First Prospective Registry in SPG Stimulation Demonstrates Pulsante® Therapy Effectively Treats Painful, Disabling Cluster Headaches
MOUNTAIN VIEW, California, January 25, 2018 — Autonomic Technologies, Inc., today announced the publication of results from the Pathway R-1 Registry study demonstrating the Pulsante® SPG Microstimulator System’s effectiveness in more than two-thirds of patients with cluster headache, a disabling neurological condition with no known cure. The study results, published in The Journal of Headache and Pain, support the positive safety and efficacy results seen in the pivotal Pathway CH-1 randomized controlled trial, for which 24-month results were published in 2016. Autonomic Technologies is a medical device company focused on the development and commercialization of innovative therapies for the treatment of severe headache.
Therapy with the Pulsante® SPG Microstimulator System works by stimulating a nerve bundle behind the nose known as the sphenopalatine ganglion (SPG). Pathway R-1 is the first prospective study to evaluate the effectiveness of SPG stimulation through one year in an open-label setting with both chronic and episodic cluster headache patients. Following the 85 patients (78 chronic, 7 episodic) that completed 12 months in the study, investigators found the treatment to be effective in 68% of patients at one year, either through a significant reduction in the frequency of attacks and/or through achieving pain relief in most attacks. Among all patients, 13,600 attacks were acutely treated with SPG stimulation in the study.
The study also demonstrated a significant reduction in attacks. On average, patients experienced 42.9% less cluster headaches at 12 months (p<0.0001, n=85) than before starting Pulsante® Therapy. Most of this reduction occurred in the first few months of therapy and was sustained throughout the study to one year. In addition to less attacks, patients also reported clinically meaningful improvements in disability levels, quality of life, and medication use.
“This study’s results are very encouraging because they reinforce clinical results seen in earlier cluster headache studies with SPG stimulation and demonstrate the therapy’s effectiveness in patients suffering from the burden and pain of cluster attacks,” said Niamh Pellegrini, President and CEO.
As seen in prior clinical studies of the device, side effects experienced in the Pathway R-1 Registry study were generally considered mild to moderate and generally resolved within a few months—similar to side effects experienced in orofacial procedures. Overall patient satisfaction was high, and 86% of patients in the study said they would recommend the therapy to someone else.
For full text of this publication please visit: https://thejournalofheadacheandpain.springeropen.com/articles/10.1186/s10194-017-0828-9
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.
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. Patients treat their cluster attacks by using an external remote controller held to their cheek to activate a microstimulator implanted above the upper jaw. After a headache is treated, the remote controller is simply moved away from the cheek, stopping therapy. The miniature implant is inserted in a 60- to 90-minute oral procedure that leaves no visible scar, then therapy is customized for each patient during in-office follow- up visits.
The Pulsante® Microstimulator System is CE marked in Europe for the for 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. The company’s initial product, the Pulsante® SPG Microstimulator System, is CE marked in Europe for acute pain relief of cluster headache and pain relief for highly disabled migraine patients. 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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