Positron Corporation Enters Into Agreement With Ochsner Clinic Foundation for Clinical Study of Its New “Affinity PET-CT 4D” Device
Positron Corporation Enters Into Agreement With Ochsner Clinic Foundation for Clinical Study of Its New “Affinity PET-CT 4D” Device
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.
纽约州尼亚加拉瀑布,2023 年 3 月 1 日(GLOBE NEWSWIRE)——提供 PET 成像系统和临床服务的分子成像设备公司Positron Corporation(“正电子” 或 “公司”)(场外交易代码:POSC)欣然宣布,它已与奥克斯纳诊所基金会和奥克斯纳健康分子成像和核心脏病学主任鲍伯博士签署了临床研究/研究协议,用于其全新 PET-CT 成像设备 Affinity™ PET-CT 4D 的临床研究。
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.
根据独立机构审查委员会(IRB)的要求,临床研究的所有程序和参与者均经过评估和批准。根据美国食品和药物管理局的规定,IRB是一个经过适当组成的小组,正式指定审查和监督涉及人类受试者的生物医学研究。
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.
IRB对临床研究的接受使Positron能够获得研究设备豁免(IDE),这是收集Positron新PET-CT设备的安全性和有效性数据所必需的。该临床研究将根据国际医学期刊编辑委员会的要求进行注册。根据向美国食品和药物管理局提交510k的要求,进行临床研究通常是为了支持PMA(上市前批准)。
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.
Positron 已满足所有标准,可以立即开始安装过程和幻像测试,为患者扫描做准备,扫描将在收到人体研究所需的 IDE 后开始。在临床试验期间,该公司还将向FDA提交其新设备510k。Positron 预计在未来 60 天内完成其临床研究和 FDA 认证。
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."
Positron总裁阿德尔·阿卜杜拉表示:“这项研究是Affinity PET-CT 4D商业化的关键,我们很高兴能与奥克斯纳诊所基金会和Bober博士等受人尊敬的行业领导者合作。我们正在进行这项严格的临床研究,以验证我们的Affinity PET-CT 4D,以证明其卓越的能力和在核分子成像的心脏病学和肿瘤学领域的强大应用。我们期待通过我们的Affinity PET-CT 4D提供最佳解决方案,满足不断扩大的核成像设备市场的需求。”
About Positron Corporation
关于正电子公司
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 Corporation 是一家分子成像设备公司,为北美的核医学医疗保健提供者提供最先进的 PET 成像系统和临床服务。Positron 专门研究心脏正电子发射断层扫描 (PET) 成像领域,这是心脏诊断的黄金标准。Positron 的创新 PET 技术、临床服务和实践解决方案使医疗保健提供者能够准确诊断冠状动脉疾病并改善患者预后,同时采用具有成本效益的药物。
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的专用PET系统Attrius® PET和独特的市场地位是促进心脏PET的采用和核成像市场增长的巨大优势。
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.
Positron 很快将提供最先进的 PET-CT 分子成像设备,使核心脏病专家能够充分利用分子成像和核医学的全部能力。Positron 的 PET-CT 还使公司能够全面服务和满足庞大的肿瘤学诊断市场的需求。Positron将继续通过与东软医疗系统公司的制造和研发合资来推进这项技术。
Forward-Looking Statements
前瞻性陈述
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.
本新闻稿包含的陈述可能构成经1995年《私人证券诉讼改革法》修订的1933年《证券法》和1934年《证券交易法》所指的 “前瞻性陈述”。这些陈述包括有关Positron Corporation及其管理层成员的意图、信念或当前预期的陈述,以及此类陈述所依据的假设。提醒潜在投资者,任何此类前瞻性陈述都不能保证未来的表现,并且涉及风险和不确定性,实际结果可能与此类前瞻性陈述所设想的结果存在重大差异。公司没有义务更新或修改前瞻性陈述以反映假设的变化、意外事件的发生或未来经营业绩的变化。
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