Saphenus Medical Technology, registered in Krems an der Donau in December 2016 and based in Baden near Vienna since 2022, makes Suralis, an add-on that lets people with a leg amputation feel their prosthetic foot touch the ground. Sensors in a sock pulled over the prosthetic foot measure pressure at the heel and forefoot, and a cuff on the residual limb turns those readings into vibrations in step with each stride. The European Commission's list of the January 2020 EIC Accelerator pilot winners lists Saphenus, of Krems an der Donau, as the only company on BFS, "Bionic Feedback System for Amputees and Diabetics", with grant-only funding. CORDIS records an EU contribution of €1,806,000 towards a total cost of €2,580,000, from 1 September 2020 to 31 August 2022.
The grant was meant to bring two products to market: SURALIS for amputees and CUTANEUS for the 7.5 million people in Europe with polyneuropathy, the nerve damage that often comes with diabetes. Six years on, Suralis is sold and paid for by insurers in Germany, Austria and Italy, according to both the project's final report and its sensor supplier IEE. CUTANEUS has not appeared.
Company file
- Legal entity
- Saphenus Medical Technology GmbH, Firmenbuch FN 462419d
- Registered
- 6 December 2016, Krems an der Donau
- Seat
- Hauptplatz 9-13, 2500 Baden, since October 2022
- Managing directors
- Rainer Schultheis (CEO) and Aaron Pitschl (CTO)
- Share capital
- €877,727 (March 2025)
- Known shareholders
- Toni Innauer GmbH, fair-finance SEVECA 1 GmbH & Co. KG; 14 active shareholders in total
- Products
- Suralis, Suralis Med (therapy kit), Hyperion (vibration therapy)
- EIC project
- BFS, EIC Accelerator pilot, January 2020 cut-off, grant only
- Staff and revenue
- Not public
Where Saphenus Stands Now
Saphenus is active. The Austrian company register shows it still registered, with annual accounts for 2025 filed in September 2026, according to the official publication platform EVI and North Data. Neither shows an insolvency filing. North Data also lists a patent publication in July 2026 and three grants from the Austrian research agency FFG between September 2024 and May 2026, of €198,396, €190,185 and €219,218. In September 2026 the company started a newsletter that it said would go out six times a year, according to its website.
The filed accounts themselves are behind paywalls, so turnover, results and headcount could not be checked. The share capital rose from €775,000 in October 2019 to €877,727 in March 2025, with new shareholders joining in 2022, 2023 and 2025, North Data shows; how much those investors paid in premium is not public. A funding database, VC Backed, lists a $599,000 "seed" round in January 2025 with the EU agency EISMEA as investor. CORDIS shows no Saphenus project after BFS, so that entry could not be verified.
The Technology: Vibrations That Stand In for a Foot
After an amputation, the brain still expects signals from the missing foot. Saphenus bets that feeding it ground-contact signals again reduces phantom pain and makes walking safer. Suralis works with any make of prosthesis, for above-knee and below-knee amputees, according to the company's FAQ. It can be combined with surgery: in targeted sensory reinnervation, a surgeon reroutes a sensory nerve from the amputated part of the leg to a patch of skin on the stump, which then serves as the contact point for the vibrations, as a team from Hannover Medical School described in Unfallchirurgie in 2024.
Systems that restore sensory information had "so far only been the subject of study protocols", that 2024 paper says (translated). Saphenus' claim to be first is therefore about a commercial, non-invasive product, not the idea. Its newer product, Hyperion, is a vibration therapy against phantom pain aimed at less active users, with vibration elements on the stump set up through a smartphone app, for €129 a month with a three-month minimum, according to the product page.
"The Suralis system powered by IEE is now clinically approved and reimbursed in several European countries, including Germany, Austria, and Italy."
IEE, sensor supplier to Saphenus, 8 October 2025What the Clinical Evidence Shows
The evidence is thin. The first paper cited by the EIC project was a case series of four amputees who had the nerve surgery and then wore a feedback device: all four reported significantly less pain, and two became pain-free, according to the Journal of Clinical Medicine in September 2021. The paper's conflict-of-interest statement declares that its lead author, the surgeon A. Gardetto, is Saphenus' chief medical officer.
The larger test was a randomised cross-over trial funded by the Austrian workers' compensation board AUVA. Its status on ClinicalTrials.gov is "terminated": it enrolled 18 people from October 2021, stopped in May 2022 because "recruitment rate of patients was not sufficient during COVID-19" and because of "problems with the quality of the primary outcome data collected", and was only registered in May 2023, after it ended. The results, published in Clinical Biomechanics in 2025 with Saphenus' CEO and CTO among the authors, found that the primary measure, stance time on the affected leg, "did not change". The authors reported "a small positive effect on functional balance and gait performance in slower-walking participants", based on 13 people who completed the trial.
Evidence gap
No published controlled trial of Suralis has phantom pain as its main outcome. The strongest pain data come from four surgical patients, reported by the company's own medical officer.
