Marizyme CEO Delivers Business Update
Marizyme CEO Delivers Business Update
JUPITER, FL, May 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Marizyme, Inc. ("Marizyme" or the "Company") (OTCQB: MRZM), today provided the following business update to the stockholders and the investing public from the Company's Chief Executive Officer, David Barthel.
佛羅里達州朱庇特，2023年5月3日（GLOBE NEWSWIRE）——通過NewMediaWire — Marizyme, Inc.（“MRZY” 或 “公司”）（OTCQB：MRZM）今天向股東和投資公衆提供了公司首席執行官戴維·巴特爾提供的以下最新業務信息。
I am pleased to bring you an update on the Company's recent developments as well as Marizyme's current business priorities and goals.
我很高興爲您介紹公司的最新發展以及Marizyme當前的業務優先事項和目標。
It has been some time since we have had the opportunity to share an update with you, and I am pleased to have the chance to do so now. The Company has continued to move forward with multiple initiatives and the team has been hard at work building a strong foundation for future success.
自從我們有機會與你分享最新情況以來已經有一段時間了，我很高興現在有機會這樣做。公司繼續通過多項舉措向前邁進，團隊一直在努力爲未來的成功奠定堅實的基礎。
Over the past year, we made progress in our R&D and commercialization efforts and have several developments in the pipeline that we believe will drive growth in the future. We also raised capital and reduced expenses where possible. We believe that our focus on business priorities is beginning to show results.
在過去的一年中，我們在研發和商業化工作方面取得了進展，並且有幾項開發正在進行中，我們認爲這些開發將推動未來的增長。我們還儘可能籌集了資金並減少了開支。我們相信，我們對業務優先事項的關注已開始取得成果。
In April, Marizyme passed its annual surveillance audit required to maintain its ISO certification and European Union ("EU") CE marking for DuraGraft, and is now actively preparing for EU Medical Devices Regulation (MDR) certification. The Company's primary business priority continues to be working with the FDA where DuraGraft is currently under review for authorization in the United States.
4月，Marizyme通過了維持DuraGraft的ISO認證和歐盟（“歐盟”）CE標誌所需的年度監督審計，目前正在積極爲歐盟醫療器械法規（MDR）認證做準備。該公司的首要業務重點仍然是與美國食品藥品管理局合作，DuraGraft目前正在接受美國食品和藥物管理局的批准審查。
Additionally, the Company has substantially expanded its intellectual property ("IP") position for DuraGraft in the United States and around the globe and has recently been awarded, granted, and/or allowed patents for Krillase and MATLOC related technologies.
此外，該公司大幅擴大了其在美國和全球範圍內DuraGraft的知識產權（“IP”）地位，最近還獲得了 Krillase 和 MATLOC 相關技術的授予、授予和/或許可專利。
Key Accomplishments and Updates
主要成就和更新
Our flagship product, DuraGraft, is not yet available in the United States but is currently under review for authorization by the FDA. DuraGraft is commercially available in the EU and certain other markets.
我們的旗艦產品 DuraGraft 尚未在美國上市，但目前正在接受美國食品藥品管理局的審批。DuraGraft 已在歐盟和某些其他市場上市。
DuraGraft Accomplishments
DuraGraft 成就
- Generated revenue with our distribution partners from sales in Spain, Philippines, Germany, -Switzerland, Singapore, Malaysia, Turkey, Ireland, and Austria.
- Engaged Kimal PLC as exclusive distribution partner in the United Kingdom.
- Engaged Medical Instruments S.p.A as exclusive distribution partner in Italy.
- Completed regulatory and manufacturing transition to produce "Marizyme" labeled DuraGraft products for sale in the EU and certain other markets.
