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Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting

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WALTHAM, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 – October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.

“Our scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,” said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. “We look forward to sharing these data with the ophthalmology community as we work toward bringing pegcetacoplan to patients with GA as quickly as possible.”

The U.S. marketing application for pegcetacoplan for GA is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2022. Apellis plans to submit a marketing authorization application to the European Medicines Agency by the end of this year.

Presentation details:

  • Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials – RET10 – Friday, Sept. 30 – 4:30 – 4:36 p.m. CST
  • The Role of AI-Guided OCT Imaging in Geographic Atrophy – RET19 – Saturday, Oct. 1 – 3:13 – 3:19 p.m. CST
  • Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA024 – Sunday, Oct. 2, 8:12 – 8:19 a.m. CST
  • Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA069 – Sunday, Oct. 2, 4:45 – 4:52 p.m. CST

e-Poster:

  • Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS® Registry – PO427

About DERBY and OAKS
DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS received masked treatment for 24 months. All patients who completed the DERBY or OAKS studies were invited to participate in the GALE open-label extension study.

About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than 5 million people worldwide, including one million people in the United States.1,2 This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.3 GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.4 C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no approved treatments for GA.

About Pegcetacoplan for Geographic Atrophy (GA)
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy.

About Apellis 
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in complement, we ushered in the first new class of complement medicine in 15 years with the approval of the first and only targeted C3 therapy. We are advancing this science to continually develop transformative medicines for people living with rare, retinal, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

Apellis Forward-Looking Statement 
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of anticipated regulatory submissions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the FILLY, DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the FILLY, DERBY and OAKS trials will be accepted by the FDA or foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact: 
Lissa Pavluk
[email protected]
617.977.6764

Investor Contact: 
Meredith Kaya 
[email protected]
617.599.8178

1 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
2 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
4 Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223–261.

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Artificial Intelligence

Department of Health – Abu Dhabi partners with MBZUAI and Core42 to launch Global AI Healthcare Academy

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May 13, 2024

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ABU DHABI, UAE, May 13, 2024 /PRNewswire/ — The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate, signed a Memorandum of Understanding (MoU) with Mohamed bin Zayed University of Artificial Intelligence (MBZUAI), the leading AI research-based academic institution located in Abu Dhabi, and Core42, a G42 company offering AI solutions, during Abu Dhabi Global Healthcare Week (ADGHW). This MoU will launch the global AI Healthcare Academy to the health workforce. The MoU was signed by Dr. Rashed Obaid Al Suwaidi, Executive Director of Healthcare Workforce Planning Sector at DoH, Sultan Al Hajji, Vice President of Public Affairs and Alumni Relations at MBZUAI and Talal Al Kaissi, Executive Vice President, Chief Product and Global Partnership Officer at Core42.

 
 
