Healthcare Industry News:  Prometra 

Devices Drug Delivery FDA

 News Release - August 7, 2015

Flowonix Medical Inc. Announces FDA Approval of New Product

MOUNT OLIVE, N.J., Aug. 7, 2015 -- (Healthcare Sales & Marketing Network) -- Flowonix Medical, Inc., announced today that its newest product, the Patient Therapy Controller (PTC™), has been approved for market release. The PTC interfaces with the company's Prometra® platform of intrathecal infusion devices. A small, hand-held device with a touch-screen, the PTC allows the patient to initiate a bolus delivery of medication from the implanted pump.

"The new Patient Therapy Controller or PTC allows patients to administer a bolus of medication as needed," stated Dr. Jason Pope, President of Summit Pain Alliance in Petaluma, California. "Patients need only to press the Rx button and hold the PTC over the implanted pump. The PTC then communicates with the pump and the supplemental medication is delivered. It is intuitively easy to use and it provides greater flexibility for pump patients."

Chronic pain is estimated to affect 116 million Americans. Back pain alone is the leading cause of disability in Americans under 45 years old. Flowonix is dedicated to providing ongoing solutions designed for the relief of pain. In 2015, Flowonix has received approval for three new products including the Prometra II, the longest-lasting targeted drug delivery device available.

"Breakthrough pain can be a significant problem for this patient population. Oral medications are not ideal for treating breakthrough pain because of the potential for side effects and abuse," stated Dr. W. Porter McRoberts, Medical Director of Interventional Spine, Pain and Neurosurgery at Holy Cross Hospital in Fort Lauderdale, Florida. "The PTC allows a patient experiencing breakthrough pain to deliver a bolus of pain medication which provides quick and effective pain relief. Not only can the PTC help to control breakthrough pain better, it may help reduce or eliminate the need for oral analgesics."

Flowonix President and CEO, Steven Adler added, "Our new Patient Therapy Controller demonstrates our ongoing commitment to making the Prometra drug delivery system the most advanced infusion system available. This device will allow a great number of patients, specifically those with variable pain pathologies, to benefit from targeted drug delivery."

About Flowonix

Flowonix Medical Inc. (, headquartered in Mt. Olive, NJ, is dedicated to working with healthcare professionals to help ease suffering associated with chronic pain and allow patients to reclaim their lives through innovation and therapy advancements. The strategic business goal of Flowonix Medical Inc. is to become the leading implantable drug delivery company in the world. Founded in 2005, Flowonix Medical Inc. received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. The company received approval by the FDA to market the Prometra in 2012. Flowonix Medical Inc. has been granted multiple patents, and is focused on working closely with physicians to rapidly improve the capabilities of implantable drug delivery and management systems.
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Source: Flowonix Medical

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