Marizyme CEO Delivers Business Update

October 23, 2023

JUPITER, FL, Oct. 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:

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


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

Source: Marizyme Inc.

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. 06, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - 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 was granted a de novo 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.

With the granting of this de novo, 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 de novo granted, 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.

Marizyme Announces IP Developments for DuraGraft® and Its Pipeline Products

May 10, 2023 08:00 ET| Source: Marizyme Inc.

JUPITER, FL, May 10, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Marizyme, Inc. ("Marizyme" or the "Company") (OTCQB: MRZM), a multi-technology biomedical company focused on the accelerated development and commercialization of medical technologies that improve patient health outcomes, announced today that it has recently received additional granted patents and notices of allowance for three of its core technologies in several key markets further strengthening the Company’s intellectual property.

Patents have recently been granted in the United States, India, South Korea, and Vietnam covering the Company’s flagship commercial product, DuraGraft™, and patent applications have additionally been allowed in Canada and Vietnam. The issued patents and allowed patent applications protect Marizyme’s flagship commercial product DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries that is authorized for use in Europe and other countries outside of the United States. It is considered an investigational product in the United States and is not yet authorized for use in the United States.

“The countries in which patents are allowed or granted represent large and rapidly expanding cardiac surgery markets and significantly expand our patent estate for DuraGraft and present tremendous commercialization and licensing opportunities for us,” said David Barthel, Marizyme’s CEO.

The DuraGraft patent portfolio now 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, and pending related applications in the U.S. and other countries.

Another patent application covering Marizyme’s Krillase™ enzyme technology was recently allowed in Europe resulting in additional patent protection. The patent relates to mixtures of enzymes from Antarctic krill for use in the treatment of a disease related to, or an inflammatory condition caused by, a biofilm formed on a soft tissue of a mammal with the treatment including treating soft tissue with Krillase to remove or prevent formation of a biofilm.  Krillase products are currently under development and not yet authorized for use.

Additionally, a patent application covering Marizyme’s MATLOC™ technology was also recently allowed in Europe.  The patent application relates to a method for mixing two reagents to produce a detectable reaction in a microfluidic chip.  The method allows for the detection of albumin and/or creatinine using a passive mixing microfluidic chip to be potentially used for chronic kidney disease assessment.  MATLOC devices are currently under development and not yet authorized for use.

Marizyme’s global patent and IP portfolio is managed by Dentons US LLP, the world’s largest law firm with hundreds of patent lawyers and IP professionals in more than 80 countries.  Dentons US LLP provides quality seamless legal services on an international scale.  Dentons has been consistently ranked for the past years as a top leading life sciences and health care law firm.  “Joining forces with Dentons has allowed Marizyme to step up innovation, growth and value creation in markets around the world, which is important as we continue to expand and protect our intellectual property,” said David Barthel.

About Marizyme:

Marizyme is a multi-technology biomedical company dedicated to the accelerated development and commercialization of medical technologies that improve patient health outcomes. Marizyme is focused on the development and commercialization of medical technologies, devices and related products. Currently, we are focused on developing three medical technologies and products – DuraGraft™, MATLOC™ and Krillase™ – each of which is backed by a portfolio of patented or patent-pending assets.

DuraGraft® is approved for use in the EU as well as certain other markets. DuraGraft™ has not been approved for use in the U.S. MAR-FG-001, MATLOC™ and Krillase™ are not approved for sales in any market.  For more information about Marizyme, please visit www.marizyme.com.

For information relating to the IP of Marizyme, Inc. please contact info@marizyme.com or 914-714-8615.

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

T&J Brothers group discloses its recent progress.

Los Angeles, CA, 8/7/2023 – T&J Brothers Group, LLC, a privately held investment company and real estate consultancy firm with a strong commitment to social responsibility, proudly announces a significant milestone within its portfolio. Marizyme, Inc., a company in which T&J Brothers Group invested three years ago, has filed an S1 for uplisting to senior exchange such as Nasdaq or the NYSE in July 2023, and being listed as one of its principal stockholders (1). T&J Brothers Group is excited to witness Marizyme’s progress and looks forward to the potential growth and positive impact of this development in the healthcare innovation sector.

