Labor and Delivery technology that improves risk prediction 10x for postpartum hemorrhage, saving lives, reducing maternal complications and cutting obstetrics costs for health systems and payers.
Vasowatch’s mission is to develop clinical decision support technology to improve the birthing experience for all mothers. Our product is novel Labor and Delivery technology (US patent pending) that provides continuous monitoring of a mother’s risk for postpartum hemorrhage, excessive blood loss after childbirth, the leading cause of maternal deaths and complications globally. We provide up to ten times greater predictive accuracy hours ahead of delivery, beyond current expert-based risk assessments administered at hospital admission, saving lives, reducing maternal complications and lowering obstetrics costs for health systems and payers. Postpartum hemorrhage is prevalent, impacting over fourteen million women annually. In the US hemorrhage persists as the biggest cause of maternal mortality in Labor & Delivery, despite the fact that 98.4% of all US births occur in an acute care hospital setting. For every woman who dies, there are a hundred who experience complications including emergency hysterectomies, blood transfusions, acute kidney injuries and post-traumatic stress disorder. What distinguishes hemorrhage from other causes of maternal mortality and morbidity is that up to 90 % of these occurrences are preventable. Delays in recognition leading to delayed or ineffective care occurred in three-quarters of cases. Shockingly 40% of the women who go on to hemorrhage are assessed as 'low risk' at the start of their labor. A woman’s hemorrhage risk status can change during Labor and Delivery. Current detection methods underestimate blood loss by up to 50% and are hampered by recent staffing shortages, sicker mothers, and growing racial inequities in obstetrics care.
Vasowatch has built an experienced and diverse leadership team, qualified to bring our life-saving technology to market.
- Christine Rohan, CEO, led business development and service growth over a 25-year career at GE, directed innovation at BCBSA, and guided successful early stage digital health startups.
- James Weimer PhD, is Assistant Professor of Computer Science and Biomedical Engineering at Vanderbilt University. Dr. Weimer is an expert in machine learning research and its application. He led development of the algorithm, overseeing its refinement.
- Det Ansinn, CTO, is a serial entrepreneur with extensive expertise delivering innovative technology to health care systems.
- Harish Sehdev MD, Medical Advisor. Dr. Sehdev is a Penn Medicine physician, Professor of OBGYN, and Director of Prenatal Diagnosis Unit at Pennsylvania Hospital.
- Stefanie Modri MSN RN C-MNN is an obstetrics nurse with over 25 years of clinical experience and a faculty member at the University of Pennsylvania School of Nursing.
Vasowatch will initially target US health systems in states with high maternal mortality and birth volumes, including TN. Advocacy for use of Vasowatch will be driven by the leadership of obstetrics departments. Key decision makers will be the Director of Maternal Fetal Medicine (MD) and Director of Women’s Services (RN). We will focus on obstetrics departments that are part of large integrated delivery networks (IDN). IDNs have the resources to support innovation pilots (including innovation budgets and staff), clinical care setting options and built in growth potential. They are also most likely to include influential clinicians, e.g. State Maternal Mortality Commission members and researchers, who have the expertise that can persuade their peers to adopt a novel technology.
These systems are educating the next generation of clinicians. Larger systems have the potential to deliver greater impact on costs, outcomes and health equity. One early adopter/state will be enough to engage with the state’s Maternal Mortality Commission, Medicaid Plan and the local Blue Cross Blue Shield Plan, setting a new standard for hemorrhage care. Ultimately, payers, e.g. commercial insurers, self-insured employers and Medicaid, will reimburse based on cost savings, quality improvement and societal impact. Vasowatch is device agnostic, integrating with existing heart rate sensors and dashboards, optimizing accessibility and affordability of our life saving solution. We plan on establishing distribution partnerships with medical technology and maternity platform vendors who have established distribution capability. We believe Vasowatch can set a new standard in hemorrhage care.
