INSIGHTEC CHAIRMAN OF THE BOARD AND CEO, MAURICE R. FERRÉ TO PRESENT AT 2023 MILKEN INSTITUTE GLOBAL CONFERENCE
Fri, April 28, 2023 at 8:28 PM GMT
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.
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.
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.”
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.”
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.”
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.
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.
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
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.
FDA grants new approval for essential tremor treatment from Insightec
DECEMBER 20, 2022 BY SEAN WHOOLEY
The Exablate Neuro system. [Image from Insightec’s website]
Insightec announced today that it received additional FDA approval for treating essential tremor with its Exablate Neuro platform.
Essential tremor commonly affects both sides of the body, Insightec noted in a news release. The new approval allows appropriate patients to receive treatment on their second side at least nine months after treatment of the first side.
Exablate Neuro uses focused sound waves safely guided by MRI. It provides tremor treatment to patients with medication-refractory essential tremor and Parkinson’s disease.
“This FDA approval is a very important milestone for us and demonstrates our unwavering commitment to expanding the treatment options for people living with essential tremor,” said Dr. Maurice R. Ferré, CEO and chair of the board of directors at Insightec. “It’s very common for patients who’ve benefited from tremor reduction from the first side treatment to ask about having the second side treated. This approval paves the way for them to do that.”
How Insightec garnered its latest FDA approval
Insightec said its sponsored study included 51 patients across seven U.S. centers. It evaluated Exablate Neuro for safety and efficacy endpoints out to six months.
Data demonstrated a highly significant reduction in tremor following treatment of the patients’ second side. Results proved immediate and sustained through at least six months of follow-up. According to Insightec, this falls in line with results from the treatment of the first side.
Insightec said the study demonstrated a significant improvement in functional disability. This suggests a clinically meaningful impact on activities of daily living. That includes eating, drinking and writing.
Patients reported the majority of adverse events in the study as mild. Exablate Neuro demonstrated a similar safety profile in treating the second side as it did for the first side.
“We are happy to have an option for patients with essential tremor to ultimately receive focused ultrasound treatment on both sides of the brain,” said Dr. Michael G. Kaplitt, professor and executive vice-chair of neurological surgery, New York Presbyterian Hospital-Weill Cornell Medicine, and principal investigator of this study. “The investigators are working with Insightec to share the full results of the study with the professional community in an academic publication to further help practitioners guide their patients going forward.”
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.
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.
INSIGHTEC RECEIVES FDA IDE APPROVAL FOR PROSTATE CANCER COMPARATIVE STUDY USING HIGH INTENSITY FOCUSED ULTRASOUND TECHNOLOGY
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:
To read more about Exablate Prostate's first US commercial patient treatment:
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.
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.
FIRST US COMMERCIAL PATIENT TREATED FOR PROSTATE DISEASE WITH INSIGHTEC INCISIONLESS FOCUSED ULTRASOUND SYSTEM
Insightec Exablate Prostate system used at a United States hospital commercially for the first time by Stanford Health Care
SAN FRANCISCO and MIAMI, Feb. 3, 2022 /PRNewswire/ -- Insightec, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today the treatment of the first US commercial patient for prostate disease at Stanford Health Care using Insightec’s Exablate Prostate system.
The Insightec Exablate Prostate system uses sound waves to ablate, or destroy, targeted tissue in the prostate. The treatment is performed in a single session under Magnetic Resonance Imaging (MRI) guidance for high resolution visualization of the patient's anatomy for precise targeting and real-time temperature monitoring. The treatment is incisionless, typically allowing patients to quickly return to normal activity with minimal complications.
"We are deeply committed to continuing to transform patient care with minimally invasive, innovative surgical procedures. The Exablate Prostate system will help support a better quality of life for people diagnosed and living with prostate disease," commented Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors.
Stanford Health Care participated in clinical trials for the Exablate Prostate system and reported minimal damage to adjacent structures and low rates of impact on potency and continence. 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.
To read more about Exablate Prostate FDA clearance: https://insightec.com/insightec-announces-fda-clearance-for-exablate-prostate/.
Insightec cuts SPAC merger valuation
4 Jan, 2022 15:28
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
FDA clears Insightec's MRI-guided sound wave technology to treat prostate cancer
by Andrea Park | Dec 3, 2021 11:20am
FDA clears Insightec Exablate Prostate device
DECEMBER 1, 2021 BY SEAN WHOOLEY
Insightec announced today that it received FDA 510(k) clearance for its Exablate Prostate system for treating prostate tissue.
Haifa, Israel-based Insightec designed its Exablate Prostate system to use high-intensity focused ultrasound to ablate targeted tissue in the prostate. Health providers perform the procedure under magnetic resonance imaging (MRI) guidance for high-resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring.
According to a news release, the treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal activity with minimal complications.
Clinical trial results demonstrated that the Exablate Prostate system resulted in minimal damage to adjacent structures with low rates of impact on potency and continence, Insightec said.
“Insightec remains focused on achieving strategic milestones and expanding into indications beyond neurosurgery such as approval for prostate tissue ablation,” Insightec CEO & Chairman Dr. Maurice R. Ferré said in the release. “Incisionless surgery is transforming patient care with a surgical option that is considerably less invasive.”
Testing at UVA linked to recently-approved treatment for Parkinson’s disease
By NBC29 Newsroom
Published: Nov. 18, 2021 at 8:49 PM GMT?+2?|Updated: 18 hours ago
CHARLOTTESVILLE, Va. (WVIR) - The FDA has approved a new treatment for Parkinson’s disease that was tested at the University of Virginia School of Medicine.
The treatment is an incisionless form of brain surgery is Insightec’s Exablate Neuro.
UVA is one of only 37 medical centers in the country with the capacity to offer this treatment.
Prior to the approval, treatments for symptoms related to Parkinson’s disease included drugs and invasive deep-brain surgeries.
Would be nice If our 50% owned company Plaza would learn to translate Hebrew into American .
So we could all participate in the new Co .
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
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.
India Ministry of Health and Family Welfare Approves Exablate Neuro Focused Ultrasound Platform
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."
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.
?nsightec Announces Seoul National University Hospital Is Installing Exablate Neuro Platform
By INSIGHTEC Aug 8, 2021
Expanding patient access to incision-free Focused Ultrasound treatment
HAIFA, Israel and MIAMI, Aug. 9, 2021 /PRNewswire/ -- Insightec®, a global healthcare company focused on creating the next generation of patient care, announced Seoul National University Hospital is installing the company's Exablate® Neuro platform. The Exablate Neuro (Exablate 4000) platform uses Focused Ultrasound to ablate targets deep in the brain for a therapeutic effect.
"This is the first installation of our first-to-market Focused Ultrasound technology in a public hospital in South Korea," commented Ori Atar, Director of Asia Growth Markets at Insightec. "It is exciting to know that more patients will now have access to an incisionless treatment option."
"Focused Ultrasound provides a precision tool for neurosurgical treatments," Prof. Kim Seung Ki, Head of Neurosurgery SNUH explains. "Clinical evidence has demonstrated a positive impact on patient quality of life with a favorable safety profile."
There are 81 leading medical centers globally that have established Focused Ultrasound programs with the Exablate Neuro. Insightec partners with Huons, a manufacturer of pharmaceutical products and distributor of medical solutions, to bring Focused Ultrasound to Korean healthcare systems.
"Bringing advanced technology that improve people's health to the largest public hospital is a major milestone," says Key-An Um, CEO of Huons. "Medical centers are realizing the value that a Focused Ultrasound program can bring to patient care."
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