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Marizyme, Inc. Agrees to Acquire All Assets of Somahlution
JUPITER, FLA, December 17, 2019 Marizyme, Inc. (Marizyme or the Company), a publicly traded (OTC:MRZM) company focused on acquiring late-stage drug and medical device assets to develop for use in the acute care space, announced today that they have agreed to acquire all of Somahlutions assets including their DuraGraft® intellectual property and derivative works. DuraGraft is a first-in-class, revenue generating, cleared product in Europe which will transfer to Marizyme as part of the acquisition. At the closing Marizyme will issue 10 million shares of restricted common stock and a warrant to purchase 3 million shares of restricted common stock at a strike price of $5 per share. The agreement is contingent on raising $10 Million to expand distribution of DuraGraft in new and existing markets and to support US FDA clearance.
Mr. James Sapirstein, Marizyme, Executive Chairman, commented, We are excited to be taking the next phase of our growth working with Somahlution. With their deep platform technology, seasoned technical leadership and a compelling clinical development plan, we are poised to deliver strong shareholder value for Marizyme. We expect our relationships in Europe and South America, combined with their approved product, will result is significant sales growth in 2020.
The flagship product, DuraGraft is a CE-marked and patented product that protects vascular grafts against ischemic injury and is the only product registered and indicated for graft protection and preservation during bypass and other vascular surgeries including Coronary Artery Bypass and Peripheral Bypass surgery. DuraGraft protects graft tissue from harvesting through anastomosis and is used as a treatment to maintain the structural and functional integrity of free vascular grafts. The use of DuraGraft is associated with reductions of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization and MACE.
Dr. Hugo Morales Ballejo, MD, FACC states that Coronary artery bypass grafting (CABG) is a most critical operation requiring very important care in each step. One of these important steps is the meticulous care of the vascular graft (VG). It is imperative to avoid damage of the graft endothelium. A damaged endothelium precipitates in VG disease leading to VG failure. DuraGraft addresses this need and was developed to prevent endothelial damage and ischemic injury thereby preventing VG disease and hence VG failure.
Dr. Satish Chandran, Somahlution, CEO, added, We believe Marizyme will be an excellent partner for us. DuraGraft has undergone extensive and rigorous clinical testing in Europe and Canada and has been cleared for use throughout the EU and several other countries around the world. While DuraGraft is already generating revenue, Marizyme will allow us to expand DuraGrafts reach throughout Europe and North and South America.
Coronary Artery Bypass Grafting Surgery alone in the South American and European markets represent a patient population win excess of 600,000 cases per year for which DuraGraft use can be indicated.
Welcome2Pinkyland
5 years ago
$MRZM NEWS! MARIZYME, INC.’S (OTC PINK: MRZM) MB102 PRODUCT TO INITIALLY FOCUS ON PEDIATRIC STROKE MARKET
Sacramento, CA, March 28, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Spotlight Growth has published new content on Marizyme, Inc. (“Marizyme” or the “Company”) (OTC Pink: MRZM), a biotechnology company focused on its clinically-tested and patented use of protease therapeutic platform called Krillase. Clinical testing and research have shown Krillase to be a treatment for acute ischemic stroke, myocardial infarction, deep-vein thrombosis, wound/burn care, and more. Krillase is classified as a Class III medical device in Europe for the treatment of chronic wounds.
The financial article and video provide an overview of Marizyme, the Krillase platform, latest news, and further analysis.
International Alliance of Pediatric Stroke: Stroke a “Top Ten” Leading Cause of Death in Children
The truth is that stroke can impact people of all ages and backgrounds. Commonly misconstrued as an illness that primarily impacts the elderly, stroke can occur in young adults, children, infants, and even prior to birth. In fact, there are two key categories of pediatric stroke: perinatal and childhood.
Perinatal refers to the time period between the last 18 weeks of gestation through the first thirty days of life. Childhood stroke occurs in youth aged 1 month to 18 years.
In fact, according to the International Alliance of Pediatric Stroke (IAPS), stroke is a “top ten” leading cause of death in children. Furthermore, 60% of children that do survive a stroke “will have permanent neurological deficits, most commonly hemiparesis or hemiplegia,” according to the IAPS.
Furthermore, the National Stroke Association says that stroke occurs in roughly 1 out of 4,000 live births and the risk of stroke until age 18 is almost 11 out of 100,000 per year.
Despite pediatric stroke’s prevalence and high medical need, there are currently no FDA-approved treatments for the condition.
