FREEHOLD, NJ / ACCESSWIRE / March 22, 2016 / MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST) (the "company" or "Medifirst") would like to update shareholders on the progress of its FDA 510(k) submission for The Time Machine Laser Series.
Medifirst is pleased to announce that it has successfully completed a Skin Surface Temperature Study as requested by the FDA as part of their most recent request for more information. Using live human subjects, the test was required to show that the Time Machine Laser can maintain skin temperature within a specified range of degrees for a specific treatment times and other details as related to the usage on the live subjects. The test was performed by Laser Lab Corp under its approved IRB (Institutional Review Board) status to perform clinical studies for new possible usages, protocols and treatments for the Time Machine Laser Series.
Commented CEO Bruce J. Schoengood, "We are very pleased with the positive results of the Skin Surface Temperature Study and we are excited to complete the one remaining lab test currently being performed by Intertek Labs. We are working very diligently with Intertek and have successfully completed many of the tests as required as part of the EC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility test as requested by the FDA. Once all the test results are completed, we will submit all the data to Medifirst's FDA consultants to prepare and submit the company response." Continued Schoengood, "Although the deadline to respond back to the FDA is June, we are still on schedule to complete our response well in advance of the deadline, and we will continue to update our progress and completion of our response to be submitted back to the FDA."
As recently announced, Laser Lab Corp granted Medifirst Solutions options to license other fields-of-use for the The Time Machine Laser Series line as well as other wavelengths and colors. Furthermore, Laser Lab Corp granted the Company a right of first refusal allowing Medifirst to review and to consider to license other technologies. Laser Lab Corp is working on expanding its multi-site IRB Study nationwide to further its new laser application claims with hospitals and other medical organizations with its laser technology lines.
About Medifirst Solutions, Inc.
Medifirst Solutions, Inc. is a Nevada corporation that is headquartered in New Jersey. The company seeks innovative medical and healthcare products and technologies which are targeted to both medical and healthcare professionals, as well as everyday consumers. Medifirst is developing and establishing both consumer and professional medical cliental that can serve as a pipeline that will allow for distribution of future products and services. For more details visit www.medifirstsolutions.com for more information.
About the Lasers
Medical Lasers Manufacturer, Inc., a Nevada company, ("MLM"), a Medifirst subsidiary, will specialize in producing high quality diode-pumped solid-state lasers. The laser division, including products and treatment programs, will be operated out of MLM. The company's focus is to help patients with specific cosmetic skin conditions, as well as relief of muscle and joint pain and muscle spasm and inflammation. Driven by the huge demand for minimally invasive skin and pain treatments, the global market for medical and therapeutic lasers have been estimated to grow as high as to $4 billion in 2015.
Forward-Looking Statements: The statements in this press release that relate to the company's expectations with regard to the future impact on the company's results from new products in development are forward-looking statements, and may involve risks and uncertainties, some of which are beyond our control. Such risks and uncertainties are described in greater detail in our filings with the U.S. Securities and Exchange Commission. Since the information in this press release may contain statements that involve risk and uncertainties and are subject to change at any time, the company's actual results may differ materially from expected results. We make no commitment to disclose any subsequent revisions to forward-looking statements.
Contact: Investor Relations
Phone: (732) 786-8044
Email: info@medifirstsolutions.com
Website: www.medifirstsolutions.com
