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KOMISJA NADZORU FINANSOWEGO |
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Raport bieżący nr |
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2020 |
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Data sporządzenia: |
2020-01-11 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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Reporting Ninth Published Study Reinforcing Efficacy of CompuFlo Epidural Instrument
as an Objective Tool to Identify the Epidural Space and Reduce Risk of Accidental
Dural Puncture
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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 a new simulation study published in Anesthesiology Research & Practice,
in an article entitled: “Epidural Needle Extension through the Ligamentum Flavum Using
the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique:
A Simulation Study."
The study verifies that the CompuFlo® Epidural System _“CompuFlo"_ helps anesthesiologists
to identify the epidural space with improved accuracy and less variation thus limiting
over-advancement of an epidural needle that can lead to complications when inserting
an epidural needle. Easier identification of the epidural space is essential to
reducing the number of epidural attempts and risk of accidental dural puncture.
As reported in the article, accidental dural puncture is particularly troublesome
in the obstetric population as more than half of all patients who experience accidental
dural puncture with epidural needles may eventually develop a post-dural puncture
headache. The article further reports that the overall quality of evidence for preventive
measures is generally weak, and therefore good knowledge of lumbar anatomy together
with a carefully performed technique are extremely important.
The simulation study evaluated the final position of a Tuohy epidural needle after
penetration of analogue ligamentum flavum during the identification of the epidural
space. Fifty-two expert anesthesiologists compared the use of CompuFlo® Epidural
Instrument versus their standard loss-of-resistance technique. The results of the
study demonstrated that an epidural technique performed with CompuFlo® resulted in
very low variability between anesthesiologists, in which the needle was positioned
in a safer location after entry into the epidural space. In comparison, using the
standard loss-of-résistance technique the epidural needle was found to have greater
variability in its final position as well as shown to be over-advanced into the epidural
space when compared to the CompuFlo® Epidural Instrument.
The Board of Directors of the Company believes that the ninth published study further
validates the CompuFlo® Epidural System’s ability to safely and effectively identify
the epidural space. The unique computer-controlled real-time pressure sensing technology
provides anesthesiologists an objective and quantifiable technique to build confidence.
The CompuFlo® Epidural Instrument gives anesthesia providers objective pressure and
fluid measurements to verify the epidural space has been reached. This real-time Dynamic
Pressure Sensing technology® reliably differentiates true from false loss of resistances.
As noted in the article, the authors are not aware of any other devices on the market
that can effectively distinguish between a true loss-of-resistance and a false loss-of-resistance
as demonstrated by the CompuFlo® Epidural Instrument. CompuFlo can connect to glass
or plastic LOR syringes so the anesthesia provider will receive additional objective
information in real-time without sacrificing their LOR technique.
Study investigators include, Alessandra Coccoluto, Matteo Velardo, and Emanuele Capogna
from the European School of Obstetric Anesthesia, Maternal Neonatal Simulation Centre,
in Rome, Italy. Dr. Capogna is a Advisory Board Member of Milestone Scientific, Inc.,
the majority shareholder of the Issuer.
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RB_ASO: Reporting Ninth Published Study Reinforcing Efficacy of CompuFlo Epidural Instrument
as an Objective Tool to Identify the Epidural Space and Reduce Risk of Accidental
Dural Puncture 
