Flowonix Receives FDA Approval for Software Upgrade Designed to Improve User Experience

MOUNT OLIVE, N.J., Feb. 5, 2019 /PRNewswire/ -- Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Flowonix Maestro™ Software for Clinician Programmers used to program Prometra® Pump Systems. The new software is designed to improve the user experience for both clinicians and patients. Flowonix expects to begin introducing the new software to customers and implementing the technology in practices nationwide in February.

"Physicians continue to be drawn to the Prometra System due to its ability to provide consistently accurate dosing using a novel micro-bolus delivery mechanism that delivers medication rapidly and broadly to the spinal cord," said Jason Poston, MD, an interventional pain physician in Idaho Falls, Idaho. "The easy-to-use Flowonix Maestro Software will further simplify the process of introducing this pump technology into physicians' practices, and, more importantly, increase the opportunities for patients to benefit from it."

The newly approved Flowonix Maestro Software includes significant improvements, such as the inclusion of automatic calculations and increased dosing flexibility during bridge bolusing, enhancements to Periodic Flow and Multiple Rate Flow capabilities, and modifications to the programmer workflow designed to reduce complexity and ensure necessary steps are taken during programming. The Flowonix Maestro Software builds on the robust, easy- to-use software currently used with Prometra Clinician Programmer.

"We are excited to introduce the Flowonix Maestro Software into clinics around the country, as the enhancements included in the software were driven by feedback provided directly by our customers," said Larry Heaton, President and CEO, Flowonix Medical, Inc. "We are confident the combination of the Flowonix Maestro Software and the novel drug delivery mechanism of the Prometra Pump will strengthen our position in the marketplace and set the company up for long-term success in targeted drug delivery.

About the Prometra® II Programmable Infusion System

The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of drug therapy, including: Infumorph (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/mL).

About Flowonix

Flowonix Medical, Inc. (www.flowonix.com), headquartered in Mt. Olive, New Jersey, is working with healthcare professionals to help improve patients' lives through targeted drug delivery innovation and therapy advancements. Founded in 2005, Flowonix is working closely with physicians and patients to enhance the capabilities of implantable drug delivery systems. Our goal is to become the leading implantable drug delivery company in the world.   For more information, please visit http://www.flowonix.com.

FLOWONIX and PROMETRA are registered trademarks of Flowonix Medical, Inc. 

INFUMORPH is a registered trademark of West-Ward Pharmaceuticals.

PL-15111-00
February 2019

SOURCE Flowonix Medical, Inc.