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Unity HA Awarded Breakthrough Device Designation from FDA

September 8, 2022

Unity HA announces today that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Pulsante® SPG Microstimulator System for the treatment of acute headache pain associated with chronic cluster headaches.  Unity HA is a medical device company focused on the development and commercialization of innovative therapies for the treatment of cranial autonomic disorders, particularly severe headache.

“The FDA recognition of Unity HA’s technology to substantially impact chronic cluster headaches is a significant milestone. The Pulsante SPG Microstimulator has treated over 700 patients in the US and EU to date.” says Dr. Peter Bonutti, Unity HA’s president.  “Recently the results of a double blind, randomized controlled clinical trial has been published in The Lancet journal1, and this breakthrough designation brings us closer to a potential long term treatment option for patients with cluster headaches.  This therapy has the potential for decreasing acute pain as well as frequency and severity of this severely disabling condition.”

About the Pulsante® SPG Microstimulator System

The Pulsante Microstimulator System, a development stage therapy potentially offers on-demand stimulation of the sphenopalatine ganglion (SPG), which plays a critical role in headaches with autonomic features, such as cluster headache. The Pulsante® SPG Microstimulator is activated using an external remote controller, allowing patients to deliver as-needed stimulation to relieve the attack.

About Cluster Headache

Cluster headache is a highly disabling chronic neurological condition characterized by intense stabbing pain in the area of one eye, often accompanied by swelling, tears and nasal congestion. The pain inflicted by the condition is recognized as among the most severe known to humankind. Sufferers can have headache attacks multiple times per day, each lasting 15 minutes to three hours. Approximately 1 in 1,000 people suffers from cluster headaches.

There is no cure for the condition. Current treatments to relieve symptoms include preventive and acute abortive drugs, including injectable medications and inhaled oxygen. As some patients are not candidates for these medications and others may not experience any benefit from them, there is a considerable need for new treatment options.

The Breakthrough Devices Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices through frequent interactions with the manufacturer during in development, assessment, and review of innovative medical devices.

About Unity HA

Unity HA is a medical device company focused on the development and commercialization of innovative therapies for the treatment of autonomic disorders, particularly severe headache.   The company acquired the intellectual property of Autonomic Technologies, Inc.’s (ATI) and continues to advance cost effective technologies for the prevention and treatment cluster headaches as well as future indications for sphenopalatine ganglion neuromodulation.

  1. Goadsby, P. J., Sahai-Srivastava, S., Kezirian, E. J., Calhoun, A. H., Matthews, D. C., McAllister, P. J., Costantino, P. D., Friedman, D. I., Zuniga, J. R., Mechtler, L. L., Popat, S. R., Rezai, A. R., & Dodick, D. W. (2019). Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. The Lancet Neurology, 18(12), 1081–1090.