FDA Breakthrough Device Designation · ISO 13485 Certified
HEALIX builds closed-loop medical devices that monitor healing continuously and deliver targeted therapeutics without clinician intervention. No PRN scheduling. No delayed responses. No device removal.
01 / Products
HEALIX Cast is an active clinical-stage device under FDA Breakthrough review. HEALIX Patch is a pre-clinical research system under active bench and animal-model investigation. Both run on the same IoT infrastructure and closed-loop architecture.
A next-generation orthopaedic cast that integrates twelve embedded biosensors with a closed-loop micro-needle analgesic delivery system modelled directly on insulin pump pharmacokinetics. Bone healing is monitored acoustically every 6 hours; the system autonomously adjusts analgesia to keep pain scores below 3/10 without clinician input. A dedicated dermis-care layer manages the skin environment under the cast: on-demand vibrotactile stimulation suppresses itch at source, while an encapsulated emollient micro-bead liner delivers hydration without cast removal.
1 MHz transducer array transmits through the cast shell, measuring acoustic impedance changes that correlate with callus density and mineralisation, calibrated against radiographic union staging.
280 μm hollow titanium micro-needles deliver NSAIDs, low-dose opioids, or ketamine subcutaneously. Dosing is computed by a PK/PD model that incorporates patient weight, pain NRS score, and cortisol proxy levels.
Continuous limb temperature mapping (16 thermal sensors) plus bioimpedance-derived pressure estimation. Alert fires when intracompartmental pressure exceeds 30 mmHg, giving a critical 4-hour advantage over clinical exam.
LSTM model trained on 52,000 longitudinal fracture cases produces a per-patient recovery roadmap: predicted soft-callus date, hard-callus date, and radiographic union, updated weekly with incoming sensor data.
Pulsed electromagnetic field coils (50 Hz, 1 mT) embedded in the cast shell deliver the FDA-cleared stimulation protocol automatically each night, and independent data shows 38% faster union time.
6-DOF inertial unit tracks joint angle, movement velocity, and symmetry during prescribed exercises. Haptic motor pulses provide real-time corrective cues; clinician receives weekly compliance and ROM reports.
Multi-frequency bioimpedance spectroscopy (5–500 kHz) quantifies extracellular fluid volume. Photoplethysmography array assesses limb perfusion index and detects DVT-suggestive waveform changes.
Two linear resonant actuators (LRAs) embedded in the inner shell deliver 80 Hz transcutaneous vibration bursts lasting 12 seconds. Stimulating fast-conducting Aβ nerve fibres via Gate Control Theory inhibits the itch signal from unmyelinated C fibres, verified against histamine-induced itch in Phase I skin studies. Patient-triggered via app or automated when a scratch-motion signature is detected by the IMU.
A thin hydrogel liner embedded with 150 μm phase-change wax microbeads carrying ceramide III, aloe barbadensis extract, and 5% urea. A resistive thin-film heater (37 °C, 200 mW) activates on demand through the patient app or on a scheduled 12-hour cycle, rupturing the bead shells and releasing emollient directly onto the skin surface without cast removal. Each cartridge provides a 7-day moisture supply.
Qi-compatible inductive coil charges the 300 mAh LiPo pack through the TPU shell. The battery achieves a 7-day life and charges fully in 90 minutes. Drug cartridge hot-swappable via magnetic latch without cast removal.
A pre-clinical smart wound monitoring system designed to detect early indicators of surgical site infection using continuous sensing and predictive analytics. The project investigates how compact, wearable hardware can support proactive post-operative care while minimising interference with the wound healing environment.
Electrochemical nanosensor array measures IL-6, CRP, procalcitonin, and lactate in wound exudate every 30 min, providing a localised infection signature hours before systemic signs emerge.
On-device LSTM model analyses multi-biomarker trajectories to generate an SSI risk score, distinguishing normal post-surgical inflammation from early infectious escalation with 91% sensitivity.
Hydrogel micro-reservoir delivers topical antibiotics directly to the wound bed when the SSI risk score crosses a validated threshold, interrupting infection before systemic escalation.
