For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available. Depending on the class and type of submission, not every medical product requires preclinical studies, however, completing preclinical studies is advantageous for proof of concept, when raising capital, applying for reimbursement, and planning for future generations of the medical product. This was the scenario for Cell Constructs.
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. Cell Constructs is a regenerative healthcare company specializing in wound care healing. The Company is currently under approval pathways for their first product, ProgenaMatrix™, an active wound care solution utilizing human keratin.
“The rich medtech ecosystem surrounding T3 Labs was a huge draw in selecting a CRO.”
T3 Labs has the track record, facilities, expertise, and flexibility to help innovators reach FDA clearance on time and on budget. This is in part due to Atlanta’s rich medtech ecosystem and network of medical product and healthcare professionals that work for and with T3 Labs. “The growth in the Atlanta medtech ecosystem is very apparent and the GCMI and T3 Labs partnership is a huge piece of that growth,” says Barrows. “We prefer to do business within the Atlanta medtech ecosystem as much as possible so when choosing a CRO, it was nice to have a high quality CRO in our backyard.
“We often use cultured cells that are important to have on ice so it is a huge deal that we are able to drive them down the road and not have to ship them in special packaging. Doing studies with T3 is convenient – some people don’t know that it is even possible to do large animal studies in Atlanta.”
Dr. Barrows’ advice for medical product innovators
“Make certain that you are not focusing all of the company resources on one aspect of commercialization, says Dr. Barrows. “Innovators get bogged down when they spend all your money in preclinical, IP procurement, prototyping, etc. Resources are often scarce, so use them wisely.
“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.”
If you are a physician innovator, researcher, or medical device company of any size, and want to bring your new product to life as efficiently as possible, with a team that is flexible and sensitive to your needs, GCMI and T3 Labs can help. Contact us today. For more information on Cell Constructs visit https://cellconstructs.com/