Approximately 1.5 billion people in the world have hypertension while 78 million U.S. adults have high blood pressure
America’s biggest killer, cardiovascular disease, is making a deadly comeback. Accordingly to the Wall Street Journal, the death rate for cardiovascular disease, which includes heart disease and strokes, has fallen 4% since 2011 after dropping more than 70% over six decades.
Our Cardiac Monitoring Device features a real-time implantable blood pressure sensor. A miniature device equipped with a long-term monitoring system, it is implantable under local anesthesia in an outpatient procedure. It accurately and continuously measures the arterial blood pressure waveform, the electrocardiogram, respiratory rate, tidal volume, hemoglobin oxygen saturation, and the sounds of the heart, lungs and upper airway. Sensor data feeds predictive algorithms to improve diagnostics and medication dosing related to hypertension and other cardiac issues, ultimately leading to prediction and prevention of adverse cardiac events. Relevant data is sent to your smart device, and a central monitoring station, for advanced analysis by machine learning (AI) computer algorithms and a clinician.
Hypertension and BP variability significantly increase the risk for adverse cardiovascular events; real-time monitoring with our sensor enables not only timely detection of significant changes in physiology with alerts and alarms, but also a robust database of BP and vital sign trend data obtained from hundreds of ambulatory patients that will be used to optimize models of cardiovascular risk in relation to diet, exercise, medications, devices, and surgical interventions – crucially important information not only for patients, but also for public health officials and for life, disability, and health insurance companies. This clinically relevant trend data does not currently exist.
Real-time monitoring could reduce the incidence and severity of acute and chronic cardiovascular adverse events and transform the way physicians practice clinical medicine in the outpatient setting.
Our prototype long-term implantable BP monitoring system is currently being tested in-vitro and in-vivo in anesthetized canines to demonstrate the feasibility and optimize the implantation process. The company is currently developing two devices that address the largest areas of healthcare concern and costs: cardiovascular health (prevention of heart attack, stroke, heart failure, kidney failure, and sudden death) and opioid misuse (prevention of overdose).
These devices are based on proprietary cost-effective monitoring technology employing sensors and diagnostic algorithms to track and assess a person’s health status in an ambulatory setting, remotely, in real-time, and unobtrusively to eliminate patient compliance issues and ensure data accuracy while reducing healthcare costs and improving outcomes.
After demonstrating the feasibility of the long-term implantable optical BP sensor under development, funding will be used to optimize the long-term implantable sensor head design, develop an implantable battery and telemetry module, and evaluate the monitoring system long-term in large animals with chronic hypertension. The ultimate goal is to commercialize a long-term implantable optical BP sensor that continuously measures the arterial pulse waveform, blood oxygen levels, temperature, and potentially additional vital health measurements, with the safety, accuracy, stability, and reliability required for FDA approval. These anticipated impacts and our BP sensor’s use of 3D printing and various pressure sensing technologies qualify RTM’s BP sensor as pertaining to advanced manufacturing.
We used our own resources to perform the initial assessment, which included a review of regulatory issues, marketing research, patent filings, bench experiments to evaluate sensors, and 3D modeling of the device configuration. Proceeding from the engineering description and prototype design phase, RTM developed a working prototype that will be tested in a bench setting and then with initial animal studies, and we intend to continue testing with longer-term animal studies followed by human studies. Based on our initial research and testing, we use sensors and other biomaterials that have already been approved by the FDA. The goal is to show the feasibility of the sensor head approach incorporated in the prototype device. Successful feasibility will be determined by accurate, reliable data continuously collected by a stable and functional device implanted in a canine thanks to our Sponsored Research Agreement in place with Thomas Jefferson University to proceed with animal studies.