Luis Alvarez is intimately familiar with the world of traumatic injuries.
A veteran who served in Iraq in 2004 and 2005, Alvarez had spent years watching his colleagues be failed by existing medical innovations.
"When we got back to the States, physicians were able to salvage their limbs, but a few months later, their limbs had to be amputated," Alvarez said. "It was either a complete recovery or amputation."
That prompted Alvarez to begin researching other potential therapies for patients who were at risk of losing limbs. Through his work at the U.S. Department of Defense after serving in Iraq, as well as later research at MIT, Alvarez realized that the answer to the problem he was trying to solve may lie in regenerative medicine.
It would take a number of years for Alvarez to fully develop the technology that now underpins his startup, Theradaptive. First, Alvarez would manage a number of different medical development programs as the founding deputy director of the Department of Defense's Regenerative Medicine Program office, where he oversaw a portfolio ranging from early-stage S&T to Phase II clinical trials.
"It basically gave me a bird's-eye view of hundreds of different programs, from academic to industrial to corporate," Alvarez said.
Ultimately, Alvarez left that position to enter a Ph.D. program in biological engineering at MIT. There, he began developing a computational platform that turns a recombinant protein called BMP-2 into a material-binding variant called AMP2, which can be used to coat implants, devices and injectable carriers to enable targeted, long-term delivery.
"The platform basically lets us take an protein and modify it so it sticks to certain materials," Alvarez said. "BMP-2 is really powerful. Wherever you place it in the body, bone will form there. Of course, it's a double-edged sword, because if you don't have a way to deliver it, you can have nasty side effects. [With AMP2,] bone will only form where the implant is. It's a beautiful way to control the delivery."
Alvarez finished developing the technology as a Hertz Foundation Fellow at MIT and used it for the foundation of Theradaptive, which he spun out in 2017. Today, Theradaptive is a 10-person company based in Boston with a new R&D facility in Frederick, Maryland.
So far, Theradaptive has raised more than $9 million in non-dilutive funding from the Department of Defense and the Maryland Stem Cell Research Fund. Theradaptive is also in the process of raising a seed round from institutional investors, which Alvarez hopes to close by the end of the summer. The company also has a strategic partnership with another company Alvarez founded in 2017: Elevian, a Harvard University spinout developing therapeutics to treat aging-associated diseases.
Theradaptive has yet to have its technology approved by the U.S. Food and Drug Administration. The startup has applied for Investigational Device Exemption (IDE) status with the intention of beginning in-human clinical trials in 2021. Already, it has conducted preclinical studies at the Mayo Clinic and the Cleveland Clinic, including a spinal fusion study and a large-animal long bone study.
As Alvarez sees it, taking the startup route rather than staying in the academic world will allow him to get his technology into the world faster—a lesson he learned working at the Department of Defense.
"The fastest way to get a new medical innovation into the hands of patients and physicians was a nimble business," he said. "We have a focused effort to do that. Not academic, necessarily, and not large industrial. I felt, 'Here's a very impactful innovation. If it doesn't get out, it'll just sit on the shelf. It'll be an academic paper, nothing more.'"
