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HistoSonics System Targets First Pancreatic Tumors
Feasibility Trial Evaluates Safety of Histotripsy to Destroy Pancreatic Tumors
MINNEAPOLIS--BUSINESS WIRE--
HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the first patients with pancreatic tumors were successfully treated in the company sponsored GANNON trial. The feasibility trial is designed to evaluate the safety of histotripsy, a novel non-invasive technology that destroys targeted tumor tissue using focused ultrasound, in up to 30 patients with inoperable pancreatic adenocarcinoma tumors diagnosed with unresectable locally advanced disease (Stage 3) or those where a small number of tumors have spread to other parts of the body (Stage 4).
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The GANNON trial is being conducted at Sant Pau Hospital in Barcelona, Spain, led by Dr. Santiago Sánchez Cabús, Clinical Head of Hepatopancreatobilliary Surgery at the Hospital de Sant Pau and Professor of Surgery at the Autonomous University of Barcelona.
Pancreatic tumors are one of the most difficult to treat, affecting over 510,000 people globally each year, and an estimated 66,440 patients diagnosed in the United States alone in 2024¹,². With the highest mortality rate of any major tumor type, pancreatic tumors are currently the third leading cause of tumor-related death in the United States, following lung and colon, and is expected to become the second by 2030².
With a five-year relative survival rate of 13% across all stages of disease progression and limited surgical options for most patients, new treatment modalities such as histotripsy are urgently needed. Fewer than 20% of patients suffering from pancreatic tumors are eligible for surgery due to progression of disease at the time of diagnosis. Pancreatic tumors are often surrounded by dense, impenetrable fibrotic tissue that limits the effectiveness of systemic or pharmacologic therapies, due to lack of penetration to effectively reach and target the tumor cells.²,³
"Histotripsy has the potential to revolutionize treatment for patients with pancreatic tumors that were previously considered to be untreatable with traditional approaches. Its novel mechanism of action targets both the tumor and surrounding fibrotic tissue, offering new hope for patients with advanced disease, who represent the majority of cases," said Joan Vidal-Jove, M.D., Medical Director, HistoSonics.
"Most patients with pancreatic tumors face limited treatment options and are ineligible for surgery due to advanced stage of disease," said Mike Blue, HistoSonics CEO and President. "We believe histotripsy provides a non-invasive option to target tumors that were previously considered untreatable," said Mike Blue, HistoSonics CEO and President. "Our goal is to expand the potential of histotripsy in multiple tumor types, delivering meaningful improvements in outcomes for patients and families. Our early research from the GANNON trial will inform us and our physician partners in optimizing histotripsy to make a significant impact on patient lives."
The use of the Edison System in pancreatic application is limited to investigational use.
About the Edison® System
The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.
About HistoSonics
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.
/Public Release. This material from the originating organization/author(s) might be of the point-in-time nature, and edited for clarity, style and length. Mirage.News does not take institutional positions or sides, and all views, positions, and conclusions expressed herein are solely those of the author(s).Rise Of Pancreatic Cancer Diagnoses Might Reflect Increased Early Detection
Experts have been concerned by rising rates of pancreatic cancer in young adults, but new research reveals the jump in cases has not been accompanied by any increase in deaths from the disease. Photo by Adobe Stock/HealthDay News
Experts have been concerned by rising rates of pancreatic cancer in young adults, but new research reveals the jump in cases has not been accompanied by any increase in deaths from the disease.
Why? According to the scientists behind the finding, today's more highly sensitive imaging scans may be catching early, nonlethal cases of pancreatic cancer in people under 40 that were simply missed before.
"Reports from several registries have garnered concerns over the increasing incidence of pancreatic cancer among younger persons, particularly women in the United States and globally," the researchers wrote in their report. "Although some attribute this trend to increasing rates of obesity, others have found no obvious cause."
But when the team drilled down on the data, they came to a surprising conclusion: It turns out that statistics on pancreatic cancer lump together two very different types of tumors that happen to emerge in the same organ -- endocrine cancers and adenocarcinomas.
The first type tends to take years to grow and spread, while the second is typically fast-moving and aggressive.
"The increasing incidence of pancreatic cancer in younger Americans is primarily due to increased detection of smaller, early-stage endocrine cancer -- not an increase in pancreatic adenocarcinoma," the researchers wrote.
So the fact that new cases of pancreatic cancer are rising while deaths are not, "suggests that the recent increase in early-onset pancreatic cancer reflects detection of previously undetected disease, rather than a true increase in cancer occurrence."
In the study published Monday in the Annals of Internal Medicine, researchers led by Dr. Vishal Patel, a surgical resident at Brigham and Women's Hospital in Boston, did not not argue that cases of pancreatic cancer are indeed rising among the young: Data from 2001 to 2019 showed that the number of pancreatic cancer surgeries among people between the ages of 15 and 39 has roughly doubled in women and men.
Interestingly, the increase was confined to cancers that were in the very early stages. That finding points to a phenomenon known as overdiagnosis: a rise in incidence without a linked rise in deaths.
More lethal adenocarcinomas are sometimes discovered early, when they surface in abdominal scans done for other reasons. But the incidence of adenocarcinomas at every stage has remained stable in young people, the study authors noted.