Reinforcing Abu Dhabi’s position as a leading destination for healthcare and life sciences, the partnership seeks to establish a framework of collaboration to strengthen the Emirate’s position at the forefront of technology-enabled and data-driven healthcare systems. The new AI Healthcare Academy will help to build a global AI-trained workforce, which is capable of advancing diagnostic and operational efficiency, significantly improving patient care, and streamlining healthcare processes around the world.
Sultan Al Hajji, Vice President of Public Affairs and Alumni Relations at MBZUAI, said: “Healthcare is a key research pillar for MBZUAI, because we recognise the transformative and life-saving potential of AI across a wide range of diagnostic and treatment areas. In addition to our recent effort in establishing the Institute of Digital Public Health, we are proud to partner with The Department of Health – Abu Dhabi in launching the new AI Healthcare Academy. MBZUAI will provide the Academy our world-class faculty to facilitate AI workshops and training to upskill the healthcare workforce in support of the UAE leadership’s vision to become a global hub for AI and a centre for life sciences.”
Through leveraging advanced technologies and harnessing the power of AI, DoH seeks to upskill the health workforce, enhance local practices and contribute to broader medical research and treatment modalities worldwide. By embracing AI-driven technologies, healthcare professionals can stay at the forefront of innovation, fostering collaboration and knowledge exchange on a global scale.
By collaborating with MBZUAI through its Institute of Digital Public Health, the Academy will encompass ground-breaking research. These efforts will encourage public-private partnerships, fostering collaboration to secure ample funding and ensure ongoing sustainability, setting the academy for long-term success and supporting responsible and impactful innovation.
Under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of Abu Dhabi Executive Council, Abu Dhabi Global Healthcare Week (ADGHW) is a major government initiative from DoH, taking place between 13 and 15 May 2024.
For more information please visit: https://www.adghw.com/
About Department of Health – Abu Dhabi (DoH):
The DoH is the regulatory body of the healthcare sector at the Emirate of Abu Dhabi and ensures excellence in healthcare by monitoring the health status of the population. DoH defines the strategy for the health system, monitors and analyses the health status of the population and performance of the system. In addition, DoH shapes the regulatory framework for the health system, inspects against regulations, enforce standards, and encourages adoption of world-class best practices and performance targets by all healthcare service providers in the Emirate. DoH also drives programmes to increase awareness and adoption of healthy living standards among the residents of the Emirate of Abu Dhabi in addition to regulating scope of services, premiums and reimbursement rates of the health system.
For further information on DoH, visit https://www.doh.gov.ae/ and follow on X, Instagram, Facebook, LinkedIn and YouTube.
About Mohamed bin Zayed University of Artificial Intelligence (MBZUAI)
MBZUAI is a graduate, research university focused on artificial intelligence, computer science, and digital technologies across industrial sectors. The university aims to empower students, businesses, and governments to advance artificial intelligence as a global force for positive progress. MBZUAI offers various graduate programs designed to pursue advanced, specialized knowledge and skills in artificial intelligence, including computer science, computer vision, machine learning, natural language processing, and robotics. For more information, please visit www.mbzuai.ac.ae.
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Vantiva Ships Over 125 Million Open-Source RDK Devices Globally

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May 13, 2024

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Milestone includes RDK-Broadband and RDK-Video devices shipped to Network Service Providers across the world
PARIS, May 13, 2024 /PRNewswire/ — Vantiva (Euronext Paris: VANTI), a global technology leader enabling Network Service Providers (NSPs) to connect consumers worldwide, today announced that it has shipped more than 125 million RDK-based customer premise equipment (CPE) products since 2012, strengthening its market share as of 2024. RDK is a fully modular, portable and customizable open-source software solution that standardizes core functions used in video, broadband and Internet of Things (IoT) devices. Vantiva has been an active member of the RDK community since its inception, providing RDK solutions across IP, Hybrid and Quadrature Amplitude Modulation devices. In 2014, Vantiva contributed software that helped enable RDK to expand its applicability to broadband devices, meeting the demand of operators worldwide for greater technical commonality among suppliers.

 
“Vantiva has played a vital role in helping RDK become a driving force for innovation across broadband and video globally,” said Jason Briggs, President and General Manager of RDK. “Network Service Providers understand the benefits RDK provides in terms of versatility and software commonality, and the importance of having a proven CPE partner, like Vantiva, who can help them deliver at scale. We look forward to continuing to collaborate with Vantiva to extend the reach of RDK for many years to come.”  
RDK-Broadband (RDK-B) is an open platform for broadband devices that provides customers with an industry-leading standard of technology facilitating efficiencies in development cycles through collaborative industry contributions that drive lean business results. Operators can efficiently introduce a wider array of enhanced offerings, like parental controls or cybersecurity, while maintaining complete control over design, development, deployment and data management. RDK-Video (RDK-V) provides developers and operators with a unified software stack for set-top boxes (STBs) and home gateways across a broad range of complex video and management functions, including rendering, content, device management and networking.
“RDK has grown exponentially thanks to the leadership of RDK Management and to the more than 600 companies that contribute to the RDK community,” said Leopold Diouf, Senior Vice President of the product division at Vantiva. “By leveraging RDK as a platform, Vantiva delivers innovative software solutions to a globally diverse range of NSPs and multiple access technologies – DOCSIS, fiber and fixed wireless access. This approach provides our clients with the latest software advancements efficiently and effectively, empowering them to focus their efforts on new services that drive their businesses forward.”
All of Vantiva’s DOCSIS gateways ship with RDK-B as the default software stack. Vantiva’s RDK-V STBs are deployed with leading NSPs across the globe. 
Achieving more than 125 million RDK devices shipped is the latest strategic milestone in Vantiva’s ongoing commitment to providing open and innovative technologies for customers and operators around the world. Vantiva’s goal is to bring seamless connectivity and premium entertainment experiences to consumers by creating best-in-class CPE and partnering with the most innovative companies in the connected home ecosystem. 
ContactsVantiva Press Relations     [email protected]   
Thatcher+Co. for [email protected] 
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Ambient Intelligence Market Size to Grow USD 185.5 Billion by 2032 at a CAGR of 25.7% | Valuates Reports

