SBIR-STTR Award

Direct to Phase II

There is an unmet clinical need for an accurate, standalone, continuous non-invasive blood pressure (cNIBP)monitor. Current non-invasive, occlusive arm cuff-based BP technologies are inaccurate and provide only single-point BP measurements. In US hospitals, there are close to 44 million in-patient admissions and surgeries peryear that require BP monitoring, but periodic cuff-based measures lead to monitoring gaps and poorer outcomes,including 300,000 preventable cardiac arrests per year. In hospitals, continuous BP monitoring can be achievedwith invasive intra-arterial pressure (IAP) monitoring, but with significant risks. Apart from critical care and otherhospital settings, cNIBP technology has broader application in 103 million Americans with hypertension, aleading cause of stroke and heart attacks. Initial market focus for Dynocardia is to develop standalone cNIBPalternative to IAP and arm cuff-based devices for use in intensive care units and operating rooms. Dynocardia'sViTrack® is the first standalone, cuff-less, wrist wearable device for cNIBP monitoring. Compared to other cNIBPtechnologies, the advantages of ViTrack include: (1) New method for continuous measurement of BP without acuff: ViTrack uses skin force/displacement information to provide a direct, continuous measurement of systolicand diastolic BP. This method is analogous to the gold standard auscultatory method in which the physicianmeasures systolic and diastolic BP directly with an arm cuff and stethoscope (sound) at a single time point, butViTrack measures continuously; (2) Accuracy: At least as accurate as the gold standard (3) Novel Technology:First-of-its-kind cuff-less, wearable technology; (4) Versatility: Also measures respiratory, heart rate otherhemodynamic parameters; and (5) Ease of Use: Utilizes a camera-based optomechanical sensor that can lockpulsation automatically without need for precise placement. In SBIR Phase 1-like preclinical studies, using thefully automated lab prototype, in large and small animal studies, ViTrack correlated one-to one (R2= 0.96) withinvasive IAP. In clinical studies of 80 outpatients over a wide range of BPs, ViTrack met FDA equivalencystandards for measuring BP and in further outpatient studies, continuously measured beat-to-beat BP reliably,demonstrating its feasibility as a standalone cNIBP monitor. The goal of this Direct to Phase II proposal is torefine the current prototype to build clinical study devices as per ISO13485 design controls and then assessclinical performance in human subjects to produce an optimized commercially viable ViTrack device for use incritical care settings. The outcome of this study will establish ViTrack as the first standalone, wearable cNIBPalternate to IAP and enable next phase funding to build the production equivalent ViTrack wrist devices, as aprelude to final clinical validation and FDA 510(k) clearance.

Public Health Relevance Statement:
Project Narrative ViTrack® is the first-of-its-kind, wearable, standalone, continuous non-invasive blood pressure device for effective BP monitoring in patients in hospitals to prevent complications and reduce healthcare costs. The ViTrack will also contribute to better diagnosis and management of hypertension or high blood pressure to prevent strokes and heart attacks.

Project Terms:
Evaluation ; Measurement ; Systems Integration ; Funding ; Life ; mechanical ; Mechanics ; Pulse ; Physiologic pulse ; Hour ; Upper arm ; System ; Clampings ; Closure by clamp ; respiratory ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Outcome Study ; Emergency Department ; Emergency room ; Accident and Emergency department ; American ; Performance ; Proxy ; novel ; Categories ; novel technologies ; new technology ; Devices ; Position ; Positioning Attribute ; Admission ; Admission activity ; Modeling ; Skin ; prevent stroke ; Stroke prevention ; preventing ; prevent ; BMI ; BMI percentile ; BMI z-score ; Quetelet index ; Body mass index ; Data ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Update ; Validation ; Wireless Technology ; wireless ; Monitor ; Development ; developmental ; preclinical study ; pre-clinical study ; design ; designing ; Outcome ; prototype ; commercialization ; standard measure ; hypertension control ; hypertension management ; product development ; arm ; improved outcome ; profiles in patients ; patient profile ; wearable device ; wearable electronics ; wearable technology ; manufacturability ; Home ; Animals ; Atrial Fibrillation ; Auricular Fibrillation ; Blood Pressure ; Blood Pressure Monitors ; Continuous Sphygmomanometers ; Calibration ; Clinical Research ; Clinical Study ; Clinical Trials ; Communities ; Critical Care ; Data Collection ; Diagnosis ; Electronics ; electronic device ; Goals ; Gold ; Heart ; Heart Arrest ; Asystole ; Cardiac Arrest ; Heart Rate ; Cardiac Chronotropism ; hemodynamics ; Hospitals ; Hydrostatic Pressure ; Hypertension ; Vascular Hypertensive Disease ; Vascular Hypertensive Disorder ; high blood pressure ; hyperpiesia ; hyperpiesis ; hypertensive disease ; Inpatients ; Institutes ; Intensive Care Units ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Massachusetts ; Methods ; Methodology ; Motion ; Myocardial Infarction ; Cardiac infarction ; Myocardial Infarct ; cardiac infarct ; coronary attack ; coronary infarct ; coronary infarction ; heart attack ; heart infarct ; heart infarction ; Noise ; Operating Rooms ; Optics ; optical ; Outpatients ; Out-patients ; Patient Admission ; Patients ; Periodicity ; Cyclicity ; Rhythmicity ; Physicians ; pressure ; Production ; Risk ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Computer software ; Software ; sound ; Stroke ; Apoplexy ; Brain Vascular Accident ; Cerebral Stroke ; Cerebrovascular Apoplexy ; Cerebrovascular Stroke ; brain attack ; cerebral vascular accident ; cerebrovascular accident ; Technology ; Testing ; Therapeutic Equivalency ; Bioequivalence ; Clinical Equivalency ; Generic Equivalency ; drug bioequivalence ; drug bioequivalent ; Time ; Universities ; Wrist ; Measures ; Health Care Costs ; Health Costs ; Healthcare Costs ; ergonomics ; Custom ; base ; human subject ; Pump ; sensor ; Stethoscopes ; Clinical ; Phase ; Medical ; Series ; Ensure ;