A Second Look at Vivostat's EIC Accelerator Bowel-Leak Sealant

When a surgeon removes a piece of cancerous bowel and joins the two ends, the join can leak. Stool escapes into the abdomen, and the patient may need another operation or may die. Vivostat, a Danish maker of sealants prepared from a patient's own blood, told the European Commission that its product Obsidian ASG "may therefore reduce leakage by more than 50%". In the European Innovation Council's October 2020 cut-off, the EU agreed to pay €2,140,775 of a €3,058,250 project to prove it in a randomised trial, according to CORDIS.

The trial ran. The proof has not arrived. Vivostat's final report on CORDIS says 277 patients were enrolled, that "final results are delayed", and that a final results report would follow on 30 April 2025, according to the project's periodic report. On ClinicalTrials.gov the study was last updated in July 2024, its status is now listed as "unknown" and no results are posted. No paper reporting the trial's outcome could be found in PubMed, and the company's news page does not mention it.

Where Vivostat Stands Now

Vivostat is active. It filed its accounts for the year to 30 April 2026 in July 2026, according to North Data, and it is advertising a live surgical workshop on Obsidian ASG at Kepler University Hospital in Linz for 6 and 7 December 2026 on its website. In 2025 it exhibited at European surgical congresses and became the Danish and Swedish distributor of a spinal endoscopy system made by Nexon Medical, according to its news page.

Its owner changed at the end of 2025. Vivostat International GmbH "has acquired 100% ownership of Vivostat A/S", which "will continue to operate independently with the same management team", the company announced without giving a price. The Danish register recorded the new shareholder on 16 December 2025, replacing TSJ Denmark Holding ApS, and the long-serving chair Gudmund T. Korsgaard, former managing director Sven Lange and board member John Riis Mortensen left the board that week, according to North Data; ownr also lists the GmbH as 100% owner. The buyer is a young company: it was registered in Vienna on 19 September 2025 with €100,000 of capital, lists real estate development and trade in medical instruments as its purpose, and has Erna Immobilien GmbH as shareholder, according to North Data. Who stands behind Erna Immobilien could not be verified.

The Technology: A Seal From the Patient's Own Blood

Surgeons join bowel ends with stitches or staples. Obsidian ASG adds a layer on top: the patient's own blood, about 120 millilitres in a Vienna study protocol, is processed in Vivostat's machine into a matrix of fibrin and platelets, which is applied to the join during the operation. The company says the matrix seals and releases growth factors that speed healing, and that no thrombin or bovine components are added, according to the objective of its earlier Phase 1 project. The same blood-processing system underpins Vivostat's older products: Vivostat Fibrin and Vivostat PRF for uses including cardiac, thoracic and burn surgery, Obsidian RFT for anal fistulas and ArthroZheal for arthroscopy, as listed on its website. Its Obsidian ASG page cites the low leak rate of 2.3% but no comparison with a control group.

The evidence for the leak claim is thin. It rests on a retrospective, single-arm study by surgeons at two Austrian hospitals, which found leaks in 6 of 261 patients, or 2.3%, without a control group, published in Surgical Technology International in 2021. A Danish feasibility study at Aarhus University Hospital, published in April 2025 in the International Journal of Colorectal Disease, applied Obsidian ASG in 50 rectal cancer operations. It was fully applied in 15 cases (30%) and "almost complete" in the rest, with problems including "material depletion, machine error, and time constraints", and the authors concluded that "further large-scale, multi-center randomized trials are needed". The Medical University of Vienna has published a protocol to test the sealant on 25 patients after pancreatic surgery.

What the EIC Award Promised, and What CORDIS Shows

The European Commission's list of the October 2020 EIC Accelerator pilot winners names Vivostat A/S of Allerød for OBSIDIAN, grant only, and no other beneficiary for the project. CORDIS lists Vivostat as sole participant. The grant agreement was signed on 21 April 2021 and the project ran from 1 May 2021 to 30 April 2024. A year before the pilot win, Vivostat had received €50,000 under the SME Instrument Phase 1 to design the trial. Its report from 2020 said that, to show a reduction in leaks of at least 33%, "the required sample was calculated to be 1.300 patients".

