Under the direction of Founder and CEO Luis Alvarez, Theradaptive is transforming the landscape of tissue regeneration through its proprietary protein engineering platform. With applications spanning orthopedics, spine surgery, dental implants, and even immuno-oncology, the company is redefining regenerative medicine by enabling localized, precise, and long-lasting therapeutic effects.
Alvarez’s career trajectory was shaped by his 20-year service in the U.S. Army, where he learned of a problem called delayed amputation—a limb amputation that occurs significantly later than the initial injury, often due to the inability to regenerate bone and other tissues. “The original problem was how to deliver therapeutics with anatomical precision to regenerate tissue and avoid amputation,” Alvarez shared. This pivotal experience inspired him to pursue a PhD at MIT, where he developed Theradaptive’s core technology.
Alvarez’s entrepreneurial path was further reinforced by his work in the Army’s R&D and medical acquisition programs. “I helped manage the DoD’s regenerative medicine program, seeing what worked, what didn’t, and what could be done better,” he explained. This unique blend of scientific and operational expertise laid the foundation for Theradaptive’s launch.
Bone regeneration technologies have remained largely stagnant, relying on outdated techniques like autografts and cadaver bone implants. “If you need to regenerate bone today, your options are outdated,” Alvarez noted. “We’re still harvesting cells from patients, creating a second injury, or using last-century cadaver bone technology.”
Theradaptive’s approach addresses these issues by ensuring precise, controlled, and localized bone formation with no off-target effects. “We engineered therapeutic proteins to stay in place and remain active for many months without migration,” he explained.
Theradaptive’s platform works by engineering therapeutic proteins that bind tightly to implantable scaffolds. This enables the proteins to remain active at the targeted site for extended periods, promoting bone and tissue regeneration exactly where needed.
“Our lead product uses an electrospun composite material that acts as a scaffold, and our novel osteoinductive protein AMP2 binds to that scaffold,” Alvarez explained. “Surgeons place the implant where bone formation is needed—such as between vertebrae in the spine—and the protein triggers the body’s natural bone-growing process.” This approach ensures that bone forms only in the intended location, reducing the risk of complications.
Theradaptive’s platform is also highly adaptable across different clinical applications. “You don’t need to use a different product for other parts of the body; all you do is use a different kit size,” Alvarez noted. This versatility supports applications in spine fusion, dental implants, cranial repair, and immuno-oncology. “Wherever you want to keep a potent therapeutic from being systemically distributed and want to keep it in a specific place, that’s where our platform shines.”
In immuno-oncology, Theradaptive has engineered various interleukin proteins that stimulate immune activity in and around tumors. “We place protein-coated particles in and around the tumor, triggering a powerful immune response in that localized area,” Alvarez explained. “This approach avoids the toxic systemic side effects associated with traditional chemotherapy or immunotherapy. You can deliver ultra-high doses safely.”
Theradaptive’s progress has been fueled by a strategic blend of government and private funding. The company has raised $33 million in equity financing and secured $26 million in non-dilutive funding from sources like the Department of Defense and the Maryland Stem Cell Research Fund. “The DoD and state of Maryland played a critical role early on with grants and contracts which attracted early venture funding,” Alvarez acknowledged.
Theradaptive is currently in a global Phase I/II clinical trial for its lead product, OsteoAdapt, targeting spinal fusion in the lower back. This study includes ALIF, TLIF, and LLIF indications for which Theradaptive has several FDA Breakthrough Medical Device Designations. The company recently expanded its clinical trial sites in the United States and Australia, with plans to begin a Phase III study by late 2025. “We’re also launching a dental implant clinical study that could cut the time to final implant placement by several months or even allow immediate implant placement in many cases,” Alvarez announced.
Looking ahead, Theradaptive plans to explore label expansion into areas like cranial repair and immuno-oncology, leveraging the same protein engineering platform. “We believe we can make all existing bone grafts obsolete by offering certainty of outcome, better safety, greater speed, and ultimate ease of use,” Alvarez said confidently.
Theradaptive’s initial focus will be assessing the safety and efficacy of its AMP2 platform in a new device for lumbar fusion called OsteoAdapt SP.
According to LSI’s global Surgical Procedure Volumes (SPV) database, by the end of 2024, approximately 513,000 lumbar fusions will be performed in the United States. From 2023 to 2028, lumbar fusion procedures are projected to increase at a CAGR of 5.3%, reaching an estimated 631,000 procedures.
As the volume of procedures increases worldwide, the Serviceable Addressable Market (SAM) will also experience healthy growth. According to LSI’s Market Analysis and Projections (MAP) database, the worldwide market for spine fusion devices will reach $10.4 billion by the end of 2024. We project that this market will grow at a CAGR of 4.0% from 2023 to 2028.
Alvarez has been selected to present at LSI USA ‘25 next March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Alvarez to the event in Dana Point, CA, where he will share the latest updates on Theradaptive’s technology and development.
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