CT scans are a preferred modality for diagnosing diseases in the patients. This modality has increased to about 80 M CT scans per year in USA alone. One CT scan radiation dose can be equivalent to undergoing 100 X-rays. Recent studies have shown that there is a risk of cancer caused due to radiation dose used during CT scans. The market for dose reduction is being driven by regulatory trends, media blitz, public awareness and care providers concern for patient safety and potential loss of patients to other hospitals for want of low radiation CT scan capability. The Total Available Market (TAM) is $3.5 B. The market opportunity for this product in China is bigger than the market opportunity in USA.
The big 4 CT scanner vendors – GE, Siemens, Philips and Toshiba have spent over $500 M in developing a solution to reduce radiation dose for CT scans. All of them use some variation of Iterative Reconstruction (IR) technique. This solution has limitations such as -modest dose reduction limited to 25% to 40%, processing time per CT scan study 5 minutes to 50 minutes, incompatibility with installed base of CT scanners, waxy and blurry images not liked by radiologists, $100K to $200 K cost per scanner.
Our software, PixelShine™, works on off-the-shelf PC/ server or on a virtual machine under VMware located in data center of any imaging center. Our solution has the following advantages – reduces radiation dose by 70%-80%, processes a CT scan study in less than 1 minute, can work will existing installed base of CT scanners, is vendor agnostic, images appear like FBP images that radiologists are used to.
We are the first and the only Company in USA which has developed this software based on Deep Learning concepts (DL) – a special discipline of Artificial Neural Network (ANN) for removing noise in noisy CT scans acquired at low radiation dose. This work is based on a patent from University of Chicago exclusively licensed to us for worldwide use.
We obtained FDA 510 (k) clearance in September 2016 and since then we have been conducting some studies in a semi-formal and informal manner to verify the efficacy of the software before the product launch for commercial deployment. The studies conducted by Mass General Hospital (MGH), University of Virginia (UVA), have concluded that PixelShine significantly improved the diagnostic quality of CT noisy scans acquired at reduced radiation dose – such as 20-30% of the radiation used in standard protocols. This establishes the potential of PixelShine™ as a disruptive technology making a major impact on the practice of medical imaging.
Our team consists of Jagdish Vij and Ramesh Neelmegh – co-founders of the Company. Both Jagdish and Ramesh are serial entrepreneurs and have been working in startups since early 1990’s. Akira Hasegawa, PhD, is our Chief Technology Officer (CTO) and has over 20 years of experience in developing software for medical imaging. Founders are complemented by a group of practicing radiologists, engineers with many years of experience in developing medical imaging software and by an experienced sales team with excellent knowledge of the medical imaging software sales/purchase dynamics.