Leading molecular imaging medical device company, Positron Corporation (OTC:POSC) announced entering into a Novation Agreement with Shenyang Intelligent Neuclear Medical Technology Co, LTD.
Neuclear Medical Technology is a wholly owned subsidiary of Neusoft Medical Systems, which transfers the original Business Cooperation Agreement to include Intelligent Neuclear Medical, Neusoft’s subsidiary.
Intelligent Neuclear Medical and Positronenter an agreement for redefiningsome key responsibilities and functions of every party. This will ameliorate long-term production and controlof the relationship. Positron has expanded asa manufacturer with Intelligent Neuclear Medical as the core contracted components supplier. This is significant for registering it with FDA for A 510k submission and Medical Device Clearance of its Affinity PET-CT imaging device.
Positron would be adhering to FDA requirements, quality regulations as well as import regulations. This will enable the company to comply with FDA requirements and also perform procedural reviews more efficiently. The company also considers the fresh structure an apt arrangement for direct input and greater communication throughout the division with engineering, management, and component production.
Adel Abdullah, President of Positron said that the company is pleased with the new organizational structure. Abdullah added that it is proof of the focus on R&D and advancing nuclear products. The President further stated that the formation of the
Intelligent Neuclear Medicine subsidiary with Positron as the lead will improve the execution and efficiencies. Lastly, he expressed excitement about bringing to market the Affinity PET-CT 4D and also being a core key part of expanding nuclear cardiology imaging market.
Positron Corporation also announcedimplementing a Clinical Study Agreement with Ochsner Clinic Foundation as well as Dr. Bober, Director of Molecular Imaging and Nuclear Cardiology at Ochsner Health.
All participants and procedures for the study have been approved and assessed as needed by an independent Institutional Review Board. An IRB will be constituted for reviewing and monitoring biomedical research involving human subjects.
Positron has met the criteria for starting the installation process as well as phantom testing for patient scans, which would start on receiving an IDE as needed for human studies. During the trial period, the firm would also be submitting the
new device 510k to FDA. Positron is expecting to finish the study as well as FDA Certification within two months.
Adel Abdullah, President of Positron said that the study is pivotal in the commercialization of Affinity PET-CT 4D. He expressed pleasure in working with distinguished industry leaders in Ochsner Clinic Foundation and Dr. Bober. He further stated that the company is conducting the clinical study for validating
Affinity PET-CT 4D’s for demonstrating its superior capabilities as well as robust utilization across oncology and cardiology segments. Abdullah is looking forward to meeting the demands of expanding the nuclear imaging device market with Affinity PET-CT 4D.