CorMatrix receives FDA approval to expand its early feasibility IDE study of the Cor TRICUSPID ECM valve Cardiology2.0 – Cardiology2.0

CorMatrixCardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, has receivedFDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the CorTRICUSPID ECMvalve* for pediatric and adult patients.

The CorTRICUSPID ECMvalve has been successfully implanted in the 11th patient enrolled in the expansion by Dr.Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center inIndianapolis, Indiana&principal investigator for the adult component of the study.The CorTRICUSPIDECMvalve is a next generation, first of its kind, biologic, seamless, and stentless cardiac valve composed of extracellular matrix or ECM.

The most recent implant of the CorMatrixCorTRICUSPIDvalverepresents an important step toward realizing an implantable, regenerating tissue engineered heart valve. We are now broadening the study to additional centers which will greatly increase our enrollment. So far the valves are performing very well, and patients are excited to be part of this important innovation, said Dr. Marc W Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center inIndianapolis, Indiana&principal investigator for the adult component of the CorMatrixCorTRICUSPID IDE safety and feasibility clinical trial.

CorMatrixis very excited to expandenrollment of the adult arm of itsFDA early feasibility IDE studyfor the CorTRICUSPIDECMvalve.This is just one step closer to ultimately providing biologic valve technology to an ever expanding patient need. The CorTRICUSPID ECMvalveis the first of its kind that provides a new treatment option. As a result, we are very pleased to receive the approval from the FDA to expand the number of study patients and centers,saidEdgar Rey, President &CEO, CorMatrixCardiovascular, Inc.

CorMatrixCardiovascular, Inc. is a regenerative biotechnology company based in metroAtlanta, Georgia. A pioneer and leader in regenerative science and technology, the company was founded to address congestive heart failure, the largest global disease management challenge and unmet cardiovascular clinical need.

*CorTRICUSPID ECMvalveis an investigational device and not commercially available.

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CorMatrix receives FDA approval to expand its early feasibility IDE study of the Cor TRICUSPID ECM valve Cardiology2.0 - Cardiology2.0