Delving into the Latest Updates on Sonablate Corp. with Synapse

Overview

Basic Info

Introduction

Sonablate Corp. specializes in creating and manufacturing high intensity focused ultrasound surgical ablation systems. Their products include the Sonablate 450, which is designed for minimally invasive prostate cancer treatment, the Sonablate 500 for treating localized prostate cancer with reduced side effects, and the Sonatherm, which utilizes a laparoscopic probe to deliver robotic ablative therapy to soft tissue. The company was established in 2004 by Stephen R. Puckett Sr. and George M. Suarez and is based in Charlotte, North Carolina.

The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.

Start Date11 Sep 2024

Sponsor / Collaborator

Sonablate Corp.

NCT03595722 / Unknown statusNot ApplicableIIT

High Intensity Focused Ultrasound as a Treatment for Rectal and Pelvic Cancers - Laboratory and Clinical Feasibility Studies

The hypothesis of the study is that high intensity focused ultrasound (HIFU) can be used safely to treat rectal and pelvic cancer. The study consists of two trials exploring the use of HIFU in rectal and pelvic cancer to establish the safety and potential efficacy of HIFU in this instance.
The first trial is a feasibility study looking at patients with early rectal cancer. We aim to recruit thirty patients with early rectal cancer who are due to undergo an operation to remove their cancer. After recruiting and consenting them for the trial, we will treat their rectal cancer with HIFU. Approximately one week after treatment they will undergo their normal cancer operation. This will allow us to demonstrate the safety of HIFU as a treatment for rectal cancer and evaluate the changes in rectal and surrounding tissue under the microscope after the cancer is treated with HIFU. In addition, we will monitor patients for any complications and the impact this treatment has on their quality of life. We will monitor the response of various markers for cancer with blood tests.
The second trial aims to evaluate the treatment of a cohort of patients with inoperable rectal cancer. We aim to recruit thirty patients with either inoperable pelvic cancers - rectal, cervical or endometrial, or cancers that have returned after previous operations. We will offer these patients treatment of their cancer using HIFU. We will monitor the symptoms they experience and impact on their quality of life both before and at multiple time points after the treatment with HIFU. We will compare MRI scans before and after treatment to evaluate the effect HIFU has in reducing the size of the cancer. We hope to show that using HIFU in this group of patients can be both effective and lead to an improvement in both their symptoms and quality of life.

Start Date11 Jul 2019

Sponsor / Collaborator

Imperial College London

[+1]

NCT02756884 / CompletedEarly Phase 1IIT

Phase I/Phase II Safety and Preliminary Efficacy Study Using Low Frequency Ultrasound in Addition to Adipose Derived Stem Cells (ADSCs) in Patients With Moderate to Severe Lower Extremity Peripheral Arterial Disease (PAD)

This is a single center, open label, prospective, randomized, controlled study in patients with non- revascularizable moderate or severe lower extremity Peripheral Arterial Disease (PAD) receiving autologous stem cells therapy (minimally manipulated). This study will enroll a maximum of 10 subjects in this study. The patients will be divided into two groups. One group will receive Adipose Derived Stem Cells (ADSCs) alone and the other group will receive low frequency ultrasound before the addition of ADSCs. The randomization will be 1:1. If the results of this pilot study are not clearly different, there will be a need for a phase II study to support the results.
Baseline, 6 week, 3 month and 6 month assessments of 6 min walking distance (6MWT), Ankle Brachial Indexes (ABIs)/Toe Brachial Indexes (TBIs), Transcutaneous Partial Oxygenation (TcPO2) and Rutherford assessments will be performed for the study group. Prior to the stem cell treatment, the ultrasound group patient will receive noninvasive transcutaneous pulsed focused ultrasound around the involved vessel(s) in the affected extremity. All patients will then receive 200 million autologous stromal vascular fraction cells containing adipose derived stem cell therapy: 1/3 of the cells will be delivered intra-venous proximal to the lesion (not retrograde), 1/3 of the cells will be delivered intra- adventitia proximal to the lesion and 1/3 of the cells will be delivered by intra- muscular injection along the vessel path (20-30 injections each separated by1.5 inch). Standard therapy for PAD patients will not be interrupted for the duration of the study. Standard therapy for PAD is defined as cardiovascular general measures like lifestyle changes, smoke cessation, exercise, cardiovascular rehabilitation, etc. All participants have already received maximal non-surgical therapy. Safety will be monitored on an ongoing basis.

