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 moved placement from the masseter (cheek) to the temporalis (temple) so the optical window stays coupled overnight. Temple heart rate and SpO₂ are the product now. Jaw-load features follow on the same hardware. See For Researchers for methods work with a McGill / RI-MUHC researcher.
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 a medical device path later. Foundation patents are granted in the US and EU. We do not claim medical clearance today.
Hardware ↔ BOM map
| Generation | BOM | PCB | Module (U5) | Firmware |
|---|---|---|---|---|
| Gen1 (pilot · kits gated) | PCB00003-TGM-BOM-REV8 | REV10 pilot (REV8 prod data) | Kaga ES2832AA2 · nRF52832 | 1.0.85 (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.
Foundation
- Optical myography (OMG) / PPG approach for jaw load
- Patent protection (US & EU)
- Early masseter → temporalis placement research
Gen1 platform build
Hardware: Gen1 · BOM REV8 · PCB00003 · ES2832AA2
- PCB00003 clip + Oralable charging case (USB-C · not Qi)
- Kaga ES2832AA2 (nRF52832) · MAXM86161 PPG · LIS2DTW12 accel
- iOS app + BLE TGM streaming (50 Hz PPG/ACC)
- Invitation beta / early adopters
Gen1 firmware lineage
Hardware: Gen1 · BOM REV8 · PCB REV10 · ES2832AA2 · FW 1.0.6x → 1.0.70
- App Store / TestFlight presence
- REV10 assemblies on BOM REV8 (not yet shipped to clinic)
- Honest device state (charger / bench / worn) + green-only LED
- OTA DFU path for field updates
Vitals Phase 0 — Gen1 (You are here)
Hardware: Gen1 · BOM REV8 · PCB REV10 · ES2832AA2 · FW 1.0.85 · app 4.3.3 (build 5)
- Temple / temporalis placement (no muscle-fit calibration)
- Heart rate (green PPG) with signal-quality gating
- SpO₂ (red / IR) with quality gating
- Battery & charge cards; Device LED mirror in app
- Worn detect from IR pulse (not die temperature)
- Overnight state hypnogram in the patient app (Dashboard + Share) — device-inferred quiet / tonic / phasic / rescue / recovery after a long wear night
- Clinical Temporalis PDF export (hypnogram-first; full detail pack)
- Beacon Hospital clinic kits gated — charge-to-temple on each unit before handoff (target: five Oralable-only kits)
- Not yet: kits shipped, clench/grind product UI, Protocol B, professional app for Beacon
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
- Overnight bands + state hypnogram UX polish (already in patient app for long nights)
- Actigraphy / jaw vibration from accelerometer
- Protocol B / muscle calibration flows (when gates pass)
- Oralable for Professionals (after share gate — not Beacon Day-1)
- Clinical PDF / handshake summaries (TFI, SASHB, events)
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
Stage B — medical device path (later)
Primary on Gen2 (BOM REV9 / REV11); Gen1 sunset after parity
- Stage A first: wellness wearable (not claimed as a medical device today)
- Foundation patents: 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
- Overnight view — In-app state hypnogram (and Share PDF) for device-inferred overnight patterns after ≥6 h worn — not a medical sleep study
- 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. A Beacon Hospital clinic program is planned; kits have not yet shipped. That work does 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
- General: hello@oralable.com
- Support: support@oralable.com
- Research: research@oralable.com
- Press: press@oralable.com