Hypertension affects two-thirds of adults over the age of 65. Persistently elevated blood pressure has been shown to lead to arterial stiffening, left ventricular hypertrophy and accelerated atherosclerosis that triples the risk of myocardium infarctions, congestive heart failure or strokes. Hypertension remains the leading modifiable contributor to cardiovascular and a cerebrovascular disease. As a result, hypertension is recognized as the primary or contributing cause of more than 410,000 deaths per year in the United States. Further, hypertension is the main cause of nearly 55 million annual healthcare visits. Reducing blood pressure by only 13mmHg could reduce the risk of cardiovascular and cerebrovascular deaths by a staggering 13% and save the nation nearly $18B health care dollars. Despite the implications of properly managing hypertension, 20% of hypertensives remain undiagnosed and only 53% of diagnosed hypertensives have controlled blood pressure.
The inability to accurately diagnose and properly manage high blood pressure is in part related to the limitations of current monitoring practices and solutions. Improved blood pressure monitoring will reduce office visits, improve efficiency for healthcare providers, facilitate appropriate treatment and increase patient satisfaction.
The Company has developed a robust method of measuring blood pressure known as differential pulse arrival time (DPAT). DPAT is based on the concept that the pulse wave generated by the heart contracting arrives at the right before the left arm because of inherent anatomical delay. Bold has discovered that the difference in arrival times is an indicator of blood pressure. DPAT eliminates the inaccurate assumptions made with Pulse-Transit-Time regarding contraction delay and unknown travel distances by measuring at symmetrical endpoints. The result is increased resolution, fidelity and accuracy.
Bold Diagnostics has developed a functional engineering prototype that implements the theory of DPAT. The device acquires the peak arrival times of the pulse waveforms arriving at the left and right digital arteries with custom finger-based photoplethysmographs. The engineering prototype simultaneously obtains reference measurements obtained from a Finapres Medical Systems (FMS) NOVA vascular unloading system (Finapres® NOVA FDA 510(k) # K141460; Amsterdam, The Netherlands). The custom PPG sensors transmit green wavelength light generated with a light emitting diode through the fingertip and subsequently measures the rate of absorbance due to pulsing arterial blood with a photodetector to identify the pulse waveform. Pulse peak timestamps are then transmitted via Bluetooth to a computer running a Matlab script for real-time data acquisition and post-processing derivation of blood pressure from DPAT. The current prototype allows for reliable and robust data processing in a presentable package that ensures patient safety while obtaining accurate beat-to-beat blood pressure measurements using the FDA cleared FMS NOVA system.
We have conducted a preliminary IRB approved pilot study (n=20) at the Northwestern Memorial Hospital to demonstrate proof of concept using the functional engineering prototypes in a normotensive population. Results validated our hypothesis by demonstrating (i) the pulse waveform arrives at the right before the left digital artery, (ii) the difference in pulse arrival times change, (iii) that the change in pulse arrival time inversely correlates to changes in pressure and (iv) differential pulse arrival times can be used to derive absolute blood pressures.
DPAT is currently protected by a comprehensive PCT patent filing (PCT/US2016/056350) on October 11th, 2016 with an effective priority date of October 12th, 2015. The company will be nationalizing the PCT patent filing in Q1/Q2 of 2018 with a focus on major markets areas that include the European Union, Asia and Japan.
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