MILESTONE (MMD): Receiving 510(k) FDA Clearance for CompuFlo® Epidural Instrument - raport 7

Raport bieżący nr 7/2017

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

The Board of Directors of Milestone Medical Inc. (WAR: MMD, "the Company", "the Issuer"), today announced the CompuFlo® Epidural Computer Controlled Anesthesia System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The CompuFlo® Epidural System provides anesthesiologists and other Health Care Providers for the first time, the ability to quantitatively determine and document the pressure at the needle tip in real-time. The CompuFlo® Epidural's proprietary DPS Dynamic Pressure Sensing Technology™ (DPS) allows the CompuFlo® Epidural to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space.

The Board of Directors of Issuer is pleased to receive marketing clearance from the FDA, which is considered globally to be the regulatory gold standard in premarket review.

Looking ahead, the Company is now focused on reaching out to the top key opinion leaders in the U.S., as the Issuer has been doing successfully across Europe. The CompuFlo® Epidural System's ease of use allows use by medical professionals with varying levels of experience, which further drives the value proposition of this technology. In addition, due to what is seen as the device's add-on value proposition, the Company plans to seek reimbursement codes over and above those already in place for traditional epidural procedures.

510(k) FDA Clearance was supported by the COMPASS Study (CompuFlo® Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo® Epidural Instrument. The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundred-sixty (160) required epidural procedure for acute pain management during labor and delivery. The CompuFlo® Epidural with Dynamic Pressure Sensing Technology resulted in the anesthesiologists objectively identifying the epidural space with 99% success on the first attempt. The COMPASS study involved use of the CompuFlo Epidural in 21 obese subjects (BMI > 31), with performance in this group found to be comparable to the performance seen in patients with lower BMIs. However due to the relatively small sample size of obese patients studied, the safety and effectiveness profile in this subgroup of patients is not fully known.

Based on the nonclinical and clinical tests conducted, it was demonstrated that the CompuFlo Epidural device is as safe, as effective and performs as well as or better than the legally marketed predicate devices.

The overall results of the COMPASS study demonstrated that the CompuFlo® Epidural can serve as an everyday epidural needle placement confirmation solution.