Upon FDA approval, we will license the software to US obstetrics hospitals on a subscription basis by birth volume ~$150/birth or an average $250K/hospital, delivering $500,000 of hospital cost savings. To prove product market fit, Vasowatch plans to hire a small direct sales team. In parallel, we will negotiate distribution agreements with global med tech and maternity platform vendors who have established capabilities in obstetrics sales and support, accelerating top line sales and market share. We have had discussions with GE Healthcare Technologies, Philips, Organon, Medtronic, and Diana Health. We will pursue WHO designation and license the solution for global distribution. We expect that the sales process will take six months to a year, with sales efforts beginning upon completion of the pivotal trial (mid-2026), six months ahead of anticipated FDA approval of Vasowatch’s De Novo application. Clinical pilot sites will be converted as early adopters and will serve as references for future sales. Vasowatch will initially staff five geographic regions, led by a sales leader and a clinical support specialist (RN) beginning in 3Q2026. Contracting with an average of two hospitals per state in the first three years will exceed our business plan goals, achieving profitability. An 8% market share would yield a $36M annuity at 90% gross margin. We have received fourteen letters of intent to pilot from hospital systems representing 70,000 annual births, more than our first year sales forecast of 50,000 births.
A 300-patient clinical pilot is a crucial ‘next step’ to commercializing Vasowatch’s life-saving technology, informing a successful pivotal trial. We have already demonstrated that the Vasowatch System can predict women at high risk of postpartum hemorrhage (PPH) with sensitivity and specificity exceeding standard of care and now need to demonstrate that the Vasowatch System can reduce PPH rates in clinical practice and integrate into clinical practice with a usable workflow. The data from this trial will then be used to inform a subsequent pivotal clinical trial to support an FDA De Novo pre-market approval application. The $800,000 funds that we are raising will be used for the following:
- Recruitment, enrollment, data pull and outcomes for 300 patients -
- Program management of clinical pilot including services of Clinical Operations Leader and CEO - Software engineering, including integration, software changes and support - Pilot hardware (wearable sensors, tablets)
- Usability analysis - Regulatory consulting supporting a second pre-submission meeting with the FDA
- Instructional video for clinicians and recruiting materials for patients
- Clinical pilot insurance - Admin/legal support for the pilot program We have identified our clinical pilot/trial site as ChristianaCare's Christiana Hospital in Newark DE, part of the Perinatal Research Collaborative in the Northeast, working with Principal Investigator Matthew Hoffman MD MPH FACOG, Director of Obstetrics & Gynecology.
The Vasowatch system includes a heart rate wearable, the proprietary patent-pending algorithm, and a mechanism to communicate maternal hemorrhage risk to clinicians. The wearable collects maternal heart rate data during active labor. The data is sent continuously to the algorithm for analysis from admission to delivery. The software identifies signatures in maternal heart rate timing data modeled to correlate with myometrial fatigue, a leading cause of hemorrhage. If a change occurs indicating heightened hemorrhage risk, a notification is sent to the woman’s care team for immediate patient assessment. Vasowatch has developed version 1.0 of the system, integrating Sibel Health's 510(K) cleared ANNE(R) Chest sensor with the algorithm and an ipad mini bedside and web-based nurses' station dashboard. This system is ready to deploy in a clinical pilot. The system has cleared the IT review at the pilot site, ChristianaCare Hospital. To inform the algorithm, Vasowatch conducted an observational study on a diverse population of 525 women at Pennsylvania Hospital, part of Penn Medicine. We determined that hemorrhage risk prediction can be significantly improved prior to delivery using a patient’s own heart rate data with up to ten times the sensitivity and comparable positive predictive value, compared to current admission risk screening tools. Statistically significant improvements were observed six hours prior to delivery. Vasowatch presented this research at the Society of Maternal Fetal Medicine Pregnancy Meeting in an oral presentation delivered on February 14, 2024.We have replicated the results using heart rate vs. waveform data.
STTR Phase I award - $244,000 Penn Health Tech grants - $68,000 Penn School of Nursing grant - $10,000 Nemera Innovation prize - $5,000 Laerdal Million Lives Fund SAFE - $100,000 mHUB Product Impact Fund SAFE - $75,000 Raynier Seed Fund SAFE - $25,000 MATTER Health SAFE - $25,000 Friends and Family Convertible Promissory Notes - $200,000
