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 labeled, clinical trial assessing the CompuFlo® technology in correctly identifying the epidural space during an epidural procedure to a prestigious European pain management society in advance of this organization’s annual meeting in 2016.
The Company designed the study, in conjunction with its Scientific Advisory Board, and in agreement with the U.S. Food and Drug Administration (FDA), to assess the safety and effectiveness of the pressure sensing technology in identification of the epidural space as part of the acute and chronic pain management.
Successful and safe performance of epidural anesthesia or epidural injections relies on correct identification of the epidural space. Preliminary study results suggested that the non-invasive CompuFlo® technology was as accurate and effective as the current standard of medical practice, loss of resistance technique assisted with the radiological X-ray based fluoroscopy in objectively and accurately identifying the epidural space. Data further suggested that the Compuflo® technology has the potential to successfully replace current standard of medical care while eliminating exposure to radiation.
The Board of Directors of the Issuer is pleased to have submitted initial results of this prospective, open labeled, clinical trial to one of the most prestigious European pain management societies. The Board of Directors of the Company believes that the ability of the Compuflo® technology to confirm the epidural space in real time as opposed to the current 2 step approach, will provide significant advantages for anesthesiologists and patients. The current process requires advancing an epidural needle via loss of resistance technique and then confirming the space by injecting contrast and visualizing it under X-ray fluoroscopy. Along with other benefits, the Compuflo® technology has the potential to significantly reduce cost and avoid radiation exposure for the patients and medical practitioners.
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