MYELIN-01 · CLASS III NEURAL INTERFACE · REV 04
Myelin-01
A biocompatible neural mesh at the brainstem that measurably enhances autonomic, sleep, and cognitive physiology — in closed loop, under seven independent fail-safe gates.
01 · PLACEMENT & SIGNAL FLOW
How it works
- 01
Conformal placement
Minimally invasive placement of a flexible mesh contoured to the dorsal brainstem surface.
- 02
Continuous sensing
2,048 channels read efferent and afferent autonomic traffic at 30 kHz per channel.
- 03
On-device inference
Edge models estimate physiological state — arousal, recovery, inflammation — every cycle.
- 04
Closed-loop modulation
Sub-threshold stimulation nudges the autonomic system toward target setpoints.
SIGNAL CHAIN · CLOSED LOOP
Sense → decide → modulate in under 300 microseconds
2,048ch · 0.5 µV noise floor
16-bit · 30 kHz / ch
2 TOPS · INT8 edge core
Closed-loop policy · ±80 µA
Charge-balanced · biphasic
UWB + BLE 5.4 · encrypted
LATENCY BUDGET
- Sense
- 33 µs
- Infer
- 240 µs
- Decide
- 12 µs
- Stim
- 9 µs
- Total loop
- < 300 µs
FAIL-SAFE LADDER · SEVEN INDEPENDENT GATES
Every stimulation pulse crosses seven gates before leaving the die.
- G01Hardware charge balancing
Every pulse integrator resets to net-zero charge before the next stim window opens.
- G02Independent watchdog MCU
A separate die supervises the stim core and cuts power on any missed heartbeat.
- G03Thermal cutoff at 0.8 °C rise
On-die thermistors gate duty cycle before tissue temperature can drift.
- G04Stim envelope limiter
Amplitude, pulse width, and frequency all clamp against a certified safe envelope.
- G05Cryptographic command signing
Ed25519-signed commands validated inside the on-die secure element.
- G06Remote kill switch
Clinician and patient can revoke stim authority instantly over an authenticated channel.
- G07Explant-safe anchoring
Conformal, non-penetrating anchoring validated for retrieval in long-term primate studies.
02 · CAPABILITIES
Beyond brain-computer interface
Six capabilities, one mesh. Each runs continuously on-device — select a capability to see its technical basis and measured effect.
Autonomic regulation
+112% vs baselineClosed-loop modulation of heart rate, respiration, and vagal tone via brainstem efferents.
Continuous estimation of sympathovagal balance drives sub-threshold stimulation of vagal efferents, holding target setpoints for heart-rate variability and respiratory sinus arrhythmia across circadian phase.
03 · PHYSIOLOGICAL ENHANCEMENT
How the mesh enhances the wearer
Baseline versus MYELIN across four physiological systems. Data drawn from the ongoing 142-participant, 90-day cohort under IDE.
MEASURED · N=142 · 90-DAY COHORT
Vagal tone restored, HRV widened
Closed-loop stimulation of vagal efferents smooths beat-to-beat variability and lifts parasympathetic reserve toward athletic ranges.
- RMSSDwas 32ms0ms
- Resting HRwas 74bpm0bpm
- Vagal tone indexwas 0.420.00
04 · CLINICAL WORKFLOW
From implantation to intervention — patient-safe by construction
Five supervised stages. Every transition requires a co-signed authorization, and every intervention is envelope-limited before it leaves the die.
STAGE · S01
Implantation
Minimally invasive conformal placement of the mesh at the dorsal brainstem under image guidance.
- Sub-occipital keyhole access under neuronavigation.
- Mesh unfolds along the pial surface — no parenchymal penetration.
- Inductive coil seated in the retro-auricular pocket.
PATIENT-SAFE PACING
Explant-safe anchoring · verified in 24-month primate cohorts.
TRACE · S01
● IDLE
05 · COMPARISON
Head-to-head
| Feature | MYELIN | Cortical BCI | Wearable EEG |
|---|---|---|---|
| Implant site | Brainstem mesh | Cortical array | Scalp / wrist |
| Signal reading | Limited | ||
| Autonomic regulation | |||
| Sleep & recovery optimization | Partial | ||
| Mood / stress modulation | |||
| Adaptive neuroplasticity | Research only | ||
| Modular wireless firmware | Limited | ||
| Encrypted on-device keys | Varies | Rare | |
06 · SAFETY & BIOCOMPATIBILITY
Engineered to belong in the body
Five concentric safety layers wrap the mesh core. Each layer is independently verifiable and mapped to an external standard.
FAIL-SAFE ARCHITECTURE · DEFENSE IN DEPTH
5 independent safety layers, each verifiable in isolation.
Parylene-C encapsulation
Conformal biocompatible barrier isolates the electrode assembly from cerebrospinal fluid, tested across the full 10993 biological evaluation battery.
07 · SPECIFICATIONS
Specs
- Mesh footprint
- 8.2 × 6.4 mm
- Channel count
- 2,048
- Sampling rate
- 30 kHz / channel
- Closed-loop latency
- < 300 µs
- Power
- Inductive, 2.4 mW avg
- Wireless
- UWB + BLE 5.4
- Firmware updates
- Signed OTA, modular
- Encryption
- AES-256 · Ed25519
- Designed lifetime
- 10+ years in vivo
08 · FAQ
Frequently asked
How is MYELIN different from a brain-computer interface?+
BCIs typically read cortical signals to control external devices. MYELIN sits at the brainstem and closes the loop on the autonomic nervous system — reading and modulating.
Is the implant procedure reversible?+
The mesh is designed for retrieval. Conformal anchoring avoids penetrating parenchyma and supports explant if clinically indicated.
Who is eligible for the current trial?+
Adults with qualifying autonomic, sleep, or mood-regulation indications. Eligibility is reviewed by the trial clinical board.
How is my neural data protected?+
All data is encrypted on-device with keys that never leave the implant controller. You hold custody of decryption.
Can the firmware be updated after implantation?+
Yes. Firmware modules are signed and delivered over a secure wireless channel; updates can be rolled back on-device.