At Alcyone, we harness the power of microfabrication in biomedical engineering to integrate drug delivery, bioelectronics, and ultrasound to unlock new possibilities in diagnosis and treatment of chronic CNS disorders.
The Alcyone MEMS Cannula (AMC) provides for precise convection-enhanced CNS delivery directly to a neurological target.
The AMC was designed to produce a wide array of critical improvements over existing convection-enhanced delivery solutions, and it includes many additional features which represent significant value additions. It was also developed to be universally compatible with commercial stereotactic frames.
At Alcyone, we are creating a customized, smart intrathecal delivery system that leverages CSF dynamics, physiological pulsatility, and volume displacement for better intrathecal CNS delivery.
|Program||Discovery||Proof of Concept||Product Approval|
Alcyone MEMS Cannula (AMC™)
Consistent and repeatable targeted drug delivery microcatheter.
ReFlow™ Ventricular System
CSF management system for the treatment of Hydrocephalus.
Intrathecal Drug Delivery System
High-efficiency pulsatile delivery and optical system.
Next-Gen Chronic AMC (Implantable)
Fully implantable system with port for out-patient procedures.
Utilizing blood vessels as highways to organs, delivering therapy safely without damage to the blood vessel.
Study 2401BT-002P (CAPTIVE) is a Phase 2 study being conducted in collaboration with Merck to evaluate the efficacy and safety of DNX-2401 in combination with pembrolizumab (KEYTRUDA), Merck’s anti-PD-1 therapy. Adult subjects diagnosed with glioblastoma or gliosarcoma that have experienced disease progression after initial treatment may be eligible.
Study 2401BT-IFN-001 (TARGET-1) is a Phase 1b study evaluating the safety and efficacy of administering DNX-2401 as monotherapy or DNX-2401 followed by treatment with interferon gamma (Actimmune). Adult subjects diagnosed with glioblastoma or gliosarcoma that have experienced disease progression after initial treatment may be eligible.
*The Alcyone MEMS Cannula (AMC™) System, a neuro-ventricular cannula, has US Food and Drug Administration (FDA) 510(k) clearance, Health Canada Licensing, and CE Marking. It is indicated for use in the U.S. and Canada for the injection of Cytarabine or the removal of cerebrospinal fluid from the ventricles of the brain during an intracranial procedure, and approved in Europe for injection or removal of substances from the brain and/or ventricles of the brain during intracranial procedures. The AMC is a dual-lumen, MR-compatible injection and aspiration cannula and can be used with existing commercial imaging and stereotactic systems. The AMC is not intended for implant, and it is intended for single patient use only.
** The Pulsar System is not yet available for commercial use and has not yet been cleared by the FDA.
*** The ReFlow™ Ventricular System is not available for commercial use. The ReFlow™ Ventricular System is pending 510 (k) clearance from the U.S. Food and Drug Administration, and CE Marking.