Artificial Intelligence
RenalytixAI Files Submission Seeking U.S. FDA Clearance of KidneyIntelX
NEW YORK, Aug. 26, 2020 (GLOBE NEWSWIRE) — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, announces that it has filed a submission seeking clearance of KidneyIntelX™ with the U.S. Food and Drug Administration (FDA). This FDA filing builds on the Company’s regulatory and commercialization program, which includes the June 12, 2020 announcement that the New York State Department of Health has issued a clinical laboratory permit for commercial clinical testing of KidneyIntelX.
KidneyIntelX is designed to provide potentially critical new information to health care providers, insurance payors and population health managers in an effort to support optimization of care delivery, improve patient outcomes and reduce the $120 billion annual cost1 of chronic and end-stage kidney disease to the United States healthcare system.
In May 2019, RenalytixAI announced that KidneyIntelX was granted Breakthrough Device designation by FDA, the first such designation for an artificial intelligence-enabled in vitro diagnostic for kidney disease publicly announced by any company. FDA clearance is now being sought for the intended use of KidneyIntelX, in conjunction with clinical evaluation, as an aid to further assess the risk of progressive decline in kidney function within a period of up to five years in patients over the age of 21 with type 2 diabetes and existing chronic kidney disease (“CKD”). Patients with CKD and type 2 diabetes account for 20-30 percent of the estimated 37 million U.S. patients with CKD2.
Performance data provided by RenalytixAI in the FDA 510(k) submission is based on a multi-center validation study of more than 1,100 patients demonstrating that KidneyIntelX accurately identifies patients in early CKD stages 1, 2 and 3 who are at highest risk of progressive decline in kidney function and/or kidney failure.
About Kidney Disease
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15 percent of U.S. adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it, and 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. Kidney disease is referred to as a “silent killer” because it often has no symptoms and can go undetected until a very advanced stage. Each year kidney disease kills more people than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.
* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
About RenalytixAI
RenalytixAI is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. RenalytixAI’s products are being designed to make significant improvements in kidney disease diagnosis, clinical care, patient stratification for drug clinical trials and drug target discovery. For more information, visit www.renalytixai.com.
Sources
1 United States Renal Data System: https://www.usrds.org/media/2371/2019-executive-summary.pdf
2 https://pubmed.ncbi.nlm.nih.gov/29054846/
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: our ability to achieve regulatory clearance of KidneyIntelX from the FDA and the ability of KidneyIntelX to curtail costs of CKD and end-stage kidney disease and improve patient outcomes. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have not yet commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our final prospectus filed with the SEC on July 17, 2020, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
Media Contacts:
United States:
Maggie Markert
Zer0 to 5ive for RenalytixAI
(484) 574-1855
[email protected]
Outside of the United States:
Walbrook PR Limited
Paul McManus / Lianne Cawthorne
Tel: 020 7933 8780 or [email protected]
Mob: 07980 541 893 / 07584 391 303
Artificial Intelligence
EZVIZ unveils its groundbreaking H9c Dual-lens Smart Pan-and-tilt Camera series: a new paradigm for automated, all-round outdoor protection
By combining a pan-and-tilt panoramic lens and a fixed 180-degree wide-angle lens, one H9c Dual smartly secures large areas with performance better than that of two ordinary ones.
HOOFDDORP, Netherlands, May 6, 2024 /PRNewswire/ — EZVIZ, a leading global player in innovative smart home security, proudly introduces the H9c Dual series, its latest dual-lens outdoor pan-and-tilt cameras that redefine smart protection for homes and small businesses. With options in 2K and 3K resolutions, their groundbreaking design combines a sharp bullet camera and a flexible PT camera, addressing complex security needs effectively. The interlinked dual lenses work collaboratively to safeguard wide property areas, detect and track activities, and offer auto-patrol options for hands-free security.
“The H9c Dual challenges traditional outdoor cameras with unrivaled vision, unmatched automation, and high versatility for basically any scenario,” said Candice Tu, the lead product manager, “EZVIZ leads the way in the development and application of advanced dual-lens technology. This underlines our dedication to bringing cutting-edge technology within reach for practical, everyday situations.”
At the core of the H9c Dual is its groundbreaking dual-lens technology, highlighted by EZVIZ’s distinctive co-action function. The two lenses can work independently at two static viewing angles or act together as a team. When the fixed lens detects motions, the pan-and-tilt lens automatically rotates to track the same activity. This co-action function can also be manually controlled through the EZVIZ App.
The series addresses unnoticed blind spots by offering a 180-degree comprehensive view in a single frame, supplemented by the bottom PT lens for intricate close-ups. Both lenses, with high resolutions of 2K/3K, use built-in AI chips to detect people and vehicles in customizable zones, ensuring users are informed of crucial activities. Users can set up to four patrol spots for the PT lens to complete automatic rotations on a schedule.
Equipped with powerful LEDs, the H9c Dual provides color night vision up to 40 meters and warns potential trespassers with a loud siren and dazzling flashlight upon detection. Offering superior protection compared to a traditional two-camera system, the H9c is a breeze to set up thanks to its adaptable mounting design. Users can manage and control their H9c through the user-friendly EZVIZ App, and enjoy seamless integration with prevailing voice assistants and the larger EZVIZ ecosystem.
Learn more at www.ezviz.com.
