About RTM

RTM Vital Signs LLC seeks to develop and commercialize a system that utilizes a minimally invasive implantable medical device to monitor essential medical diagnostic data automatically, accurately, and efficiently – in real time.

This innovative approach transcends the limitations of ad hoc vital sign readings and periodic data transmissions and will support the much needed transformation of healthcare from reactive and hospital-centered to preventive, proactive, evidence-based, person-centered, and focused on well-being rather than on disease. Our approach partners technology-based solutions with biobehavioral health research that will produce continual data patterns transmitted to a central monitoring station that can be accessed by smart phones and the like for immediate and accurate physician diagnostic and dosage intervention. The device will employ sensor technology and can be managed in a non-invasive way. The accurate real time vital sign readings produced (including blood pressure) eliminate the issue of patient non-compliance and enable immediate intervention to avoid the costs of a heart attack or an emergency room visit for a false heart attack. This breakthrough will deliver value by cost-effectively improving the quality of life of patients while also keeping hospital costs down by reducing false admittance.

Approximately 1.5 billion people in the world have hypertension, and as of 2013, 78 million U.S. adults (33 percent) have high blood pressure.

Hypertension costs an estimated 131 billion dollars annually in healthcare expenditures, and this number is rising. The American Heart Association suggests improved communication with patients and other health care providers because only 52 percent of people being treated for hypertension have their high blood pressure under control.

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.

RTM was founded in March 2014 to develop and commercialize a real-time implantable blood pressure (BP) sensor and vital sign monitoring system to continuously monitor the arterial BP waveform and other vital sign data of ambulatory patients with cardiovascular disease (hypertension, ischemic heart disease, valve disease, arrhythmias and CHF) and ambulatory patients at risk for a serious adverse event. Physicians, nurses, and emergency personnel will use an external monitor to download recently recorded data and vital sign trend data to determine the etiology of new patient symptoms and the effectiveness of medical therapy; in addition, real-time algorithms will be used to diagnose a significant change in patient physiology. Outpatient therapy will be applied more quickly, more effectively, and more efficiently using real-time trend data, diagnostic algorithms, and timely adjustments in medical therapy.

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.

Our prototype long-term implantable BP monitoring system is currently being tested in-vitro and in-vivo in anesthetized canines to demonstrate feasibility and optimize the implantation process.

After demonstrating 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 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 tested in a bench setting and then with initial animal studies, and we intend 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.