RIVANNA MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Despite being correlated to poor health outcomes, eme

Description

DESCRIPTION (provided by applicant): Despite being correlated to poor health outcomes, emergency department (ED) overcrowding occurs several times per week in 90% of all EDs in the US. A primary contributor to ED overcrowding is high demand for radiology services (i.e. X-rays), which are relied upon for diagnosis of bone fractures in 7.2 million non-time- sensitive suspected bone fracture patients per year. The total financial impact of this time and resource- consuming task is estimated at more than 1.9 Bper year in the US. Ultrasound has been widely investigated as an alternative to X-ray for fracture diagnosis and assessment of treatment (i.e. fracture reduction) in the ED; however, conventional ultrasound image quality of bone anatomy is poor, has a limited field of view, and is challenging to interpret. This Phase I SBIR proposal seeks funding to test the feasibility of a portable ultrasound-based 3D bone imaging device, referred to as the FractureFinder, for diagnosis of bone fractures in the ED. Keytechnological innovations of this project include a new conformable, piston-array-based 3D imaging transducer that is technologically advanced over conventional ultrasound due to: reduced bone imaging artifact, increased field of view, and conformabilityto the shape of the patient's skin surface. Additionally, an advanced bone imaging sequence and reconstruction method is introduced that enhances delineation of bone surfaces. The long-term goal of this project is to create a compact, portable ultrasound-based 3D bone imaging system with sensitivity and specificity for bone fractures equivalent to that of digital X-ray. The Phase I hypothesis is that an ultrasound-based 3D bone imaging device can be fabricated to achieve equivalent fracture detection performance to X-ray in an ex vivo porcine tibia-fibula fracture model. A functional handheld ultrasound prototype incorporating a conformable transducer with dimensions lt 25 cm x 20 cm x 6 cm will be fabricated. Bone imaging reconstruction techniques will bedeveloped in simulation to achieve resolution lt= 200 m with sensitivity gt 99% over bone angles spanning 100 . The imaging techniques and reconstruction algorithms will be implemented on the prototype and tested in an ex vivo whole porcine tibia- fibulamodel. Research plans for Phase II include a refined prototype with industrial design and graphic user interface development for the purposes of conducting an in vivo pilot study at the University of Virginia Hospital. The proposed 3D bone imaging device is expected to speed diagnosis of bone fractures in the ED, allowing faster treatment and patient discharge without using valuable radiology resources. It is estimated that the device could save at least 6.3 million ED hours and 1.16 B to the healthcare system, annually. The fully saturated US emergency medicine market for the FractureFinder is estimated at 120 M in revenues per year. Additional applications for the product include rural healthcare, sports medicine, battlefield, and orthopedic, the latterof which has an estimated fully saturated US market of 209 M/yr. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Despite being correlated to poor health outcomes, emergency department (ED) overcrowding is a frequent problem in United States hospitals, with high demand for radiology services (i.e. X-ray fracture diagnosis) representing a major contributing factor. Although medical ultrasound is an alternative to X-ray for fracture diagnosis and assessment of treatment that could potentially reduce cost, wait times, and radiation exposure, conventional ultrasound suffers from poor bone image quality, a limited field of view, and image interpretation challenges. The long-term goal of this project is to develop and commercialize a compact ultrasound-based 3D bone imaging system with sensitivity and specificity for bone fracture detection substantially equivalent to digital X-ray, with potential savings of at least 6. million hrs/yr in ED waiting time and 1.16 billion/yr to the US healthcare system.