Qualigen seeks to enter the $10 Billion CABG market with non-binding MOU to acquire Marizyme

Rhea-AI Summary

Qualigen Therapeutics (NASDAQ: QLGN) has entered a non-binding Memorandum of Understanding (MOU) to acquire Marizyme (OTC: MRZM), following their 2024 co-marketing agreement. The acquisition targets the $10 billion Coronary Artery Bypass Graft (CABG) market through Marizyme's FDA-cleared DuraGraft technology.

DuraGraft addresses a critical need in CABG surgeries, where saphenous vein graft failure rates reach 20-40% within the first year and approximately 50% within 5-10 years. The technology aims to prevent oxidative damage and slow vein graft failure progression, potentially reducing repeat procedures and hospital stays.

The deal, subject to due diligence, final terms, and shareholder approval, is expected to generate revenue by the end of fiscal 2025, with commercialization strategy development planned for the third quarter.

Positive

• Access to FDA-cleared product in $10B CABG market
• Revenue generation expected by end of fiscal 2025
• Potential cost savings for hospitals through reduced procedures
• Large market opportunity with 500,000+ annual CABG surgeries in US

Negative

• Non-binding MOU with no guaranteed completion
• Deal requires further due diligence and shareholder approval
• Revenue generation not immediate, starting end of 2025

Insights

Biotech M&A Specialist

Qualigen's non-binding MOU to acquire Marizyme represents a strategic pivot toward immediate commercialization and market-ready assets. The potential acquisition follows their 2024 co-marketing agreement, suggesting a methodical approach to full integration after initial collaboration.

This transaction targets the $10 billion CABG market with DuraGraft, an FDA-cleared platform technology that addresses a critical unmet need: the 20-40% of saphenous vein grafts that fail within the first year and approximately 50% that fail within 5-10 years post-surgery.

For Qualigen, with its modest $2.37 million market capitalization, accessing this substantial market through an already-cleared product could transform its financial trajectory. The acquisition bypasses years of costly development and regulatory hurdles, offering a shortcut to commercial operations.

However, several key elements warrant investor scrutiny: First, the non-binding nature of the MOU means this deal remains preliminary. Second, no financial terms have been disclosed, making valuation impossible to assess. Third, the timeline for revenue generation appears optimistic with commercialization strategies developing in Q3 and revenue expected by year-end 2025.

For a small-cap biotech company like Qualigen, acquiring revenue-generating assets with regulatory clearance represents a prudent de-risking strategy, potentially accelerating their path to sustainable operations while reducing reliance on capital markets for ongoing funding.

Cardiovascular Medical Device Expert

DuraGraft's technology addresses a fundamental challenge in cardiac surgery: preserving vein graft viability. During the approximately 500,000 CABG procedures performed annually in the US, saphenous veins harvested for bypass grafting undergo significant stress and oxidative damage before implantation.

The clinical value proposition is compelling – by preventing oxidative damage to vein grafts, DuraGraft targets the root cause of graft failure, potentially reducing the substantial failure rates (20-40% in year one, 50% within 5-10 years). This addresses both patient outcomes and healthcare economics through fewer repeat procedures.

From a market penetration perspective, CABG procedures represent a concentrated market where adoption can be driven through relatively targeted efforts at cardiac surgery centers. The technology's hospital savings potential through reduced repeat procedures creates an economic incentive aligned with clinical benefits.

The commercialization strategy will face challenges typical in the cardiovascular device space: establishing clinical workflow integration, securing favorable reimbursement positioning, and demonstrating real-world cost-effectiveness. The Q3 2025 timeline for commercialization strategy development suggests initial market entry activities rather than full-scale launch.

For Qualigen, DuraGraft represents an entry into cardiovascular care with a product addressing a significant clinical need. The market size and persistent issue of graft failure create substantial opportunity, though successful execution will require specialized cardiovascular sales expertise and clinical education programs.

CARLSBAD, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company”) announced today they have entered a non-binding Memorandum of Understanding (MOU) to acquire Marizyme (OTC: MRZM).

