STTR Phase I: Ultrasonic Fracture Healing Assessment

Sonogen Medical, Inc., Chevy Chase MD

Investigators

Abstract

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a novel medical device algorithm for assessing the status of bone fracture healing using ultrasound measures. The system aims to provide advantages to current X-ray based paradigms by reducing cost and radiation exposure, and by enabling portability. An estimated 130 million X-Ray procedures are performed in the US each year, at a cost of $16 billion with as much as 25% redone due to quality issues. Furthermore, 2.8 million patients are considered at risk for delayed/non-union fractures. The combined market potential is $1.3B/year as a software solution to ultrasound equipment vendors and $1.4B/year for at home monitoring. This Small Business Technology Transfer (STTR) Phase I project aims to develop the company’s proprietary fracture healing algorithm utilizing ultrasound data. During the first phase the company will acquire, analyze, and compare in-vivo ultrasound, X-ray, and micro-CT data in a lapine model across the healing cycle of surgically induced tibial diaphysis fractures. The company aims to de-risk their fracture healing to monitor the stage of orthopedic healing versus X-rays with 90% statistical confidence. The risks to be addressed include signal characterization versus noise ratio, back-scattering, and fracture healing classification. The results of the Phase 1 study will provide a working algorithm suitable to begin human feasibility testing. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.