MILESTONE (MMD): Milestone Medical Inc. Submits Initial Results of Clinical Trial Using CompuFlo® Epidural Instrument - raport 36

The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”), today announced that it has submitted initial results of the Company’s prospective, open label, clinical trial assessing the CompuFlo® technology in correctly identifying the epidural space during an epidural procedure in obese patients to a prestigious American pain management society in advance of this organization’s annual meeting in 2016.

Success of the epidural technique depends upon the correct identification of the epidural space. The incidence of difficult epidural catheter placement and early failure is significantly more likely among the morbidly obese population. The increased amount of subcutaneous and epidural fat in the obese population can pose a significant challenge to successful epidural catheter placement.

After IRB approval and under United States Food and Drug Administration Investigations Device Exemption, patients were enrolled in a prospective controlled multi-center trial and were randomized to have the epidural space identified by either standard of care methods utilizing the loss of resistance technique or by utilizing real-time pressure measurement at the epidural needle tip via the CompuFlo® Epidural Instrument. A blinded independent observer evaluated correct identification of the epidural space defined as correct spread of dye demonstrated by fluoroscopy.

Study results suggested that the non-invasive CompuFlo® technology was able in real time to objectively and accurately identify the epidural space in obese patients when compared to radiological X-ray based fluoroscopy. Data suggested that the CompuFlo® technology has the potential to avoid exposure of the patient to radiation without compromising procedure effectiveness.

The second submission focusing on morbidly obese patients follows the earlier submission focusing on a broader patient population. The Board of Directors of the Issuer sees the initial results from this study as encouraging due to the fact that identification of the epidural space has traditionally been more difficult and has a higher rate of morbidity in obese patients.

The Board of Directors of the Issuer believes that the instruments have the potential to improve both safety and efficacy of epidural injection procedures. Moreover, unlike procedures utilizing fluoroscopy, CompuFlo® has the added potential benefit of avoiding patient exposure to radiation without compromising procedure safety or efficacy.

Legal basis: § 3 subparagraph 1 of the Exhibit 3 to the Alternative Trading System Rules “Current and Periodical Information in the Alternative Trading System on the NewConnect Market".

Osoby reprezentujące spółkę:
Joseph D'Agostino - CFO