JUPITER, FL, April 16, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Marizyme, Inc. ('Marizyme', OTCQB: MRZM) announces today a Co-Development Agreement (the “Agreement”) with Qualigen Therapeutics, Inc. (“Qualigen”) (NASDAQ: QLGN) to advance the commercialization of Marizyme’s first-in-class FDA cleared product, DuraGraft™. .

佛罗里达州朱庇特（JUPITER，FL），2024年4月16日（Global NEWSWIRE）--通过NewMediaWire，Marizyme，Inc.（“Marizyme”，OTCQB:MRZM）今天宣布与Qualigen Therapeutics，Inc.（“Qualigen”）（纳斯达克：QLGN）签署共同开发协议（“协议”），以推进Marizyme的首个FDA批准产品DuraGraft™的商业化。。

DuraGraft™ was granted a De Novo – FDA Clearance on October 4, 2023, from the U.S. Food and Drug Administration (FDA).  DuraGraft™ is labeled for use as a vascular conduit solution indicated for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries and is intended for the flushing and storage of the saphenous vein grafts used in CABG surgery.

DuraGraft™于2023年10月4日获得美国食品和药物管理局（FDA）的从头批准。DuraGraft™被标记为血管导管溶液，适用于接受冠状动脉旁路移植术（CABG）手术的成年患者，用于冲洗和储存CABG手术中使用的大隐静脉移植物。

According to the Society of Thoracic Surgeons, there are over 500,000 CABG procedures performed annually in the U.S., representing a major market for this commercial-ready product.  .

根据胸外科医师协会的数据，美国每年有超过500000例CABG手术，代表了这种商业化产品的主要市场。。

Pursuant to the Agreement, Qualigen will help support the commercial launch in the United States of DuraGraft™, including post-clearance clinical studies to advance the use of DuraGraft™ in the U.S., by providing up to $1.5 million in funding over the next several months for these purposes.  In return, Qualigen will receive a share of Marizyme’s gross profit on future U.S.

根据该协议，Qualigen将在未来几个月内为这些目的提供高达150万美元的资金，帮助支持DuraGraft™在美国的商业推出，包括清除后临床研究，以推动DuraGraft™在美国的使用。作为回报，Qualigen将在未来的美国市场上分享Marizyme的毛利润。

sales of the product, capped at a 2X return on Qualigen’s invested capital. Qualigen has also purchased an exclusive negotiation period ending May 31, 2024, for purposes of proposing and outlining a broader strategic relationship between the two companies..

该产品的销售，以Qualigen投资资本的2倍回报率为上限。Qualigen还购买了一个截至2024年5月31日的独家谈判期，目的是提出并概述两家公司之间更广泛的战略关系。。

David Barthel, CEO of Marizyme, stated: “This is an exciting opportunity for Marizyme to accelerate the commercialization of DuraGraft™.  In addition to the non-dilutive funding that Qualigen will provide, we believe strongly in the importance of this technology and commercial potential for DuraGraft™ in the United States, and look forward to building this strategic relationship.”.

Marizyme首席执行官David Barthel表示：“这是Marizyme加速DuraGraft™商业化的一个令人兴奋的机会。除了Qualigen将提供的非稀释性资金外，我们坚信这项技术的重要性和DuraGraft™在美国的商业潜力，并期待着建立这种战略关系。”。

Michael Poirier, CEO of Qualigen, stated: “We are thrilled to be supporting the Marizyme team.  This agreement provides Qualigen with participation in an FDA-cleared commercialization project with a visible path to revenue generation in the short term.  It also allows us the flexibility to broaden this relationship over the next four months.” .

Qualigen首席执行官迈克尔·波里耶（Michael Poirier）表示：“我们很高兴能支持Marizyme团队。该协议为Qualigen参与FDA批准的商业化项目提供了一条可见的短期创收途径。这也使我们能够灵活地在未来四个月内扩大这种关系。”。

About Marizyme

关于Marizyme

Marizyme, Inc. is a medical technology company changing the landscape of cardiac care by delivering innovative solutions for coronary artery bypass graft (CABG) surgery. Marizyme's first in-class product, DuraGraft™, was granted a de novo clearance on October 4, 2023, from the U.S. Food and Drug Administration (FDA).

Marizyme，Inc.是一家医疗技术公司，通过为冠状动脉旁路移植术（CABG）手术提供创新解决方案，改变了心脏护理的格局。Marizyme的一流产品DuraGraft™于2023年10月4日获得美国食品和药物管理局（FDA）的从头批准。

DuraGraft™, with its CE Mark, continues to drive sales growth for Marizyme internationally in Europe and Asia, and will now target the U.S. market to drive further utilization and sales..

带有CE标志的DuraGraft™继续推动Marizyme在欧洲和亚洲的国际销售增长，现在将瞄准美国市场，以推动进一步的利用和销售。。

About Qualigen Therapeutics, Inc.

关于Qualigen Therapeutics，Inc。

Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Until the sale of its diagnostic business in 2023, Qualigen had a 20+ year history developing, marketing and selling medical devices in the United States and internationally.

Qualigen Therapeutics，Inc.是一家临床阶段治疗公司，专注于开发成人和儿科癌症的治疗方法。在2023年出售诊断业务之前，Qualigen在美国和国际上开发、营销和销售医疗器械已有20多年的历史。

Currently, Qualigen’s investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. QN-302 is currently in a Phase 1a clinical trial.  The preclinical compounds within Qualigen’s family of Pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm.

目前，Qualigen的研究性QN-302化合物是一种小分子选择性转录抑制剂，对癌细胞中普遍存在的G4具有强结合亲和力；这种结合可以通过稳定G4以防止“解旋”，从而有助于抑制癌细胞增殖。QN-302目前正在进行1a期临床试验。Qualigen家族泛RAS癌基因-蛋白质相互作用抑制剂小分子中的临床前化合物被认为可以抑制或阻断突变RAS基因蛋白质与其效应蛋白的结合，从而使突变RAS的蛋白质无法引起进一步的伤害。

In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.  .

理论上，这种作用机制可能有效治疗约四分之一的癌症，包括某些形式的胰腺癌，结直肠癌和肺癌。