Capillary Biomedical, Inc. and Jefferson collaborated for seven years to develop an optimized subcutaneous tissue insulin delivery catheter, the weak link of an artificial pancreas system. Current commercial insulin infusion catheters need be replaced every two to three days because insulin absorption (PK) becomes highly variable. We developed a novel catheter system that functions reliably for 10 to 14 days and is currently in clinical trials around the world to obtain FDA and CE Mark approval. Jefferson received significant funding from NIH, foundations, and Capillary to perform bench and animal testing. Capillary Biomedical was acquired by the insulin pump company Tandem in 2022 for $ 25 million.
Thomas Jefferson University is currently collaborating with RTM Vital Signs, LLC to develop wearable and implantable sensors capable of continuously monitoring and analyzing a patient’s vital sign trend data to detect and predict clinical deterioration in the hospital and outpatient setting prior to developing a serious adverse event.
We are focused on developing a wearable Respiratory Monitoring System that resembles a pediatric stethoscope head with miniature microphones that is adhered to the skin over the proximal trachea (see photo). The microphones measure the sounds of airflow during inhalation and exhalation. Our machine learning/AI algorithm converts the sounds of airflow in the trachea into measurements of respiratory rate, tidal volume, minute ventilation, duration of apnea, patterns of breathing, degree of snoring (partial airway obstruction), and heart rate. Actionable alerts and alarms are based upon the absolute value of each parameter, the direction of change, and the rate of change. Sensor data will be transmitted wirelessly to the nurse’s cell phone, bedside display, nursing station, and the hospital’s electronic medical record. We completed an NIH-STTR funded clinical trial at Jefferson Health in 2022 in surgical patients managed with anesthetics and opioids to demonstrate feasibility.
RTM and Jefferson recently received a 3-year NIH-SBIR Fast-Tract award ($2.7 million) to optimize the sensor’s adaptive filtering and active noise cancellation software, following by a clinical trial at TJUH in surgical patients managed post-op with opioid medications. Ten US patents have been issued on the sensor hardware and a Risk-Index Score algorithm designed to detect and predict clinical deterioration on the general floor of the hospital, with a focus on opioid induced respiratory depression. We plan to evaluate the Respiratory Monitoring System for the early detection of sepsis, worsening heart failure, and respiratory compromise due to pneumonia while in the hospital and after hospital discharge.
Our implantable Cardiovascular Monitoring System will continuously measure and analyze an ambulatory patient’s arterial blood pressure waveform, electrocardiogram, respiratory rate, tidal volume, breathing pattern, oxygen saturation, and core temperature. The sensor was developed and implanted for 12 months in a large animal model at Jefferson to demonstrate safety and feasibility. Our diagnostic algorithms are designed for early detection and management of ambulatory outpatients with heart failure, resistant hypertension, and ischemic heart disease. Ten US patents have been issued on the sensor hardware and method of surgical implantation.
In addition, our laboratory is currently collaborating with Janssen (J&J) to develop and test an autoinjector device for delivering medication into the subcutaneous tissue. We are also working with Becton Dickinson/Embecta to develop an insulin patch pump, and test pump performance in ambulatory swine. We are also working with Perikinetics to develop a peritoneal insulin delivery system, and test device performance in swine at Thomas Jefferson University. We are about to finish a multi-center clinical trial sponsored by Dexcom, Inc. to obtain FDA clearance for using glucose sensors in the hospital in place of finger sticks.