Start Date03 Jun 2015

Sponsor / Collaborator

Medcath of Little Rock LLC

[+1]

100 Clinical Results associated with Sonablate Corp.

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14

Literatures (Medical) associated with Sonablate Corp.

01 Apr 2011·The Journal of the Acoustical Society of America

Real-time tissue change monitoring during the treatment of prostate cancer using Sonablate 500 with high intensity focused ultrasound.

Author: Chen, Wo-Hsing ; Carlson, Roy F. ; Schatzl, Georg ; Sanghvi, Narendra T. ; Marberger, Michael

Tissue change monitoring (TCM) during HIFU is an essential required feedback during the HIFU treatment. The Sonablate 500 (SB500) HIFU is enhanced with quantitative, real-time TCM software that estimate changes in tissue properties due to HIFU treatment of prostate cancer. TCM generates energy reading based on spectral analysis of the two-dimensional rf backscattered ultrasound signals acquired during HIFU. These energy changes are correlated to tissue temperature. TCM results are overlaid on the real-time ultrasound image in green, yellow, and orange to represent low, medium, and high degree of change in backscattered energy levels. To validate the TCM process five patients with histologically confirmed, organ confined prostate cancer were enrolled for the study. Needles containing three thermocouples were placed transperineally under TRUS guidance in the prostate to monitor temperatures from focal zone, posterior to the focal zone and on the lateral gland where no HIFU was applied. The measured temperatures in the HIFU treatment zones were from 70–114 °C (average 84 °C). The TCM results, estimated tissue temperatures were from 75 to 100 °C for 83% of treatment sites with an average tissue temperature of 91 °C.

01 May 2006·The Journal of the Acoustical Society of America

Noninvasive prostate surgery using high-intensity focused ultrasound

Author: Sanghvi, Narendra T.

The salient features of ultrasound are to provide both medical diagnostic and therapeutic applications due to its short wavelength in soft tissue. These combinations have motivated us to apply ultrasound for the noninvasive surgery of the prostate diseases for both benign and malignant tumors. Over a decade of engineering and clinical research a successful transrectal ultrasound device, the Sonablate, has been developed and clinically practiced for the treatment of localized prostate cancer as well as benign prostatic hyperplasia. The main advantages of using the Sonablate device are on-line imaging of the prostate in 2D and 3D, accurate therapy planning, and real-time monitoring of treatment. The long-term, over 6 years follow-up clinical results from two multicenter clinical studies indicate no severe long-lasting side effects and acceptable efficacy of the treatment. The primary benefits of this treatment are fewer complications, outpatient procedure, and very quick recovery. The presentation will include design of the device, characterization of therapy and imaging transducer, and treatment parameters for the effective clinical results.

01 Apr 2003·The Journal of the Acoustical Society of America

High intensity focused ultrasound (HIFU) for treatment of T1/T2 prostate cancer

Author: Koch, M. ; Gardner, T. ; Sanghvi, N.

This FDA approved phase I/II clinical trial is to evaluate the safety and efficacy of the Sonablate device (Focus Surgery, Inc.) for the treatment of organ confined prostate cancer. 20 patients with biopsy proven prostate cancer, Gleason ≤7 and PSA ≤10 were treated under general anesthesia. Outcome data included serum PSA collected at day 3, 14, 30, 90, 180, PSA nadir (mean/median), and biopsy results at 6 months. Quality of life was assessed using the International Prostate Symptom Score, International Impotence and Erectile Function score, and the SF-36 health survey. The mean patient age is 62.0, Gleason score of 6.18, PSA of 5.2, and prostate size 26.0 g<th>m. Mean PSA results were 5.62, 44, 20, 1.68, 0.87, and 0.44 ng/ml at screening, 48–72 hours, 14 days, 30 days, 90 days and 180 days, respectively. There was one patient (9%) with a positive TRUS biopsy at 6 months, which resulted in a retreatment. There were no rectal injuries. Average pre-treatment IPSS, IIEF, and SF-36 scores were 9.55, 16.1, and 103.5. At the 30 day follow-up, they were 18.3, 3, and 97.4, respectively. HIFU is a minimally invasive modality that achieves complete prostatic ablation and is efficacious in the treatment of low-stage prostate cancer.

6

News (Medical) associated with Sonablate Corp.