Photo – https://mma.prnewswire.com/media/2404810/EZVIZ_H9c_Dual_Lens_Pan_Tilt_Wi_Fi_Camera.jpg
View original content:https://www.prnewswire.co.uk/news-releases/ezviz-unveils-its-groundbreaking-h9c-dual-lens-smart-pan-and-tilt-camera-series-a-new-paradigm-for-automated-all-round-outdoor-protection-302136133.html
Artificial Intelligence
Red light therapy for repairing spinal cord injury passes milestone
BIRMINGHAM, England, May 6, 2024 /PRNewswire/ — Patients with spinal cord injury (SCI) could benefit from future treatment to repair nerve connections using red and near-infrared light.
The method, invented by University of Birmingham scientists and patented by University of Birmingham Enterprise, delivers light directly to the site of the injury.
Their latest research, published in Bioengineering and Translational Medicine, determined an optimal ‘dose’ for this novel approach, and showed it can deliver therapeutic improvements including significant restoration of sensation and movement, and regeneration of damaged nerve cells.
Researchers led by Professor Zubair Ahmed used cell models of SCI to determine the frequency and duration of light required to achieve maximum restoration of function and stimulate nerve cell regrowth.
They found delivery at a wavelength of 660nm for one minute a day increased cell viability (the number of live cells) by 45% over five days’ treatment.
Professor Ahmed said: “The effect of 660nm light was both neuroprotective, meaning it improved survival of nerve cells, and neuroregenerative, meaning it stimulated nerve cell growth.”
The researchers also investigated the effect of light therapy in preclinical models of SCI, using an implantable device and transcutaneous delivery with the light source placed against the skin. They showed comparable results for both methods, with a one-minute dose of 660nm light, delivered daily for seven days resulting in reduced tissue scarring, increased levels of proteins associated with nerve cell regeneration, improvements in the connections between cells and significant functional recovery.
This is the first time transcutaneous and direct light delivery have been compared in SCI. Professor Ahmed said: “To make light therapy viable for treating SCI in humans an implantable device will be required, to provide line of sight to damaged tissue and the opportunity for greater accuracy and standardise dosing without impedance due to the thickness of the skin and other tissues surrounding the spinal cord.”
The researchers are planning to develop an implantable device for use in humans with traumatic SCI. They have already received further funding and are seeking commercial partners or investors to develop a prototype device to take into first-in-man clinical trials.
Full release here.
University of Birmingham Enterprise helps researchers turn ideas into products and services that meet real-world needs. Follow us on LinkedIn and X.
Photo: https://mma.prnewswire.com/media/2404909/University_of_Birmingham_Enterprise.jpg
Media enquiries: Ruth Ashton
Commercial enquiries: Veemal Bhowruth
View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/red-light-therapy-for-repairing-spinal-cord-injury-passes-milestone-302136233.html
Artificial Intelligence
TerraPay Continues to Attract Top Industry Talent, Names Hassan Chatila as Vice President and Global Head of Network
LONDON, May 6, 2024 /PRNewswire/ — TerraPay, a leading global money movement company, is excited to announce the appointment of Hassan Chatila as Vice President – Global Head of Network.
This key addition to TerraPay’s global network leadership also marks a critical step in the company’s ongoing strategy to simplify and streamline global money movement for businesses and individuals alike, underscoring its commitment to enhancing its network capabilities.
With over 20 years of experience in the cross-border payments, Hassan brings with him a rich legacy of leadership and innovation. Before joining TerraPay, he served as the Global Head of Western Union’s Account Payout Network, where he played a pivotal role in expanding and optimizing the network to support seamless global transactions. His impressive career portfolio also includes key leadership roles at Earthport and Temenos, where he led significant payments transformation initiatives and drove substantial growth.
In this new role at TerraPay, Hassan will lead the expansion and optimization of TerraPay’s global payout network. He will work closely with internal and external stakeholders to enhance the network’s capabilities, ensuring that TerraPay continues to offer its partners transparent and efficient payment solutions.
Welcoming Hassan to the team, TerraPay Founder and CEO, Ambar Sur, said, “It gives me great pleasure to welcome Hassan on board. As an industry expert, he comes with a highly reputable cross-border payment expertise and deep leadership experience. On TerraPay’s journey of growth, Hassan’s appointment is a critical step in furthering our network expansion goals. I look forward to working together and further deepen TerraPay’s position as a global money movement leader.”
Hassan Chatila, VP – Global Head of Network, TerraPay, commented on his new role, saying, “I am thrilled to join TerraPay at this pivotal time. Over the years, TerraPay has built an expansive global money movement network driven by the mission to build a borderless world of payments. I look forward to leveraging my experience to further develop our network capabilities, create new opportunities across markets and help TerraPay achieve its ambitious goals.”
For media inquiries, please contact [email protected]
About TerraPay
TerraPay simplifies global money movement – by providing a single connection to the most expansive cross-border payments network regulated in 31 global markets and enabling payments to 144 receive countries, 210+ send countries, 7.5Bn+ bank accounts and 2.1Bn+ mobile wallets. TerraPay is on a mission to connect a borderless financial world, making moving money everywhere instant, reliable, transparent and fully compliant. TerraPay pushes the boundaries for global businesses – ranging from banks, fintechs and money-transfer operators to travel businesses, creator economy platforms and e-commerce marketplaces – while driving financial inclusion in even the most inaccessible markets. Founded in 2014, TerraPay is headquartered in London, with global offices in Bangalore, Dubai, Miami, Bogota, Dar es Salaam, Kampala, Hague, Dakar, Joburg, Nairobi, Milan, Singapore and is expanding rapidly, having received funding from leading investors, including the IFC (the World Bank), Prime Ventures, Partech Africa and Visa.
Logo: https://mma.prnewswire.com/media/1222771/TerraPay_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/terrapay-continues-to-attract-top-industry-talent-names-hassan-chatila-as-vice-president-and-global-head-of-network-302135445.html
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