Meanwhile, less harmful endocrine tumors are being detected on the pancreas by increasingly sensitive CT scans or MRIs, which are being used for various purposes more often than before, the researchers explained.
"The more you are imaged, the more these things will turn up," study author Dr. H. Gilbert Welch, a senior researcher in the Center for Surgery and Public Health at Brigham and Women's Hospital, told the New York Times.
And once something is discovered, doctors and patients alike may feel they need to act.
"Sometimes we see things on imaging and we have to go after it," Dr. Folasade May, a gastroenterologist at the University of California, Los Angeles, told the Times. "People might end up with a big surgery. But it is hard to tell who needs the surgery and who doesn't."
The doubling of such surgeries in young people with pancreatic cancer suggests that many are having that operation.
"A lot of patients say, 'Get it out,'" study author Dr. Adewole Adamson, an overdiagnosis expert at the University of Texas at Austin. "When someone tells you that you have cancer, you feel like you have to do something."
What should doctors and patients know going forward?
"Pancreatic cancer now can be another cancer subject to overdiagnosis: the detection of disease not destined to cause symptoms or death," the researchers wrote. "Overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity... And mortality."
More information
The University of Pennsylvania has more on pancreatic cancer.
Copyright © 2024 HealthDay. All rights reserved.
HistoSonics Edison® Histotripsy System Treats First Pancreatic Tumor Patients In GANNON Trial
Feasibility Trial Evaluates Safety of Histotripsy to Destroy Pancreatic Tumors
MINNEAPOLIS, December 16, 2024--(BUSINESS WIRE)--HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the first patients with pancreatic tumors were successfully treated in the company sponsored GANNON trial. The feasibility trial is designed to evaluate the safety of histotripsy, a novel non-invasive technology that destroys targeted tumor tissue using focused ultrasound, in up to 30 patients with inoperable pancreatic adenocarcinoma tumors diagnosed with unresectable locally advanced disease (Stage 3) or those where a small number of tumors have spread to other parts of the body (Stage 4).
The GANNON trial is being conducted at Sant Pau Hospital in Barcelona, Spain, led by Dr. Santiago Sánchez Cabús, Clinical Head of Hepatopancreatobilliary Surgery at the Hospital de Sant Pau and Professor of Surgery at the Autonomous University of Barcelona.
Pancreatic tumors are one of the most difficult to treat, affecting over 510,000 people globally each year, and an estimated 66,440 patients diagnosed in the United States alone in 2024¹,². With the highest mortality rate of any major tumor type, pancreatic tumors are currently the third leading cause of tumor-related death in the United States, following lung and colon, and is expected to become the second by 2030².
With a five-year relative survival rate of 13% across all stages of disease progression and limited surgical options for most patients, new treatment modalities such as histotripsy are urgently needed. Fewer than 20% of patients suffering from pancreatic tumors are eligible for surgery due to progression of disease at the time of diagnosis. Pancreatic tumors are often surrounded by dense, impenetrable fibrotic tissue that limits the effectiveness of systemic or pharmacologic therapies, due to lack of penetration to effectively reach and target the tumor cells.²,³
"Histotripsy has the potential to revolutionize treatment for patients with pancreatic tumors that were previously considered to be untreatable with traditional approaches. Its novel mechanism of action targets both the tumor and surrounding fibrotic tissue, offering new hope for patients with advanced disease, who represent the majority of cases," said Joan Vidal-Jove, M.D., Medical Director, HistoSonics.
"Most patients with pancreatic tumors face limited treatment options and are ineligible for surgery due to advanced stage of disease," said Mike Blue, HistoSonics CEO and President. "We believe histotripsy provides a non-invasive option to target tumors that were previously considered untreatable," said Mike Blue, HistoSonics CEO and President. "Our goal is to expand the potential of histotripsy in multiple tumor types, delivering meaningful improvements in outcomes for patients and families. Our early research from the GANNON trial will inform us and our physician partners in optimizing histotripsy to make a significant impact on patient lives."
Story Continues
The use of the Edison System in pancreatic application is limited to investigational use.
About the Edison® System
The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.
About HistoSonics
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.
For more information on the GANNON Trial please reference NCT06282809 at: GANNON Trial Information on ClinicalTrials.Gov. For information on the Edison Histotripsy System please visit: www.Histosonics.Com/. For patient related information please visit: www.Myhistotripsy.Com/.
¹Globocan 2022: https://gco.Iarc.Fr/today/en/fact-sheets-cancers
²Source for statistics: American Cancer Society: Cancer Facts & Figures 2024 and Pancreatic Treatment Options
³Norton J, Foster D, Chinta M, Titan A, Longaker M. Pancreatic Cancer Associated Fibroblasts (CAF): Under-Explored Target for Pancreatic Cancer Treatment. Cancers. 2020; 12(5):1347.
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20241216604376/en/
Contacts
Josh KingVice President of Global Market AccessJoshua.King@histosonics.Com608-332-8124
Kimberly HaKKH Advisorskimberly.Ha@kkhadvisors.Com917-291-5744
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