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GE Healthcare and Lantheus Phase III Clinical Trial Finds [18F]flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease

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  • Phase III clinical trial of [18F]flurpiridaz PET diagnostic radiopharmaceutical meets co-primary endpoints for detecting Coronary Artery Disease (CAD)
  • Trial also met its first key secondary endpoint, demonstrating higher diagnostic efficacy for [18F]flurpiridaz PET compared to SPECT Myocardial Perfusion Imaging (MPI)
  • With a half-life roughly 12 times longer than currently approved cardiac PET radiotracers, if approved, [18F]flurpiridaz has the potential to expand patient access to PET MPI
  • This radiotracer is part of GE Healthcare’s pipeline of Molecular Imaging diagnostics aiming to increase diagnostic accuracy and improve patient outcomes across key care areas

CHALFONT ST GILES, United Kingdom and NORTH BILLERICA, Mass., Sept. 13, 2022 (GLOBE NEWSWIRE) — GE Healthcare and Lantheus Holdings Inc (NASDAQ: LNTH) have announced that the recent Phase III clinical trial of their investigational radiotracer, [18F]flurpiridaz, has met its co-primary endpoints of exceeding a 60 percent threshold for both sensitivity and specificity for detecting Coronary Artery Disease (CAD). The findings, shared at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida, U.S., also demonstrate [18F]flurpiridaz Positron Emission Tomography (PET) has higher diagnostic efficacy and image quality in patients with suspected CAD, compared with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the predominant procedure used in nuclear cardiology today. SPECT MPI represents approximately 6 million procedures per year in the U.Si.

The Phase III Open-Label Study, which involved over 600 patients across sites in the U.S., Europe and Canada assessed the diagnostic efficacy of [18F]flurpiridaz in detecting CAD, the most common form of heart diseaseii and the leading cause of death globallyiii, with invasive coronary angiography as a standard of truth. More than 120 million people are affected by CAD globally each yeariv and in the U.S. alone, approximately 20 million adults have CAD, with nearly 383,000 deaths recorded in 2020v.

If approved, this investigational agent would offer the advantages of 18F, with broad available distribution and a half-life of almost two hours, removing the need for it to be manufactured in the immediate vicinity of the imaging department. This longer half-life could also make Flurpiridaz (18F) Injection suitable for exercise stress testing, which is not feasible with existing cardiac PET radiotracers.

Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke’s Hospital, Missouri, US, shared: “These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [18F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.”

Dr. Francois Tranquart, MD, PhD, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, said: “The positive Phase III trial results are a key step towards future approval of Flurpiridaz (18F) Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease. This is another example of GE Healthcare investing in our portfolio of Molecular Imaging products to help improve diagnostic accuracy and patient outcomes.”

GE Healthcare has led the funding and development of [18F]flurpiridaz, and, if the imaging agent is approved, will have global commercialization rights. Lantheus has collaborated on the development and will also collaborate on potential commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales.

GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Its Molecular Imaging portfolio combines an innovative pipeline with established proprietary products across cardiology, neurology and oncology.

About GE Healthcare:

GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 48,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

Follow us on FacebookLinkedInTwitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

About Lantheus

With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com

GE Healthcare Media Contact:
Debbie Leven
[email protected]
+44 7785 456999

Lantheus Contacts:

Investors

Mark Kinarney
Vice President, Investor Relations
978-671-8842
[email protected]  

Media

Melissa Downs
Senior Director, Corporate Communications
646-975-2533
[email protected]  

________________________________

i Data on File: AMR Market Guide 2021.

ii WHO Factsheet 2020. Cardiovascular diseases (CVDs). 11 June 2021.

iii Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.

iv Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. July 23 2020.

Centers for Disease Control and Prevention. Heart Disease Facts. Accessed July 15 2022.

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

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Saviynt Appoints James Ross as RVP-ANZ to Strategically Accelerate Growth in the Australia and New Zealand Region

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LOS ANGELES, May 22, 2024 /PRNewswire/ — Saviynt, a leading provider of cloud-native identity and governance platform solutions, today announced the appointment of James Ross as RVP-ANZ as the company has seen rapid growth in the Australia and New Zealand (ANZ) region, with double digit growth year over year.

