midastouch017
3年前
INSIGHTEC CHAIRMAN OF THE BOARD AND CEO, MAURICE R. FERRÉ TO PRESENT AT 2023 MILKEN INSTITUTE GLOBAL CONFERENCE
PR Newswire
Fri, April 28, 2023 at 8:28 PM GMT
https://www.yahoo.com/lifestyle/insightec-chairman-board-ceo-maurice-172800693.html
Dr. Maurice Ferré to join more than 900 leaders in business, government, philanthropy, health, and entertainment for four-day event focused on "Advancing a Thriving World"
LOS ANGELES, April 28, 2023 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using focused ultrasound technology to transform patient care, today announced that Maurice R. Ferré MD, the Chairman of the Board of Directors and CEO, will be a featured speaker at the 2023 Milken Institute Global Conference in Los Angeles, California on Monday, May 1, 2023 at 11:30 a.m. PST.
Dr. Ferré will join a panel discussion entitled, "The Drive Toward More Non-Invasive Treatments for Patients" to discuss recent advancements in focused ultrasound technology for the treatment of essential tremor, Parkinson's disease and other movement disorders. Additionally, Dr. Ferré will highlight on-going clinical trials where focused ultrasound is combined with novel therapeutics for delivery across the blood brain barrier (BBB) in patients with glioblastoma, metastatic lung cancer, Alzheimer's Disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis. Other featured panelists include Neal F. Kassell, Founder and Chairman, Focused Ultrasound Foundation; Pejman Ghanouni, MD, PhD and Associate Professor of Radiology, Stanford University; Zhen Xu, Professor, Biomedical Engineering, University of Michigan and Chase Koch, Founder and CEO, Koch Disruptive Technologies & Founder of Stand Together Ventures and Stand Together Music.
The conference will run April 30 - May 3 at The Beverly Hilton in Los Angeles, CA. Conference panels will cover a myriad of domestic and global topics such as growth in disruptive technology, global energy markets, healthcare innovation and policy, digital asset regulation, supply chain disruption, biomedical innovation, geopolitics and cybersecurity, artificial intelligence, corporate philanthropy, the future of work, wellness, impact investing, and more.
Visit the 2023 Milken Institute Global Conference website for more information and to access session livestreams.
midastouch017
3年前
FAU AND INSIGHTEC PARTNER TO TREAT NEUROLOGICAL DISORDERS
FAU, Insightec, Neurological Diseases, Focused Ultrasound, Collaboration
The collaboration will advance scientific knowledge about the use of focused ultrasound to treat brain diseases, including Parkinson’s disease and Alzheimer’s disease.
https://www.fau.edu/newsdesk/articles/fau-insightec-collaboration
BY GISELE GALOUSTIAN | 4/28/2023
During his trade mission trip to Israel, Florida Gov. Ron DeSantis announced a new agreement between Florida Atlantic University and Insightec, a global health care company headquartered in Haifa, Israel. This agreement will enable FAU and Insightec to collaborate to advance scientific knowledge about the use of focused ultrasound to treat brain diseases, including Parkinson’s disease and Alzheimer’s disease.
By harnessing acoustic energy, Insightec’s innovative technology uses focused ultrasound to treat diseases in different ways. Currently, high intensity focused ultrasound (HIFU) is a United States Food and Drug Administration-approved means of creating lesions that treat Parkinson’s disease. More recently, the system has been used under different paradigms to non-invasively modulate and disrupt the blood-brain barrier, a network of blood vessels that plays a key role in keeping harmful substances from reaching the brain. At the same time, the blood-brain barrier also prevents the uptake of most pharmaceuticals, which makes it difficult to treat diseases of the brain. Alzheimer’s disease and other neurological diseases may be treated by opening the blood-brain barrier.
FAU and Insightec will explore opportunities to collaborate on research using focused ultrasound in pre-clinical settings both to non-invasively introduce therapeutic drugs across the blood-brain barrier to accelerate development of treatments for these neurological diseases and optimize HIFU and low intensity focused ultrasound to change the way the nervous system functions.
“Gov. DeSantis has set the stage to place neurological diseases such as Alzheimer’s disease at the forefront of health issues in the state of Florida and we appreciate his vision and continued support,” said Brad Levine, FAU Board of Trustees chair. “This important partnership between Florida Atlantic University and Insightec will help to propel novel therapies to meaningfully impact brain health and attain patient access to advanced care.”
As part of the agreement, FAU will leverage its clinical and academic expertise in the areas of preclinical research and basic sciences related to neurological conditions as well as its capacity and capabilities to conduct clinical research in these areas. Insightec will provide its expertise and resources related to research and development as well as its pre-clinical and clinical experience with the focused ultrasound platform.
“Improving the lives of patients is core to our mission at Insightec, and Florida Atlantic University shares our mission,” said Maurice R. Ferré, M.D., CEO and chair of the board of directors for Insightec. “There is a great urgency to accelerate the pace of medical innovation to treat neurological diseases. Together with our academic research partners at FAU we will advance preclinical and clinical investigations and further examine the potential of the therapeutic power of focused soundwaves.”
FAU has a vibrant neuroscience ecosystem including its state-of-the-art FAU Stiles-Nicholson Brain Institute located on the John D. MacArthur Campus in Jupiter, which serves as a collaborative hub for neuroscience and fosters connections to unravel the complex mysteries of the brain to ultimately improve quality of life.
Julie Pilitsis, M.D., Ph.D., dean and vice president for medical affairs in FAU’s Schmidt College of Medicine, will lead FAU’s clinical research efforts. She has had National Institutes of Health funding on focused ultrasound for the past 10 years and is considered a leading expert in the arena. She is a board-certified practicing neurosurgeon who is a national expert in movement disorders, including Parkinson’s disease, and in chronic pain.
“We are incredibly excited to partner with Insightec on ultrasound technology, which has the potential to be a gamechanger in how we treat patients with Alzheimer’s and Parkinson’s disease and how we ensure that each patient is offered the best treatment,” said Pilitsis.
An estimated 6.5 million Americans ages 65 and older are living with Alzheimer’s disease, which is the sixth leading cause of death for those age 65 and above in the U.S., according to the Alzheimer’s Association. Florida has the second highest incidence of Alzheimer’s in the country, with an estimated 580,000 cases. According to the Parkinson’s Foundation, nearly 1 million people in the U.S. are living with the disease, with an estimated four percent of people diagnosed before age 50. Florida is among four states in the U.S. with the highest incidences of Parkinson’s disease.
“Focused ultrasound is an amazing tool that affords us the opportunity to treat many brain diseases in a variety of ways,” said Gregg Fields, Ph.D., interim vice president for research at FAU, executive director of the Institute for Human Health and Disease Intervention (I-Health), and program director for “Research University Alzheimer’s Research Using Exablate Neuro-focused Ultrasound,” a clinical trial collaboration between FAU, Delray Medical Center and Insightec. “We look forward to continuing our collaboration with Insightec on this newest initiative to further explore this technology’s ability to treat some of the most debilitating and costly neurological disorders.”
midastouch017
3年前
SonALAsense Announces Completion of First Cohort in Phase 2 Study of SONALA-001 Sonodynamic Therapy for Recurrent Glioblastoma
https://www.businesswire.com/news/home/20230308005307/en/SonALAsense-Announces-Completion-of-First-Cohort-in-Phase-2-Study-of-SONALA-001-Sonodynamic-Therapy-for-Recurrent-Glioblastoma
Company’s Phase 2 clinical trial aims to find meaningful clinical endpoints regarding tumor regression and survival rates.
March 08, 2023 08:00 AM Eastern Standard Time
OAKLAND, Calif.--(BUSINESS WIRE)--SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), today announced that the first cohort in SDT-202 was fully enrolled. SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM). The objectives of SDT-202, which builds upon a previous proof-of-concept (POC) trial conducted by Nader Sanai, MD, Chief Scientific Officer and Director at the Ivy Brain Tumor Center at Barrow Neurological Institute, are to evaluate the safety, optimal dose, and efficacy of SDT.
“Our goal is to offer patients a good quality of life and make rGBM manageable, rather than lethal.”
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The first cohort in SDT-202 was enrolled at Cleveland Clinic by principal investigator Matthew Grabowski, MD.
“In the previous POC study, Dr. Sanai and his team demonstrated that SONALA-001 SDT was well tolerated and led to targeted oxidative stress and cell death in human high-grade glioma tissue without harming surrounding tissue,” said Dr. Mitchel Berger, MD, FAANS, who chairs SonALAsense’s Scientific Advisory Board. “Within four days after a single treatment, there was tumor cell death. The speed of action and repeatability of this unique therapy has the potential to be a game-changer for patients living with rGBM.”
At the start of the SDT procedure, a patient is given an injection of SONALA-001, an intravenous formulation of aminolevulinic acid (ALA). The drug is taken up selectively by cancer cells because they need ALA to make the heme molecule. Next, MR-guided ultrasound is used to focus ultrasound waves to create light in the brain through a process called sonoluminescence. The light activates a byproduct of SONALA-001 to create a “smart bomb” that is designed to trigger immediate and programmed cell death only in cancer cells.
“At SonALAsense, we are excited to further develop SONALA-001 SDT as a potential approach to treat this devastating brain cancer. Current options for rGBM, such as surgery, radiation, chemotherapy, and antibody drugs have significant side effects,” said Mark de Souza, PhD, Chief Executive Officer at SonALAsense. “Our goal is to offer patients a good quality of life and make rGBM manageable, rather than lethal.”
Dr. Grabowski at the Cleveland Clinic, along with other investigators at collaborating sites including the University of California San Francisco, Mayo Clinic, Ivy Brain Tumor Center, MD Anderson, NYU, and West Virginia plan to enroll approximately 50 participants in SDT-202. Patients interested in the trial can learn more at clinicaltrials.gov.
“Recurrent glioblastoma multiforme is a devastating brain cancer. We in the brain tumor community are eager for alternative treatments to prolong and improve our loved ones’ quality-of-life,” said Ralph DeVitto, President and Chief Executive Officer of the American Brain Tumor Association (ABTA). “We look forward to the outcomes of this clinical trial and learning more about the potential benefits of sonodynamic therapy.”