MRZM: Initial MB102 Treatment Application To Focus On Pediatric Stroke
Marizyme currently has a Krillase-derived treatment pipeline consisting of four different applications. The company’s MB102 product is specifically for the treatment of ischemic stroke using Krillase. Management sees a major opportunity in initially focusing MB102’s development and testing on the pediatric stroke market, due to its high medical need and lack of currently available treatments.
On March 15, 2019, Marizyme announced that it had received feedback from the FDA from a Pre-IND application for a Type B meeting request. The FDA’s feedback provided strong guidance and expectations for Marizyme, which will help the company develop proper procedures and game plan for the MB102 product. Here are the key points Marizyme provided from the FDA’s feedback:
Both intra-arterial and intravenous routes of administration need to be tested pre-clinically prior to initiation of clinical studies.
Safety pharmacology testing (CNS, respiratory and cardiovascular) can be incorporated into the pivotal GLP toxicity studies instead of being run as separate studies.
No safety genotoxicity studies are required prior to initiating clinical studies.
Marizyme will need to fully characterize the raw material for viral contamination and enzymatic profile.
For more information on Marizyme, please visit: marizyme.com and http://spotlightgrowth.com/index.php/2019/03/25/this-company-is-working-on-a-novel-thrombolytic-therapy-for-pediatric-stroke/ and
Welcome2Pinkyland
5 years ago
$BOOM $MRZM Signs LOI With Chromocell to Acquire or License Assets
*PR was released after hours around 5pm EST 3/18/19
FORT COLLINS, Colo., March 18, 2019 (Newswire.com) – Marizyme, Inc. (“Marizyme” or the “Company”), a publicly traded (OTC: MRZM) company focusing on acquiring late-stage drug assets for use in the acute care space and related areas, announced today that they signed a Letter of Intent to evaluate the licensing or acquisition of certain non-opiate pain relief and rare disease assets from Chromocell Corporation (“Chromocell”), pending further due diligence from both companies.
Mr. James Sapirstein, Executive Chairman of Marizyme, Inc., commented: “This opportunity is a perfect fit with Marizyme’s strategic direction. We are very pleased to work with Chromocell and proceed with the due diligence process.”
The treatment of acute and chronic pain remains a significant challenge, due to insufficient efficacy, negative side effects and abuse potential of currently available therapeutics. Chromocell’s discovery and development programs are focused on the development of breakthrough therapeutics for neuropathic and nociceptive pain. Chromocell’s lead candidate CC8464 has completed Phase 1 clinical trials in the United States.
Mr. Christian Kopfli, Chief Executive Officer of Chromocell, Inc. said: “Evaluating a partnership with Marizyme to bring our products to market is an exciting development for our company. Non-opiate analgesics are critical for treating patients with acute and chronic pain.”
About Marizyme, Inc.
Marizyme, Inc. is a development-stage company dedicated to the commercialization of therapies that address the urgent need of higher mortality and costs in the acute care space. Specifically, Marizyme will focus its efforts on developing treatments for disease caused by thrombus (stroke, acute myocardial infarctions or AMIs and deep vein thrombosis or DVTs), and chronic wound care conditions. These conditions combine for over $26 billion dollars in potential market opportunity and are responsible for sending over millions of patients to the hospital every year in the U.S. alone.
The Company’s first product candidates are derived from Krillase™ Technology, a broad intellectual property portfolio around a novel system of proteolytic enzymes. Marizyme completed the acquisition of these assets and intends to develop several product candidates that will address unmet medical needs in the acute care setting. For more information about the Company, visit www.marizyme.com.
Welcome2Pinkyland
5 years ago
$MRZM NEWS! Marizyme, Inc. Receives FDA Feedback on Development Plan for Krillase(TM) in Pediatric Stroke
FORT COLLINS, CO / ACCESSWIRE / March 15, 2019 / Marizyme, Inc. ("Marizyme" or the "Company"), a publicly traded (OTC PINK: MRZM) company focusing on acquiring late-stage drug assets for use in the acute care space for development and commercialization, announced today that they have received FDA feedback regarding their development plan for Krillase™ (MB102) in pediatric stroke. In preparation for initiating development activities for MB102, Marizyme requested feedback from the FDA using a Pre-IND application for a Type B meeting request.
https://www.accesswire.com/users/newswire/images/538302/0fadee8c-4ec2-4db0-a658-4d4d85a46869.png
Key points from the FDA's feedback include the following:
Both intra-arterial and intravenous routes of administration need to be tested pre-clinically prior to initiation of clinical studies.
