Freehold, NJ, Aug. 22, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — MEDIFIRST SOLUTIONS, INC. (MFST) (the “Company” or “Medifirst”), a provider of innovative laser technology with its FDA 510(k) cleared Infrared Time Machine TTML-810/2000 Laser Thermal Therapeutic Device and a provider of Specialty Pharmacy Drug Consulting Services and Distributor of USA Premium Hemp and CBD products available at www.usacbdshopper.com, is pleased to provide a company update.
Medifirst is pleased to announce that they are working with its affiliate and consulting groups in setting up a clinical trial for the treatment in reducing Oral Mucositis that will include three testing locations. Medifirst recently announced a new expansion and direction for its Time Machine Therapeutic Laser for the application of Photobiomodulation (PBM) to treat a side effect of cancer therapy called Oral Mucositis. This would involve adding a new claim and a new name for the laser treatment program via an FDA pre-submission application for the FDA 510(k) cleared Time Machine TTML-8102000 Laser Thermal Therapeutic Device. Discussions are underway with two Universities that have expressed interest to participate. Additionally, Dr. Ronald L. Rubin DMD, an Oral & Maxillofacial Surgeon and the Medifirst Medical Director, will conduct one of the studies in his Florida practice. Dr. Rubin, a Specialist in Head and Neck Cancer, (he was granted an American Cancer Society Fellowship in Head and Neck Cancer at the Tufts-New England Medical Center in Boston) will be setting up an IRB for the treatment protocols and is the Chief Clinical Investigator that will guide the Universities with the treatment protocols and over-seeing the clinical review. It must be noted that the Company cannot guarantee the participation of the Universities until all the details and procedures have been formulated and all terms agreed to.
It is the opinion of the Company that Photobiomodulation is becoming a mainstream treatment modality in the medical community and the FDA 510(k) cleared TTML-810/2000 Infrared laser has shown that its safety and efficiency to meet the proper guideline for a CPT approval process. Although we cannot guarantee a new code will be approved, we believe that the Time Machine TTML-810/2000 Infrared Laser, in the coming months, may receive a CPT code for specific pain treatments. CPT codes are the billing codes used for reimbursement for services and treatments by the healthcare providers.
A Medifirst affiliate partner has previously filed for a $3,000,000 grant to perform a study for home usage (OTC) for the Time Machine TTML-810/2000 Infrared Laser. The company received the first round of comments back from the NIH grant oversight committee and will be submitting its answers back for an October review meeting date. With millions of people suffering from everyday pain, Medifirst considers “home use” a major priority if the laser can be proven safe and FDA cleared for home use. Commented CEO Bruce J. Schoengood, “FDA clearance for ‘home use’ would potentially be one of the biggest markets we can target for our Infrared Laser. The home treatment, as well as in Nursing Homes and Assisting Living facilities, could help people suffering from pain and provide a treatment option in the convenience of their home. Many people are not physically able to travel several times a week to a doctor’s office and it can be a financial burden as well.” Once approved, the patient would receive a prescription and pick up the laser at their doctor’s office or medical supply store. Since the process is ongoing, Medifirst cannot, at this time, guarantee the grant will be approved.
Medifirst anticipates further updates and details regarding these developments in the upcoming weeks and months.
About Oral Mucositis
Oral Mucositis affects about 400,000 patients annually in the United States, affecting their cheeks, lips, gums, inner cavity and the tonsillar region. Treatment options today are rather limited. Patients are usually given pain medication and/or an antiseptic/anti-inflammatory mouthwash. Beyond that, there’s not much doctors can do for the painful condition that, at advanced stages, can inhibit a patient’s ability to eat, speak or maintain health. We believe that laser therapy can be effective in treating Oral Mucositis and the Company anticipates working with industry professionals to advance and explore using laser technology for this condition.
About the Time Machine Laser
The Time Machine Laser is the only all-in-one, affordable, FDA cleared, Infrared, 810nm, 2000mW power, small, hand-held portable laser marketed for pain relief in the U.S. The Time Machine Laser, which has been extensively tested and approved by Intertek for safety and electrical standards, has the power and frequency often found in large and expensive stationary units and at a fraction of the cost. Medifirst Solutions, Inc., in response to its Premarket Notification 510(k) submission for “The Time Machine” Series Laser, received clearance from the U.S. Food and Drug Administration (“FDA”) to market its infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device. The Lasers is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. Visit www.medifirstsolutions.com for more information. Follow on Twitter @Medi_First and for Facebook visit Medifirst Solutions.
About the USA Premium CBD Products
The statements in this press release that relate to the company’s expectations about 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. This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity.
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