InvestmentPitch Media Video Features Marizyme's CEO David Barthel Discussing Receipt of FDA Clearance for Its Flagship DuraGraft Medical Device
InvestmentPitch Media Video Features Marizyme's CEO David Barthel Discussing Receipt of FDA Clearance for Its Flagship DuraGraft Medical Device
VANCOUVER, BC / ACCESSWIRE / October 13, 2023 / Marizyme, Inc. (OTCQB:MRZM), a global multi-technology biomedical company dedicated to the accelerated development and commercialization of medical technologies that improve patient health outcomes, is featured in today's video by InvestmentPitch Media.
不列顛哥倫比亞省溫哥華/ACCESSWIRE/2023 年 10 月 13 日/ InvestmentPitch Media今天的視頻介紹了Marizyme, Inc.（OTCQB: MRZM）是一家全球多技術生物醫學公司，致力於加快改善患者健康結果的醫療技術的開發和商業化。
The company was recently granted a de novo from the U.S. Food and Drug Administration for its first-in-class product, DuraGraft. With the granting of this de novo, DuraGraft is the first and only medical product that is FDA cleared for use as an intra-operative vascular conduit storage and flushing solution during Coronary Artery Bypass Grafting or CABG surgeries and is also the only approved product available for this indication in Europe and other countries.
該公司最近憑藉其同類首創產品DuraGraft獲得了美國食品藥品監督管理局的重新授權。隨着該項從頭獲得批准，DuraGraft是第一款也是唯一一款獲得美國食品藥品管理局批准在冠狀動脈搭橋術或CABG手術期間用作術中血管導管儲存和沖洗溶液的醫療產品，也是歐洲和其他國家唯一獲准用於該適應症的產品。
DuraGraft has been studied extensively in clinical studies including imaging studies, which showed that saphenous vein grafts treated with DuraGraft have reduced graft wall thickening compared to standard-of-care, saline-treated grafts at 12 months post-CABG surgery. DuraGraft use is also associated with reduced long-term mortality through three years post-CABG surgery.
包括影像學研究在內的臨床研究對DuraGraft進行了廣泛的研究，結果表明，在CabG手術後的12個月內，與標準護理的鹽水處理移植相比，使用DuraGraft處理的隱靜脈移植可以減少移植物壁的增厚。使用DuraGraft還可以在CabG手術後三年內降低長期死亡率。
For more information, please view the InvestmentPitch Media video which provides additional information about this news and the company along with video comment from David Barthel, CEO of Marizyme. If you are unable to view this video, please watch it on InvestmentPitch Media's YouTube channel at this link: (click here)
欲了解更多信息，請觀看InvestmentPitch Media視頻，該視頻提供了有關此新聞和公司的更多信息，以及Marizyme首席執行官大衛·巴特爾的視頻評論。如果你無法觀看此視頻，請通過以下鏈接在 InvestmentPitch Media 的 YouTube 頻道上觀看：（點擊這裏）
Heart disease is the leading cause of death for both men and women in the United States, with coronary artery disease, which affects the blood flow to the heart, being the most common type of heart disease. About 660,000 people in the U.S. die from heart disease every year-that's 1 in every 4 deaths and on average 1 person every 40 seconds. According to the CDC the estimated average annual US cost of coronary heart disease is $219 billion.
心臟病是美國男性和女性的主要死因，而影響心臟血液流向心臟的冠狀動脈疾病是最常見的心臟病類型。在美國，每年約有66萬人死於心臟病，相當於每4例死亡中就有1人死亡，平均每40秒就有1人死於心臟病。據美國疾病預防控制中心估計，美國每年因冠心病造成的平均損失爲2190億美元。
The DuraGraft patent portfolio is growing and includes granted patents and pending applications in more than 30 countries globally, including patents granted in the United States, Europe, Australia, India, Argentina, South Africa, Mexico, and several Asian countries. In addition to its flagship DuraGraft product, the company has a diverse pipeline portfolio to address unmet clinical needs in several large markets that management believes provides significant clinical and economic opportunities.
DuraGraft的專利組合正在增長，包括全球30多個國家的已授權專利和待批申請，包括在美國、歐洲、澳大利亞、印度、阿根廷、南非、墨西哥和幾個亞洲國家授予的專利。除了旗艦產品DuraGraft外，該公司還擁有多樣化的產品組合，可以滿足幾個大型市場中未得到滿足的臨床需求，管理層認爲這些市場提供了重要的臨床和經濟機會。
With the FDA de novo granted, the company will now focus on executing its plan for US commercialization with an emphasis on driving utilization in hospital-integrated networks using its own direct sales force.
隨着FDA de novo的批准，該公司現在將專注於執行其在美國的商業化計劃，重點是利用自己的直銷隊伍提高醫院綜合網絡的利用率。
The shares are trading at $0.155.
這些股票的交易價格爲0.155美元。
For more information, please visit the company's website , contact Harrison Ross, VP of Finance, at 561-433-6626 or by email at HRoss@marizyme.com
欲了解更多信息，請訪問公司網站，致電 561-433-6626 或發送電子郵件至 HRoss@marizyme.com 聯繫財務副總裁哈里森·羅斯
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SOURCE: InvestmentPitch Media
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