PA-22-176, SBIR, Development of a wearable light-based remote monitoring system for early detection of postpartum hemorrhage
PA-22-176,SBIR,开发可穿戴式光基远程监测系统,用于产后出血的早期检测
基本信息
- 批准号:10821955
- 负责人:
- 金额:$ 29.59万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-30 至 2024-09-29
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
PROJECT SUMMARY
There is an urgent need to develop technologies which address preventable causes of maternal deaths and
improve maternal health outcomes. In the United States (US) there exist deeply concerning racial and ethnic
disparities in maternal health outcomes (with black mothers experiencing a >3x higher mortality rate than non-
black mothers). Furthermore, the US has the highest maternal mortality of any high-income country and is one
of only two countries in the world where maternal mortality is rising. This SBIR project is focused on addressing
postpartum hemorrhage (PPH), defined as severe bleeding after delivery, because it is a leading cause of
maternal morbidity and mortality, and >90% of deaths from PPH are considered preventable with early
detection and early treatment. The product of this SBIR project, Maternal aRMOR (remote monitoring optical
reader), will be a wrist-worn sensor and integrated mobile app that obstetric providers use to detect early blood
loss (when inexpensive and accessible treatments like pharmacologic agents and balloon tamponade are most
effective). Maternal aRMOR uses laser speckle imaging to quantify peripheral blood flow. Maternal aRMOR
works by sensing and alerting providers to the changes in blood flow that occur in early hemorrhage when the
body shunts blood to its core to protect vital organs. Unlike visual estimation of blood loss, Maternal aRMOR
provides clinicians with real-time, quantitative information about a patient’s hemodynamic state. Aim 1 of this
Phase I SBIR will evaluate the potential confounding effects of skin pigmentation and motion on aRMOR
signal, to ensure robust and equitable device performance. Aim 2 will establish a subject-specific perfusion
range to improve personalized hemorrhage risk assessment. Aim 3 will demonstrate development of a mobile
app that interfaces between the wearable Maternal aRMOR device and healthcare providers to provide
continuous monitoring for PPH. Phase II of this SBIR project will focus on development of a commercial-grade
device and clinical studies to demonstrate the impact of Maternal aRMOR for improving health and decreasing
healthcare cost associated with PPH. Initial target customers include the >3,200 US-based obstetric hospitals
who serve ~6M patients annually. Ultimately, Maternal aRMOR will set a new clinical standard for early PPH
diagnosis enabling rapid treatments to prevent the devastating complications of delayed hemorrhage
diagnosis, including transfusion, surgery, and death, that currently impact millions of mothers each year.
项目总结
项目成果
期刊论文数量(0)
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