What the EIC Grant Promised, and What CORDIS Shows
BFS was Saphenus' second EU grant. A Phase 1 feasibility study, IPS, received €50,000 from August 2018 to January 2019, according to CORDIS, and the BFS objective says the Phase 1 business plan "shall now be further implemented". The project ran its full 24 months. Its final report lists the 2021 case series, a "therapy concept" deliverable, reimbursement precedents in Germany, Austria and Italy, talks with health institutions in the Arab world, new Saphenus research and development centres and the "Austria's Born Global Champion" title in September 2021. It says the first-year multicentre study was delayed by COVID-19 and that suppliers missed delivery dates for "further series development".
The report mentions polyneuropathy patients only as a future group. It names no CUTANEUS prototype, study or launch, and the company's current website offers only products for amputees. The FFG's success story on the project repeats the 7.5 million polyneuropathy patients as the target group but cites no product for them either.
- SURALIS for amputees on the marketDeliveredFirst user fitted in 2021 per the company; reimbursed in DE, AT and IT per CORDIS and IEE.
- CUTANEUS for polyneuropathy and diabeticsNot deliveredNo prototype, study or launch announced.
- Multicentre clinical studyNot achievedTerminated early with 18 enrolled; main measure unchanged.
- Insurer reimbursementDeliveredPrecedents in three countries; German statutory insurers and the BG pay, per the company.
- Project completed on timeDeliveredClosed August 2022 after 24 months, report published.
Customers, Partners and an FDA Claim
In October 2024 Saphenus' CTO and CFO presented Suralis at Ternopil National Medical University in Ukraine, which reported that "six hundred Suralis feedback system devices are already used in Europe and the USA", according to the university's report. The figure was given at the company's visit and could not be checked against any filing. In November 2024 Saphenus named Uniprox as its distribution partner in Germany, in a website announcement that carries only the headline and logo.
In April 2024 the company announced that Suralis had received "FDA-Zulassung", US approval, in a post that gives no clearance number or device class. The FDA's establishment registration and device listing database returns no establishment named Saphenus and no device with the proprietary name Suralis, and the FDA's open data return no 510(k) clearance for either name. What kind of US status the company holds could not be verified.
What the company says
The world's first feeling leg prosthesis, US approval, and "the first Austrian company" funded by the EIC Accelerator "of Horizon Europe".
What the record shows
A reimbursed product in three countries, no FDA database entry, one trial stopped early, and a Horizon 2020 pilot grant, not a Horizon Europe one.
The last point matters for accuracy rather than substance. A 2024 company post calls Saphenus the first Austrian company to receive the EIC Accelerator "von Horizon Europe"; CORDIS files BFS under Horizon 2020's SME Instrument, the programme the EIC Accelerator pilot ran under before Horizon Europe began in 2021.
The Money
Public money has carried much of the company's development. Besides the two EU grants, North Data lists Austrian seed financing of €576,000 and €60,000 in March 2018, €400,000 under a COVID-19 aid scheme in December 2021, and the three FFG grants since 2024. Saphenus is not on the EIC Fund's list of invested companies, which names 326 organisations across 17 pages; the 2020 award was grant only, so no EIC equity was expected. Early backers include Toni Innauer GmbH, a shareholder since January 2018, and the fund fair-finance SEVECA 1, which joined in October 2022, according to North Data.
Why Europe Should Care
The EU counts 90 million people with a disability and, in its updated strategy for the rights of persons with disabilities, adopted on 6 May 2026, lists "accessible and affordable assistive technologies" as a key action. A retrofit that works on any prosthesis and is paid for by public insurers fits that aim better than a new high-end limb. The war in Ukraine has added demand: Ternopil's university cited unofficial data of 200,000 Ukrainian amputees when Saphenus visited, and said patients in Ukraine were already using the device.
The Verdict
Half the grant delivered
Saphenus turned its amputee product into something insurers in three countries pay for. The diabetic half of the BFS grant never shipped, the one controlled trial missed its main measure, and the company's US approval claim cannot be found in FDA records.
Saphenus and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Sources
- CORDIS, BFS fact sheet
- CORDIS, BFS periodic report
- CORDIS, IPS fact sheet
- European Commission, EIC Accelerator selected companies, 8 January 2020 cut-off
- EVI, Saphenus Medical Technology GmbH publications
- North Data, Saphenus Medical Technology GmbH
- EIC Fund, invested companies
- ClinicalTrials.gov, NCT05895253
- Clinical Biomechanics, randomised cross-over trial, 2025
- Journal of Clinical Medicine, case series of four patients, 2021
- Unfallchirurgie, gait-synchronised vibrotactile feedback, 2024
- IEE, Medical Innovation Award 2025
- Ternopil National Medical University, Saphenus visit, October 2024
- FFG, Success Story: Bionic Feedback
- Saphenus, FDA announcement, April 2024
- FDA, establishment registration and device listing search
- Saphenus, reimbursement in Germany, April 2024
- Saphenus, Uniprox distribution partner, November 2024
- Saphenus, awards, April 2024
- Saphenus, about us
- Saphenus, FAQ
- Saphenus, Hyperion
- Saphenus, newsletter, September 2026
- VC Backed, Saphenus Medical Technology
- European Commission, strategy for the rights of persons with disabilities
