Late last week, T3 Labs, GCMI, Georgia Tech and Emory announced that GCMI signed a letter of intent to acquire ownership interest in T3 Labs from Emory / St. Joseph’s Hospital, Inc.
We are happy to convey that it’s business as usual for our existing preclinical testing and bioskills training sponsors. You can expect to continue to receive the highest value available from our preclinical CRO’s testing and training programs with no change in timelines with the added benefit of additional product development resources available at a moment’s notice. Our team’s commitment to quality, continuity and service remain unwavering.
Continuing to provide the highest value possible in a preclinical CRO for medtech testing and training
Whether you are a multinational medical device manufacturer, a small medical device developer, or physician or academic innovator, T3 Labs will continue to:
- Operate independently as a non-profit organization.
- Provide the multidisciplinary tools and expertise customers need to initiate and navigate the process from concept to cure to commercialization is at your fingertips.
- Maintain the same timelines (IACUC and other study deliverables) and deliver responsive, rapid and reliable fee-for-service preclinical testing and training at our world-class labs in Atlanta, Georgia.
- Protect sponsor intellectual property and publications rights by adhering to strict confidentiality policies and procedures.
Expanding access to the multidisciplinary professionals critical to the success of medical device innovators at startups and large firms alike
As a business unit of GCMI, T3 Labs’ sponsors will now have even greater access to more of the needs its clients may need to accelerate product development life cycles and build product portfolios. In addition to T3 Labs testing and training services, the combined organization will offer services to include iterative, quality-driven device prototyping, new company formation and incubation, and regulatory support. All are required for true translational research and to drive medical innovation.
From the press release formally issued by GCMI on Friday, July 29:
“From concept to development through clinical trials, the critical infrastructure to support successful medtech innovation resides within close proximity to our facilities,” said GCMI Executive Director Tiffany Wilson. “Placing T3 Labs under GCMI’s umbrella will enhance operational efficiencies for both, creating and maintaining a capital efficient environment through collaboration and resource alignment. This is a high value proposition for medtech innovators, entrepreneurs, and regional economic development.
“Medical device innovation is a complex, expensive process, yet there is a tremendous need for novel solutions to unmet clinical needs. Given Atlanta’s fantastic resources, which include expertise at GCMI, T3 Labs, Georgia Tech and Emory Healthcare, we can help derisk many new medical technologies in a methodical way, making the process more transparent and predictable, decreasing the time required for a new device to get to market and attracting more investment.”
Young companies like Strataca Systems and Matrix Surgical, spawned with the help of GCMI, have successfully completed preclinical work at T3 Labs and are now well into the FDA approval and commercialization process. Our new, formal relationship with GCMI makes engineering and market analysis expertise (including regulatory approval processes) even easier for you to access. The experts at GCMI are not just neighbors and development partners, they are part of the team and directly connected to our collective success.
Good laboratory practice (GLP) studies conducted at T3 Labs have helped more than 30 medical devices achieve FDA /CE regulatory approval. In just one example, Atlanta-based CardioMEMS developed the world’s first wireless implantable device that measures and monitors pulmonary artery pressures for heart failure patients through preclinical work at T3 Labs. CardioMEMS was acquired by St. Jude Medical in 2014 for $455 million.
In our sponsors’ own words:
- “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.” – CardioMEMS / St. Jude Medical
- “As close as you can come to a real O.R. experience,” – Stryker
- “T3’s recommendation accelerated our product refinement testing and preclinical trials saving ALung time and money at every step along the way.” – ALung Technologies
- “At the conclusion of every program, we depart [T3 Labs] with a great brand name.” – Applied Medical
Connect with T3 Labs and GCMI:
If you are a medical device innovator with a ‘back of the napkin’ idea, have a product in development and are evaluating its readiness for preclinical testing, or if you need the very best in bioskills training for your physicians and allied health professionals, T3 Labs and GCMI stand ready to serve you as we have for scores of leading medtech companies for the past two decades. Email email@example.com, call (404) 251-0600, or visit our websites – www.t3labs.org and www.devices.net.