Paradromics Inc., a leading developer of brain-computer interfaces (BCI), announced its acceptance into the U.S. Food and Drug Administration's newest program for innovative devices, the Total Product Life Cycle Advisory Program.
According to the FDA, the TAP accelerator program was launched to "help spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance."
The TAP program was created exclusively for devices designated by the FDA as Breakthrough Devices. The Paradromics Connexus® Direct Data Interface has received two such designations from the FDA: one recognizing its potential to help patients communicate again after losing the ability to speak and a second for its ability to help patients with severe loss of movement to control computer devices. The FDA Breakthrough Device Designations provide an expedited review process for transformative medical devices with the potential to treat irreversible, debilitating conditions. TAP further accelerates the review process by providing additional opportunities for rapid communication between regulators and companies.
Matthew Willsey, MD, PhD, a leading neurosurgeon at the University of Michigan Medical School states, "I'm excited to see BCI technologies, such as the Connexus device, entering the clinical phase. This is one step closer to restoring movement to people with paralysis, or speech to those who have lost this function."
Paradromics is one of two companies with fully implantable BCIs capable of recording from single neurons, and the only company to achieve this using durable materials and packaging. Those qualities provide a sizable advantage: the ability to obtain very high-resolution data over long periods of time. This high-resolution data can enable complex applications like decoding intended speech. The first use of the technology will be for individuals living with ALS, spinal cord injury, and stroke who have lost their ability to communicate. Future applications of the technology will be in treatment-resistant mental health, such as depression.
"We are happy to partner more closely with the FDA" said Paradromics CEO, Matt Angle. "Building a device that senses neural signals with single neuron resolution and works reliably in the body for years was challenging. There are easier approaches, but they aren't as good for patients. We want to deliver the best possible device on the safest possible timeline, and so we appreciate access to the TAP program."
In preparation for its clinical trial in 2025, Paradromics is also announcing the launch of the Paradromics Patient Registry, where patients can submit their interest in participating in the trials when they begin. Establishing this line of communication with potential patients further supports Paradromics' efforts to ensure that innovative technologies are brought to patients as swiftly and safely as possible.
