SATPC0034243 Tab 04 4 SOW.pdf

Statement of Work

Introduction

Bone loss during long‐duration spaceflight remains a concern for astronaut health and operational readiness. A major challenge is the inability to assess skeletal health during a mission. While dual‐ energy X‐ray absorptiometry (DXA) assessment of bone mineral density is routinely used to screen astronauts before flight selection and to assess the impact of spaceflight on skeletal health upon return to Earth, it is not suitable for use during spaceflight. Prior work has shown that rates of bone loss during spaceflight are highly variable, suggesting that some astronauts could benefit from interventions to prevent bone loss during exploration missions, whereas others may not require such interventions. However, currently there are no techniques capable of assessing the rate of bone loss during a spaceflight mission.

Radiofrequency echographic multi‐spectrometry (REMS) is an innovative ultrasound‐based approach that holds promise for assessing changes in bone mass during a spaceflight mission (Figure 1). In brief, REMS evaluates bone status by collecting raw, unfiltered ultrasound signals, so‐ called radio frequency (RF) ultrasound signals. Scans are acquired at the proximal femur and lumbar spine using a 3.5MHz convex ultrasound probe. The device operator controls the position and focus of the transducer, while automated software identifies the proper spectra for analysis. The acquired ultrasound spectral signal is compared to previously acquired spectra from healthy individuals and used to estimate bone mineral density (BMD). The analysis also estimates a T‐score (e.g., the number of standard deviations above or below a young normal reference database) and Z‐score (e.g., the number of standard deviations above or below a sex‐ and age‐matched reference database). The device is manufactured by EchoLight Medical (Lecce, Italy), and is approved by the Food and Drug Administration (FDA) for use in human subjects and has a Conformité Européenne (CE) mark for use in human subjects in Europe.

Objective/Requirement Provide REMS ultrasound device and services so that it can be used to measure bone mineral density on the hip and spine of human subjects.

Lead time for delivery: May 17, 2024

Characteristics, Scope, and Spec o Installation, Training, and Maintenance services before and between bed rest campaigns o Main unit and convex probe with workstation and cart for moving between subject beds o Proprietary software for REMS methodology o Database management software for tracking and exporting human subject data o

Data needed:

Bone Mineral Density, T‐score, and Z‐score DICOM export files REMS Fragility Score Measures 5‐year Fracture probability measure o Data described above should be output by the device

Milestone 1: Cost

‐ Delivery of REMS ultrasound device and accessories to JSC for IT approval and tagging

‐ Approved by the Food and Drug Administration (FDA) for use in human subjects and has a Conformité Européenne (CE) mark for use in human subjects in Europe

‐ Software needed to obtain and view images ‐ Installation and training at the German Aerospace Center in Cologne Germany ‐ Instruction manual for administering the scans and exporting data

105K

Milestone 2:

‐ 5‐year warranty and maintenance services Software updates

79K

Discounted Price for Research ‐35.5K

‐ Total 147.5K

Period of Performance: 3/01/2024 – 7/31/2024

Location:

Echolight Medical Corp., 1800 West Loop South, suite 1740

Houston, TX 77027

EIN 92‐0921265

Phone: 929 364 7963 sales@echolightmedical.com www.echolightmedical.com