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) February 11, 2016

 

MEDIFIRST SOLUTIONS, INC

(Exact name of registrant as specified in its charter)

 

Nevada		333-178825		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 February 11, 2016, the Company issued a press release to 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. The press release is attached as an exhibit to this report.

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. 

Section 9- Financial Statements and Exhibits 

Item 9.01 Exhibits

 

Exhibit No.		Description
99.1		Press Release dated February 11, 2016

 

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: February 12, 2016	By:	/s/ Bruce Schoengood
		Bruce Schoengood President and Chief Executive Officer

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Contact:	Investor Relations
Phone:	(732) 786-8044
Email:	info@medifirstsolutions.com
Website:	www.medifirstsolutions.com

 

MEDIFIRST SOLUTIONS, INC. ANNOUNCES

UPDATE ON FDA SUBMISSION

  

Freehold, NJ – February 11, 2016 – MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST) (the “company” or “Medifirst”) would like to update shareholders on the progress of its 510(k) submission to the Food and Drug Administration (FDA). Commented CEO Bruce J. Schoengood, “We are pleased to inform our shareholders that The Time Machine Infrared Laser System is in the final stages of review for 510(k) approval.” Working with Medifirst’s FDA consulting firm, the company is progressing to gather the information and reports necessary to respond to the request for additional information regarding the hand-held laser system received from the FDA. The deadline for the company to respond is June 2016, but Medifirst anticipates it will have the response completed within the next eight weeks. Upon the completion of the review process to the satisfaction of the FDA, and being awarded 510(k) clearance, Medifirst will begin to sell its laser units across the United States. The company believes that the approval will also jump-start international sales for several distributors in South America and Europe.

 

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. Continued CEO Schoengood, “This technology represents huge potential growth for the company and we have assembled a team of industry professionals that have assisted in the FDA process. The FDA request for additional information is a common request and we are very excited to complete the process. We appreciate the support and patience of our shareholders and the company will be updating shareholders on company events and progress on a regular basis.” Medifirst believes that the laser devices are very unique and offer an easy-to-use, mobile, affordable and effective product for many different health care professionals.The Time Machine Laser System can serve to enhance their current treatment protocols, as well as produce additional revenue streams from the treatment range Medifirst believes The Time Machine Infrared Laser System is capable of delivering to such health care professionals. Please visit www.medifirstsolutions.com and the Medifirst social media pages for more information.

 

About the Lasers

Medical Lasers Manufacturer, Inc. (“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. MLM’s manufacturer consists of a group of engineers with decades of experience in laser research and manufacturing that have been providing customized laser products to a wide variety of universities and labs.

 

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.

 

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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.