Day: June 7, 2021

June 7, 2021

• Intelligent, scalable, secure and interoperable solutions seamlessly connect people, technology and data to support clinical decisions at every point of care to help improve health outcomes, patient and staff experience and reduce cost of care
• Philips shares its vision on how digital transformation is driving the delivery of healthcare for more resilient systems

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, will showcase its latest connected, secure and scalable informatics solutions at the HIMSS and Health 2.0 European Congress, taking place virtually from June 7 – 9, 2021. Philips will showcase its deep clinical and operational expertise and innovations that foster collaboration and optimize workflows, helping clinicians and health system leaders to improve health outcomes, patient and staff experiences and reduce cost of care.

The pandemic has prompted a focus on virtual care as it showed its value as a scalable enabler to help deliver quality care when resources are limited. Care providers are looking for informatics solutions and technology infrastructures that help them to support this new model of care for both elective and acute settings. Findings of the recently published Future Health Index indicate that nearly two in three healthcare leaders are currently prioritizing investments in telehealth. The last year also underscored the need for centralized and efficient data management. To help clinicians improve patient outcomes and reduce the tremendous workload of healthcare workers, interoperability and vendor agnostic solutions are key to integrating data to drive predictive and actionable insights, and for those insights to be disseminated efficiently and effectively across the healthcare network so that the right care can be delivered at the right time, anywhere.

“The digital transformation helps to change the delivery of healthcare. To drive improvements in quality and efficiency of care, organizations must leverage integrated informatics solutions,” said Roy Jakobs, Chief Business Leader Connected Care, Philips. “At this year’s HIMSS & Health 2.0 European Health Conference, we’re excited to showcase our robust, interoperable infrastructures that unite devices, data, technology, and people. Our deep clinical and operational expertise delivers connected and secure informatics solutions that are scalable across clinical and operational departments, to help empower the people behind the data – from our cloud-enabled digital platforms, to our patient engagement, to our virtual care solutions.”

Spotlighting Philips’ solutions to deliver right care, at the right time, anywhere
During the virtual HIMSS & Health 2.0 European event, Europe’s largest virtual and digital health event, Philips will focus on the following 2021 key informatics themes: Healthcare Anywhere, Digital Transformation, Business Models, Healthcare Consumerization and Precision Care. Philips’ propositions available across these areas enable predictive, precise and virtual care, based on Philips’ secure, cloud-based HealthSuite digital platform, addressing the quadruple aim of better health outcomes, improved patient and staff experience, while lowering the cost of care; they include:

• Acute Patient Management – continuous monitoring keeping data with the patient, distributing critical physiological trends and insights to care teams at all points of care. Philips’ acute patient management solutions bring together devices, analytics, services to allow for early detection and appropriate intervention in a secure, agile and resilient ecosystem.
• Integrated Diagnostics – Philips Diagnostic Informatics Suite allows data curation at the point of care, fostering clinical collaboration across diagnostic and clinical service lines, as well as improving streamlined workflows and reducing variation. Data brought to meaningful insights to support a more precise diagnosis and lower total cost of ownership.
• Virtual Care – Philips’ telehealth solutions and capabilities enable customers to extend where, when and how care is delivered –because location should never limit patient care. Virtual care can help to improve efficiency while maintaining quality of care and optimizing staff allocation and productivity through data-driven insights.

At the virtual conference, Philips will also participate in the following live and on-demand sessions:

• Keynote Presentation on Widening our Perspective on Digital Maturity – Shez Partovi, MD, Chief Innovation and Strategy Officer, Philips, will be part of this conversation on June 7^th, 4:20 – 5:00pm CET. A recording will also be available on-demand for those who cannot tune in live.
• Best Practice Session on Digital Maturity Featuring Informed Perspectives from HIT Leaders – on-demand, 20-minute session available on the HIMSS platform during the conference.

Details on all sessions and the full program can be found here.