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May 13, 2024

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BANGALORE, India, May 13, 2024 /PRNewswire/ — Ambient Intelligence Market is Segmented By Component (Hardware, Software, Service), By Technology (Bluetooth Low Energy, RFID, Ambient Light Sensor, Software Agents, Affective Computing, Biometrics, Others), By End User (Residential, Retail, Healthcare, Office Building, Automotive, Others).

The Global Ambient Intelligence Market was valued at USD 19.2 Billion in 2022, and is projected to reach USD 185.5 Billion by 2032, growing at a CAGR of 25.7% from 2023 to 2032.
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Major Factors Driving the Growth of Ambient Intelligence Market:
The market for ambient intelligence is expanding rapidly thanks to a number of important considerations. The need for ambient intelligence solutions is primarily being driven by the growing integration of smart technology into common things, together with improvements in IoT (Internet of Things) and AI (Artificial Intelligence). Market expansion is further accelerated by the growing global adoption of smart home and smart city projects. Furthermore, the adoption of ambient intelligence systems is fueled by the increasing need for individualized user experiences and seamless connection across a variety of industries, including healthcare, retail, and automotive. Together, these elements are fueling the market for ambient intelligence, which is expected to revolutionize how humans interact with our surroundings.
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TRENDS INFLUENCING THE GROWTH OF THE GLOBAL AMBIENT INTELLIGENCE MARKET: 
By redefining patient care and experience, ambient intelligence hardware combined with affective computing technology in the healthcare sector is driving the growth of the ambient intelligence market. With the use of affective computing, medical professionals may monitor mental health issues, gauge patient moods, and customize treatment regimens by analyzing physiological signs such as voice tonality and facial expressions. Hardware with ambient intelligence, including sensors and smart devices integrated into medical settings, makes data collecting and interpretation easier and improves patient involvement and professional decision-making. Affective computing and ambient intelligence together enhance healthcare outcomes and stimulate the market by encouraging creativity and efficiency in the provision of healthcare services.
The market for ambient intelligence is expanding due to the growing need for smart home automation solutions. By adding smart technologies that automate chores and adjust to their needs, homeowners want to improve comfort, convenience, and energy efficiency in their houses. Voice-activated assistants, lighting control systems, and smart thermostats are a few examples of ambient intelligence technologies that provide seamless automation and connection, spurring market growth and acceptance in the smart home space.
Ambient intelligence solutions are becoming more and more popular because of the need for individualized user experiences in a variety of industries, such as retail, healthcare, and entertainment. Ambient intelligence systems anticipate user wants, preferences, and behaviors by utilizing data analytics, machine learning, and context-aware computing. This allows them to provide customized experiences that increase user pleasure and engagement. This customized strategy increases market growth by cultivating brand distinction and consumer loyalty in addition to enhancing user experiences. The aging population and the rise in chronic illness rates have made ambient assisted living technologies more important, which has fueled the healthcare industry’s growth in the ambient intelligence market.
The market is expanding as a result of rising consumer adoption of ambient intelligence technologies and their advantages in everyday life. Customers are more likely to embrace ambient intelligence solutions in other areas of their lives when they see the efficiency, convenience, and personalization that these solutions provide in a variety of domains, such wearables, smart homes, and linked autos. Additionally, as smart gadgets and digital assistants proliferate, customers become more acquainted with ambient intelligence principles, which facilitates wider acceptance and market growth.
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AMBIENT INTELLIGENCE MARKET SHARE:
Due to a variety of factors, including the early adoption of modern technologies, the presence of several important companies in the ambient intelligence vendor market, and the significant digitization of different industries in the area, North America held the biggest market share for ambient intelligence in 2022.
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Key Companies:
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