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 Devices, 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 minimal sales of the Company’s medical devices in the United States and Europe. 

 

During Milestone Scientific filed for (k) marketing clearance with the U.S. Food and Drug Administration (FDA) for both intra-articular and epidural injections with the ® Computer Controlled Anesthesia System (the “ Epidural System”).  In the FDA approved the Epidural System for epidural injections.  Milestone Scientific is in the process of meeting 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 filed a new (k) application for the device in In the FDA provided Milestone Scientific with a  list of questions on the intra-articular (k) application filed in Milestone Scientific is in the process of reviewing and responding to FDA questions.