September 8, 2023 — Positron Corporation, a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA. on September 18, 2023.
Positron’s clinical study/research will be guided by leading nuclear cardiologist Dr. Robert Bober, Director of Molecular Imaging and Nuclear Cardiology at Ochsner Health System. The objective of the clinical study is to obtain key data that will represent the performance and efficacy of Positron’s new state-of-the-art PET-CT imaging device. The clinical study will be registered in accordance with the requirements of the International Committee of Medical Journal Editors and follows the requirements of the Institutional Review Board. The initial phase of the clinical study will consist of phantom testing and subsequent imaging of human patients once Positron receives its Investigational Device Exemption from the FDA. In parallel with the clinical study Positron will submit its 510k and Registration to the FDA for clearance to market and sell the Affinity PET-CT.
The clinical study of Positron’s Affinity PET-CT is designed to provide key information that evaluate the new system and its full capabilities with multiple radiopharmaceuticals and new coronary flow software applications that will enhance physician’s diagnostic analysis. The results of the clinical study will be essential for Positron to properly market and commercialize its Affinity PET-CT.
Adel Abdullah, President of Positron, stated, “the start of the clinical study with Dr. Bober and Ochsner Clinic is a significant milestone and one that sets all our plans in motion towards the launch of our PET-CT product. Now with Positron as the device manufacturer we will oversee and direct the many details required for validation, FDA Clearance, and offering of our state-of-the-art PET-CT product to customers.” Mr. Abdullah continued, “becoming the manufacturer required the transfer, organization, preparation and review of thousands of pages of documentation for the Company and FDA and although this was a long process it has worked to our benefit, placing Positron in the best position to capitalize on an expanding nuclear imaging industry that is seeking a molecular imaging scanner that best serves physicians, practices and patients.”