For more information on Philips’ solutions that will be showcased at the virtual HIMSS European conference, visit: www.philips.com/himss and follow @PhilipsLiveFrom for updates. For continued conversations around Philips’ innovation in health informatics, join us virtually or in-person at HIMSS Global taking place August 9-13, 2021 in Las Vegas, NV, USA.

For further information, please contact:

Anna Hogrebe
Philips Global Press Office
Tel: +1 416 270 67 57
E-mail: anna.hogrebe@philips.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 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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• Virtual care collaboration

 

June 7, 2021

Healthcare leaders partner to streamline the path from cancer diagnosis to survivorship for better outcomes

Amsterdam, the Netherlands, and Stockholm, Sweden – Royal Philips (NYSE: PHG, AEX: PHIA), and Elekta (EKTA-B.ST) today signed agreements to deepen their existing strategic partnership to advance comprehensive and personalized cancer care through precision oncology solutions.

The extended collaboration builds on the two companies’ successful cooperation in the fast-emerging field of magnetic resonance (MR)-guided adaptive radiation therapy. Through deeper cross-portfolio collaboration, Philips and Elekta will utilize their complementary capabilities to further improve patient care.

Benefiting patients throughout the care pathway
Oncology care is transforming, driven by an increasingly precise diagnosis of each tumor, and a continuously expanding range of therapy options. To fully capitalize on these opportunities, healthcare providers require integrated solutions throughout the entire cancer care pathway, from diagnosis to treatment and follow-up.

This integrated approach has the potential to provide:

• Quicker, more accurate visualization of the tumor
• Easier decision of optimal treatment strategy
• Earlier assessment of therapy response
• More effective and efficient therapy delivery

The strengthened strategic partnership intends to further deliver a superior experience in diagnosis and adaptive, personalized treatments for clinicians, shorter treatment times and more precise therapy for patients, and lowered costs of care for healthcare providers.

“To capitalize on the opportunities presented by increasingly precise diagnosis and the fast-expanding range of therapies available for cancer patients, it’s essential to provide integrated systems and solutions that provide the right insights at the right time throughout each patient’s care journey,” said Kees Wesdorp, Chief Business Leader of Precision Diagnosis at Philips. “By deepening our already-successful collaboration with Elekta, we will accelerate towards our goal of providing clear care pathways and predictable outcomes for every cancer patient. Today’s announcement is an important next step in the implementation of our strategy in precision diagnosis.”

“I expect this extended partnership to unlock opportunities that will provide better outcomes for people with cancer,” said Gustaf Salford, Elekta’s President and CEO. “Together, we’ll combine advanced informatics and image-guided radiation therapy solutions to deliver greater precision in oncology. This means easier selection by clinicians of the optimal treatment strategy and more efficient and effective therapy delivery.”

In this preferred, although non-exclusive, partnership, Elekta and Philips will leverage their capabilities to pursue integrated vendor-agnostic solutions, enhancing interoperability between the two parties’ systems and software in order to drive precision in oncology.

For further information, please contact:

Mark Groves
Philips Global Press Office
Tel: +31 631 639 916
E-mail: mark.groves@philips.com

Mattias Thorsson
Vice President, Head of Corporate Communications, Elekta
Tel: +46 70 865 8012
E-mail: mattias.thorsson@elekta.com

Cecilia Ketels
Head of Investor Relations, Elekta
Tel: +46 76 611 76 25
E-mail: cecilia.ketels@elekta.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 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Elekta
For almost five decades, Elekta has been a leader in precision radiation medicine. Our more than 4,000 employees worldwide are committed to ensuring everyone in the world with cancer has access to – and benefits from – more precise, personalized radiotherapy treatments. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm Exchange. Visit elekta.com or follow @Elekta on Twitter.

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• Philips-Ingenia-MR-RT

REGULATED INFORMATION 
INSIDE INFORMATION

Nyxoah BETTER SLEEP Trial Reaches its Primary Endpoints

Mont-Saint-Guibert, Belgium – 7 June 2021, 7:00 am CET / 1:00 am ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the BETTER SLEEP trial reached its primary safety and performance endpoints.