Marizyme, Inc. (“Marizyme” or the “Company”) (OTCQB: MRZM) is a multi-technology biomedical company focused on the accelerated development and commercialization of medical technologies that improve patient health outcomes, announced today that it has recently received additional granted patents and notices of allowance for three of its core technologies in several key markets further strengthening the Company’s intellectual property.

Marizyme’s flagship product, DuraGraft®, and the company has granted patents covering this product in the United States, India, South Korea, and Vietnam. The issued patents and allowed patent applications protect Marizyme’s flagship commercial product DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries that is authorized for use in Europe and other countries outside of the United States.

(DuraGraft®, is an investigational product used during Coronary Artery Bypass Grafting (CABG) surgery.)

Building on their international success, Marizyme is looking to enter the US market. Yet, DuraGraft is currently under review by the FDA for authorization in the United States.

“The countries in which patents are allowed or granted represent large and rapidly expanding cardiac surgery markets and significantly expand our patent estate for DuraGraft and present tremendous commercialization and licensing opportunities for us,” said David Barthel, Marizyme’s CEO.

T&J Brothers group has beliefs in making a meaningful impact on society and the environment centers around responsible and sustainable practices, prioritizing the well-being of current and future generations. Marizyme inc has being one of their key investments.

They are convinced that healthcare innovation for coronary artery disease treatments offers significant benefits by delivering better and accessible medical solutions, improving patient outcomes, and potentially alleviating the strain on healthcare systems through more effective prevention and management of this common cardiovascular condition.

About T&J Brothers group:

T&J Brothers Group is an California llc, founded by zhonghao chen and xingyu yang, the company is a private investment company and real estate consultancy firm. With an active pursuit of both private and public investment opportunities worldwide, the company focuses on long-term structural value investing and industrial innovation across sectors like biopharmaceuticals, life health, and hard technology. Its investment portfolio encompasses early-stage venture capital, public companies, and merger and acquisition deals. Alongside offering business consulting for small enterprises and consultancy services for small-scale real estate investments, T&J Brothers Group remains committed to Environmental, Social, and Governance (ESG) principles. They prioritize sustainability, reduce their carbon footprint, preserve biodiversity, and embrace renewable energy. The company promotes diversity and inclusion in the workplace, engages with local communities for social development, and upholds ethical practices with transparency through a diverse and independent board.

Source:

1: SEC: Marizyme S1 filing(Pg. 126) : https://d18rn0p25nwr6d.cloudfront.net/CIK-0001413754/14bcff86-f30f-4a3a-9848-908e7f7ec436.pdf

www.tjbrothers.com/about-us

www.globenewswire.com/news-release/2023/05/10/2665486/0/en/Marizyme-Announces-IP-Developments-for-DuraGraft-and-Its-Pipeline-Products.html

medcitynews.com/?sponsored_content=new-technology-for-cabg-surgery-procedures

New Technology for CABG Surgery Procedures

Medical Technology company Marizyme, Inc. highlights its flagship product, DuraGraft®.

Jun 15, 2023 at 12:00 PM

Marizyme, Inc. (OTCQB:MRZM) is a medical technology company dedicated to the accelerated development and commercialization of devices that improve patient outcomes. This MedTech company has achieved several milestones and looks to complete many more in 2023.

Marizyme’s flagship product, DuraGraft®, continues to make impressive strides in the cardiac surgery industry and is generating revenue internationally in countries including Spain, the Philippines, Germany, Switzerland, Singapore, Malaysia, Turkey, Ireland, Austria, and the UK. Building on their international success, Marizyme is now looking to enter the US market. According to a business update provided by the Company on May 5, 2023, DuraGraft is currently under review by the FDA for authorization in the United States.

