Program
What we are building, and in what order.
Research instrumentation, designed to be low-cost and carefully measured, for studying the brain’s own maintenance systems. Bench first. Independent verification before people. Evidence before claims. Technical detail follows the results.
The idea
Can the systems the brain already uses to maintain itself be measured — and, safely, supported? That is our research question.
A healthy brain clears its own waste, powers its own repair, feeds and protects its own tissue and rewires its own connections, and much of that work is linked to sleep. Research over the past fifteen years has mapped these systems in detail and shown that they weaken with age and in neurodegenerative disease. That knowledge was won with research-grade equipment in university laboratories.
Our thesis is that research instruments that measure these systems precisely enough to test whether they can be supported can be engineered to be far simpler, safer and less expensive than the instruments used to discover them — at a cost that lets independent labs repeat our measurements and lets the right questions be studied more widely.
Here we describe how we work, where we are and what each step takes. The specifics of our approach follow when the results are ready for independent review.
What this is
A research instrument program with a clear path: a bench instrument first, independent verification next, then supervised human studies with ethical oversight, and from there a regulatory determination. Nothing described here is a product. See our commitments.
Why hardware
Many of the brain’s maintenance processes are physical as much as chemical: fluid moving, vessels changing diameter, energy being produced and distributed. Physical systems can be measured directly and checked by independent instruments, which is what makes the question of whether they can be supported testable. Hardware also has a different cost structure from a drug; once the engineering is right, it can be made inexpensively and reproduced anywhere.
How we work
Built to be checked by someone who was not in the room.
Measure, do not assume
Everything the hardware does is measured by instruments independent of the ones that control it, so a fault in either is visible rather than hidden.
Safety has its own authority
Safety functions are engineered separately from everything else and can stop the system regardless of what the rest of it believes. This is standard practice in safety-critical engineering, and we hold ourselves to it from the first bench unit.
Everything is recorded
Results are logged in enough detail that an outside reviewer can reconstruct and audit them without taking our word for anything.
Certified components, verified as a system
Design goal: build from industrial components that carry their own certifications (for example, electrical safety of a power supply), chosen for cost and availability. Those certifications cover the components; the assembled system is verified separately, and we publish measured results rather than inferred ones.
Publish, including failures
Bench results will be shared in plain language as they are produced, negative results included. Specific designs follow when they have earned it.
Three tracks
Where the platform goes once the bench has earned it.
Each track has its own evidence requirement and regulatory route. The bench work below serves all three; nothing moves to a track until the instrument has been characterized and independently verified.
An affordable research and clinical instrument
Bench instrument first, then independent verification, supervised studies with clinical collaborators and a formal regulatory determination. The goal is a unit authorized by FDA for its intended use and priced so that laboratories and clinics can own one. NeuroClearance record
A consumer line for everyday self-improvement
Lullwave is a separate consumer line intended to fit FDA’s general-wellness policy for low-risk products: wellness claims only, no diagnosis or treatment, and no dependence on the regulated track’s timeline. Counsel review of that fit is part of the plan. Nothing is for sale yet. NeuroClearance record
Coordinated systems for rehabilitation and recovery
The direction described in our filings: coordinated, multi-modality systems that support recovery and rehabilitation under supervision, with each modality added only after its own measurement, independent review and safety case. A research hypothesis with no timeline and no claim of benefit. Research hypothesis
Roadmap
Where we are.
Each stage has an exit gate. We advance on evidence, not on a calendar.
- Done 2025 – September 2026
Literature synthesis and safety concept
Literature synthesis and the safety concept are complete; the open library was published October 9, 2026. The prototype specification is being finalized during assembly. Six U.S. provisional patent applications have been filed as we continue to build the research and technical portfolio; their contents are private.
- Under way updated October 13, 2026
First bench unit
Components for the first bench configuration arrived and were inventoried in late September 2026. Assembly has begun; the prototype specification is being finalized. Exit criterion: an integration record identifying the configuration, then a measurement-characterization report (repeatability, calibration and timing under stated conditions). Non-human only.
- Next
Independent verification
Measurement accuracy and safety behavior verified by people outside the program, with the reviewer’s scope and findings published. Bench data published as approved summaries, including what did not work.
- Then
Regulatory pathway and clinical partners
Formal regulatory determination, risk management, and design of supervised research studies with academic and clinical collaborators under appropriate ethical oversight.
- Goal
Evidence, then authorization
If — and only if — supervised studies support it and regulators authorize it, make any resulting system available through appropriate channels, priced for access.
Regulatory status
NeuroClearance systems are investigational research instruments under development for supervised research. Human studies will run under independent ethical oversight and, where required, an FDA Investigational Device Exemption. Any system intended for wider use will go through regulatory review first, and claims of benefit will follow the evidence and the regulators’ determination. NeuroClearance is also developing Lullwave, a separate consumer wellness line that makes wellness claims only. For investors, see the investor brief; nothing on this site is an offer of securities.
Bench update cadence
We will show our work.
As the first unit comes together we will publish short, plain-language bench notes here and to the community list: what was measured, how, and what it means. Negative results included.
Want the notes?
Dated entries are on the Updates page. Email [email protected] with the subject “Updates” and we will add you to the list.
Open research needs
Three problems with a defined first contribution are posted on Partner with us: a calibration, timing and uncertainty plan; an endpoint and alternative-explanations review; and research-readiness requirements.