New Study Validates Milestone Scientific’s CompuFlo® Instrument for Epidural Space Identification in Difficult Patients

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Research published in the International Journal of Obstetric Anesthesia finds:

  • Objective identification of the ligamentum flavum and epidural space
  • Difficult blocks rescued in a single attempt
  • Differentiation between false and true loss of resistance for accurate placement

LIVINGSTON, N.J., Nov. 13, 2018 (GLOBE NEWSWIRE) — Milestone Scientific Inc. (NYSE: MLSS) today announced a new clinical study published in the International Journal of Obstetric Anesthesia that finds the CompuFlo® Epidural System to be successful in objectively identifying the epidural space—even in difficult patients. Accurate epidural space identification can build physician and resident confidence while reducing the number of attempts, poor catheter placement and accidental dural punctures that can be costly to the hospital and painful for the patient.

Study authors from the Citta di Roma Hospital and Careggi Hospital in Italy, conclude, “We [have] validated the CompuFlo device as a means of adequately identifying the ligamentum flavum and the epidural space. And our preliminary findings suggest that it could assist the physician in training when performing epidural insertion.”

The article titled, “Experimental Validation of the CompuFlo® Epidural Controlled System to Identify the Epidural Space and its Clinical Use in Difficult Obstetric Cases,” confirms the instrument’s ability to distinguish between a true and false loss of resistance for accurate epidural placement. Additional findings include:

  • Successful first attempt CompuFlo “rescues” with difficult patients, in which two previous attempts at performing epidural space identification failed with a loss-of resistance syringe
  • Correlation between what an anesthesia provider subjectively feels using a standard loss-of-resistance syringe and the objective measurements displayed by the CompuFlo instrument when pressure changes – which offers quantifiable confirmation and confidence the epidural space has been properly accessed

Mark Hochman, D.D.S., Inventor and Clinical Director for Milestone Scientific, comments on the new study, “This further validates that the CompuFlo-Epidural System is able to safely and effectively identify the epidural space, giving providers a proven alternative to the loss-of-resistance syringe. CompuFlo offers an objective, quantifiable, real-time technique that can build provider confidence and success.” 

Study investigators include Dr. Giorgio Capogna, Dr. Michela Camorcia, Dr. Alessandra Coccoluto, Dr. Massimo Micaglio and Dr. Matteo Velardo. The abstract is available at: https://www.obstetanesthesia.com/article/S0959-289X(18)30005-0/fulltext  

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a medical device company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and instruments for medical, dental, cosmetic and veterinary applications. Milestone’s computer-controlled systems are designed to make injections precise, efficient, and virtually painless. Milestone’s proprietary DPS Dynamic Pressure Sensing technology® is our technology platform that advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures and intra-articular joint injections. For more information please visit our website: www.milestonescientific.com.

Safe Harbor Statement

This press release contains forward-looking statements regarding the timing and financial impact of Milestone’s ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone’s control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone’s periodic filings with the Securities and Exchange Commission, including without limitation, Milestone’s Annual Report for the year ended December 31, 2017. The forward looking statements in this press release are based upon management’s reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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