#Sweden #Gothenburg #Bladder Cancer #CE Mark #Multi4 Medical

Breakthrough in Bladder Cancer Treatment by Multi4 Medical

The Swedish MedTech firm, Multi4 Medical, has reached a major milestone by securing the CE mark for its innovative Multi4 System, which revolutionizes the approach to bladder cancer treatment. This unprecedented system allows for cancer detection and treatment in a single outpatient visit, eliminating the need for an operating room, general anesthesia, or hospitalization. The significance of this breakthrough cannot be overstated, as it represents a paradigm shift in the field of urologic cancer care across Europe.

The Multi4 System: A Game Changer for Patients

The Multi4 System is heralded as the world's first all-in-one instrument that enables urologists to perform comprehensive treatments endoscopically on awake patients. This previously cumbersome procedure, which typically required a scheduled surgery and anesthesia, has been distilled into a swift process that can be accomplished within minutes during a routine doctor's visit. Dr. Miden Melle-Hannah, urologist and CEO of Multi4 Medical, emphasized the groundbreaking nature of this achievement:

"The CE mark is a historic milestone for Multi4 Medical and for cancer care in Europe. The Multi4 instrument integrates all necessary functions into a single compact device and is the first system where cancer tissue is automatically transported out through the instrument itself and captured in a container. This makes treatment streamlined, safe, and feasible in an outpatient setting."

The system incorporates advanced technology to enable local anesthesia application directly to the tumor, precise resection of cancerous tissue, and automated transportation of tissue samples to ensure timely pathology analysis. Should complications, such as bleeding, occur, the system is equipped to address them all while the patient remains awake, allowing them to return home immediately after the procedure.

Advantages Over Conventional Methods

Historically, the standard approach to bladder cancer treatment involves a transurethral resection of bladder tumor (TURBT) procedure, which is labor-intensive. This involves an operating room environment and general anesthesia, with long waiting times for patients. In contrast, the Multi4 System allows immediate procedures right after detection, significantly reducing patient wait times while alleviating pressure on operating departments and providing a more cost-effective solution for healthcare systems. Remarkably, the Multi4 System is already backed by a reimbursement code that simplifies its implementation across hospitals.

Clinical Validation and Regulatory Approvals

The CE mark certification was achieved following a successful clinical study at Sahlgrenska University Hospital, where results showed the efficacy of the Multi4 System in 18 patients, all of whom received treatment with outstanding outcomes. Dr. Melle-Hannah stated,

"With the Multi4 System, we can transform the entire care pathway for bladder cancer patients – from scheduled hospital surgery to immediate outpatient treatment. We now look forward to offering Swedish patients treatment with the Multi4 System."

This milestone follows a remarkable regulatory journey for Multi4 Medical, which earlier this year also received FDA clearance for the U.S. market. The dual certification opens up avenues for commercial operations in both Europe and the United States, positioning Multi4 Medical at the forefront of innovative cancer treatment.

Recognitions and Future Prospects
Multi4 Medical has garnered several accolades, including Startup Company of the Year at Techarenan and €2.5 million in support from the European Commission's Innovation Council. The company is also participating in the global MedTech Innovator accelerator program, further cementing its reputation in the medical technology landscape.

In closing, Multi4 Medical's innovative solutions not only offer a glimpse into the future of bladder cancer care but also showcase the immense potential of medical technology to improve patient outcomes significantly. With ongoing applications of its technology to other cancer types, the landscape of cancer treatment is poised for transformative change.

For more information, reach out to Dr. Miden Melle-Hannah, Urologist and CEO at Multi4 Medical, at +46 736 929 000 or via email at [email protected].

About Multi4 Medical

Multi4 Medical is a pioneering Swedish medical technology company that has developed a patented automated system for cancer diagnostics and treatment. The Multi4 System is designed to provide outpatient treatment for bladder cancer, negating the need for invasive procedures. Based in Gothenburg, Sweden, Multi4 Medical is committed to expanding its technological offerings across various cancer types and enhancing patient care.