The Company also continues to strengthen the IP around DuraGraft®, with patents recently granted in the United States, India, South Korea, and Vietnam. Additional patent applications have been allowed in Canada and Vietnam. For more information on DuraGraft’s IP, and Marizyme’s other related technologies, please refer to their latest news release:
Marizyme Announces IP Developments for DuraGraft and Its Pipeline Products

Current Landscape of CABG Surgery

Coronary Artery Bypass Graft (CABG) surgery is the most common cardiac surgery in the world with over 1 million CABG procedures performed annually worldwide.(1) With an estimated 500,000 procedures performed annually in the US alone, expansion into the US market is essential, and Marizyme is well positioned to take a piece of the ~$16.1 billion market.(2)(3)

During CABG surgery, bypass grafts are used to re-route blood around blockages in native coronary arteries. The types of grafts used are most often the patient’s own vessels. It is important to remember that the new graft (vein/artery) is alive and fragile. It deserves the same protection and treatment as any other tissue or organ being transplanted.

DuraGraft® is a first-in-class CE marked intra-operative graft storage and flushing solution used during coronary artery bypass graft surgeries. DuraGraft is authorized for use in Europe and other counties outside of the United States, DuraGraft is not yet authorized for use in the United States.

Pipeline Products

Marizyme seeks to be an innovator to address unmet clinical needs in plastic and reconstructive surgery — specifically fat grafting. Fat grafting is a surgical process used in medical reconstructive and other plastic surgery procedures in which fat is transferred from one area of the body to another (known as “autologous fat grafting” or simply “fat grafting”) to correct a defect, replace injured tissue, or to make cosmetic enhancements. MAR-FG-001 is formulated as a tumescent solution base that protects adipose tissue during adipose tissue harvesting and storage.
The global market for autologous fat grafting was estimated to be $699.96 million in 2021 and is projected to grow at a CAGR of 8.62% until 2028 (“Global Autologous Fat Grafting Market – Industry Trends and Forecast to 2028,” Data Bridge Market Research December 2020).

According to Data Bridge Market Research, the global market for autologous fat grafting was estimated to be $699.96 million in 2021 and is projected to grow at a CAGR of 8.62% until 2028. With 22.4 million plastic surgeries performed annually in the United States(4) there is potential for widespread implementation of innovative fat grafting systems.

MATLOC™, a second pipeline product currently under development has been designed for the screening and diagnosing of chronic kidney disease (CKD) at point-of-care. In the US, about 37 million people have CKD and approximately 80 million people are at risk for developing it. But the majority (90%) who have this chronic condition are not even aware of it, according to the CDC. MATLOC will increase testing, early detection, and continuous monitoring of CKD and its progression to facilitate timely therapeutic and clinical intervention at an early disease stage when interventions can be effective in slowing disease progression.

In conclusion, Marizyme is a medical technology company with a strong focus on the commercialization of its flagship product, DuraGraft, supported by the development of its pipeline products. Marizyme provides a well-rounded opportunity – investors and medical professionals alike would be wise to keep a close eye on Marizyme’s progress and its potential impact on the global healthcare landscape.

To learn more about Marizyme, Inc., please visit their website at: click here.

[1] Weill Cornell Medicine. (2020, July 7). Method using artery for coronary artery bypass linked to better long-term outcomes than vein grafts. Weill Cornell Medicine Newsroom. https://news.weill.cornell.edu/news/2020/07/method-using-artery-for-coronary-artery-bypass-linked-to-better-long-term-outcomes-than
[2] HonorHealth. (n.d.). Coronary artery bypass grafting. HonorHealth. https://www.honorhealth.com/medical-services/cardiac-care/treatment-options/coronary-artery-bypass-grafting
[3] Mordor Intelligence. (2021). Coronary Artery Bypass Grafting Market – Growth, Trends, COVID-19 Impact, and Forecasts (2021 – 2026). Mordor Intelligence. https://www.mordorintelligence.com/industry-reports/coronary-artery-bypass-grafting-market
[4] American Society of Plastic Surgeons. (2020). Plastic Surgery Statistics Report. American Society of Plastic Surgeons.
https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-2020.pdf

T&J Brothers Group partner, Zhonghao Chen accepted into Forbes Business Council

Forbes Business Council is an invitation-only community for successful business owners and

Leaders.

