The Edison System, developed by the U.S.-based company HistoSonics and utilizing histotripsy technology for the non-invasive treatment of liver tumors, has received CE certification, authorizing its use across the European Union. For Synektik Group, the exclusive distributor of the system in Poland, the Czech Republic, Slovakia and the Baltic States, this enables the commercialization of the technology across the markets covered by the partnership.
Histotripsy is a completely non-invasive treatment method that uses focused ultrasound to mechanically destroy tumor tissue. The procedure is performed without surgical incisions, ionizing radiation or thermal energy. The Edison System remains the only commercially available system utilizing histotripsy technology. Clinical studies have demonstrated a technical success rate of more than 95%.
– Breakthrough medical technologies require two things before they can truly change clinical practice: demonstrated safety and efficacy, and regulatory approval for clinical use. Receiving CE certification marks the beginning of histotripsy’s European development phase. We believe that, just as robotic surgery did several years ago, this technology also has the potential to gradually redefine the standard of care for selected cancers. The CE certification is an important milestone not only for HistoSonics, but also for our partnership – said Cezary Kozanecki, Founder and CEO of Synektik.
As part of its partnership with HistoSonics, Synektik Group is responsible for the sale of Edison systems, their installation, service and the supply of consumables in Poland, the Czech Republic, Slovakia and the Baltic States. The partnership model generates revenue from Edison system sales, service and consumables required for the procedures.
– We have a well-established sales organization and many years of experience introducing the most advanced medical technologies across our region. As was the case with the da Vinci systems, we expect the first users to be the most innovative medical centres, while the pace of market adoption will depend primarily on reimbursement processes and the accumulation of clinical experience – said Dariusz Korecki, Vice President of the Management Board of Synektik.
The Edison System is currently approved for the treatment of liver tumors. At the same time, HistoSonics is developing additional applications for histotripsy technology. The company is conducting clinical studies and regulatory processes related to the use of the system in the treatment of kidney and pancreatic cancers. In May this year, HistoSonics submitted an application to the U.S. Food and Drug Administration (FDA) to expand the system’s therapeutic indications to include the treatment of kidney tumors.
The granting of CE certification coincides with a period of rapid growth at HistoSonics. In June, the company completed another financing round, increasing its valuation to approximately USD 3 billion. The proceeds will be used to accelerate the global commercialization of the Edison System, expand clinical research, and increase manufacturing and operational capacity, supporting the technology’s further global expansion.
– HistoSonics’ rapid growth and strong investor interest confirm the potential of this technology. In our opinion, Edison has the potential to become one of the most promising technologies currently being developed in the field of non-invasive cancer treatment – added Cezary Kozanecki.
The histotripsy technology developed by HistoSonics addresses a significant unmet medical need in oncology. Approximately 27,000 new cases of primary liver, kidney and pancreatic cancers are diagnosed each year across the markets covered by Synektik Group. The potential application of the technology is even broader, as metastatic liver tumors occur many times more frequently than primary liver cancers.
To date, Edison systems have been installed in approximately 150 medical centres, primarily in the United States, but also in the United Kingdom, Hong Kong and the United Arab Emirates. More than 5,000 procedures have already been performed using the technology, while HistoSonics continues to expand its installed base and clinical evidence.
The development of the partnership with HistoSonics is consistent with 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 the da Vinci robotic surgical systems, Symani microsurgical robots, the ZAP-X radiosurgery platform, the Exablate Neuro MR-guided focused ultrasound system (MRgFUS), BD Rowa and Loccioni pharmacy automation solutions, as well as the Group’s nuclear medicine portfolio, the Edison System expands Synektik’s offering with another non-invasive treatment technology.
