ProArc Turned an EIC Accelerator Grant Into a Reworked BPH Implant

ProArc Medical wants to treat an enlarged prostate by cutting a shallow groove inside it and seating a small nitinol ring in the cut, so the ring holds the urethra open. In 2019 the European Union backed that idea with an EU contribution of €1,943,725 towards a €2,776,750 project called ClearRing, according to CORDIS. The stated aim was a randomised clinical trial at three medical centres that would "enable ProArc to obtain the CE mark" and then apply for reimbursement. The project closed on 31 January 2022. Neither the randomised trial nor a CE mark is on the public record. The device has since been renamed Omega, and in October 2026 it is still being tested in two small single-arm studies, according to ClinicalTrials.gov.

ProArc was selected at the 3 April 2019 cut-off of the EIC SME Instrument Phase 2, the Horizon 2020 pilot that preceded the EIC Accelerator, and appears as the sole beneficiary of ClearRing in the European Commission's list of selected companies. The award was a grant only, with no equity. The company announced it in July 2019 as a "$2.2 million" grant, according to its press release and Globes.

Where ProArc Stands in 2026

ProArc Medical Ltd is a private company listed as active in the Israeli Registrar of Companies, incorporated on 26 July 2010, with its last annual report filed for 2024 and a registered address in Yokneam Illit, according to the registrar's open data. Israeli private companies do not publish their accounts, so revenue, losses and equity could not be checked.

The clearest recent sign of life is a financing. On 1 July 2026 the Trendlines Group, the Singapore-listed Israeli incubator that co-founded ProArc, announced that it and companies related to its controlling shareholder Librae Holdings would each put up to $195,000 into "ProArc Ltd." through a simple agreement for future equity (SAFE), according to its SGX filing; the Trendlines June 2026 update repeats it. A SAFE converts into shares at a later priced round, so the filing implies that round has not yet happened. The Israel Innovation Authority lists ProArc as a 2024 winner of its Expedited Program, at the R&D stage with 10 employees, according to its company page.

Both Omega studies were updated on ClinicalTrials.gov in September 2026 and show the status "active, not recruiting", with primary completion reached on 30 April 2026 and final completion expected in February 2027, according to the records for the Israel and New Zealand study and the Georgia pilot. No results have been posted. The company's website says "early interim results have exceeded expectations" but gives no numbers, and announces a US Food and Drug Administration pivotal trial "launched in 2027, enrolling over 200 patients in the United States and Canada". The website still carries the EU acknowledgement for grant agreement 872707.

The Technology: A Ring Cut Into the Prostate

Benign prostatic hyperplasia (BPH) is the non-cancerous enlargement of the prostate with age, which squeezes the urethra and makes urination weak, frequent and incomplete. Men are usually treated first with drugs, and then with surgery that removes tissue, such as transurethral resection of the prostate, which works but carries risks including sexual side effects. Between the two sit minimally invasive treatments, among them implants that pull the prostate lobes apart from inside the urethra.

ProArc's device combines a small incision with an implant. A delivery device is passed through the urethra, a balloon widens the narrowed section, a diathermy (electrical cutting) unit makes a shallow circular incision, and a super-elastic ring is released into the groove so that it sits inside the tissue rather than in the urine stream, according to a CORDIS results article from July 2022, which says the procedure takes less than 10 minutes. Burying the ring is meant to avoid the migration and encrustation (mineral build-up) that affect stents left in the urethra; CORDIS's project summary goes further and claims "0% chance of migration or encrustation", a claim no published data checked for this article supports.

The Omega is the same concept under a new name. The trial records describe "an implant delivered into the prostate tissue" placed in a "circumferential incision" made by "a static diathermy incision mechanism", and call it a "prostatic reshaping device", the phrase used for ClearRing in the first-in-human study registered in 2015. The company's website now pitches it as a "dual therapy" that combines incision with mechanical retraction. The Trendlines portfolio page lists ProArc's product as "the Omega solution".

What the EIC Project Promised, and What the Record Shows

ClearRing was ProArc's second EU grant. A four-month SME Instrument Phase 1 feasibility study from January to April 2018 received €50,000 to plan the market launch, supply chain and the clinical and regulatory route towards ISO 13485 and a CE mark, according to CORDIS. The Phase 2 grant agreement was signed on 16 September 2019, with the project start set at 1 August 2019 and end on 31 January 2022.