About SonALAsense
SonALAsense is a clinical-stage company developing sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination for the treatment of recurrent glioblastoma multiforme, diffuse intrinsic pontine gliomas, and other life-threatening cancers. SDT utilizes SONALA-001 (a drug) in combination with MR-guided focused ultrasound (a device) to selectively target and kill tumor cells. Follow SonALAsense on Twitter and LinkedIn and visit our website at sonalasense.com.
Contacts
Valerie Enes
venes@spectrumscience.com
408-497-8568
midastouch017
3年前
INSIGHTEC ANNOUNCES POSITIVE COVERAGE DECISION BY CIGNA FOR FOCUSED ULTRASOUND TO TREAT ESSENTIAL TREMOR
Cigna is the fourth national payor to cover the outpatient procedure.
HAIFA, Israel & MIAMI, Jan. 31, 2023 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that Cigna is the fourth national payor to cover focused ultrasound for treating medication-refractory essential tremor.
"We are so excited to have another national payor providing access to focused ultrasound to non-Medicare patients," said Dee Kolanek, Insightec Vice President of Market Access and Reimbursement. "We want to extend our thanks to leading insurers like Cigna for their decision to cover this game-changing outpatient treatment for essential tremor patients."
Essential tremor, a movement disorder that causes uncontrollable shaking, affects an estimated ten million Americans. For patients whose tremor does not respond to medications, focused ultrasound is performed in a single, outpatient procedure with many patients showing immediate improvement of tremor in the treated hand with minimal complications.
"This is important progress towards our goal of expanding access to this transformative treatment option and we want to thank Cigna for their positive coverage decision," added Maurice R. Ferré MD, Insightec's CEO and Chairman of the Board of Directors. "Now, more patients with essential tremor can get back their ability to live independently, return to work, and improve their mental and physical health."
Cigna becomes the fourth national payor to cover the treatment after Anthem, Aetna, and Blue Cross Blue Shield Association gave positive coverage decisions in December 2022, April 2021, and August 2018, respectively. There are currently more than 125 treatment centers around the world using Insightec's Exablate® Neuro platform to treat essential tremor. Focused ultrasound treatment for medication-refractory essential tremor is covered by Medicare in all 50 states.
midastouch017
3年前
A sound you can’t hear but may one day change your life
By Kristen Rogers, CNN
Published 10:17 AM EST, Sun January 15, 2023
https://edition.cnn.com/2023/01/15/health/focused-ultrasound-tremor-depression-ocd-wellness/index.html
Brenda Hric consults with neurosurgeon Dr. Jeff Elias, who conducted her focused ultrasound.
Undergoing clinical trials around the world is a brain surgery that doesn’t need an incision or produce any blood yet drastically improves the lives of people with essential tremor, depression and more. The procedure, known as a focused ultrasound, aims sound waves at parts of the brain to disrupt faulty brain circuits causing symptoms.
“Focused ultrasound is a noninvasive therapeutic technology,” said Dr. Neal Kassell, founder and chairman of the Focused Ultrasound Foundation. “We’ve said that focused ultrasound is the most powerful sound you will never hear, but sound that someday could save your life.”
Kassell describes the way it works as “analogous to using a magnifying glass to focus beams of light on a point and burn a hole in a leaf.”
“With focused ultrasound, instead of using an optical lens to focus beams of light,” he added, “an acoustic lens is used to focus multiple beams of ultrasound energy on targets deep in the body with a high degree of precision and accuracy, sparing the adjacent normal tissue.”
The procedure has been significantly beneficial for people with essential tremor, a neurological disorder that causes involuntary and rhythmic shaking. The disorder can affect almost any body part, but the tremors typically occur in hands — even during simple tasks such as eating, drinking or writing.
Essential tremor is usually more prominent on one side of the body and can worsen with movement. It’s most common in people 40 and older, and it affects nearly 25 million worldwide, according to a 2021 study.
Such was the case with Brenda Hric, 80, who recently underwent focused ultrasound at the University of Virginia, a pioneering institution of the procedure.
Hric’s tremors made her uncomfortable in social situations because she was afraid of spilling or knocking something over, she told CNN.
But just 44 seconds of focused ultrasound waves got rid of her tremor.
“I looked at my hand, and I could see that it was not moving, and that was the first time I had been able to see my fingers still in about 20 years,” Hric said. “I think it’s definitely a miracle, and I thank the Lord for it.”
How it works
Focused ultrasound is a form of functional neurosurgery, the targeting of precise structures deep in the brain to change it, to restore function or, in this case, to stop a tumor. It’s an alternative treatment for those who, like Hric, don’t respond to or stop being affected by conventional medication treatment, experts said.
“In a simplistic sense, you can imagine that there’s a bunch of abnormal neurons in this one target that are firing away uncontrollably, causing the tremor, the shaking,” Kassell said.
Focused ultrasound technology uses a transducer to force beams of sound waves to converge at one point to raise the temperature and destroy tissue.
Before receiving high-intensity focused ultrasound, the one necessary for treating essential tremor, patients need to have their heads shaved since air can sometimes get trapped in hair follicles.
The patient then undergoes MRI and CT scans so doctors can use the resulting images to map the structure of the brain and the target.
Pictured are scans of Hric's brain. Focused ultrasound signficantly improved the 80-year-old's tremors.
The Insightec Exablate Neuro, a focused ultrasound platform, instructs how many beams should be used to do the treatment, then neurosurgeons might do what Dr. Jeff Elias calls “test shots, just to make sure we’re focused right at the bull’s-eye.”
A UVA Health neurosurgeon who treated Hric, Elias is a pioneer of treating essential tremors using ultrasound waves. In 2011, he led the clinical trials critical for gaining regulatory approval of this procedure in the United States.
“These (test shots) are really low energy, but we want to see if our treatment is exactly where we want it,” he said. “This is our chance to kind of sight the rifle.”
Four 11-second treatment doses significantly improved Hric’s tremor. The entire procedure lasted less than two hours, with most of it spent mapping the brain and testing the target.
Beforehand, Hric had trouble drawing inside the lines of circles. Focused ultrasound helped her color inside the lines.
Pros and cons
Generally, anyone with an essential tremor diagnosis not responding to medications would be eligible for focused ultrasound treatment, said Dr. Nir Lipsman, a scientist at Sunnybrook Health Sciences Centre in Toronto and director of Sunnybrook’s Harquail Centre for Neuromodulation.
People who can’t undergo MRI scans due to claustrophobia or having metal inside their body aren’t eligible for focused ultrasound, said Dr. Noah Philip, a professor of psychiatry and human behavior at Brown University’s Alpert Medical School. Philip is also lead for mental health research at the VA RR&D Center for Neurorestoration and Neurotechnology.
Ideally, the benefits of focused ultrasound are permanent, Lipsman said. “If you’re able to destroy the part of the brain responsible for the tremor, it should be a permanent effect,” he said. “At one year, however, some of these patients will have a rebound or recurrence of their tremor, and we don’t know why that is.”
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Such a return can happen with medication treatment, too, though — which is why some essential tremor patients turn to focused ultrasound in the first place.
But some patients have experienced the benefits five years after undergoing focused ultrasound, according to a 2022 study by Elias.
Potential side effects of focused ultrasound are why the mapping and testing parts of the procedure are so important. If the wrong area is targeted or treated excessively, a patient’s balance and stability can be harmed long term.
“The most common risks that we encounter in patients is a temporary numbness or tingling that can sometimes happen in the treated arm or in the lip area,” Lipsman said. “The vast majority of the time that goes away with time.”
Other common, but usually temporary, risks include slight unsteadiness on one’s feet after the procedure. But doctors don’t use a general anesthetic or hospitalize patients for this procedure, he added.
What’s next in the field
Today, focused ultrasound technology is used globally in various stages, including clinical trials and approved regulatory use. There are more than 170 clinical uses — including for neurodegenerative disorders and tumors of the brain, breast, lung, prostate and more — and the field is growing, Kassell said.
“You can watch the effect of the ultrasound treatment in real time while the treatment’s being administered, whereas with radiation, the effect of the treatment is invisible while it’s being administered,” Kassell said. “And it takes weeks or months for the effect of radiation to become apparent.”
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Use for depression and obsessive-compulsive disorder is on the table, according to a small 2020 study by Lipsman and a team of researchers. They found focused ultrasound was safe and effective in improving symptoms for people with major depression and OCD. But further studies are needed.
One limitation of focused ultrasound is that not every person’s skull is made equal, Lipsman said.
“The density of the skull has a major impact on the ability of ultrasound to travel through it,” he added. “It’s rare, but there are some patients that, try as we might, we cannot make an effective lesion in the brain. The skull does not allow the passage of ultrasound. So that’s a technical limitation of the technology, something that we’re actively working on.”
Focused ultrasound isn’t available for every condition, but experts said they are hopeful that “medicine’s best-kept secret” will one day become a standard treatment.
“My belief is that in 10 years,” Kassell said, “focused ultrasound will be a mainstream therapy that is affecting millions of patients every year around the world. It’ll be widely accepted.”
CNN’s Adeline Chen contributed to this report.
midastouch017
4年前
Insightec Announces Financing up to $200 Million to Fund Continued Growth
HAIFA, Israel and MIAMI, Sep. 1, 2022 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it signed a credit facility for up to $200 million with affiliates of existing shareholders Perceptive Advisors and Community Fund. The financing has provided Insightec with $100 million at closing, with an additional $100 million of financing potentially available in tranches through 2024. The credit facility is interest-only for five years and matures on August 31, 2027.
"This financing allows Insightec to invest in driving adoption of incisionless neurosurgery to treat patients with Essential Tremor and Parkinson's Disease, while continuing to advance innovation and clinical trials for expanded applications of the company's technology in neuro-oncology and other neurological conditions," said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. "We are pleased to have continued support from Perceptive Advisors and Community Fund. Insightec is a true global company. We are focused on supporting and growing our world class customer base of medical centers across the Americas, Europe, and Asia."
"Perceptive is excited to expand its partnership with Insightec by providing growth capital to support commercialization and expansion of its incisionless platform," said Sam Chawla, Portfolio Manager of Perceptive Advisors. "With a global installed base of 120 systems, FDA approvals for Essential Tremor, Parkinson's Disease and Prostate, and a pipeline of future potential indications, we are excited about Insightec's ability to offer care to many patients suffering from diseases with only limited or invasive alternative therapies."
