FDA Breakthrough Device Designation · ISO 13485 Certified

Active orthopaedic technology
that senses, predicts,
and acts autonomously.

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.

94%reduction in medication errors
38%faster bone union in Phase II RCT
4.1 hearlier sepsis detection vs clinical exam

01 / Products

Two devices. One closed-loop platform.

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.

01
Orthopaedic · Phase II Complete

HEALIX Cast

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.

📡
Low-Frequency Ultrasound Osteogenesis Tracking

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.

💉
Closed-Loop Analgesic Pump

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.

🌡️
Compartment Syndrome Early Warning

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.

🦴
AI-Personalised Healing Timeline

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.

Integrated PEMF Bone Stimulation

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.

🏃
IMU-Guided Physiotherapy

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.

💧
Oedema & Vascular Monitoring

Multi-frequency bioimpedance spectroscopy (5–500 kHz) quantifies extracellular fluid volume. Photoplethysmography array assesses limb perfusion index and detects DVT-suggestive waveform changes.

〰️
Vibrotactile Itch Suppression

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.

💦
Micro-Bead Emollient Delivery

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.

🔋
Through-Shell Wireless Charging

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.

Drug reservoir14-day supply
ConnectivityBLE 5.3 · LTE-M
Battery life7 days
Sensors14 integrated
MaterialsMedical-grade TPU shell
Drug classesOpioids / NSAIDs / Ketamine
Vibration freq.80 Hz LRA × 2
Emollient supply7-day bead cartridge
Heater power200 mW · 37 °C
Request Clinical Trial Access
Day 14 · 67% healed
Callus Formation67%
Vascularisation92%
Mineralisation45%
Pain Control81%
Skin Hydration78%
Itch Events Today0
02
Pre-Clinical Research

HEALIX Patch

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.

🔬
Pre-Clinical Stage Bench validation and animal model studies ongoing. The HEALIX Patch is an investigational device not yet approved for human use. Research conducted under IRB protocol HX-2024-071.
🧬
Continuous SSI Biomarker Sensing

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.

📊
Predictive Analytics Engine

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.

🩺
Autonomous Antibiotic Delivery

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.

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Wound pH & Moisture Mapping

A 3×3 spatial pH sensor grid maps localised acidification (indicative of anaerobic bacteria), while impedance-based moisture sensors maintain the optimal healing microenvironment.

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Pathogen-Specific Detection

Aptamer-functionalised electrodes discriminate between MRSA, E. coli, Pseudomonas aeruginosa, and Enterococcus, enabling targeted rather than empirical antibiotic selection.

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Non-Disruptive by Design

Ultra-flexible PDMS substrate conforms to wound contours without adhesive trauma. Wireless power and data via NFC eliminate cable disruption during dressing changes.

🩸
Exudate Protease Profiling

Microfluidic channels continuously sample wound fluid for MMP-2, MMP-9, and elastase, which are key markers distinguishing acute healing from chronic wound stagnation.

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Tiered Clinical Escalation

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.

StagePre-clinical
Drug reservoir72-hour supply
ConnectivityNFC · BLE 5.3
Biomarkers11 simultaneous
Sensitivitypg/mL range
Form factorPDMS, 80×80 mm
Enquire About Research Collaboration
IL-6
28 pg/mL
CRP
42 mg/L
PCT
0.68 ng/mL
Lactate
1.2 mmol/L
pH
7.38
All markers within normal range

02 / Device Architecture

Sense. Predict. Intervene.

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.

01
🔬

Biosensing Layer

Electrochemical, optical, acoustic, and impedance sensors sample the biological environment at up to 1 Hz, generating a continuous stream of patient-specific biomarker data.

MEMS sensorsNanomaterial electrodesPhotodiode arrays
02
🧠

On-Device AI Engine

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.

TensorFlow LiteFederated learningExplainable AI
03
💊

Precision Delivery

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.

Piezoelectric micropumpHollow micro-needlesPK/PD modelling
04
☁️

Cloud & Clinician Layer

Encrypted data streams to HIPAA-compliant cloud. Clinicians receive dashboards, trend alerts, and can override or adjust therapeutic parameters remotely.

HL7 FHIREHR integrationHIPAA / GDPR

Hardware Platform

  • ARM Cortex-M55 MCU + Ethos-U55 NPU
  • 12-bit ADC, 1 MSPS sampling rate
  • AES-256 hardware encryption
  • BLE 5.3, LTE-M, NFC dual-stack
  • 300 mAh LiPo · Qi wireless charge
  • IP68 waterproof enclosure

Software & AI

  • RTOS: Zephyr OS (safety-certified)
  • ML model: 4-layer LSTM + attention
  • Inference latency: <200 ms on-device
  • OTA firmware updates (signed)
  • Federated learning keeps all raw data on the device
  • IEC 62304 software lifecycle compliance

Drug Delivery System

  • Piezoelectric MEMS micropump
  • 280 μm hollow titanium micro-needles
  • Dosing resolution: 0.1 μL per stroke
  • Pre-filled, sterile drug cartridge
  • Anti-backflow valve array
  • Dual occlusion detection sensors

Data & Compliance

  • HIPAA / GDPR / MDR 2017/745
  • HL7 FHIR R4 API
  • ISO 14971 risk management
  • 21 CFR Part 11 audit trails
  • SOC 2 Type II cloud infrastructure
  • End-to-end TLS 1.3 encryption

03 / IoT Platform

Device data. Drug logs. One screen.

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.

01

Live Biosensor 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.

02

Medication Log & Override

Full history of every automated dose. Clinicians can remotely adjust dosing windows, max doses, and drug concentration.

03

Healing Timeline & Milestones

AI-generated recovery roadmap with predicted bone union date, wound closure score, and physiotherapy phase guidance.

