Inside Biomendex's EIC Accelerator Project on Flexible Bone Grafts

Surgeons who need bone to fill a gap usually take it from the patient's own hip, which hurts and, by the company's count, causes complications in up to half of cases. Synthetic substitutes avoid the second operation, but most are brittle ceramics or pastes. Biomendex, a 2018 spin-off of Tampere University in Finland, makes Adaptos, a porous composite that can be cut, shaped and squeezed into a defect and springs back, like the spongy bone inside a vertebra.

In the EIC SME Instrument Phase 2 round of 5 June 2019, the forerunner of today's EIC Accelerator, the European Commission selected Biomendex for ADAPTOS, a grant-only project with an EU contribution of €2,248,750 towards a total cost of €3,212,500, according to CORDIS. Biomendex is the only beneficiary of the project in the Commission's list of June 2019 winners, which gives its address as Pirkkala. The application promised €17 million of revenue and 35 employees by 2023. Seven years later the first Adaptos product for humans has been cleared in the United States, not in Europe, and the company reported revenue of €42,000 for 2025.

Where Biomendex Stands Now

Biomendex is active. The Finnish trade register lists it as a registered limited company with no liquidation or bankruptcy entries, according to the Finnish Patent and Registration Office's open data, and Kauppalehti shows the same status. On 17 February 2026 the US Food and Drug Administration cleared Adaptos Fuse Bone Graft as a bone void filler, application K253524, received on 13 November 2025, according to the FDA's 510(k) database. The company announced it the next day as "a transformational milestone", in the words of chief executive Pasi Kankaanpää, and trade outlet ORTHOWORLD reported it on 20 February. The clearance covers surgically created or traumatic bone defects in the posterolateral spine, the intervertebral disc space and the pelvis.

On 26 August 2026 Biomendex said the first US patients had been operated on with Adaptos Fuse and that Mayo Clinic was "expanding the use" in neuro and spine surgery. It did not say how many patients or which hospitals. Biomendex announced the incorporation of a US subsidiary, Biomendex Inc., in May 2025; no second source for that entity was found.

The Technology: A Bone Substitute That Bends

Adaptos is a composite of beta-tricalcium phosphate, 45S5 bioactive glass and a biodegradable polymer, poly(L-lactide-co-ε-caprolactone), foamed with supercritical carbon dioxide into a porous structure that resembles cancellous bone, according to a CORDIS results article. The US patent on the material, US11524094B2, names Kaarlo Paakinaho and Minna Kellomäki as inventors and Biomendex as assignee; it was filed in September 2017 and granted in December 2022. Its description reports a ceramic content of 50% by weight, porosity of 65 to 67%, and samples that recovered 95% of their height after being compressed by half in water at body temperature.

That combination is the claimed difference. Ceramic granules and blocks, the established synthetic option, crumble when pressed into an irregular cavity; putties lose their structure. Adaptos is meant to handle like the patient's own bone while dissolving over time and being replaced by new bone. The CORDIS article says patents were granted in Australia, China, Finland, Japan and the United States, with applications pending in the EU and Canada. Whether Adaptos heals bone better than competing substitutes has not been shown in a published randomised human trial; the comparison is what the knee study described below is designed to test.

What ADAPTOS Promised, and What CORDIS Shows

When it announced the grant on 30 September 2019, Biomendex said the money would pay for clinical trials, production scale-up and go-to-market work "over the next 24 months". CORDIS shows a project that ran from 1 October 2019 to 30 September 2024. The objective set out three tasks: scale up the Adaptos production line, build reference cases at three hospitals in a multi-country clinical trial, and bring orthopaedic surgeons on board.

The final periodic report, covering April 2023 to September 2024, says an up-scaled supercritical CO2 reactor was installed in a cleanroom and its processes validated. It says the pandemic forced the clinical study to be "replanned and rebuilt" around major Finnish hospitals, that the lead hospital began recruiting patients in the last reporting period and a second site followed, and that a pre-submission was filed with the FDA, since the US 510(k) route needs preclinical rather than broad clinical studies. It does not report a CE mark, sales to hospitals or any figure for revenue or jobs.

1. Scale up Adaptos productionDeliveredUp-scaled CO2 foaming reactor set up in a cleanroom and validated, per the CORDIS report.
2. Multi-country clinical trial at 3 hospitalsLateStarted April 2024, six months before the project ended; still running with completion estimated for December 2028, per ClinicalTrials.gov.
3. Market entry in Europe (CE mark)Not achievedNo CE mark for a human Adaptos product has been announced.
4. Surgeon onboardingDeliveredKnow-how agreement with Mayo Clinic in October 2024, extended to foot and ankle in July 2025.
5. €17M revenue and 35 staff by 2023Missed€24,000 revenue and 7 staff in 2023, per the filed accounts.

