Positron Corporation Announces Plans for Clinical Study of its New “Affinity PET-CT 4D” Nuclear Imaging Device
Positron Corporation (OTC: POSC) announces a collaboration with Dr. Robert Bober and Ochsner Health for a clinical study of its new Affinity PET-CT 4D imaging device. This FDA-compliant study, commencing mid-January 2023, aims to evaluate the device's image quality and performance in cardiac PET imaging. Dr. Bober's leadership is pivotal for gathering empirical data essential for marketing the system. Following completion and FDA 510k certification, Positron intends to commercialize the device in Q1 2023, targeting nuclear cardiology and oncology markets.
- Collaboration with Dr. Bober enhances credibility and expertise in nuclear cardiology.
- Scheduled clinical study will provide empirical data essential for marketing Affinity PET-CT 4D.
- Anticipated commercialization in Q1 2023 after FDA certification enables entry into nuclear cardiology and oncology markets.
- None.
Niagara Falls, NY, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a nuclear medicine PET imaging systems and clinical services company, is pleased to announce the Company’s collaboration with Dr. Bober and Ochsner Health, the largest non-profit, academic healthcare system operating in Louisiana, for the clinical study of Positron’s new “Affinity PET-CT 4D” nuclear imaging device.
The clinical study is sponsored by Positron and will be conducted by Dr. Robert Bober, Director of Molecular Imaging and Nuclear Cardiology of Ochsner Health. Dr. Bober has furnished a plan for the clinical study to an Institutional Review Board (IRB), which reviews and monitors biomedical research involving human subjects in accordance with FDA regulations.
Performing such an extensive clinical study requires a comprehensive investigational plan, patient selection criteria, labeling, and monitoring with records and reports which adhere to Good Clinical Practices (GCP). Following the formalization of the plan with IRB and on-site installation the clinical study is expected to begin in mid-January with an estimated time of completion of three (3) weeks. The study will be performed at Ochsner Health’s New Orleans facility under the guidance of Dr. Bober. The study will provide empirical data necessary for proper representation of the system’s image quality, performance, and efficacy with cardiac PET imaging agents. Testing will encompass an extensive array of patients, comprising of a diverse range of ages, body habitus, and clinical indications. The results of the study and data received will be organized by Dr. Bober and disseminated as collateral for Positron’s Affinity PET-CT 4D marketing efforts.
Adel Abdullah, President of Positron, stated, “We are very pleased to be working with Ochsner Health and Dr. Bober, the pre-eminent opinion leaders in nuclear cardiology, who bring tremendous value to the assessment of our new PET-CT system. Dr. Bober is at the forefront of nuclear cardiology and has been instrumental in Positron’s progress throughout this whole process; he is a brilliant physician and consummate professional; we are very fortunate to have his guidance. The support and expertise of Dr. Bober and Ochsner Health enables Positron to launch our Affinity PET-CT 4D with full confidence as to the systems performance across both cardiology and oncology segments of nuclear molecular imaging.”
Upon completion of the clinical study and 510k FDA Certification, Positron expects to commercialize the Affinity PET-CT 4D to the nuclear cardiology and oncology communities in Q1 2023.
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 only system “the Attrius®” and unique market position are substantial advantages in facilitating the adoption of cardiac PET and the growth of the nuclear cardiology imaging market.
Positron 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 expand and service the demands of the vast oncology diagnostics marketplace. Positron will continue to advance the technology through its manufacturing and R&D venture with Neusoft Medical Systems. Positron was founded in 1983 and is based in Niagara Falls, NY.
Forward-Looking Statements
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. 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.
FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact:
Investor Relations Contact:
Skyline Corporate Communications Group, LLC
Lisa Gray, Senior Account Manager
One Rockefeller Plaza, 11th Floor
New York, NY 10020
Office: (646) 893-5835
Email: lisa@skylineccg.com
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