New Clinical Trial Finds Milestone Scientific’s CompuFlo® Instrument a Safe Alternative to Current Standards of Care
Publication in top ranked Anesthesia & Analgesia Journal compares CompuFlo pressure sensing to fluoroscopy and loss of resistance
LIVINGSTON, N.J., Jan. 28, 2019 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced the results of a four hundred patient clinical trial by researchers from the University of Miami, University of Texas and Northwestern University, and two prominent California-based pain clinics. Published-Ahead-of-Print in Anesthesia & Analgesia (the official Journal of the International Anesthesia Research Society), the randomized, controlled study compared the effectiveness of the CompuFlo® Epidural System (“CompuFlo”) in labor and delivery and chronic pain management, where loss of resistance and fluoroscopy are the current standards of care. CompuFlo was found to be ninety-nine percent successful in objectively identifying the epidural space — even in challenging patients with a higher body mass index.
Performance of epidural anesthesia depends on successful identification of the epidural space. While fluoroscopy is associated with high success, it exposes patients to radiation and requires appropriate radiological equipment. Loss of resistance is subjective and consequently associated with higher failure rates and accidental dural punctures that require further treatment and interventions such as epidural blood patches.
CompuFlo features an innovative Dynamic Pressure Sensing technology® that differentiates tissue types by pressure signatures at the tip of the needle that are imperceptible by touch. This allows the instrument to accurately identify location and discriminate between true and false loss of resistance objectively and in real-time.
The data from this pivotal study confirms that CompuFlo is a safe and highly effective alternative to current standards of care. The instrument avoids patient radiation exposure when compared to fluoroscopy and demonstrated greater accuracy when compared to loss of resistance.
The clinical trial also found:
- CompuFlo’s procedure time was the same as the current standard of care
- Labor and delivery epidurals performed with CompuFlo resulted in no accidental dural punctures, compared to four dural punctures with loss of resistance
Leonard Osser, Interim Chief Executive Officer of Milestone Scientific, commented, “We are committed to providing anesthesiologists and pain physicians technology that has the potential to improve success rates, reduce complications and lower costs. The findings of this clinical trial by five independent providers validates the CompuFlo epidural instrument as a safe, proven alternative to loss of resistance and fluoroscopy.”
Study investigators include Ralf E. Gebhard, MD, Tobias Moeller-Bertram, MD, Douglas Dobecki, MD, Feyce Peralta, MD, Evan G. Pivalizza, MBChB, FFASA, Madhumani Rupasinghe, MBBS, FRCA, Sanja Ilic, MD, and Mark Hochman, DDS (Milestone Scientific’s Director of Clinical Affairs and Director of Research and Development). The publication is available online at: https://journals.lww.com/anesthesia-analgesia/Abstract/publishahead/Objective_Epidural_Space_Identification_Using.96416.aspx.
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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.
David Waldman or Natalya Rudman
Crescendo Communications, LLC
Released January 28, 2019