Flexpoint Announces Approval for Phase Two Development With Haemoband Surgical, Ltd.
Marketwired
DRAPER, UT--(Marketwired - Jun 25, 2013) - Flexpoint Sensor Systems, Inc. (OTCQB: FLXT), (http://www.flexpoint.com/) recently announced that they had completed all tasks included in the Phase One development of a disposable directional colonoscope application with Haemoband Surgical, Ltd., a Northern Ireland-based company specializing in unique medical technologies. Flexpoint has received approval for and is well into the tasks involved in completion of Phase Two development and expects this phase to be completed during the next 60 days.
Phase Two development includes refinements to the sensor, completion of the development of the electronics package to accompany the scope and colonoscope device, which uses Flexpoint's patented Bend Sensor® technology to monitor the device's position as it is administered to the patient. Phase Two also includes production of working prototypes to be used for in-field testing. Upon completion of the Phase Two testing, Phase Three will begin. It is anticipated that this final phase will include incorporation of any design changes identified in Phase Two and production of several working colonoscope devices and the associated electronics in preparation for completion of medical trials and gathering of the information necessary for completion of the needed governmental certifications. It is anticipated that the device will initially be approved for use in Europe and use will expand to the US market as the necessary approvals are obtained. It is expected that the needed certifications in Europe can be completed by late this year or early next year.
Phase Two will include actual testing of completed systems. This will be followed by field trials of production ready units for completion of the required certifications. Executives from both Flexpoint and Haemoband anticipate that full production could begin as early as late 2013 - early 2014. There is pent-up demand for inexpensive, accurate methods of determining the position of the colonoscopes around the world, and Haemoband's device is the first of its class. Once development and certification of the device is completed it is anticipated that Flexpoint will enter into a long term Manufacturing and Supply Agreement with Haemoband.
As previously announced, testing to date has demonstrated the ability of Flexpoint's sensor to graphically display the shape of the colonoscope and to accurately detect any looping of the scope. With more accurate readings on the position of the device, doctors can minimize complications that can arise from the colonoscope coiling, and can cut down on the time necessary to perform the procedure. With incorporation of the Bend Sensor, the current monitoring equipment can now graphically display the position and formation of the colonoscope. This is a distinct advantage over the capabilities of the existing equipment.
Flexpoint CEO Clark Mower stated, "We are pleased that the results to date have been so positive and that Haemoband has continued to aggressively pursue completion of the development and testing of this device. It has been exciting to see development progress as rapidly as it has. It has been a pleasure to be involved in a synergistic relationship with a progressive and technically advanced company. We look forward to completing the development, testing and medical trial phases during the remainder of 2013, and anticipate that we will have a final product ready for launch during the first half of 2014."
Colin Foster, CEO Haemoband Surgical, said, "It is exciting to see an innovative idea develop into a viable business opportunity. We are very pleased with the performance of our business partner, Flexpoint, and look forward to introducing a valuable range of medical devices which will play an important role in improving patient safety."
Annual demand for colonoscopy ranges from 2.21 to 7.96 million procedures in the United States, according to an article published in MedScape Today magazine. One of the difficulties with the procedure is providing an inexpensive means of locating the exact position of the colonoscopes. With the use of a sensor array and monitoring equipment it appears to be possible to locate the positioning of the colonoscopes.
Because of the demand, and the fact that this is a disposable device, it is anticipated that Flexpoint could begin producing sensors for this device beginning with initial sales early next year and building up to millions of sensors annually as acceptance and incorporation of the sensors occurs. Growth in the medical sensors industry has been robust in recent years, and is expected to reach $12.4 billion by 2016, according to one report (http://www.sensorsmag.com/specialty-markets/medical/news/sensor-integration-medical-devices-growing-8369). Pressure and flow sensors are singled out for particularly strong growth -- which are two of Flexpoint's main competencies. With its Haemoband partnership, Flexpoint gains entry into an industry that will likely factor prominently in its future growth.
About Haemoband Surgical Ltd
Haemoband Surgical was founded in 2005 in Belfast, Northern Ireland, by Essam Ghareeb and Colin Foster. Mr Ghareeb's profession as a lower gastrointestinal surgeon, and Mr Foster's experiences in the medical marketplace and in bringing products to a global market, led to the design, development and launch of Haemoband, the first automatic multi-action, pre-loaded, disposable ligator onto the global market. Haemoband Surgical works to the highest levels of quality possible and has achieved many quality certifications. The most recent of which is a FDA 510k clearance. For further information please visit www.haemoband.com
About Flexpoint: Flexpoint Sensor Systems (OTCQB: FLXT) is an innovative technology firm specializing in developing products that feature the Company's patented Bend Sensor® and related technology. The Bend Sensor® is a groundbreaking sensing solution that is revolutionizing applications in the automotive, safety, medical and industrial industries. The Bend Sensor's single-layer, thin film construction cuts costs and mechanical bulk while introducing a range of functions and stylistic design possibilities that have never before been available in sensing technology. Flexpoint's technology and expertise have been recognized by the world's elite business and academic innovators for over 17 years. The company is setting a new standard for sensing solutions in the "smart" age of technology.
Forward-Looking Statements This press release contains certain forward-looking statements. Investors are cautioned that certain statements in this release are "forward-looking statements" and involve both known and unknown risks, uncertainties and other factors. Such uncertainties include, among others, certain risks associated with the operation of the company described above. The Company's actual results could differ materially from expected results.