Los Angeles, CA, August 3, 2023, T&J Brothers Group LLC, a private investment and consulting company, announces that their associate has been welcomed as a member of the Forbes Business Council. This prestigious council is recognized as a leading global platform for accomplished business owners and leaders, offering opportunities for growth and networking.

Zhonghao's selection was made by a review committee, which considered his extensive and diverse experience. The acceptance criteria were centered around a proven track record of effectively contributing to business growth metrics, along with recognition of personal and professional accomplishments and accolades.

 Zhonghao: I am elated to be a part of the Forbes Business Council, as it offers a fantastic opportunity to share my expertise and connect with fellow professionals in my industry. This esteemed platform provides a powerful avenue for collaboration and learning from accomplished individuals, driving our company towards greater success. The chance to engage with industry leaders and exchange innovative ideas is truly invigorating. The Forbes Business Council's vast network and resources will undoubtedly enhance our strategic vision, enabling us to expand and thrive on a higher scale. I look forward to contributing actively, fostering meaningful relationships, and embracing the exciting prospects that lie ahead.

 About T&J BROTHERS GROUP

 T&J Brothers Group is a private investment and real estate consultation company with significant capital from a multi-family office and strong connections in real estate, wealth, and financial services. They actively pursue global private and public investment opportunities, focusing on long-term value investing and industrial innovation in areas like biopharmaceuticals, technology, and carbon neutrality. Their diverse investments span early-stage venture capital, private equity, public companies, and M&A.

 ABOUT FORBES COUNCILS

 Forbes Councils is a collective of invitation-only communities created in partnership with

Forbes and the expert community builders who founded Young Entrepreneur Council

(YEC). In Forbes Councils, exceptional business owners and leaders come together

with the people and resources that can help them thrive.

 

SOURCE T&J Brothers Group

Marizyme Announces the Closing of My Health Logic Acquisition Along With Initial Financing

Dec. 23, 2021 3:31 PM ET | Source: Marizyme Inc.

Jupiter, FL - (NewMediaWire) - December 23, 2021 - Marizyme Inc. (“Marizyme” or the “Company”) (OTCQB:MRZM), is pleased to announce the closing of its acquisition of My Health Logic Inc., a subsidiary of Health Logic Interactive Inc. (TSXV:CHIP.H), along with a concurrent financing.

My Health Logic’s “lab-on-chip” technology platform and patient-centric digital point-of-care device, MATLOC 1, further strengthens Marizyme’s life science technology product pipeline. Marizyme is actively seeking FDA approval for both MATLOC1 and a second product, DuraGraft.

My Health Logic’s MATLOC and Lab-on-Chip Technology Platform

The excitement over microfluidics, also known as lab-on-a-chip technology, lies in its potential for producing revolutionary, timely, accessible, and practical point-of-care devices; devices that are patient-centric (one-to-many, rather than doctor centric, one-to-one) and support self-care and independence. Microfluidics is a technology for analyzing small volumes of fluids, with the potential to miniaturize complex laboratory procedures onto a small microchip, hence the term “lab-on-chip” (LOC).

My Health Logic’s lab-on-chip technology is currently being developed to diagnose the three leading biomarkers for chronic kidney disease (CKD), a disease estimated to affect 37 million Americans – or one out of every seven people – and which costs the US public healthcare system over $80 billion a year. By combining the lab-on-chip technology with MATLOC 1 we expect to be able to quantitatively read the two urine biomarkers, albumin and creatine, necessary for effective CKD screening at point-of-care with results available instantly on a patient’s smartphone.

MATLOC 2, the Company’s next generation point-of-care device is designed to quantitatively assess eGFR using a blood-based biomarker. eGFR is a key measure of kidney function health and/or stage of kidney disease and is designed to provide a complete quantitative diagnostic assessment for CKD, potentially eliminating the need for lab visits and in-person assessment.

