For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available.
Once Bio2 Technologies reached the second stage in the process from concept to cure to commercialization – preclinical – they entrusted T3 Labs to deliver three consecutive studies for the first completely porous structural bioactive glass for bone void filling resulting in FDA 510(k) clearance in 14 months.
Bio2 Technologies Chief Technical Officer Janet Krevolin, Ph.D. recently shared with us the top challenges in preclinical research for Bio2 and how the team accelerated the preclinical process with T3 Labs. Janet has over 25 years experience in research and product development in the orthopedic industry. Prior to joining Bio2 she held the position of Vice President, Global Product Development for Zimmer Holdings, Inc. (NYSE:ZMH). Dr. Krevolin holds a doctorate in Mechanical Engineering from the University of Texas and currently teaches biomedical engineering design process at Tufts University.
Limiting the number of “$10,000” days between development and commercialization is critical to a new product’s, and especially a new medical device company’s success.
“With a solid, team-based plan in place, the moment we had our implants ready, T3 Labs was ready to do the cadaveric study,” Krevolin says. “T3 had the instrumentation we needed and the pilot work progressed very quickly.”
“Many times you find yourself waiting on preclinical due to scheduling difficulties. This was not the case with T3 once we were ready to go, there was no delay. Any challenges were addressed quickly and correctly.”
The value of a pilot study and solid preparation
“Many developers initiate discussions on preclinical studies with a request for a GLP study in 2 weeks,” says T3 Labs Preclinical Program Director Evan Goldberg. “Ultimately you will need GLP, but have you tried a pilot? Is your team fully developed? Is histology on-board? Does everyone know their roles and responsibilities? These are questions that must be answered in advance of any GLP study in order to maximize the investment in, and increase the odds of superior results from, preclinical testing.
“Bio2’s commitment to a solid process including a cadaveric study and a pilot in vivo study prepared them exceptionally well for a successful GLP study on the first go-round.”
“I am convinced the inclusion of both the cadaveric and in vivo non-GLP pilot studies contributed to the efficiency and quality of our GLP study and ultimately the success of our 510(k) submission,” Dr. Krevolin says.
Surgical and Veterinary Expertise
“The ability to smoothly work through the surgeries onsite was immensely valuable to our team and process,” Dr. Krevolin says. “T3’s counsel on the proper model, along with the veterinary team’s commitment to understanding our product, how to implant it and where, and the team’s high level of surgical capability and quality systems gave us the ‘whole shebang’ in one preclinical relationship.”
T3 Labs’ preclinical staff includes 5 DVMs with more than 80 years of combined experience in preclinical operations. This expertise enables our sponsors to rest assured knowing the proper models are selected and protocols are rigorously designed and executed. Our veterinary experience enables T3 to deliver consistency in study design, excellence in execution and innovation in preclinical solutions.
T3’s surgical expertise, particularly in the large animal models necessary for initial proof-of-concept and feasibility, as well as definitive GLP data for 510(k) and PMA regulatory approval, enable our sponsors to evaluate new medical devices of all types, including orthopedic, in clinically relevant preclinical models.
The bottom line: delivering the highest value preclinical testing available
In preclinical studies, Vitrium successfully demonstrated:
- Bone ingrowth throughout implant at eight weeks and continuing bone mineralization through 24 weeks.
- Equivalent performance compared to other bone graft substitutes.
- Implant resorption ongoing at 24 weeks post-op.
“As our first revenue generating product with 510(k) clearance, the success of our preclinical partnership is immensely important from every perspective including credibility with our principals and investors,” Dr. Krevolin says. “Prior to [your first] 510(k) clearance, you are a startup with but an idea. Thanks to a robust, highly competent team including T3 Labs and Vitrium’s superior combination of bioactivity, resorbability and structural capability compared to synthetic bone void fillers or allograft, we are now improving lives and outcomes for orthopedic surgeons, their patients and their insurers as well.”
“T3 Labs is a high quality, dependable, time-sensitive and collegial team with whom we are proud to work. They cover everything you need in a preclinical product, including the right model and pathway to GLP at the right price.”
According to Dr. Krevolin, Bio2 Technologies is developing a cervical fusion device on which it hopes to clarify its FDA pathway and advance into the next stages of the commercialization pathway in early 2017. We look forward to continuing to help them bring their bioactive glass platform into new musculoskeletal applications.
For more information on T3 Labs’ preclinical testing and bioskills training programs, contact Orthopedic Preclinical Testing Program Director Evan Goldberg via email firstname.lastname@example.org.
For more information on Vitrium including case study and monograph, click here.