The project's single published periodic report, for the period ending 31 January 2022, says ProArc "optimised the ClearRing implant and delivery system", reshaped the implant "for improved safety and efficacy" and implemented "an electronic delivery system". On the trial, it says "Ethics documents" had been submitted in several locations, the protocol had been "fully defined" and "first surgeries are expected in early 2021", according to the CORDIS reporting page. The report contains no trial results.

Six months after the project ended, the CORDIS results article said ProArc was "getting ready for its multicentre pilot study" of its latest device, after which it would apply for regulatory approval and run "a large-scale global pivotal study", with market entry expected "in 3 to 4 years". ClinicalTrials.gov dates the first enrolment in the two Omega studies to 7 February 2023 in Georgia and 23 July 2023 in Israel and New Zealand, about 12 and 18 months after the EIC project closed. Neither study is randomised: both have a single treatment arm and no control group.

1. Optimised implant and delivery systemDeliveredReshaped implant and electronic delivery system, per the periodic report; now in trials as Omega.
2. Randomised trial at 3 medical centresNot achievedNo trial enrolment registered during the project; the studies started in 2023 are single-arm.
3. CE markNot achievedNo CE mark announced by the company or reported by any third party.
4. Reimbursement in target countriesNot achievedNo product on sale, so no reimbursement.
5. Clinical results of the redesigned deviceNot publicInterim results claimed on the website; none posted on ClinicalTrials.gov.

The clinical record before the award is also thin in public. The first-in-human ClearRing study enrolled 29 patients at Rambam in Haifa and Pauls Stradins Clinical University Hospital in Riga between December 2015 and May 2019, but its registry record has no posted results. CORDIS says that trial put ClearRing "next to the gold standard treatment in terms of efficacy", without numbers. The one peer-reviewed paper found, in Current Urology in 2018 and funded by ProArc, describes the implant in eight dogs, with significant widening of the urethra and no severe complications.

The Money

ProArc's funding is hard to pin down. Caplight's company profile puts total funding at $2.2 million and lists a Series A in May 2023 with no amount, while StartupIM's company record gives $19.0 million. Neither cites its source, and neither figure could be confirmed. What the primary records show: the two EU grants totalling €1,993,725; Israel Innovation Authority grants, which the company and the Authority both mention; a September 2020 round in which Agriline and the Trendlines Group invested about $3.0 million and $0.8 million respectively across four portfolio companies including ProArc, with no split given, according to Trendlines; and the July 2026 SAFE of up to $390,000.

Trendlines held 18.65% of ProArc's outstanding shares and 15.83% on a fully diluted basis, according to its 2022 annual report. Tiger Brokers reported in April 2025 that Librae-related entities would invest about $1.9 million in ProArc Medical and another Trendlines company, Sol Chip, combined; the underlying SGX filing was not found, so the amount for ProArc could not be verified.

Why Europe Should Care

Europe's population is ageing, and enlarged-prostate symptoms rise with age; ProArc's own CORDIS summary says over 70% of men in their 60s have them. A cheap outpatient procedure that preserves sexual function would ease pressure on urology departments, which was the public-health case the EU funded. The European angle of the project was regulatory: the grant paid for the evidence to reach a CE mark under EU device rules, now the Medical Device Regulation (EU) 2017/745, and reimbursement in European health systems.

That is not where the company is heading. Its trial sites are in Israel, New Zealand and Georgia, none of them EU member states, and its website names a US and Canadian pivotal trial as the next step, with a clinical advisory board drawn from Texas, New York, Florida, Toronto and Montreal as well as New Zealand. Riga, the one EU site in ProArc's trial history, appears only in the study completed in 2019. No plan for a European launch is public.

The Verdict

A grant funds development, not sales, and urology devices take years to prove. ProArc has kept the technology alive through a change of chief executive, from David Nitsan in 2019 to Gilad Hizkiyahu by 2022, and has kept investors on board. Whether the Omega becomes a product depends on results that are not yet public and a pivotal trial that has not yet started. This article is based on public records and published statements, linked throughout; ProArc was not asked for comment.