Perella Weinberg Partners acted as the company's financial advisor in connection with the credit facility.
About Insightec
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai, and Tokyo.
midastouch017
4年前
INSIGHTEC RECEIVES FDA IDE APPROVAL FOR PROSTATE CANCER COMPARATIVE STUDY USING HIGH INTENSITY FOCUSED ULTRASOUND TECHNOLOGY
Insightec
Jun 30, 2022, 10:06 ET
Study will evaluate the safety and efficacy of the treatment with the Exablate Prostate system compared to active surveillance of prostate cancer
HAIFA, Israel and MIAMI, June 30, 2022 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue. This study will evaluate the safety and efficacy of focal treatment using high intensity focused ultrasound when compared to active surveillance in men living with prostate cancer.
The Insightec Exablate Prostate system uses sound waves to ablate, or destroy, targeted tissue in the prostate. The treatment is performed under Magnetic Resonance Imaging (MRI) guidance for high resolution visualization of the patient's anatomy for precise targeting and real-time temperature monitoring. The single session treatment does not require incisions and allows patients to quickly return to normal activity with minimal complications.
"We are excited to continue this important research that can impact on the standard of care for prostate cancer treatment," said Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and principal investigator for the study. "Exablate Focused Ultrasound has been shown to provide an accurate, safe, and effective option to engage the prostate gland directly in select patients based on 2-years biopsy outcomes. The new trial will build on this success and help further enhance treatment options."
"At Insightec, we are committed to the next generation of prostate cancer research and patient care," said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. "Through technological innovation and medical advancements, there has been significant progress made in treating the prostate over the last decade, but we're not done yet. Our goal for this study is to demonstrate the clinical benefits of Exablate Prostate and provide patients with the opportunity for improved quality of life outcomes."
A previous Insightec-sponsored clinical trial led by Memorial Sloan Kettering Cancer Center for the Exablate Prostate system reported minimal damage to adjacent structures and low rates of impact on potency and continence, supporting function and quality of life for patients. The new comparative study builds on the evidence of this clinical trial and aims to further enhance prostate treatment options and improve clinical outcomes.
The Insightec Exablate Prostate system received 510(k) FDA clearance in November 2021, making way for the system to be offered to patients in a commercial facility and for further clinical studies. In January 2022, the system was used to treat prostate disease in its first US commercial patient.
Results from the new study will define the role of focal therapy to delay and avoid radical therapy for men with prostate cancer and support expanded clinical adoption of the technology and increased access for patients through insurance reimbursement.
To read more about Exablate Prostate FDA 510K clearance:
https://insightec.com/insightec-announces-fda-clearance-for-exablate-prostate/
To read more about Exablate Prostate's first US commercial patient treatment:
https://insightec.com/first-us-commercial-patient-treated-for-prostate-disease-with-insightec-incisionless-focused-ultrasound-system/
midastouch017
4年前
INSIGHTEC RECEIVES FDA IDE APPROVAL AND “BREAKTHROUGH” DESIGNATION FOR NSCLC BRAIN METS STUDY AND IDE APPROVAL FOR LIQUID BIOPSY STUDY
https://insightec.com/insightec-receives-fda-ide-approval-and-breakthrough-designation-for-nsclc-brain-mets-study-and-ide-approval-for-liquid-biopsy-study/
Designation and approvals mark key milestones in advancing Insightec Blood Brain Barrier (BBB) clinical roadmap using Acoustic Therapy
HAIFA, Israel & MIAMI, Florida, March 9, 2022 — Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval of two pivotal investigational device exemptions (IDE) for its Exablate Neuro system – one for primary non-small cell lung cancer (NSCLC) that has metastasized to the brain in conjunction with standard-of-care Keytruda®, and one for enhanced efficacy of liquid biopsy for recurrence monitoring of patients with primary brain cancer. The FDA has also granted “Breakthrough Device” designation for the NSCLC treatment, helping to expedite its development and review.
Insightec plans to launch the LIMITLESS study (NSCLC) to assess the clinical benefit of using noninvasive, low-intensity focused ultrasound combined with systemic immunotherapy in the treatment of patients with brain metastases from lung cancer.
“The use of low-intensity focused ultrasound (LIFU) with microbubbles to open up the blood brain barrier (BBB) is an exciting advance in neuro-oncology that holds promise to become a paradigm shift in the treatment of patients with brain tumors,” said study Principal Investigator Dr. Manmeet Ahluwalia, MD, MBA, Chief of Solid Tumor Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida. “The unique synergy of LIFU BBB opening for improved drug delivery, neoantigen release and immune priming is a potential game-changer in our field that will help us build on current treatment options available for these patients.”
Liquid biopsy is a new approach for noninvasive cancer subtyping, treatment selection, monitoring residual disease, early identification of treatment responders versus non-responders, and assessment of tumor progression versus pseudoprogression.
“Despite remarkable progress in other cancers, liquid biopsy has had limited success in brain tumors due to the presence of the blood brain barrier, which limits signal detection in the bloodstream,” said Dr. Achal Singh Achrol, MD, FAANS, Chief Medical Officer of Insightec. “Preclinical and early human studies have demonstrated that low-intensity focused ultrasound (LIFU) can transiently increase the permeability of the blood brain barrier and allow passage of region-specific biomarkers to enable noninvasive liquid biopsy in brain tumors. This pivotal clinical trial will investigate for the first time the clinical benefit to this approach as a novel alternative to invasive neurosurgical biopsies.”
“Insightec continues to collaborate with leading researchers to advance the use of acoustic therapy in the brain,” said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. “This work focuses on safely opening the blood brain barrier using low frequency acoustic energy and has the potential to transform current therapeutic and diagnostic approaches for conditions like brain cancer. Our ultimate goal is, as always, to positively impact patient lives.”
The Exablate Neuro device is already FDA approved for the treatment of medication-refractory Essential Tremor and Parkinson’s Disease. At the close of 2021 there were 42 medical centers in the United States using the Insightec Exablate Neuro device to treat patients with these conditions. The Insightec Exablate Prostate system has received FDA 510K clearance for ablating prostate tissue with high intensity Focused Ultrasound.
About Insightec
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai, and Tokyo.
Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.
midastouch017
4年前
Insightec cuts SPAC merger valuation
4 Jan, 2022 15:28
Gali Weinreb
Elbit Medical, a shareholder in the Israeli medical device company, reports that if the merger goes ahead it will be at a lower valuation than previously reported.
Israeli medical device company Insightec is the latest company to fall 'victim' to the weakness on the SPAC merger market on Wall Street. The company reported in October that it was in talks for a SPAC merger at a company valuation of $2 billion. Today, Elbit Medical (TASE: EMTC), which has a 3.1% stake in Insightec, notified the Tel Aviv Stock Exchange (TASE) that due to the market conditions, if the merger goes ahead, it will be at a lower valuation than reported in October. No further details were disclosed. Insightec has developed a device for minimally invasive surgery based on ultrasound.
Only last week, Israeli trading platform eToro reported that it had agreed to cut the valuation of its planned SPAC merger by 15% to $8.4 billion, after money. Other Israeli companies waiting to complete their SPAC mergers are Gett (formerly Get Taxi) and fintech company Pagaya.
Insightec was founded in 1999 and has developed and markets a non-invasive system for using focused MRI-guided ultrasound waves to destroy tissue, for treatment of non-Parkinson tremors, and to clear "blood-brain blockage" and tumors.
Insightec is controlled by US company Koch Disruptive Technologies (KDT), which has invested an overall $200 million for a 40% stake. In 2020, KDT led a $136 million financing round at a $1.3 billion valuation. In May 2021, Insightec's second largest shareholder York Capital sold its 7% stake at a company valuation of $1 billion to Peregrine Ventures and Israeli institutional investors Leumi Partners and Mor Investments. York remains with a 13% stake. Elbit Medical, once a dominant investor in the company, has sold most of its shares and remains with a 3.1% stake.
Insightec has recently received two important FDA clearances, in treating Parkinson's disease and prostate growths, which paves the way for future marketing possibilities. The company tends to see its revenue grow from quarter to quarter but still reports large losses.
Published by Globes, Israel business news - en.globes.co.il - on January 4, 2022
midastouch017
5年前
Insightec Announces FDA Approval of Exablate Neuro for the Treatment of Parkinson's Disease
The device is indicated for unilateral pallidotomy for medication-refractory patients with moderate to severe motor complications
https://www.prnewswire.com/news-releases/insightec-announces-fda-approval-of-exablate-neuro-for-the-treatment-of-parkinsons-disease-301414996.html
MIAMI, Nov. 3, 2021 /PRNewswire/ -- Insightec®, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the U.S. Food and Drug Administration (FDA) has approved the Exablate® Neuro for treating advanced Parkinson's Disease patients suffering from mobility, rigidity, or dyskinesia symptoms.
The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus (GPi) during a pallidotomy. The treatment is incisionless, does not require brain implants, and has less risk of infection than invasive surgery.
"Movement disorder neurologists now can offer their Parkinson's patients a less invasive surgical option as part of their treatment plan," Paul S. Fishman, MD, PhD, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine.
"This approval is significant in that it adds Focused Ultrasound as an incisionless surgical option to treat motor symptoms of Parkinson's disease," added Howard M. Eisenberg, MD, R.K. Thompson Professor, Department of Neurosurgery at the University of Maryland and Principal Investigator.
Parkinson's disease (PD), a neurodegenerative disorder, affects an estimated one million patients in the United States. Tremor, rigidity, slow movement (bradykinesia), and postural instability are the cardinal features of PD. When medication induces side effects or is not well tolerated, surgical treatments, such as Focused Ultrasound, may be considered.
"This expanded approval of clinical indications to treat Parkinson's Disease signifies the growing understanding and acceptance of Focused Ultrasound as an effective treatment modality," commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors. "More importantly, it drives our continued efforts to help transform the lives of people living with debilitating neurological and other conditions."
