The Board of Directors of Milestone Medical Inc. (WAR: MMD, the Company, the Issuer), today provided a business update for the first quarter ended March 31, 2015.
The Company’s focus in 2015 has been commercializing the epidural and intra-articular (“IA”) instruments. The Issuer has been in active discussions with distributors in a number of countries in Europe. In March the Company signed first exclusive European distribution agreement for the epidural instrument in Poland with TRIMED Sp.z.o.o., one of the largest distributors of diagnostic equipment in Poland. The Issuer looks forward to announcing similar agreements in other European markets this year. At the same time, the Company is introducing the epidural instrument to key opinion leaders in Poland and other target European markets to help demonstrate and publicize the efficacy of the instrument. Upon completion of these pilot programs and the additional validation that the Issuer anticipates will come from the U.S. clinical trials, the Company expects to commence full scale commercialization of the epidural instrument.
Multi-site clinical trials of the Company’s epidural instrument are underway in the U.S. and the Issuer looks forward to the conclusion of these trials later this year, which the Company expects will be a catalyst for full commercial launch with both international and U.S. distribution partners. In the short time since the Company’s FDA registration approval to commence with the clinical trials, over 100 clinical trial participants have completed the clinical trial procedures and the estimate is that 400 clinical trial participants will be in the study. The Issuer will keep investors informed as it reaches benchmarks in terms of new enrollees. Upon successful completion of the clinical trials and statistical analysis of the studies, the Issuer will return to the FDA for final marketing clearance. The U.S. epidural market is estimated at over $7 billion annually and over 2.4 million women in the U.S. receive epidurals while in labor each year with another 1.6 million women who give birth choosing not to have an epidural, mainly due to safety concerns. In Europe, the addressable market for epidurals is estimated to be even larger than the U.S. The Company continues to advance the intra-articular instrument as well; however it is difficult to accurately predict the exact timing as the U.S. regulatory process is outside of the Company’s control.
The Company currently remains focused on uplisting from the NewConnect Market to the Main Market of the Warsaw Stock Exchange. The Issuer believes transitioning to the Main Market will help increase awareness and expand the number of potential investors in the Company. At the same time, Milestone Medical Poland will apply for a variety of grants in Europe, which would help the Issuer to expand both its production as well as its R&D capabilities in Europe.
The Issuer is now in the development stage, which entails ongoing expenditures for regulatory approval and marketing of its medical instruments. However, the Company continues to carefully manage its expenses. In addition to the capital the Issuer has raised, Milestone Scientific has extended a $2 million line of credit, which provides the Company additional working capital to execute its business model and further reinforces Milestone Scientific’s confidence in the Issuer’s strategy.
The Company reminds investors that executive management team of the Issuer will host a conference call at 2:30 p.m. Central European Time (8:30 a.m. Eastern Time), on Thursday, May 28, 2015. The conference call can be accessed via a live Internet webcast on the Company's website at www.medicalmilestone.com. A webcast replay of the conference call will be accessible on the Company’s website at www.medicalmilestone.com for 90 days.
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