Therma Bright's Investment Partner Inretio Announces Successful Completion of GLP Study for PREVA(TM) Thrombectomy Device
Therma Bright's Investment Partner Inretio Announces Successful Completion of GLP Study for PREVA(TM) Thrombectomy Device
Both Companies Anticipates Approval to Launch of Human Clinical Trials
兩家公司都預計將批准啓動人體臨床試驗
Tel Aviv, Israel and Toronto, Ontario--(Newsfile Corp. - June 7, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, and its investment Inretio Inc., an innovative Israeli medical device company , has announced the successful completion of a Good Laboratory Practice (GLP) study for its breakthrough PREVA mechanical thrombectomy device. This significant milestone brings the device one step closer to human clinical trials and eventual market availability, marking a major advancement in the treatment of ischemic stroke.
以色列特拉維夫和安大略省多倫多--(Newsfile Corp.——2023年6月7日)——Therma Bright Inc.(多倫多證券交易所股票代碼:THRM)(OTCQB:TBRIF)(“Therma” 或 “公司”)及其投資的以色列創新醫療器械公司Inretio Inc. 宣佈成功完成了Good 實驗室實踐 (GLP) 研究了其突破性的 PREVA 機械血栓切除裝置。這一重要的里程碑使該設備離人體臨床試驗和最終上市又近了一步,標誌着缺血性中風治療取得了重大進展。
The GLP study, conducted at the Shamir Medical Center's Research Unit, demonstrated the PREVA device's ability to effectively remove blood clots, confirming its potential to revolutionize the treatment of ischemic stroke. GLP studies are essential for this class of medical device and usually precede the initiation of First-in-Human (FIH) studies that are requested by the various regulatory agencies, including Israel's Ministry of Health, U.S. Food and Drug Administration (U.S. FDA), Health Canada (HC), European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA-Japan).
在沙米爾醫學中心研究部進行的GLP研究證明了PREVA設備有效去除血栓的能力,證實了其徹底改變缺血性中風治療的潛力。GLP 研究對此類醫療器械至關重要,通常先於各種監管機構(包括以色列衛生部、美國食品藥品監督管理局(U.S. FDA)、加拿大衛生部(HC)、歐洲藥品管理局(EMA)和製藥和醫療器械管理局(PMDA-Japan)的要求進行首次人體試驗(FIH)。
"The PREVA device achieved overall removal of 100% of the clot in 100% of the cases during the GPL study," shared Raviv Vine, CEO of Inretio. "We are thrilled with the results we've seen in the GLP study. Our team has worked tirelessly to develop a device that could make a meaningful difference in the treatment of ischemic stroke, and we believe these results move us one step closer to achieving that goal."
Inretio首席執行官Raviv Vine分享說:“在GPL研究期間,PREVA設備在100%的病例中實現了100%的血塊的總體去除。”“我們對在GLP研究中看到的結果感到非常興奮。我們的團隊孜孜不倦地努力開發出一種可以對缺血性中風的治療產生有意義的改變的設備,我們相信這些結果使我們離實現這一目標又近了一步。”
Current thrombectomy procedures are based on stents that open inside the clot without aspiration, leading to potential fragmentation and secondary damage to the brain tissue. This can result in new blockages downstream, causing significant impact on the patient's quality of life. The PREVA device is uniquely designed to mechanically remove blood clots from the brain, using a distal basket to 'ensnare' the clot, protecting the brain from any sub-clots breaking off during the procedure. This leads to more successful revascularization of the brain, preventing further damage and complications, and potentially improving patient outcomes.
目前的血栓切除術以支架爲基礎,支架無需抽吸即可在血塊內打開,這可能會導致腦組織碎片化和繼發性損傷。這可能會導致下游出現新的阻塞,對患者的生活質量造成重大影響。PREVA 設備採用獨特設計,可以機械地清除大腦中的血塊,使用遠端籃子 “圈住” 血塊,保護大腦免受手術過程中任何子血塊破裂的影響。這可以更成功地進行大腦血運重建,防止進一步的損傷和併發症,並有可能改善患者的預後。
"We wish to congratulate Raviv and his talented team on the success of the GLP study," shared Rob Fia, CEO of Therma Bright. "We're equally excited that the results will help Inretio move forward in securing regulatory approval for human trials with the PREVA thrombectomy device."