The Exablate Neuro device received approval by the FDA for the treatment of medication-refractory Essential Tremor in 2016 and for Tremor-dominant Parkinson's Disease in 2018. There are currently 37 medical centers in the United States using the Insightec Exablate Neuro device to treat patients with medication-refractory Essential Tremor and Tremor-dominant Parkinson's Disease.
midastouch017
5年前
India Ministry of Health and Family Welfare Approves Exablate Neuro Focused Ultrasound Platform
https://www.bakersfield.com/ap/news/india-ministry-of-health-and-family-welfare-approves-exablate-neuro-focused-ultrasound-platform/article_bdf9ad7d-8ba8-5514-9b11-891c555d6ae3.html
HAIFA, Israel and MIAMI, Fla., Sept. 20, 2021 /PRNewswire/ -- Insightec ®, a global healthcare company focused on transforming patient care, announced its incisionless neurosurgery platform, the Exablate® 4000, has received market approval by the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare of India.
The Exablate 4000 (Exablate Neuro) platform uses MR-guided focused ultrasound to precisely ablate a small target deep within the brain without incisions. The approval will enable treatment of patients in India living with Essential Tremor, Tremor-dominant Parkinson's Disease and Neuropathic Pain.
"This approval adds to the growing recognition of the value of Focused Ultrasound for global healthcare systems," commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors. "More importantly, expanded access to our technology is helping to transform the lives of people living with debilitating medical conditions."
Essential Tremor is a neurological condition that causes uncontrollable shaking in an estimated 41 million people worldwide. More than 80 medical centers around the globe are treating Essential Tremor patients with the Exablate Neuro on a regular basis. Performed in a single session in an MRI suite, many patients experience immediate tremor relief in the treated hand with minimal side effects.
"This technology offers appropriate patients immediate tremor control with a less invasive procedure that requires no incisions or anesthesia with minimal complications," said Prof. Paresh Doshi, Director of Neurosurgery at Jaslok Hospital and Research Centre and Group Advisor Functional Neurosurgery, Apollo Group of Hospitals, President of The Neuromodulation Society of India and Past President of the Indian Society for Stereotactic and Functional Neurosurgery. "Global clinical studies have demonstrated the procedure as approved is safe and helps patients to regain daily function."
About Insightec
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory Essential Tremor and Tremor-dominant Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
midastouch017
5年前
Healthcare firm 'excited' over China's innovation
By LIU ZHIHUA | chinadaily.com.cn | Updated: 2021-08-06 09:42
http://global.chinadaily.com.cn/a/202108/06/WS610c93a7a310efa1bd667122.html
As a large market with increasing emphasis on the use and advancement of technologies, particularly in medicine, China presents an opportunity for growth and innovation of technology. [Photo/IC]
China's staunch commitment to promoting high-quality development and further opening up its market to foreign investors and companies will help accelerate innovation, which will allow high-tech companies to flourish and help foreign enterprises to operate successfully in the nation, said a top executive of Insightec, a global healthcare company headquartered both in Haifa in Israel, and Miami in the United States.
Founded in Israel, Insightec is the first in the world to launch a magnetic resonance-guided focused ultrasound (MRgFUS) platform to treat targets in the brain for movement disorders without incisions.
Maurice R. Ferre, CEO and chairman of Insightec, said China's pursuit of high-quality development and deepening of reforms is beneficial for people and businesses alike.
As a large market with increasing emphasis on the use and advancement of technologies, particularly in medicine, China presents an opportunity for growth and innovation of technology, as well as for innovation-focused companies addressing the challenges of an aging population.
"As a foreign enterprise, we are excited to seize the available opportunities to expand our operations and services in China and cooperate with local providers and partners," he said, adding the company will continue to make investments in China.
The company is very bullish in China, and expects the country to be its largest market, thanks to the nation's huge domestic market with aging population, and cost-effectiveness of the company's products, Ferre said.
As China enters a new phase of dual-circulation development pattern and promotes higher-level opening-up, its adherence to improving the business environment and its innovation-driven strategy are providing stronger impetus to increase foreign investment, experts said.
Data from the Ministry of Commerce showed China's actual use of foreign capital surged to 607.84 billion yuan ($94 billion) in the first half, up 28.7 percent year-on-year and up 27.1 percent over the first-half figure of 2019.
In the healthcare sector, where a series of major policy reforms have been introduced since 2015, internationalization and innovation have become an inevitable trend in the country's pharmaceutical industry in order to encourage innovation and improve quality healthcare accessibility and affordability.
Zhang Fei, associate director of the Institute of Foreign Investment, which is part of the Chinese Academy of International Trade and Economic Cooperation, said China has provided substantial investment returns to many foreign-funded companies, making a solid contribution to the world economic recovery and the establishment of a globally open economy.
She predicted sectors related to technological revolution and industrial transformation, like high-end manufacturing, smart terminals, autonomous driving, sensors, 5G and digitalization, will become the key areas of foreign investment during the 14th Five-Year Plan period (2021-25).
Ferre said business environment in China for foreign companies has been very favorable, and while applying "a lot of regulatory rigor",Chinese authorities have been "receptive" and have given a pathway for approvals for the company's technology that provides incisionless treatment to patients suffering from essential tremor and tremor-dominant Parkinson's disease.
The company entered China in 2014 with an office in Shanghai, and thanks to the favorable business environment in China for foreign companies, its latest product, called the Exablate Neuro system, was smoothly introduced in the Chinese market.
midastouch017
5年前
Huons to supply focused ultrasound MRI to SMC
https://www.koreabiomed.com/news/articleView.html?idxno=11548
Huons said Monday that it is speeding up installing ExAblate Neuro to Samsung Medical Center (SMC) in September to provide magnetic resonance-guided focused ultrasound surgery (MRgFUS) for those with brain diseases.
Huons said Monday that it would install a magnetic resonance-guided focused ultrasound device, ExAblate Neuro, at Samsung Medical Center to provide safer surgery for people with brain diseases.
Huons said Monday that it would install a magnetic resonance-guided focused ultrasound device, ExAblate Neuro, at Samsung Medical Center to provide safer surgery for people with brain diseases.
Huons acquired exclusive rights to supply ExAblate Neuro developed by the Israeli biotechnology company Insightec in 2019. The device uses a non-invasive surgical method to remove the specific tissue that causes abnormal brain function by using MRgFUS, unlike the existing therapy that requires cutting a bony opening in the skull.
The device has no risk of bleeding or infection, and the surgeons can monitor the surgical site in real-time through MRI images while performing an operation. Patients who receive surgery with ExAblate Neuro recover rapidly and return to their usual daily activities.
“If Huons installs the device at SMC, people with brain disorders will receive safer operations,” Huons said.
Regulatory agencies in 23 countries, including the U.S. Food and Drug Administration, have authorized ExAblate Neuro, and 82 hospitals and other medical institutions are using the device, it added.
“ExAblate Neuro is a new device that has shown excellent therapeutic effect for brain diseases, such as tremor,” Samsung Medical Center Neurosurgery Department Professor Lee Jung-il said. “We are glad to introduce a novel, cutting-edge treatment system that has drawn the attention of the neurosurgery communities worldwide.”
Ori Atar, the director of Insightec’s Asian Growth Markets, said, “We are pleased to supply ExAblate Neuro to Samsung Medical Center that provides excellent patient-centered medical services in Korea.”
Ori Atar added that the company expects ExAblate Neuro to become a new treatment option in Korea, stressing the effectiveness of treatment for brain diseases has been proven globally with studies of various illnesses.
Huons CEO Eom Gi-an also said. “Korean patients can receive therapies for brain disease using ExAbalte Neuro, as Samsung Medical Center decided to install the device. We will provide more treatment options for patients.”
midastouch017
5年前
Insightec Announces Registration Approval Of Exablate Neuro By Singapore Health Sciences Authority
Positive momentum continues to bring Focused Ultrasound to global patients living with Essential Tremor and Tremor-dominant Parkinson's Disease
http://m.koreaherald.com/amp/view.php?ud=20210705000139
HAIFA, Israel and MIAMI, July 5, 2021 /PRNewswire/ -- Insightec®, a global healthcare company focused on creating the next generation of patient care, announced approval of the Exablate® Neuro platform by the Health Sciences Authority (HSA) in Singapore.
The Exablate Neuro (Exablate 4000) platform uses Focused Ultrasound to ablate a target deep in the brain. The unilateral treatment is suitable for patients with Essential Tremor (age 22 or older) or Tremor-dominant Parkinson's Disease (age 30 or older) who have not responded to medications.
"The value of Focused Ultrasound for medical centers treating movement disorders is greatly improved patient care," said Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors. "Our technology enables patients to go from a life dominated by tremor to the potential for a calm, steady hand."
There are 81 leading medical centers globally that have established Focused Ultrasound programs with Exablate Neuro. Insightec is working with Transmedic Group, a leading distributor of advanced medical technology in Southeast Asia, to advance adoption of the Exablate Neuro in the Singapore market.
"We are excited to bring this transformational technology to medical centers in Singapore," commented Teo Kee Meng, Transmedic Managing Director. "More importantly, patients will now have the option to choose a treatment that is outpatient and incisionless."
About Insightec
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate® Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with Essential Tremor and Tremor-dominant Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
Follow us on Facebook, LinkedIn and Twitter or visit www.insightec.com for more information.
midastouch017
5年前
Insightec Announces Samsung Medical Center Is Joining Focused Ultrasound Community
https://www.kpvi.com/news/national_news/insightec-announces-samsung-medical-center-is-joining-focused-ultrasound-community/article_3c35046e-deea-54c5-852a-471a2dfb7bc5.html
The program offers treatment for patients with Movement Disorders, pain, and behavioral disorders in South Korea
HAIFA, Israel and MIAMI, July 5, 2021 /PRNewswire/ -- Insightec®, a global healthcare company focused on creating the next generation of patient care, announced Samsung Medical Center is establishing a Focused Ultrasound program with the adoption of Exablate® Neuro. The Exablate Neuro (Exablate 4000) platform uses Focused Ultrasound to ablate targets deep in the brain for a therapeutic effect.
"Leading neuroscience departments at medical centers around the globe recognize the value of adopting Focused Ultrasound as a treatment option for patient care," commented Ori Atar, Director of Asia Growth Markets at Insightec. "We are excited by the growth of adoption in the Korean market."
