A startup called NeuroPace is hoping to get approval to sell its first neural implant. NeuroPace's work is just one example of a booming market in the nascent field of neural devices.
NeuroPace, which in July submitted a brain implant for epilepsy treatment to the U.S. Food and Drug Administration for approval after a decade of development, hopes to have its RNS system approved within a year.
"I believe that in the next decade, multiple closed-loop and open-loop brain stimulation devices will replace destructive surgical therapies," said Martha Morrell, chief medical officer of NeuroPace, at the BioMedDevice Forum.
Trials of epilepsy implants have given researchers a glimpse into the technology's potential to treat a wide range of serious conditions, from pain and depression to Parkinson's and Alzheimer's diseases.
"This is the first time we've been able to peer into the brain and see changes in real time," Morrell said. "We can use this as a tool for disease management."
NeuroPace's RNS implant, which has two homemade chips, has found that abnormal brain activity in epilepsy patients is more intense than previously thought.
"There had been no previous records of patients with epilepsy diagnosed, and it turns out that seizures are just the tip of the iceberg," Morrell said. "We found that these patients needed up to 600 stimulations a day, each lasting one to two minutes."
Doctors can program the device to sense and respond to a variety of conditions, and NeuroPace maintains a database that can be used for long-term studies of brain wave activity.
Morrell said the potential of such devices is to release micro-drugs and electrical stimulation to targeted areas of the brain. New electrode arrays and sensors can expand the symptoms for which such devices are applicable. In addition to brain waves, researchers are also studying changes in brain blood flow, oxygen, neurotransmitters and even temperature to analyze symptoms.
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