# Multifunctional coagulation and platelet profiling during cardiaccirculatory support

> **NIH NIH R41** · COALESENZ INC. · 2024 · $295,915

## Abstract

ABSTRACT
Our goal is to advance a novel, hand-sized hemostasis profiler, iCoagLAB as a companion diagnostic during
mechanical circulatory support (MCS) to predict potentially lethal bleeding in patients. MCS involves a broad
group of technologies that provide hemodynamic support to manage a range of complex cardiac conditions,
including advanced heart failure, cardiogenic shock, high-risk coronary interventions, severe cardiac or lung
dysfunction, or to facilitate cardiac surgery. Although MCS technologies have expanded treatment options for
high-risk patients, between 15-40% of patients experience life-threatening bleeding. Multiple factors including
underlying coagulopathies, clotting factor consumption, shear stresses created by mechanical pumping, platelet
impairments and fibrinolytic activation increase bleeding risk, exacerbated by heparin administered to prevent
clotting in the MCS circuit. Therefore, to assess bleeding risk, frequent coagulation testing is essential.
Unfortunately, conventional laboratory tests take too long, are ineffective in the context of rapidly changing
coagulation in critical patients, and are poorly correlated with bleeding events, resulting in hemostasis
management that is often imprecise with devastating consequences. The ability to treat rapidly evolving
coagulation impairments in those at risk is therefore restricted by the absence of tools to assess coagulation
comprehensively and swiftly at the point-of-care. As a consequence, major bleeding resulting from impaired
coagulation, remains the leading cause of death during MCS.
 Coalesenz Inc., a Boston-based start-up, is developing a novel hemostasis profiler (iCoagLAB) to rapidly
quantify several relevant coagulation and platelet parameters concurrently during MCS and provide a decisive
risk score to identify the likelihood of major bleeding. In iCoagLAB, a laser source illuminates the blood sample
and a camera images laser speckle patterns reflected from the sample over time. By analyzing laser speckle
intensity fluctuations during coagulation, we can quantify multiple coagulation metrics including prothrombin time,
activated clotting time, fibrin polymerization, fibrinolysis, platelet function, and hemoglobin and hematocrit. With
1/10th the weight and footprint of competing technologies, Coalesenz’s new hand-sized iCoagLAB instrument
lends itself for comprehensive coagulation and platelet profiling at the poc.
 Although iCoagLAB opens the opportunity to assess bleeding at the poc, the existing technology currently
is not tailored for use in patients during MCS. A key limitation is that current reagents are not suitable for testing
the wide range of heparin doses typical in MCS patients. Moreover, our existing single-channel disposables
permit only one assay at a time using blood that is pre-mixed with liquid reagents, increasing the test duration
and complexity of workflow. Therefore, in this Phase 1 proposal our objectives are to develop and test novel
mill...

## Key facts

- **NIH application ID:** 10922390
- **Project number:** 1R41HL170886-01A1
- **Recipient organization:** COALESENZ INC.
- **Principal Investigator:** Seemantini K Nadkarni
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $295,915
- **Award type:** 1
- **Project period:** 2024-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922390

## Citation

> US National Institutes of Health, RePORTER application 10922390, Multifunctional coagulation and platelet profiling during cardiaccirculatory support (1R41HL170886-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10922390. Licensed CC0.

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