Positron Corporation Announces First Step in Validation of its New PET-CT Device
Positron Corporation (OTC: POSC) has announced the purchase of its first Affinity PET-CT system from Neusoft Medical Systems, which is currently in transit to the U.S. for validation. This marks a crucial step in launching the device, aimed at cardiac and oncology imaging. The company plans to reveal details about participating hospitals and expects to submit a 510K application to the FDA soon. President Adel Abdullah highlighted the excitement among industry partners for the upcoming validation studies, set to begin in September and conclude by November 2022.
- First Affinity PET-CT system purchased, indicating progress in product development.
- Upcoming validation studies are expected to enhance credibility and market positioning.
- Plans to submit 510K application to the FDA, opening paths for regulatory approval.
- None.
Niagara Falls, NY, Aug. 16, 2022 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a nuclear medicine PET imaging device systems and clinical services company, is pleased to announce that its first PET-CT system has been purchased and is in transit from its partner Neusoft Medical Systems. Positron’s system named “Affinity PET-CT" is en route from China to its validation partner in the United States, which is set to arrive in late September 2022.
This important milestone marks the beginning of the most critical step in the launch of Positron’s Affinity PET-CT nuclear imaging device. The Company will soon announce the hospital, physician, and other key parties performing and participating in the Company’s validation procedure, with performance results to follow.
The Company also expects to submit the systems 510K application to the FDA in the coming weeks.
Adel Abdullah, President of Positron, stated, “The validation and performance review of Positron’s new Affinity PET-CT is a key step for the introduction of the system to both cardiac and oncology imaging and diagnostics. I’m proud of our team, especially the many leading nuclear imaging industry parties that have all agreed to assist and perform the comprehensive studies necessary to showcase our state-of-the-art PET-CT system. All are excited to begin in September with an expected completion date by November 2022.”
About Positron Corporation
About Positron: Positron Corporation is a nuclear medicine PET imaging device company specializing in the field of cardiac Positron Emission Tomography imaging - the gold standard in cardiac diagnostics. Positron’s innovative PET technology, clinical services and practice solutions enables healthcare providers to more accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron's PET only system, market position and approach in facilitating the adoption of cardiac PET are substantial advantages to the growth of the market and Positron. Positron will soon offer a state-of-the-art PET/CT imaging device that will enable nuclear cardiologists to utilize the full power of nuclear imaging. This same PET/CT device allows Positron to address and meet the needs and demand of the vast oncology diagnostics marketplace.
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
FAQ
What milestone has Positron Corporation achieved with its Affinity PET-CT system?
What is the expected timeline for the validation studies of Positron's Affinity PET-CT system?
When does Positron plan to submit its 510K application to the FDA?
How does the Affinity PET-CT system benefit cardiac and oncology imaging?
