The Edison system, developed by US-based HistoSonics and using histotripsy technology for the non-invasive treatment of liver tumours, has received CE certification authorising its use in the European Union.
For the Synektik Group, the system’s exclusive distributor in Poland, the Czech Republic, Slovakia and the Baltic states, the certification opens the way for the commercialisation of the technology across the markets covered by the partnership.
Histotripsy is a completely non-invasive treatment method that uses focused ultrasound waves to mechanically destroy cancerous tissue. The procedure requires no surgical incisions, ionising radiation or thermal energy.
The Edison system remains the only commercially available platform using histotripsy technology. Its technical treatment success rate, confirmed in clinical trials, exceeds 95%.
“Breakthrough medical technologies require two elements before they can begin to make a genuine difference in clinical practice: confirmation of their safety and effectiveness, and regulatory approval for their use. Receiving CE certification means that histotripsy is beginning a new phase of its development in Europe.
“We believe that, just as robotic surgery did several years ago, this technology has the potential to gradually transform the standard of care for selected cancers. CE certification is an important milestone not only for HistoSonics, but also for our partnership,” said Cezary Kozanecki, founder and CEO of Synektik.
Synektik to handle sales, installation and servicing
Under its partnership with HistoSonics, the Synektik Group is responsible for the sale, installation and servicing of Edison systems, as well as the supply of materials used during procedures, in Poland, the Czech Republic, Slovakia and the Baltic states.
The cooperation model is expected to generate revenue from the delivery of Edison systems, their servicing and the supply of materials required to perform procedures.
“We have a well-developed sales organisation and many years of experience in introducing the most advanced medical technologies across the markets of our region.
“As was the case with da Vinci systems, we expect the first users to be the most innovative medical centres. The pace of further market development will depend primarily on reimbursement processes and the accumulation of clinical experience,” said Dariusz Korecki, Vice-President of the Management Board of Synektik.
Further applications under development
The Edison system is currently approved for the treatment of liver tumours. At the same time, HistoSonics is developing additional applications for histotripsy technology.
The manufacturer is conducting clinical trials and regulatory procedures relating to the use of the system in the treatment of kidney and pancreatic cancers. In May 2026, the company submitted an application to the US Food and Drug Administration to expand the system’s therapeutic indications to include the treatment of kidney tumours.
The CE certification comes during a period of rapid growth for HistoSonics. In June 2026, the company completed another funding round that increased its valuation to approximately USD 3 billion.
The funds raised will be used to accelerate the global commercialisation of the Edison system, advance clinical research and expand the company’s operational and manufacturing capacity, supporting the technology’s further international expansion.
“HistoSonics’ rapid development and the interest shown by investors confirm the potential of this technology. In our view, Edison has an opportunity to become one of the most promising technologies currently being developed in the field of non-invasive cancer treatment,” Kozanecki added.
Addressing growing demand for new cancer treatments
The technology developed by HistoSonics responds to the significant demand for new therapeutic tools to address the growing burden of cancer.
Approximately 27,000 cases of primary liver, kidney and pancreatic cancer are diagnosed annually in the countries in which the Synektik Group operates.
However, the technology’s potential application is considerably broader, as metastatic lesions in the liver occur many times more frequently than primary liver cancers.
To date, Edison systems have been installed at approximately 150 medical centres, primarily in the United States, but also in countries and markets including the United Kingdom, Hong Kong and the United Arab Emirates.
More than 5,000 procedures have already been performed using the technology. The manufacturer continues to expand its network of installations and its clinical database.
Synektik expands its advanced medical technology portfolio
The development of the partnership with HistoSonics forms part of Synektik’s strategy of building a portfolio of advanced medical technologies and systematically expanding its offering across the markets in which the Group operates.
Alongside technologies including da Vinci robotic surgical systems, Symani microsurgical robots, the ZAP-X radiosurgery platform, the Exablate Neuro system for the treatment of tremor using MR-guided focused ultrasound, BD Rowa and Loccioni pharmacy automation systems, and solutions developed in the field of nuclear medicine, the Edison system adds another non-invasive treatment technology to the Group’s portfolio.
Source: Synektik / CEO Magazine Poland