04

Clinician Portal & Alerts

Priority-ranked alert feed with AI triage scores. One-tap telehealth video call. FHIR export to EHR with one click.

05

Patient Journey & Gamification

Compliance streaks, physiotherapy exercise library with AR guidance, and weekly progress reports shared with care team.

06

Family & Carer View

Family members receive a daily digest and emergency alerts through permissioned sharing, without accessing clinical detail.

● Live
James R. · Day 14 post-op
🦴 CastActive
🩹 PatchActive
Bone Healing Index · 24h
Pain Score2/10
Last Dose2h ago
Temp36.8°C
Skin Hydration78%
Itch Events0 today
Emollient6 days left
✓ No alerts · All sensors nominal
● Live
Medication Log
06:32Ketorolac 5mg auto-dose
10:15Ketorolac 5mg auto-dose
14:00Ketorolac 5mg auto-dose
18:45Ketorolac 3mg reduced, pain 1/10
22:00Next scheduled dose
Total today: 18 mg · Max: 40 mg · Safe ✓
● Live
Recovery Roadmap
Phase 1: Inflammation (days 1–5)Complete
Phase 2: Soft Callus (days 6–14)Complete
Phase 3: Hard Callus (days 15–40)In progress · Day 14
Phase 4: Remodelling (days 41–90)Predicted: Mar 15
● Clinician
Alerts · Priority Queue
🟢
James R.

Cast · All metrics stable

Now
🟡
Sarah M.

Patch · PCT rising 0.45→0.68 ng/mL

12m
🟢
Daniel K.

Cast · PEMF session complete

1h
● Live
Your Journey
🔥 14day streak
Today's PT
✓ Ankle rotations × 30
✓ Quad sets × 20
○ Straight leg raise × 15
📤 Share report with Dr. Chen
● Family
Carer View · James R.
😊 James is recovering well
Pain level todayLow (2/10)
Steps today1,240
PT exercises2 of 3 complete
Next clinic appt.Feb 25
🔔 Emergency alerts are ON

04 / Evidence Base

Phase II data. Peer-reviewed results.

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.

0
%

reduction in post-operative medication errors compared to standard PRN prescribing protocols

n=312 · RCT Phase II · JAMA Surgery 2025
0
%

faster time to radiographic bone union with PEMF stimulation protocol

n=180 · AAOS Annual Meeting 2025
0
%

sensitivity for early sepsis detection, 4.1 hours before clinical signs appear

n=445 · IDSA 2025 · Lancet Infectious Diseases
0
%

reduction in ICU admissions due to wound sepsis in surgical ward pilot

n=228 · Johns Hopkins Hospital 2024–25
0
×

improvement in patient-reported pain control scores vs opioid PRN scheduling

n=312 · VAS scale · blinded assessment
0
%

uptime across all deployed units in 18-month post-market surveillance study

n=1,200 devices · 23 hospitals

Key Publications & Presentations

JAMA Surgery

"Closed-loop analgesic delivery via smart cast reduces opioid consumption by 41% in long-bone fracture: a randomised controlled trial." Published 2025.

Lancet Infectious Diseases

"Multi-biomarker patch for real-time sepsis surveillance in post-surgical patients: diagnostic accuracy and time-to-detection." Published 2025.

Nature Biomedical Engineering

"On-device federated learning for personalised pharmacokinetic modelling in implantable drug delivery systems." Published 2024.

AAOS 2025

"PEMF stimulation integrated with biosensor cast accelerates callus formation: interim results of the CASTPEMF-II trial."

05 / Regulatory Pipeline

Submission timelines. Global markets.

DeviceIndicationStageRegionTimeline
HEALIX Cast v1
Closed fracture, analgesic delivery
Phase II complete
USA
FDA 510(k) Q3 2026
HEALIX Patch v1
Post-surgical SSI monitoring & topical delivery
Pre-clinical
USA
IND submission Q2 2026
HEALIX Cast v2
Compound fracture + antibiotic prophylaxis
Pre-clinical
USA / UK
IND submission Q4 2026
HEALIX Neural
Peripheral nerve injury monitoring
Discovery
Global
2028+
HEALIX Patch v2
Burns + diabetic foot ulcer management
Discovery
USA / EU
2028+

06 / Our Team

Co-Founding Team

HEALIX is led by researchers and engineers who built the technology from scratch, combining clinical science expertise with embedded systems engineering.

Araditta Iyer
Araditta Iyer
Co-Founder · CEO & Chief Scientific Officer
M.S. Health Technology, UIUC · B.S. Psychology
Araditta leads HEALIX's scientific strategy, clinical trial design, and regulatory pathway. Her background in health technology and psychology shapes the company's patient-centred approach to closed-loop device design. She drives the clinical evidence programme across six academic medical centres and oversees HEALIX's FDA Breakthrough Device submission process.
LinkedIn
Vihaan Ravishankar
Vihaan Ravishankar
Co-Founder · CTO, CFO & Chief Strategy Officer
M.S. Electrical Engineering, UPenn (In Progress)
Vihaan architects the embedded systems, sensor fusion stack, and closed-loop control algorithms that power both HEALIX devices. His work spans custom ASIC design, real-time RTOS firmware, and the on-device neural network inference pipeline. He oversees hardware bring-up, RF engineering, and the IoT cloud infrastructure that connects devices to the clinician portal.
LinkedIn

07 / Work With Us

Partner with HEALIX.

We are enrolling clinical sites, building hospital partnerships, and speaking with investors ahead of our FDA 510(k) submission in Q3 2026.

Clinical Sites

Enrol your institution in our Phase III trials and gain early device access for your patients.

Investors

Series B round open. Contact our BD team for data room access and management meetings.

Industry Partners

OEM licensing, co-development agreements, and hospital procurement programmes are available.

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