Flowonix Submits PMA Supplements for Prometra® Implantable Pump System

Mount Olive, NJ, September 15, 2014 - Flowonix Medical Inc., a medical device company focused on providing advanced, implantable drug delivery solutions, today announced that it has submitted Premarket Approval (PMA) supplements to the U.S. Food and Drug Administration (FDA) seeking approval of proposed advancements to the Company's Prometra® Implantable Pump System.

These supplements propose the addition of new features to the current Prometra Pump system designed to provide enhanced functionality and greater convenience, which include a new Clinician Programmer, Patient Therapy Controller and other enhancements to the Prometra Pump.  

"These proposed additions to the Prometra system are indicative of Flowonix's ongoing commitment to innovation and to enhancing our technology for the benefit of patients and clinicians," said Steve Adler, President and CEO of Flowonix. "When initially approved by the FDA in 2012, the Prometra system represented the first substantive advancement in pump technology in more than 10 years, offering patients greater assurance than ever in the precision of pump-based drug delivery. Since then, our team has focused on driving further improvement of the system, with the goal of establishing Prometra as the gold standard in intrathecal drug delivery for the treatment of chronic pain. We believe that the continued evolution of the Prometra system through these and other future modifications will position Flowonix to build upon the unparalleled accuracy, longevity and safety of the current Prometra system, extending its best in class capabilities to patients suffering from chronic pain."

The new Clinician Programmer is designed to facilitate faster, easier programming of the Prometra Pump. It allows for highly-precise programming with a simpler, more user-friendly interface than the currently approved Prometra Programmer.

Enhanced features of the new Prometra Clinician Programmer include:

·         Smaller overall form factor that replaces push button controls with an integrated touch screen;

·         Upgrade of the 3.25" monochrome screen to a brighter, 4.2" color LCD;

·         Enhanced bolus delivery modes;

·         The ability to store additional patient information such as physician contact details;

·         More flexibility in dosage units.

The addition of the Patient Therapy Controller to the current Prometra system will allow patients to self-deliver a bolus dose of medication as prescribed by their physician, giving the patient greater control over their treatment.

"The conclusion of our study Long-Term Follow-Up of a Novel Implantable Programmable Infusion Pump, which was published in the Journal of Neuromodulation in 2012, was that the Prometra pump demonstrates accurate drug delivery and provides an effective and safe means for intrathecal administration of morphine sulfate for treatment of chronic intractable pain. In addition, the product advancements proposed under these PMA supplements have the potential to improve treatment  for chronic pain sufferers who are candidates for targeted drug delivery, while empowering clinicians to more effectively manage patient care," said Richard Rauck, MD, of the Carolinas Pain Institute in Winston-Salem, North Carolina, and lead author of the follow-up study

Dr. Rauck continued, "The features proposed for the new Prometra Clinician Programmer are intended to simplify the programming and reprogramming of implanted Prometra pumps, while the added ability to program in microgram units will allow for increased precision in patient dosing. Furthermore, the flexibility in dosing provided by the Patient Therapy Controller will offer the ability to improve the treatment of patients whose pain can evolve and worsen over the course of treatment, such as that often experienced by our cancer patients with refractory pain."