Alphatec Holdings Inc. and Theradaptive Inc. have forged a strategic partnership agreement to widen the scope of osteoconductive bone grafts in spinal fusions.

Concurrently, Theradaptive has initiated a Series B investment round to help expand its proprietary protein-engineering platform across global therapeutic applications.

Under the terms of the agreement, ATEC gains exclusive U.S. commercial rights to market and distribute Theradaptive’s OsteoAdapt osteoinductive bone graft for spinal fusion. The agreement represents a landmark regenerative medicine partnership for the spine industry, structured to deliver significant long-term value through a combination of upfront and milestone payments and a perpetual royalty structure, according to the companies.

“The partnership with Theradaptive represents an important milestone in the continued evolution of ATEC’s procedural ecosystem,” ATEC Chairman/CEO Pat Miles said. “We have built a strong foundation of procedural spine solutions through informatics, imaging, navigation, and instrumentation, and the industry has long sought biologic solutions that can further enhance fusion outcomes in a meaningful way. OsteoAdapt is that solution. By integrating this breakthrough technology into our Organic Innovation Machine, we are poised to set a new standard for clinical distinction in spine.”

Leveraging proprietary AMP2 protein technology, OsteoAdapt is currently being evaluated in clinical trials in spine and dental applications and is subject to U.S. Food and Drug Administration (FDA) PMA approval. The technology has received three FDA Breakthrough Device Designations, underscoring its potential to address significant unmet medical needs in bone regeneration.

To help finance the clinical studies and the rapid scaling of its technology platform alongside the ATEC partnership, Theradaptive has launched a Series B investment round. This capital will facilitate the OASIS Pivotal trial’s advancement in spinal fusion and the manufacturing scale-up and build-out in support of future commercialization.

“In ATEC, we have found the ideal partner to bring this revolutionary technology to the patients who need it most,” Theradaptive Founder/CEO Luis Alvarez, Ph.D., stated. “The synergy between our engineered protein platform and ATEC’s commercial reach, coupled with the initiation of our Series B round, ensures that we are capitalized to deliver a new era of regenerative medicine”.

The U.S. spine surgery market exceeds $10 billion annually, with the biologics segment representing a more than $2 billion opportunity. OsteoAdapt’s targeted approach represents a paradigm shift intended to make traditional allograft and synthetic alternatives obsolete, Theradaptive bigwigs claim. The sustained sales growth from ATEC’s sales force provides confidence in maximizing market penetration and returning value to Theradaptive with the ongoing royalties.

Through its wholly owned subsidiaries, Alphatec Spine Inc., EOS imaging S.A.S., and SafeOp Surgical Inc., ATEC is a medical device company dedicated to revolutionizing the approach to spine surgery through clinical distinction. ATEC’s Organic Innovation Machine develops new approaches that integrate seamlessly with the company’s expanding InformatiX platform to better inform surgery and more safely and reproducibly achieve the goals of spine surgery. ATEC’s vision is to be the standard bearer in spine.

Theradaptive is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, dental, and soft tissue repair and targeted therapeutics in diverse areas such as immuno-oncology. The company leverages its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. OsteoAdapt SP is an investigational device limited by U.S. law to investigational use.