Qualigen and Marizyme have entered an MOU dated March 28, 2025. This is the logical next step in acquiring Marizyme, following on our co-marketing agreement established in 2024. Upon completion of full due diligence, we will proceed with the final structure and deal terms which will be subject to shareholder approval following the filing of an S4.

There can be no assurance that any transaction will be completed or that definitive agreements will be executed.

Marizyme’s DuraGraft is an FDA cleared platform technology in the Coronary Artery Bypass Graft (CABG) market. The CABG market is over $10 billion in revenue annually. It is estimated there are more than 500,000 CABG surgeries performed every year in the US. In CABG surgery, saphenous vein graft (SVG) failure rates are a concern, with approximately 50% failing within 5 to 10 years, and between 20-40% failing within the first year. DuraGraft has the potential to change the landscape of cardiac care by preventing oxidative damage, therefore slowing the progression of vein graft failure. DuraGraft has the potential to increase hospital savings through the reduction of repeat procedures and hospital stays.

“We are extremely excited to bring Marizyme into the Qualigen Therapeutics company. Having an already FDA cleared product in our portfolio of businesses will provide the company with rapid revenue growth beginning in 2025. We look forward to providing further updates to shareholders as we make progress on completing diligence and finalizing terms of the transaction “stated Kevin Richardson II, Chief Executive Officer of Qualigen.

David Barthel, Chief Executive Officer of Marizyme, stated, “We are thrilled to have an agreement worked out with Qualigen. By combining the two companies we will be able to leverage our FDA cleared DuraGraft medical device and begin generating revenue. We should begin to see our commercialization strategy develop in the third quarter with revenue expected by the end of fiscal 2025. Bringing Duragraft to market will have a positive impact for shareholders, and more importantly for patients and the healthcare system”.

ABOUT MARIZYME

Marizyme Inc. is a multi-technology Life Science company engaged in the research, manufacture and commercialization of medical devices, diagnostics and first-in class products to address unmet clinical needs.
https://marizyme.com/

About Qualigen Therapeutics, Inc.

For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company may in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. The Company’s forward-looking statements are based on current beliefs and expectations of its management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding the timing of the offering. Any or all of the forward-looking statements may turn out to be wrong or be affected by assumptions the Company makes that later turn out to be incorrect, or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the Company’s ability to regain compliance with Nasdaq’s continued listing requirements, including the Company’s ability to file its Form 10-K for the period ended December 31, 2024, or otherwise in the future, or otherwise maintain compliance with any other listing requirement of The Nasdaq Capital Market, the potential de-listing of the Company’s shares from The Nasdaq Capital Market due to its failure to comply with the continued listing requirement of The Nasdaq Stock Market, LLC, or its alternatives, or otherwise in the future, and the other risks set forth in the Company’s filings with the Securities and Exchange Commission, including in its Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by the Company’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Investor Relations
ir@qlgntx.com.

FAQ

What is the market size for QLGN's potential DuraGraft acquisition?

The Coronary Artery Bypass Graft (CABG) market targeted by DuraGraft generates over $10 billion in annual revenue, with more than 500,000 CABG surgeries performed yearly in the US.

When will QLGN's acquisition of Marizyme generate revenue?

Revenue generation is expected to begin by the end of fiscal 2025, with commercialization strategy development starting in Q3 2025.

What problem does DuraGraft solve in CABG procedures?

DuraGraft prevents oxidative damage and slows vein graft failure, addressing the 20-40% failure rate in the first year and 50% failure rate within 5-10 years of CABG surgeries.

What are the next steps for QLGN's acquisition of Marizyme?

Following the non-binding MOU, the next steps include completing due diligence, finalizing deal terms, filing an S4, and obtaining shareholder approval.

How will the Marizyme acquisition benefit QLGN's business?

The acquisition will add an FDA-cleared product to QLGN's portfolio, enabling rapid revenue growth starting 2025 and entry into the $10B CABG market.