The Board of Directors of Milestone Medical Inc. (WAR: MMD, the Company, the Issuer), today provided a business update for the second quarter ended June 30, 2015.
The Company remains focused on the commercial rollout of the epidural and intra-articular instruments as its top priority in 2015. Specifically, the Issuer is continuing its efforts to identify and meet with distributors in a number of countries in Europe and has made the progress. In June, the Company entered into its second exclusive distribution agreement for the sale of epidural instruments in Italy with Moss S.P.A, one of the leading distributors of diagnostic and specialty surgery equipment in Italy. The fact that this agreement includes 3 year guaranteed minimums reinforces their confidence in the market potential of epidural instrument. In June, the Issuer also commenced first shipments and sales of its epidural instrument to Trimed Sp. z.o.o, one of the largest distributors of diagnostic equipment in Poland, which purchased a small number of instruments for internal use and training purposes as it ramps up for a formal launch later this year. Introducing the instruments initially to key opinion leaders in Poland and other European markets provides important independent validation regarding the instrument’s efficacy and will help drive market adoption. In May, the Company signed a Memorandum of Understanding with Fidia Farmaceutici SpA, a specialty pharmaceutical company based in Italy, for the co-development and manufacture of a custom intra-articular drug delivery instrument for Fidia’s hyaluronic acid formulations. Fidia is one of the leading global manufacturers of hyaluronic acid formulations for joint pains.
The Issuer is also making progress advancing its medical instruments through the FDA regulatory process. The Company is moving forward with U.S clinical trials of its epidural instrument at several premier sites in the U.S. Recently, the Issuer announced successful results of the interim analysis of the COMPASS Study (CompuFlo® Assessment Study). The analysis demonstrated that the instrument correctly identified the epidural space location and clearly achieved the goal set by the FDA IDE Investigational Plan. To date, over 200 participants have completed the clinical trial procedures and the Issuer’s goal is to enroll up to 400 patients at five separate sites. The Issuer expects the clinical trial and accompanying statistical analysis to be completed this year, at which time the Company will return to the FDA for final marketing clearance. The Company anticipates that the additional validation from the U.S. clinical trials will also help accelerate the commercial launch of its medical instruments in Europe.
At the same time, the Issuer is broadening its U.S. distribution strategy beyond the current focus on labor and delivery markets to include a network of regional distribution partners whose strengths include hospitals, clinics and pain management centers. The U.S. epidural market is estimated at over $7 billion annually and in Europe the addressable market for epidurals is estimated to be even larger. Meanwhile, the Issuer 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 and the planned public offering of its shares. The Issuer believes transitioning to the Main Market will help increase awareness and expand the audience of potential investors in the Company. The Issuer is in the final stages of regulatory approval of its Prospectus which funds will be used for the continued expansion of the Company’s sales and marketing initiatives, as well as additional working capital to accelerate the launch of its epidural and intra-articular instruments in Europe. At the same time, Milestone Medical is applying 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.
Despite of the fact that the Issuer reported first revenues, Milestone Medical is still in the development stage as the Company prepares for full commercial rollout of its medical instruments. The Issuer continues to carefully manage its expenses, which are mainly attributable to regulatory approval, pursuing new distribution partners and marketing of its medical instruments. The Issuer believes the $2.0 million line of credit provided by Milestone Scientific reinforces the confidence in the Issuer’s strategy, and should provide the Company sufficient capital to finalize the FDA regulatory approval process.
The Company reminds investors that executive management team of the Issuer will host a conference call at 3:00 p.m. Central European Time (9:00 a.m. Eastern Time), on Thursday, September 3, 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