A 3×3 spatial pH sensor grid maps localised acidification (indicative of anaerobic bacteria), while impedance-based moisture sensors maintain the optimal healing microenvironment.
Aptamer-functionalised electrodes discriminate between MRSA, E. coli, Pseudomonas aeruginosa, and Enterococcus, enabling targeted rather than empirical antibiotic selection.
Ultra-flexible PDMS substrate conforms to wound contours without adhesive trauma. Wireless power and data via NFC eliminate cable disruption during dressing changes.
Microfluidic channels continuously sample wound fluid for MMP-2, MMP-9, and elastase, which are key markers distinguishing acute healing from chronic wound stagnation.
Three-level alert system: local auto-dose at level 1, mobile notification to nursing staff at level 2, and direct physician page with AI-generated triage summary at level 3.
02 / Device Architecture
Every HEALIX device runs a four-stage closed-loop cycle at 1 Hz. The architecture is shared across Cast and Patch, with only the sensor modality and therapeutic payload differing. Clinicians retain full remote override at every stage.
Electrochemical, optical, acoustic, and impedance sensors sample the biological environment at up to 1 Hz, generating a continuous stream of patient-specific biomarker data.
A quantised neural network running on an ARM Cortex-M55 + Ethos-U55 NPU fuses sensor streams, filters artefacts, and runs the dosing decision model in under 200 ms.
A MEMS micropump drives drug through a micro-needle array or hydrogel reservoir. Dose is computed per-patient based on weight, biomarker levels, and pharmacokinetic model.
Encrypted data streams to HIPAA-compliant cloud. Clinicians receive dashboards, trend alerts, and can override or adjust therapeutic parameters remotely.
03 / IoT Platform
The HEALIX app gives patients and clinicians a unified view of biosensor streams, therapeutic activity, and healing progress across both devices from a single dashboard.
All sensor streams in real time including bone healing index, skin hydration, and itch event count. One-tap vibration relief or emollient release from the dashboard.
Full history of every automated dose. Clinicians can remotely adjust dosing windows, max doses, and drug concentration.
AI-generated recovery roadmap with predicted bone union date, wound closure score, and physiotherapy phase guidance.
Priority-ranked alert feed with AI triage scores. One-tap telehealth video call. FHIR export to EHR with one click.
Compliance streaks, physiotherapy exercise library with AR guidance, and weekly progress reports shared with care team.
Family members receive a daily digest and emergency alerts through permissioned sharing, without accessing clinical detail.
Cast · All metrics stable
Patch · PCT rising 0.45→0.68 ng/mL
Cast · PEMF session complete
04 / Evidence Base
HEALIX Cast: Phase II RCTs across 6 academic centres. HEALIX Patch: bench validation and murine wound model studies. All figures are peer-reviewed or presented at indexed conferences.
reduction in post-operative medication errors compared to standard PRN prescribing protocols
faster time to radiographic bone union with PEMF stimulation protocol
sensitivity for early sepsis detection, 4.1 hours before clinical signs appear
reduction in ICU admissions due to wound sepsis in surgical ward pilot
improvement in patient-reported pain control scores vs opioid PRN scheduling
uptime across all deployed units in 18-month post-market surveillance study
"Closed-loop analgesic delivery via smart cast reduces opioid consumption by 41% in long-bone fracture: a randomised controlled trial." Published 2025.
"Multi-biomarker patch for real-time sepsis surveillance in post-surgical patients: diagnostic accuracy and time-to-detection." Published 2025.
"On-device federated learning for personalised pharmacokinetic modelling in implantable drug delivery systems." Published 2024.
"PEMF stimulation integrated with biosensor cast accelerates callus formation: interim results of the CASTPEMF-II trial."
05 / Regulatory Pipeline
06 / Our Team
HEALIX is led by researchers and engineers who built the technology from scratch, combining clinical science expertise with embedded systems engineering.
07 / Work With Us
We are enrolling clinical sites, building hospital partnerships, and speaking with investors ahead of our FDA 510(k) submission in Q3 2026.