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Precisis lines up EU approval for 'brain pacemaker' to treat epilepsy

2022-09-23

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来源: FierceBiotech

The EASEE technology, which Heidelberg-based Precisis has termed a “brain pacemaker,” works by sending bioelectric pulses to stabilize the area of the brain linked to epileptic seizures.

Though drugs can help treat many cases of epilepsy, for the roughly 30% of patients with drug-resistant cases, it can take decades to find an effective alternative.

A neurostimulation system newly approved in Europe is aiming to change that. The EASEE system—named for its epicranial application of stimulation electrodes for epilepsy—was developed by Germany’s Precisis as a minimally invasive treatment for epilepsy that can be introduced in its early stages, as soon as multiple drug options fail.

With the EASEE system’s newly bestowed CE mark, the technology will be immediately available to adult epilepsy patients in the E.U., Precisis announced Friday.

The EASEE technology, which its Heidelberg-based maker has termed a “brain pacemaker,” works by sending bioelectric pulses to stabilize the area of the brain linked to epileptic seizures. It delivers two types of stimulation, neither of which can be felt by the patient: high-frequency pulses that arrive every two seconds to ward off oncoming seizures and longer phases that are applied for 20 minutes a day for long-term regulation of the brain. The pace and intensity of the pulses can be continuously adapted to each patient’s needs.

The system comprises a pulse generator that’s implanted in the chest area and connects through a cable to an electrode pad, which is placed just under the skin of the scalp to deliver the neurostimulation therapy. Both implants are placed during minimally invasive operations that can be completed back-to-back in the same procedure and that eliminate the need for drilling into the skull or physically interacting with the brain at all.

In a pair of clinical trials of the technology, about half of participants saw the frequency of their seizures cut by at least 50% after six months of using the EASEE system, and four patients were completely seizure-free. Almost all of the trials’ participants saw at least some improvement in their seizure frequency—with a median reduction of 52%—and only four of 31 experienced no benefit at all from the system.

“The low-risk implantation procedure and the outstandingly positive spectrum of side effects suggest that EASEE will be a future therapeutic option for drug-refractory focal epilepsies,” said Andreas Schulze-Bonhage, M.D., Ph.D., head of the epilepsy department at University Hospital Freiburg in Germany, who headed up the clinical studies.

With European approval locked down, the company has now turned its focus to its continued pursuit of regulatory clearance in the U.S.

The EASEE system is already on the FDA’s radar: In February of this year, the neurostimulator received the agency’s breakthrough device designation, which spotlights potentially groundbreaking technologies for hard-to-treat health conditions and streamlines their paths toward FDA authorization.

Precisis is also looking to expand the current indication for the system, with plans to launch a study of its efficacy in children and teenagers later this year.

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