|KOMISJA NADZORU FINANSOWEGO|
|Raport bieżący nr||1||/||2020|
|Skrócona nazwa emitenta|
|Reporting Ninth Published Study Reinforcing Efficacy of CompuFlo Epidural Instrument as an Objective Tool to Identify the Epidural Space and Reduce Risk of Accidental Dural Puncture|
|Art. 17 ust. 1 MAR - informacje poufne.|
| The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”), today announced a new simulation study published in Anesthesiology Research & Practice, in an article entitled: “Epidural Needle Extension through the Ligamentum Flavum Using the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique: A Simulation Study.”
The study verifies that the CompuFlo® Epidural System (“CompuFlo”) helps anesthesiologists to identify the epidural space with improved accuracy and less variation thus limiting over-advancement of an epidural needle that can lead to complications when inserting an epidural needle. Easier identification of the epidural space is essential to reducing the number of epidural attempts and risk of accidental dural puncture.
As reported in the article, accidental dural puncture is particularly troublesome in the obstetric population as more than half of all patients who experience accidental dural puncture with epidural needles may eventually develop a post-dural puncture headache. The article further reports that the overall quality of evidence for preventive measures is generally weak, and therefore good knowledge of lumbar anatomy together with a carefully performed technique are extremely important.
The simulation study evaluated the final position of a Tuohy epidural needle after penetration of analogue ligamentum flavum during the identification of the epidural space. Fifty-two expert anesthesiologists compared the use of CompuFlo® Epidural Instrument versus their standard loss-of-resistance technique. The results of the study demonstrated that an epidural technique performed with CompuFlo® resulted in very low variability between anesthesiologists, in which the needle was positioned in a safer location after entry into the epidural space. In comparison, using the standard loss-of-résistance technique the epidural needle was found to have greater variability in its final position as well as shown to be over-advanced into the epidural space when compared to the CompuFlo® Epidural Instrument.
The Board of Directors of the Company believes that the ninth published study further validates the CompuFlo® Epidural System’s ability to safely and effectively identify the epidural space. The unique computer-controlled real-time pressure sensing technology provides anesthesiologists an objective and quantifiable technique to build confidence. The CompuFlo® Epidural Instrument gives anesthesia providers objective pressure and fluid measurements to verify the epidural space has been reached. This real-time Dynamic Pressure Sensing technology® reliably differentiates true from false loss of resistances. As noted in the article, the authors are not aware of any other devices on the market that can effectively distinguish between a true loss-of-resistance and a false loss-of-resistance as demonstrated by the CompuFlo® Epidural Instrument. CompuFlo can connect to glass or plastic LOR syringes so the anesthesia provider will receive additional objective information in real-time without sacrificing their LOR technique.
Study investigators include, Alessandra Coccoluto, Matteo Velardo, and Emanuele Capogna from the European School of Obstetric Anesthesia, Maternal Neonatal Simulation Centre, in Rome, Italy. Dr. Capogna is a Advisory Board Member of Milestone Scientific, Inc., the majority shareholder of the Issuer.
|MESSAGE (ENGLISH VERSION)|
|PODPISY OSÓB REPREZENTUJĄCYCH SPÓŁKĘ|
|Data||Imię i Nazwisko||Stanowisko/Funkcja||Podpis|
|2020-01-11||Joseph D'Agostino||Chief Financial Officer||Joseph D'Agostino|