30 Jan 2023

·www.businesswire.com

UK Focused Ultrasound Foundation Announces Launch

LONDON--( BUSINESS WIRE )--The UK Focused Ultrasound Foundation (UK FUSF), dedicated to advancing the development and adoption of focused ultrasound in the UK, today announced its formal launch. Focused ultrasound is a groundbreaking platform technology that uses ultrasound energy guided by real-time imaging to treat tissue deep in the body, without incisions or radiation. The Foundation will celebrate its launch with an event being held on 31 January at the House of Lords with important guests including MPs, members of the House of Lords, business leaders, and experts from medical charities and some of the UK’s leading research institutions, including the Institute of Cancer Research, Oxford University, and Imperial, King’s and University Colleges, London. Currently, focused ultrasound treatment for both prostate cancer and essential tremor has National Institute for Health and Care Excellence (NICE) approval and National Health Service England (NHS) coverage. 1,2 The technology has 32 regulatory approvals worldwide and is in various stages of research and development for nearly 170 diseases and conditions including Alzheimer’s disease, Parkinson’s disease, metastatic breast tumours, and tumours of the brain, liver, pancreas, and prostate. Launch of the UK FUSF will help enable donations to be applied directly to laboratory research and clinical trials in the UK, accelerating and expanding the exceptional work that has been ongoing for several years. It is hoped this will significantly increase the accessibility to already approved focused ultrasound-based treatments, which currently have limited availability in the UK. Specific areas of focus for the UK FUSF include cancer immunotherapy, brain diseases, pancreatic cancer, prostate cancer, and pediatric applications. “ Our vision at the Foundation is for focused ultrasound to be used in the UK to improve the lives of millions of people afflicted with a wide variety of serious medical disorders in the shortest time possible,” said Foundation Chairman Philip Keevil. “ By identifying opportunities, inspiring collaboration, raising awareness and overcoming barriers, the Foundation will shorten the time from laboratory research to widespread treatment using this remarkable and versatile technology.” The UK FUSF is an independent charity registered with the Charity Commission and HMRC, and GiftAid Eligible. It works closely with, but is independent of, the US-based Focused Ultrasound Foundation, aligning on goals and resources to advance focused ultrasound to treat millions worldwide. The Institute of Cancer Research in the UK was selected in 2013 by the US organization as the second global Focused Ultrasound “Center of Excellence” (there are now only 10 worldwide). UK FUSF is already partnering with the prostate cancer charity Prost8 UK and focused ultrasound device manufacturer Sonablate to increase access of focused ultrasound treatment for patients diagnosed with prostate cancer by co-funding the deployment early this year of a new prostate cancer treatment device at Guys & St Thomas' Hospital in London. “ I’ve been studying the use of focused ultrasound technology in oncology and have worked with the US Foundation for many years,” said Professor Gail ter Haar of The Institute of Cancer Research. “ The launch of the UK FUSF is an incredibly important milestone. This organisation will further catalyse development and adoption of the technology, bringing much needed innovative new treatments to our community and beyond.” The potential of focused ultrasound to be a game-changing treatment for so many diseases has attracted the attention of celebrities including musician Peter Gabriel, an honorary member of the UK FUSF Advisory Council. Said Mr. Gabriel, “ Sound has been the stuff I work with every day of my life. It’s thrilling to see how powerful it can be when ingeniously applied to healthcare. I’m delighted to see these pioneering technologies take root in the UK.” About the UK Focused Ultrasound Foundation Together with our sister organisation in the US, the UK Focused Ultrasound Foundation is working to provide patients with this noninvasive, life-changing treatment option in the shortest time possible. The UK FUSF will contribute financial and human resources to foster collaboration, to build knowledge and to streamline the process and overcome barriers. Focused ultrasound research in the UK has been funded by the US Foundation since 2009. For more information visit https://ukfusf.org/ . About Focused Ultrasound Focused ultrasound uses ultrasound energy guided by real-time imaging to treat tissue deep in the body without incisions or radiation. It is approved in the UK to treat prostate cancer and essential tremor. Dozens of additional indications are approved elsewhere in the world, including the United States, Europe and Asia. The technology is in various stages of research and development for nearly 170 diseases, including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, metastatic breast tumours, and tumours of the brain, liver and pancreas. Click here to watch a 6-minute video about focused ultrasound in the UK. References 1.National Institute for Health and Care Excellence 2005. High-intensity focused ultrasound for prostate cancer. Interventional procedures guidance [IPG118] . Available at: https://www.nice.org.uk/guidance/ipg118/chapter/1-Guidance . Last accessed January 2023. 2. National Institute for Health and Care Excellence 2018. Unilateral MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor. Interventional procedures guidance [IPG617] . Available at: https://www.nice.org.uk/guidance/ipg617/chapter/1-Recommendations . Last accessed January 2023.

