Flowonix Medical Inc. and Alliance Spine and Pain Centers Announce First Prometra® II Implant in Georgia

Next-generation Intrathecal Infusion Device Successfully Implanted in Pain Patient

Jun 29, 2015, 08:03 ET from Flowonix Medical, Inc.

MOUNT OLIVE, N.J., June 29, 2015 /PRNewswire/ -- Flowonix Medical, Inc. and Alliance Spine and Pain Centers announced today that the first implant of its Prometra® II intrathecal infusion pump took place on June 24, 2015 in Georgia. The intrathecal infusion device was implanted in a 56-year-old female suffering from severe chronic pain due to multiple sclerosis. The patient has been unable to get pain relief from oral pain medications due to severe adverse effects.  The procedure was performed by Dr. David Rosenfeld.

"The Prometra pump offers clinicians an important option for treating patients suffering from chronic pain. In addition to the economic and clinical advantages of implantable pump therapy, the Prometra pump contains innovative technology for very accurate drug delivery and increased device longevity," stated Dr. Rosenfeld.

Prometra II builds on the technology of the Prometra family. The most significant advancement in the Prometra II device is its proprietary flow-activated safety valve or FAV™ technology, which is designed to allow patients to safely undergo magnetic resonance imaging (MRI). MRIs can be contraindicated for patients with implanted devices because of the strong electromagnetic energy from these systems which can interfere with proper device function. The Prometra II system is labeled as MR-Conditional and can safely undergo such scans providing specific conditions are followed. These specific steps are described in the Instructions for Use supplied with the product.

Over 100 million Americans suffer from some form of chronic pain caused by injury or disease, and in some cases the pain is severe enough that it interferes with the person's ability to work or lead a normal life. For such individuals, conventional pharmacological therapy or other pain strategies are often insufficient to control their pain. Implantable intrathecal drug pumps can help alleviate pain by automatically delivering pain medicine directly to the intrathecal space around the spine. In many cases, pain relief can be obtained with much less pain medication than conventional drug therapy.

"We realize this is an important milestone in the therapy for this patient, but it is also an important milestone for us as this is the first implant of the Prometra II system in Georgia," stated Steven Adler, President and CEO of Flowonix. "Our goal at Flowonix is to provide doctors and their patients all over the world with the most accurate, innovative, and reliable intrathecal infusion systems available. We congratulate Dr. Rosenfeld on the first implant of the Prometra II in Georgia, and we wish all the best to the patient."

About Flowonix

Flowonix Medical Inc. (www.flowonix.com), 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.

For more information, please visit http://www.flowonix.com.

About Alliance Spine and Pain Centers

In our centers, Alliance Spine and Pain Management physicians focus on non-surgical treatments to treat the root cause of spine pain—helping people get the relief they need. These spine procedures are clinically proven and follow the strict guidelines of the American Academy of Pain Management. Our Physicians are fellowship-trained in Interventional Pain Management, a relatively new medical specialty which focuses on relieving pain through minimally-invasive procedures. Interventional Pain Management utilizes a variety of techniques to treat conditions associated with chronic pain, including epidural steroid injections, medial branch blocks, facet joint injections, discographic injections, pulse radiofrequency neurotomy and spinal cord stimulation. These procedures are in contrast to higher-cost, often failed, major back surgery and prescription neurotics which often cause unintended physiological and psychological consequences to the patient.

Our state-of-the-art outpatient surgical facilities are approved by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the formal accrediting body for healthcare facilities nationwide.

We, as an organization, also maintain meaningful relationships with hospitals in the area in order to ensure that our patient's receive the appropriate treatment when medically necessary.

Our practice includes patients covered by commercial insurance, Medicare, and workman's compensation.

Alliance Spine and Pain Management serves patients and families by focusing solely on ending back pain -- and helping patients avoid spine surgery.  During procedures, patients have the option of receiving a moderate level of sedation in order to ensure that they are fully comfortable. For over 80% of our patients, the result is successful and a significant amount of their pain is relieved.  Our ultimate goal is to use a comprehensive approach to give patients increased mobility, relieve them of pain, and help them avoid unnecessary spine surgeries.  We wish to improve each patient's lifestyle, overall wellness and certainly, their quality of life.

All of our procedures are performed while patients are under sedation to ensure that each patient is fully comfortable. For over 80% of our patients, the result is successful. Their pain is gone! That is our goal -- to give patients increased mobility, relieve them of pain, and help them avoid back surgery. We wish to improve each patient's lifestyle, overall wellness -- and certainly, their quality of life.

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SOURCE Flowonix Medical, Inc.



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