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KOMISJA NADZORU FINANSOWEGO |
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Raport bieżący nr |
7 |
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2019 |
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Data sporządzenia: |
2019-12-19 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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Milestone Medical Provides Year-End Update on Commercial Rollout of CompuFlo® Epidural
System
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Podstawa prawna |
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Art. 17 ust. 1 MAR - informacje poufne.
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Treść raportu: |
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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.
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