Introduction of Hans Wiksell

Hans Wiksell, born on January 28, 1944, in Stockholm, is a Swedish engineer, entrepreneur, and professor emeritus in clinical applications of electromagnetic and acoustic waves at Karolinska Institutet.

In 1967, he founded Comair AB to offer electronics consulting, later innovating in water purification and medical equipment systems. In 2004, Wiksell established NeoDynamics AB, focused on advancing cancer treatment and diagnostics, which was later recognized as one of Sweden’s 20 most innovative companies.

Wiksell’s pioneering work includes developing brain tumor treatment equipment using high-frequency heat, the Sonocut ultrasound aspiration system, and the Lithocut kidney stone crusher, distributed internationally with Gambro AB. He also led advancements in transurethral microwave treatment for benign prostatic hyperplasia and standardized biopsy procedures. His recent projects include the Fourier biopsy system, designed to reduce cancer cell spread, and Preferential Radio Frequency Ablation, a minimally invasive breast cancer treatment.

Breast cancer

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer deaths among women worldwide. WHO statistics from 2022 report over 2.2 million new cases and nearly 685,000 deaths globally. In Sweden, approximately 9,000 women are diagnosed annually, constituting 30% of all cancers in women. While breast cancer treatments primarily involve surgery, other methods such as radiation, hormonal, and chemotherapy are also common, all requiring extensive interventions. Screening has contributed to higher diagnosis rates, although incidences have declined slightly in recent years, especially in older age groups.

CCTBH

CCTBH uses heat-induced denaturation of cancer cells with a method combining Micro-Pulse Precision Placement (MPP), Anti-Seeding (AS), and True Temperature Measurement (TTM) to address limitations in traditional Radiofrequency Ablation (RFA). Guided by real-time ultrasound, the electrode is precisely positioned within the tumor under local anesthesia, minimizing cell spread and stabilizing placement. The tumor is heated to 70°C, with a surrounding safety zone maintained at 43.5°C for 5–15 minutes, automatically halting once the treatment dose is achieved.

This approach offers:
1. Patient-Friendly: A simple, painless, and rapid procedure allowing immediate return to daily activities.
2. Cost-Effective: Potentially applicable to over 50% of new breast cancer cases, significantly reducing healthcare costs.
3. Short Recovery: Minimally invasive, enabling faster recovery and reduced resource usage compared to surgery.

The timeline

CCTBH AB’s journey began with promising initial results when Hans Wiksells successfully conducted clinical studies on approximately 50 patients. These studies demonstrated significant advantages over conventional treatment methods, showing the new approach to be cheaper, simpler, and notably producing fewer side effects.

Building on these positive results, CCTBH AB formed a strategic partnership with Hans Wiksell to further develop and refine the method. This collaboration led to the filing of three patents to protect the innovative technology. To ensure their intellectual property position, CCTBH AB then engaged the internationally renowned patent office Rouse to conduct a comprehensive analysis of the patent landscape in all relevant areas related to their patent applications.

The company recently achieved another significant milestone by completing a feasibility study. This study serves as the foundation for their next steps: obtaining production tenders for three testing devices and securing CE marking for these products. Production is scheduled to be operational by the turn of the year 2022/23.

Looking ahead, CCTBH AB is actively preparing to commence new clinical trials. These trials are set to begin as soon as the trial apparatus is completed, marking the next phase in the company’s development process.

Patent

In 2021, CCTBH applied for patents on innovative methods to enhance breast cancer treatment using Radiofrequency Ablation (RFA), focusing on precise temperature control, treatment completion verification, and secure needle placement. Following a recent feasibility study, CCTBH aims to produce testing devices with CE marking by late 2023, with Prevas AB offering SEK 6 million for initial development. About 50 successful treatments have been completed, and further clinical studies, led by Fredrik Wärnberg, are planned for early 2023 at Sahlgrenska and St. Göran hospitals.