RenovaCare Announces Termination of StemCell Systems R&D Agreement
RenovaCare Announces Termination of StemCell Systems R&D Agreement
SCOTTSDALE, Ariz., May 03, 2022 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; ), a clinical-stage developer of patented technologies for isolating and spraying cells for the regeneration of skin and other organs and tissues, today announced the termination of its July 1, 2020 Strategic Research and Development Agreement with StemCell Systems GmbH (SCS) and the closure of the RenovaCare R&D Innovation Center in Berlin, Germany. This decision ceases on-going development of the prototype for the closed, automated Cell Isolation Device and the portable, disposable SkinGun™ spray device. Development may resume at SCS or other Contract Manufacturing Organizations, upon the availability of adequate funds.
亞利桑那州斯科茨代爾,2022年5月3日(Global Newswire)--RenovaCare,Inc.(代碼:RCAR;)是一家臨牀階段的皮膚及其他器官和組織再生專利技術開發商,該公司今天宣佈終止2020年7月1日與Stemcell Systems GmbH(SCS)簽訂的戰略研究和開發協議,並關閉位於德國柏林的RenovaCare研發創新中心。這一決定停止了正在進行的封閉式自動細胞分離設備和便攜式一次性SkinGun™噴霧設備的原型開發。在獲得足夠資金的情況下,SCS或其他代工組織可以恢復開發。
As previously announced, the Company has suspended patient enrollment in its clinical study (CELLMIST 1) for the evaluation of the safety and feasibility of the manual CellMist™ System and its electronic SkinGun™ spray device as an autologous stem cell treatment of adult burn patients. Patients previously enrolled and treated with RenovaCare therapies and technologies will continue to receive ongoing care as per the FDA protocol. The clinical study and IDE remain open for possible resumption, and enrollment in the study may continue if capital funding becomes available in the future, for which there can be no assurances.
正如之前宣佈的那樣,該公司已經暫停了其臨牀研究(CELLMIST 1)的患者登記,以評估手動CellMist™系統及其電子SkinGun™噴霧設備作為成人燒傷患者自體幹細胞治療的安全性和可行性。以前登記並接受RenovaCare療法和技術治療的患者將繼續按照FDA協議接受持續護理。臨牀研究和IDE仍然開放,可能會恢復,如果未來有資金支持,該研究的登記可能會繼續,這一點無法得到保證。
About RenovaCare
關於RenovaCare
RenovaCare, Inc. is a developer of new generation autologous stem cell therapies for the regeneration of human organs and tissues. The Company's initial product under development targets the body's largest organ, the skin. The Company's flagship technology, the CellMist™ System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist™ System facilitates rapid healing of wounds or other afflicted tissues when applied topically as a gentle cell mist using the patented RenovaCare SkinGun™. The Company's SkinGun™ is used to spray a liquid suspension of a patient's stem cells – the CellMist™ cell suspension – onto wounds.
RenovaCare,Inc.是新一代用於人體器官和組織再生的自體幹細胞療法的開發商。該公司正在開發的首批產品以人體最大的器官皮膚為目標。該公司的旗艦技術CellMist™系統通過連續的蛋白酶消化,從捐贈者組織中提供組織特異性多能細胞的單細胞懸液。當使用專利的RenovaCare SkinGun™以温和的細胞噴霧的形式局部應用時,RenovaCare細胞噴霧™系統有助於傷口或其他受影響組織的快速癒合。該公司的SkinGun™用於將患者幹細胞的液體懸浮液--細胞霧™細胞懸浮液--噴灑到傷口上。
RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Company's planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.
RenovaCare產品目前正在開發中。它們不能在美國出售。不能保證該公司向美國食品和藥物管理局提交的計劃或提交的文件將被FDA接受或批准。
For additional information, please call Amit Singh at: 1-888-398-0202 or visit:
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Investors and others should note that we announce material financial information to our investors using Securities and Exchange Commission (SEC) filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the Company, RenovaCare, Inc., development and other corporate matters that are in the public domain. At this time, the Company will not post information on social media that could be deemed to be material information unless that information was provided to public distribution channels first.
投資者和其他人應該注意到,我們通過提交給美國證券交易委員會(SEC)的文件和新聞稿向投資者公佈重要的財務信息。我們使用我們的網站和社交媒體與我們的訂户、股東和公眾就公司、RenovaCare,Inc.的發展和其他屬於公共領域的公司事務進行溝通。目前,公司不會在社交媒體上發佈可能被視為重要信息的信息,除非該信息首先提供給公共分發渠道。
We encourage investors, the media, and others interested in the Company to review the information we post on the Company's website and the social media channels listed below:
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Legal Notice Regarding Forward-Looking Statements
關於前瞻性陳述的法律通知
No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although RenovaCare, Inc. (the "Company") believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: the timing and success of clinical and preclinical studies of product candidates, the potential timing and success of the Company's product programs through their individual product development and regulatory approval processes, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, obsolescence of the Company's technologies, technical problems with the Company's research, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company's operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company's ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, and other risks. There can be no assurance that further research and development will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that the Company will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
本文中的任何陳述都不應被視為購買或出售任何證券的要約或要約的邀約。本新聞稿包含基於當前預期或信念以及對未來事件的一些假設的前瞻性陳述。儘管RenovaCare公司(“本公司”)認為前瞻性陳述中反映的預期及其所依據的假設是合理的,但它不能保證這些預期和假設將被證明是正確的。前瞻性陳述涉及假設並描述我們未來的計劃、戰略和預期,通常可以通過使用“可能”、“將”、“應該”、“可能”、“預期”、“預計”、“估計”、“相信”、“打算”或“項目”或這些詞語的否定或這些詞語的其他變體或類似術語來識別。告誡讀者不要過度依賴這些前瞻性陳述,因為這些陳述受許多因素和不確定性的影響,包括但不限於:候選產品的臨牀和臨牀前研究的時機和成功、公司產品計劃通過各自的產品開發和監管批准程序的潛在時機和成功、不利的經濟條件、激烈的競爭、缺乏有意義的研究結果、新競爭對手和產品的進入、資本不足、意外成本和運營赤字、一般和行政成本的增加、合同或協議的終止、公司技術的過時。公司研究的技術問題、用品和零部件的價格上漲、涉及公司的訴訟和行政訴訟, 可能收購導致經營虧損或表現不如預期的新業務或技術,意外虧損,公司經營結果、財務狀況和股票價格可能的波動和波動,訴訟和和解案件中發生的損失,公司業務所有權的稀釋,不利宣傳和新聞報道,無法執行研究、開發和商業化計劃,主要高管和研究科學家的損失或退休,以及其他風險。不能保證進一步的研究和開發將驗證和支持我們的初步研究和研究的結果。此外,不能保證將獲得必要的監管批准,也不能保證公司將能夠在其技術的基礎上開發具有商業可行性的產品。此外,可能導致實際結果大不相同的其他因素在該公司最近提交給證券交易委員會的Form 10-Q和Form 10-K文件中進行了討論。這些報告和文件可在美國證券交易委員會維護的公共資料室查閲和複印,地址為華盛頓特區20549,NE.F Street 100號。您可以致電美國證券交易委員會,電話:1-800-美國證券交易委員會-0330,獲取有關公共資料室運作的信息。美國證券交易委員會還維護着一個互聯網網站,其中包含報告、委託書和信息聲明, 以電子方式向公司的美國證券交易委員會提交的有關發行人的其他信息沒有義務公開發布對這些前瞻性陳述的任何修訂的結果,這些修訂可能會反映此後的事件或情況,或反映意外事件的發生。