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Positron Corporation Announces Plans for Clinical Study of Its New “Affinity PET-CT 4D” Nuclear Imaging Device

Positron Corporation Announces Plans for Clinical Study of Its New “Affinity PET-CT 4D” Nuclear Imaging Device

正電子公司宣佈其新型「親和性 PET-CT 4D」核成像裝置臨床研究計畫
GlobeNewswire ·  2022/12/21 00:00

Niagara Falls, NY, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Positron Corporation ("Positron" or the "Company") (OTC: POSC), a nuclear medicine PET imaging systems and clinical services company, is pleased to announce the Company's collaboration with Dr. Bober and Ochsner Health, the largest non-profit, academic healthcare system operating in Louisiana, for the clinical study of Positron's new "Affinity PET-CT 4D" nuclear imaging device.  

紐約州尼亞加拉瀑布,2022年12月20日(環球通訊社)正電子公司(“正電子”或“公司”)(場外交易:POSC)美國路易斯安那州最大的非營利性學術醫療保健系統公司Ochsner Health很高興地宣佈,該公司與Bober博士和Ochsner Health合作,對Positron的新型“Affacy PET-CT 4D”核成像設備進行臨牀研究。

The clinical study is sponsored by Positron and will be conducted by Dr. Robert Bober, Director of Molecular Imaging and Nuclear Cardiology of Ochsner Health. Dr. Bober has furnished a plan for the clinical study to an Institutional Review Board (IRB), which reviews and monitors biomedical research involving human subjects in accordance with FDA regulations.

這項臨牀研究由正電子公司贊助,將由奧克斯納健康公司分子成像和核心臟病學董事的羅伯特·博伯博士進行。Bober博士已經向機構審查委員會(IRB)提交了這項臨牀研究的計劃,該委員會根據FDA的規定審查和監測涉及人類受試者的生物醫學研究。

Performing such an extensive clinical study requires a comprehensive investigational plan, patient selection criteria, labeling, and monitoring with records and reports which adhere to Good Clinical Practices (GCP). Following the formalization of the plan with IRB and on-site installation the clinical study is expected to begin in mid-January with an estimated time of completion of three (3) weeks. The study will be performed at Ochsner Health's New Orleans facility under the guidance of Dr. Bober. The study will provide empirical data necessary for proper representation of the system's image quality, performance, and efficacy with  cardiac PET imaging agents. Testing will encompass an extensive array of patients, comprising of a diverse range of ages, body habitus, and clinical indications. The results of the study and data received will be organized by Dr. Bober and disseminated as collateral for Positron's Affinity PET-CT 4D marketing efforts. 

進行如此廣泛的臨牀研究需要一個全面的研究計劃、患者選擇標準、標籤以及使用符合良好臨牀實踐(GCP)的記錄和報告進行監測。隨着IRB計劃的正式確定和現場安裝,臨牀研究預計將於1月中旬開始,預計完成時間為三(3)周。這項研究將在Ochsner Health的新奧爾良設施中進行,由Bober博士指導。這項研究將提供必要的經驗數據,以恰當地表示系統的圖像質量、性能和心臟PET顯像劑的療效。測試將涵蓋廣泛的患者,包括不同的年齡、身體習慣和臨牀適應症。研究結果和收到的數據將由Bober博士組織,並作為Positron的Affacy PET-CT 4D營銷活動的抵押品進行傳播。

Adel Abdullah, President of Positron, stated, "We are very pleased to be working with Ochsner Health and Dr. Bober, the pre-eminent opinion leaders in nuclear cardiology, who bring tremendous value to the assessment of our new PET-CT system. Dr. Bober is at the forefront of nuclear cardiology and has been instrumental in Positron's progress throughout this whole process; he is a brilliant physician and consummate professional; we are very fortunate to have his guidance. The support and expertise of Dr. Bober and Ochsner Health enables Positron to launch our Affinity PET-CT 4D with full confidence as to the systems performance across both cardiology and oncology segments of nuclear molecular imaging." 

Positron的阿德爾·阿卜杜拉·總裁説:“我們非常高興能與Ochsner Health和Bober博士合作,他們是核心髒病學領域的傑出意見領袖,他們為我們新的正電子發射斷層掃描系統的評估帶來了巨大的價值。Bober博士站在核心臟病學的前沿,在整個過程中對正電子的進步起到了重要作用;他是一位才華橫溢的內科醫生和完美的專業人士;我們非常幸運地得到了他的指導。在Bober博士和Ochsner Health的支持和專業知識的支持下,正電子公司能夠推出我們的Affacy PET-CT 4D,對核分子成像的心臟病學和腫瘤學領域的系統性能充滿信心。“

Upon completion of the clinical study and 510k FDA Certification, Positron expects to commercialize the Affinity PET-CT 4D to the nuclear cardiology and oncology communities in Q1 2023.

在完成臨牀研究和510k FDA認證後,正電子希望在2023年第一季度將Affacy PET-CT 4D商業化,用於核心髒病學和腫瘤學社區。

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,為北美各地的核醫學保健提供者提供最先進的PET成像系統和臨牀服務。正電子公司專門從事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。正電子的創新PET技術、臨牀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 only system "the Attrius®" and unique market position are substantial advantages in facilitating the adoption of cardiac PET and the growth of the nuclear cardiology imaging market.

正電子公司專用的正電子發射計算機斷層成像系統“The ATTRIUS®”和獨特的市場地位是促進心臟正電子發射計算機斷層掃描的採用和核心臟病成像市場增長的實質性優勢。

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 expand and service 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 was founded in 1983 and is based in Niagara Falls, NY.  

正電子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能力。正電子的PET-CT還使公司能夠擴大和服務於巨大的腫瘤學診斷市場的需求。正電子將通過與東軟醫療系統公司的製造和研發合資企業繼續推進這項技術。正電子公司成立於1983年,總部設在紐約州尼亞加拉瀑布。

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.

本新聞稿包含的陳述可能構成1933年《證券法》和經1995年《私人證券訴訟改革法》修訂的1934年《證券交易法》所指的“前瞻性陳述”。這些陳述包括關於正電子公司及其管理層成員的意圖、信念或當前預期的陳述,以及這些陳述所基於的假設。提醒潛在投資者,任何此類前瞻性陳述都不是對未來業績的保證,涉及風險和不確定因素,實際結果可能與此類前瞻性陳述中預期的大不相同。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

欲瞭解更多信息,請訪問公司網站,或聯繫:
投資者關係聯繫人:
天際通信集團有限責任公司
高級客户經理麗莎·格雷

One Rockefeller Plaza, 11th Floor
New York, NY 10020
Office: (646) 893-5835
Email: lisa@skylineccg.com

洛克菲勒廣場一號,11樓
紐約州紐約市,郵編:10020
辦公室:(646)893-5835
電子郵件:lisa@sky lineccg.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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