Somahlution Announces Agreement with Leipzig Heart Center to Use DuraGraft® in Patients undergoing Coronary Artery Bypass Surgery

Somahlution Announces Agreement with Leipzig Heart Center to Use DuraGraft in Patients undergoing Coronary Artery Bypass Surgery

DuraGraft a one-time intraoperative treatment used during vascular surgery to reduce the incidence of complications associated with graft failure.

 

JUPITER, FL April 8, 2020 Marizyme (MRZM:OTCQB) and Somahlution, a global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, today announced that it received an agreement from Leipzig Heart Center in Germany to use the companys flagship product, DuraGraft in CABG patients.

Leipzig Heart Center, an internationally recognized leader in cardiac surgery that performs approximately 4000 CABG surgeries per year, is part of the ongoing EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits with DuraGraft [VASC], to Evaluate the Safety and Performance of DuraGraft. Based on promising outcomes observed in the registry, the Center will extend the registry to begin using DuraGraft in diabetic patients receiving at least one vein graft.

We have seen encouraging evidence that reinforces the importance of appropriate graft treatment during surgery and the role of DuraGraft in improving outcomes and we are now interested in evaluating these effects in the diabetic patient population specifically, said Dr. Martin Misfeld of Leipzig Heart Center.

Patients with diabetes, in general, have worse clinical outcomes following CABG surgery and are more susceptible to adverse events following graft failure compared to non-diabetics and so there is much excitement regarding the use of DuraGraft in these patients.

The endothelial damage inhibitor DuraGraft has shown promising results in several preclinical studies and large-scale clinical investigations to adequately protect and preserve vascular conduits. Therefore, its use in diabetic CABG patients will provide further important data on its safety and potential to protect the grafts and improve clinical outcomes in this high-risk cohort of patients said Dr. Maximilian Emmert from the German Heart Center Berlin, Germany and PI of the VASC Registry.

Dr. Satish Chandran, CEO of Somahlution stated We look forward to continuing in this important research with the Leipzig Heart Center and are extremely excited to offer this innovative technology to appropriate CABG patients for years to come.

About CABG and DuraGraft

When patients with heart disease undergo CABG surgery, free vein or arterial grafts harvested from the leg, arm or chest are frequently used to bypass occluded coronary arteries; about 90% of CABG surgeries use at least one free vein graft. In most cases, in the time between harvesting and bypass grafting, the free graft is stored in saline or autologous blood which do not protect the graft from ischemic injury thereby increasing the risk of ischemia-reperfusion injury and graft disease and ultimate failure leading to post-CABG myocardial infarction and the need for repeat revascularization procedure.

DuraGraft is a CE-marked product that protects vascular grafts against ischemic injury and is the only product approved for graft protection and preservation during bypass and other vascular surgeries. DuraGraft protects graft tissue from harvesting through anastomosis and is used during vascular surgery (including CABG) as a treatment to maintain the structural and functional integrity of isolated vascular grafts. The use of DuraGraft is associated with the reduction of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization, and MACE.

Clinical studies in over 3,000 patients support the long-term safety and efficacy of DuraGraft compared to unapproved standard of care solutions. The use of DuraGraft in CABG surgery is associated with statistically significant lower risks for clinical complications following CABG; 45% reduction in non-fatal myocardial infarction (MI) (p <.0001), 35% reduction in repeat revascularization (p=0.037), and 19% reduction of MACE (a composite of all major adverse cardiac events) (p=0.005). [i]

About Somahlution

Somahlution is a global leader in the development of products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications. The companys flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications associated with graft failure. DuraGraft enhances CABG surgical outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.

For more information about Somahlution, please visit http://www.somahlution.com/

About Leipzig Heart Center

The Leipzig Heart Center, located in Leipzig Germany, belongs to the Helios Kliniken Group and is one of the leading and most recognized Heart Centers in all of Europe. The Leipzig Heart Center, which is also a medical teaching and research Center, has played a significant role in pioneering and developing many innovative cardiac therapies, such as minimally invasive heart valve surgery, catheter-based valve replacement procedures and other procedures which are now performed all around the globe. Approximately 44,000 patients are treated annually at the Center with 4500 heart surgeries performed yearly.

About Marizyme, Inc.

Marizyme, Inc. (the Company) is a development-stage company dedicated to the commercialization of therapies that address the urgent need relating to higher mortality and costs in the acute care space. Specifically, Marizyme will focus its efforts on developing and acquiring treatments for those diseases.

For more information about Marizyme, visit www.marizyme.com.

Forward-Looking Statements

This press release may contain certain forward-looking statements, including those relating to the Marizymes 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 Companys control, affect the Companys operations, performance, business strategy and results and there can be no assurances that the Companys 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. Forward-looking 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, including those risks set forth in the Companys risk factor disclosure in its Registration Statement on Form 10K filed with the Securities and Exchange Commission (SEC File No. 000-53223), 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 press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Somahlution

Karen Coviello, 561-433-6630

Marketing Communications

Karen.Coviello@Somahlution.com

Trackback URL: https://www.somahlution.com/somahlution-announces-agreement-with-leipzig-heart-center-to-use-duragraft-in-patients-undergoing-coronary-artery-bypass-surgery/trackback/

Leave a comment:

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.