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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: |
2020-05-13 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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Publication of Study Validating Efficacy of CompuFlo CathCheck System to Confirm and
Monitor the Placement of an Epidural Catheter
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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 the publication of a study in the Open Journal of Anesthesiology,
in an article entitled, "Confirmation of Epidural Catheter Location by Epidural Pressure
Waveform Recordings by the Compuflo® Cath-Checker System," reinforcing the efficacy
of the CompuFlo® CathCheck™ System to confirm the correct placement and positioning
of an epidural catheter for use during and after an epidural procedure.
For the purposes of this study, the CompuFlo Epidural System utilized the new CathCheck™
technology to combine both objective in-line pressure measurements and detection of
a pulsatile pressure waveform in a single system. This prospective, open trial is
the first study to investigate the capability of the CompuFlo® CathCheck™ System to
detect the pulsatile waveform confirming the correct placement of an epidural catheter,
which provides an important metric in seconds to a healthcare worker in order to determine
if a catheter is functioning properly or not. The current standard-of-care lacks
such an objective means when making this determination and relies primarily on the
administration of a medication through the catheter and then waiting 20 to 40 minutes
for a patient’s response to determine if that catheter is dysfunctional or not. In
contrast, the CathCheck™ system provides the important information in real-time to
make the appropriate determination, allowing greater efficiency and improved patient
care.
The study received formal approval from the Institutional Ethics Committee of Lazio
1 in Roma, Italy. The study was performed on 30 epidural catheters previously used
for post cesarean analgesia and about to be removed. All the patients were given 5
mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline,
the catheter was connected to CompuFlo® CathCheck™ System to record the occurrence
of pulsatile waveforms or their disappearance during its removal. Pulsatile waveforms
_originating from the spinal cord and transmitted through the dura in synchrony with
heart rate_ were observed in all the catheters properly located in the epidural space
and disappeared when the catheter was extracted from the epidural space. The pulsatile
pressure waveform analysis through the epidural catheter resulted in a sensitivity
of 100%, a positive predictive value of 100%, a specificity of 100% and a negative
predictive value of 100%.
The Board of Director of the Company is honored to have the results of this study
featured in this journal with its global audience of anesthesiologists. The findings
of this open trial further validate the ability of the CompuFlo® CathCheck™ System
to safely and accurately identify location of the needle or catheter in the epidural
space. Publications such as these serve to highlight the benefits of our technology,
which should help drive broad adoption among leading anesthesia providers around the
world. The unique computer-controlled real-time pressure sensing technology combined
with pulsatile pressure waveform measurement has the potential to transform the administration
of epidural procedures and subsequent monitoring of catheter placement following an
epidural procedure by confirming the placement of a catheter within seconds, versus
20–40 minutes using conventional methods. The Board of Director of the Company believes
the CathCheck™ feature will help to significantly reduce time and cost for the institution
by providing a more reliable way to re-check the catheter throughout the day to ensure
that the catheter has not been displaced.
Study investigators include, Giorgio Capogna, Michela Camorcia, Cristiana Berritta,
Mark Hochman and Matteo Velardo from EESOA Maternal Neonatal Simulation Center, Roma,
Italy and Cittàdi Roma Hospital, Roma, Italy. Dr. Capogna is MD, Head of the Department
of Anesthesiology at Città di Roma Hospital in Rome and a Member of Milestone Scientific’s
Scientific Advisory Board. Mark Hochman is D.D.S, Director of Clinical Affairs for
Milestone Scientific Inc., the licensor of the Company’s computer-controlled injection
and drug delivery technology.
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RB_ASO: Publication of Study Validating Efficacy of CompuFlo CathCheck System to Confirm and
Monitor the Placement of an Epidural Catheter
