Alcyone Lifesciences said today that its ThecaFlex DRx system won breakthrough device status from the FDA.
The Lowell, Mass.-based company’s system features an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and infusion of therapies.
“The breakthrough device designation for the ThecaFlex DRx System is an important milestone in the advancement of therapy enabling technologies, to provide potentially safer and more effective treatment of patients with debilitating neurodegenerative diseases such as SMA and Huntington Disease. Intrathecally delivered therapies are often challenging to administer, and this novel delivery system will make such drugs more readily accessible to broader patient populations,” Dr. Richard Finkel, chief of the neurology division at Nemours Children’s Hospital, said in prepared remarks.
“The Alcyone team and our clinical investigators are very pleased that as a breakthrough device, the ThecaFlex DRx system will be eligible for prioritized regulatory reviews as we prepare to file an investigational device exemption clinical trial submission with the FDA this year to evaluate the safety and efficacy of the device in patients with spinal muscular atrophy,” Elsa Chi Abruzzo, VP of regulatory, clinical & quality affairs at Alcyone, added.
“Though currently the ThecaFlex DRx System is designed for patients three years of age and older who tend to have more complex spinal anatomy preventing [lumbar puncture] or who generally have more anxiety regarding LP than younger children, Alcyone is planning to miniaturize the ThecaFlex DRx System to also benefit some of these younger patients who may not be able to tolerate LP without sedation,” CEO PJ Anand said.