"Focused Ultrasound enables performing precise, minimally invasive treatments," Prof. Jung Il Lee, Professor, Department of Neurosurgery, Samsung Medical Center explains. "The clinical evidence of the treatment demonstrates good tremor control and a favorable safety profile for patients whose hand tremor affects their daily functioning."
There are 81 leading medical centers globally that have established Focused Ultrasound programs with Exablate Neuro. Insightec is partnering with Huons, a manufacturer of pharmaceutical products and distributor of medical solutions, to expand Focused Ultrasound programs in the Korean market.
"Our mission is to deliver solutions that improve people's health," says Key-An Um, CEO of Huons. "We are eager to bring Focused Ultrasound to medical centers and help transform the lives of people living with movement disorders."
midastouch017
5年前
Non-invasive brain cancer treatment targeting glioblastomaHippocratic Post | 20th May 2021
https://www.hippocraticpost.com/cancer/non-invasive-brain-cancer-treatment-targeting-glioblastoma/
A non-invasive Brain Cancer Treatment has been announced by Ivy Brain Tumor Center, SonALAsense and Insightec: The First Patient Dosed in First-in-Human Clinical Trial of Non-invasive Sonodynamic Therapy for the Treatment of Brain Cancer. The study combines metabolic targeting of glioblastoma with inert drug activated using MRI-guided focused ultrasound.
The Ivy Brain Tumor Center at Barrow Neurological Institute, the largest early-phase drug development program for brain cancer in the world, has announced the dosing of its first patient in a first-in-human Phase 0 clinical trial of sonodynamic therapy (SDT), a non-invasive drug-device combination developed by SonALAsense in collaboration with Insightec. This historic study aims to develop a new non-invasive treatment option for patients with recurrent glioblastoma (rGBM) and other high-grade gliomas.
“The potential value of an effective, non-invasive treatment option for patients with glioblastoma cannot be overstated,” said Nader Sanai, MD, Director of the Ivy Brain Tumor Center. “We are uniquely positioned to rapidly assess the safety and biological impact of this ground-breaking new strategy. In my career, I have never seen an approach quite like it.”
The Ivy Brain Tumor Center is evaluating sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology in combination with SonALAsense’s proprietary formulation of 5-aminolevulinic acid (Sonala-001) in a Phase 0 clinical trial. Sonala-001 is administered intravenously and metabolized selectively by tumor cells. The drug’s non-toxic by product is then activated using non-invasive MR-guided focused ultrasound, enabling selective targeting of tumour cells without impacting the matrix of surrounding normal brain cells.
“This novel modality may prove to be an indispensable new tool for patients, families, and physicians racing against what is often a fatal disease and one that has not seen an FDA-approved drug in decades. The non-invasive aspect of this treatment is particularly unique, as we are always looking to preserve patient quality of life while aggressively treating such tumours,” said Shwetal Mehta, PhD, Deputy Director and COO of the Ivy Brain Tumor Center.
The first patient treated with sonodynamic therapy was a 44-year-old man from Uruguay with a high-grade glioma. In his words: “I chose to be the first patient on this clinical trial because I wanted to do something for the greater good. I also wanted to do something that would make my daughters proud and show them I am doing everything in my power to fight this. From the time I was diagnosed three years ago, I have conducted extensive research on the latest therapies for brain cancer and this was at the top of my list. The treatment was non-invasive, non-toxic, and targeted only the cancer cells, so I’m very happy to be a part of it.”
“It is exciting to see this breakthrough technology moving forward into clinical development for the benefit of brain cancer patients. We are pleased to be working with the experts at the Ivy Brain Tumor Center to conduct this study using their innovative Phase 0 clinical trial approach which will rapidly assess the effects of this first-in-class therapy. Our aim is to bring a noninvasive treatment option to patients and make glioblastoma a manageable disease,” said Stuart Marcus, MD, PhD, Founder, CEO and CMO of SonALAsense.
To learn more about this Phase 0 clinical trial, including eligibility criteria, visit: https://www.clinicaltrials.gov/ct2/show/NCT04559685
midastouch017
5年前
Insightec Announces Positive Coverage Decision By Aetna For MR-guided Focused Ultrasound To Treat Essential Tremor
First National Payor to Cover Outpatient Procedure Beyond Medicare in all 50 States
https://www.prnewswire.com/news-releases/insightec-announces-positive-coverage-decision-by-aetna-for-mr-guided-focused-ultrasound-to-treat-essential-tremor-301277969.html
MIAMI, April 27, 2021 /PRNewswire/ -- Insightec®, a global healthcare company focused on creating the next generation of patient care, announced today that Aetna is the first national payor to cover MR-guided Focused Ultrasound for treating medication-refractory Essential Tremor.
"This is a huge step in expanding patient access to non-Medicare patients," said Dee Kolanek, Insightec Vice President of Reimbursement. "We applaud leading insurers like Aetna for their decision to cover this outpatient treatment for patients suffering from Essential Tremor."
Essential Tremor, a movement disorder that causes uncontrollable shaking, affects an estimated ten million Americans. Many patients do not get satisfactory relief from available medications, causing them to withdraw from personal, professional, and social interactions. Focused ultrasound is performed in a single, outpatient procedure with many patients showing immediate improvement of tremor in the treated hand with minimal complications.
"Focused Ultrasound technology has come a long way since the initial Essential Tremor pilot trial," said Dr. Jeffrey Elias, the Director of Stereotactic and Functional Neurosurgery at the University of Virginia. "Today, the clinical community is able to provide strong real-world evidence in support of coverage decisions."
"Developing amazing technology is just the beginning – patient access is critical," commented Maurice R. Ferré MD, INSIGHTEC'S CEO and Chairman of the Board of Directors. "We continue to focus on helping transform the lives of millions of people by giving them back their ability to live independently, return to work, and improve their mental and physical health."
There are currently more than 60 Treatment Centers around the world using Insightec's Exablate® Neuro platform to treat Essential Tremor patients on a regular basis. Focused ultrasound treatment for medication-refractory Essential Tremor is covered under Medicare in all 50 states and is a covered benefit under 30 independent Blue Cross Blue Shield Association plans and nine private payors.
midastouch017
5年前
Ivy Brain Tumor Center, SonALAsense and Insightec Announce the First Patient Dosed in First-in-Human Clinical Trial of Noninvasive Sonodynamic Therapy for the Treatment of Brain Cancer
https://finance.yahoo.com/news/ivy-brain-tumor-center-sonalasense-120000567.html
Ivy Brain Tumor Center
Tue, March 30, 2021, 3:00 PM·4 min read
Study combines metabolic targeting of glioblastoma with inert drug activated using MRI-guided focused ultrasound
An Ivy Center clinical research nurse administers SonALAsense's proprietary formulation of 5-aminolevulinic acid (Sonala-001) to the first patient enrolled in a drug-device combination study for recurrent high-grade glioma.
An Ivy Center clinical research nurse administers SonALAsense's proprietary formulation of 5-aminolevulinic acid (Sonala-001) to the first patient enrolled in a drug-device combination study for recurrent high-grade glioma.
An Ivy Center clinical research nurse administers SonALAsense's proprietary formulation of 5-aminolevulinic acid (Sonala-001) to the first patient enrolled in a drug-device combination study for recurrent high-grade glioma.
The team at the Ivy Brain Tumor Center prepares its first patient to receive sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology.
The team at the Ivy Brain Tumor Center prepares its first patient to receive sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology.
The team at the Ivy Brain Tumor Center prepares its first patient to receive sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology.
Phoenix, AZ, March 30, 2021 (GLOBE NEWSWIRE) -- The Ivy Brain Tumor Center at Barrow Neurological Institute, the largest early-phase drug development program for brain cancer in the world, has announced the dosing of its first patient in a first-in-human Phase 0 clinical trial of sonodynamic therapy (SDT), a noninvasive drug-device combination developed by SonALAsense in collaboration with Insightec. This historic study aims to develop a new noninvasive treatment option for patients with recurrent glioblastoma (rGBM) and other high-grade gliomas.
WATCH VIDEO
“The potential value of an effective, noninvasive treatment option for patients with glioblastoma cannot be overstated,” said Nader Sanai, MD, Director of the Ivy Brain Tumor Center. “We are uniquely positioned to rapidly assess the safety and biological impact of this groundbreaking new strategy. In my career, I have never seen an approach quite like it.”
The Ivy Brain Tumor Center is evaluating sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology in combination with SonALAsense’s proprietary formulation of 5-aminolevulinic acid (Sonala-001) in a Phase 0 clinical trial. Sonala-001 is administered intravenously and metabolized selectively by tumor cells. The drug’s non-toxic byproduct is then activated using noninvasive MR-guided focused ultrasound, enabling selective targeting of tumor cells without impacting the matrix of surrounding normal brain cells.
“This novel modality may prove to be an indispensable new tool for patients, families, and physicians racing against what is often a fatal disease and one that has not seen an FDA-approved drug in decades. The noninvasive aspect of this treatment is particularly unique, as we are always looking to preserve patient quality of life while aggressively treating such tumors,” said Shwetal Mehta, PhD, Deputy Director and COO of the Ivy Brain Tumor Center.
The first patient treated with sonodynamic therapy was a 44-year-old man from Uruguay with a high-grade glioma. In his words: “I chose to be the first patient on this clinical trial because I wanted to do something for the greater good. I also wanted to do something that would make my daughters proud and show them I am doing everything in my power to fight this. From the time I was diagnosed three years ago, I have conducted extensive research on the latest therapies for brain cancer and this was at the top of my list. The treatment was noninvasive, non-toxic, and targeted only the cancer cells, so I’m very happy to be a part of it.”
“It is exciting to see this breakthrough technology moving forward into clinical development for the benefit of brain cancer patients. We are pleased to be working with the experts at the Ivy Brain Tumor Center to conduct this study using their innovative Phase 0 clinical trial approach which will rapidly assess the effects of this first-in-class therapy. Our aim is to bring a noninvasive treatment option to patients and make glioblastoma a manageable disease,” said Stuart Marcus, MD, PhD, Founder, CEO and CMO of SonALAsense.
