The company's Windows-based ComfortScan 2.0 software suite currently consists of three individual elements, including ComfortScan acquisition software for patient data acquisition, ComfortNet for image database management, and ComfortView for image processing and display, allowing reading and diagnostic interpretation by physicians. Highly sophisticated imaging processing and display capabilities make the image data available to physicians for reading in near real time.
"Completion of this version of the ComfortScan system software suite reflects the company's long-term efforts to make ComfortScan an important tool for improving breast cancer diagnosis", stated Phillip C. Thomas, CEO and Co-founder of DOBI Medical. "The latest clinical test results indicate that physicians using the ComfortScan system on women referred to biopsy can identify cancers that mammography alone may not have visualized. The release of version 2.0 marks the completion of a significant milestone in our preparation for a larger, blinded multi-physician read, a key part of the final submission module of our FDA Pre-Market Approval (PMA) application."
Mr. Thomas added that in order to submit the company's PMA clinical study for FDA approval of the ComfortScan 2.0 system, which is currently planned for the second quarter of this year, important additional work remains to be done to improve diagnostic specificity through continued refinement of ComfortScan reading rules and more physician training on those reading rules.
A. Robert Sohval, PhD, Vice President of Research and Development at DOBI Medical, indicated the new version of the ComfortScan software should aid physicians in a number of additional areas. "The new software advances in ComfortScan image acquisition and processing, with a number of improved image reconstruction techniques, are designed to help improve visualization of potential sites of angiogenesis within the breast", according to Dr. Sohval. "Furthermore, faster set-up time and higher scan acceptance rates will also reduce the time it takes to scan and the need to rescan patients. Physicians will benefit from the ability to more easily retrieve ComfortScan files from the image archive and across a network."
The new software also enables a quick review of colour-mapped images to aid physicians in identifying regions of increased vascularity in the breast. To enhance information flow, images can be easily printed or digitally archived for future use and interpretation, allowing clinicians to manage their databases of these medical images. ComfortScan 2.0 is also now compliant with DICOM 3.0 (Digital Imaging and Communications in Medicine) - a standard for viewing and distributing information in the medical diagnostic imaging industry, and supports Storage Class, Query/Retrieve and Worklist Management.
The company has now enrolled over 1000 patients, at multiple locations across the United States, to take part in its multi-centre clinical trial designed to help determine the efficacy of the ComfortScan system in its prospective role as an adjunct to screening mammography. The company currently anticipates that it will complete patient enrollment during the first calendar quarter of 2006. Most common imaging technologies do not identify angiogenesis, which has been linked in many independent scientific studies to the growth and development of malignant tumours. Therefore, the ComfortScan system will be evaluated, in conjunction with screening mammography, in this PMA clinical study for its potential to improve a physician's ability to accurately identify benign lesions in those cases that are being sent to biopsy based on mammography (specificity). As noted above, improving overall diagnostic accuracy by increasing true negative rates, while maintaining true positive (sensitivity) levels will be necessary for submission of the PMA clinical study to the FDA.
DOBI Medical is a developmental stage, medical imaging company working to create a new means for the improved diagnosis of malignant breast disease through the identification of abnormal vascularization (angiogenesis) associated with tumours. The company'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 identification and management of breast cancer as an adjunct to screening mammography. The ComfortScan system is intended to achieve this by providing new, physiology-based imagery of abnormal vascularization in the breast that is not readily available today.
The ComfortScan system has CE Mark and UL designations, and DOBI Medical is a certified ISO 9001:2000 and ISO 13485:2003 company. The ComfortScan system is not yet commercially available in the United States as it is limited by United States law to investigational use until approved by the FDA, which cannot be guaranteed. Sales of the ComfortScan system to international distributors are limited to sales for investigational use for installation at clinical trial sites.