Paradromics Accepted to FDA Regulatory Acceleration Program, New Patient Registry Announced

AUSTIN, Texas, July 1, 2024 /PRNewswire/ — Paradromics Inc., a leading developer of brain-computer interfaces (BCIs), today announced its acceptance into the U.S. Food and Drug Administration’s latest Innovative Devices Program, Full product life cycle consulting programAccording to the FDA, the TAP accelerator program was launched to “help accelerate the development of and provide patients with more rapid and widespread 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 re-communicate after losing the ability to speak, and the other for its ability to help patients with severe mobility loss control computer devices. FDA Breakthrough Device designations provide an expedited review process for transformative medical devices with the potential to treat irreversible, devastating conditions. TAP further speeds the review process by providing additional opportunities for rapid communication between regulators and companies.

Matthew WillseyMD, PhD, leading neurosurgeon in University of Michigan Medical School states, “I am excited to see BCI technologies like the Connexus device enter the clinical phase. This is a step closer to restoring movement to those with paralysis or speech to those who have lost this function.”

Paradromics is one of only two companies with fully implantable BCIs capable of recording from single neurons, and the only company to do so with durable materials and packaging. These features provide a significant advantage: the ability to obtain very high-resolution data over a long period of time. This high-resolution data could enable complex applications such as decoding intended speech. The technology’s first application will be in people living with ALS, spinal cord injury and stroke who have lost the ability to communicate. Future applications of the technology will be in treatment-resistant mental health conditions such as depression.

“We look forward to working more closely with the FDA,” said Paradromics CEO, Matte angle“Building a device that detects neural signals with single-neuron resolution and works reliably in the body for years has been a challenge. There are easier approaches, but they’re not as good for patients. We want to deliver the best possible device in the safest possible time, so we appreciate having access to the TAP program.”

As we prepare for a clinical trial in 2025, Paradromics is also announcing the launch of the Paradromics Patient Registry, where patients can register their interest in participating in the trials as they begin. Establishing this line of communication with potential patients further supports Paradromics’ efforts to ensure that innovative technologies are delivered to patients as quickly and safely as possible.

About Paradromics Inc.

Paradromics (www.paradromics.com), with headquarters in Austin, Texasintroduces a high-throughput brain-computer interface (BCI). The first application of the Connexus® Direct Data Interface is a BCI-enabled augmentative communication device for people with severe motor impairments. This technology has the potential to revolutionize the treatment of neurological and brain-related conditions, from sensory deficits to mood disorders—enabling millions of people to live happier, healthier, more enriched lives.

Contact with the media:
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Gavin Mathie
Driving Force Laboratory
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SOURCE Paradromics