science | May 30, 2019

Nina Tandon’s Revolutionary Bone Reconstruction Company Approved for FDA Trial

Nina Tandon’s company EpiBone has received FDA clearance to begin its first clinical trialmaking it one step closer to providing patients with precision-fit skeletal implants grown from their own cells.

Nina Tandon believes we are close to unlocking the regenerative capabilities of our own bodies. As the founder and CEO of EpiBone, Tandon uses stem cells and 3D printing to “grow” skeletal implantsthereby replacing the need for synthetic materials like metal and plastic, which fail over time. 


“Right now, when an implant fails, we just go back and repeat the surgery. But when we take a personalized approach, we can actually circumvent these limitations,” Tandon explains. The decrease in the need for secondary surgeries will gradually lift some of the stress on our healthcare system, proving that personalized methods don’t have to be more expensive. 


EpiBone’s technology also eliminates the need to “harvest” bone from other areas of a patient’s body, thereby reducing pain, surgical time, and the length of recovery. Instead, after scanning the bone defect, stem cells are taken from a patient’s fat cells and placed in an incubator that mimics the natural environment of the body (using animal bone and cartilage). The result is functional bone and cartilage that emerges ready for implantation, and provides a precision fit. 


In its first human clinical trial approved by the FDA, EpiBone plans to enroll six patients to demonstrate the safety and effectiveness of its technology. “We are proud of the work that has been put into this IND, and are grateful to our entire team,” Tandon said. “Our goal is to help as many patients as we can to regain optimal form and function, in the most seamless, long-term, and natural way possible.”


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