To learn more about this Phase 0 clinical trial, including eligibility criteria, visit: https://www.ivybraintumorcenter.org/phase-0-clinical-trials/current-trials/sonodynamic-therapy-in-recurrent-high-grade-glioma/
Click to Tweet: .@IvyBrainTumCtr has treated its first patient in a first-in-human clinical trial of a noninvasive drug-device combination therapy for recurrent #glioblastoma developed by @SonALAsense in collaboration with @INSIGHTEC. Read the press release: https://bit.ly/3cA7MgM
midastouch017
5年前
How Rush University Medical Center is transforming neurosurgical care —
https://www.beckershospitalreview.com/hospital-management-administration/how-rush-university-medical-center-is-transforming-neurosurgical-care-insights-from-4-physician-leaders.html?utm_campaign=bhr&utm_source=website&utm_content=featured-articles
Insights from 4 physician leaders
In Collaboration with Insightec
For many patients, the daily suffering from debilitating conditions like essential tremor and tremor-dominant Parkinson's disease has become an all too familiar and unwelcomed way of life. For years, medications and invasive surgeries have been their main or primary treatment options.
However, since 2016, a revolutionary innovation by Insightec has helped to quietly transform patient lives all over the world. Using acoustic energy, hospitals and neurosurgeons are helping to transform patient care by using focused ultrasound to precisely and effectively treat deep inside the brain in a single outpatient procedure.
Becker’s Hospital Review recently spoke with four leaders at Rush University Medical Center in Chicago about this groundbreaking technology:
K. Ranga Rama Krishnan, MB, ChB, CEO, Rush University System for Health
Richard Byrne, MD, Chairman, Department of Neurosurgery
Sepehr Sani, MD, Director, Stereotactic Functional Neurosurgery
Leo Verhagen Metman, MD, PhD, Director, Movement Disorder Interventional Program
These leaders discussed the role innovative technology is playing in transforming care in their organization, described how focused ultrasound has enhanced the patient experience in neurosciences and shared their perspectives on the future of neuroscience care and innovation.
Strategic investments in technology require constant environmental scanning
When Rush University Medical Center evaluates its strategic investments in technology, a single overarching goal guides the team: to deliver the best possible care to all patients. That means having the right cutting edge capabilities, the right workforce, and the ability to provide the right treatment in the right place at the right time.
The leadership team focuses on blending research, education, and clinical expertise in such a way that the organization is continuously learning about new innovations. Of particular interest are technologies that target the five clinical areas where Rush University Medical Center strives to be a market leader: neurosciences, cancer, bone and joint diseases, cardiac conditions, and metabolic disease.
"We are constantly looking over the horizon and examining new technologies that the FDA will be reviewing over the next six months to two years that could add value to our patients," Dr. Krishnan said. "Focused ultrasound was one of those innovations."
Once the FDA approves a promising new treatment, the team determines the right time to bring it into the organization. A series of questions steers this evaluation process, such as: Does the innovation address a problem or patient need that isn't adequately being addressed today? Can Rush University Medical Center create a sustainable practice around a focused ultrasound program? And, does staff already exist within the Rush system to support the technology, such as, in the case of focused ultrasound, Dr. Sani and Dr. Verhagen?
"As a neurologist at a premier movement disorder center, I knew that we should have focused ultrasound for our patients," Dr. Verhagen said. "We are very excited that in just one year, a particularly challenging year, 50 essential tremor patients received this innovative treatment."
Focused ultrasound can be life changing for essential tremor and tremor-dominant Parkinson's patients
In 2016, Exablate Neuro became the first and only focused ultrasound platform to receive FDA approval to treat medication-refractory essential tremor, and in 2020 nationwide Medicare coverage for the procedure was received. After reviewing the clinical data, market potential and business opportunity, Rush University Medical Center's neuroscience service line decided to proceed with the strategic investment in the Exablate Neuro platform. In March 2020, Rush University Medical Center launched its focused ultrasound program.
The Exablate Neuro platform provides an incisionless, anesthesia-free, outpatient treatment approach. Rather than working in an operating room with a scalpel, neurosurgeons perform the focused ultrasound treatment from the control room of an MRI suite equipped with nothing more than a computer, keyboard, and mouse. The procedure can have immediate therapeutic effect, often leaving patients, family members and healthcare workers in tears of joy.
"It's all about the patients," said Maurice R. Ferré MD, Chair and CEO of Insightec. "Our technology offers neuroscience leaders the opportunity to help transform the lives of people living with debilitating hand tremor and return to living an independent and productive life."
The procedure has minimal complications, little to no risk of infection and has attracted a patient population that has been delaying treatment for years, maybe decades, waiting for something new. Focused ultrasound has become a preferred treatment choice for many patients for whom medications have not provided satisfactory tremor improvement because it does not require surgical incisions, typically only takes a few hours, and has very little follow-up or maintenance afterwards. The most common post-treatment side effects reported by subjects in Insightec-sponsored clinical studies included imbalance/gait disturbance, numbness/tingling and headache/head pain. As with all medical procedures, there is risk for long-term effects.
"In general, these are very well-informed individuals who know about all the treatment modalities, including surgical interventions that have been around for decades," Dr. Sani said. "They have made a conscious choice that they would never undergo an invasive procedure and would simply live with the condition. Insightec has delivered a major paradigm shift, not just in terms of the technology, but also in terms of the value it adds to patient care."
"Each patient is a unique individual," Dr. Verhagen said. "I evaluate the severity of their tremor, the impact it has on their life, as well as discuss their expectations from treatment. Focused ultrasound is a good treatment option for a large group of patients that have no other option available."
The key to successful focused ultrasound programs is a combination of technology, people and processes
"You can't launch a focused ultrasound program simply by buying the equipment; you need the right people with the right background who know how to use the technology. Dr. Sani and Dr. Verhagen have been working with tremor patients for a long time. They were the right people with the right interest," Dr. Krishnan said.
Insightec's collaboration is another factor that has contributed to the success of Rush University Medical Center's focused ultrasound program. "Insightec provided their expertise that enabled us to build a roadmap to make it clinically and financially feasible to implement the treatment," Dr. Krishnan said. "The solution is provided in a way that's sustainable for both the short- and the long-term."
"Hospitals face shifting priorities and challenges when adopting innovation while remaining focused on patient care," Dr. Ferré said. "A focused ultrasound program may help strengthen the profile of the neuroscience program with a specialized service line for a patient population that is looking for treatment options."
When asked about the biggest lesson learned from launching this focused ultrasound program, Dr. Sani emphasized the need for a well-planned and organized approach. To support the focused ultrasound program, Rush University Medical Center has created a set of administrative processes and protocols that deliver a positive patient experience.
Staff members, not computers, answer a dedicated phone number and respond to all email messages within 24 hours. In addition, a dedicated program coordinator guides patients and interested referring physicians. To support patient evaluations, the team has developed a defined workflow. In some cases, the team can conduct those evaluations remotely — an important consideration given current concerns about COVID-19.
"If a patient does need to come to the office for a formal evaluation, we ensure that all the testing and assessments are completed in a single visit," Dr. Sani said. "Having a streamlined approach to this treatment makes a real difference to patients. For us, that's been a key factor in the success of the program."
Looking ahead, focused ultrasound may be a viable treatment for additional indications
While movement disorders like essential tremor and tremor-dominant Parkinson's disease are established indications for focused ultrasound, experts agree that researchers have just started to scratch the surface of this technology's potential.
"There is potential for expansion of the indications for focused ultrasound," Dr. Byrne said. " We need to work through the research and participate in the research, but there's more to come and we plan to be on the forefront of it going forward."
Rush University Medical Center is committed to exploring how it can use this innovative technology to provide relief to patients. "The way I look at every innovation is to ask whether there's a patient population that we can serve by bringing the technology in," Dr. Krishnan said "If the answer is yes, it doesn't matter how many other health systems are already offering the treatment. We should try to bring it into Rush."
midastouch017
6年前
Philips and InSightec partner to expand access to MR-guided focused ultrasound for incisionless neurosurgery
December 17, 2020 04:00 ET | Source: Royal Philips
Companies to develop compatibility of Philips’ MR Ingenia 3.0T and 1.5T systems with the InSightec Exablate Neuro platform
Amsterdam, the Netherlands and Haifa, Israel – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology and InSightec, a global healthcare company focused on the therapeutic power of acoustic energy, today announced a collaboration to expand access to MR-guided focused ultrasound for incisionless neurosurgery. By developing compatibility between Philips’ advanced MR systems and the Exablate Neuro platform from InSightec, the two companies will support expanded access to MR-guided focused ultrasound for the treatment of Essential Tremor and other neurological disorders. The expansion of access to this innovative treatment option has the potential to significantly improve the patient and staff experience, enhance health outcomes and lower the cost of care.
Essential Tremor is a neurological condition that typically causes shaking of the hands, head and voice, and may also cause shaking of the legs and trunk. The tremor begins mildly and progresses over time, and in some patients, is severe enough to interfere with daily activities, such as personal care, eating or getting dressed. Essential Tremor is one of the most common movement disorders in the world [1]. MR-guided focused ultrasound uses high-intensity sound waves, guided by magnetic resonance imaging, to target and treat the area of the brain responsible for the tremor. The incisionless treatment option is often performed in an outpatient setting, with many patients showing immediate tremor relief with minimal complications.
“As a leading innovator in MR imaging to support precise diagnosis and targeted therapies, we continue to expand the role of MR in providing precision guidance for minimally invasive therapy solutions into new treatment areas,” said Arjen Radder, General Manager for MR at Philips. “By partnering with InSightec we are expanding access to Philips’ advanced MR capabilities to a wider range of healthcare providers, including neurosurgery practices both in-hospital and in outpatient settings, as well as the global research community. Together, we aim to advance towards clear care pathways with predictable outcomes for every patient.”
“InSightec is committed to expanding patient access for MR-guided focused ultrasound, which is rapidly being adopted as a standard of care worldwide for treating Essential Tremor, as well as continuing to develop a research pipeline for the treatment of many other disorders,” said Maurice R. Ferré MD, InSightec CEO and Chairman of the Board of Directors. “Partnering with Philips will help increase adoption of our innovative technology to transform patient care.”
