UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 

 

Date of Report (Date of earliest event reported) March 10, 2016 (March 8, 2016)

 

MEDIFIRST SOLUTIONS, INC 

(Exact name of registrant as specified in its charter)

 

Nevada   000-55465   27-3888260
(State or other   (Commission File Number)   (IRS Employer
jurisdiction incorporation)       Identification No.)
         
4400 Route 9 South, Suite 1000, Freehold, NJ   07728
(Address of principal executive offices)   (Zip Code)

 

Registrant's telephone number, including area code: (732)-786-8044

  

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

  
 

 

Section 7-           Regulation FD

 

Item 7.01            Regulation FD Disclosure

 

On March 8, 2016, Medifirst Solutions, Inc. (the “Company”) issued a press release updating shareholders on the progress of the Company’s Premarket Notification 510(k) submission to the U.S. Food and Drug Administration for the Company’s “The Time Machine” Series Laser. In the press release, the Company’s Chief Executive Officer, Bruce Schoengood, also announced that the Company entered into an agreement allowing the Company to license other medical and cosmetic applications of the laser series for future commercialization and FDA 510(k) submissions.

 

A copy of the press release is attached herewith as Exhibit 99.1.

 

The information in this Item 7.01 disclosure, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section. In addition, the information in this Item 7.01 disclosure, including Exhibits 99.1, shall not be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Section 9-          Financial Statements and Exhibits  

 

Item 9.01 Exhibits

 

Exhibit No.   Description
     
99.1   Press Release dated March 8, 2016

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. 

  MEDIFIRST SOLUTIONS, INC.
   
Dated: March 10, 2016 By:  /s/ Bruce Schoengood
   

Bruce Schoengood

President and Chief Executive Officer

  

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Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Contact: Investor Relations

Phone: (732) 786-8044

Email: info@medifirstsolutions.com

Website: www.medifirstsolutions.com

 

 

MEDIFIRST SOLUTIONS ANNOUNCES

EXPANSION TO THE TIME MACHINE LASER SERIES 

 

Freehold, NJ – March 8, 2016 – MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST) (the “company” or “Medifirst”) would like to update its shareholders on the progress of its 510(k) submission, as well as announce a new license agreement for the Time Machine Laser Series.

 

Medifirst is pleased to announce that it has signed an agreement with Laser Lab Corp, a Florida Company, which recently sponsored the IRB (Institutional Review Board) to perform clinical studies for new possible usages, protocols and treatments for the Time Machine Laser Series.

 

Laser Lab Corp has recently completed a clinical study for the Time Machine Laser Series. The company believes that Laser Lab Corp’s completed study for the lasers successfully shows very positive results for patients on whom the laser technology was used to help reduce inflammation, wound healing and pain. The study results demonstrated very promising data suggesting that, by utilizing the The Time Machine Laser technology and protocols for its anti-inflammation ability, the healing of skin wounds was enhanced. Subjects with skin wounds were not only having trouble healing, the areas were extremely inflamed and the patients were in pain. We believe that the lasers and protocols used on the patients not only made the healing process faster, but also reduced the inflammation after each laser treatment. 

 

Commented CEO Bruce J. Schoengood, “We recently memorialized in an executed agreement, Medifirst’s option to utilize all the research and development that Laser Lab Corp has put towards it new clinical trials, including the development and future progress for wound healing applications on other Time Machine Lasers models. This includes both the right to license (i) all existing certifications and completed tests related to the wound healing application and protocols; and (ii) all future applications and additional laser technology. Wound healing, especially as it relates to incisions and procedures preformed in hospitals, surgical centers and doctor’s offices, could present tremendous sales growth for the Time Machine Laser Series. We believe that any surgeon that makes an incision into the skin can use The Time Machine Laser to help prevent infection, promote healing, and reduce scarring, swelling and inflammation.”

Medifirst is also pleased to announce that it has engaged the services of Intertek, a respected worldwide lab and testing facility, to perform rigorous safety and electrical testing on the company’s lasers, as requested by the FDA in its request for more information in support of the company’s 510(k) submission. Commented Alan Schwartz, President of MDI Consultants, the firm engaged to oversee the 510(k) submission, “Once the FDA has provided the company with 510(k) clearance for its recent filing, future filings focused on additional protocols, usages and efficacy would likely be cleared in a significantly faster manner due to our ability to leverage the data and engineering reports used to support the current submission.”

 

Medifirst will release more details of the license agreement in the upcoming days, as well as continue to update its shareholders on the current FDA submission.

 

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.

 

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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.