Biosensor Technology

Living Condensed Matter

In Prevention and Management of Chronic Disease

Next generation Lifestyle and Healthcare Device

Executive summary

LCM Biosensor Technologies develops the new generation metabolic health self-monitoring wearables applicable in healthcare and wellbeing and IoT based preventative healthcare systems.

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

The prototype device that has been used in clinical proof of concept study with diabetic and healthy subjects.

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.

Intercellular substance itself at its heterophase region at physiological conditions acts as a nature biosensor with the selectivity to glucose molecules & extremely high sensitivity to heat flow that in turn results in dependence of osmotic pressure of intercellular substance vs glucose concentrations and heat input.

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

The device connects – through a wireless connection – with the computer for analysis and review of the near real time visualization of monitoring data by doctors. Using the cloud platform, it is able perform in real time a thorough analysis of diabetes and healthy persons data to monitor diagnostics results that lead to better decision making and an increased health data equity

CONTACTS

Email: info@rdintercell.com
Adress: USA 20 Maple Avenue, East Setauket, NY 11733

Website development and promotion Mazzed Digital Studio