|KOMISJA NADZORU FINANSOWEGO|
|Raport bieżący nr||7||/||2019|
|Skrócona nazwa emitenta|
|Milestone Medical Provides Year-End Update on Commercial Rollout of CompuFlo® Epidural System|
|Art. 17 ust. 1 MAR - informacje poufne.|
| The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”), today announced significant progress over the past year, setting the stage for the commercial rollout of the CompuFlo® Epidural System in 2020, which The Issuer believes will be a turning point for the Company. The primary focus of the Issuer in 2019 was successfully trialing CompuFlo® Epidural System in multiple hospitals and medical schools—placing the system with key opinion leaders, continuing important clinical studies and working with anesthesiologists in the U.S. and Europe. This was a necessary first step to establish credibility before these institutions would formally adopt and begin broader deployment of the CompuFlo® Epidural System. At present, the Company has two hospitals purchasing our disposables with many more trialing our system. Ospedale “Pugliese Ciaccio” di Catanzaro is the first hospital in Italy to use CompuFlo for all epidurals in labor and delivery following several extensive trials in Italy. The instrument was selected for its real-time, objective verification that can help reduce failure rates, which require further treatment and interventions. The Issuer is pleased to report the feedback thus far has been positive and the CompuFlo® Epidural System has exceeded the expectations with over two thousand successful procedures to date. This is a significant achievement compared to the traditional loss of resistance technique, which has a high associated medical risk and morbidity. Given the success, and consistent with the rollout strategy, the Company is in the final stages of several important commercial agreements and look forward to providing further updates in the weeks ahead.
Going forward, the commercial rollout strategy involves several key steps. Firstly, the Issuer is building upon the nine completed and published clinical studies and have begun meeting with Group Purchasing Organizations (GPO) in order to obtain approval of the CompuFlo® Epidural System within their facilities. Some of these GPOs have between 3,000 to 5,000 hospitals within their network. Getting this approval should shorten the sales cycle and open the Company up to large markets. Part of that GPO strategy was getting on the federal schedule, which the Company achieved through the contract with RedOne Medical Inc., which allows the Issuer to sell into all federal medical facilities.
Secondly, the Board of Directors of the Company is meeting with insurance carriers to garner their support on making the CompuFlo® Epidural System the preferred technique for performing epidural injections. This is based on the strong clinical data showing a 100% reduction in epidural punctures and complication rates by using the CompuFlo® Epidural System, as seen in the Hidalgo study published in the Open Journal of Anesthesiology, October 2019, in which 600 cases were completed without a single dural puncture. The Issuer believes that this and several other studies have proven the validity of the CompuFlo® Epidural System, which not only benefits patients but also should lower the cost associated with treating these complications. Up until now, there have been no other available procedures in the labor and delivery setting since 1921. The Company can now demonstrate a significant economic value proposition to both of these entities.
Given the positive feedback thus far, the Board of Directors of the Issuer is very encouraged for the future of the Company. While the Board of Directors of the Issuer believes that its system can be used for a variety of epidural procedures and other medical applications, the initial focus is on the labor and delivery market. With close to four million births in the U.S. each year, the Board of Directors of the Issuer believes that the risk factors and potential liability associated with the traditional loss of resistance technique, make this market ideally suited to new technologies. In terms of the broader epidural market, over $5 billion is spent annually on epidural injections in the US alone, with over 11 million epidural procedures performed each year in the US and over 30 million worldwide. The Board of Directors of the Issuer would like to personally thank all shareholders for your continued support and look forward to an exciting year in 2020.
|MESSAGE (ENGLISH VERSION)|
|PODPISY OSÓB REPREZENTUJĄCYCH SPÓŁKĘ|
|Data||Imię i Nazwisko||Stanowisko/Funkcja||Podpis|
|2019-12-19||Joseph D'Agostino||Chief Financial Officer||Joseph D'Agostino|