Most women who have surgery for stress urinary incontinence, the leaking of urine when coughing, sneezing or lifting, are treated with a strip of synthetic mesh placed under the urethra. The mesh works, but it can erode through the vaginal wall, and in 2018 the British government paused its use for this condition. Soranus, a company founded by Özgür Yeniel, a gynaecologist at Ege University in Izmir, developed a hand-held suturing device for a mesh-free alternative: an operation through the vagina that stitches the patient's own tissue to a ligament on the side wall of the pelvis.
The European Commission selected the project, VACS-D, in the EIC Accelerator pilot's 8 January 2020 cut-off as a grant-only award, listing "SORANUS ARGE VE DANISMANLIK HIZMETLERI SANAYI TICARET ANONIM SIRKETI" of Izmir as its only beneficiary and giving no website. CORDIS records an EU contribution of €683,375 towards a total cost of €976,250, with the company at Ege University's technology park in Bornova. The same legal name sponsors the device's trials on ClinicalTrials.gov, and the company's website, SoranusMed, cites grant agreement 954909, which ties the brand to the EIC winner.
Company file
- Legal entity
- Soranus Arge ve Danismanlik Hizmetleri Sanayi Ticaret A.S., trading as SoranusMed
- Headquarters
- Ege University technology park, Bornova, Izmir, Turkey
- Founder
- Prof. Özgür Yeniel, gynaecologist, Ege University
- Chief executive
- Ozer Baysal, formerly of Pfizer, per the company website
- Incorporated
- Not verified; the team formed in 2018, per CORDIS
- Products
- VACS device (incontinence); SmartUric (overactive bladder) and a prolapse device in development
- Investors
- Two unnamed angel investors, per the company's CORDIS report
- EIC project
- VACS-D, January 2020 cut-off, grant only, CORDIS 954909
- Staff
- Not public
Where Soranus Stands Now
Soranus is still working on the device. It sponsored a long-term follow-up of its trial patients that ran from February 2025 to March 2026, according to ClinicalTrials.gov, and on 7 and 8 October 2026 its doctors presented the trial results and a cadaver imaging study at the International Continence Society's annual meeting, in abstracts that name the company and the EIC grant (abstract 11 and abstract 104). Its website lists two further products in development: SmartUric, a wearable nerve stimulator for overactive bladder, and a device for pelvic organ prolapse that is "nearing the end" of development.
What the record does not show is a business. Neither the website nor any news source found for this article announces a market launch, a hospital customer, a distributor or a licensing deal for the VACS device. The company's legal status, accounts and staff numbers could not be checked: the Turkish Trade Registry Gazette at ticaretsicil.gov.tr only shows notices to registered users who log in, and no free register extract was found.
The Technology: Stitches Instead of a Sling
The standard operation, the midurethral sling, places a polypropylene tape under the urethra through a small vaginal cut; the transobturator tape (TOT) is one version of it. Before slings, the reference treatment was the Burch colposuspension, an abdominal operation that uses stitches, not mesh, to lift the tissue around the bladder neck. The CORDIS objective says VACS-D "preserves the advantages while eliminating the disadvantages" of both: it is done through one vaginal incision, like a sling, but relies on the patient's own tissue, like the Burch.
The procedure, vaginal arcocolposuspension (VACS), stitches the front vaginal wall to the arcus tendineus fascia pelvis, a band of connective tissue along the pelvic side wall. Doing that through a narrow vaginal opening is what the device is for. Its final version, according to the company's CORDIS report, has 14 parts, a purpose-made needle, a suture loading apparatus and a safety mechanism that controls how the needle passes from one jaw to the other. A cadaver study of eight pelvic specimens with MRI, presented at ICS 2026, found that VACS restored urethral support "comparable to Burch colposuspension, but through a distinct mechanism".
The mesh question in context
Slings have not been banned. The UK pause allowed them "when there is no viable alternative", and the European Commission's scientific committee concluded in 2015 that complications are higher with the larger meshes used for prolapse than with incontinence slings. The US Food and Drug Administration still describes mesh mini-slings as having "comparable clinical performance" to traditional slings. A mesh-free device therefore competes with an accepted, cheap standard, not with a withdrawn one.
What the EIC Project Promised, and What CORDIS Shows
The grant agreement was signed on 22 April 2020, two months after the Brussels interview that NTV, citing the İHA news agency, said was scheduled for 20 February 2020. In that report Yeniel said the prototypes had been built in an earlier project funded by KOSGEB, Turkey's small business agency, and that the EU application had been written with support from TÜBİTAK, the national research council. VACS-D ran from 15 June 2020 to 14 June 2022 and closed on schedule with two periodic reports.
The final report lists the work as done: a redesigned device, a new needle and loading tool, cadaver studies that were "100% satisfactory", a CE mark for a Class IIa device in the third week of May 2021, and a clinical study at Ege University Hospital and Istanbul University with 60 patients. It also set targets beyond the project: sales of "a minimum of 1.250.000 units" in the first five years, and 43 hires (5 engineers, 10 sales and marketing staff, 3 regulatory officers and 25 production workers) in the first two years after launch. The CE mark is documented only by the company's own report; its website does not mention it, and no second source for it was found.