The COVID Pandemic massively accelerated the ongoing transformation in Healthcare. Connected consumer electronic devices are enabling 24/7 home-based digital healthcare. Consumers have the desire and are now empowered to manage their own healthcare.

With MATLOC we strive to create earlier detection and prevention of CKD, allowing patients and healthcare systems to prevent the enormous costs of kidney failure, transplant, and/or dialysis. After completing the technology for CKD assessment, the Company plans to explore other biomarkers for chronic diseases to be measured at point-of-care.

Acquisition of Senior Officers and New Appointments of CFO and VP of Finance

Additionally, Marizyme is pleased to announce that David Barthel, who was appointed as Marizyme’s Chief Executive Officer on November 10, 2021, was appointed as a member of the Company’s board of directors on December 20, 2021.

Also, two of My Health Logic’s senior officers, George Kovalyov, CPA, and Harrison Ross, CFA will join the Company in leadership roles.

George Kovalyov will become Marizyme’s CFO. Mr. Kovalyov is a founding member of the My Health Logic team and is a CPA with cross border transaction experience. Before My Health Logic, Mr. Kovalyov was VP of Finance for Phivida Holdings, a publicly traded Company that raised over $19 million post its IPO and was successfully acquired. Furthermore, Mr. Kovalyov has 11 years’ experience as a financial controller, working on public company audits and financial statements for both US GAAP and IFRS.

Harrison Ross will become Marizyme’s VP of Finance. Mr. Ross is another founding member of the My Health Logic team and brings extensive knowledge of the MATLOC device and the accompanying lab-on-chip technology. Mr. Ross has experience in both public and private capital markets. In addition to creating another currently TSXV-listed company, Mr. Ross spent 9 years on the buy-side managing investments at registered firms and family offices.

Marizyme Announces Financing

Marizyme is also announcing that, concurrent with the closing of the My Health Logic Acquisition, the Company closed a private placement in the amount of $6 million, consisting of Units of Convertible Notes and Warrants at a price per Unit of $1.75.  This new investment will allow the Company to continue with its business development needs and prepare and file with the Securities and Exchange Commission (the “SEC”) a Form S-1 registration statement (the “Registration Statement”) for an anticipated public offering and Nasdaq uplisting in 2022.  Subject to satisfaction of certain conditions, the purchaser of the Units has agreed to invest up to an additional $4 million in the Company. Specifically, the Purchaser has agreed to subscribe for $2,000,000 in additional Units upon the Company’s filing of the Registration Statement, and an additional $2,000,000 upon the Company’s submission of responses to a first round of comments on the S-1 filing expected to be received from the SEC shortly after the S-1 filing.  In connection with this investment, the company also exchanged approximately $1,456,039 in previously-issued outstanding convertible notes and warrants in exchange for the new Convertible Notes and Warrants.

About Marizyme, Inc.

Marizyme is a life science company, based in Jupiter, FL that is engaged in the research, development and commercialization of technologies and products to prevent, treat and diagnose diseases with unmet clinical needs. The Company's flagship product, DuraGraft®, is an intra-operative vascular graft storage solution that inhibits endothelial damage and leads to improved clinical outcomes by reducing the incidence of complications associated with vein graft failure after bypass surgery. DuraGraft enhances coronary artery bypass grafting (CABG) surgical outcomes by significantly reducing major adverse cardiac events such as repeat revascularization and myocardial infarction. DuraGraft is approved for use in the EU and several Asian countries but is not yet approved for use in the U.S. Marizyme is also focused on the development and marketing of products based on its clinically tested and previously patented protease based therapeutic Krillase® platform. Krillase is not approved for use in the U.S. For more information about Marizyme, visit www.marizyme.com.

About My Health Logic

My Health Logic is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use My Health Logic’s patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. More information about My Health Logic is available at www.healthlogicinteractive.com.

