HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, has announced the marketing authorisation of its “breakthrough” platform via the US Food and Drug Administration’s (FDA) de novo classification request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorisation makes Edison the first and only histotripsy platform available in the USA.
“This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception in 2001, overcoming what was once thought to be impossible”, commented Mike Blue, President, and CEO of HistoSonics.
FDA authorisation was based, in part, on data from the #HOPE4LIVER trials in 13 trial sites across the USA and Europe. Data pooled from both the USA and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumours. Histotripsy was noted to have achieved both primary safety and efficacy endpoints in the pooled data where 44 subjects were evaluated for safety and 44 tumours treated were evaluated for efficacy.
Important to note was the heterogeneity of the treated subjects, 18 of which had hepatocellular carcinoma (HCC) tumours and 26 had metastatic tumours to the liver from the colon, rectum, breast, and other primary origins. As recently presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 meeting (9–13 September, Copenhagen, Denmark), a technical success rate of 95.5% was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumours. Also, only three procedure related Common Terminology Criteria for Adverse Event (CTCAE) Grade 3 or higher adverse events through 30 days post-histotripsy were observed across all 44 subjects treated, representing a complication rate of 6.8% with each event being common to focal liver therapies and not specific to histotripsy.
“This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible—integrating the many complexities of histotripsy into a completely non-invasive clinical platform,” commented Mike Blue, president, and CEO of HistoSonics. The company noted it has expanded its commercial and operational capacity over the previous year in preparation for commercial activities. Blue added, “We have been thoughtfully adding professionals with deep domain experience in operations, market development and education and are prepared to begin scheduling physician training immediately. This is a fantastic day for patients who will benefit from the novel advantages of histotripsy, and I commend the FDA for working so expeditiously with us throughout the review process.”
The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumours, at sub-cellular levels. HistoSonics’ Edison System uses proprietary technology and advanced imaging to deliver personalised, non-invasive histotripsy treatments with precision and control. The company believes that the novel mechanism of action of their proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualisation and control, unlike any modality that exists today.
“As a surgeon, it’s rewarding to be able to offer a procedure where we can precisely destroy liver tumours without using a scalpel or needles, hopefully enabling the patient’s quick recovery while avoiding certain complications like surgical site infections or radiation illness common with other modalities,” commented Joe Amaral MD, vice president of medical affairs for HistoSonics. “Based on the data and patient experiences in our studies we are confident histotripsy will have a meaningful impact for patients suffering from unresectable liver disease, including liver tumours, and we look forward to the role histotripsy will play in treatment strategies going forward,” added Amaral.
The Edison System is indicated for the non-invasive destruction of liver tumours, including unresectable liver tumours, using a non-thermal, mechanical process of focused ultrasound.