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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

正電子公司與奧克斯納診所基金會達成協議,對其新的 “Affinity PET-CT 4D” 設備進行臨床研究
GlobeNewswire ·  2023/03/01 22:40

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.

紐約州尼亞加拉大瀑布,2023年3月1日(GLOBE NEWSWIRE)——提供PET成像系統和臨床服務的分子成像設備公司正電子公司(“Positron” 或 “公司”)(場外交易代碼:POSC)欣然宣佈,它已與Ochsner Clinic Foundation和Ochsner Health分子成像和核心心臟病學董事波伯博士簽訂了臨床研究/研究協議對其新型 PET-CT 成像設備 Affinity™ PET-CT 4D 的研究。

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均已按照獨立機構審查委員會 (IRB) 的要求進行評估和批准。根據美國食品藥品管理局的規定,IRB是一個經過適當組成的小組,正式指定審查和監測涉及人類受試者的生物醫學研究。

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對臨床研究的接受使Positron能夠獲得研究設備豁免(IDE),這是收集Positron新款PET-CT設備的安全性和有效性數據所必需的。臨床研究將根據國際醫學期刊編輯委員會的要求進行註冊。根據向FDA提交510k的要求,臨床研究通常是爲了支持PMA(上市前批准)而進行的。

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已滿足所有標準,可以立即開始安裝過程和幻影測試,爲患者掃描做準備,患者掃描將在收到人體研究所需的IDE後開始。在臨床試驗期間,該公司還將向FDA提交其新設備510k。Positron預計將在未來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."

Positron總裁阿德爾·阿卜杜拉表示:“這項研究是Affinity PET-CT 4D商業化的關鍵,我們很高興能與Ochsner Clinic Foundation和Bober博士如此受人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,以驗證我們的Affinity PET-CT 4D,以證明其在覈分子成像的心臟病學和腫瘤學領域的卓越能力和強大的利用率。我們期待通過我們的Affinity PET-CT 4D提供最佳解決方案,滿足不斷擴大的核成像設備市場的需求。”

About Positron Corporation

關於正電子株式會社

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 是一家分子成像設備公司,爲北美各地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。Positron專門研究心臟正電子發射斷層掃描(PET)成像領域,這是心臟診斷的黃金標準。Positron的創新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預後,同時實踐具有成本效益的藥物。

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的專用PET系統Attrius® PET和獨特的市場地位是促進心臟PET的採用和核成像市場的增長的巨大優勢。

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.    

Positron將很快提供最先進的PET-CT分子成像設備,使核心髒病專家能夠充分利用分子成像和核醫學的全部能力。Positron的PET-CT還使公司能夠提供全面的服務,滿足龐大的腫瘤學診斷市場的需求。Positron將繼續通過其與東軟醫療系統的製造和研發合資企業來推進這項技術。

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.

本新聞稿包含的聲明可能構成經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”。這些陳述包括關於Positron Corporation及其管理層成員的意圖、信念或當前預期的陳述,以及此類陳述所依據的假設。提醒潛在投資者,任何此類前瞻性陳述都不能保證未來的表現,涉及風險和不確定性,實際業績可能與此類前瞻性陳述所設想的結果存在重大差異。公司沒有義務更新或修改前瞻性陳述以反映假設的變化、意外事件的發生或未來經營業績的變化。

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

欲了解更多信息,請訪問公司網站,或聯繫:
投資者關係聯繫人:
Skyline 企業傳播集團有限責任公司
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 10020
辦公室:(646) 893-5835
電子郵件:lisa@skylineccg.com


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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