MILESTONE (MMD): Completion of clinical trials for its epidural instrument - raport 1

Raport bieżący nr 1/2019

Podstawa Prawna:
Art. 17 ust. 1 MAR - informacje poufne.

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.