Biosensor Technology
Living Condensed Matter
In Prevention and Management of Chronic Disease
Next generation Lifestyle and Healthcare Device
Executive summary
COMPANY
The global challenge – UN Sustainable Development Goals — Goal 3. Ensure healthy lives and promote well-being for all at all ages. Non-communicable diseases prevention and treatment. Metabolic Health self-monitoring technologies, applicable for early diagnoses & prevention and treatment of Diabetes and related Cardiovascular and Renal Diseases.
PROBLEM
We discovered the universal biomarker of metabolic health unknown before – osmotic pressure of intercellular substance of human living tissue, characterizing the cellular metabolism and invented the breakthrough platform technology for health self-monitoring, actionable in prevention & early diagnoses of diabetes and interrelated chronic diseases. Technology allows to monitor blood glucose and other molecular biomarkers, calorie intake and blood pressure continuously and noninvasive in real time by optical-osmotic transducer placed on the skin surface WO2021101416 METHOD AND DEVICE FOR LIVING TISSUE SPECTROSCOPY (wipo.int) .
SOLUTION
Our solution has been validated in a proof-of-concept clinical study with 50+ healthy and diabetic subjects with total over 500 tests with 30 minutes duration of each test, including over 252 tests with 42 diabetic subjects, which compared accuracy of our prototype device to that of FDA-approved conventional finger-prick glucometers. Eight prototypes of industrial prototype MVP (TRL 6) manufactured and tested to continue clinical validation. The prototyping and assembling of pre — production prototype MVP(TRL7) is in progress.
CURRENT STATUS
Finalize the assembling and testing of MVP (TRL 7) and start mass production
NEXT STEPS
The Product.
LCM Biomarker Platform – “clinic — on — the — wrist” allows to monitor noninvasive in real time various tissue and molecular biomarkers actionable in early diagnostics & prevention and treatment of Diabetes and related chronic diseases:
- Blood glucose;
- Metabolic molecular biomarkers: triglycerides, carbohydrates, hyaluronic acid and others;
- Metabolic rate & Calorie intake;
- Blood pressure / Blood Oxygen.
Healthcare and Wellbeing applications:
- Diagnostic & monitoring biomarkers — early diagnostics & prevention of chronic diseases: metabolic, cardiovascular, renal; breast cancer/breast self- examination; nutrition monitoring & management; skin metabolic health self-monitoring.
- Pharmacodynamic /response biomarkers to evaluate the response to medical condition or clinical intervention; monitoring biomarkers to optimize the insulin therapy.
Unlike currently available consumer devices, such as Fitbit, Apple Watch and Biostrap, that only provide nonspecific information on physical activity and heart rate, our noninvasive LCM Biosensor collects molecular level data that is actionable in early prevention of chronic disease – diabetes and cardiovascular diseases.
The holy grail of prevention and treatment of chronic disease – breakthrough product LCM Biosensor perfect for both treatment and early diagnostics of diabetes and cardiovascular, diseases.
The Prototype
Our solution has been validated in a proof-of-concept clinical study with 50+ healthy and diabetic subjects with total 500 tests with 30 minutes duration of each test, including other 252 tests with 42 diabetic subjects, which compared accuracy of our prototype device to that of FDA approved conventional finger-prick glucose meters.
The Working Principle
The skin epidermis itself acts as a natural glucose biosensor that transforms glucose
concentration change into an osmotic pressure
change what in turn leads to change in
intercellular microfluidics flow via epidermis
towards the skin surface.
Our device isolates this signal by osmotic
transducer placed on the skin surface that
converts osmotic pressure of intercellular
substance into analog electrical signal. We have invented the breakthrough LCM biosensor technology
allowing to monitor blood glucose and blood pressure noninvasive
and continuously by high accuracy real time measurement of the
osmotic pressure of intercellular substance of living tissue by
sensors placed on the skin surface. The product is a smart
integrated multi — sensor device with integration of unique
biosensor technique into isothermal phase transition
microcalorimeter.
Diagnostic Utility
Our device allows to detect the short-term jump changes of blood sugar in the form of a single pulse
signal. This “jump changes” specificity of diabetic sugar dynamics was unknown before. Now we can
determine the blood insulin dynamics by calculations based on blood sugar dynamics that in turn leads
to possibility of real time assessment of insulin resistance of individuals.
At last, but not a least, it was clinically proved, the intercellular osmotic pressure is a biomarker of human diabetes state:
our product can distinguish healthy, pre-diabetic and diabetic individuals based on the volatility of blood sugar dynamics
and osmotic pressure without the need to calibrate the device by finger-prick measurements
Here is an example of comparison measurements during Glucose Tolerance Test of healthy patient.
We can see good correlation between non-invasive sensor readings of 2 channels prototype and finger prick measurements.
Cloud-based telemedicine for healthcare and wellbeing
CONTACTS
Email: info@rdintercell.com
Adress: USA 20 Maple Avenue, East Setauket, NY 11733
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