The BETTER SLEEP trial was designed to assess the long-term safety and performance of the Genio® bilateral hypoglossal nerve stimulation system (the “Genio® system”) in 42 adult OSA patients with and without Complete Concentric Collapse (CCC) of the soft palate.

Top-line results from the BETTER SLEEP study showed:

•  A statistically significant mean reduction in Apnea Hypopnea Index (AHI) from baseline to six months post implantation in the whole cohort (CCC and non-CCC patients)
•  A statistically significant mean reduction in AHI from baseline to six months post implantation in the CCC patient subgroup
•  42.9% of the study population had CCC

The Company expects to announce additional data with respect to the study as further analyses are conducted.

Dr. Richard Lewis, MBBS, FRACS, Principal Investigator of the BETTER SLEEP study, from Royal Perth Hospital and the University of Western Australia commented: “The top-line results of the BETTER SLEEP study are extremely encouraging. The most impressive aspect of the results is the responder rate of the CCC patient subgroup. These patients are excluded from unilateral hypoglossal nerve stimulation, but the BETTER SLEEP results showed a significant reduction in AHI in these patients following treatment with the Genio® system, which is the first device designed to deliver bilateral stimulation of the hypoglossal nerve. Overall, we have achieved a very high responder rate in both CCC and non-CCC patients, and the treatment with the Genio® system was well tolerated. We look forward to publishing this data in a leading medical journal.”

Olivier Taelman, CEO of Nyxoah, stated: “We are excited by the top-line data, with the primary performance and safety endpoints met, supporting our belief that the Genio® system’s bilateral stimulation of the hypoglossal nerve, has the potential to provide positive clinical outcomes for patients with CCC. We already engaged with the EU Notified Body to review these study data, with the goal of expanding the CE-marked indication to include CCC patients. In parallel, we plan to initiate dialogue with the FDA to further discuss the Genio® system as a potential treatment option for patients with CCC.” Mr. Taelman continued, “Additionally, we observed a 70% responder rate in the non-CCC patient subgroup based on the Sher criteria, which strengthens our confidence in ongoing study outcomes.”

About BETTER SLEEP Trial
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea, or BETTER SLEEP, is a multicenter, prospective, open-label, two-group clinical trial, designed to assess the safety and performance of the Genio® system for the treatment of OSA in adult patients with and without CCC. The BETTER SLEEP trial includes a subgroup of CCC patients who are currently contraindicated for unilateral hypoglossal nerve stimulation. The trial was authorized by the Australian and New Zealand regulatory authorities and is being conducted in nine local medical centers. The primary safety endpoint was the incidence of device-related serious adverse events six months post-implantation. The primary performance endpoint was the change in the AHI score from baseline to six months post-implantation measured by counting the number of events (apnea or hypopnea) that occur per hour collected during an overnight sleep study. Patients with moderate to severe AHI scores between 15 and 65 and aged between 21 and 75 years were eligible for enrollment if they failed, refused, or did not tolerate PAP treatment. Patients with a body mass index above 32 kg/m² were excluded.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio® system, a CE-marked, patient-centered, minimally invasive, next generation hypoglossal neurostimulation therapy for treatment of moderate to severe OSA. OSA is the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for potential CE-mark indication expansion, the DREAM IDE pivotal study for potential FDA approval and the post-marketing EliSA study in Europe to evaluate the long-term safety and efficacy of the Genio® system.

For more information, please visit www.nyxoah.com.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal
law to investigational use in the United States.

Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding Nyxoah’s expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; and the utility of prior clinical data, including data from the BETTER SLEEP study, in potentially obtaining FDA approval of the Genio® system. Forward-looking statements are based on Nyxoah’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ.  Forward-looking statements contained in this announcement are made as of this date, and Nyxoah undertakes no duty to update such information except as required under applicable law.

Contacts:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 23 55

Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com

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• ENG_Nyxoah – BETTER SLEEP Data PR – FINAL