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Vasowatch Inc is redefining maternal health with a first-in-class, non-invasive digital biomarker that predicts postpartum hemorrhage (PPH) before delivery. Using heart rate wearables and a proprietary algorithm, Vasowatch identifies myometrial fatigue — the leading cause of hemorrhage — in real time. By giving clinicians hours of advance warning, the platform enables faster, more effective care, improving outcomes and addressing racial disparities in maternal mortality.

Lead Program & Pipeline

  • Lead product: Vasowatch System, a SaMD (Software as a Medical Device) Class II De Novo

  • Predicts PPH by detecting myometrial fatigue from streaming maternal heart rate

  • Continuously updates hemorrhage risk status during labor via wearable sensors

  • Clinical pilot (300 patients) underway to validate system accuracy, usability, and impact

  • 14 Letters of Intent to pilot from U.S. health systems totaling 70,000+ births/year

Technology Differentiators

  • First tool to predict PPH physiologically — not by historic or demographic risk

  • Uses FDA-cleared wearables + proprietary algorithm for non-invasive monitoring

  • Provides hours of advance notice before delivery, enabling timely interventions

  • Targets a $2B global market with subscription-based reimbursement model

Stage & Investment

  • Stage: Preparing for pivotal trial; pre-revenue

  • Funding Raised: <$500K

  • IP: Licensed patent + provisional patent from Vanderbilt; includes software copyrights

  • Regulatory Pathway:

    • SaMD Class II De Novo

    • FDA pre-submission meeting completed; Breakthrough Device Designation applied

    • Targeting De Novo submission by 2026; FDA approval forecast for 2027

  • Collaborators: Vanderbilt, University of Pennsylvania, ChristianaCare, GE Healthcare, Philips, Organon

What's Next

  • Execute 300-patient clinical pilot (est. 12 months)

  • Submit second pre-submission meeting request to FDA

  • Finalize pivotal trial design and verification/validation testing

  • Secure strategic distribution partnerships and prepare for commercialization

Leadership

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Christine Rohan, MBA, BSE
CEO
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Stefanie Modri, MSN, RN
Co-founder
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