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.
紐約州尼加拉瀑布,2023 年 3 月 1 日(GLOBE NEWSWIRE)-正電子公司(「正電子」或「公司」)(OTC:POSC),一家提供 PET 成像系統和臨床服務的分子成像設備公司,很高興地宣布,它已與 Ochsner 診所基金會和 Ochsner 診所基金會的臨床研究/研究協議以及 Osner 心臟健康總監 Bober 醫生簽署了臨床研究/研究協議其新的 PET-CT 成像設備 — 親和力™ PET-CT 4D 的臨床研究。
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.
臨床研究的所有程序和參與者已根據獨立機構審查委員會(IRB)的要求進行了評估和批准。根據 FDA 法規,IRB 是正式指定審查和監測涉及人類受試者的生物醫學研究的適當組成的小組。
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.
通過 IRB 接受臨床研究允許正電子獲得試驗設備豁免 (IDE),這是收集正電子新型 PET-CT 設備的安全性和有效性數據所必需的。臨床研究將按照國際醫學雜誌編輯委員會的要求進行註冊。臨床研究最經常進行,以支持 PMA(上市前批准)在向 FDA 提交 510k 的要求。
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.
正電子已滿足所有標準,可立即開始安裝過程和幻象測試,以準備患者掃描,這些掃描將在接收人類研究所需的 IDE 之後開始。在臨床試驗期間,公司還將向 FDA 提交其新設備 510k。正電子預計在未來 60 天內完成其臨床研究和 FDA 認證。
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."
阿德爾·阿卜杜拉, 正電子總裁, 說,「這項研究是在親和 PET-CT 4D 的商業化的關鍵,我們很高興能夠在奧赫斯納診所基金會和博伯這樣尊敬的行業領導者合作.我們正在進行這項嚴格的臨床研究,以驗證 Affinity PET-CT 4D,以展示其在心髒病學和腫瘤學領域的核分子成像領域的卓越功能和強大的利用率。我們期待通過 Affinity PET-CT 4D 提供最佳解決方案來滿足不斷擴大的核成像設備市場的需求。」
About Positron Corporation
關於正電子公司
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.
正電子公司是一家分子成像設備公司,為整個北美的核醫學醫療保健提供者提供最先進的 PET 成像系統和臨床服務。正電子專門研究心臟正電子發射斷層掃描(PET)成像領域-心臟診斷的黃金標準。正電子創新的 PET 技術、臨床服務和實踐解決方案使醫療保健提供者能夠準確診斷冠狀動脈疾病並改善患者療效,同時實踐具有成本效益的醫學。
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.
正電子的專用 PET 系統 Attrius® PET 和獨特的市場地位在促進心臟 PET 的採用和核影像市場的增長方面具有重大優勢。
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.
正電子將很快提供最先進的 PET-CT 分子成像設備,該設備將使核心髒病學家能夠充分利用分子成像和核醫學的全部功能。正電子的 PET-CT 還使公司能夠全面服務並滿足龐大的腫瘤醫學診斷市場的需求。正電子將透過與東軟醫療系統合作的製造和研發合作,繼續推進該技術的發展。
Forward-Looking Statements
前瞻性陳述
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.
本新聞稿包含根據《1995 年私人證券訴訟改革法》修訂的《1933 年證券法》和《1934 年證券交易法》所指的「前瞻性陳述」。這些聲明包括關於正電子股份有限公司的意圖、信念或目前期望,以及其管理層成員的聲明,以及此類陳述所依據的假設。潛在投資者會被警告,任何此等前瞻性陳述並不保證未來表現,並涉及風險和不明朗因素,而實際結果可能與該等前瞻性陳述所擬定的結果有重大不同。本公司沒有義務更新或修訂前瞻性聲明,以反映變更的假設、意外事件的發生或未來經營業績的變更。
FOR FURTHER INFORMATION, please visit the company's website at , 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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投資者關係聯絡人:
天際線企業傳播集團有限責任
麗莎·格雷, 高級客戶經理
洛克菲勒廣場一號 11 樓
紐約州紐約
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電郵地址:lisa@skylineccg.com