Commercialization Readiness for a Portable PET Insert System for Simultaneous TOF-PET and MR Brain Imaging

Project Summary Neurological and mental health disorders cost the United States more than $800 billion each year. Alzheimer’s disease (AD) alone costs the U.S. an estimated $345 billion in 2023. The recent approval of anti-amyloid treatments for AD underscores the urgency for early diagnosis. Accurate diagnosis of various neurological and mental health disorders, including brain tumors, epilepsy, Alzheimer’s disease, and depression, often requires both PET and MRI scans, typically involving separate PET/CT and MRI procedures. This sequential approach not only causes patient inconvenience and delayed diagnosis, but it also leads to image fusion error and additional radiation exposure from the CT scan. Hybrid PET/MRI systems, capable of simultaneous PET and MRI scanning, present a solution to these challenges. However, their adoption is hindered by the prohibitive costs of current permanently-integrated systems, which includes approximately $5 million for purchasing the system, plus an additional $1.5-2 million for room renovations. In the U.S., only about 60 integrated PET/MRI systems are in use, compared to 13,500 MRI systems. Existing whole-body PET/CT and PET/MRI systems are also limited in spatial resolution and photon sensitivity needed for brain imaging. PETcoil is addressing these challenges by commercializing a portable, brain-dedicated PET system that can be inserted into (and removed from) any MRI system to lower the cost to achieve simultaneous PET/MRI by 10-fold compared to current permanently-integrated PET/MRI system. The PETcoil insert system also achieves over 3 times higher photon sensitivity and over 4 times finer volumetric spatial resolution over current PET/MRI systems, enhancing lesion detection and quantification in brains. In Phase II, we developed a functional PET insert prototype. The current CRP program focuses on optimizing the design for mass production and preparing for regulatory submission, with three specific aims: (1) Collaborate with a product development firm to finalize the industrial design and manufacturing process for the production unit. (2) Verify and validate the safety and performance of the production unit for regulatory submission in collaboration with Stanford University. (3) Work with a seasoned consultant to develop a regulatory strategy and prepare for the FDA submission. This includes holding pre- submission meetings with the FDA, compiling the required materials, and submitting the regulatory application. This CRP program will culminate in a production-ready brain PET insert, set for manufacturing and regulatory submission, poised to enable widespread dissemination of PET/MRI technology for characterizing neurological and mental health disorders.