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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# SUMMARY:

The invention listed below is directed to a device to measure placental oxygen saturation in pregnant women from 20 weeks of pregnancy to delivery. The device monitors maternal tissue oxygen saturation, blood oxygen saturation, breathing rate, heart rate, and heart rate variability from signal, fetal movement activity and potentially fetal heart rate and heart rate variability. This technology was discovered and is being developed by the National Institute on Child Health and Human Development (NICHD). The NICHD is currently seeking a licensee and/or collaborator to further develop this technology.

# FOR FURTHER INFORMATION CONTACT:

                        Inquiries related to this licensing and collaboration opportunity should be directed to: Zarpheen Jinnah, Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702. Telephone: (240)-276-5530;                               ( print page 84824)                            Facsimile: (240)-276-5504; Email:                         *zarpheen.jinnah@nih.gov.*                         A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to this invention.                    

# SUPPLEMENTARY INFORMATION:

The following patent application is available for licensing and/or collaboration under a Cooperative Research and Development Agreement (CRADA):

US Provisional Application No. 63/451,066.

Achieving expeditious commercialization of federally funded research and development is consistent with the goals of the Bayh-Dole Act, codified as 35 U.S.C. 200-212.

## Background and Description of Technology

Monitoring placental oxygenation level and maternal physiological signals can be useful to assess mother and fetus well-being during pregnancy. Additionally, fetal movement has long served as a measure for fetal well-being and nervous system development helping to identify adverse pregnancy outcomes. Identification of complications during pregnancy can allow for earlier interventions, including medications to reduce risk of perinatal mortality and maternal gene therapy. Researchers at NICHD have created a wearable and wireless device and protocol for continuously monitoring the placental oxygenation levels, multiple physiological signals and movement activities of a fetus and mother. The device includes a compact control board, a flexible near-infrared spectroscopy (NIRS) probe, and multiple accelerator probes. A classification algorithm based on Monte-Carlo simulations of multiple layers model computes oxygen saturation of the placenta. There are one or more accelerator probes attached to different body parts of the mother to detect mother movement activities and to eliminate the effect of mother movement on fetal movement. The overall data acquisition rate of this device is 10 Hz or more. With this acquisition rate, the output of the device contains extra physiological signal such as maternal respiratory and cardiac functions, and fetal cardiac functions.

## Potential Commercial Applications

A low cost wearable device, similar to a smart watch, in which a pregnant woman can wear regularly to monitor both mother and fetus health conditions.

Competitive Advantages:
    - Wearable and non-invasive placenta and fetal monitoring device.
    - Capable of 24/7 continuous monitoring of mother and fetal well-being.

## Development Stage

Clinical development.

Dated: November 30, 2023.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2023-26736 Filed 12-5-23; 8:45 am]

BILLING CODE 4140-01-P