Ossiform ApS

Ossiform® is dedicated to improving the lives of people with bone defects. We are forming a new generation of structural bioactive bone substitutes to reduce complications, improve functional outcomes, and accelerate recovery.

We are continuously working to redefine bone replacements through progressive research and close collaboration with physicians and industry partners. Our patient-centric approach and commitment to innovation, quality, and progress steer our efforts to provide best-in-class implant solutions that facilitate the natural forming of new bone.

The short way of describing the business; We Print Bone

The income statement for the period 01.01.25 - 31.12.25 shows a profit/loss of DKK -7,891,755 against DKK -12,699,427 for the period 01.01.24 - 31.12.24. The balance sheet shows equity of DKK 9,363,336. Management considers the financial result to be in line with expectations.

Primary target for Ossiform is to get market access for the Ossiform Bone by initially obtaining FDA clearance and secondly a CE mark. Main activities through 2025 have been to perform a study to show both fast and robust bone ingrowth as well as measuring the degradation rate of the Ossiform Bone. Positive results are seen from the study, indicating both effect and safety of the product, and final analyses have been prepared which are to be part of the submission for the FDA.…

In 2026 resources are directed to where they can be most effective to obtain market authorization, with a focus on obtaining the FDA clearance for the Ossiform Bone, entering the US market and setting up a larger clinical study both at hospitals in the USA and EU. The studies are set up both to show clinical relevance of the Ossiform Bone as well as to initiate the MDR process and prepare for CE mark certification. Highly skilled clinical experts, US advisors and KOLs are hired to give guidance on clinical use, to form and implement the market access strategy, to connect to first-class hospitals and plan and help performing the studies.

Development will proceed to reach market with needed and asked for products that will give patients a better outcome.

A convertible loan of £1,3M was obtained in June through Westhill Capital in London. Besides securing additional capital, no events that would influence the evaluation of this annual report have occurred after the end of the financial year