Pulsante® Therapy Awarded Prestigious Forfait Innovation Package to Fast-Track Medical Innovation for Cluster Headache in France
MOUNTAIN VIEW, Calif., March 12, 2018 /PRNewswire/ — Autonomic Technologies, Inc., today announced that the College of the French National Authority for Health (HAS) issued a favorable opinion on a Forfait Innovation package for the Pulsante® SPG Microstimulator System. The award will support a randomized controlled trial for patients suffering from cluster headache. Autonomic Technologies is a medical device company focused on the development and commercialization of innovative therapies for the treatment of severe headache.
The Forfait Innovation program was launched to accelerate the introduction of promising medical innovation in France while simultaneously collecting data to support a longer-term reimbursement decision. Funding is allocated only to select medical technologies that demonstrate truly breakthrough innovation that brings significant clinical benefits and/or reduces healthcare system costs.
“Five years after our participation in the European Pathway CH-1 study, this is an important step in allowing use of the innovative sphenopalatine ganglion stimulation system at French tertiary headache centers to treat severe cluster headache sufferers,” said Professor Michel Lantéri-Minet, a neurologist at Centre Hospitalier Universitaire de Nice.
Centers across France will participate in the clinical study for pain relief in patients suffering from cluster headache. The costs of the study will be underwritten by the French national insurance system in partnership with Autonomic Technologies.
“We’re thrilled that the National Authority for Health has chosen to recognize the innovative approach of Pulsante® therapy and develop further evidence of its ability to help patients suffering from this debilitating disease,” said Niamh Pellegrini, President and CEO.
ABOUT PULSANTE® THERAPY
The Pulsante® SPG Microstimulator is a novel, miniaturized wireless device designed for patient-controlled, on-demand therapy to relieve the acute pain of cluster attacks. The miniature implant is inserted above the upper jaw in a 60- to 90-minute oral procedure that leaves no visible scar. The Pulsante® SPG Microstimulator System is CE marked in Europe for the acute pain relief of cluster headache and pain relief for highly disabled migraine patients. More than 500 patients have received the therapy to date. The device (also known as the ATI® Neurostimulation System) is currently under an IDE study in the United States for the acute relief of chronic cluster headache.
ABOUT AUTONOMIC TECHNOLOGIES
Autonomic Technologies, Inc. (ATI) is a medical device company headquartered in the San Francisco Bay Area, focused on the development and commercialization of innovative therapies for the treatment of severe headache. ATI is backed by world-class European and US investors including Edmond de Rothschild Investment Partners, Forbion Capital Partners, HBM Healthcare Investments, Kleiner Perkins Caufield and Byers, InterWest Partners, Aberdare Ventures, Novartis Venture Funds, Capital Royalty Group and Cleveland Clinic. For more information, please visit: pulsante.com.
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