30 Jan 2023

·www.businesswire.com

UK Focused Ultrasound Foundation Announces Launch

LONDON--( BUSINESS WIRE )--The UK Focused Ultrasound Foundation (UK FUSF), dedicated to advancing the development and adoption of focused ultrasound in the UK, today announced its formal launch. Focused ultrasound is a groundbreaking platform technology that uses ultrasound energy guided by real-time imaging to treat tissue deep in the body, without incisions or radiation. The Foundation will celebrate its launch with an event being held on 31 January at the House of Lords with important guests including MPs, members of the House of Lords, business leaders, and experts from medical charities and some of the UK’s leading research institutions, including the Institute of Cancer Research, Oxford University, and Imperial, King’s and University Colleges, London. Currently, focused ultrasound treatment for both prostate cancer and essential tremor has National Institute for Health and Care Excellence (NICE) approval and National Health Service England (NHS) coverage. 1,2 The technology has 32 regulatory approvals worldwide and is in various stages of research and development for nearly 170 diseases and conditions including Alzheimer’s disease, Parkinson’s disease, metastatic breast tumours, and tumours of the brain, liver, pancreas, and prostate. Launch of the UK FUSF will help enable donations to be applied directly to laboratory research and clinical trials in the UK, accelerating and expanding the exceptional work that has been ongoing for several years. It is hoped this will significantly increase the accessibility to already approved focused ultrasound-based treatments, which currently have limited availability in the UK. Specific areas of focus for the UK FUSF include cancer immunotherapy, brain diseases, pancreatic cancer, prostate cancer, and pediatric applications. “ Our vision at the Foundation is for focused ultrasound to be used in the UK to improve the lives of millions of people afflicted with a wide variety of serious medical disorders in the shortest time possible,” said Foundation Chairman Philip Keevil. “ By identifying opportunities, inspiring collaboration, raising awareness and overcoming barriers, the Foundation will shorten the time from laboratory research to widespread treatment using this remarkable and versatile technology.” The UK FUSF is an independent charity registered with the Charity Commission and HMRC, and GiftAid Eligible. It works closely with, but is independent of, the US-based Focused Ultrasound Foundation, aligning on goals and resources to advance focused ultrasound to treat millions worldwide. The Institute of Cancer Research in the UK was selected in 2013 by the US organization as the second global Focused Ultrasound “Center of Excellence” (there are now only 10 worldwide). UK FUSF is already partnering with the prostate cancer charity Prost8 UK and focused ultrasound device manufacturer Sonablate to increase access of focused ultrasound treatment for patients diagnosed with prostate cancer by co-funding the deployment early this year of a new prostate cancer treatment device at Guys & St Thomas' Hospital in London. “ I’ve been studying the use of focused ultrasound technology in oncology and have worked with the US Foundation for many years,” said Professor Gail ter Haar of The Institute of Cancer Research. “ The launch of the UK FUSF is an incredibly important milestone. This organisation will further catalyse development and adoption of the technology, bringing much needed innovative new treatments to our community and beyond.” The potential of focused ultrasound to be a game-changing treatment for so many diseases has attracted the attention of celebrities including musician Peter Gabriel, an honorary member of the UK FUSF Advisory Council. Said Mr. Gabriel, “ Sound has been the stuff I work with every day of my life. It’s thrilling to see how powerful it can be when ingeniously applied to healthcare. I’m delighted to see these pioneering technologies take root in the UK.” About the UK Focused Ultrasound Foundation Together with our sister organisation in the US, the UK Focused Ultrasound Foundation is working to provide patients with this noninvasive, life-changing treatment option in the shortest time possible. The UK FUSF will contribute financial and human resources to foster collaboration, to build knowledge and to streamline the process and overcome barriers. Focused ultrasound research in the UK has been funded by the US Foundation since 2009. For more information visit https://ukfusf.org/ . About Focused Ultrasound Focused ultrasound uses ultrasound energy guided by real-time imaging to treat tissue deep in the body without incisions or radiation. It is approved in the UK to treat prostate cancer and essential tremor. Dozens of additional indications are approved elsewhere in the world, including the United States, Europe and Asia. The technology is in various stages of research and development for nearly 170 diseases, including Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, metastatic breast tumours, and tumours of the brain, liver and pancreas. Click here to watch a 6-minute video about focused ultrasound in the UK. References 1.National Institute for Health and Care Excellence 2005. High-intensity focused ultrasound for prostate cancer. Interventional procedures guidance [IPG118] . Available at: https://www.nice.org.uk/guidance/ipg118/chapter/1-Guidance . Last accessed January 2023. 2. National Institute for Health and Care Excellence 2018. Unilateral MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor. Interventional procedures guidance [IPG617] . Available at: https://www.nice.org.uk/guidance/ipg617/chapter/1-Recommendations . Last accessed January 2023.

