Synektik, a provider of advanced solutions for medicine and the leading Polish producer of radiopharmaceuticals, has signed an agreement with the U.S.-based company HistoSonics, which has developed a revolutionary method for treatment of liver tumours. HistoSonics is the world leader in the development of histotripsy, an innovative, entirely non-invasive and highly effective method for destroying soft-tissue tumours, with potential application also in the treatment of tumours in other organs
Synektik has become the exclusive distributor of the Edison system, produced by HistoSonics, for Poland, Czechia, Slovakia and the Baltic States. Synektik will be responsible, among other things, for sales and servicing of the systems, and for distribution of materials required to perform the procedures. The agreement was signed for a period of three years, with the possibility of an extension.
Histotripsy is a revolutionary new therapy for treating soft-tissue tumours. In 2023 it was approved by the US Food and Drug Administration for treatment of liver tumours. The technology also has potential applications for the treatment of tumours of the kidney and pancreas (clinical trials are currently underway for these indications), and in the future also for prostate and breast tumours and sarcomas.
“We are thrilled that Synektik, which for years has contributed to the modernization of Polish healthcare by delivering advanced medical technologies, including da Vinci robotic systems, will introduce another groundbreaking technology to Poland and neighbouring countries,” said Cezary Kozanecki, founder and CEO of Synektik. “It enables totally non-invasive removal of tumours of the liver, and in the future also tumours of other organs. We regard our partnership with HistoSonics—the world leader in the development of histotripsy, redefining the treatment of soft-tissue tumours—as a recognition of our achievements to date in implementing innovations in medicine, and as proof of trust by another global player in medical technologies.”
The Edison system manufactured by HistoSonics is currently the only solution in the world using the histotripsy technology. So far these devices have been installed at over 150 facilities, mainly in the United States. The first Edison systems are already available also in the UK, Singapore, Hong Kong, and the United Arab Emirates. To date over 3,000 procedures have been conducted using the Edison system, and this number is growing rapidly from month to month. The technical effectiveness of treatment by this method, as confirmed in clinical trials, exceeds 95%.
A technology breakthrough in oncology
Histotripsy is an entirely non-invasive treatment method, without using scalpel or incisions. It also does not use ionizing radiation or thermal energy, as is the case in radiotherapy or thermoablation. The treatment is based on precisely targeted high-intensity sound waves, which penetrate the patient’s body and focus exclusively on the diseased tumour tissue. This method exploits the phenomenon of cavitation: in the treatment area, ultrasound forms microscopic bubbles, which implode in a fraction of a second, resulting in mechanical destruction of the diseased tissue at the sub-cellular level. At the same time, histotripsy minimally impacts the surrounding structures, such as blood vessels, nerve fibres and bile ducts. The harmless remnants from total destruction of the diseased tissue is naturally absorbed by the organism over the course of one to two months, without the need for surgical removal and without leaving scars.
The Edison system employs advanced imaging technologies, including an integrated USG system, as well as a robotic control system, to ensure highly precise treatment. This enables safely avoiding critical anatomic structures and protects healthy tissue. The treatment is conducted under general anaesthesia, solely for the purpose of completely immobilizing the patient. Along with the accompanying activities, the treatment lasts up to about three hours, while the actual removal of the tumour takes from several to several dozen minutes, depending on the size of the tumour. It is possible to destroy several tumours in a single session. In most cases the therapy is limited to a single treatment. It is typically a one-day procedure, and the patient can return home the same day or the next day, most often without significant side effects such as pain.
Approval in the European Union expected soon
According to Cezary Kozanecki, “HistoSonics is expected to obtain CE certification within the first quarter of this year. This is necessary for use of the Edison system and the histotripsy method for treating liver cancer in the European Union. After obtaining this certification, we will be able almost immediately to launch the sale of Edison systems to healthcare facilities in Poland, Czechia, Slovakia, and the Baltic countries of Lithuania, Latvia and Estonia. The rate of spread of this technology will largely depend on when histotripsy treatments qualify for coverage by the National Health Fund in Poland and equivalent institutions in neighbouring countries. It should be pointed out that in Poland alone, according to data from the National Cancer Register, over 2,000 people die from liver cancer every year.”
Cezary Kozanecki added: “We anticipate that, as in the case of the da Vinci robotics, Edison systems will first be delivered to private clinics, and later installed also at public institutions. We installed the first da Vinci system in 2018, and today we oversee 83 such devices in Poland and a total of 121 across the region. There are now as many as three da Vinci systems in place at some institutions.”
As in the case of the da Vinci robotic systems, manufactured by Intuitive Surgical, Synektik’s model for cooperation with HistoSonics will be based on revenue generated from the delivery and startup of the Edison system at healthcare facilities, as well as ongoing servicing of the devices. An additional recurring source of revenue will come from the supply of patient packets, containing one-off membranes essential for carrying out the procedure.
