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midastouch017

12/17/20 9:17 AM

#1320 RE: midastouch017 #1319

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.

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midastouch017

02/10/21 5:54 AM

#1325 RE: midastouch017 #1319

China National Medical Products Administration Approves MR-guided Focused Ultrasound To Treat Essential Tremor And Tremor-dominant Parkinson's Disease

https://www.prnewswire.com/il/news-releases/china-national-medical-products-administration-approves-mr-guided-focused-ultrasound-to-treat-essential-tremor-and-tremor-dominant-parkinson-s-disease-803587279.html

Insightec is strategically positioned for expansion in the China market

HAIFA, Israel and MIAMI, Feb. 10, 2021 /PRNewswire/ -- Insightec®, a global healthcare company focused on creating the next generation of patient care, announced it received market approval by The National Medical Products Administration (NMPA), the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration, or CFDA).

The approval for the Exablate® 4000 (Exablate Neuro) platform, will enable unilateral Focused Ultrasound treatment for patients living with debilitating tremor from Essential Tremor and Tremor-dominant Parkinson's Disease that has not responded to medications.

"This achievement reflects positive momentum to bring Focused Ultrasound to movement disorder patients in China," commented Maurice R. Ferré MD, Insightec CEO and Chair of the Board of Directors. "We are committed to improving the quality of life of patients in China and worldwide with impactful therapeutic treatments."

MR-guided Focused Ultrasound (MRgFUS), also referred to as high-intensity Focused Ultrasound, delivers acoustic energy precisely to the Vim of the thalamus, considered to be responsible for tremor, to heat and ablate the tissue. The procedure does not require surgical incisions, implants or anesthesia.

Nearly 60 leading neurosurgeons in medical centers around the globe are treating patients with hand tremor from Essential Tremor or Tremor-dominant Parkinson's Disease on a regular basis with the Exablate Neuro. Performed in a single session in an MRI suite, many patients experience immediate tremor relief with minimal side effects, returning home the same day.

"There are millions of people in China living with diminished function due to hand tremors from Essential Tremor and Tremor-dominant Parkinson's Disease," said Peng Qiu, Insightec China Country Manager. "Our elderly communities will now have an option that uses highly advanced technology that is less invasive."

Exablate Neuro has received marketing approval for Essential Tremor from the U.S. Food and Drug Administration (FDA) and regulatory bodies in Argentina, Australia, Canada, Chile, Europe, Israel, Japan, Kazakhstan, Korea, Russia, Taiwan and Turkey.

Insightec's Exablate Body system is used in 20 hospitals across China to treat symptomatic uterine fibroids.