Safety pharmacology testing (CNS, respiratory and cardiovascular) can be incorporated into the pivotal GLP toxicity studies instead of being run as separate studies.
No safety genotoxicity studies are required prior to initiating clinical studies.
Marizyme will need to fully characterize the raw material for viral contamination and enzymatic profile.
For the proposed clinical studies Marizyme will need to test for immunogenicity of MB102 and justification for testing a thrombolytic therapy in healthy volunteers.
Mr. Michael K. Handley, Chief Executive Officer of Marizyme, Inc., commented: "We are very pleased with the FDA feedback to our Pre-IND Type B meeting request on our Krillase™ development program for pediatric stroke. We believe we can address each of the points raised and we look forward to continuing to work closely with FDA to move into the clinic."
About Pediatric Stroke¹
Although stroke is often viewed as occurring primarily in the elderly, it also strikes infants, children, young adults and can even occur before birth. The risk of stroke in children is greatest in the first year of life, and peaks during the perinatal period (roughly the weeks before and immediately after birth). Stroke also occurs in about one of every 4,000 live births. The risk of stroke from birth through age 18 is nearly 11 per 100,000 children per year and is one of the top 10 causes of death for children. Of children surviving stroke, 50 percent to 80 percent will have permanent neurological deficits, most commonly hemiparesis or hemiplegia (total or partial paralysis on one side of the body), cognitive and sensory impairments, epilepsy, speech or communication disorders, visual disturbances, poor attention, behavioral problems and poor quality of life.
About MB102
MB102 is a novel and patent pending formulation of endovascularly delivered proteases that have demonstrated the capability to quickly and safely remove clots causing ischemic blockages in human vasculature. The first indication will be ischemic stroke in pediatrics as there are currently no approved thrombolytic therapies approved for use in children suffering from ischemic stroke.
About Marizyme, Inc.
Marizyme, Inc. is a development-stage company dedicated to the commercialization of therapies that address the urgent need of higher mortality and costs in the acute care space. Specifically, Marizyme will focus its efforts on developing treatments for disease caused by thrombus (stroke, acute myocardial infarctions or AMIs and deep vein thrombosis or DVTs), and chronic wound care conditions. These conditions combine for over $26 billion dollars in potential market opportunity and are responsible for sending over millions of patients to the hospital every year in the U.S. alone.
The Company's first product candidates are derived from Krillase™ Technology, a broad intellectual property portfolio around a novel system of proteolytic enzymes. Marizyme completed the acquisition of these assets and intends to develop several product candidates that will address unmet medical needs in the acute care setting. For more information about the Company, visit www.marizyme.com.
Forward-Looking Statements
This press release contains certain forward-looking statements, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company’s actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
¹American Stroke Association FACT Sheet
Investor and Media Contact
Michael K. Handley
Chief Executive Officer
Phone: +1.970.295.4372
Email: info@marizyme.com
SOURCE: Marizyme, Inc.
Welcome2Pinkyland
5 years ago
$MRZM NEWS! Marizyme, Inc.'s Krillase Therapeutic Platform Shows Wide Medical Application and Treatment Potential -- Spotlight Growth
Sacramento, CA -- March 14, 2019 -- InvestorsHub NewsWire -- Spotlight Growth has published new content on Marizyme, Inc. (“Marizyme” or the “Company”) (OTC Pink: MRZM), a biotechnology company focused on its clinically-tested and patented use of protease therapeutic platform called Krillase. Clinical testing and research have shown Krillase to be a treatment for acute ischemic stroke, myocardial infarction, deep-vein thrombosis, wound/burn care, and more. Krillase is classified as a Class III medical device in Europe for the treatment of chronic wounds.
The comprehensive report provides an overview of Marizyme, the Krillase platform, latest news, and management’s plans to continue growing the company.
ResearchAndMarkets: Global Wound Care Market Estimated Worth $42.07 Billion By 2024
The global population continues to age, as fewer people continue to have children. According to the World Bank, the global population aged 65 or older has grown from 4.97% in 1960 to an estimated 8.70% in 2017. Aside from the aging population, global society suffers from poor diet and increasingly sedentary lifestyles. This has led to a worldwide increase in diseases such as diabetes and obesity. These factors present a number of challenges for society, particularly healthcare services and technology to meet growing demand for care.