ESG goals

Dear investors and clients:

We are very happy to announce that our team is now establishing and building an initiative devoted for ESG (Environmental, Social and Governance). We focus ESG industry, we consider ESG Criteria in our investment targets. We believe it is impossible to be a responsible participant in today’s society without paying attention to ESG. Our team believes in financially compelling opportunities in ESG which will also drive value to investors. We are proudly committed and invested with our time and patience in discovering and standing behind these opportunities knowing our hearts in a good place.

The green energy and sustainable business will take lead for the future growth at lease 10-15 years. According to the Paris Agreement, its goal is to keep global warming considerably below 2 degrees Celsius, preferably 1.5, compared to pre-industrial levels.

Countries aspire to reach global peaking of greenhouse gas emissions as soon as possible to produce a climate neutral world by mid-century to meet this long-term temperature objective.

The Paris Pact is a watershed moment in the international climate change process because it is the first time that a legally binding agreement binds all nations together in a common cause to fight climate change and adapt to its repercussions.

By 2020, although huge increases in climate change action are required to meet the Paris Agreement's goals, the years since its coming into force have already spawned low-carbon solutions and new markets. Carbon neutrality targets are being set by an increasing number of governments, regions, cities, and businesses. Zero-carbon solutions are becoming more competitive across a variety of economic sectors that account for 25% of total emissions. This trend is especially obvious in the electricity and transportation sectors, and it has opened a slew of new business opportunities for those who get in early. By 2030, zero-carbon solutions may be competitive in industries that account for more than 70% of world emissions. We are still far from the goals! There are many opportunities for us to make the change for the world!

We will focus on the three points of our business related to the Paris Agreement: Finance, Technology, and Capacity-Building.

Finance:

The Paris Agreement maintains that affluent countries should lead in providing financial support to less developed and vulnerable countries, while also encouraging voluntary contributions from other Parties for the first time. Because large-scale expenditures are necessary to considerably cut emissions, climate finance is required for mitigation. Climate finance is also critical for adaptation, as large financial resources are required to adjust to the negative effects of climate change and mitigate its consequences.

Technology:

The Paris Agreement outlines a goal of fully implementing technological development and transfer in order to improve climate change resilience while also lowering GHG emissions. It establishes a technological framework to provide overarching guidance to the Technology Mechanism's efficient operation. Through its policy and implementation arms, the mechanism is increasing technology development and transfer.

Capacity-Building:

Many of the issues posed by climate change are beyond the capabilities of many developing countries. As a result, the Paris Agreement places a strong emphasis on developing nations' climate-related capacity-building efforts and calls on all wealthy countries to increase their assistance for such efforts.

In order to make the world better than just have maximum profits, T&J brothers group will continue to make the impact for the world and try our best to fight with climate change.

Thank you.

Sincerely,

James

Marizyme is Pleased to Announce the Appointment of David Barthel as CEO

David Barthel on the left, photo taken by Marizyme, inc staff.

Source: Marizyme Inc.

JUPITER, Fla., Nov. 16, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Marizyme Inc. (“Marizyme” or the “Company”) (OTCQB:MRZM), is pleased to announce the hiring of Mr. David Barthel as the Chief Executive Officer for Marizyme. In his role Mr. Barthel will look to advance the Company’s technology pipeline and stay committed to the commercialization efforts of DuraGraft in Europe and Asia while focusing on the FDA submissions for DuraGraft and MATLOC 1 in the US. In addition, Mr. Barthel will lead the Company through its financing initiatives, strengthening the financial position of the Company in preparation for an anticipated Nasdaq listing in 2022.

Mr. Barthel founded The SmartPill Corp. and led the company as CEO & President until its acquisition by medical device giant, Medtronic. Mr. Barthel successfully took The SmartPill company, developing an innovative ingestible sensor-based capsule for diagnosing GI motility disorders, from its initial patent, through the entire product development process, raising more than $70 million in multiple funding rounds. Mr. Barthel led his team through multiple clinical trials, manufacturing, FDA approval, commercialization and successful insurance reimbursement.  After the acquisition by Medtronic, Mr. Barthel joined the company as Area Vice President, GIH Southeast Division.

