Positron Corporation Enters into Agreement with Ochsner Clinic Foundation for Clinical Study of its New “Affinity PET-CT 4D” Device
Positron Corporation (OTC: POSC) has entered a Clinical Study/Research Agreement with Ochsner Clinic Foundation for its new Affinity™ PET-CT 4D device. This agreement facilitates the collection of safety and efficacy data, crucial for obtaining an Investigational Device Exemption (IDE) from the FDA. The independent Institutional Review Board has approved all study procedures, allowing preparations for patient scans to begin post-IDE approval. The company aims for completion of the clinical study and FDA certification within 60 days, marking a significant step toward commercialization.
- Executing a Clinical Study/Research Agreement with Ochsner Clinic Foundation enhances credibility.
- Approval from an independent IRB allows for IDE acquisition, essential for clinical trials.
- Positron plans to submit its 510k application alongside the clinical study, streamlining FDA approval.
- Completion of the study and certification expected within 60 days, signaling rapid development.
- None.
Niagara Falls, NY, March 01, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a molecular imaging device company that offers PET imaging systems and clinical services, is pleased to announce that it has executed a Clinical Study/Research Agreement with Ochsner Clinic Foundation and Dr. Bober, Director of Molecular Imaging and Nuclear Cardiology at Ochsner Health, for the clinical study of its new PET-CT imaging device, the Affinity™ PET-CT 4D.
All procedures and participants for the clinical study have been evaluated and approved as required by an independent Institutional Review Board (IRB). Under FDA regulations, an IRB is an appropriately constituted group formally designated to review and monitor biomedical research involving human subjects.
Acceptance of the clinical study by the IRB allows Positron to obtain an Investigational Device Exemption (IDE) which is required to collect safety and efficacy data for Positron’s new PET-CT device. The clinical study will be registered in accordance with the requirements of the International Committee of Medical Journal Editors. Clinical studies are most often conducted to support a PMA (Pre-Market Approval) as required in the submission of a 510k with the FDA.
Positron has met all criteria to immediately begin the installation process and phantom testing in preparation for patient scans that will begin upon receiving an IDE as required for human studies. During the clinical trial period, the Company will also submit its new device 510k to the FDA. Positron expects completion of its clinical study and FDA Certification within the next 60 days.
Adel Abdullah, President of Positron, stated, “This study is key in the commercialization of the Affinity PET-CT 4D and we are very pleased to be working with such esteemed industry leaders in Ochsner Clinic Foundation and Dr. Bober. We are conducting this rigorous clinical study for the validation of our Affinity PET-CT 4D’s to demonstrate its superior capabilities and robust utilization across cardiology and oncology segments of nuclear molecular imaging. We look forward to meeting the demands of an expanding nuclear imaging device market with our Affinity PET-CT 4D providing an optimal solution.”
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, Attrius® PET, and unique market position are substantial advantages in facilitating the adoption of cardiac PET and the growth of the nuclear 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 fully service and meet 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.
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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