The trial that the EIC grant paid for was much smaller. The fact sheet promised a "large-scale multicenter clinical trial" in up to 15 hospitals in 7 countries with about 440 patients. The final report describes a "single-blind, randomized, multicenter pilot study (explorative design)" with about 250 patients at 15 sites in 6 countries, and ClinicalTrials.gov lists 13 sites in Austria, Germany, Italy, Serbia and Spain. Vivostat's own annual accounts called it "a pivotal randomized clinical trial" in 2022 and 2023, according to filings with the Danish Business Authority. Its accounts for 2023/24 said "the clinical data report is expected to become available in the spring of 2025". The accounts for 2024/25 and 2025/26 do not mention the trial.

1. Randomised multicentre trial, about 440 patientsPartly277 enrolled after the target was cut to about 250 and the design to an exploratory pilot, per CORDIS.
2. Final trial results report, 30 April 2025Not deliveredNo results on ClinicalTrials.gov, in PubMed or from the company by October 2026.
3. Market access and reimbursement, focus on GermanyDeliveredGerman OPS procedure code granted by January 2024 and reimbursement in South Africa, per the CORDIS report.
4. Commercialisation plan and distributor launchDeliveredPlan finalised; Obsidian ASG approved in the EU, Serbia, South Africa, Israel and the UAE, per CORDIS, and sold through distributors.

The commercial side moved further than the clinical one. The final report says Obsidian ASG is approved in the EU, Serbia, South Africa, Israel and the UAE, with registration under way in Brazil, Japan, Russia and Saudi Arabia, and that partnerships in the United States were dropped after the FDA said the product would need a Pre-Market Approval or a Biologics License Application. The project's promise of "accumulated revenue of EUR 53,49 million 5-year post-project" cannot be checked: Vivostat does not publish revenue, and its 2022/23 accounts said sales of Obsidian ASG, Obsidian RFT and ArthroZheal were "still at a relatively low level". In 2022/23 the company also bought "certain Intellectual Property Rights and marketing rights for Obsidian ASG covering most countries in Europe and the Middle East", booked as goodwill; the seller is not named. CORDIS names the Austrian company Rivolution as co-developer of the product.

The Money

Vivostat was already profitable when it applied. It made a net profit in every year from 2018/19 to 2025/26 except 2020/21, when COVID-19 postponed elective surgery and a supplier's bankruptcy forced a write-off of DKK 739,000. Sales also suffered from regulatory uncertainty after its British notified body, LRQA, stopped certifying in September 2019 because of Brexit; its new notified body, Eurofins in Italy, issued new CE certificates in May 2021, according to its annual accounts. The figures below match those on ownr.

The EU grant appears in the accounts as special income of DKK 8.772 million in 2021/22, DKK 4.785 million in 2022/23 and DKK 2.392 million in 2023/24, a total of about DKK 15.95 million. Over the same period, the company declared dividends of DKK 5 million for 2021/22, DKK 1.5 million for 2022/23 and DKK 3 million for 2023/24, paid to its then parent company. The filings do not link the two. No dividend was proposed for 2024/25.

Growth has not followed. Average staff were 10 in 2019/20 and 10 in 2025/26. Gross profit, the closest public measure of sales, was DKK 11.31 million in 2019/20 and DKK 13.97 million in 2025/26, down from DKK 14.69 million a year earlier. Net profit fell to DKK 1.47 million in 2025/26, cash dropped to DKK 123,079 while inventories rose to DKK 10.24 million, and bank loans stood at DKK 767,249, against none a year earlier. Equity stood at DKK 28.75 million. The company still carries an accumulated tax loss of DKK 75.95 million from its early years. The 2025/26 accounts were not audited but given an extended review by its accountants.

Why Europe Should Care

The CORDIS report counts more than 538,000 new cases of colorectal cancer in Europe each year, most of them treated with surgery, and leak rates of about 4% after colon and 10% after rectal resection. Cutting complications of cancer treatment falls under Europe's Beating Cancer Plan, which covers prevention, diagnosis, treatment and quality of life. Vivostat makes its device in Denmark and sells it through distributors across most of Europe, according to its website, and its 2025/26 accounts say 98% of revenue comes from exports, mainly to Europe.

The policy value of OBSIDIAN, though, lay in the evidence. A randomised trial was the step that could move a sealant backed by one uncontrolled study into routine surgical practice and reimbursement, and the company's own report expected it to "validate and support the implementation" of the product. Without published results, surgeons, payers and the EU have no randomised answer to the question the grant was meant to settle.

The Verdict

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