2017 was a year for the books! Our sponsors continue to receive regulatory approvals maximizing their investment in preclinical research, and our bioskills training program continues to ensure physicians and surgeons develop the skills required to fully realize the value of the medtech innovations. As we put a bow on a remarkable year, we want to share the advancements made by T3 in 2017, as well as the goals that will be our focus in the year to come.
Here are a few highlights from 2017:
ALung Receives IDE Approval to Conduct VENT-AVOID Trial of the Hemolung RAS for the US Market
Huge congratulations to our sponsor ALung Technologies who, this year, received IDE approval to conduct VENT-AVOID trial of the Hemolung RAS for the US market. Forty hospitals will enroll up to 800 patients in the trial.
ALung selected T3 Labs as the GLP preclinical CRO partner in support of their IDE application for the Hemolung RAS. ALung completed four preclinical studies with T3 Labs leading up to the GLP study.
“I am convinced T3’s recommendations have accelerated our product refinement testing and preclinical trials, saving ALung time and money at every step along the way. Through smart trial and error, we have gone from inconsistent initial outcomes to a position of confidence that we have determined the best protocol to use.”
T3 Labs sets gold standard in preclinical testing for CorAmi: a medtech company revolutionizing drug delivery for Atrial Fibrillation
Dr. Rebecca Levit, Chief Scientific Officer of CorAmi Therapeutics, is working in partnership with Emory University to develop a combination hydrogel delivery catheter and therapeutic hydrogel focused on cardiac applications. The preliminary data collected at T3 Labs shows that the technology is effective in changing the electrical tendencies of the heart: a prospective game-changer for the estimated 10 million Americans and 30 million worldwide living with AF.
“We value T3 Labs because of the top-notch facilities and expertise,” says Dr. Levit. “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 derisk 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 addition to scientific expertise.”
Selecting the right preclinical partner: Why Cell Constructs utilizes T3 Labs as their trusted CRO
Dr. Tom Barrows, President & Chief Science Officer of Cell Constructs is an industry veteran, has tackled the preclinical process numerous times and understands the value in completing preclinical studies, even when they are not required. When the time came to select a CRO to test their first device, Barrows entrusted T3 Labs as Cell Construct’s preclinical partner.
“Find a partner, especially for preclinical, that has external resources and contacts to help you tackle the process in the most efficient way. For us, that was T3 Labs. We did not need to pay a fee to have a very detailed proposal – we wanted very specific asks and the T3 team was very accommodating. The team allowed us to make changes as the process went on, use our own techs – who they welcomed with open arms – and to stay and complete a study that was taking much longer than expected.”
“We cannot think of a better CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.”
Expanding our national and international reach
T3 team members attended several conferences, each providing new knowledge, contacts, and opportunities. Here are our takeaways from a few 2017 conferences.
- The latest in transcatheter cardiovascular therapeutics and innovation from TCT 2017
- An Evening of Medical Device Development: The FDA and Pediatric Medical Devices
- Coming together at ACG 2017 to advance care for patients with GI disorders
- Infection prevention in orthopedic medical devices, rigorous FDA regulations, & more: our AAOS 2017 takeaways
- Talking Good Lab Practices(GLP) with FDA Representatives and Industry Leaders at SQA 2017
Keep up with the T3 team’s travels on our events page and follow us on our active LinkedIn and Twitter profiles!
2018 will bring a brand new logo encompassing all of the GCMI service lines including T3 Labs. There will be a new cohesive website that highlights all our capabilities. We hope to launch these in Q1 2018, so stay tuned for this launch, partner stories and expansion of our ecosystem news!