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 6, 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 6, 2023, Marizyme, Inc. (the “Company”) issued a press release announcing that it had received clearance from the U.S. Food and Drug Administration for its medical device product, DuraGraft™, for use as an intra-operative vascular conduit storage and flushing solution used during coronary artery bypass graft surgeries. 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 6, 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 6, 2023	MARIZYME, INC.

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

Exhibit 99.1

Marizyme, Inc. Announces FDA Clearance for Flagship Product, DuraGraft^™

DuraGraft is the first and only FDA cleared medical device for use as an intra-operative vascular conduit storage and flushing solution used during CABG surgeries.

JUPITER, FL., Oct. 6, 2023/New Media Wire/ — Marizyme, Inc. (OTCQB:MRZM) (“Marizyme” or the “Company”), a global medical technology company focused on the development of products to address unmet clinical needs today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its 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. The mechanism of action for DuraGraft is through the reduction of oxidative damage which maintains the structural and functional integrity of vascular conduits. DuraGraft has been studied extensively in clinical studies including imaging studies. These studies show 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.

Cardiac care is a large and rapidly growing industry; according to the CDC the estimated average annual US cost of coronary heart disease is $219 billion. CABG is the most common type of open-heart surgery in the United States with more than 500,000 surgeries performed each year. David Barthel, Marizyme CEO, stated that DuraGraft has the potential to change the landscape of cardiac care.

DuraGraft is the first and only medical product that is FDA cleared for use as an intra-operative vascular conduit storage and flushing solution used during CABG surgeries and is also the only approved product available for this indication in Europe and other countries.

DuraGraft is the only patented product for this indication in CABG and other vascular surgeries. The DuraGraft patent portfolio is growing and includes granted patents and pending applications in over 30 countries throughout the world, including patents granted in the United States, Europe, Australia, India, Argentina, South Africa, Mexico, and several Asian countries.

With the FDA clearance achieved, 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.

“With this significant milestone reached, our company, Marizyme, can now present this breakthrough to cardiac surgeons and their CABG patients. This is a rapidly growing market that provides Marizyme the opportunity to meet its mission statement and completely change the landscape of cardiac care.”

David Barthel, CEO, Marizyme, Inc.

About Marizyme:

Marizyme is a global medical technology company focused on the development of products to address unmet clinical needs. Marizyme has a diverse pipeline portfolio and is currently focused on the development and commercialization of medical technologies in cardiac care, mainly through its flagship product, DuraGraft.

DuraGraft™ is cleared for use in the US and approved for use in the EU and certain other markets. 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’s annual reports on Form 10-K under the heading “Risk Factors” as filed with the Securities and Exchange Commission. 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

Cover	Oct. 06, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 06, 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
Entity Emerging Growth Company	false