Butterfly Medical and the EIC Accelerator: An Implant for BPH

Butterfly Medical, based in Yokneam, Israel, makes a nitinol implant placed in the urethra through the prostate that pushes apart the gland's enlarged side lobes, relieving the urinary symptoms of benign prostatic hyperplasia without cutting, burning or removing tissue. It was selected in the EIC Accelerator's March 2023 cut-off with blended finance and received an EU grant of €2.50 million for a €4.82 million project that ran from September 2023 to August 2025, according to CORDIS. The objectives were a smaller, fully disposable delivery system, FDA and EU MDR approvals, and a pivotal trial with 222 more patients in 20 European and US hospitals.

The final report says the company completed enrolment in its pivotal trial, finished developing the new delivery system and was "almost done with the required testing prior to launching a clinical trial", and passed its 2025 MDR audit "with zero findings", according to the CORDIS reporting page. The randomised, double-blind pivotal trial enrolled 244 patients and completed 12-month follow-up in January 2026, according to PR Newswire. Its results have not been published.

Where Butterfly Medical Stands Now

In May 2026 Butterfly raised $21 million in a Series C, above its target, with the European Innovation Council among new and existing investors, according to PR Newswire. Chief executive Patrick MacCarthy said "U.S. regulatory filings" were "underway" and the focus was on "preparing for commercialization". The device has a CE mark in Europe. The long-term follow-up of Israeli patients continues until 2027, according to ClinicalTrials.gov. The company's website news page has not been updated since 2022.

The Technology: Holding the Prostate Open

Benign prostate enlargement affects about half of men in their fifties and most men over 80, the company says. Drugs must be taken for life and can cause dizziness and sexual side effects; surgery removes tissue and needs hospital time. Butterfly's implant sits in the prostatic urethra and retracts the side lobes, it can be removed, and it is fitted under local anaesthetic. Competing minimally invasive treatments are already on the market in the US, so approval alone will not guarantee sales.

What the EIC Award Promised, and What the Record Shows

The EIC project promised a pivotal trial, a next-generation delivery system and approvals in the US and under the EU's medical device regulation. The trial exceeded its enrolment target and finished follow-up. The delivery system was developed but not yet tested in patients. MDR transition was progressing, and the FDA filing followed the project's end.

1. Pivotal trialDelivered244 enrolled, follow-up done.
2. New delivery systemPartialDeveloped, not in trial.
3. EU MDR certificationIn progress2025 audit, zero findings.
4. FDA approvalPendingFiling underway, 2026.

The Money

The EU paid 52% of the project. The final report says Butterfly raised about $12 million over its first eight years. Board chairman Nayan Parekh, of New Rhein Healthcare Investors, said the company had reached a stage similar to competitors "with less than half the capital". The EIC's contribution to the Series C is not disclosed.

What Cannot Be Checked

Why Europe Should Care

An ageing Europe will see more men with prostate enlargement, and office-based treatments can free operating theatres. Butterfly already holds a CE mark, so European patients could benefit before US ones. The EIC funding helped complete a large randomised trial, the kind of evidence many device start-ups never produce.

The Verdict

Butterfly Medical and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.