Biologicinputoutputsystems

Market position

BIOS positions itself in the brain-computer interface and neural interface field, differentiating by interfacing with the peripheral nervous system rather than directly with the brain. It is listed as a life sciences member company of MTEC and is categorized in biotechnology, health care and medical devices.

Rather than interfacing directly with the brain, BIOS's Universal Neural Interface connects to the peripheral nervous system, which the company frames as a "USB port for the human body" providing bidirectional control and sensory feedback for prosthetic limbs. Its FDA Breakthrough Device Designation and university spin-out technology platform are additional stated distinguishing factors.

Technology

The core product is an implantable universal neural interface system for peripheral nerve implantation, using implanted electrode arrays to record motor intent and to deliver stimulation for sensory feedback in a closed loop. Stated technology areas include peripheral nerve interfacing, closed-loop neural recording and stimulation, AI/machine-learning neural decoding, robotic prosthesis sensor integration, advanced implantable materials and biocompatibility, and immersive training software. Associated expertise covers neural engineering, prosthetics and robotic control integration, clinical trial implementation for implantable devices, medical device regulatory strategy, and intellectual property development.

Go-to-market

The company pursues a regulated medical device path, conducting clinical investigations of its implanted peripheral nerve interface and having obtained FDA Breakthrough Device Designation to expedite review. It works through collaborations with academic partners, notably the University of Utah Neurorobotics Lab, external advisory teams, and interest registries for patients, caregivers and providers, and it recruits staff via its website. The company has also lobbied the U.S. government according to a congressional-affairs data provider.

Individuals with limb loss, initially upper limb loss, together with the clinicians who fit and support advanced prosthetic limbs; the company also maintains registries of patients, caregivers and healthcare providers. Company-reported news references applications for veterans.

Geography

U.S.-focused: the website states it is intended only for individuals in the US and that goods and services may not be available elsewhere, and its terms of service are governed by California law. Technology and clinical activity are tied to the University of Utah, from which the platform was spun out, and to the Utah NeuroRobotics Lab.

History

Founded in 2021 as a spin-out of the University of Utah technology platform, BIOS announced in March 2024 that the FDA had granted Breakthrough Device Designation covering investigation of the BIOS system for control of and sensory feedback from robotic prosthetic upper limbs. Subsequent company-reported milestones include a collaboration that improved its implantable neural interface, the appointment of Chris Duncan, MD as Chief Medical Officer, a presentation at the Utah Life Sciences Summit, a tour of the Utah NeuroRobotics Lab by congressional and state delegations, and a feature of its work with the University of Utah Neurorobotics Lab at Super Bowl LIX.

Risks & controversies

The BIOS system is an investigational medical device that is not approved for general use; the company's website states such use is limited to investigational use only under U.S. federal law and that site information is not medical, regulatory or legal advice.