Replies to post #1804 on Elbit Imaging Ltd (EMITF)

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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

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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."