The clinical evaluation, led by Dr. Henrik Kjölhede at Sahlgrenska University Hospital, tracked 18 patients to validate the safety and efficacy of the Multi4 System. The device integrates local anesthesia, tissue resection, biopsy collection, and coagulation into a single 2 mm instrument. This approach eliminates the need for general anesthesia and traditional hospitalization, addressing a significant bottleneck in urological care.
Following CE-mark approval, the company has begun patient treatments in Sweden. Multi4 Medical is now preparing to leverage this clinical data to accelerate its U.S. launch, where the system has already received FDA clearance. The company, backed by investors including Erik Selin and Fredrik Strömholm, aims to reduce waitlists and lower per-procedure costs by scaling this outpatient model to broader cancer indications.
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