Associated tags: Science, Neoplasm, Liver, Patient, FDA, Physician, Thomas Edison, Sale, Food, Safety, Pharmaceutical industry, Medical imaging, Infection, Needle, Blue, Bleeding, Kidney, Health
Locations: UNITED KINGDOM, EUROPE, DENMARK, US, ASIA PACIFIC, NORTH AMERICA, UNITED STATES, MINNESOTA, MICHIGAN, ENGLAND, NICE, UK
Retrieved on:
Wednesday, February 14, 2024
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Pharmaceutical industry The Edison Histotripsy System was measured against four distinct eligibility criteria that were required of applicants for consideration in the IDAP program.
Key Points:
- The Edison Histotripsy System was measured against four distinct eligibility criteria that were required of applicants for consideration in the IDAP program.
- HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control.
- Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.
- The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
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Medical imaging Key Points:
- View the full release here: https://www.businesswire.com/news/home/20240109791302/en/
Example of HistoSonics technology targeting kidney tissue to be destroyed in a non-invasive histotripsy procedure.
- While surgical intervention is the “gold standard” in removing kidney tumors, a non-invasive approach with histotripsy provides the potential to destroy targeted tumors without damaging non-targeted kidney tissue.
- Use of the Edison System in kidney applications is limited by federal law to investigational use.
- The #HOPE4KIDNEY Trial is expected to support a future expansion of the indication to include the destruction of kidney tissue/tumors.
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Medical imaging In the same week Cleveland Clinic treated their initial patients suffering from liver tumors utilizing histotripsy.
Key Points:
- In the same week Cleveland Clinic treated their initial patients suffering from liver tumors utilizing histotripsy.
- HistoSonics' image guided sonic beam therapy system uses proprietary technology and advanced imaging to deliver non-invasive, personalized treatments with precision and control.
- The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue at sub-cellular levels.
- By destroying targeted liver tumors, histotripsy opens the opportunities for patients to be downstaged and bridged for surgical resections and transplantation,” said Dr. Hernandez-Alejandro.
Retrieved on:
Tuesday, November 28, 2023
The collaboration leveraged Introworks' expertise in strategic messaging, storytelling and breakthrough creative to ensure this groundbreaking medical technology receives the attention it deserves.
Key Points:
- The collaboration leveraged Introworks' expertise in strategic messaging, storytelling and breakthrough creative to ensure this groundbreaking medical technology receives the attention it deserves.
- "We are thrilled to have the opportunity to work closely with HistoSonics in launching this extraordinary new medical technology," said Bob Freytag, CEO of Introworks.
- This product is especially rewarding because it allows us to directly contribute through our partnership to advancing a revolutionary medical technology."
- Introworks Fractional Launch Navigators offer flexible marketing staffing support to ensure that critical launches and initiatives meet company timelines and goals.
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Medicaid We commend CMS on facilitating access to breakthrough devices like ours for Medicare patients, many of whom historically have had delayed access to innovative technology,” commented HistoSonics President and CEO Mike Blue.
Key Points:
- We commend CMS on facilitating access to breakthrough devices like ours for Medicare patients, many of whom historically have had delayed access to innovative technology,” commented HistoSonics President and CEO Mike Blue.
- HistoSonics’ Edison Histotripsy System combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels.
- Additionally, the American Medical Association (AMA) has recently issued a new Category III CPT code for histotripsy of kidney tissue.
- The release of this new code represents a major reimbursement milestone as hospitals across the US will be able to submit claims directly related to the service.
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Medical imaging Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.
Key Points:
- Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.
- View the full release here: https://www.businesswire.com/news/home/20231009669222/en/
HistoSonics Edison Histotripsy System (Photo: Business Wire)
FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe.
- HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control.
- The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
Retrieved on:
Monday, February 13, 2023
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Medical imaging MINNEAPOLIS, Feb. 13, 2023 /PRNewswire/ -- HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the US Food and Drug Administration (FDA) has approved the company sponsored #HOPE4KIDNEY Trial which is designed to evaluate the safety and technical success of the Edison System in targeting and destroying targeted primary renal tumors, completely non-invasively and without the need for incisions or needles. FDA approval of the #HOPE4KIDNEY IDE Trial comes after the company recently submitted results to the agency from their #HOPE4LIVER Trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors.
Key Points:
- FDA approval of the #HOPE4KIDNEY IDE Trial comes after the company recently submitted results to the agency from their #HOPE4LIVER Trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors.
- "We are very pleased with the FDA's approval of our #HOPE4KIDNEY Trial and appreciative of the agency's prompt review process.
- HistoSonics' image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control.
- The #HOPE4KIDNEY trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.
Retrieved on:
Monday, February 13, 2023
Science,
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Abdomen,
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Medical imaging MINNEAPOLIS, Feb. 13, 2023 /PRNewswire/ -- HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the US Food and Drug Administration (FDA) has approved the company sponsored #HOPE4KIDNEY Trial which is designed to evaluate the safety and technical success of the Edison System in targeting and destroying targeted primary renal tumors, completely non-invasively and without the need for incisions or needles. FDA approval of the #HOPE4KIDNEY IDE Trial comes after the company recently submitted results to the agency from their #HOPE4LIVER Trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors.
Key Points:
- FDA approval of the #HOPE4KIDNEY IDE Trial comes after the company recently submitted results to the agency from their #HOPE4LIVER Trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors.
- "We are very pleased with the FDA's approval of our #HOPE4KIDNEY Trial and appreciative of the agency's prompt review process.
- HistoSonics' image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control.
- The #HOPE4KIDNEY trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.
Retrieved on:
Tuesday, December 13, 2022
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Thomas Edison MINNEAPOLIS, Dec. 13, 2022 /PRNewswire/ -- HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive, novel sonic beam therapy, announced today that it has raised $85 million in a financing led by Johnson & Johnson Innovation - JJDC, Inc., with participation from existing investors including Venture Investors, Lumira Ventures, Yonjin Venture, and the State of Wisconsin Investment Board, among others. Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects. Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison™, the company's novel histotripsy therapy platform, throughout the body.
Key Points:
- Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects.
- Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison, the company's novel histotripsy therapy platform, throughout the body.
- HistoSonics recently submitted safety and efficacy data from its #HOPE4LIVER Clinical Trials to the US Food and Drug Administration (FDA) and expects market authorization in 2023.
- HistoSonics also announced today the appointment of Erica Rogers, President and CEO of Silk Road Medical, Inc., to the company's Board of Directors.
Retrieved on:
Tuesday, December 13, 2022
IPO,
Physician,
Clinical trial,
Food,
Patient,
Sale,
Science,
State of Wisconsin Investment Board,
Liver,
FDA,
US Foods,
Safety,
Signature Bank,
Neoplasm,
Pharmaceutical industry,
Thomas Edison MINNEAPOLIS, Dec. 13, 2022 /PRNewswire/ -- HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive, novel sonic beam therapy, announced today that it has raised $85 million in a financing led by Johnson & Johnson Innovation - JJDC, Inc., with participation from existing investors including Venture Investors, Lumira Ventures, Yonjin Venture, and the State of Wisconsin Investment Board, among others. Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects. Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison™, the company's novel histotripsy therapy platform, throughout the body.
Key Points:
- Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects.
- Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison, the company's novel histotripsy therapy platform, throughout the body.
- HistoSonics recently submitted safety and efficacy data from its #HOPE4LIVER Clinical Trials to the US Food and Drug Administration (FDA) and expects market authorization in 2023.
- HistoSonics also announced today the appointment of Erica Rogers, President and CEO of Silk Road Medical, Inc., to the company's Board of Directors.
