Bone Regeneration
A funded path to first-in-human
OssiGel's therapeutic development is executing against a funded, milestone-driven timeline.
TLR4
TLR6
IND/CTA
FIH
Phase II
NOW
~2028/2029
End of DENOVOSS
Preclinical package + CTA-ready dossier
Early 2029
Submission
Phase I, Q3 2029
First patient dosed
Q1 2032
Initiation
Milestones so far
From first patent to first data, the record of a company building on validated biology.
August 2022
A priority patent was filed covering the MSOD-B mesenchymal stem cell line, the biological basis of OssiGel's regenerative mechanism.
December 2024
Dhalion Biotech AB spun out of the University of Basel to consolidate the OssiGel IP and technology under a single commercial entity.
December 2025
A peer-reviewed PNAS paper confirmed the engineered cartilage graft is intrinsically immunosuppressive and osteoinductive in vivo.
2026
Non-dilutive funding secured to date includes Sten K Johnsons Stiftelse and a €2.5M EIC Transition grant, DENOVOSS, awarded to advance OssiGel from TRL4 to TRL6.
See the full OssiGel material profile
Regulatory pathway
OssiGel's classification sits at the boundary of two EU pathways. The primary route pursued is EU ATMP, since the material is derived from a genetically engineered cell line but fully decellularized before use, cell-based in origin yet cell-free in the final product, a novel classification the team treats as a point of differentiation rather than a liability.
An alternative under consideration is EU Medical Device, MDR Class III implantable, potentially faster and less costly, though still requiring rigorous clinical safety and performance evidence. The University of Basel, lead on regulatory strategy, has prior engagement with both EMA and Swissmedic on OssiGel's classification, and a formal Scientific Advice procedure is planned within DENOVOSS to lock in the pathway ahead of CTA submission.
