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Flowonix® Medical Inc. And Cerebral Therapeutics Announce World-First Clinical Trial Delivering Medication Directly Into The Brain For Patients With Refractory Epilepsy

MOUNT OLIVE, N.J., March 14, 2017 /PRNewswire/ -- Flowonix Medical Inc. of New Jersey, and Colorado-based Cerebral Therapeutics, announced today the first patients implanted with the Prometra

® II Programmable Infusion System in the Australian Direct Drug Administration for Refractory Epilepsy (ADDRESS) clinical trial at St. Vincent's Hospital, Melbourne, Australia. The jointly developed therapy features a micro-infusion device that tightly controls drug delivery to a region of the brain for patients with medically refractory epilepsy.

ADDRESS is the first multi-center dose ranging clinical study assessing intracerebroventricular (ICV) delivery of the drug valproate (valproate sodium) in patients with focal seizures, with temporal lobe onset with or without secondary generalization. Nine patients will take part in this experimental treatment, wherein patients will receive ICV administration of valproate via the Flowonix Prometra II Programmable Pump.  Clinicians associated with the trial are encouraged with the preliminary results in reducing the number of epileptic seizures.

"We are really excited to be able to study this new treatment option for patients in the ADDRESS trial – it may offer new hope to those with uncontrolled epilepsy," stated Professor Mark Cook, Chair of Medicine and Director of Neurosciences at St. Vincent's Hospital in Melbourne, Australia.

Refractory epilepsy, referred to as uncontrolled, intractable, or drug-resistant epilepsy, occurs when medications do not bring seizures under control. Epilepsy patients that are refractory to oral anti-epileptic drug treatment have significantly higher mortality, higher morbidity, higher economic costs and diminished quality of life compared to those who suffer from epilepsy that can be adequately controlled with medical management. About one in three people with epilepsy progress to refractory epilepsy.

"The ability to target-deliver anti-epilepsy medication through an established infusion pump delivery could be a treatment with profoundly positive ramifications," stated Dr, Ashwini Sharan, Neurosurgical and Neurological Professor at Jefferson University, and President of the North American Neuromodulation Society. "This is the first time in the world this approach is being taken."

Dan Abrams, Chief Executive Officer of Denver-based Cerebal Therapeutics, noted that this is the first time implantable programmable pumps have been used to deliver medication directly to the brain, in the same way they are used to manage spinal pain by delivering medications to the intrathecal space.

According to the World Health Organization, nearly one person in six suffers from some type of neurological condition, amounting to over one billion individuals worldwide. Many neurological conditions can be addressed with medications, but there is still significant unmet medical need.

"Neurological disorders can be devastating to patients and their families, who are often left with few options," stated Larry Heaton, Chief Executive Officer of Flowonix Medical, Inc. "Flowonix is emerging as a world leader in implantable drug infusion systems used to treat pain, and we have particular expertise in the accurate and reliable delivery of microdoses of medication."

He continued, "As the first trial of its kind, the ADDRESS study is a signficant milestone for Flowonix Medical, Inc., Cerebral Therapeutics, the healthcare community, and patients worldwide. If the clinical study results in demonstrated positive outcomes, it would benefit patients who have refractory epilepsy and establish targeted drug delivery directly to the brain. It is gratifying when technological advancements offer such exciting possibilities for a new group of patients in need."

About the Prometra® II Programmable Infusion System

The Prometra Programmable Infusion System is FDA approved for intrathecal infusion of Infumorph® (perservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP). The Prometra II Pump is not approved for the ICV administration of valproate in the USA or Australia, and is being studied as an investigational use only device in Australia.

About Flowonix

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

About Cerebral Therapeutics

Cerebral Therapeutics, LLC (www.cerebraltherapeutics.com) is a privately-held company founded with the goal of addressing the well-recognized limitations of existing treatments for uncontrolled neurological diseases. Cerebral Therapeutics is combining advanced micro-dosing technology with proprietary medications to precisely deliver treatments to the other side of the blood-brain barrier to improve the lives of patients with uncontrolled neurological disease. With a promising route of administration, Cerebral Therapeutics offers a new approach to managing neurological diseases by means of delivering ideal dosing to targeted sites within the brain. Initially, Cerebral Therapeutics is focused on improving outcomes and propagation in the brain. Future cerebral therapeutic areas include obesity, Alzheimer's disease, Parkinson's disease, anxiety spectrum disorder, and brain cancer. 

Flowonix and Prometra are registered trademarks of Flowonix Medical, Inc. 

Important Safety Information

Please visit http://www.flowonix.com/sites/default/files/prometra_ii_pump_mri_conditions.pdf for important MRI conditions and safe scanning. To learn more on full Prescribing Information, including Warnings, and Instructions for Use, please visit http://www.flowonix.com/healthcare-provider/resources/instructions-for-use  and click on available resources.


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