LOWELL, Mass., Feb. 20, 2018 /PRNewswire/ -- Alcyone Lifesciences, Inc., a privately-held company focused on transforming disease modifying therapies for central nervous system (CNS) disorders today announced the separation and spin-off of its Hydrocephalus business. The new company, known as Anuncia, Inc., is an independent company focused on better treatment of Hydrocephalus and cerebrospinal fluid dysfunctions.
The separation and spin-off of Anuncia from Alcyone comes on the heels of receiving the EU CE Mark and US FDA Clearance of ReFlow Ventricular System for the treatment of hydrocephalus. The FDA 510(k) clearance and EU approval of the ReFlow Ventricular System permits Anuncia to commercialize the innovative technology for treatment of hydrocephalus in the US, and Europe, to provide qualified clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid (CSF) flow in a non-flowing shunt.
Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus. Although shunts facilitate treatment for many cases, according to The Hydrocephalus Association1 at least 50 percent of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries. Further, according to Sarkiss et al., 2014, 40 percent of obstructions, the leading cause of shunt failure, have been shown to occur within the first-year post surgery.
The costs of these, often-emergent, revision surgeries to restore CSF flow and alleviate painful symptoms, present a heavy emotional and financial burden to patients, families, and healthcare facilities. Though the Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions; it is designed to provide a non-invasive option for neurosurgeons to restore CSF flow in a non-flowing shunt, which may potentially avert emergency revision surgery.
"Alcyone Lifesciences and Anuncia will each be stronger, more focused and more competitive as leading standalone companies in their respective markets," said Edgar D. Jannotta, Jr., Director at Alcyone and Anuncia. "This decision comes after a thorough strategic review by the Board that showed that as independent companies, Alcyone and Anuncia, will be better positioned competitively and enjoy added flexibility to pursue strategic partnerships in their respective markets."
Jeffrey Quillen and Patrick Connolly of Foley Hoag LLP advised Alcyone in connection with the spin-off and will represent Alcyone and Anuncia as general corporate counsel going forward.
Alcyone Lifesciences, Inc.Alcyone Lifesciences, based in Massachusetts, is a privately-held company focused on transforming disease modifying therapies for rare, orphan and debilitating neurological disorders through an advanced precision delivery platform. For more information, please visit www.alcyonels.com
Anuncia, Inc.Anuncia, based in Massachusetts, is an independent privately-held company focused on developing products for better treatment of hydrocephalus and CSF dysfunctions. For more information please visit www.reflowventcath.com
ContactAlcyone Life Sciences, Inc.PJ AnandChief Executive [email protected]
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The separation and spin-off of Anuncia from Alcyone comes on the heels of receiving the EU CE Mark and US FDA Clearance of ReFlow Ventricular System for the treatment of hydrocephalus. The FDA 510(k) clearance and EU approval of the ReFlow Ventricular System permits Anuncia to commercialize the innovative technology for treatment of hydrocephalus in the US, and Europe, to provide qualified clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid (CSF) flow in a non-flowing shunt.
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Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus. Although shunts facilitate treatment for many cases, according to The Hydrocephalus Association1 at least 50 percent of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries. Further, according to Sarkiss et al., 2014, 40 percent of obstructions, the leading cause of shunt failure, have been shown to occur within the first-year post surgery.
The costs of these, often-emergent, revision surgeries to restore CSF flow and alleviate painful symptoms, present a heavy emotional and financial burden to patients, families, and healthcare facilities. Though the Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions; it is designed to provide a non-invasive option for neurosurgeons to restore CSF flow in a non-flowing shunt, which may potentially avert emergency revision surgery.
"Alcyone Lifesciences and Anuncia will each be stronger, more focused and more competitive as leading standalone companies in their respective markets," said Edgar D. Jannotta, Jr., Director at Alcyone and Anuncia. "This decision comes after a thorough strategic review by the Board that showed that as independent companies, Alcyone and Anuncia, will be better positioned competitively and enjoy added flexibility to pursue strategic partnerships in their respective markets."
Jeffrey Quillen and Patrick Connolly of Foley Hoag LLP advised Alcyone in connection with the spin-off and will represent Alcyone and Anuncia as general corporate counsel going forward.
Alcyone Lifesciences, Inc.Alcyone Lifesciences, based in Massachusetts, is a privately-held company focused on transforming disease modifying therapies for rare, orphan and debilitating neurological disorders through an advanced precision delivery platform. For more information, please visit www.alcyonels.com
Anuncia, Inc.Anuncia, based in Massachusetts, is an independent privately-held company focused on developing products for better treatment of hydrocephalus and CSF dysfunctions. For more information please visit www.reflowventcath.com
ContactAlcyone Life Sciences, Inc.PJ AnandChief Executive [email protected]
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SOURCE Alcyone Lifesciences, Inc.