- Final device design, needle and loading toolDeliveredDescribed in the CORDIS report; a US patent for the suturing device was granted in 2024, per Google Patents.
- Cadaver studiesDeliveredReported on CORDIS; MRI cadaver study presented at ICS 2026.
- CE mark, Class IIaCompany claimMay 2021, per the CORDIS report only.
- Randomised clinical studyLateCompleted in October 2023, 16 months after the project ended.
- Patent protection for the original devicePartialThe PCT family cited on CORDIS lapsed in the US and Europe; newer suturing device patents were granted.
- Market launch and 1,250,000 units in five yearsNot achievedNo launch, sale or distributor announced.
- 43 hires after launchNot achievedNo launch, and no hiring announced.
The Trial: Small, Unblinded and Encouraging
The randomised trial compared VACS with transobturator tape at Ege University and Istanbul University from 7 January 2022 to 6 October 2023, according to ClinicalTrials.gov. It was open-label, so surgeons and patients knew which operation was done. The registry entry was first submitted on 28 November 2023, after the study had ended, so it was registered retrospectively.
The results presented at ICS 2026 favour the device on paper. Objective cure at 12 months was 88.9% for VACS against 77.8% for the sling, and 64.7% against 61.1% at an extended follow-up of about 43 months. The authors report no mesh-related complications in the VACS group and two cases of delayed mesh extrusion with the tape, and conclude that VACS gives "comparable continence outcomes" without synthetic material. They do not claim superiority, and with 57 women at 12 months and 36 at the long-term visit the trial is too small to settle the question.
The sources disagree on the details. ClinicalTrials.gov records 67 women enrolled, while the CORDIS report and the ICS abstract give 60. The company's website speaks of "48-month follow-up" data, while the abstract describes about 43 months. The website also says the device was "shown to be equally effective", which matches the abstract's wording of comparability rather than an advantage.
The Money and the Patents
The CORDIS report says two angel investors joined the board at a valuation of "15 million USD" and that "EIC support helped us to create a 15 Million USD valued company in two years". The investors, the amount invested and the date are not named, and no second source for the round was found. Soranus is not among the 326 companies on the EIC Fund portfolio list, checked across all 17 pages; its award was grant only. CORDIS lists VACS-D as the company's only EU project.
The intellectual property has shifted. The patent CORDIS cited, PCT/TR2019/050048, was first filed by Ege University in March 2018 with Yeniel as inventor and transferred to Soranus in May 2021. Its European application was deemed withdrawn in 2025 and its US application was abandoned, according to Google Patents. A newer suturing device, with Turkish priority from September 2021, is protected by US patents 11,931,022, granted on 19 March 2024, and 12,383,256, granted on 12 August 2025, both assigned to Soranus.
What could not be verified
The company's incorporation date, filed accounts, staff, revenue, the angel round, the CE certificate and whether the device has been sold to any hospital. The Turkish register could not be checked without a login, and the company has published no figures.
Why Europe Should Care
Stress urinary incontinence is common and mostly affects women, and the European debate over vaginal mesh has created demand for surgery that does not leave implants behind. A CE-marked, mesh-free device that matches the sling would give surgeons in Europe an option that does not depend on the mesh products under scrutiny since the Commission's 2015 scientific opinion. VACS-D is also an example of Horizon 2020 money reaching Turkey, a programme to which, as Yeniel noted in the NTV report, the country itself contributed.
What the company said
A surgical approach that "will become the method of choice", a company valued at $15 million, and 1,250,000 devices sold in five years.
What the record shows
A finished device, a CE mark claimed in May 2021, a trial of 60 to 67 women with results on a par with the sling, and two US patents. No launch, customer or partner is public.
The Verdict
The engineering got done, the business did not show up
The EIC grant paid for what a small surgical device company needs before it can sell: a finished instrument, a CE mark by the company's account and a randomised trial against the standard of care. The results support the claim that the mesh-free operation works about as well as a sling. Six years after the award, though, there is no public sign that the device is being sold, and the sales and hiring targets in the final report remain unmet.
Soranus has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.
Sources
- CORDIS, VACS-D fact sheet and periodic report
- European Commission, EIC Accelerator selected companies, 8 January 2020 cut-off
- ClinicalTrials.gov, NCT06173180 and NCT07483138
- ICS 2026, abstract 11 and abstract 104
- SoranusMed website
- NTV (İHA), 18 February 2020, archived copy
- Google Patents, US 11,931,022, US 12,383,256, EP 3749223 and US 2024/0050090
- EIC Fund, invested companies
- Turkish Trade Registry Gazette
- UK government, pause on vaginal mesh for incontinence, 17 July 2018
- European Commission, SCENIHR opinion on surgical meshes, 17 December 2015 and European Association of Urology summary
- US FDA, stress urinary incontinence surgical mesh considerations
