商务合作
动脉网APP
可切换为仅中文
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that leading physicians from four prestigious medical centers have completed their review and signed off on the study results for submission to the Chinese National Medical Products Administration (NMPA).
佐治亚州桃树角(商业新闻)——LuViva高级宫颈扫描的制造商Guided Therapeutics,Inc.(OTCQB:GTHP)今天宣布,来自四个著名医疗中心的主要医生已经完成了他们的审查,并签署了研究结果,以提交给中国国家医疗产品管理局(NMPA)。
Approximately 460 women were tested with LuViva at four leading hospitals in China. There were no adverse events reported with the use of LuViva during the study, proving once again that LuViva is safe when used as directed. The study was led by Professor Dr. Kong Beihua of Qilu Hospital at Shandong University and Dr.
大约460名女性在中国四家主要医院接受了LuViva测试。。这项研究由山东大学齐鲁医院的孔北华教授和。
Sui Long, Director of the Gynecology Hospital at Fudan University. Professor Kong is the current Vice Chairman of the Chinese Society of Obstetrics and Gynecology Society. Dr. Sui has summarized the results of the four clinics and his report, along with other information required by NMPA, is expected to be filed within the next four to five weeks.
复旦大学妇科医院院长隋龙表示。孔教授现任中国妇产科学会副会长。隋博士总结了四家诊所的结果,他的报告以及NMPA要求的其他信息预计将在未来四至五周内提交。
While the actual results in terms of test accuracy will be known when filed with NMPA, the physicians who reviewed and compiled the data believe the results are “well above that expected by NMPA” and therefore “are expected to result in approval of LuViva for sale in China.”.
虽然在向NMPA提交测试准确性方面的实际结果将是已知的,但审查和汇编数据的医生认为结果“远高于NMPA的预期”,因此“预计将导致LuViva在中国销售的批准”。
About Guided Therapeutics
关于引导疗法
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care.
Guided Therapeutics,Inc.(OTCQB:GTHP)是一家基于其专利生物光子技术的快速无痛测试平台的制造商,该技术利用光线在细胞水平上早期检测疾病。该公司的第一款产品是LuViva®高级宫颈扫描,这是一种非侵入性设备,用于在护理时即时检测宫颈疾病。
In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com..
根据已发表的报告,在一项针对有宫颈疾病风险的女性的多中心临床试验中,该技术能够比传统方法早两年检测出宫颈癌。有关更多信息,请访问:www.guidedinc.com。。
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and 'Early detection, better outcomes' are registered trademarks owned by Guided Therapeutics, Inc.
Guided Therapeutics LuViva®Advanced Circal Scan是一种研究设备,受联邦法律限制,只能在美国进行研究。LuViva、wave徽标和“早期发现,更好的结果”是Guided Therapeutics,Inc.拥有的注册商标。
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas.
。对这些事项和主题领域的讨论通常受到围绕未来预期的固有风险和不确定性的限制,并且可能与Guided Therapeutics涉及任何或多个此类事项和主题领域的实际未来经验存在实质性差异。
Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and subsequent filings..
这些风险和不确定性包括与产品商业化的早期阶段、产品市场接受程度的不确定性、分销渠道的发展或有效性的不确定性、医疗器械行业的激烈竞争、先前融资中筹集的资金的充足性和实现其预期收益的能力、未来开发产品或继续经营的资本的不确定性、产品监管批准的不确定性以及对许可知识产权的依赖性有关的风险和不确定性,以及在提交给SEC的Guided Therapeutics报告(包括Guided Therapeutics截至2023年12月31日的10-K财年年度报告和随后的文件)中不时在“风险因素”标题下更全面描述的风险和不确定性。。