A Maryland biotech led by an Army veteran and former West Point professor has raised an additional $26 million to move its targeted therapeutics platform into human trials.
Theradaptive is focused on developing tissue regeneration therapies in orthopedics, an area of interest to founder and CEO Luis Alvarez, who saw service members having delayed amputations during his time in the Army. He later went back to MIT to find a solution to that problem — working on tissue regeneration, which resulted in a spinout of Theradaptive.
It announced the fundraising round on Thursday morning. Alvarez told Endpoints News that the round included the same investors that invested in a seed round in 2021, and the biotech has now raised over $50 million.
The company raised $13 million in notes and SAFEs. The remaining $13 million is new equity and is expected to last the company for up to 18 months.
Founded in 2016, Theradaptive is working on engineering proteins to interact with certain materials, including implants and injectables. Engineering proteins this way allows for “local — very local, very persistent delivery — of therapeutics that have long-acting effects, but then avoid systemic exposure,” Alvarez said.
The funds will enable Theradaptive to work on meeting regulatory requirements and scale up good manufacturing practices, in preparation for a Phase II clinical trial for a spinal fusion product starting later this year.
“We have already designed the trial and discussed it with the FDA,” Alvarez said, adding that FDA gave the company permission to skip a Phase I study and go straight into Phase II for spinal fusion. The plan is to enroll around 65 patients.
So far, FDA has given three breakthrough medical device designations to the company for spinal indications.
The round also will also support expanding Theradaptive’s platform beyond orthopedics — with the company highlighting oncology and dental as possibilities.
A previous seed round announced in 2021 raised $6.2 million, led by AMP Squared Capital Partners and joined by the Maryland Venture Fund and OrthoRebirth. The company has also received $11.2 million from the Department of Defense.
