Sam Brusco, Associate Editor03.11.24
ONWARD Medical has been accepted into the U.S. Food and Drug Administration (FDA)’s new Total Product Lifecycle Advisory Program (TAP) for its brain-computer interface (BCI) technology.
This news follows ONWARD’s announcement last week that it had been awarded breakthrough device status from the FDA for its investigational ARC-BCI system. ONWARD is the second BCI company to be accepted into the program.
Being accepted into TAP gives ONWARD early and frequent strategic engagement with the FDA, patients, providers, and payers to help with more rapid development and widespread patient access. The company will benefit from more timely premarket interactions, earlier identification and mitigation of development risks, and a more efficient premarket review process.
The ARC-BCI system pairs BCI with the company’s ARC-IM therapy to restore mobility after spinal cord injury (SCI). Two clinical feasibility studies have supported ARC-BCI’s potential to date, including one in 2021 and 2023 that restored lower and upper limb mobility, respectively.
These were the first studies in history where someone regained thought-driven movement of the limbs following paralysis.
“We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver. “TAP enables us to reduce the time and cost to deliver the benefits of ARC-BCI to people living with paralysis.”
This news follows ONWARD’s announcement last week that it had been awarded breakthrough device status from the FDA for its investigational ARC-BCI system. ONWARD is the second BCI company to be accepted into the program.
Being accepted into TAP gives ONWARD early and frequent strategic engagement with the FDA, patients, providers, and payers to help with more rapid development and widespread patient access. The company will benefit from more timely premarket interactions, earlier identification and mitigation of development risks, and a more efficient premarket review process.
The ARC-BCI system pairs BCI with the company’s ARC-IM therapy to restore mobility after spinal cord injury (SCI). Two clinical feasibility studies have supported ARC-BCI’s potential to date, including one in 2021 and 2023 that restored lower and upper limb mobility, respectively.
These were the first studies in history where someone regained thought-driven movement of the limbs following paralysis.
“We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver. “TAP enables us to reduce the time and cost to deliver the benefits of ARC-BCI to people living with paralysis.”