones and obtain the funding to close on the second tranche of the private placement we completed in December, 2003;
• the success of our investor relations program to create and sustain interest and liquidity in our stock, which is thinly traded over the counter;
• our ability to obtain third party reimbursement from government and private payers; and
• our ability to compete on price and quality.
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 may 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 and consider, including our 2003 Annual Report on Form 10-KSB, our Second Quarter Report, 2004 ended on June 30, 2004 on Form 10-QSB, and our Registration Statement on Form SB-2 filed on September 14, 2004 and pending SEC review, all of which may be accessed from our website at igaot.pt. 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: 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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