Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 23, 2023

MARIZYME, INC.

(Exact name of registrant as specified in its charter)

Nevada

000-53223

82-5464863

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

555 Heritage Drive, Suite 205, Jupiter, Florida		33458
(Address of principal executive offices)		(Zip Code)

(561) 935-9955

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

☐

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Not applicable.

Item 7.01.

Regulation FD Disclosure.

On October 23, 2023, Marizyme, Inc. (the “Company”) issued a press release announcing a business update. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information furnished pursuant to this Item 7.01 (including Exhibit 99.1 hereto), shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such a filing.

Forward-Looking Statements

The press release and the statements contained therein include “forward-looking” statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. In some cases, you can identify these statements because they contain words such as “may,” “will,” “believes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “should,” “seeks,” “future,” “continue,” “plan,” “target,” “predict,” “potential,” or the negative of such terms, or other comparable terminology that concern the Company’s expectations, strategy, plans, or intentions. Forward-looking statements relating to expectations about future results or events are based upon information available to the Company as of today’s date and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. Forward-looking statements include, but are not limited to, the Company’s expectations regarding its plan for U.S. commercialization of DuraGraft™, the potential for DuraGraft™ to be used in cardiac care delivery services, its financial position and operating performance, its expectations regarding its business strategy, its business initiatives, its operating performance, trends in its business, the effectiveness of its growth strategy, its market opportunity, and demand for its products and services in general. The Company’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks and uncertainties described in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. All subsequent written and oral forward-looking statements concerning the Company or other matters and attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. The Company does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof, except as required by law.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description of Exhibit
99.1		Press Release dated October 23, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, Marizyme, Inc. has duly caused this current report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 23, 2023	MARIZYME, INC.

	By:	/s/ David Barthel
		David Barthel
		Chief Executive Officer

Exhibit 99.1

Marizyme CEO Delivers Business Update

JUPITER, FL, October 23, 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:

“I am very pleased to bring you an update on the Company’s FDA Clearance for DuraGraft™ as well as Marizyme’s business priorities for 2024.

“After our last business update on May 3, 2023, the Company has been focused on securing FDA clearance for DuraGraft, developing our United States (U.S.) commercialization plan, completing our application for new technology add-on payments (NTAP) designation for Medicare reimbursement for DuraGraft™ (beginning in October 2024), and driving DuraGraft revenue in Europe and Asia. We have been successful or made progress in all these strategic initiatives.

“The big news and win is that we were granted a De Novo – FDA Clearance – on October 4, 2023 from the U.S. Food and Drug Administration (FDA) for our first-in-class product, DuraGraft™. DuraGraft is labelled 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. This is a huge accomplishment for the Company and will allow us the opportunity to market DuraGraft in the U.S. for the 500,000 CABG procedures performed annually in the U.S.¹

“Our U.S. commercialization plan is focused on penetrating and driving utilization in hospital integrated networks and the cardiac suite, utilizing a small targeted and efficient direct sales force, direct sales targeting with patient focus on diabetics, and high-risk patients and utilizing digital marketing. We are excited with the opportunity to drive immediate revenue based on our strong clinical data and indication for use.

“We have also had success this year driving DuraGraft™ sales in Europe and Asia, with 1,131 DuraGraft™ kits shipped so far this year, compared to the 485 DuraGraft™ kits shipped last year. We have been working closely with our new distribution partners in Austria, the UK and Italy. We are anticipating continued sales growth in 2024.

“We have also been raising capital and reducing expenses where possible. We believe that our focus on aligning resources with business priorities continues to show results.

“As part of our U.S. commercialization plan, we have been working with a large hospital integrated network to execute on a strategic partnership for a planned multi-center randomized DuraGraft™ clinical trial in the U.S. and a utilization agreement to use DuraGraft™ across the hospital network.

“Additionally, the Company continues to expand its intellectual property (IP) position for DuraGraft™ in the U.S. and around the globe. Here are our 2024 business priorities:

¹The Society of Thoracic Surgeons, “Coronary Artery Bypass Grafting (CABG).” The Patient Guide to Heart, Lung, and Esophageal Surgery, May 2019.

2024 Business Priorities

	●	DuraGraft™ U.S. commercialization including engagement of hospital integrated networks and utilization with a small direct sales force.
	●	Pursuing potential strategic partnership for a multi-center DuraGraft™ clinical trial and utilization agreement.
	●	Increasing European Union sales with our exclusive distribution partners.
	●	Manufacturing sustainability with U.S. manufacturing and logistics providers.
	●	Executing our business plan with our cardiac care focus.
	●	Expanding the DuraGraft™ product platform with a powder formulation.
	●	Establishing strengthened capital resources and maintaining corporate governance.
	●	Developing further our intellectual property portfolio.
	●	Supporting publications and clinical data on DuraGraft™ to support commercialization.

Final Thoughts

“I will continue to provide further updates on our business developments and plans in the months to come. It has been a long road for everyone, but as we approach 2024, we have built this business with strong fundamentals, a talented team and a very lean and efficient operation. I look forward to a very successful 2024.

“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.”

About Marizyme

Marizyme, Inc. (OTCQB:MRZM), Jupiter, FL is a medical technology company dedicated to the accelerated development and commercialization of innovative products that improve patient outcomes. Marizyme’s flagship product, DuraGraft™, has been granted a de novo from the U.S. Food and Drug Administration, allowing the Company to focus on changing the landscape of cardiac care by delivering innovative solutions for Coronary Artery Bypass Grafting surgery. DuraGraft™, with its CE Mark, continues to drive sales growth for the Company internationally and will now target the U.S. market to drive utilization and sales.

For more information about Marizyme, please visit www.marizyme.com.

Forward Looking Statements

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.

For more information please contact:

Harrison Ross, Marizyme, Inc.

561-433-6626

Hross@marizyme.com

Source: Marizyme, Inc.

Cover	Oct. 23, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 23, 2023
Entity File Number	000-53223
Entity Registrant Name	MARIZYME, INC.
Entity Central Index Key	0001413754
Entity Tax Identification Number	82-5464863
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	555 Heritage Drive
Entity Address, Address Line Two	Suite 205
Entity Address, City or Town	Jupiter
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	33458
City Area Code	561
Local Phone Number	935-9955
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Not applicable.
Entity Emerging Growth Company	false