As Company Advances Planning for FDA Submission and Future Growth
MINNEAPOLIS, Sept. 19, 2022 /PRNewswire/ — HistoSonics, (www.histosonics.com), the developer and producer of a very non-invasive platform and proprietary sonic beam remedy, introduced immediately the publication of outcomes from their potential Phase I scientific trial, named the THERESA Trial, performed in Barcelona, Spain. The research reported outcomes on eleven focused tumors within the eight sufferers handled who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 sufferers (7 tumors), breast most cancers metastases in 1 (1tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1tumor). Importantly, the first endpoint of technical success was achieved in all procedures. The secondary security profile endpoint was achieved as an impartial information security monitoring board recognized no device-related opposed occasions noticed as much as 30 days after histotripsy.
The science of histotripsy makes use of centered sound power to provide managed acoustic cavitation that mechanically destroys and liquifies focused liver tissue at sub-cellular ranges. Uniquely, the HistoSonics platform additionally supplies physicians the flexibility to plan, goal, deal with and monitor the destruction of tissue beneath steady real-time visualization and management, not like any modality that exists immediately. Results of the research, just lately revealed within the International Journal of Hyperthermia (THERESA Trial), demonstrated that the HistoSonics’ histotripsy system met its co-primary endpoints of acute security (30 day) and technical success (capacity to deal with focused quantity of liver tissue) in liver tumors of each major and secondary origin.
“Being able to safely target and treat tumors in this advanced patient population, non-invasively and without ionizing radiation means a great deal not only to patients with multi-focal disease but could also provide a bladeless surgical option for patients in earlier stages”, mentioned co-Principal Investigator Joan Vidal-Jove MD, PhD, a surgical oncologist with the Kuhab Institute in Barcelona. Dr. Vidal-Jove’ and Dr. Xavier Serres led the research on the three Barcelona based mostly hospitals that participated within the trial which included, Vall d’Hebron University Hospital, Mutua Terrassa University Hospital and Clinica Diagonal.
The revealed THERESA Trial outcomes additionally demonstrated that the histotripsy system might be used to efficiently goal and deal with a number of tumors in the identical process, or single fraction, with one affected person receiving three therapies to three distinct tumors, one affected person receiving remedy for two tumors and the remaining sufferers having just one tumor handled. “The publication of the THERESA Trial represents a landmark study demonstrating the safety and acute technical success of hepatic histotripsy, and we look forward to results of our next generation histotripsy system in destroying targeted liver tumors in our ongoing #HOPE4LIVER Trials”, says Dr. Joseph Amaral, HistoSonics’ VP of Clinical and Medical Affairs. HistoSonics intends to make use of information from the #HOPE4LIVER Trials being performed the US and Europe to assist regulatory submission to the FDA within the coming months.
HistoSonics additionally commented that they’ve begun assembly with the FDA on their plans for a kidney tumor trial to begin in 2023 and are additionally presently conducting pre-clinical translational research within the pancreas. The Company has additionally just lately accomplished renovation of its manufacturing facility in Plymouth, MN and has employed further personnel throughout all capabilities to organize for upcoming development.
HistoSonics is a privately held medical gadget firm creating a non-invasive platform and proprietary sonic beam remedy using the science of histotripsy, a novel mechanism of motion that makes use of centered ultrasound to mechanically destroy and liquify undesirable tissue and tumors. The firm is presently centered on the continued growth of its Edison™ Platform, international scientific research, and new strategic tasks together with future scientific functions and platforms. HistoSonics has places of work in Ann Arbor, Michigan and Minneapolis, MN.
For extra data please go to: www.histosonics.com/
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