MILESTONE (MMD): Milestone Medical Inc. Provides Business Update Regarding Launch of New Medical Instruments - raport 5

The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”), today provides a business update on the status of its new medical instruments based on Milestone Scientific’s computer‐controlled injection and drug delivery technology. These new medical instruments represent alternatives to the syringe and are designed to provide cost reductions, safe, controlled painless injections. Below the Company presents the newest statement of the Company’s Management Board regarding launch of the Company’s epidural and intra-articular instruments.

Leonard Osser, Chief Executive Officer of the Company confirmed that the Company is making progress in launching its new epidural and intra-articular (“IA”) instruments. As previously disclosed, the Company has now received CE Mark marketing clearance for its epidural and IA instruments in Europe, which marks an important milestone. Currently, the Company is in the process of pursuing distribution agreements in Europe and anticipates finalizing the first of these arrangements in Europe over the coming months. The Company is also pleased to have announced important distribution agreements for its epidural and IA instruments in China. China represents a sizable market opportunity and these agreements contain minimum purchase requirements following CFDA marketing clearance, illustrating the confidence of the Company’s distribution partner. The Company plans to commence the CFDA marketing clearance process following FDA marketing clearance in the United States.

In the U.S., a major U.S. distributor has been approved for the Company’s epidural instrument. Once the Company receives FDA marketing clearance, the guaranteed minimums will begin with immediate shipments. The Company is now in the process of commencing additional clinical trials, which the Company has confidence will go well, having previously conducted successful clinical trials on epidurals with its predicate instrument which has FDA approval. The Company’s plan is to complete these new clinical studies in the second quarter of 2015. After a statistical analysis of the studies, the Company plans to return to the FDA for final marketing clearance. The Company also continues to advance the IA instrument; however it is difficult to accurately predict the exact timing as the regulatory process is outside of the Company’s control.

Legal basis: Section 3.1 of the Exhibit 3 to the Alternative Trading System Rules “Current and Periodical Information in the Alternative Trading System on the NewConnect Market”.

Osoby reprezentujące spółkę:
Joseph D'Agostino - CFO