Multi4 Medical Publishes Landmark Clinical Study in Prestigious BJUI - Initiates First Patient Treatments in Europe
First-in-human study in British Journal of Urology International confirms bladder cancer treatment can shift from the operating room to the outpatient clinic-enabling complete treatment and diagnostic sampling in minutes on awake patients.
GOTHENBURG, Sweden, Sept. 14, 2026 /PRNewswire/ -- Multi4 Medical, a pioneering medical technology company, today announced the publication of its landmark clinical research in BJU International (BJUI), one of the world's most prestigious and high-impact urology journals. The peer-reviewed study, "First-in-human outpatient management of recurrent NMIBC with the Multi4 instrument," details the complete development journey—from initial concept and prototype through preclinical and clinical validation—culminating in the world's first all-in-one instrument for outpatient bladder cancer management that performs both therapeutic treatment and diagnostic tissue sampling in a single, rapid procedure.
In parallel with this publication, Multi4 Medical has initiated its first patient treatments in Sweden, following the receipt of its CE-mark approval earlier this year.
From Clinical Breakthrough to Market Reality
The study, conducted at Sahlgrenska University Hospital under the leadership of Dr. Henrik Kjölhede (Department of Urology) in collaboration with Joakim Håkansson at RISE (Research Institutes of Sweden), demonstrates that patients with Non-Muscle Invasive Bladder Cancer (NMIBC) can be successfully and safely treated with the Multi4 System in an office-based outpatient setting, completely eliminating the need for general anesthesia, operating rooms (ORs), or hospitalization.
"Having our peer-reviewed data published in BJUI at the exact moment we begin treating patients in the clinic is a spectacular milestone. It proves what is possible when disruptive innovation creates immediate value for all stakeholders: patients receive faster and safer care, urologists gain a vastly superior tool, and the healthcare system achieves unprecedented operational efficiency and cost savings. It is incredibly rewarding to have reached this inflection point," says Dr. Miden Melle-Hannah, urologist, founder, and CEO of Multi4 Medical.
New All-In-One Technology
The Multi4 instrument features a highly integrated, patented design packed into a single 2 mm micro-instrument. During a standard outpatient visit, the urologist can use this single tool to:
- Apply local anesthesia directly to the tumor.
- Precisely resect the cancer tissue.
- Automatically extract and retrieve the tissue samples into an integrated container for pathology analysis.
- Perform coagulation and ablation to control bleeding as needed.
This entire procedure is performed on an awake patient in a matter of minutes, replacing a highly resource-intensive, scheduled surgery under general anesthesia (TURBT) with a simple outpatient care intervention.
Exceptional Speed of Execution and Global Scalability
Multi4 Medical has achieved an extraordinary series of regulatory and scientific milestones signaling world-class execution:
- FDA Clearance secured for the US market.
- CE-Mark Approval obtained for the European market.
- BJUI Publication validating first-in-human clinical efficacy.
- Commercial Launch with active patient treatments underway in Europe.
"Multi4 Medical is a prime example of world-class medtech innovation and execution," says Erik Selin, Chairman of the Board. "To secure FDA clearance, CE-mark approval, publish in a top-tier peer-reviewed journal, and transition directly into clinical patient treatments demonstrates exceptional speed and execution capability".
Parallel US Market Expansion
With FDA clearance already secured, Multi4 Medical is working in parallel to launch clinical operations in the United States. Demand and interest from leading US urology clinics and Ambulatory Surgery Centers (ASCs) are exceptionally strong. The clinical data and real-world experience gained from the initial European roll-out will serve as a powerful catalyst to accelerate commercial adoption across the US, where shifting procedures out of the expensive OR setting is a massive economic driver for payors and providers.
Unlocking Substantial Value for Patients and Healthcare Providers
The BJUI publication confirms that the Multi4 technology is safe, highly effective, and clinically viable.
- For Patients: Immediate treatment upon cancer detection (eliminating weeks of anxiety), no risks associated with general anesthesia, same-day discharge, and minimized risk of complications.
- For Providers & Payors: Significant reduction in OR waitlists, cost-per-procedure savings, and increased clinical throughput.
About the Study
The published paper details the clinical evaluation of 18 patients with recurrent NMIBC at Sahlgrenska University Hospital, demonstrating outstanding safety and procedural success. It represents the first clinical proof-of-concept for complete outpatient bladder cancer management.
Access the full study here: https://onlinelibrary.wiley.com/doi/full/10.1111/bju.70445
For more information, please contact:
Dr. Miden Melle-Hannah
Urologist, Surgeon, Founder & CEO, Multi4 Medical
+46 73 692 90 00
[email protected]
About Multi4 Medical
Multi4 Medical is a Swedish medical technology pioneer developing patented, automated systems for cancer diagnostics and treatment. The company's flagship product, the Multi4 System, revolutionizes bladder cancer care by moving treatment from the operating room to the outpatient clinic. Backed by both FDA clearance and CE-mark, Multi4 Medical is a portfolio company of real estate magnate Erik Selin, alongside a syndicate of highly respected, active medtech investors including Fredrik Strömholm, Per Langö, Emil Billbäck, Erik Gatenholm, and Ulf Rosén. The proprietary platform technology is highly scalable and is currently being developed for application in other cancer indications.
Multi4 Medical is the recipient of numerous prestigious industry accolades, including Startup Company of the Year (Techarenan), a €2.5 million grant from the European Innovation Council (EIC), and participation in the prestigious global MedTech Innovator accelerator program.
Dr. Miden Melle-Hannah
Urologist, Surgeon, Founder & CEO, Multi4 Medical
+46 73 692 90 00
[email protected]
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The following files are available for download:
PRESS RELEASE 260914 US pdf |
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Multi4 -first All-in-one device for cancer treatment |
SOURCE Multi4 Medical
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