Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

Cambridge-based Sinaptica Therapeutics, a company that provides electromagnetic treatments for patients with neurodegenerative diseases, announced that it has received Breakthrough Device Designation from the FDA for its non-invasive SinaptiStim-AD system, used to treat cognitive impairment and functional decline in Alzheimer’s patients.

SinaptiStim uses neurostimulation and brainwave monitoring technologies with an AI personalization engine to deliver electromagnetic therapy for cognitive and functional decline in Alzheimer’s patients.

The FDA approval is based on the results of a Phase II clinical trial in patients with mild to moderate Alzheimer’s disease, which has yet to be published in a peer-reviewed journal.

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The system is intended for research use only. FDA approval accelerates device development, evaluation and review. It also gives Sinaptica priority review and interactive communication through the premarket review process with the FDA.

“This is an important milestone for the Company as it helps establish our regulatory path for FDA approval of our SinaptiStim AD System,” said Rich Macary, President of Sinaptica Therapeutics, in a statement. “We plan to continue working toward the start of our pivotal study over the next year and to further advance the emerging field of electromagnetic therapeutics because of their unique ability to modulate key mechanisms of synaptic plasticity and network connectivity in targeted regions of the brain.”

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Other companies use neurostimulation, the targeted modulation of specific parts of a patient’s brain, spinal cord or peripheral nervous system, to treat various other conditions.

DyAnsius, a California-based medical device company specializing in the autonomic nervous system, offers Primary Relief, a percutaneous electrical nerve stimulation (PENS) system for the management of postoperative pain following cardiac surgery. Last month, the PEN system received FDA approval.

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Publicly traded NeuroPace develops implantable devices to treat neurological disorders. The RNS system is a neurostimulation therapy device for adults who frequently suffer from disabling epileptic seizures.

In August last year NeuroPace has launched its nSight platform. The portal collects information about a patient’s seizures and health progress to provide physicians with data points to personalize care soon after the company went public.


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