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Regulatory
22 September 2021
Man & Science announces U.S. FDA Breakthrough Device Designation granted for the treatment of chronic cluster headache
Designation granted by the FDA’s Center for Devices and Radiological Health for the company’s minimally invasive neuromodulation therapy
Mont-Saint-Guibert (Belgium), September 22, 2021- Man & Science SA, a private medical device company focused on the development of innovative solutions for headache disorders, announced today that it has been granted a Breakthrough Device Designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its minimally invasive innovative neuromodulation therapy for the treatment of Chronic Cluster Headache (CCH).
The FDA’s Breakthrough Designation Program aims to help patients and healthcare providers to receive timely access to breakthrough technologies with potentially more effective treatment of life-threatening or irreversibly debilitating diseases or conditions.
Under the Program, the FDA will provide the Man & Science’s OCCIPITAL NERVE FIELD STIMULATION SYSTEM (ONFS) with priority review and interaction with FDA’s experts throughout the premarket review phase.
“We are pleased to have received Breakthrough Device Designation for our proprietary ONFS system for CCH patients, recognizing that our solution is innovative. This Breakthrough Designation should accelerate our market authorization process in the US.”
— Robert Taub, CEO of Man & Science
FDA Breakthrough Device Designation does not constitute FDA clearance or approval.
About Man & Science
Man & Science SA is a privately owned, clinical-stage medical device company based in Liège, Belgium. The company develops next-generation, minimally invasive neuromodulation technologies for the treatment of chronic and debilitating neurological disorders. Its programmes include the ONFIELD pilot clinical study, which is evaluating a miniaturised occipital nerve stimulation (ONS) implant in patients with chronic, refractory cluster headache, as well as an injectable peripheral nerve stimulation (iPNS) platform designed to shift neuromodulation from surgery to injection and expand access to neuromodulation for patients with severe migraine and other neurological disorders.
Media contact
Hugues Wallemacq, Chief Executive Officer, hugues.wallemaq@manandscience.com
Forward-looking statements. This press release may contain forward-looking statements about clinical development, regulatory plans and future activities. These are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Man & Science undertakes no obligation to update them.
CAUTION: Investigational devices. The ONSS and iSPGS systems are investigational devices and are not approved or cleared for commercial use in any market. In the United States: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use. In the European Union: Exclusively for clinical investigation under Regulation (EU) 2017/745 (MDR). FDA Breakthrough Device Designation does not constitute FDA clearance, approval, or marketing authorization.
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