Postpartum Hemorrhage Risk Assessment Device

A point-of-care non-invasive tool designed to alert the hemorrhaging woman of impending danger and to seek timely medical care.

Hemorrhage remains as one of the common and often preventable causes of maternal death, especially in resource poor settings. To date the most reliable method of assessing a bleeding woman’s status has been clinical exam accompanied by a laboratory evaluation of her blood count. In resource poor settings (e.g. Africa and rural US) access to laboratory evaluation is limited and expensive. Our solution is a point-of-care non-invasive tool designed to alert the woman of impending danger so that she can seek medical care. Blood is collected through our proprietary non-invasive sampler, and inserted into a low-cost reader, which will assess the blood count and alert the woman of her status including impending danger (death).

To date, the available solutions include Abbott iSTAT, which is used by medical facilities and carries a substantial cost, a WHO distributed basin to catch the blood which only provides an estimation of the blood loss, is cumbersome, and inaccurate.

Our solution is non-invasive (minimal training of attendant or family required), markedly inexpensive compared with other solutions, does not require extensive training, provides an objective measure of the blood count, and may be deployed in various settings involving bleeding after child birth including under-resourced countries, rural regions of developed countries, home births, birthing centers, and has potential for use in trauma settings as well as non-childbirth related bleeding such as excessive menstrual bleeding.

This is a new technology, specifically aimed at postpartum hemorrhage.

With use of technology we are able to provide an exact measure of the bleeding mother's blood count rather than a guess of blood loss.

Clinical validation trials at the University of Texas Medical Branch in Galveston, Texas.

Based on our customer discovery process, we plan to provide our technology to birth attendants in rural United States, as well as Global Non-Profit Organizations (including NIH Global Health Network) with mission aimed at maternal mortality reduction to reach underserved areas in Asia, Central America, and Africa.

During our NSF I-Corps customer discovery process, we found that our best approach will be through the American College of Nurse Midwives, AWHONN, and ACOG nationally, as well as the NIH NICHD Global Health Network and World Health Organization internationally to reach local governments for deployment.

We are currently not in non-investigative clinical use.

We hope to perform our clinical validation trial on 120 women in the next 12 months. Thereafter, with appropriate regulatory approvals in place, we hope to expand to rural United States first, rural Mexico second, and other countries thereafter.

Drs. Milner and Estrada: Biomedical Engineering with history of development of several devices from bench to bedside

Drs. Haeri, Saade, and Saad: Maternal-Fetal Medicine specialists with extensive history of clinical research including NIH NICHD Maternal-Fetal Medicine Units Network membership

Ms. Torres: Business development with start-up experience in both USA and Mexico

Handheld device (blood counter): one time purchase

Proprietary non-invasive blood sampler (insert): single-use (required recurrent purchase)

Not only are we hoping to utilize funding from the Solve program toward our clinical validation trials, but more importantly we hope to be exposed to the mentorship, network, and resources of the Solve program in carrying our technology from bench to regulatory approval and to the bedside. Given that our solution is aimed for underserved countries, we felt that Solve's wide reach was the perfect venue for our presentation.

Funding, networking with leaders at global non-for-profit organizations, and business mentorship.