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Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure

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Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions.Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.

NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ — Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.

“This approval is very exciting and has the potential to transform care for HF patients. Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” stated Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.

In addition, Cordella enables:

Seated PA pressure measurements, preferred by most patients, with a handheld reader.Patient visibility into key health trends to support healthy lifestyle changes.Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.Reimbursement for implantation and ongoing management through existing reimbursement pathways.

“At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management,” commented Harry Rowland, CEO and co-founder of Endotronix. “With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.”

Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.

About Endotronix
Endotronix innovates at the intersection of medtech and digital health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
In Europe, the Cordella PA Sensor System is Exclusively for Clinical Investigation.
The Cordella HF System is commercially available in the U.S. and Europe.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

 

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NAVEE Launches ST3 Pro and GT3 Pro at CES 2025, Receives UL and TÜV Rheinland Certifications

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LAS VEGAS, Jan. 10, 2025 /PRNewswire/ — NAVEE, a global leader in intelligent short-distance mobility, today announced the North American launch of its flagship electric scooters, ST3 Pro and GT3 Pro, at CES 2025. The event, running from January 7 to January 10, also marks the company’s achievement of two prestigious awards that validate its leadership in smart mobility.

UL verification: Micromobility Performance Range, Energy Consumption and Acceleration

During CES, UL awarded the ST3 Pro-U and GT3 Pro-U with the “Micromobility Performance Range/Energy Consumption/Acceleration” verification. This recognition validates NAVEE’s engineering excellence, with both scooters exceeding rigorous standards for range, energy efficiency, and acceleration. Bryan Bai, NAVEE’s Vice President and Head of North American Sales, and Sherry He, vice president and general manager of Consumer, Medical and Information Technologies at UL Solutions, presided over the award ceremony.

TÜV Rheinland Certification: Range at Max. Speed

Simultaneously, TÜV Rheinland granted the ST3 Pro its “Range at Max. Speed” certification, verifying that the scooter delivers on its promised maximum speed range capabilities. Jay Yang, Vice President of Greater China Electrical at TÜV Rheinland, presented the certification to NAVEE, underscoring the scooter’s exceptional performance standards.

“These launches at CES 2025 represent a significant milestone in our mission to advance smart mobility technology for consumers worldwide,” said Lu Jian, Brand Representative of NAVEE. “The UL verification and TÜV Rheinland certification demonstrate our unwavering commitment to excellence and validate the real-world performance our customers can expect.”

ST3 Pro and GT3 Pro: Redefining Smart Mobility

The ST3 Pro and GT3 Pro represent the next evolution in urban transportation. Engineered for the demands of modern city commuting, these premium electric scooters combine exceptional range and acceleration with sophisticated smart features. The prestigious UL verification and TÜV Rheinland certification affirm NAVEE’s position as an industry pioneer in electric mobility innovation.

About NAVEE

Founded in 2021, NAVEE has quickly emerged as a leader in the global electric mobility market. With a presence in over 30 countries and more than 200,000 users, NAVEE is revolutionizing urban commuting with stylish, reliable electric scooters. The company continues to invest heavily in research and development, ensuring it remains at the forefront of innovation in the electric mobility sector.

For more information, visit: NAVEE Official Website https://www.naveetech.com/

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SOURCE NAVEE

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Fintech nsave launches investment platform, offering people from distressed economies protection from inflation with compliant and safe investments abroad

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nsave offers trusted dollar, sterling or euro accounts abroad to people from high inflation countries.Customers can now access a range of US equities, ETFs and funds.TQ Ventures leads $18mn financing, with participation from Sequoia Capital, Y Combinator, ACE Ventures, and Proton.

LONDON and GENEVA, Jan. 10, 2025 /PRNewswire/ — nsave, the provider of trusted, compliant accounts abroad to people from countries with high inflation, has today announced the launch of an investment product, enabling people at risk of financial exclusion to protect and grow their wealth.

The company also confirmed an $18mn Series A investment led by TQ Ventures with participation from Sequoia Capital, Y Combinator, ACE Ventures, and Proton Foundation, to accelerate their growth.