- Contributed to recent publications on DuraGraft-related clinical data in high impact peer-reviewed medical journals:
- Troponin/Szalkiewicz et al. Graft Preservation Confers Myocardial Protection during Coronary Artery Bypass Graftin. Published in Frontiers of Cardiovascular Medicine(1),
- Left Main/Caliskan et al. Clinical Event Rate in Patients with and Without Left Main Disease undergoing Isolated Coronary Artery Bypass Grafting: Results from the European DuraGraft Registry. Published in European Journal of Cardiothoracic Surgery(2),
- Whole Cohort/Sandner et al. Clinical Outcomes and Quality of Life After Contemporary Isolated Coronary Bypass Grafting: A Prospective Cohort Study. Published in The International Journal of Surgery(3)
- 我們的分銷合作伙伴通過在西班牙、菲律賓、德國、瑞士、新加坡、馬來西亞、土耳其、愛爾蘭和奧地利的銷售創造了收入。
- 聘請 Kimal PLC 作爲英國的獨家分銷合作伙伴。
- 聘請醫療器械 S.p.A 作爲意大利的獨家分銷合作伙伴。
- 完成監管和製造過渡，生產標有 “Marizyme” 標籤的DuraGraft產品，在歐盟和某些其他市場銷售。
- 爲近期在高影響力同行評審醫學期刊上發表的有關 DuraGraft 相關臨床數據的文章做出了貢獻：
- 肌鈣蛋白/Szalkiewicz 等人移植物保存可在冠狀動脈旁路移植過程中提供心肌保護。發表於 心血管醫學前沿(1)，
- Left Main/Caliskan 等人接受孤立冠狀動脈旁路移植術的有左主病和無左主病患者的臨床事件發生率：來自歐洲DuraGraft登記處的結果。發表於 歐洲心胸外科雜誌(2)，
- Whole Cohort/Sandner 等人當代孤立冠狀動脈旁路移植術後的臨床結果和生活質量：一項前瞻性隊列研究。發表於 國際外科雜誌(3)
Pipeline Products
管道產品
- MAR-FG-001 – Based on Marizyme's CytoProTM technology, this product is under development for use in fat-grafting procedures during plastic and reconstructive surgical procedures.
- MATLOC – An integrated point-of-care screening and diagnosis device for chronic kidney disease under development under a Sponsored Research Agreement.
- MAR-FG-001 — 基於 Marizyme 的 CytoProTM 技術，該產品正在開發中，用於整形和重建外科手術期間的脂肪移植手術。
- MATLOC — 根據贊助研究協議，正在開發一種針對慢性腎臟病的綜合牀旁篩查和診斷設備。
2023 Business Priorities
2023 年業務優先事項
- Seeking Authorization by the FDA for use of DuraGraft in the United States for CABG surgery procedures.
- Preparing the U.S. market for DuraGraft with key opinion leaders and a strategic partner.
- Generating recurring revenue with global distribution partners.
- Expanding distribution network with a focus on Europe and Asia.
- Advancing MAR-FG-001 into clinical development.
- Establishing strengthened capital resources and maintaining corporate governance.
- Developing further our intellectual property portfolio.
- Supporting publications and clinical data on DuraGraft to support commercialization.
- 尋求美國食品藥品管理局的授權，以便在美國使用DuraGraft進行CABG外科手術。
- 與主要意見領袖和戰略合作伙伴一起爲DuraGraft美國市場做準備。
- 與全球分銷合作伙伴一起創造經常性收入。
- 擴大分銷網絡，重點關注歐洲和亞洲。
- 推進 MAR-FG-001 進入臨床開發。
- 加強資本資源，維護公司治理。
- 進一步發展我們的知識產權組合。
- 支持有關DuraGraft的出版物和臨床數據，以支持商業化。
Stock Exchange Listing Update
證券交易所上市更新
On February 14, 2022, the Company initially filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") for registration of an underwritten public offering and simultaneous listing of its securities on the Nasdaq Capital Market tier of The Nasdaq Stock Market LLC ("Nasdaq"). On April 21, 2023, the Company filed a formal request with the SEC for its consent to the withdrawal of its registration statement because it does not intend to pursue the contemplated public offering at this time.
2022年2月14日，公司最初向美國證券交易委員會（“SEC”）提交了S-1表格的註冊聲明，用於註冊承銷公開發行並將其證券同時在納斯達克股票市場有限責任公司（“納斯達克”）的納斯達克資本市場層面上市。2023年4月21日，該公司向美國證券交易委員會提出正式請求，要求其同意撤回其註冊聲明，因爲該公司目前不打算進行擬議的公開募股。
The Company is continuously evaluating market conditions with its advisors, and in the future may proceed with its listing application with Nasdaq or seek approval for listing of its securities on another national securities exchange in connection with a direct listing, a public offering, or other listing process.
公司正在不斷與其顧問一起評估市場狀況，將來可能會繼續向納斯達克申請上市或尋求批准將其證券在另一家國家證券交易所上市，涉及直接上市、公開發行或其他上市程序。
Final Thoughts
最後的想法
We expect to provide further updates on our business developments and plans in the months to come.
我們預計將在未來幾個月內進一步提供有關我們的業務發展和計劃的最新信息。
I want to thank everyone involved in Marizyme for their support and commitment to the Company. Please feel free to reach out to me with any questions at DBarthel@marizyme.com.
我要感謝所有參與Marizyme的人對公司的支持和承諾。如有任何疑問，請隨時通過 DBarthel@marizyme.com 與我聯繫。
Sincerely,
Dave Barthel, Chief Executive Officer
Marizyme, Inc.
真誠地，
首席執行官戴夫·巴特爾
Marizyme, Inc.