Saviynt has solidified its position as a key player in the cloud identity security landscape with its Identity Cloud. The company’s continued focus on innovation and client satisfaction has contributed significantly to building a safer Australia with prominent customers across the energy and utilities, finance, retail, energy, and transport and logistics sectors.
“James’ appointment as the Regional Vice President (RVP) for ANZ marks a strategic move to accelerate growth and solidify market presence in the region,” said Dan Mountstephen, SVP APAC at Saviynt. “With a proven track record of dynamic leadership at Collibra, ForgeRock, and CA Technologies, James brings a wealth of experience and expertise to the role. His visionary approach and collaborative spirit are poised to inspire and mobilize teams toward ambitious targets.”
Saviynt has consistently expanded its client base and deepened its relationships with existing customers through customized solutions and unparalleled support, cementing its reputation as a trusted partner in the region’s cybersecurity ecosystem. As RVP ANZ, Ross is set to foster key partnerships and implement agile strategies to propel the company towards new heights of success in the dynamic ANZ market.
“Joining Saviynt excites me because it’s an opportunity to help more organizations simplify their identity ecosystem in order to drive efficiencies and improved security posture. I am committed to leveraging Saviynt’s cutting-edge solutions to continue to broaden our partnerships in the region to improve our accessibility for customers, strengthen our regional delivery, whilst continuing to provide a great customer experience,” said Ross.
To learn more about Saviynt, please visit our website.
About Saviynt
Saviynt empowers enterprises to secure their digital transformation, safeguard critical assets, and meet regulatory compliance. With a vision to provide a secure and compliant future for all enterprises, Saviynt’s cutting-edge solutions have been recognized as industry leaders. For more information, please visit www.saviynt.com.
Press Contact
Jacklyn [email protected]
Photo: https://mma.prnewswire.com/media/2418209/James_Ross_RVP_ANZ_Saviynt.jpg
 

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Appdome Sweeps Cybersecurity Excellence Awards

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Unified Mobile Defense Platform Recognized for Innovation and Leadership Across Nine Cybersecurity Categories
REDWOOD CITY, Calif., May 21, 2024 /PRNewswire/ — Appdome, the mobile app economy’s one-stop shop for mobile defense, today announced it has received a total of nine (9) Cybersecurity Excellence Awards. The Appdome Unified Mobile App Defense Platform was awarded best in class across nine categories in recognition of the comprehensive breadth, depth and value of the Appdome platform to brands and enterprises alike.

