Multi4 Medical, a Swedish company founded by the urologist Miden Melle-Hannah, makes a 2-millimetre instrument that fits through a standard cystoscope and does four jobs in one: it injects local anaesthetic into a bladder tumour, cuts it out, transports the tissue out through the instrument into a container for pathology, and cauterises the wound. The aim is to replace transurethral resection, done in an operating theatre under general or spinal anaesthesia, with a 20-minute procedure on an awake patient in a urology clinic. Its EIC Accelerator project receives an EU contribution of €2,493,000 and ran from September 2024 to August 2026, according to CORDIS.

The project's first report describes a single-centre, first-in-human study of 17 patients under local anaesthesia, in which all four functions worked as intended with "no unexpected safety signals", according to CORDIS. The US Food and Drug Administration cleared the Multi4 System under 510(k) number K250522 on 27 June 2025, according to the FDA database. It received its CE mark in May 2026, according to Multi4 Medical. In September 2026 the study was published in BJU International and Multi4 began treating patients in Sweden, according to Multi4 Medical.

Jun 2025FDA 510(k) clearance
May 2026CE mark
2 mmInstrument diameter
17-18Patients in clinical evidence

Company file

Legal entity
Multi4 Medical AB, Jönköping
Founder and CEO
Miden Melle-Hannah, urologist
Chairman
Erik Selin
Product
Multi4 System, single-use four-in-one instrument
Clinical partner
Sahlgrenska University Hospital, with RISE
Approvals
FDA 510(k) K250522, CE mark
EIC funding
Grant only, €2.49M

Where Multi4 Medical Stands Now

Multi4 says it has started commercial patient treatments in Sweden and is preparing clinical operations in the United States, where it reports strong interest from urology clinics and ambulatory surgery centres. It says an established reimbursement code supports adoption. The company is backed by the property investor Erik Selin, its chairman, and a group of private medtech investors; the amounts invested have not been disclosed. Its Swedish accounts were not accessible in free sources.

"The CE mark is a historic milestone for Multi4 Medical and for cancer care in Europe."

Miden Melle-Hannah, urologist and CEO of Multi4 Medical, May 2026

The Technology: Four Tools Through One Channel

Bladder tumours are usually found by cystoscopy in a clinic, then removed weeks later in a scheduled operation. Multi4's instrument lets the urologist treat at the point of detection. The EIC report says it works with commonly used cystoscopes without modification and that tissue samples were adequate for pathology. Bladder cancer recurs often, and each recurrence means another procedure, so a cheaper outpatient option addresses a repeat cost.

What the EIC Award Promised, and What the Record Shows

The project set out to show safety and tolerability in a first-in-human study cleared by a national authority, to build the evidence for CE marking and to prepare for market. All three happened within the project period or weeks after it. The evidence base is small: the EIC report counts 17 patients, while the company and the BJUI paper count 18, in a single hospital. Larger studies on recurrence and health economics are described as next steps.

  1. First-in-human studyDeliveredSahlgrenska.
  2. CE markingDeliveredMay 2026.
  3. Market introductionStartedSweden, Sep 2026.
  4. Recurrence and cost dataNot yetFuture studies.

The Money

The EIC award was a grant only, with no equity. Multi4 has not disclosed any funding round, its revenue or its price per instrument. Sweden's innovation agency Vinnova lists an earlier Multi4 project among those it funded, according to Vinnova.

What Cannot Be Checked

Questions for the EIC

How many patients have been treated commercially, how many hospitals have bought the system, what it costs compared with an operating-theatre resection, and why the study's patient count differs between the EIC report and the company are not public.

Why Europe Should Care

The EIC report calls bladder cancer one of the most expensive cancers to manage, with practice little changed since the 1960s. Moving treatment out of operating theatres frees scarce capacity and anaesthesia staff. A Swedish device that reached both US and European approval within the EIC grant period is a rare quick result for the programme.

What the award promised

A first-in-human study, evidence for CE marking and market preparation.

What the record shows

Study done, FDA clearance, CE mark and first patients treated.

The Verdict

Delivered, evidence still thin

Multi4 did what it told the EIC it would do. Whether urologists adopt it at scale depends on larger studies still to come.

Multi4 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.