Computer Vision Systems Laboratories Corp.
OTC Bulletin Board : CVSL

August 03, 2011 08:00 ET

Computer Vision Systems Laboratories Corp. (Formerly Cardio Vascular Medical Device Corp.) Enters Into an Agreement to Be the Exclusive Supplier of the Sentinel BreastScan

In the US and Throughout the World

BOCA RATON, FLORIDA--(Marketwire - Aug. 3, 2011) - Computer Vision Systems Laboratories Corp. (OTCBB:CVSL), [Formerly known as Cardio Vascular Medical Device Corp., changed its name effective June 26, 2011] announced today that it has executed an agreement with Infrared Sciences Corp. to license the rights, title and interest in the intellectual property surrounding the Sentinel BreastScan. This agreement will give Computer Vision Systems Laboratories ("CVSL") exclusive rights to manufacture and supply the system throughout the world. It will also give CVSL the rights to the system's FDA 510k clearance and to transfer its CE Mark for marketing within the European Union. The Company filed an 8k with the SEC detailing the agreement on July 14, 2011.

In addition, the Company will continue to develop the prototype and market for its patented guidewire technology. The Company plans to attempt to develop a valid prototype and if successful conduct trials in medical clinics and/or hospitals under an FDA investigational device exemption. If positive results are obtained the Company will seek to start formal trials under an IRB approved protocol. In parallel the Company will attempt to obtain an FDA 510k for the device and select suitable manufacturers that can manufacture the device. If FDA 510k approval is obtained the Company will seek to license the related technology to strategic partners that can manufacture and/or distribute the guidewire.

About the Sentinel Breast Scan

The Sentinel BreastScan is an advanced non-invasive infrared breast imaging system used as an adjunctive modality by doctors specializing in breast imaging and breast cancer treatment. The system helps fill the void in modalities that can especially benefit young women.

Utilizing infrared imaging and proprietary software employing artificial intelligence techniques, Sentinel BreastScan™ is designed to be used as an adjunctive test with mammography, ultrasound or clinical examination for the early detection of breast cancer. It is an FDA- 510k cleared, non-invasive touchless procedure offered to women of any age, to help determine current breast health. Test results are immediately available in the form of a fully-interpreted, objective report, to assist in the doctor's determination of breast health.

The Sentinel BreastScan's ease of use and proprietary software provides the doctor with physiological breast data, which can provide very early, indirect indications of areas of concern, as well as pinpointing the location of anomalies. This differs from the anatomical data provided by mammography, ultrasound or MRI, which require that any anomaly be sufficiently developed to be physically detectable.

The Sentinel BreastScan™ is also a beneficial early detection method for young women of the age where detection is typically limited to palpation through self breast exams (SBE) or clinical breast exams (CBE), because cancers detected only through palpation are usually more advanced and therefore more threatening to the patient's health.

The Sentinel BreastScan does not replace mammography or ultrasound, nor is it intended to stand alone as a single test that can determine overall breast health. It can greatly improve the efficacy of those technologies by drawing attention to areas standard mammograms might miss such as areas within dense breast tissue or by localizing areas to be further investigated using ultrasound or MR technology.

We also plan to expand the role of our infrared imaging technology, in accordance with our FDA 510k, "indications for use" and devote R&D resources to the detection of skin cancer. Skin cancer has no approved imaging modalities and is detected by visual observation by a dermatologist followed by subsequent biopsy of suspicious lesions. Our early research has shown the ability of our technology to detect certain invisible skin cancers.

About the Maneuverable Guidewire

This guidewire (US Patent 7,141,024 Nov 28, 2006) is unique, easy to use, and intended for use in all PTCA procedures. The maneuverable coiled guidewire is based on the "Buckling" theory in which the tip is bent according to the force applied to it. It is made of a super elastic NiTi (nickel titanium) PTFE (Teflon) coated coil and a 0.15mm wire disposed in it. The distal end of the coil is treated in such a way that when the inner wire is pulled the distal tip buckles and bends accordingly. This feature will allow the doctor to easily maneuver through the most tortuous vessels.

About Computer Vision Systems Laboratories

Computer Vision System Laboratories Corp, was formerly named Cardio Vascular Medical Device Corp., and is currently traded on the OTC BB under the symbol CVSL.OB. The Company is not generating any revenue at this time, either from the Sentinel BreastScan or from its guidewire patent. New funding is critical to the future growth of the company. If funds are secured, the Company will identify and hire additional management and marketing executives, as well as customer service personnel. It will establish operations in Florida and once all required systems are operational, it will commence marketing of the Sentinel BreastScan system. The Company plans to lease the Sentinel BreastScan directly to doctors and other qualified medical professionals through a third party leasing company.

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