Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), 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. 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.”
About Positron Corporation
Positron Corporation is a molecular imaging device company that offers a state-of-the-art PET imaging system and clinical services to nuclear medicine healthcare providers throughout North America. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging – the gold standard in cardiac diagnostics. Positron’s innovative PET technology, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine.
Positron’s dedicated PET system “the Attrius®” and unique market position are substantial advantages in facilitating the adoption of cardiac PET and the growth of the nuclear imaging market.
Positron expects it will soon offer a state-of-the-art PET-CT molecular imaging device that will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT also allows the Company to fully service and meet the demands of the oncology diagnostics marketplace. Positron will continue to advance and manufacture the technology through its supply, development, and R&D cooperative with Shenyang Intelligent Neuclear Medical Technology Co, LTD a subsidiary of Neusoft Medical Systems.
This press release contains statements which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.
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