APPLICATION
Autonomic Regulation & Stress Resilience
Closed-loop vagal modulation stabilizes sympathovagal balance across circadian phase.
HRV +112%
cortisol reactivity −54%
MYELIN-01 · CLASS III INVESTIGATIONAL NEURAL INTERFACE
A biocompatible mesh at the brainstem that senses and gently steers the autonomic nervous system — in a continuous closed loop.
A BCI reads the cortex to drive external devices. Myelin-01 sits at the brainstem and closes the loop on your own physiology — heart rate, respiration, sleep architecture, stress response.
FLAGSHIP OUTCOME · N=142 · 90-DAY IDE
+112%HRV
CLOSED-LOOP VAGAL MODULATION · RMSSD VS BASELINE
§ 01 · THE CLOSED LOOP
Sense. Decide. Modulate. Tissue responds. Repeat — hundreds of times per second.
Sense
2,048 ch · 30 kHz
Decide
On-device inference
Modulate
Sub-threshold pulse
Tissue
Autonomic response
SENSE2,048 channels @ 30 kHz
The reading half of the loop. A continuous physiological state vector — arousal, recovery, inflammation — streamed and inferred on-device. Real-time diagnostics live here.
DECIDEOn-device inference
Edge models estimate setpoint error every cycle. No cloud round-trip; no external hardware in the path.
MODULATESub-threshold · charge-balanced
Envelope-limited biphasic pulses nudge the autonomic system toward target. Every pulse is hardware-clamped before it leaves the die.
TISSUEAutonomic response
Efferent traffic reaches the target organ; afferent feedback returns to the sense channels — closing the loop.
The loop runs autonomously on-device at ~2.4 mW. No external hardware in the path.
§ 02 · WHAT THE LOOP IS FOR
Three therapeutic applications — one mechanism.
APPLICATION
Sleep & Recovery
Phase-locked slow-wave and REM entrainment, gated by on-device sleep staging.
12% → 24%
deep sleep fraction
APPLICATION
Adaptive Neurorehabilitation
Spike-timing-dependent stimulation scaffolds motor recovery on afferent traffic.
Fugl-Meyer +38%
12-week motor gain
§ 03 · SPECIFICATIONS
Myelin-01 · engineering brief
- Form factor
- 8.2 × 6.4 mm flexible conformal mesh
- Placement
- Dorsal brainstem surface · non-penetrating
- Channels
- 2,048 @ 30 kHz each
- Closed-loop latency
- < 300 µs
- Power
- Inductive · 2.4 mW average
- Comms
- UWB + BLE 5.4 · signed OTA firmware
- Lifetime
- 10+ years in vivo
- Cryptography
- AES-256 · Ed25519 · on-device keys
§ 04 · SAFETY & TRUST
Every command is bounded by hardware, verified by cryptography, and reversible by design.
SEVEN INDEPENDENT FAIL-SAFE GATES
G01Hardware charge balancing
G02Independent watchdog MCU
G03Thermal cutoff · 0.8 °C
G04Stim envelope limiter
G05Ed25519 command signing
G06Remote kill switch
G07Explant-safe anchoring
ENCRYPTED NEURAL MESH
AES-256 payload encryption with Ed25519 command signing. Keys are minted and custodied on-device inside the secure element — they never leave the implant controller.
STANDARDS MAPPING
- ISO 10993
- IEC 62304 CLASS C
- AAMI/ISO 14708-3
- FIPS 140-3