“We congratulate Appdome on being recognized as an award winner in 9 categories of the 2024 Cybersecurity Excellence Awards,” said Holger Schulze, CEO of Cybersecurity Insiders and founder of the 600,000-member Information Security Community on LinkedIn, which organizes the 9th annual Cybersecurity Excellence Awards. “With over 600 entries across more than 300 categories, the awards are highly competitive. Appdome’s achievement reflects outstanding commitment to the core principles of excellence, innovation, and leadership in cybersecurity.”
Within a single pane of glass, Appdome delivers the most complete set of no-code, no-SDK, fully automated mobile defenses to mobile brands and enterprises, empowering mobile developers, cybersecurity, fraud and IT teams to deliver on any mobile cyber objective quickly and easily.
The nine (9) categories in which Appdome received a Cybersecurity Excellence Award are:
Mobile Security Platform: Appdome is the only enterprise-grade mobile security platform built for full mobile defense lifecycle management, visibility and control to brands and enterprises alike, including key features for build, test, release, monitor, response, and compliance automation. Mobile Security Automation: Appdome is the only mobile defense solution that uses machine learning to code and build over 300+ mobile app security, anti-fraud, anti-cheat, anti-malware, anti-bot, geo-compliance and other defenses in Android & iOS apps in the DevOps pipeline.Mobile Social Engineering Defense:  The Appdome Social Engineering Prevention solution is the first of its kind to protect mobile users from voice phishing (Vishing) scams and other imposter scams, T.O.A.D. attacks, Remote Access Trojans (RATs), Gold Pickaxe, FaceID bypass and more without an SDK or external servers.Mobile Bot Defense: The Appdome MOBILEBot™ Defense solution is the first mobile anti-bot solution to come out of the box compatible with any industry standard web application firewall (WAF) on the market and provide multi-layered bot, credential stuffing and Account Take Over (ATO) defense without an SDK, external server, performance limits, or restrictions.Mobile Geo Compliance:  Only the Appdome Mobile Geo-Compliance solution guarantees accurate and authentic geo location of mobile devices, applications and users without code or coding in the mobile app, without implementing an SDK and without deploying additional servers.Mobile XDR: The Appdome ThreatScope™ Mobile XDR solution is the only mobile attack and threat monitoring service that comes pre-packaged into the mobile defense lifecycle, requires no device agent, device profile, separate code, coding, SDK or server, and provides real-time detection and automated response across internal (employee facing) and external (consumer facing) Android & iOS apps.DevOps Mobile Security Tool: The Appdome platform’s fully integrated Security Release Management™ capabilities and Appdome Certified Secure™ mobile DevSecOps certification offer the only true enterprise-grade compliance assurance, audit and control for mobile defense at brands and enterprises, allowing quick verification that all security, anti-fraud and compliance objectives have been met.   Mobile Application Security:  With 300+ separate defenses for mobile apps, Appdome has the most comprehensive set of mobile application security features available in one product, fully compatible with all mobile Android & iOS apps.”Nine Cybersecurity Excellence Awards for Mobile Defense tells a very compelling story for the incredibly complex Dev, Sec, and Ops challenges organizations face detecting and defeating mobile-based risks and attacks,” said Chris Roeckl, Chief Product Officer at Appdome. “Point products make these challenges worse by adding complexity and overloading already taxed cyber and engineering teams. Appdome is the only platform simplifying work, bringing all these unique challenges under a single pane of glass, delivering 300+ protections and simultaneously resolving the security, fraud, resilience and compliance challenges brands and enterprises face.”
Learn more about the award-winning Appdome Platform at www.appdome.com or request a personalized demo at https://www.appdome.com/request-a-demo/appdome-home/
The full list of awards are available from the Cybersecurity Excellence Awards website  https://cybersecurity-excellence-awards.com/
About AppdomeThe Appdome mission is to protect every mobile app and mobile user in the world. Appdome provides the mobile industry’s only Unified Mobile App Defense platform, powered by a patented mobile coding engine, Threat-Events™ Threat-Aware UX/UI Control, and ThreatScope™ Mobile XDR. Using Appdome, mobile brands eliminate complexity, ship faster and save money by delivering 300+ Certified Secure™ mobile app security, anti-malware, anti-fraud, mobile anti-bot, anti-cheat, geo compliance, MiTM attack prevention, code obfuscation, social engineering and other protections in Android and iOS apps with ease, inside the mobile DevOps and CI/CD pipeline. Leading financial, healthcare, government and m-commerce brands use Appdome to protect Android and iOS apps, mobile customers and mobile businesses globally. Appdome holds several patents including U.S. Patents 9,934,017 B2, 10,310,870 B2, 10,606,582 B2, 11,243,748 B2 and 11,294,663 B2. Additional patents pending.
Logo – https://mma.prnewswire.com/media/772169/AppDome_Logo_9_27_23.jpg

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Courageous Whistleblowers Reclaim Derogatory Terms As Data Shows 80% of Financial Professionals Stay Silent on Suspected Internal Fraud, Fearing Retaliation

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Enron whistleblower, Sherron Watkins, alongside stars of Apple TV’s The Big Conn, Sarah Carver and Jennifer Griffith, reclaim derogatory labels for whistleblowers          Concerning new data shows more than half of financial professionals in the UK and US have spotted or suspected internal fraud in their workplaces, yet four out of five stay silent fearing retaliation          32% of professionals in finance have seen whistleblowers victimized behind their back or to their faceJACKSONVILLE, Fla., May 21, 2024 /PRNewswire/ — New data from fraud detection software company Medius shows more than half of financial professionals in the UK and US (56%) have spotted or suspected internal fraud in their workplaces yet four in five (81%) stayed silent. When asked why, 45% of professionals cited the fear of recrimination.