(1) Frontiers in Cardiovascular Medicine. (2022, July 28). Graft Preservation Confers Myocardial Protection during Coronary Artery Bypass Grafting. Frontiers.
（1）《心血管醫學前沿》。（2022 年 7 月 28 日）。移植物保存可在冠狀動脈旁路移植術期間提供心肌保護。前沿。
(2) European Journal of Cardiothoracic Surgery. (2022, August 5). Clinical Event Rate in Patients with and Without Left Main Disease undergoing Isolated Coronary Artery Bypass Grafting: Results from the European DuraGraft Registry. Oxford Academic.
（2）《歐洲心胸外科雜誌》。（2022，8月5日）。接受孤立冠狀動脈旁路移植術的有左主病和無左主病患者的臨床事件發生率：來自歐洲DuraGraft登記處的結果。牛津學者。
(3) International Journal of Surgery. (2023, March 14.) Clinical Outcomes and Quality of Life After Contemporary Isolated Coronary Bypass Grafting: A Prospective Cohort Study. Published in The International Journal of Surgery. Journals.
(3)《國際外科雜誌》。（2023 年，3 月 14 日。）當代孤立冠狀動脈旁路移植術後的臨床結果和生活質量：一項前瞻性隊列研究。發表在《國際外科雜誌》上。期刊。
About Marizyme
關於 Marizyme
Marizyme is a multi-technology biomedical company dedicated to the accelerated development and commercialization of medical technologies that improve patient health outcomes. Marizyme is focused on the development and commercialization of medical technologies, devices and related products. Currently, we are focused on developing three medical technologies and products – DuraGraft, MATLOC and Krillase – each of which is backed by a portfolio of patented or patent-pending assets.
Marizyme 是一家多技術生物醫學公司，致力於加速改善患者健康狀況的醫療技術的開發和商業化。Marizyme專注於醫療技術、設備和相關產品的開發和商業化。目前，我們專注於開發三種醫療技術和產品——DuraGraft、MATLOC和Krillase，每種技術和產品都由專利或正在申請專利的資產組合提供支持。
DuraGraft is approved for use in the EU as well as certain other markets. DuraGraft has not been approved for use in the U.S. MAR-FG-001, MATLOC and Krillase are not approved for sales in any market. For more information about Marizyme, please visit .
DuraGraft 已獲准在歐盟以及某些其他市場使用。DuraGraft 尚未獲準在美國使用 MAR-FG-001、MATLOC 和 Krillase 未獲準在任何市場銷售。有關 Marizyme 的更多信息，請訪問。
Forward Looking Statements
前瞻性陳述
This press release contains statements that do not relate to historical facts but are "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can generally (although not always) be identified by their use of terms and phrases such as anticipate, appear, believe, continue, could, estimate, expect, indicate, intend, may, plan, possible, predict, project, pursue, will, would and other similar terms and phrases, as well as the use of the future tense. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on current beliefs, expectations and assumptions regarding the future of the business of the Company, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control, including the risks described in the Company annual reports on Form 10-K under the heading "Risk Factors" as filed with the SEC. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date hereof. Unless otherwise required by law, the Company undertakes no obligation to publicly update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
本新聞稿包含的聲明與歷史事實無關，但屬於1995年《美國私人證券訴訟改革法》安全港條款所指的 “前瞻性陳述”。這些陳述通常可以（儘管並非總是）通過使用術語和短語來識別，例如預期、出現、相信、繼續、可能、估計、期望、表明、打算、可能、可能、預測、追求、意志、會和其他類似的術語和短語，以及未來時態的使用。前瞻性陳述既不是歷史事實，也不是未來表現的保證。相反，它們僅基於當前對公司業務未來、未來計劃和戰略、預測、預期事件和趨勢、經濟和其他未來狀況的信念、預期和假設。由於前瞻性陳述與未來有關，因此它們受到難以預測的固有不確定性、風險和情況變化的影響，其中許多是公司無法控制的，包括公司向美國證券交易委員會提交的10-K表年度報告中在 “風險因素” 標題下描述的風險。實際業績和財務狀況可能與前瞻性陳述中顯示的業績和財務狀況存在重大差異。因此，您不應依賴這些前瞻性陳述中的任何一項。本新聞稿中的前瞻性陳述僅代表截至本文發佈之日。除非法律另有要求，否則公司沒有義務公開更新或修改這些前瞻性陳述，無論是由於新信息、未來事件還是其他原因。
For more information please contact:
Harrison Ross, Marizyme Inc.
561-433-6626
Hross@marizyme.com
欲瞭解更多信息，請聯繫：
哈里森·羅斯，Marizyme Inc.
561-433-6626
Hross@marizyme.com
譯文內容由第三人軟體翻譯。