Computer Vision Systems Laboratories Corp. Enters Into an Agreement With a Leading Guidewire Fabrication Company to Construct a Working Prototype of Our Patented Maneuverable Guidewire
2011-09-21 16:47 ET - News Release
BOCA RATON, FLORIDA -- (MARKET WIRE) -- 09/21/11
Computer Vision Systems Laboratories Corp. (OTCBB:CVSL), announced today that it has entered into an agreement with a leading guidewire fabrication company to construct a working prototype of our patented device. This agreement will give Computer Vision Systems Laboratories ("CVSL") the ability to prove out the design and to conduct demonstrations of the device for other interested parties and potential strategic partners.
If the device is shown to be satisfactory, CVSL will make any refinements as may be necessary and then attempt to e to conduct trials in medical clinics and/or hospitals under an FDA investigational device exemption contingent upon securing adequate working capital. If positive results are obtained CVSL will seek to start formal trials under an IRB approved protocol. In parallel CVSL plans to attempt to obtain an FDA 510k for the device If FDA 510k approval is obtained CVSL plans to seek strategic partners through licensing agreements and joint ventures to manufacture and/or distribute the guidewire.
CVSL as discussed in its prior press release on August 2, 2011, 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 provides Computer Vision Systems Laboratories ("CVSL") with the exclusive rights to manufacture and supply the Sentinel BreastScan 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. On July 14, 2011, CVSL filed an 8k with the SEC detailing the agreement. CVSL is in the process of identifying key individuals that may become members of an expanded management team, once it secures adequate working capital.
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 is designed to allow the doctor to easily maneuver through the most tortuous vessels.
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(TM) 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(TM) 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 Computer Vision Systems Laboratories
Computer Vision System Laboratories Corp, is currently traded on the OTC BB and OTCQB under the symbol CVSL.OB. CVSL 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 CVSL. If funds are secured, CVSL 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. CVSL plans to lease the Sentinel BreastScan directly to doctors and other qualified medical professionals through a third party leasing company.
Contacts:
Computer Vision Systems Laboratories Corp.
Editor
info@cvslab.com
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