July 25, 2023 — Positron Corporation, a leading molecular imaging medical device company, is pleased to announce that the Company has entered an Novation Agreement with Shenyang Intelligent Neuclear Medical Technology Co, LTD (Intelligent Neuclear Medical), a wholly owned subsidiary of Neusoft Medical Systems (Neusoft), that transfers the original Business Cooperation Agreement between Positron and Neusoft Medical Systems (“Neusoft”) to now include Neusoft’s subsidiary, Intelligent Neuclear Medical.
Positron and Intelligent Neuclear Medical enter this agreement to redefine certain key functions and responsibilities of each party that will improve the long-term production, control, and success of both parties’ business relationship. Positron has expanded its role as manufacturer with Intelligent Neuclear Medical designated as the Company’s contracted components supplier.
Positron’s classification as the device manufacturer is significant as it will register with the FDA as the applicant of its FDA 510k submission for Medical Device Clearance for its Affinity PET-CT imaging device. Going forward Positron will adhere to all FDA requirements, quality systems regulations, and import regulations. Through its role as manufacturer, Positron will be able to observe and comply with FDA requirements and perform future device and procedural reviews more efficiently.
Neusoft formed Intelligent Neuclear Medical as a wholly owned subsidiary to segregate all Neusoft’s current nuclear projects and products, which also includes all nuclear R&D technology initiatives. Positron considers the new structure an optimal arrangement enabling greater communication and direct input throughout the division with management, engineering and component production which will fast track deliverables moving forward.
Adel Abdullah, President of Positron, stated, “we are pleased with the new organization within Neusoft; it is a testament to their focus on R&D and advancing nuclear products. The formation of this new Intelligent Neuclear Medicine subsidiary combined with Positron taking the lead on manufacturing duties is by design so that both parties can improve the execution and efficiencies required to deliver the best PET-CT products as well as our ability to scale.” Mr. Abdullah continued, “we are excited to bring to market our Affinity PET-CT 4D and to become a key part of an expanding nuclear cardiology imaging market and the vast oncology imaging segment.”