Today’s means customers can access US equities, ETFs and soon funds managed by some of the world’s largest asset managlaunchers via the nsave app, subject to onboarding and compliance checks.

By working with regulated financial institutions and banking partners in the UK and Switzerland, nsave offers safe and compliant accounts abroad, democratising offshore services to millions of people affected by high inflation or economic uncertainty in their home countries.

nsave’s customers include young professionals who move abroad and face exclusionary and outdated compliance processes due to their country of birth, alongside people from high inflation economies, who fear their life savings will be wiped out.

Based in London and Geneva, nsave is led by former Rhodes Scholars Amer Baroudi and Abdallah AbuHashem.

nsave CEO Amer Baroudi said: “Our vision is to go beyond just protecting everyday people’s wealth by enabling safe and compliant accounts abroad, but to enable them to grow it, too.”

“For some of our customers, this is the first time they can access trusted investment services securely. We believe your passport shouldn’t determine your path to prosperity. Our compliance-by-design approach enables us to offer services safely to many more people.” 

TQ Ventures co-founder and co-managing partner, Schuster Tanger, said: “nsave is tapping into a massive market of individuals underserved by existing financial services who need secure, stable financial solutions.”

“From the outset, I was impressed by nsave’s unique approach and the strength of their team, no doubt a function of Amer and Abdallah’s own lived experience of these challenges. We’re thrilled to roll up our sleeves with nsave to create a more inclusive financial system.”

Contact:
press@nsave.com

 

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Vietnam’s Youth Rally Behind Blockchain: KuCoin Reveals Groundbreaking Insights at VTIS 2024

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HANOI, Vietnam, Jan. 10, 2025 /PRNewswire/ — KuCoin, a leading global cryptocurrency exchange, is excited to share the findings from its second edition of the KuCoin Campus Survey, conducted during the Vietnam Technology & Investment Summit (VTIS) 2024. With 926 participants surveyed from December 3rd to December 4th, 2024, the results underscore the vibrant interest in blockchain technologies among Vietnam’s youth, reinforcing KuCoin’s commitment to nurturing this vital market.

The survey, a key initiative under KuCoin Campus, highlights a strong, positive sentiment towards cryptocurrencies, with 92% of participants optimistic about the future of digital assets. Remarkably, 82% of respondents are considering blockchain-related careers, signaling a burgeoning talent pool eager for development and opportunities within the industry.

Vietnam’s strategic importance to both KuCoin and the broader crypto community is evident as 68% of participants expressed a “very high interest” in blockchain, making it a critical hub for crypto innovations and community engagement. Additionally, 73% of respondents currently hold cryptocurrencies, demonstrating a mature market ready for further expansion and adoption.

The survey also uncovered a significant inclination towards diverse blockchain roles, with data analysis (24%), marketing (22%), and business development (21%) being the most coveted. These insights are invaluable as they highlight the areas of highest potential and interest among the future workforce.

Vietnam has been and will continue to be a key market for us,” said Alicia Kao, the Managing Director of KuCoin. “As the People’s Exchange, we are committed to empowering and equipping this new generation with the tools they need to succeed in the evolving digital landscape.”

View the full report here (EN version, VN Version), or visit KuCoin’s official website for further information.

About KuCoin

Founded in 2017, KuCoin is one of the pioneering and most globally recognized technology platforms supporting digital economies, built on a robust foundation of cutting-edge blockchain infrastructure, liquidity solutions, and an exceptional user experience. With a connected user base exceeding 37 million worldwide, KuCoin offers comprehensive digital asset solutions across wallets, trading, wealth management, payments, research, ventures, and AI-powered bots. KuCoin has garnered accolades such as “Best Crypto Apps & Exchanges” by Forbes and has been recognized among the “Top 50 Global Unicorns” by Hurun in 2024. These recognitions reflect its commitment to user-centric principles and core values, which include integrity, accountability, collaboration, and a relentless pursuit of excellence.

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