The partnership will involve the development of compatibility between the InSightec Exablate Neuro platform and Philips’ MR Ingenia Elition 3.0T, Ingenia 3.0T and Ingenia 1.5T systems. This includes the Ambition 1.5T MR, the industry’s first and only commercially available fully sealed magnet for more productive, helium-free operations [2]. Philips’ MR therapy portfolio also includes its Ingenia MR-OR intraoperative MR for use during neurosurgical procedures, as well as its leading MR-only radiotherapy applications, which enable clinicians to quickly execute complete imaging protocols for prostate, female pelvis, brain, head and neck, and spine.
The parties expect market introduction for the compatible systems in 2023 with offerings available for both existing and new customers.
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938289/
[2] Compared to the Ingenia 1.5T ZBO magnet.
For further information, please contact:
Mark Groves
Philips Global Press Office
Tel.: +31 631 639 916
E-mail: mark.groves@philips.com
Lyndsay Isaksen
G&S Business Communications for InSightec
Tel.: +1 917 595 3032
E-mail: lisaksen@gscommunications.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
About InSightec
InSightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company’s Exablate® Neuro platform focuses sound waves, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-dominant Parkinson’s Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. InSightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo. For more information, please visit: www.insightec.com.
midastouch017
6年前
SonALAsense Pioneers Sonodynamic Therapy, a First-in-Class Noninvasive Therapy for Lethal Brain Cancers; Enters Into a Collaboration and License Agreement With Insightec and a Collaboration Agreement with Ivy Brain Tumor Center to Conduct the First-in-Man Clinical Trial for Recurrent Glioblastoma
Non-Invasive Drug-Device Treatment Aims to Target Brain Cancers Selectively, Turning them from Lethal Diseases into Manageable Conditions: Led by Experts with Decades of Experience Developing and Commercializing Drug-Device Systems in Photodynamic Therapy and New Drug Therapies for Orphan Diseases
SonALAsense is a clinical-stage company developing ALA sonodynamic therapy (SDT) as a first-in-class, non-invasive drug-device combination for the treatment of recurrent glioblastoma multiforme and other deadly cancers. SDT utilizes MRI-guided focused ultrasound (the device) in combination with aminolevulinic acid (a drug) to selectively target and kill tumor cells.
BERKELEY, Calif., Dec. 14, 2020 /PRNewswire/ -- SonALAsense, a pioneer with the goal of managing fatal cancers so patients can become survivors, today announced the first of its kind non-invasive sonodynamic therapy (SDT) platform technology for treating recurrent glioblastoma multiforme (rGBM) and other lethal brain cancers.
rGBM is a deadly cancer with limited treatment options. SonALAsense's SDT aims to make rGBM manageable, rather than lethal, with a unique combination therapy where aminolevulinic acid (ALA) is taken up selectively by tumor cells. The drug is then activated by non-invasive MRI-guided ultrasound, effectively targeting only tumor cells for destruction.
Giving hope to patients through strategic collaborations
The company has entered into a Collaboration and License Agreement with Insightec to develop and commercialize its focused ultrasound technology in oncology for use in ALA SDT. The company also entered into an Agreement with the Ivy Brain Tumor Center at Barrow Neurological Institute to conduct a first-in-human clinical trial in rGBM using their innovative Phase 0 approach to rapidly assess safety, and biological and clinical efficacy of ALA SDT.
The ALA SDT process works by a dual action which quickly kills brain tumor cells and simultaneously triggers programmed tumor cell death within 48 hours in animal models. ALA is currently FDA approved as a visual aid for neurosurgeons as the selective fluorescence of its metabolite in GBM cells helps guide surgical excision. Because of ALA's unique selectivity for gliomas as well as the precision-targeted energies of MRI-guided focused ultrasound used for SDT, we believe the treatment should be safe for normal brain tissue.
"The discovery that light-activated drugs can also be activated by focused ultrasound has led to our development of sonodynamic therapy, which is the achievement of my life's goal, to bring renewed hope to brain tumor patients without the use of invasive procedures," said Stuart Marcus, MD, PhD, Founder, CEO and CMO of SonALAsense. "There have been many studies and research around treating rGBM and other lethal brain tumors over the years, but none have been proven effective. ALA SDT has the potential to meaningfully improve the length and quality of patients' lives."
"The Ivy Brain Tumor Center strives to be at the forefront of best-in-class solutions so that we can identify early-stage therapies for accelerated development," said Nader Sanai, MD, Director and Chief Scientific Officer of the Ivy Brain Tumor Center. "We are proud to collaborate with SonALAsense to work towards the first non-invasive drug-device combination therapy for glioblastoma and other aggressive brain tumors. This novel modality has the potential to change the lives of hundreds of thousands of patients and their families, worldwide."
Leading with expertise
SonALAsense is led by experts with decades of deep experience in developing and commercializing drug-device systems in Photodynamic Therapy and new drug therapies for orphan disease.
Founder, CEO and CMO Stuart Marcus, MD, PhD, has pioneered photodynamic therapy systems for 33 years, with multiple FDA approved drug-device products. He has spent the past 27 years working towards this breakthrough technology that has the potential to turn rGBM patients into cancer survivors.
COO and CFO Mark de Souza, PhD, is an entrepreneur in the rare disease space and has been a biotech executive for over 15 years.
Director of Clinical Research Anna Houlihan has over 20 years of clinical operations experience, with prior experience at DUSA Pharmaceuticals and Lederle.
The company is supported by a scientific advisory board that boasts prominent physicians in the neuro-oncology, oncology, neurosurgery, ophthalmology, and radiology space, including:
Scott Plotkin, MD, PhD, Chief, Division of Neuro-Oncology, MGH, Armenise Harvard Professor of Neurology, Harvard Medical School.
Mitchel S. Berger, MD, Professor and Chairman, Neurosurgery, UCSF.
Pejman Ghanouni, MD, PhD, Associate Professor, Radiology, Stanford University Medical Center.
Robert Scott, MBBS, FRCS(Edin), FRCOphth, DM, Honorary Professor, University of Birmingham, UK
About SonALAsense
SonALAsense is a clinical-stage company developing ALA sonodynamic therapy (SDT) as a first-in-class, non-invasive drug-device combination for the treatment of recurrent glioblastoma multiforme and other deadly cancers. SDT utilizes MRI-guided focused ultrasound (the device) in combination with aminolevulinic acid (a drug) to selectively target and kill tumor cells. SonALAsense is working closely with the Ivy Brain Tumor Center to advance ALA SDT into a Phase 0/2 clinical trial in recurrent GBM.
For more information about SonALAsense, visit www.sonalasense.com.
SOURCE SonALAsense
midastouch017
6年前
INSIGHTEC Announces MR-guided Focused Ultrasound to Treat Essential Tremor Received Funding by National Health Service (NHS) England
HAIFA, Israel and MIAMI, Nov. 24, 2020 /PRNewswire/ -- INSIGHTEC®, a global healthcare company focused on the therapeutic power of acoustic energy, today announced that the National Health Service (NHS) England has approved funding for MR-guided Focused Ultrasound for the treatment of medication-refractory Essential Tremor patients from April 2021. The NHS England is the publicly funded healthcare system for England.
Essential Tremor is a neurological condition that causes shaking of the hands, head and voice, but may also cause the legs and trunk to shake. The tremor begins mildly and progresses over time, and in some patients, is severe enough to interfere with daily activities, such as personal care, writing, eating, or getting dressed. Essential Tremor affects an estimated 41 million people around the globe.
"For the approximately 50% of Essential Tremor patients who do not get satisfactory relief from medications, having another accessible treatment option available that is incisionless, and often results in immediate relief, is a major breakthrough," commented Prof Dipankar Nandi, MD, Consultant Neurosurgeon, Imperial College Healthcare NHS Trust, who treated Essential Tremor patients under a clinical trial.
MR-guided Focused Ultrasound uses high intensity sound waves, guided by magnetic resonance imaging, to target and treat the area of brain responsible for the tremor. It is an incisionless treatment option which is often performed in an outpatient setting. Focused Ultrasound treatment is currently being performed at nearly 70 medical institutions across the USA, Europe and Asia.
"St. Mary's in London has been a research partner in the development of this technology and is the first center in the UK to offer Focused Ultrasound for medication-refractory Essential Tremor patients," said Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "Reimbursement in England and around the globe is critical to help people living with debilitating tremor improve their quality of life."
https://www.prnewswire.com/news-releases/insightec-announces-mr-guided-focused-ultrasound-to-treat-essential-tremor-received-funding-by-national-health-service-nhs-england-301179509.html
midastouch017
6年前
19-Nov-2020 INSIGHTEC® incisionless MRgFUS surgery to be funded by NHS England to treat Essential Tremor condition that causes shaking of the hands, head and voice, but it can also cause legs and trunk to shake. The tremor begins mildly and progresses over time to become more severe, and in some patients, severe enough to interfere with daily activities, such as eating and writing.
“This is extremely exciting news for those living with Essential Tremor,” said Prof Wady Gedroyc, MD, Consultant Radiologist at London’s St. Mary’s Hospital. “Essential Tremor can be incredibly debilitating and impacts virtually every aspect of a person’s life. There’s a significant unmet need in terms of treatment options so I am delighted that NHS England has recognised the value that this new technology can bring to patients. I am looking forward to seeing the first NHS patients from April next year.”
MRgFUS is an incisionless treatment option for Essential Tremor, often performed in an outpatient setting, enabling patients to return home the same day. High intensity ultrasound waves, guided by MRI, converge at a small target to create a permanent lesion in the specific area of the brain responsible for the tremor.
“Medicines only work in approximately 50% of people with Essential Tremor, and so to have another treatment option available that is incisionless is a major breakthrough for this patient group,” commented Prof Dipankar Nandi, MD, Consultant Neurosurgeon, Imperial College Healthcare NHS Trust. “Now that the NHS has agreed to make focused ultrasound available from next April, it is critical that we ensure equity of access across the country, and not just for those that can make it to London.”
