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KOMISJA NADZORU FINANSOWEGO |
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Raport bieżący nr |
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2019 |
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Data sporządzenia: |
2019-01-29 |
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Skrócona nazwa emitenta |
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MILESTONE MEDICAL |
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Temat |
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Completion of clinical trials for its epidural instrument |
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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"_,
announced the results of a four hundred patient clinical trial for Issuer’s CompuFlo®
Epidural System _“CompuFlo"_ instrument by researchers from the University of Miami,
University of Texas and Northwestern University, and two prominent California-based
pain clinics. Published-Ahead-of-Print in Anesthesia & Analgesia _the official Journal
of the International Anesthesia Research Society_, the randomized, controlled study
compared the effectiveness of the CompuFlo in labor and delivery and chronic pain
management, where loss of resistance and fluoroscopy are the current standards of
care. CompuFlo was found to be ninety-nine percent successful in objectively identifying
the epidural space — even in challenging patients with a higher body mass index.
Performance of epidural anesthesia depends on successful identification of the epidural
space. While fluoroscopy is associated with high success, it exposes patients to radiation
and requires appropriate radiological equipment. Loss of resistance is subjective
and consequently associated with higher failure rates and accidental dural punctures
that require further treatment and interventions such as epidural blood patches.
CompuFlo features an innovative Dynamic Pressure Sensing technology® that differentiates
tissue types by pressure signatures at the tip of the needle that are imperceptible
by touch. This allows the instrument to accurately identify location and discriminate
between true and false loss of resistance objectively and in real-time.
The data from this pivotal study confirms that CompuFlo is a safe and highly effective
alternative to current standards of care. The instrument avoids patient radiation
exposure when compared to fluoroscopy and demonstrated greater accuracy when compared
to loss of resistance.
The clinical trial also found:
• CompuFlo’s procedure time was the same as the current standard of care
• Labor and delivery epidurals performed with CompuFlo resulted in no accidental dural
punctures, compared to four dural punctures with loss of resistance
The Board of Directors of the Issuer is committed to providing anesthesiologists and
pain physicians technology that has the potential to improve success rates, reduce
complications and lower costs. The findings of this clinical trial by five independent
providers validates the CompuFlo epidural instrument as a safe, proven alternative
to loss of resistance and fluoroscopy.
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RB_ASO: Completion of clinical trials for its epidural instrument
