HistoSonics, the manufacturer of the Edison system currently used in liver tumor treatment, for whom the Synektik Group is a distributor, has reported that it has submitted an application to the US Food and Drug Administration (FDA) to authorize this system to treat kidney neoplasms, too. Extending the therapeutic scope of using this one-of-a-kind technology developed by HistoSonics conforms with the collaboration announced in January 2026 between Synektik and HistoSonics encompassing the distribution of this solution in Poland, the Czech Republic, Slovakia and the Baltic States.
HistoSonics is a global leader in the development of histotripsy – a groundbreaking and totally non-invasive method for treating neoplasms in soft tissue. At present, it is used to treat liver tumors and is being developed with additional oncology-related applications in mind, including the treatment of neoplasms in the kidneys and pancreas.
The application to the FDA being processed under the De Novo procedure applicable to new medical technologies is predicated on the findings of the HOPE4KIDNEY clinical research whose purpose is to confirm this system’s efficacy in the treatment of neoplasms in the kidneys.
“The submission of this application is an important step towards extending the applications of histotripsy beyond the treatment of liver tumors. In this case, the intention is to cover the treatment of neoplasms in the kidneys, an area in which patients and physicians are searching for methods to save this organ and preserve its functions. We believe that histotripsy has the potential to alter how solid tumors are treated, by offering a precise and totally non-invasive treatment while simultaneously sustaining patients’ quality of life”, said Mike Blue, CEO of HistoSonics.
Synektik is of the opinion that developing additional applications for the Edison system may be of significant importance in the further dissemination of this technology in European markets, too. The Company is the sole distributor of Edison systems in Poland, the Czech Republic, Slovakia and the Baltic States. It is also responsible for the sales of these devices, their maintenance, and the supply of materials used in operations.
“HistoSonics is consistently pursuing its plan of developing the Edison system and extending the utilization of histotripsy in oncology. The progress in clinical research and regulatory processes in new indications may be of material significance in popularizing the technology and the product being developed by HistoSonics. We are profoundly convinced of the unique utility of this technology being developed by HistoSonics whose dissemination may lead to another qualitative breakthrough in combatting multiple oncological diseases, including tumors that are more difficult to treat”, as Cezary Kozanecki, CEO and Founder of Synektik assesses.
The process of obtaining CE certification for the Edison system in the treatment of liver tumors in the European Union is currently underway. It is currently being finalized. Obtaining certification will facilitate the commencement of commercializing this system on European markets, including Poland, the Czech Republic, Slovakia and the Baltic States.
“In Poland alone, approximately 2.5 thousand patients die every year due to neoplasms in the kidneys. In turn, the number of people who die from liver tumors is estimated to be at least 2 thousand per annum. Many experts are of the opinion that this number may be underestimated by as much as several times. The groundbreaking nature of the solutions offered by the Edison system combined with investments in diagnostics creates space for a genuine breakthrough in treating these disorders”, emphasizes Cezary Kozanecki.
Technological breakthrough in oncology
Histotripsy is a totally non-invasive method of treatment – without using a scalpel or making any incisions. Nor does it employ ionizing radiation or thermal energy as is the case in radiotherapy or thermal ablation. This therapy is based on precisely targeted ultrasounds that penetrate the patient’s body and are focused solely on the tumorous tissue affected by the disease. This method utilizes the phenomenon of cavitation: in the area subject to treatment, under the influence of ultrasounds, microscopic vesicles appear that implode in a mere fraction of a second, leading to the mechanical destruction of the unhealthy tissue at a subcellular level. At the same time, histotripsy affects the surrounding structures to a minimal degree, meaning blood-carrying vessels, nerve fibers and bile ducts. The remnants that pose no danger after the total destruction of the unhealthy tissue are then naturally absorbed by the body within 1-2 months without having to remove them surgically and without scarring.
The Edison system utilizes advanced imaging technologies, including an integrated ultrasound system and a roboticized control system, thereby ensuring a high level of precision during the procedure. This makes it possible to bypass critical anatomical structures and protect healthy tissue. This procedure is conducted under general anesthesia for the purpose of ensuring that the patient is totally motionless. A procedure takes up to roughly three hours including the related tasks, while the time of removal of a neoplasm itself ranges from a few minutes up to slightly under twenty minutes depending on tumor size. It is possible to remove several tumors during a single session. In most cases treatment is limited to a single procedure. This procedure is customarily done on an outpatient basis – the patient can return home the same day or on the following day, customarily without suffering any major side effects such as pain.
