Founded by Cardiologists
In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for accessible resources, including preclinical support, needed to support innovation in care for cardiovascular physicians and their patients.
In 1999, his collaboration with other Atlanta area interventional cardiologists and cardiothoracic surgeons resulted in the development of a preclinical CRO called American Cardiovascular Research Institute (ACRI). ACRI evolved to become Translational Testing and Training Laboratories, Inc. or T3 Labs, now an integral part of the Global Center for Medical Innovation.
More than two decades and hundreds of preclinical studies completed (including 30 GLP studies in the past two years alone), GCMI remains an industry leader in medtech design, development, preclinical testing and bioskills training programs.
Why choose GCMI and T3 Labs for your next cardiovascular preclinical study or bioskills training program?
We have the facilities, equipment and staff you need, an unwavering commitment to value, flexibility, accountability, high scientific proficiency and the quality and accreditation you need. https://gcmiatl.com/why-gcmi-for-your-preclinical-and-bioskills-programs
Our GLP preclinical program for cardiovascular devices includes experience in models of ischemia, in vivo vascular function or reactivity and more in:
- Interventional cardiology,
- Structural heart electrophysiology, and
- Renal nerve ablation technologies.
- Study Directors have more than 50 years’ experience (all areas).
- 60+ sponsor devices achieved regulatory approval (all types)
Evidence: in the words of our customers:
“Working with the great team at T3 Labs has dramatically improved the timeline to test the novel molecules in the clinic, most notably to heart attack patients receiving percutaneous coronary intervention (PCI).” – Dr. Lindon Young
“We value T3 Labs because of the top-notch facilities and expertise. We were in need of people with practical experience translating our device beyond the initial idea. It was easy to recognize this unmet need, but I did not understand the complexities that it would take to make it a reality: understanding the market, how to de-risk a product, how many studies we would need and what documentation is needed for FDA submission and clearance. T3 is a flexible and efficient environment to work in, in addition to the team’s scientific expertise.” – Dr. Rebecca Levit, Corami Therapeutics
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans. During our preclinical work with T3, the concept for the sensor was refined from being attached to the right ventricular septum with an anchor coil to one that is placed in the distal pulmonary artery passively anchored by wire loops. Iterative refinement resulted in an optimized configuration for ease of use during the implant procedure and long term safety. T3 labs provided the ideal environment to identify the optimal configuration prior to first clinical use.” – Jason White, St. Jude Medical
Let’s meet at TCT 2022
If you are evaluating your readiness for preclinical, actively soliciting proposals for non-GLP or GLP programs, or looking for the finest in bioskills training program facilitation, let’s meet up at #TCT2022 in Boston, September 16-19.
Contact Ashley Gazaway to schedule a meeting today. Ashley.Gazaway@t3labs.org