Technology
Innovative Technique
Innovative Approach in Analyzing Conventional PPG Signals
Micro Flow Medix transforms optical signals into continuous clinical intelligence – warning of imminent edema and occult bleeding.
How it Works
Compact sensor system
Derma
Optical signal analysis
Clinical Data
Principle of Operation
The device utilizes conventional multi-wavelength (MW) photoplethysmography (PPG) to quantify changes in tissue fluid volume by measuring light attenuation (absorption plus scattering) in the skin.
It employs unique techniques for determining most useful wavelengths and analyzing PPG signals, for which US and international patents are pending, to provide clinically relevant information.
The uniqueness of approach to analysing signals from conventional PPG lies in innovative, AI-assisted signal analysis and clinically useful interpretation. The first ever technique is used for discriminating optical signal changes due to light attenuation by intravascular and extravascular water.
Inmovative analysis of correlation between hemodilution and extravascular fluid accumulation trends is used for identifying changes in total body hemoglobin mass which serve as an indication of blood loss.
Core Principles
Trend
Monitoring
Trend-monitoring of tissue water levels is used as indication of changes in total body water (TBW) for determining body hydration status in terms “Dehydration”, “Imminent dehydration”, “Normal Hydration”, “imminent edema” and “Edema” and urging actions by alerts from automated decision support system such as “More Fluids”, “Less Fluids”, “Stop Fluids”, “Remove Fluids”, “Reduce Removal”, “Stop Removal”.
Combined trend-analysis of tissue water levels and hemodilution is used for indicating changes in total body hemoglobin mass due to bleed or transfusion.
Wavelength Optimization
Unique calibration of the prototype device is used to determine wavelengths that are most sensitive to light attenuation by hemoglobin, and by water.
Technological Approaches
Intermittent PPG approach (Circulation Obstruction Method): Repeatedly applied brief compression of microcirculation under the sensor is used for estimating changes of light attenuation specifically by extravascular water.
Intermittent PPG approach implies deriving an estimated quantity of extravascular water as indicated by a PPG DC component during an induced obstruction of circulation under a photoplethysmography sensor. Of note, during obstruction of circulation, the DC signal indicates specifically attenuation by extravascular water plus light absorbing media which do not change over short time (static component). Thus, estimating PPG signal change over time (the trend), e. g. between the sessions of induced obstruction of circulation, eliminates the impact of light attenuation by static media and serves as indication of pure changes in the quantity of extravascular – tissue – water. Same applies to trends using the continuous PPG approach.
Continuous PPG approach (Non-Occlusion Method): Combines both AC and DC PPG components:
Continuous PPG approach implies unique calculation of non-measurable light attenuation by the non-pulsatile intravascular water (DC component) based on the ratio between the measurable attenuation by pulsatile water and pulsatile hemoglobin (AC component). This value is used for calculating the non-measurable light attenuation by extravascular water from the measurable total light attenuation by non-pulsatile water (DC component). Of note, total light attenuation by non-pulsatile water is the sum of light attenuation by (non-pulsatile) extravascular water and non-pulsatile intravascular water.
Clinical Evidence
Proof-of- Concept
Initial market assessment
Validation study to investigate the relevant demand in healthcare.
In Silico testing
Computer simulations using Virtual Patient prior to In vivo studies. This digital approach involves creating computational models of clinical scenarios to test performance, safety, and efficacy of device early in the development process.
Animal Study
Proof-of-Concept study in large animals to test performance, safety sensitivity and specificity in Vivo. This study uses control methods to assess the device’s ability to monitor changes in tissue fluid level during fluid infusion and fluid removal. The rate and time controlled blood draw is used to investigate ability to indicate bleeding earlier compared to relevant hemodynamic deterioration.
Pilot observational clinical study in dialysis patients
Proof-of-Concept study in dialysis patients to test the ability to monitor changes in tissue hydration and alert to imminent intradialytic hypotension (IDH) during hemodialysis.
Multi-center Trials Underway
Multi-center patient trials in leading European and U.S. hospitals.
Regulatory Alignment
All validation follows ISO 13485, ISO 14971, IEC 62304 and is aligned with EU MDR IIb and FDA Class II 510(k) frameworks.
Roadmap
From Prototype to Standard of Care
A clear, evidence-driven path from innovation to global adoption — validated step by step.
PHASE 1
Proof of Concept
2024–2025
Proof of Concept studies using prototype, IP protection (US and PCT patents pending), Initial healtcare market validation, In Silico testing, small-scale animal study.
PHASE 2
Design Validation
2026–2028
Develope Alpha and Beta versions of a prototype, large-scale animal study, pilot study in hemodialysis patients, , ISO 13485 quality management system implemented, Design history file completed according to FDA requirements, Risk management per ISO 14971 completed, Biocompatibility testing completed (if applicable), Initial clinical evaluation or literature review completed.
PHASE 3
Clinical Validation
2028–2029
Clinical trial protocol approved by IRB/ethics committee, Primary endpoints met in clinical study, 510(k) or PMA submission prepared, Manufacturing processes validated for commercial scale, Quality management system audit-ready
PHASE 4
Regulatory Clearance
2028–2029
FDA 510(k) clearance or PMA approval received, Commercial manufacturing partner qualified, Initial inventory produced and quality tested, Sales team hired and trained Initial customer pilots completed
PHASE 5
Commercial Scale
2029–
Commercial execution
Scientific publications
Results published in peer-reviewed journals.
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