A mechanistic endpoint for cardiovascular drug trials
PhysioSense translates pulsatile waveform signals into longitudinal patient-level vascular phenotypes — enabling drug developers to observe mechanism-of-action directly, enrich trial populations, and accelerate regulatory submissions with novel digital endpoints.
Trials often lack a practical physiological readout of mechanism
- Traditional endpoints such as MACE, blood pressure, eGFR, and hospitalization measure downstream outcomes, not the physiological response unfolding over time
- Lab-based biomarkers can reflect organ stress or injury, but often provide limited visibility into the evolving vascular and circulatory changes that precede those endpoints
- Common wearable outputs such as heart rate and SpO2 are useful but often lack the physiological specificity needed for enrichment, pharmacodynamic tracking, or response stratification
- Trial populations are heterogeneous in vascular and circulatory state, which can dilute treatment effect when cohorts are not physiologically differentiated
Mechanistic physiological phenotyping for trial enrichment and response tracking
PhysioSense transforms pulsatile waveform data into interpretable physiological descriptors that can be tracked over time across sensors and study settings. These include high-level measures related to vascular load and compliance, providing a more mechanistic view of pharmacodynamic response, patient stratification, and longitudinal physiological change. Deployments can be built around wearable sensors, bedside devices, or smartphone-based PulseVu workflows depending on study design.
PhysioSense applications across the drug development lifecycle
From early-phase mechanistic studies to later-stage enrichment and post-approval evidence generation, PhysioSense adds interpretable physiological precision across the development pathway.
Pharmacodynamic Response Tracking
Assess whether a compound is producing the expected physiological response before committing to larger trials. PhysioSense provides longitudinal tracking of interpretable measures related to vascular load and compliance in small study cohorts.
Trial Population Enrichment
Patients with the same diagnosis often differ meaningfully in underlying physiology. PhysioSense can help identify subpopulations with distinct physiological patterns, supporting more targeted enrollment and potentially improving treatment-effect visibility in differentiated cohorts.
Longitudinal Physiological Monitoring
PhysioSense supports repeated physiological assessment over time using wearable, bedside, or smartphone-based workflows depending on study design. This creates a more continuous view of change between site visits and scheduled study endpoints.
Digital Endpoint Development
PhysioSense can support development of more mechanistic digital measures for clinical studies by transforming pulsatile waveform data into interpretable physiological descriptors that can be evaluated alongside conventional endpoints.
Post-Approval Studies & Real-World Evidence
Longitudinal physiological phenotyping can add useful context in post-approval studies, comparative effectiveness work, and broader evidence-generation programs by extending visibility beyond intermittent clinic-based measurements.
Responder Stratification Strategy
For programs where mechanism of action is expected to align with specific physiological states, PhysioSense can support responder-hypothesis development and subgroup strategy by identifying interpretable physiological differences at baseline and over time.
Evidence of mechanistic physiological response detection
PhysioSense waveform analysis has shown sensitivity to known pharmacological effects in medicated patient populations, supporting applications in mechanistic studies, response tracking, and trial stratification.
Vasoactive Agent Response Tracking
In monitored care settings, PhysioSense-derived physiological descriptors tracked directional changes associated with vasopressor and vasodilator administration. These waveform-based measures provided added visibility into evolving physiological response between intermittent clinical assessments.
Between-Patient Physiological Heterogeneity
Patients with similar diagnoses and routine vital signs can still differ meaningfully in underlying physiology. PhysioSense identified separable physiological patterns across patients, supporting applications in enrichment strategy, subgroup analysis, and longitudinal response assessment.
Flexible collaboration models for pharma teams
We work with pharma partners in flexible structures that can begin with a focused feasibility assessment and expand into prospective studies, endpoint development, and broader platform collaboration.
Feasibility Assessment (6–10 Weeks)
Apply PhysioSense retrospectively to existing waveform data from a completed trial, sub-study, or observational dataset to assess whether the signal shows interpretable physiological sensitivity in the target indication.
Prospective Mechanistic Sub-Study
Embed PhysioSense into an ongoing or planned study to evaluate longitudinal physiological response alongside conventional measures, using wearable, bedside, or smartphone-based capture workflows depending on protocol needs.
Endpoint & Analysis Development
Work jointly to define study-relevant physiological descriptors, analysis plans, and subgroup strategies that support mechanistic interpretation, enrichment hypotheses, or longitudinal response tracking.
Platform Collaboration & Scale-Up
Expand into broader program use, including additional studies, device integrations, or co-developed workflows that bring PhysioSense into the sponsor’s clinical development and evidence-generation strategy.
Scientific and technical capabilities for drug development
PhysioSense provides interpretable physiological analysis from pulsatile waveform data, along with the scientific support needed to help pharma teams evaluate mechanism, monitor response, and explore new study endpoints.
- Sensor-independent waveform analysis compatible with wearable, bedside, optical, and smartphone-based capture workflows
- Interpretable physiological descriptors related to vascular load and compliance
- Longitudinal patient-level tracking to assess physiological change over time rather than isolated snapshots
- Scientific collaboration support for study design, feasibility work, subgroup analysis, and mechanistic interpretation
- Flexible deployment options for retrospective analysis, prospective studies, and secured research environments
Interested in a feasibility assessment?
We can evaluate whether PhysioSense detects meaningful physiological response in your indication using existing waveform data, a prospective sub-study, or a focused pilot cohort.
Discuss a Feasibility Study