June 22, 2018 11:49 PM ET

Biotechnology

Company Overview of Alcyone Lifesciences, Inc.

Company Overview

Alcyone Lifesciences, Inc., a medical device company, focuses on development of novel treatment modalities for chronic neurological conditions. The company develops micro-fabricated delivery systems, including Alcyone MEMS (microelectromechanical system) Cannula (AMC) system, a neuro-ventricular cannula and accessories that enable neurosurgeons to select a target, navigate the AMC precisely to the target, and observe in real-time the precision delivery of the therapeutic agent under intra-procedural MRI guidance. It offers solutions for the treatment of various neurologic conditions, including brain tumor, hydrocephalus, epilepsy, and neurodegenerative diseases. The company was founded in 20...

250 Jackson Street

Unit 494 Mill No. 5 Building

Lowell, MA 01852

United States

Founded in 2010

Phone:

978-709-1946

Key Executives for Alcyone Lifesciences, Inc.

Founder, Chief Executive Officer, President and Director
Co-Founder, Consulting Chief Medical Officer and Member of Scientific Advisory Board
Vice President of Regulatory, Quality and Clinical Affairs
Age: 49
Compensation as of Fiscal Year 2017.

Alcyone Lifesciences, Inc. Key Developments

Amylon Therapeutics and Alcyone Lifesciences Enter into Partnership on Drug-Device Combo to Treat HCHWA-D

Amylon Therapeutics and Alcyone Lifesciences announce that they have entered into a collaboration partnership agreement. The companies will join forces to combine Amylon’s lead program AT-010 and Alcyone’s proprietary PulsarTM Advanced Intrathecal Precision Delivery Platform Technology, using their combined expertise to develop a drug-device combination. Amylon and Alcyone will collaborate to investigate the potential of developing AT-010 and the PulsarTM platform into a drug-device combination that will allow AT-010 to reach the brains of patients. Amylon’s lead program AT-010 is designed to prevent the onset of brain bleeds in the orphan disease HCHWA-D. Through an ultra-genetics approach, Amylon focuses on a rare genetic CNS disorder that could pave the way for going after CAA cause of cerebral haemorrhage. AT-010 is a first-in-class RNA-based oligonucleotide that works by preventing the accumulation of toxic protein by acting at the RNA level. Alcyone’s proprietary PulsarTM advanced precision delivery platform is an auto-intrathecal injector that utilizes cerebrospinal fluid dynamics to deliver therapeutics to anatomical areas in the CNS that are difficult to target. This platform has been demonstrated to increase the concentration of the therapeutic to CNS targets of interest consistently and reliably. The platform is designed to for easy deployment in the clinical setting and allows for ease of use with custom infusion algorithms for treating CNS diseases.

Alcyone Lifesciences, Inc. Receives FDA Clearance for the Alivio System for the Treatment of Hydrocephalus

Alcyone Lifesciences, Inc. announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System (Alivio System) for the treatment of hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The FDA 510(k) clearance and EU approval permit Alcyone Lifesciences to commercialize the Alivio System 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% 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% 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. The Alivio System, is comprised of a Flusher and Ventricular Catheter (VC) with a unique relief membrane. The system, in conjunction with any CSF shunt flow regulating valve and drainage catheter, is designed to address one of the two most common problems with CSF shunts -- obstructions of the ventricular catheter. To extend the life of these shunts, and avoid emergency shunt revision, retrograde flushing using flow regulating valves and invasive shunt taps have been employed by some neurosurgeons in attempt to unblock ventricular catheters. However, these methods have been inconsistent, and shunt taps can introduce risk of infection (the other most common CSF shunt problem) and risk of damage to the flow regulating valve. Alcyone worked closely with FDA during their thorough and thoughtful review of the Alivio System, and looks forward to being able to help patients, who suffer from hydrocephalus and have had numerous emergency surgeries due to blocked ventricular catheters. With FDA 510(k) clearance of the Alivio System, Alcyone is hopeful it can help clinicians offer expanded treatment options to these patients. This core concept of a fully implantable and non-invasive treatment designed to consistently unblock an occluded VC originated from results of an earlier clinical evaluation performed at Boston Children's Hospital (BCH), where the flushing concept was studied on VCs undergoing revision due to occlusions and then also flushed successfully to improve flow using the Alivio Flusher. BCH, along with Dr. Joseph Madsen, who is a pediatric neurosurgeon at BCH and a scientific advisor to the company, closely collaborated with Alcyone to advance the concept into a viable technology.

Alcyone Lifesciences Receives EU CE Mark Approval for Alivio Ventricular Catheter and Flusher System for Treatment of Hydrocephalus

Alcyone Lifesciences, Inc. announced receipt of CE (Conformité Européenne) Mark approval for European commercialization of its Alivio Ventricular Catheter and Flusher System for the treatment of Hydrocephalus. Hydrocephalus is a condition in which an excess of cerebrospinal fluid (CSF) accumulates in the ventricles and can increase the intracranial pressure (ICP) in the brain, creating a potentially life-threatening condition. CSF shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus. Many patients are at risk of shunt failure due to ventricular catheter occlusions, many requiring numerous revision surgeries by adolescence. The cost burden of hydrocephalus management is $2 billion. The burden to patients and their families is immeasurable. Hydrocephalus refers to enlargement of the ventricles and can be a result of infection, hemorrhage, neoplasm, spinal dysraphism, trauma, or a congenital etiology. An estimated 125,000 U.S. children have shunt-dependent Hydrocephalus, with an estimated prevalence of 1-1.5%. Shunt failure is common; 40% of shunts fail within the first year and 56-80% by 10 years. Between 8-10% of shunts eventually become infected Shunt malfunction can lead to an acute increase in ICP, which may be a life-threatening emergency, making early detection and treatment critical to reducing morbidity and mortality. Alcyone's Alivio Ventricular System, is comprised of a Flusher and Ventricular Catheter with unique relief membrane. The system, in conjunction with any CSF shunt, is designed to address one of the two most common problems with CSF shunts: 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 some neurosurgeons in attempt to unblock ventricular catheters. However, these methods have been inconsistent, and can introduce risk of infection (the other most common CSF shunt problem) and risk of damage to the flow regulating valve.

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