Neuro-Ventricular Cannula from Alcyone Lifesciences Gets FDA Clearance

Lowell, Mass.-based Alcyone Lifesciences Inc. has earned U.S. Food and Drug Administration 510(k) clearance for the Alcyone MEMS (microelectromechanical systems) cannula (AMC), a neuro-ventricular cannula. The AMC is a dual-lumen, MRI- (magnetic resonance imaging) compatible injection and aspiration cannula for use in the brain. The AMC is not intended for implant, and it is intended for single patient use only.

“I am thrilled for the Alcyone team. They are a highly talented and hard working group that has achieved this important company milestone in an efficient and skilled way,” said Alcyone Lifesciences’ board member Richard Upton of Harbor Light Capital Partners. “I look forward to helping them develop additional products and, ultimately, providing the best solutions for patients and their families.”

“The neuroscience community is pioneering new therapeutic agents including gene therapy, antibody and oncolytic biologic therapy that hold great promise in treating chronic CNS [central nervous system] disorders, but unfortunately they have lacked a clinically effective technology for precise CNS delivery direct to a neurological target and for optimal bio-distribution,” said PJ Anand, founder and CEO of Alcyone Lifesciences. “Given that the very potential of these new agents is dependent on optimal bio-distribution, it is our hope that the AMC will offer a solution for this critical unmet clinical need and further open the gates to novel therapeutic options for patients.”

“The AMC was developed using our game-changing proprietary microelectromechanical system (MEMS) platform. Without burdening the neurosurgery community with unnecessary additional capital equipment, the AMC can be utilized with any existing commercial imaging and stereotactic system. Neurosurgeons can select a target, navigate the AMC precisely to the target, and observe in real-time the precision delivery of the therapeutic agent, all under intra-procedural MRI guidance”, said Deep Singh, director of product development at Alcyone Lifesciences. “In addition to the MEMS tip which has dual micro-channels, the AMC features a unique patented distal end design that helps prevent reflux or back flow along the cannula shaft, which can be a significant drawback with current devices. The AMC platform device is designed for optimal targeted bio-distribution and neurosurgeon’s ease of use.”

Alcyone Lifesciences is a medical device company focused on treatment modalities for chronic neurological conditions.