LOWELL, Mass., Aug. 2, 2016 /PRNewswire/ -- Alcyone Lifesciences, Inc., a leader in neural intervention systems for neurological conditions and an innovator in the treatment of hydrocephalus, announced the clinical use of its ReFlow™ System in four patients treated to date in an institutional review board (IRB)-approved study at Boston Children's Hospital.
Hydrocephalus is a condition in which an excess of cerebrospinal fluid (CSF) accumulates in the ventricles and can increase the pressure in the brain creating a life threatening condition. CSF shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus. The youngest patients seem at highest risk of shunt failure, many requiring numerous revision surgeries by adolescence.
Alcyone's patented ReFlow™ System, comprised of a unique Flusher and Ventricular Catheter with relief membrane as components of a CSF shunt system, is designed to address one of the two most common and frustrating problems with CSF shunts resulting in emergency intervention, namely obstructions of the ventricular catheter. To extend the life of these shunts and avoid emergency shunt revision, retrograde flushing of flow regulating valves and invasive shunt taps have been employed by neurosurgeons in attempt to unblock ventricular catheters. However, these methods have been inconsistent, at best, and can introduce risk of infection (the other most common CSF shunt problem) and damage to the flow-regulating valve. The core concept to realize a fully implantable, non-invasive means that can consistently unblock an occluded ventricular catheter came from an earlier IRB study also performed at Boston Children's Hospital (BCH).
According to Dr. Joseph Madsen, a pediatric neurosurgeon at BCH and inventor of certain patent rights directed to this core concept, which is exclusively licensed to Alcyone by BCH and which has been developed by Alcyone into the ReFlow™ System, "CSF shunts have saved the lives of thousands of children and adolescents and reduced morbidity in tens of thousands more. However, efforts to limit the frequency and potential impact of shunt failure for these patients has fallen short. The Alcyone team has crafted a novel device which can potentially restore flow by mimicking the cough reflex we all use to protect our airways. It is encouraging that it works in the operating room just like it does in bench top and in vivo studies." Added Dr. Benjamin Warf, Principal Investigator of the clinical study at BCH, "This is a simple and intuitive idea, and I am very hopeful that it will benefit many children by reducing shunt problems."
PJ Anand, Alcyone's CEO and President, stated, "We are grateful for the opportunity to collaborate with BCH and patient-focused clinician scientists like Dr. Madsen and Dr. Warf. Alcyone's ReFlow™ System is a simple and elegant solution that is designed with the most vulnerable patients in mind. The ReFlow™ System essentially mimics a focused cough designed to restore flow and avoid off emergency revision surgery in these vulnerable patients. At Alcyone, we are thrilled to be involved with luminaries at Boston Children's and Cincinnati Children's in the quest to treat and improve patients' lives."
With promising initial results from BCH clinical study and completion of numerous bench and animal studies demonstrating safety and functional performance to recognized standards, Alcyone filed a 510 (k) Premarket Notification to the US Food and Drug Administration (FDA) seeking commercial approval for ReFlow™ System. Mr. Anand commented that, "Alcyone is optimistic that FDA will find Alcyone's submission comprehensive and the need for shunt components that may allow neurosurgeons to better and more safely treat their hydrocephalus patients compelling." For more information on the on-going clinical study being conducted at BCH, please refer to NCT 02651337 on ClinicalTrials.gov.
About Alcyone Lifesciences, Inc.
Alcyone Lifesciences, based in Lowell, Massachusetts, is a privately-held medical device company focused on development of novel treatment modalities for chronic neurological conditions including brain tumors, neurogenetic disorders and hydrocephalus. The Company's technology platform is based on a uniquely engineered amalgamation of microfabrication technologies along with advanced biomedical engineering with core product focus on targeted drug therapy and hydrocephalus. Alcyone's team of scientists, physicians and advisers includes recognized leaders in the field of neurology and neurosurgery. For more information, please visit www.alcyonels.com
Alcyone Life Sciences, Inc.
Chief Executive Officer
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SOURCE Alcyone Lifesciences, Inc.