Most recently, Mr. Barthel was CEO of Health Logic Interactive Inc. (“Health Logic”) and its wholly owned Subsidiary, My Health Logic Inc. (“My Health Logic”), a company focused on developing an innovative point-of-care lab-on-chip digital diagnostic device technologies for chronic kidney disease.  In less than a year, Mr. Barthel led the Company from an initial patent pending technology with proof-of-concept data to building an IP portfolio and further advancing our lab-on-chip technology platform. The Company also began development on its point-of-care device, MATLOC 1, which is expected to have a functional prototype ready for its clinical trials to take place in Q3 2022. Mr. Barthel was responsible for implementing product and software development partners, the preparation of an FDA pre-submission, leading discussions with several potential strategic partners, integrating a strong clinical and business team-based culture, and a diverse Scientific Advisory Board. He has also developed the business plan around the utilization of multiple partners for commercialization with the potential for multiple revenue streams that will ensure eventual success of the device. My Health Logic Inc., subsidiary of Health Logic which holds the MATLOC device technology and all accompanying agreements, is currently in the process of being acquired by Marizyme.

Mr. Barthel earned a Bachelor of Arts Degree from St. Norbert College in De Pere, Wi and an MBA from Lake Forest Graduate School of Management in Lake Forest, II.

Dr. Vithal Dhaduk, (Chairman) of the Board of Directors, stated the following: “We are very excited about acquiring My Health Logic and David Barthel becoming our CEO. My Health Logic developed the MATLOC technology, an innovative technology that has strong potential to improve the lives of millions of patients with chronic kidney disease.  Bringing on the very dedicated and effective management group led by David Barthel will add strength to Marizyme's current team.

This is a very strategic step for Marizyme to diversify and improve Marizyme's current product portfolio by adding more innovative, platform technologies and a strong management team. We are looking forward to bringing these new technologies to the market to serve a unique and unmet need in the chronic kidney and cardiac disease population."  

(PR) Health Logic Interactive Signs Non-Binding Letter of Intent With US Medical Device Company to Sell Wholly Owned Operating Subsidiary

TSXV: CHIP.H

CALGARY, AB, Aug. 9, 2021 /PRNewswire/ - Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSXV: CHIP.H) (OTCPK: CHYPF) is pleased to announce it has signed, on August 1, 2021, a non-binding letter of intent to sell its wholly owned operating subsidiary, My Health Logic Inc. ("My Health Logic") to Marizyme, Inc. ("Marizyme"), a Nevada medical device company publicly traded on the OTCQB (the "Transaction").

The transaction is subject to the completion of diligence, the approval of the TSX Venture Exchange, negotiation of definitive documentation, and approval of the Company's shareholders. The transaction is taking place at arms-length, and it is currently expected that the consideration for all the issued and outstanding shares of My Health Logic will be common shares in the capital of Marizyme.

Marizyme has a robust IP portfolio for its medical device platform technologies. Its leading technology, DuraGraft®, is currently under pre-submission review with the United States Food and Drug Administration ("FDA"). Durgraft is approved in 34 countries and has already achieved initial commercial sales in Europe and Asia. Marizyme intends to pursue a listing on the NASDAQ Stock Market ("NASDAQ") within the next twelve months.

The proposed terms, which are subject to change as diligence and negotiations progress, include:

  • The Company receiving 4,600,000 shares of Marizyme as consideration for the Health Logic asset. The number of shares was negotiated between parties of Marizyme and Health Logic, and the price per share is a floating number that will be finalized in the definitive agreement.

  • Marizyme plans to raise the necessary operating capital for the combined businesses once the transaction has taken place, from there, a registration and anticipated financing on a Nasdaq listing.

  • My Health Logic will become a wholly owned subsidiary of Marizyme;

  • The Company will have the right to appoint two nominees to the board of directors of Marizyme; it is expected that the management of Marizyme will change once the transaction is completed.

