Our three medical technologies – DuraGraft, MATLOC and Krillase – are expected to serve an immediate and large market need in several areas, including, cardiac surgery, CKD, and pet health. We are currently preparing DuraGraft, our endothelial damage inhibitor, or EDI, and MATLOC 1, our CKD screening and diagnostic device, for the FDA De Novo classification process and 510(k) application, respectively. We filed a pre-submission letter for DuraGraft with the FDA in November 2021 and we expect to submit the DuraGraft De Novo request to the FDA later this year. Once we file with the FDA, we expect to receive approval for the DuraGraft De Novo request later in 2022 and approval for the MATLOC 1 510(k) application sometime in 2023. Upon receiving FDA approvals, which we anticipate but cannot guarantee, we expect to quickly commercialize these two products and build revenue rapidly utilizing multiple strategic partners and revenue channels. Concurrently, our Krillase development team is planning an animal clinical study, to be conducted in 2022, which we expect will facilitate our entry into the pet health market and generate revenue through the sale of Krillase-based canine dental hygiene products. Following our introduction of Krillase into the pet health market, we plan to file an application with the FDA for the approval of Krillase for human use. With our DuraGraft, MATLOC and Krillase platforms, we have the potential for bringing three FDA-approved products to market.

For 2022, our primary business priority is achieving FDA approval of DuraGraft as a medical device for coronary bypass artery graft, or CBAG, procedures, through the De Novo classification request process. Following FDA approval of DuraGraft, which we anticipate but cannot guarantee, we expect to begin to distribute and sell DuraGraft in the United States through the efforts of a strategic partner. If we are not able to find an appropriate strategic partner, we will have to build our own marketing and sales capabilities at a significant cost to us and with no guarantee of success. DuraGraft first received its CE marking in August 2014. CE marking signifies that DuraGraft may be sold in the European Economic Area, or EEA, and DuraGraft has therefore been assessed as meeting EEA safety, health, and environmental protection requirements. We will continue marketing efforts in Europe and in other countries that accept CE marking. In addition, we intend to fully develop and market DuraGraft in the U.S. for fat grafting procedures in plastic surgery procedures.

In 2022, we also intend to prioritize the advancement of our MATLOC 1 CKD point-of-care device through the completion of a clinical trial followed by the filing of an FDA 510(k) application, which we expect the FDA to approve by the end of 2023. We will concurrently be advancing our Krillase technology through a planned animal study with the objective of generating revenue in the pet health market.

As we achieve FDA approvals, we intend to prioritize the commercialization of our DuraGraft, MATLOC and Krillase platform products through multiple distribution and marketing channels in the U.S. We expect that once we enter the commercialization phase, we will be able to rapidly generate revenue growth. Additionally, in the near term we expect to generate revenue from the sale of DuraGraft through the expansion of our international marketing efforts by our distribution partners.

Note: The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $42.31 million at Sept. 30, 2021, Additionally, the Company has negative working capital of $2,132,227 and $16,673 of cash on hand. These factors raise substantial doubt about its ability to continue as a going concern, according to the prospectus. 

**Note: As of Sept. 30, 2022, and Dec. 31, 2021, we had an accumulated deficit of approximately $62.4 million and $47.8 million, respectively.

(Background: Marizyme, Inc. increased its public offering’s sized in an S-1/A filing dated Feb. 10, 2023: The number of units was increased to 1.52 million units – up from 1.43 million units – and the assumed offering price was stated as $5.25 – below the previous range of $6.00 to $8.00 per unit – to raise $8.0 million. In that February 2023 S-1/A filing, the public offering’s size was cut by 20 percent. Each unit consists of one share of common stock and two warrants – each to buy a share of common stock. The S-1 prospectus was filed Feb.14, 2022. In the SEC filing dated Nov. 2, 2022, R.F. Lafferty & Co. was added as a joint book-runner with Univest Securities.)