All references in this report to “Milestone Scientific,” “us,” “our,” “we,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., Milestone Advanced Cosmetic Systems, Inc., Milestone Medical, Inc. and Milestone Education LLC (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: C 

 

Milestone Scientific was incorporated in the State of Delaware in Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery device, using , a single use disposable handpiece. The device is marketed in dentistry under the trademark and and in medicine under the trademark is suitable for all dental procedures that require local anesthetic. is suitable for many medical procedures regularly performed in Plastic Surgery, Hair Restoration Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedics and many other disciplines. The dental devices are sold in the United States, Canada and in other countries. To date there have been  () medical devices sold in the United States and limited amounts sold internationally, although certain medical devices have obtained CE mark approval and can be marketed and sold in most European countries. In Milestone Scientific received (k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the® Epidural Computer Controlled Anesthesia System (“Epidural”).

 

During Milestone Scientific filed for (k) marketing clearance with the FDA for both intra-articular and epidural injections with the CompuFlo® Computer Controlled Anesthesia System.  In the FDA approved the® Epidural Computer Controlled Anesthesia System for epidural injections. Milestone Scientific is in the process of introductory meetings with medical device distributors within the United States and foreign markets. Milestone Scientific’s immediate focus is on marketing its epidural device throughout the United States and Europe.

 

In we received notification from the FDA that based upon the (k)-application submitted for intra- articular injections, we did adequately document that the device met the equivalency standard required for (k) clearances. Following consultation with the FDA Office of Device Evaluation, we intend to file a new (k) application for the device in

 

In Milestone Scientific Inc. received a letter from NYSE American LLC (the “Exchange”) stating that the Company was in compliance with the continued listing standards as set forth in Section(s) (a)(i), (ii), and (iii) of the NYSE American Company Guide (the “Company Guide”).On the Company submitted a plan of compliance (the “Plan”) to the Exchange addressing how it intends to regain compliance with Section(s) (a)(i), (ii) and (iii) of the Company Guide by

 

On the Company received a letter from the Exchange stating that the Company’s Plan has been accepted by the Exchange. The Company is still in compliance with Section(s) (a)(i), (ii) and (iii) of the Company Guide and its listing on the Exchange is being continued pursuant to an extension granted by the Exchange.