29 Dec 2022

·www.businesswire.com

Global Prostate Cancer Minimally Invasive Surgery Market 2022 to 2027: Players Include Elekta, HealthTronics, Intuitive Surgical, Isoray and Profound Medical - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Global Prostate Cancer Minimally Invasive Surgery Market (2022-2027) by Product Type, Application, and Geography, Competitive Analysis and the Impact of Covid-19 with Ansoff Analysis" report has been added to ResearchAndMarkets.com's offering. The Global Prostate Cancer Minimally Invasive Surgery Market is estimated to be USD 19.25 Bn in 2022 and is expected to reach USD 30.03 Bn by 2027, growing at a CAGR of 9.3%. Market dynamics are forces that impact the prices and behaviors of the Global Prostate Cancer Minimally Invasive Surgery Market stakeholders. These forces create pricing signals which result from the changes in the supply and demand curves for a given product or service. Forces of Market Dynamics may be related to macro-economic and micro-economic factors. There are dynamic market forces other than price, demand, and supply. Human emotions can also drive decisions, influence the market, and create price signals. As the market dynamics impact the supply and demand curves, decision-makers aim to determine the best way to use various financial tools to stem various strategies for speeding growth and reducing risks. Competitive Quadrant The report includes Competitive Quadrant, a proprietary tool to analyze and evaluate the position of companies based on their Industry Position score and Market Performance score. The tool uses various factors for categorizing the players into four categories. Some of these factors considered for analysis are financial performance over the last 3 years, growth strategies, innovation score, new product launches, investments, growth in market share, etc. Ansoff Analysis The report presents a detailed Ansoff matrix analysis for the Global Prostate Cancer Minimally Invasive Surgery Market. Ansoff Matrix, also known as the Product/Market Expansion Grid, is a strategic tool used to design strategies for the growth of the company. The matrix can be used to evaluate approaches in four strategies viz. Market Development, Market Penetration, Product Development and Diversification. The matrix is also used for risk analysis to understand the risk involved with each approach. The analyst analyses the Global Prostate Cancer Minimally Invasive Surgery Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position. Based on the SWOT analysis conducted on the industry and industry players, the analyst has devised suitable strategies for market growth. Why buy this report? The report offers a comprehensive evaluation of the Global Prostate Cancer Minimally Invasive Surgery Market. The report includes in-depth qualitative analysis, verifiable data from authentic sources, and projections about market size. The projections are calculated using proven research methodologies. The report has been compiled through extensive primary and secondary research. The primary research is done through interviews, surveys, and observation of renowned personnel in the industry. The report includes an in-depth market analysis using Porter's 5 forces model and the Ansoff Matrix. In addition, the impact of Covid-19 on the market is also featured in the report. The report also includes the regulatory scenario in the industry, which will help you make a well-informed decision. The report discusses major regulatory bodies and major rules and regulations imposed on this sector across various geographies. The report also contains a competitive analysis using Positioning Quadrants, the analyst's competitive positioning tool. Market Dynamics Drivers Rising Prevalence of Prostate Cancer Along with Rapidly Aging Population Increasing Demand for Minimally Invasive Surgery Restraints Surgery Complications Opportunities Development of New Minimally Invasive Instruments Challenges Dearth of Skilled Personnel Market Segmentation The Global Prostate Cancer Minimally Invasive Surgery Market is segmented based on Product Type, Application, and Geography. By Product Type, the market is classified into Hand, Monitoring & Visualization, and Powered. By Application, the market is classified into Laparoscopy, Brachytherapy, and Cryosurgery. By Geography, the market is classified into Americas, Europe, Middle-East & Africa and Asia-Pacific. Companies Mentioned Accuray Inc. Bard Cancer Diagnostics Becton, Dickinson and Company Boston Scientific Corp. Eckert & Ziegler Ag EDAP TMS SA Elekta AB HealthTronics Inc. Intuitive Surgical Isoray Inc. Profound Medical Corp. Provision Healthcare Siemens Healthineers Ag SonaCare Medical LLC Theragenics Corp. Varian Medical Systems, Inc. For more information about this report visit https://www.researchandmarkets.com/r/6m46bu

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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