Australian epilepsy monitoring system Minder® designated as Breakthrough Device by US FDA
- Epi-Minder is developing Minder®, a novel, epilepsy monitor to revolutionize the lives of millions of people suffering epilepsy and seizures.
- FDA breakthrough device designation is for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.
- Epi-Minder will use the breakthrough devices program to expedite development and approvals of Minder.
26 April 2023, Melbourne, Australia: Australian medical device innovator Epi-Minder Pty Ltd has received FDA Breakthrough Device Designation for its ultra-long term epilepsy monitor known as Minder®.
The device is under clinical evaluation. It is a novel sub-scalp EEG monitoring technology and has the potential to transform the way epilepsy is managed and treated. Through continuous monitoring of EEG over months to years, Minder has the potential to provide more accurate seizure detection than current standard of care.
FDA Breakthrough Device designation is a major milestone. It is granted to medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and for which there are no approved alternatives. This designation will enable Epi-Minder to expedite the development and review process for Minder, potentially accelerating its availability to patients.
“Epi-Minder was founded on the belief that long term, continuous EEG monitoring of epilepsy will be transformational in the management of epilepsy. The Breakthrough Designation by the FDA is confirmation of that belief and that Minder is a breakthrough technology,” said Rohan Hoare, CEO of Epi-Minder. “We continue our efforts to bring this technology to market as soon as possible to improve the lives of those living with epilepsy.”
Minder is currently in being evaluated in the UMPIRE (sUb-scalp Monitoring ePileptic seIzuREs) clinical trial in Melbourne, Brisbane and Sydney, Australia.
-ENDS-
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Background:
About epilepsy
More than 250,000 Australians and 3.4 million Americans are currently living with epilepsy, the most common brain disorder worldwide that can affect people at any age. Refractory epilepsy affects 30 per cent to 40 per cent of these patients, who cannot be adequately managed by drug therapy to remain seizure free.
About Minder ®
Minder® is a minimally-invasive device for long-term monitoring of brain seizures, providing patients and their doctors with detailed data on seizure activity and frequency over an extended period. Patients can wear the device as they go about their normal daily activities.
Minder’s long-term monitoring of patients outside of a controlled clinical environment is expected to lead to more effective treatment of underlying conditions, including determining the effectiveness of drug therapies. Subject to clinical results, later generations of the device could include advanced detection and warning of impending seizure events.
Epilepsy affects 65 million people globally with current medications only effective in two in three cases.