Wellness Device: Oralable is not a medical device and is not intended to diagnose, treat, cure, or prevent any disease.

Clinical validation trials are underway at Beacon Hospital as part of our research program. The consumer app and hardware remain wellness tools unless and until regulatory clearances apply.

About Oralable

Simple biofeedback for personal awareness of muscle activity patterns.

Oralable is developing an accessible optical myography (OMG) platform centred on the Temporalis muscle — the natural evolution of our early masseter-focused exploration.

Our Story

We deliberately shifted placement from the masseter to the temporalis region for sleep and bruxism science: temple-adjacent coupling preserves cleaner optode geometry and coupling stability overnight, giving us a path to 100% signal integrity for hemodynamic occlusion–linked features (IR-DC / AC) in long recordings. That pivot underpins our Temporalis Fatigue Index (TFI), hypoxic burden (SASHB) rollups, and the McGill–aligned artifact program described on For Researchers.

Roadmap

Gen1 / Gen2 are hardware generations (Kaga module + BOM). Phase 0 / Phase 1+ are software feature phases — they run on Gen1 hardware today and carry forward to Gen2. Product path: Stage A wellness wearable first, then Stage B medical device later — implementing the new US patent filing as a working product (not claimed as a medical device today).

Hardware ↔ BOM map

Generation BOM PCB Module (U5) Firmware
Gen1 (shipping) PCB00003-TGM-BOM-REV8 REV10 pilot (REV8 prod data) Kaga ES2832AA2 · nRF52832 1.0.70 ship (min 1.0.63)
Gen2 (upcoming) PCB00003-TGM-BOM-REV9 REV11 Kaga ES4L15BA1 · nRF54L15 2.0.x target (not shipping)

Battery: Gen1 CG-320B ~15 mAh · Gen2 LP260820 ~30 mAh. Same clip/case charge architecture (LTC4124 / LTC6990 — not WPC Qi). Software phases do not change the BOM.

2024

Foundation

  • Optical myography (OMG) / PPG approach for jaw load
  • Patent protection (US & EU)
  • Early masseter → temporalis placement research
2025

Gen1 platform build

Hardware: Gen1 · BOM REV8 · PCB00003 · ES2832AA2

  • PCB00003 clip + Oralable magnetic charging case
  • Kaga ES2832AA2 (nRF52832) · MAXM86161 PPG · LIS2DTW12 accel
  • iOS app + BLE TGM streaming (50 Hz PPG/ACC)
  • Invitation beta / early adopters
H1 2026

Gen1 kits in the field

Hardware: Gen1 · BOM REV8 · PCB REV10 · ES2832AA2 · FW 1.0.6x

  • App Store / early access presence
  • Ed/Pedro-class kits: REV10 assemblies on BOM REV8
  • Honest device state (charger / bench / worn) + LED status matrix
  • OTA DFU path for field updates
Mid 2026

Vitals Phase 0 — Gen1 (You are here)

Hardware: Gen1 · BOM REV8 · PCB REV10 · ES2832AA2 · FW 1.0.70

  • Temple / temporalis placement (no muscle-fit calibration)
  • Heart rate (green PPG) with signal-quality gating
  • SpO₂ (red / IR) with quality gating
  • Battery & charge status cards; Device LED mirror in app
  • Manual placement modes for Gen1 charge-sense limitations
  • Beacon Hospital clinical program
  • Not yet: clench/grind detection, Protocol B, EMG-style muscle UI
Late 2026+

Muscle Phase 1+ — Gen1 software

Hardware unchanged: Gen1 · BOM REV8 · PCB REV10 · ES2832AA2 (same kits; app/FW features unlock)

  • IR-DC occlusion / hemodynamic load for clench & grind phenotypes
  • Temporalis Fatigue Index (TFI) session & hourly rollups
  • Hypoxic burden (SASHB) correlated with overnight SpO₂
  • Actigraphy / jaw vibration from accelerometer
  • Protocol B / muscle calibration flows (when gates pass)
  • Oralable for Professionals & research export workflows
  • Clinical PDF / handshake summaries (TFI, SASHB, events)
2026–2027

Gen2 hardware — new BOM

Hardware: Gen2 · BOM REV9 · PCB REV11 · ES4L15BA1 · FW 2.0.x (target)

  • Kaga ES4L15BA1 (nRF54L15, BLE 6.0) — more RAM/Flash
  • LP260820 ~30 mAh battery (longer temple sessions)
  • Same GATT / 50 Hz stream contract as Gen1 (app continues)
  • Re-validated charge-status (chrsts) → automatic on-dock when hardware allows
  • Calibrated battery SOC on case; dedicated status LED (no PPG/LED confusion)
  • Skin thermistor path for worn detect (fewer die-heat false positives)
  • Richer OTA slots; optional on-device ML (bruxism / vitals) later
  • Pilot parity: temple HR & SpO₂ gates equal or better than Gen1
2027+

Stage B — medical device path (later)

Primary on Gen2 (BOM REV9 / REV11); Gen1 sunset after parity

  • Stage A first: patent-implementing wellness wearable (not claimed as a medical device today)
  • Working embodiment of the new US patent submission (Temporalis OMG / IR-DC / TFI / SASHB)
  • Foundation patents remain: granted US & EU (details with counsel)
  • Expanded clinical validation → future 510(k) / CE exploration
  • Academic / hospital partnerships
  • Gen1 sunset after Gen2 IR-DC, RF, and iOS soak parity

What We're Building

Oralable is a personal wellness tool for overnight temple vitals today, with jaw-muscle biofeedback as Phase 1+ lands — for people curious about their patterns during sleep, work, or daily activities.

What It Monitors

  • Phase 0 (now) — Temple heart rate & SpO₂ with honest device state
  • Phase 1+ — Clenching, grinding, rest periods via IR-DC / TFI
  • Overnight context — SpO₂ burden (SASHB) alongside muscle load

What Oralable Is

  • A consumer wellness device
  • A biofeedback tool for personal awareness
  • Similar in concept to fitness trackers
  • Accessible and affordable
  • Privacy-focused (you control your data)

What We're Not (Yet)

Oralable is currently a wellness device, not a medical device. Clinical validation trials are underway at Beacon Hospital; those studies inform our roadmap and do not change the regulatory status of the consumer product today. This means:

  • We do NOT diagnose any medical conditions
  • We do NOT provide medical advice
  • We are NOT approved by FDA, CE, or other medical regulatory bodies
  • We are NOT a substitute for professional healthcare

Future Plans: We are exploring a medical device pathway for future versions. This would involve clinical validation studies, regulatory approvals, and partnerships with healthcare institutions. However, this is a multi-year undertaking and our current product should be understood as a wellness/biofeedback tool only.

Our Company

JAC Dental Solutions Limited (Amstrow)

Dublin, Ireland · Primary operating entity for Oralable

Founded to develop innovative oral health awareness tools. We believe that simple biofeedback can help people become more aware of habits they might not otherwise notice.

Contact