Therma Bright首席執行官羅布·菲亞分享說:“我們要祝賀Raviv及其才華橫溢的團隊在GLP研究中取得成功。”“我們同樣感到興奮的是,研究結果將幫助Inretio在確保PREVA血栓切除設備人體試驗獲得監管部門批准方面向前邁進。”
Inretio anticipates starting clinical trials for the PREVA device in approximately four months. The results from these studies will be submitted to the Israeli Ministry of Health for Clinical Trial clearance in humans, marking a significant milestone towards the device's commercialization.
Inretio預計將在大約四個月後開始PREVA設備的臨床試驗。這些研究的結果將提交給以色列衛生部進行人體臨床試驗,這標誌着該設備商業化的重要里程碑。
In other news, Health Canada has requested a long-term stability study of the AcuVid Covid-19 Rapid Antigen Saliva Test to determine shelf life, as well as a comprehensive post-production validation study by a third (3rd) party independent lab to further ensure that the test's sensitivity remains intact. Both studies are complex and will require manufacturing of additional test lots and the identification and hiring of a reputable third (3rd) party, highly specialized lab partner to conduct these studies.
在其他新聞方面,加拿大衛生部已要求對AcuVid Covid-19快速抗原唾液測試進行長期穩定性研究,以確定保質期,並要求第三方(第三方)獨立實驗室進行全面的後期驗證研究,以進一步確保該測試的靈敏度保持不變。這兩項研究都很複雜,需要製造額外的測試批次,並確定和僱用信譽良好的第三方(第三方)、高度專業化的實驗室合作伙伴來進行這些研究。
The Company is currently evaluating the best option and approach to ensure that all additional investments in Covid-19 diagnostic testing are sound and viable.
該公司目前正在評估最佳選擇和方法,以確保對Covid-19診斷測試的所有額外投資都是合理和可行的。
About Inretio
關於 Inretio
Inretio was born out of the need for improving stroke care and reducing thrombectomy complications. The company aims to reduce the burden of stroke and patient suffering by leading in the neurovascular field, and providing physicians with simple, yet innovative solutions1.
Inretio的誕生是出於改善中風護理和減少血栓切除術併發症的需求。該公司旨在通過在神經血管領域處於領先地位,爲醫生提供簡單而創新的解決方案來減輕中風和患者痛苦的負擔1。
About Therma Bright Inc.
關於 Therma Bright Inc
Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: .
Therma Bright是各種前沿專有診斷和醫療設備技術的開發商和合作夥伴,致力於爲消費者和醫療專業人員提供優質、創新的解決方案,以應對當今一些最重要的醫療和醫療保健挑戰。Therma Bright Inc. 在(多倫多證券交易所股票代碼:THRM)(OTCQB:TBRIF)(FSE:JNX)上市。訪問:。
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
Therma Bright公司
首席執行官 Rob Fia
rfia@thermabright.com
FORWARD-LOOKING STATEMENTS
前瞻性陳述
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization of PREVA and related technology as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information, future events or otherwise, except as required under applicable securities regulations.
本新聞稿中的某些陳述構成 “前瞻性” 陳述。這些聲明涉及未來的事件,例如新聞稿中描述的PREVA和相關技術的商業化。所有這些陳述都涉及大量已知和未知的風險、不確定性和其他因素,這些因素可能導致實際結果與此類前瞻性陳述所表達或暗示的結果有所不同。前瞻性陳述涉及重大風險和不確定性,不應將其視爲未來業績或業績的保證,也不一定能準確表明是否會取得此類結果。由於多種因素和風險,實際結果可能與預期的結果存在重大差異。儘管本新聞稿中包含的前瞻性陳述基於本新聞稿發佈之日公司管理層認爲的合理假設,但公司無法向投資者保證實際業績將與這些前瞻性陳述一致。本新聞稿中包含的前瞻性陳述自本文發佈之日起作出,除非適用的證券法規要求,否則公司不打算或有義務更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
多倫多證券交易所風險投資交易所及其監管服務提供商(該術語在多倫多證券交易所風險投資交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
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