FREEHOLD, NJ -- (Marketwired) -- 07/14/17 -- MEDIFIRST SOLUTIONS, INC. (OTC PINK: MFST) (the "Company" or "Medifirst") would like to update shareholders in a Q&A format regarding the status of current sales and operations in connection with its FDA-cleared Infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device. The following questions were selected because they represent the most common questions asked.
What has been accomplished since the Company received its clearance to market the 810 Infrared Laser for the US market?
The FDA does not give advance notice or define a timeline during their evaluation for 510(k) clearance. The process could take any number of months with no guarantee of success. Generally, when 510(k) clearance is granted, an early stage medical device company, such as Medifirst, is required to put together an infrastructure, including (i) new office space, (ii) instituting FDA controls and procedures, (iii) fine-tuning manufacturing, (iv) building and executing on a sales strategies, (v) producing custom-made cases and packaging for the medical device, and (vi) aligning all staffing, consulting and personnel needs. As Medifirst was aware that the FDA time frame was unknown and 510(k) clearance was not guaranteed, it was the Company's best judgment to delay the aggressive expansion of its operations and production before successfully receiving clearance to begin sales. Regarding sales, we presented our laser and established business relationships in Morocco, China, Asia, Mid-East and other international countries and markets. The international markets, although requiring complicated registration processes and ground work, offer the opportunity for large bulk sales which would be very beneficial for the Company's growth. Medifirst believes it has made significant progress in setting up a sales and corporate infrastructure and continues to advance these efforts further.
