At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA.
Our preclinical testing and training program leaders are trained scientists themselves, interested in understanding and participating in the science and methods behind innovations and options including medical products, devices, drugs and biologics across a wide range of therapeutic areas. They possess deep knowledge in their programmatic areas of expertise – bioskills, cardiology, orthopaedics, gastroenterology, drugs and biologics, etc. – pursuing their areas of greatest interest in close alignment with the needs of medical product developers.
In one example among many, T3 Program Director Irena Brants, along with Alizee Pathology, published the first preclinical testing documentation that a progressive regenerative response occurs as early as 7 days after renal denervation in “Circulation: Cardiovascular Interventions.” We contribute to the successful development of breakthrough, first-in-kind and first-in-human devices like the CardioMEMS HF System for St. Jude Medical and the Hemolung RAS for ALung Technologies.
“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.” – Jason White, Senior Director of Product Development, St. Jude Medical
From preclinical testing of LVADs to in vivo micro CT of orthopaedic and heart implants and beyond, our medical device testing and training program leaders possess over 125 combined years of experience across 11 programs or therapeutic specialties. We not only ensure your preclinical testing and training programs run efficiently, professionally and on-budget, we generate novel improvements to existing models, protocols and our sponsors’ products as well. Frequently we write preclinical program protocols in their entirety for our sponsors.
“T3’s recommendation for the model shift based on their experience and expertise was much more practical for this application based on our device’s capabilities and needs. I am convinced this recommendation has accelerated our product refinement testing and preclinical trials saving ALung time and money at every step along the way.” – Jeremy Kimmel, PhD, Director New Technology, ALung Technologies
Since January 2012, we have archived more than 50 GLP studies for leading medical device manufacturers of which more than 30 products like Surefire Precision have received regulatory approvals. Every day we put our skills to work for scores of industry leading medical device companies of all sizes like St. Jude Medical, ALung Technologies, Surefire Medical, Alizee Pathology, ImageIQ and more.
Let us put our collective knowledge, resources and thirst for scientific advancement to work bringing your breakthrough medical device or product from concept to commercialization to cure. We can help you get to your goal be it a financial exit or inflection point, regulatory or executive approval or successful medical device training program for practicing surgeons.
D. Andrew Stevenson, Executive Director, T3 Labs
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