Whistleblowers Sherron Watkins, Sarah Carver and Jennifer Griffith have joined forces to reclaim the derogatory names they were called after reporting serious internal financial fraud.
To help empower others to come forward, the whistleblowers are reclaiming the terms “snitch”, “rat” and “traitor”.
Sherron Watkins is the former Vice President of Enron Corporation who alerted the CEO to accounting irregularities, warning the organization “‘might implode in a wave of accounting scandals.” Watkins received national acclaim for her courageous actions and TIME magazine named her along with two others as their Persons of the Year in 2002, calling them simply ‘The Whistleblowers.’
Sarah Carver and Jennifer Griffith are the stars of Apple TV’s The Big Conn after they exposed a fraud scheme of more than $550 million while employed at the Social Security Administration. In efforts to silence their disclosures, they experienced multiple acts of severe retaliation and were denied protection. Ultimately, both Carver and Griffith were forced from employment.
Concerns of repercussions are vindicated – the survey reveals the extent to which financial professionals in the UK and US have witnessed negative consequences for whistleblowers firsthand:           
59% have seen whistleblowers subsequently left out of important decisions           33% have seen whistleblowers moved to a different team           32% have heard whistleblowers called derogatory names behind their backs or directly to their faceWhen asked what would encourage them to flag suspicious activity, 93% of workers surveyed would feel more comfortable doing so if they had more evidence, yet nearly half (48%) said the legal system simply does not adequately protect whistleblowers.
Jim Lucier, CEO at Medius, a leading global provider of cloud-based accounts payable automation and spend management solutions, said:
“White collar crime is on the rise and no organization is safe. Employees are the last line of defense against fraud but confidence to report suspicious activity is declining. AI anomaly-detection technology can provide employees with the evidence and assurances they need to be more forthcoming. Building a culture where employees feel comfortable to report their suspicions could save organizations millions in the long-run.”
Medius works with over 4,000 customers across 102 countries and processes $200 billion in annual spend. It uses the power of AI and automation to detect fraud the moment invoices are submitted safeguarding against bad actors and potential threats, internal and external.
Sherron Watkins, whistleblower who was called a “snitch”, said: “When someone is troubled by corporate wrongdoing and they attempt to sound the alarm, the pathway is uncharted, things happen organically. Normal rational people speak about their concerns with their closest friends and work colleagues, who often suggest staying safe saying “keep your head down, if you must report, go soft, nothing black and white.” Yet black and white evidence is what is needed to get the attention of those in power, either internally or with media or outside watchdog groups to prevent or stop fraudulent activity.”  
Jennifer Griffith, whistleblower who was called a “traitor”, said: “Choosing to blow the whistle involves more than just the desire to right a wrong.  It’s about protecting their employers from fraud. However, it’s more often than not seen as causing trouble for the employer, or as a self-serving action to get a financial reward. No one who chooses to blow the whistle expects to have their reputation attacked, their credibility impugned or to lose their job. The cost of ignoring a whistleblowers complaints are far greater than acknowledging that a problem exists and taking steps to fix it.  It’s been 19 years since I blew the whistle and the problems that existed then with the Social Security Administration still exist today. We must do more to protect whistleblowers.”
Sarah Carver, whistleblower who was called a “rat”, said: “The government’s attempt to conceal the fraud resulted in exacerbated damage, whereas a more prudent approach would have entailed immediate acknowledgement and rectification upon initial disclosure. The retaliatory measures aimed at silencing me made me stronger and fight harder to find someone to listen and stop the fraud.”
Georgina Hallford-Hall, CEO of Whistleblowers UK, said: “Too many organisations talk the talk but fail to engage with whistleblowers often at great cost to both. Technology used properly can remove the fear that both organisations and whistleblowers have about dealing with whistleblowing because it removes the person and focuses on the concerns or malfeasance. WhistleblowersUK are calling on the UK government to introduce an Independent Office of the Whistleblower to protect everyone from discrimination setting standards that end stigmatisation and discrimination making it safe to speak up.”
The billboard advertising campaign runs on Wall Street from Saturday, 18th May to Friday, 24th May 2024.
For more information about how Medius can prevent fraud, visit: https://www.medius.com/whistleblowing/
Notes to Editor
Methodology
The research was conducted by Censuswide with 1500 financial professionals in the UK and US (aged 18+) between 04/22/24 – 05/07/24. Censuswide abide by and employ members of the Market Research Society which is based on the ESOMAR principles and are members of The British Polling Council.
For more information, please contact: 
Fight or Flight for [email protected] / +44 330 133 0985
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/medius/r/snitch—traitor—rat–courageous-whistleblowers-reclaim-derogatory-terms-as-data-shows-80–of-fina,c3985054

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