Wound care is another key market that will be in focus due to aging populations and diseases facing the globe today. Chronic wound care is already a multi-billion-dollar market and is forecast to see continue growth.
According to ResearchAndMarkets.com, the global wound care market is estimated to grow to $42.07 billion by 2024, which represents a CAGR of 6.20% between 2018 and 2024. The market research firm notes that an increasingly aged population, growth in surgeries, and even increasing road accidents as major sources of growth for the wound care market. ResearchAndMarkets.com sees the United States as being one of the main drivers of growth, but the market researchers also see strength from other parts of the world.
Global Market Insights, Inc. estimates the global advanced wound care market to reach $13 billion by 2024, which represents a CAGR of 5.40%. The market research analysts estimate that North America will continue to dominate the market through 2024. With that said, other international markets are estimated to see faster growth over the same time period.
According to the report, “Rising incidences chronic diseases and consequent rise in number of patients with acute and chronic wounds will escalate the market growth over forecast timeframe. Favorable demographic trends such as increasing geriatric population and lifestyle changes such as adoption of sedentary lifestyle will further support rise in prevalence of chronic diseases. This is expected to escalate the prevalence of wounds and associated cost burden thereby augmenting demand for wound care products.”
MRZM: Initial Krillase Application To Focus On Wound Care and Thrombosis Markets
Marizyme, Inc.’s Krillase main active ingredient can only be derived from Antarctic krill. The mix of proteinases and peptidases helps the Antarctic krill digest and break down its food in the extremely cold environment. As a result, the specialized enzymes provide a “cutting” capability. Krillase has already been classified as a Class III medical device in Europe for the treatment of chronic wounds.
Currently, Marizyme has a product pipeline that seeks to focus on developing products that treat the most expensive conditions across the acute care market. Here is a breakdown of the breakdown of the current pipeline and where it stands in the clinical stages:
· MB101 – Therapy for Complex Infected Wounds & Burns: Completed Phase 1 trials
· MB102 – Therapy for Acute Ischemic Stroke: Nearing end of pre-clinical stage
· MB103 – Therapy for Ischemic Myocardial Infarcs: Halfway through pre-clinical stage
· MB104 – Therapy for Deep Vein Thrombosis: Early pre-clinical stage
While these represent the first four focuses that Marizyme will turn to, the company also plans to obtain additional funds over the next five years to conduct necessary research, development, and clinical testing on the Krillase platform to be a potential treatment in the following markets:
-HIV/AIDS treatment: $20.45 billion market
-Herpes treatment: $1.8 billion market
-Oral mucositis treatment: $1 billion market
-Plaque removal: $500 million market
-Canker sore treatment: $400 million market
-Gingivitis treatment: $290.50 million market
For more information on Marizyme, please visit: http://marizyme.com and http://spotlightgrowth.com/index.php/2019/03/12/spotlight-growth-report-marizyme-inc-otc-pink-mrzm/
SpotlightGrowth.com is a digital hub for micro-caps, small-caps, venture capital, private equity, crowdfunding, cryptocurrency, and other emerging growth investors. SpotlightGrowth.com serves as our media subsidiary and provides insights on small cap companies.
Welcome2Pinkyland
5 years ago
Marizyme currently has 4 product candidates derived from the protease enzyme platform acquired from ACB Holding AB. The first product candidate is MB101 which is targeted to be used to debride and heal human wounds. MB101 is a clinical stage candidate which was tested in 13 human clinical stage studies conducted by ACB Holding AB prior to this drug candidate’s acquisition by us. In these studies, which were designed as Phase II efficacy studies and conducted in Sweden, Germany, Finland, Switzerland, United Kingdom and the Netherlands, more than 500 patients were treated for wound debriding and healing. No clinical trials of MB101 have been conducted in the United States. The second product candidate is MB102 which is targeted for acute cerebral ischemic stroke in pediatric patients. It is derived from the same protease enzymes that MB101 is comprised of. MB102 is in preclinical stage of development. In June 2018, prior to our consummation of the asset acquisition, ACB Holding AB filed a Pre-IND for MB102 and received an FDA letter giving advice towards an Investigative Drug Application for MB102, which we expect to file in late 2019. MB103 is Marizyme’s third product candidate and is in preclinical development. It is derived from the same protease enzymes as MB101 and is targeted to treat acute myocardial infarction, or AMI, in human adults. The fourth and last product candidate is MB104 which is targeted to treat deep vein thrombosis. It is in early preclinical development and is derived from the same protease enzymes as MB101.$MRZM
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