“NHS funding is an important step in expanding patient access to Focused Ultrasound,” said Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "Most importantly, people living with tremor can now get back their independence and their lives.”
https://www.pharmiweb.com/press-release/2020-11-19/insightec-incisionless-mrgfus-surgery-to-be-funded-by-nhs-england-to-treat-essential-tremor
Insightec is a daughter company of EMITF
midastouch017
6年前
Lantheus Enters into Strategic Collaboration with Insightec for Use of Microbubbles in Combination with MR-Guided Focused Ultrasound for Treatment of Glioblastoma and Neurodegenerative Conditions
Published: Oct 29, 2020
NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced a strategic collaboration with Insightec Ltd., a global healthcare company focused on the therapeutic power of acoustic energy. Under the agreement, Lantheus’ microbubbles will be used in combination with Insightec’s investigational MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. The collaboration directly aligns with key Lantheus growth strategies of pursuing new applications for its microbubble franchise and expansion into oncology.
Under the terms of the agreement, Lantheus’ microbubbles will be used together with Insightec’s MRgFUS platform designed to deliver ultrasound energy deep in the brain with no incisions. The microbubbles, combined with the application of focused ultrasound, are being investigated in the temporary disruption of the blood brain barrier to potentially allow for more effective delivery of chemotherapeutic agents in the treatment of glioblastoma patients. Glioblastoma is the most aggressive malignant primary brain tumor affecting 3.19 Americans per one hundred thousand and has a less than 5% five-year survival rate.1
Lantheus will supply its microbubbles and activation devices while Insightec will be responsible for future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.
“We are thrilled to partner with Insightec to further expand our microbubble franchise within oncology and potentially neurodegenerative conditions,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “Our collaboration with Insightec could help change the paradigm in glioblastoma, an aggressive cancer for which patients and clinicians unfortunately have few options, and where the unmet medical need is truly significant.”
“Focused ultrasound has strong potential to transform the treatment of diseases that currently have poor outcomes and few options. Partnerships, like this one with Lantheus, will help Insightec’s future customers push the boundaries of what is possible in providing care to patients with neurooncologic as well as neurodegenerative diseases,” said Maurice R. Ferré MD, Chairman and CEO of Insightec.
About Glioblastoma
There are approximately 12,500 new cases of glioblastoma in the United States each year. Glioblastoma is the most commonly occurring primary malignant brain tumor, accounting for over 48% of all malignant tumors.2 Overall, median survival for glioblastoma patients is 12-15 months. Glioblastoma has a poor prognosis due to its high rate of tumor recurrence, which has been described clinically as inevitable.3 Worldwide, there are more than 240,000 estimated deaths from brain and central nervous system cancers each year, and glioblastoma represents one of the most common and lethal forms of these cancers.4
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
midastouch017
6年前
NATIONAL REIMBURSEMENT
INSIGHTEC receives national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
HAIFA, Israel and MIAMI, Sept. 1, 2020 -- INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that it has received national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
Parkinson's Disease is a progressive neurodegenerative disorder with an incidence in Japan of 1 in 100 people above the age of 60, based on a survey conducted by MHLW. INSIGHTEC's Exablate® Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is performed under Magnetic Resonance Imaging (MRI) guidance for real-time treatment monitoring.
"Parkinson's Disease patients now have a new incisionless surgical treatment option, focused ultrasound," commented Professor Takaomi Taira, Director of Stereotactic and Functional Neurosurgery, Department of Neurosurgery, Tokyo Women's Medical University (TWMU), Tokyo, Japan. "Using focused ultrasound we can precisely target and treat the brain regions which contribute to improvements of the patient's symptoms."
Exablate Neuro is approved for targeting the thalamus for treating Tremor-dominant Parkinson's Disease, and the globus pallidum for treating advanced Parkinson's Disease in patients suffering from mobility, rigidity, or dyskinesia symptoms.
"Japan is the first country in the world to cover focused ultrasound for Parkinson's Disease with nationwide public health insurance," commented Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "This is a major milestone for patients with Parkinson's Disease across Japan."
The Exablate Neuro device received MHLW approval for the treatment of medication-refractory essential tremor and National Health Insurance coverage in June 2019 and received a pre-market approval (PMA) for the treatment of Parkinson's Disease in January 2020. There are currently 12 medical institutions in Japan performing the MR-guided focused ultrasound treatment for essential tremor on a routine basis.
"This extended coverage by the National Health Insurance provides an incisionless treatment option for Parkinson's Disease patients," said Yair Bauer, Country Manager, INSIGHTEC Japan. "This adds to the existing coverage for treatment of tremor from essential tremor and Parkinson's Disease," he added
About INSIGHTEC Japan K.K.
INSIGHTEC Japan K.K. is a subsidiary of INSIGHTEC LTD. The company is the regulatory market approval holder of Exablate Neuro (Exablate 4000) and its distributor in Japan. Founded in 2005, its mission is to provide focused ultrasound treatments for neurosurgery and women's health indications, in order to significantly improve the quality of life for patients in Japan. For more information please visit: www.insightec.com/JP
About INSIGHTEC
INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery with MR-guided focused ultrasound. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
For more information, please visit: www.insightec.com
https://www.insightec.com/whats-new/press-releases/2020/insightec-receives-national-reimbursement-from-mhlw-for-treating-parkinsons-disease
midastouch017
6年前
Novant Health is first in the Carolinas to offer incisionless brain surgery for treatment of essential and Parkinson's tremor
Revolutionary technology gives patients immediate relief of debilitating tremors
By Novant Health Aug 17, 2020 Updated 19 hrs ago
CHARLOTTE, N.C., Aug. 17, 2020 /PRNewswire/ -- Novant Health today announced it is the first in the Carolinas to offer a scalpel-free treatment for essential tremor and medication-refractory tremor-dominant Parkinson's disease. The new option – called MR-guided focused ultrasound – uses sound wave energy to treat brain tissue that is the source of the tremor. No surgical incision or anesthesia is necessary, and many patients experience immediate and significant reduction in hand tremors, which can make daily activities challenging.
Novant Health has partnered with INSIGHTEC, a global medical technology innovator to bring this breakthrough technology to Charlotte. It will be the only hospital system between central Virginia and Florida to offer this new incisionless treatment of tremor.
"With MR-guided focused ultrasound, we are able to perform a procedure on the brain – without a scalpel or making a single incision," said Dr. Eric Deshaies, neurosurgeon and system physician executive of the Novant Health Neuroscience & Psychiatry Institute. "We are proud to be the only hospital system in this region to offer this innovative solution to treat tremors."
MR-guided focused ultrasound combines two technologies: magnetic resonance imaging (MRI), which pinpoints the exact location in the brain responsible for the tremor, and ultrasound, which precisely delivers over 1,000 highly focused beams of acoustic energy at that exact location without damaging any surrounding brain tissue.
Benefits of MR-guided focused ultrasound include:
No surgical incisions resulting in reduced risk of infection.
Quick recovery time, allowing a return to daily activities within days.
Performed as an outpatient procedure – most patients go home within 23 hours.
Immediate and significant reduction in hand tremors.
Treatment has minimum side effects.
Beginning in September, this new technology will be offered at Novant Health Mint Hill Medical Center, a community hospital in Charlotte. It will be led by a team of expert neurologists and neurosurgeons, including the head of functional and restorative neurosurgery for Novant Health, Dr. Charles Munyon.
"Our team is very excited to bring this technology to the region and to open up access to potentially life-changing treatment that until now has required long wait times and significant travel for patients in the Carolinas," said Munyon. "Many tremor patients have suffered for years or even decades with this debilitating and progressive condition and helping them regain the ability to dress and feed themselves, or just live a more active and independent lifestyle, is extremely rewarding."
About essential tremor
Essential tremor may start as relatively mild, but often progresses to be severe, impacting quality of life. The tremors, which are often most severe in the hands, can interfere with daily activities like getting dressed, eating, drinking and writing. Most people with essential tremor are otherwise healthy.
About tremor-dominant Parkinson's disease
For an estimated 10% of Parkinson's patients, tremor is the primary symptom with the most severe impact on daily activities. As the disease progresses, patients may experience the onset of other symptoms, but the tremor remains the one with the most severe impact on daily activities.
Traditionally, doctors have treated people with Parkinson's disease and essential tremors with medications or by surgically attaching a small electrode in the brain connected to a pulse generator implanted in the chest. MR-guided focused ultrasound provides an incisionless treatment option for individuals who do not respond to medications.
"This technology makes Novant Health and Charlotte a regional, and even national, referral site for essential tremor and tremor dominant Parkinson's disease," said Saad Ehtisham, president of the Novant Health greater Charlotte market. "Because there are no surgical incisions to check after this procedure, in-person appointments are not necessary, making this treatment option ideal for patients who have to travel to Charlotte for this procedure. This is an exciting milestone for patients and for Novant Health."
For more information about MR-guided focused ultrasound, contact nhtremor@insightec.com or call 1-800-892-0696.
midastouch017
9年前
Elbit Imaging Announces Early Repayment of Its (Series H) Notes
TEL AVIV, ISRAEL / ACCESSWIRE / December 19, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, further to its announcement dated December 11, 2017 (regarding the Company's series H and Series I bondholders approval of amendments to the trust deeds ("the Amended Trust Deed")), as follows:
1. On December 18, 2017, the Company announced that it completed the sale of its holdings in a SPV that holds the Radisson Hotel Complex in Bucharest, Romania, based on a property value of €169.2 million (the "Transaction" and "SPV," respectively).
2. The net proceeds received by the SPV (after Transaction expenses) is approximately €81 million.
The following amounts were deducted from the net proceeds so that the SPV has received a total cash amount of approximately €61.4:
2.1 The repayment of the loan to Bank Hapoalim Ltd. in the amount of approximately €11.6 million (the "Loan"). The Loan was secured, inter alia, by a lien on the SPV's shares.
2.2 An amount of €8 million was used to finance a vendor loan which has been granted for a period of 3 years, bearing interest at the rate of 5% per annum.
3. In accordance to the Amended Trust Deed, the Company:
3.1 Will start with the voluntary liquidation of Elscint Holdings & Investment N.V. - a fully owned subsidiary of the Company that holds (indirectly) the SPV.
3.2 Announced an early repayment to its (series H) notes, in a total amount of NIS 240,197,260 (which includes a principal payment of NIS 240 million and an interest payment of NIS 197,260) which will be executed on January 5, 2018.
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