SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project will prove the feasibility of a low-dose 4D cone beam tomosynthesis reconstruction algorithm for use in medical image-guided interventions. Despite the availability of highly accurate 3D guidance systems, most image-guided interventions are still performed under 2D fluoroscopy. 3D guidance is significantly more complex and expensive, as it requires the combination of 3D imaging (like CT) with surgical navigation, both expensive and complex technologies. A system capable of reconstructing a 4D scene would provide accurate and easy to use guidance for the medical professional, at lower costs. This research will develop a 3D reconstruction algorithm with quasi real-time performance (4D) that does not increase exposure to x-rays when compared to 2D fluoroscopy. The proposed technology will combine the most recent advancements in tomosynthesis, iterative reconstruction and compressed sensing and fundamentally change image-guided interventions. The broader impact/commercial potential of this project is that advanced medical procedures, like minimally invasive surgery, will be significantly improved in workflow and accessibility, reducing healthcare costs, improving outcomes and improving quality of life for patients. In the U.S. alone, a 10% shift to minimally invasive spine surgeries can reduce healthcare costs by $180M while reducing patient trauma and providing faster recoveries to 45,000 patients. This technology could be applied in other clinical areas like oncology and interventional radiology, improving a broad array of procedures and bringing a new level of excellence in medical interventions. 4D systems would compete in the intra-operative x-ray medical imaging market, a $1B market that is growing 6% annually, and in the Surgical Navigation market, a $400M market that is growing 9% annually. The proposed concept has the potential to disrupt both these markets by replacing pairs of intra-operative 3D imaging and surgical navigation systems with one 4D system that is more cost effective and easier to use.

The broader impact/commercial potential of this project is the significant improvement ofsurgical accuracy, which will dramatically reduce surgical errors, improve outcomes andreduce healthcare costs. In spine surgery alone, there are more than 500,000procedures every year in the US utilizing implants such as screws. In 4% to 11% ofthese surgeries, the implant placement is inaccurate. For the patient this translates intolonger recoveries - from days to weeks - and in many cases into a second revisionsurgery. The patient is non-productive, unable to carry out their daily routines for weeks,while the healthcare system has to absorb the costs of the longer recovery as well asthe revision surgeries. For both the healthcare and economic systems these areavoidable costs. The medical imaging technology being developed in this project hasthe potential to eliminate surgical inaccuracies across the $2.4B market of imageguidance, improving clinical applications that range from orthopedic surgery to minimallyinvasive vascular interventions, to cancer diagnosis and treatments.This Small Business Innovation Research (SBIR) Phase 2 project will demonstrate anovel imaging modality, which provides near-real-time 3D live imaging - 4D - duringsurgery. This novel system will provide surgical imaging at a lower x-ray dose thanfluoroscopy (current standard), with a geometry that allows concurrent imaging withsurgery. This 4D technology has the potential to significantly reduce surgicalinaccuracies, improve outcomes and reduce costs. Phase 1 successfully demonstratedthe feasibility of the reconstruction algorithm used by the proposed imaging modality byshowing its potential of higher surgical accuracy in a single spinal screw insertion. ThisPhase 2 project will I) prove the robustness of the reconstruction algorithm across avariety of use-cases, II) demonstrate the clinical usability of the 4D scanner, and III)confirm the clinical utility of the scanner. The clinical usability will be studied with anergonomic model in a surgical setting. The clinical utility will be proven by building asystem prototype and performing image quality and x-ray dose comparisons versusfluoroscopy and 3D in a realistic surgical setting. Preliminary results show that theseobjectives are achievable. This research is readying the technology for clinical research,regulatory clearance and commercialization.