  • The employees of, and consultants to, My Health Logic will continue to operate in the same capacity as prior to the Transaction; and

  • The Transaction is subject to the negotiation and execution of definitive documentation, the performance of any closing conditions, and TSXV and shareholder approvals.

The Company will continue to trade as a public entity on the NEX Board of the TSXV and intends to pursue a financing to commence its search for new assets to develop as part of the Company's portfolio. The Company plans to continue its application with the TSXV for a reactivation to Tier 2 of the TSXV from the NEX Board. The reactivation will be subject to finding of a new acquisition target and meeting all continued listing requirements of the TSXV Tier 2.

The Company will hold a conference call to discuss the Transaction in more detail, the conference call is scheduled to occur on August 16, 2021, at 1.30pm PST / 4.30pm EST. Please dial in toll free at 1-866-248-8441 or internationally at 1-323-289-6581.

Quote from CEO, David Barthel:

"As we have demonstrated over the past eight months, the team has the ability to accomplish its milestones as we continue to deliver on our initial goals in the clinical development of our lab-on-chip technology. These accomplishments have attracted strong interest from several potential strategic partners. Our team is pleased to be presented with this Transaction that will, if completed, allow My Health Logic to receive the necessary resources to advance its lab-on-chip technology. As well, Marizyme has a very attractive medical device pipeline that is already on an FDA pathway, is a US publicly traded entity, and is supported by a full-service US investment bank, Univest Securities.  We have moved quickly to assess this Transaction and complete initial due diligence, and are excited about the prospects at hand".

About the Company

Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use their patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at: www.healthlogicinteractive.com

About Marizyme, Inc.

Marizyme is an integrated life sciences company dedicated to the acquisition, development and commercialization of therapies that minimize mortality and costs in the acute care space. The Company's flagship product, DuraGraft®, is an intra-operative vascular graft storage solution that inhibits endothelial damage and leads to improved clinical outcomes by reducing the incidence of complications associated with vein graft failure in bypass surgery. DuraGraft® enhances coronary artery bypass grafting (CABG) surgical outcomes by significantly reducing major adverse cardiac events such as repeat revascularization and myocardial infarction. DuraGraft® is approved for use in the EU and several Asian countries but is not yet approved for use in the U.S. Marizyme is also focused on the development and marketing of products based on its clinically tested and previously patented protease based therapeutic Krillase® platform. Krillase® is not approved for use.

Further information regarding Health Logic Interactive Inc. and its disclosure documents are available on SEDAR at www.sedar.com.

Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Notes

Certain statements contained in this press release constitute "forward-looking statements". All statements other than statements of historical fact contained in this press release, including, without limitation, those regarding the execution of a definitive agreement for the Transaction and the terms thereof, the completion of the Transaction and its expected benefits, the financing to be provided by Marizyme, the listing of the Marizyme Shares on the NASDAQ, the financing to be pursued by the Company, the reactivation of the Company to the TSXV and the Company's strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words "believe", "expect", "aim", "intend", "plan", "continue", "will", "may", "would", "anticipate", "estimate", "forecast", "predict", "project", "seek", "should" or similar expressions or the negative thereof, are forward-looking statements. These statements are not historical facts but instead represent only the Company's expectations, estimates and projections regarding future events. These statements are not guarantees of future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ materially from what is expressed, implied or forecasted in such forward-looking statements. Additional factors that could cause actual results, performance or achievements to differ materially include, but are not limited to the risk factors discussed in the Company's Management's Discussion and Analysis for the year ended December 31, 2020. Management provides forward-looking statements because it believes they provide useful information to investors when considering their investment objectives and cautions investors not to place undue reliance on forward-looking information. Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements and other cautionary statements or factors contained herein, and there can be no assurance that the actual results or developments will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, the Company. These forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update or revise them to reflect subsequent information, events or circumstances or otherwise, except as required by law.

SOURCE Health Logic Interactive Inc.

Related Links

https://www.healthlogicinteractive.com/