Having a facility like T3 to test novel and breakthrough applications’ ability to save lives is crucial for battling diseases and disorders. Dr. Matheny and the original team of T3 recognized the need and saw to it that it was met.
The change in landscape for innovators was born from desperation and a desire to bring new medtech to life. T3 is built on the greatness and perseverance of physicians and innovators like Dr. Matheny who continue to help make it possible for visionaries to improve patient outcomes through research and medtech innovation with confidence.
From helping establish the organization to utilizing the lab’s resources as an innovator himself, Dr. Robert Matheny, MD, has been with T3 Labs every step of the way. The story of Dr. Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., is one rooted in a search for accessible innovation resources, including preclinical support, and the urge to generate better solutions for cardiovascular physicians and their patients. It includes the creation of T3 Labs and continues with collective success in medtech innovation, saving lives worldwide.
Meeting the need for a preclinical CRO
In 1999, Dr. Matheny collaborated with other Atlanta area interventional cardiologists and cardiothoracic surgeons with one goal in mind: taking new ideas for better medical devices, biologics, and drugs and making them into functional products. The partnership between these physicians resulted in the development of a preclinical CRO called American Cardiovascular Research Institute (ACRI). Which has evolved into Translational Testing and Training Laboratories, Inc. or T3 Labs.
“The facilities are top tier,” says Dr. Matheny. “We designed the facilities to make it easy to move from concept through protocol to budgeting and now it happens as efficiently as possible.” More than a decade later, Dr. Matheny continues to develop groundbreaking medical technologies for Cormatrix Cardiovascular Inc. from concept to cure to commercialization at T3 Labs.
Bringing ECM’s regenerative ability to life
Dr. Matheny, a fellow of the American College of Surgeons, has worked with extracellular matrix (ECM) material for cardiovascular applications since 1993, and continues to advance ECM technology with the help of T3 labs.
“I was introduced to ECM technology at Purdue while practicing in Indianapolis at St. Vincent Hospital, Cardiothoracic Surgery Division ” Dr. Matheny says. “Initially I tried getting various venture capital funds to believe in our concept. No one would, so we decided to do it ourselves.”
In 2000, Dr. Matheny founded Cormatrix Cardiovascular Inc. to further develop ECM biomaterials into devices that utilize the body’s innate ability to repair damaged cardiac and vascular tissue. In 2005, CorMatrix Cardiovascular Inc. received its first FDA clearance and shifted its focus from development to a fully integrated commercial entity. Today, the company continues to research, develop and deliver products using extracellular matrix for a variety of cardiac, vascular and other indications. Some of Cormatrix’ products have U.S. clearance and European CE mark.
To date, Dr. Matheny and Cormatrix Cardiovascular Inc. have conducted over 50 studies at T3 Labs, 9 of which have been in compliance with GLP. The 5 products that are a part of the CorMatrix Cardiovascular Inc. catalogue have been brought to market utilizing the complete range of expertise provided by T3 Labs.
Improving patient outcomes through research and innovation
Heart failure is the leading cause of death in the United States. CorMatrix Cardiovascular Inc.’’ ECM technology can aid in prevention and rehabilitation of various heart conditions, making it a product that has the potential impact millions of patients suffering from cardiovascular disease and heart failure.
Since its regulatory approval in 2005, CorMatrix’ ECM technology. has been used in more than 975 hospitals across the United States and implanted during more than 160,000 cardiovascular procedures.
The essence of our collective ability to save lives
Dr. Matheny tells a story of a surgeon who has used CorMatrix Cardiovascular Inc.’s technology for multiple operations. “Eight months after preclinical trials at T3, a colleague had a pediatric patient who was only 8 weeks old, with an irreparable mitral valve,” he begins. “They couldn’t get the baby off of the ventilator. He called me and said ‘I wish your technology was approved for use as a mitral valve.’ Shortly thereafter, the FDA approved the application asserting compassionate use. The physician inserted CorMatrix Cardiovascular.’ material to reconstruct a mitral valve in the little patient, and now she’s home. September 10th was the 1 year anniversary of that event.”
The entire T3 Labs team, especially Preclinical Study Director Irena Brants, cherishes our long-standing relationship with Dr. Matheny and Cormatrix Cardiovascular Inc.. We remain committed to helping him and his team continue to develop innovative, life-saving medical devices.
If you are a medtech innovator of any size and want to bring your new product to life as efficiently as possible, T3 Labs and GCMI can help from concept to cure to commercialization.