Marizyme, Inc. is a global medical technology company changing the landscape of cardiac care by delivering innovative solutions for CABG surgery. The Company’s first in-class product, DuraGraft™, on Oct. 4, 2023, was granted a de novo from the U.S. Food and Drug Administration (FDA).
Marizyme is one of the many featured companies slated to present at The Microcap Conference 2024, set for Jan. 31-Feb. 1 at Caesars Atlantic City Hotel and Casino. This three-day conference presented by DealFlow Events features technical programming designed for microcap investors and a presenting company track for pitching and socializing.
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 and specifically is intended for the flushing and storage of the saphenous vein grafts used in CABG surgery.
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. The mechanism of action for DuraGraft is through the reduction of oxidative damage which maintains the structural and functional integrity of vascular conduits.
DuraGraft™ is a liquid solution to replace current graft handling fluid solutions (most commonly saline and blood), which damage the key vascular conduits of CABG—veins and arteries. Further, DuraGraft does not require additional training for medical teams and does not require any changes to CABG procedures.
With an estimated 500,000 CABG surgeries taking place in the US, DuraGraft has the potential to change the landscape of cardiac care.
Marizyme’s U.S. commercialization plan is focused on penetrating and driving further utilization in hospital integrated networks and the cardiac suite, through a small, targeted and efficient direct sales force, direct sales 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,” said CEO David Barthel. “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 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.”
As part of the company’s U.S. commercialization plan, Marizyme has 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, 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.
A Brief History of Marizyme
Marizyme, originally incorporated in Nevada in March 2007, has since experienced significant evolution, adopting various names and business models under different management until March 2018 when it rebranded to focus on life sciences. The company’s reinvention set the stage for a series of targeted acquisitions to bolster its life sciences portfolio, the leading of which is DuraGraft™.
Marizyme acquired the DuraGraft-related assets from Somahlution, along with its outstanding capital stock. The expansion continued in December 2021 with the acquisition of My Health Logic and MATLOC®, a technology intended for the screening of biomarkers relating to CKD, from Health Logic Interactive Inc. This acquisition brought on board David Barthel as the new CEO, marking another milestone in Marizyme’s growth trajectory and reinforcing its potential as an attractive investment opportunity in the life sciences domain.
David Barthel, CEO, founded The SmartPill Corp. in 2002 and led the company as CEO and President until its eventual acquisition in October 2012 by medical device giant, Medtronic plc (Nasdaq: MDT). After the acquisition, Mr. Barthel served as Area Vice President, Southeast Division, at an affiliate company of Medtronic until July 2019. Afterwards, he joined Health Logic Interactive Inc. as CEO and led its sale to Marizyme in December 2021, where he has been CEO and Director ever since.
Looking to the Future
Look for potential news and updates on the company’s initiation into US commercialization following its FDA clearance, including a potential strategic partnership for a multi-center DuraGraft™ clinical trial and utilization agreement.
The company expects further financing and capital market initiatives heading into 2024.
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