The production work was delivered, and the US clearance in 2026 grew out of the regulatory files the project prepared. But the core of the plan, clinical evidence leading to sales to European hospitals, was not finished within the five years, and the commercial targets were missed by a wide margin.

Two Human Studies, One Stopped

The first human study used Adaptos granules in the jaw after tooth extraction. Biomendex announced its start in June 2021 with a target of 175 patients and said it expected to begin selling Adaptos for oral and maxillofacial use "by the end of 2022". The study, sponsored by Orton Orthopaedic Hospital, ended on 27 January 2023 with 76 patients and the status "terminated", giving "business decision" as the reason, according to ClinicalTrials.gov. The CORDIS results article says analysis of the data was under way. No results have been posted or published, and no oral product has been launched.

The second study is the one the EIC project paid to build: a randomised trial in medial open wedge high tibial osteotomy, a knee operation in which a wedge-shaped gap is opened in the shinbone. Adaptos Ortho Wedge is compared with no graft and with chronOS Wedge, an established synthetic product. The registry lists 87 planned patients, six sites in Finland and Hungary, the status "active, not recruiting" and a completion date estimated for December 2028. This trial is what a CE mark for the orthopaedic product would rest on.

What Biomendex Has Achieved Since the Award

The product that sells is for animals. Adaptos Vet was used in nine animal clinics when Biomendex applied to the EIC, according to CORDIS. The CORDIS results article puts the number of treated animals at more than 1,500, and the February 2026 FDA release at more than 2,700 veterinary orthopaedic and dental procedures. Distributors followed in Scandinavia in 2022, the EU, China and the UK in 2023, North America in January 2024 through Jorgensen Laboratories, and Australia and New Zealand in August 2025. These figures come from the company and were not independently verified.

The filed accounts show how small that business still is. Revenue rose from €7,000 in 2021 to €42,000 in both 2024 and 2025, according to Asiakastieto; Kauppalehti gives the latest figure as €41,711.66 with an average of nine staff.

Leadership changed as the company moved from research to commercial work. Pasi Kankaanpää, previously head of development for lab essentials at Sartorius, became chief executive on 1 March 2023, with founder Kaarlo Paakinaho moving out of the role. In October 2024 Biomendex signed a know-how agreement with Mayo Clinic, which "has a financial interest in the technology", according to the press release published by ORTHOWORLD and the company's own news page. Tomi Numminen became chairman in June 2025.

The Money

Biomendex has relied mainly on public money. A presentation by Kaarlo Paakinaho published by Business Tampere lists €50,000 from Business Finland's Tempo programme in 2018, €599,000 of Business Finland R&D funding in 2019, the €2.25 million Horizon 2020 grant, and a Deep Tech Accelerator package of up to €1.4 million in 2023, made up of a €400,000 grant and a €1 million loan. Business Finland named Biomendex among 17 start-ups sharing €6.8 million in the pilot in September 2023. The private side, as the company disclosed it in May 2021, is a €400,000 seed round in 2019 and a €1 million round led by Scanfert Oy in 2021.

A funding database, Signalbase, lists a $1.3 million Series A dated 18 October 2025 without naming investors. Biomendex has not announced such a round, and no second source was found, so it could not be verified.

The losses have grown with the trial and the US filing. The operating loss rose from €306,000 in 2023 to €1,099,000 in 2025, and the equity ratio was minus 14% at the end of 2025, counting capital loans as debt, according to Asiakastieto; the ratio with capital loans counted as equity is not published for free. Biomendex is not listed in the EIC Fund portfolio, which is consistent with its grant-only award.

Why Europe Should Care

Bone grafting is the second most common tissue transplant after blood transfusion, with about 4 million operations a year, according to CORDIS, and an ageing population will need more of it. The Commission's July 2025 strategy to make the EU "the world's most attractive place for life sciences by 2030" promised to support multi-country clinical trials and to simplify the medical device rules, according to the Commission and A&O Shearman. On 16 December 2025 it proposed a revision of the Medical Device Regulation aimed at faster and more predictable certification, according to Baker McKenzie and Heuking.

Biomendex shows why those plans exist. An EU-funded European implant, developed and manufactured in Tampere, was cleared for human use in the United States first, with a US clinic as its most visible partner, while its European approval waits on a trial that is not due to finish until 2028.

The Verdict

Biomendex has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.