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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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View original content:https://www.prnewswire.co.uk/news-releases/endotronix-receives-fda-premarket-approval-of-the-cordella-pa-sensor-system-for-the-treatment-of-heart-failure-302179604.html

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Cat® Simulators New Hydraulic Mining Shovel System Builds Operator Skills for Mine Sites

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Simformotion™ LLC, a leader in heavy equipment simulator training solutions, announces the release of the new Cat® Simulators Hydraulic Mining Shovel System.

PEORIA, Ill., Sept. 23, 2024 /PRNewswire-PRWeb/ — Simformotion™ LLC – a leader in heavy equipment simulator training solutions – announces the release of the new Cat® Simulators Hydraulic Mining Shovel System. Operator trainees can utilize the system inside a classroom or at satellite mine locations.

“The new Hydraulic Mining Shovel simulator system is the cornerstone of our Cat Simulators mining models. The system trains students and operators using authentic Cat controls and teaches applications found on real-world job sites,” says CEO Lara Aaron.

The hands-on training system is set in a mining environment and teaches learners how to operate the Hydraulic Mining Shovel, including inspecting the machine, spotting and properly loading trucks, and more. Correct, efficient operation increases safety, production and cost savings. Simulation is a safe alternative to using actual machines for heavy equipment operator training. Students and operators can train anytime and anywhere using simulators — no need to take a costly machine out of production, worry about the weather or, most importantly, worry about the operator’s safety.

“The new Hydraulic Mining Shovel simulator system is the cornerstone of our Cat Simulators mining models. The system trains students and operators using authentic Cat controls and teaches applications found on real-world job sites. We often hear of the struggles to find skilled operators. Cat Simulators systems help companies build their own workforce,” says CEO Lara Aaron.

The Cat Simulators Hydraulic Mining Shovel system is available in multiple languages and includes SimU Campus™, a built-in reporting software that records and generates reports of learners’ simulation sessions and compares their performance to Caterpillar benchmarks. The system features authentic Cat controls, a motion system, exclusive walkaround machine inspection training, and a companion SimScholars™ curriculum, making the training package a unique offering.

The companion SimScholars online curriculum is a one-to-one match with the simulator model and can be used in the classroom or for remote learning. It is an interactive, turn-key solution complete with instructor guides, videos, quizzes and more. Integrate the Cat Simulators Hydraulic Mining Shovel system and its curriculum together for a unique, blended learning experience.

For even more training value and for a more immersive experience, add VR Edition. With the VR headset and patented VR Now technology, users experience a larger view of the virtual environment with greater depth perception. The simulator is portable and easy to move from a training room to a trailer to satellite locations.

About Simformotion™ LLC

©Copyright 2024 Simformotion™ LLC is a leader in heavy equipment simulator training solutions. Simulation can help address initiatives such as safety and production; while ensuring training can be delivered anytime day or night, regardless of weather conditions. Cat Simulators are chosen as training solutions in such markets as mining, construction, forestry, government, and trade and vocational schools. Simformotion™ LLC is a licensee of Caterpillar Inc. As used herein, “Simformotion” means Simformotion™ LLC, a Delaware limited liability company.

About Caterpillar Inc.

About Caterpillar Inc. With 2023 sales and revenues of $67.1 billion, Caterpillar Inc. is the world’s leading manufacturer of construction and mining equipment, off-highway diesel and natural gas engines, industrial gas turbines and diesel-electric locomotives. For nearly 100 years, we’ve been helping customers build a better, more sustainable world and are committed and contributing to a reduced-carbon future. Our innovative products and services, backed by our global dealer network, provide exceptional value that helps customers succeed. Caterpillar does business on every continent, principally operating through three primary segments – Construction Industries, Resource Industries and Energy & Transportation – and providing financing and related services through our Financial Products segment. Visit us at caterpillar.com or join the conversation on our social media channels at caterpillar.com/en/news/social-media.html.

CAT, CATERPILLAR, LET’S DO THE WORK, their respective logos, “Caterpillar Corporate Yellow,” and the “Power Edge” and “Modern Hex” trade dress, as well as corporate and product identity used herein, are trademarks of Caterpillar and may not be used without permission. www.cat.com / www.caterpillar.com Third party trademarks are the property of their respective owners.

Media Contact
Kim Roberts, Simformotion, 1 3096703200, kroberts@simformotion.com, https://simformotion.com/

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GR0 CEO Kevin Miller Snags C-Suite Insiders CEO of the Year Award for Brand Optimization

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GR0 Co-Founder and CEO Kevin Miller Honored for Excellence in Leadership, Innovation, and Industry Impact

LOS ANGELES, Sept. 23, 2024 /PRNewswire-PRWeb/ — Kevin Miller, Co-Founder and CEO of GR0, was awarded CEO of the Year for brand optimization from the prestigious C-Suite Leadership Awards Program. This recognition underscores Miller’s outstanding leadership, innovation, and transformative impact in the digital marketing industry.

Recognized for celebrating excellence in senior executives, the C-Suite Leadership Awards Program highlights remarkable achievements in business. Emphasizing the importance of exceptional leadership, innovation, and industry impact, the program honors high-performing executives who inspire success while shaping the future of their companies.

As Co-Founder and CEO of GR0, Kevin Miller has propelled his company to the forefront of the digital marketing industry. Leveraging extensive expertise from roles at Google and Open Listings, Miller has spearheaded notable successes for GR0, including accolades such as a Platinum dotCOMM award in 2024 and a Best SEO Company award from Clutch in 2021.

Assisting both D2C and B2B clients, GR0 is known for delivering measurable growth and impactful results as a trusted agency for businesses seeking transformative omnichannel digital marketing solutions.

Miller’s dedication to his team and commitment to fostering an exemplary working environment have not gone unnoticed. He was recognized with a Best CEO Award from Glassdoor and was instrumental in GR0 being named a Best Company for Women by Great Place to Work in 2024. These achievements underscore Miller’s holistic approach to leadership, focusing on business success and employee well-being.

For further details on Miller’s remarkable achievements and to explore GR0’s transformative digital marketing strategies, visit GR0’s website.

About GR0: A leading omnichannel digital marketing agency based in Los Angeles, GR0 delivers exceptional growth and impactful results for a diverse clientele. With a record of innovation and recognition in digital marketing, GR0 sets benchmarks and drives success stories for businesses worldwide.

Media Contact

GR0 Agency, GR0, +1 (310) 439-1887, performancepr@gr0.com, gr0.com 

View original content:https://www.prweb.com/releases/gr0-ceo-kevin-miller-snags-c-suite-insiders-ceo-of-the-year-award-for-brand-optimization-302253897.html

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First Pacific Bank expands its instant payments offerings with Finastra, driving growth

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With Finastra Payments To Go, the bank enhances its payments infrastructure and unlocks new opportunities 

LAKE MARY, Fla., Sept. 23, 2024 /PRNewswire/ — Finastra today announced that First Pacific Bank, a Southern California-based community bank that offers custom financial solutions for individuals and businesses, has selected Finastra Payments To Go to modernize its payments infrastructure. The cloud-based, SaaS payments hub solution will help the bank to deliver FedNow send and receive services 24/7, support ISO 20022 compliance, and enable its projected growth. 

As part of Finastra’s commitment to Open Finance, Payments To Go offers seamless connectivity to other software providers, fintechs, and financial institutions, giving banks the flexibility needed to deploy modern and agile payment solutions quickly and efficiently.

“Our selection of Payments To Go was driven by the need for a robust instant payments platform that supports our growth and innovation plans, particularly as we expand our commercial business,” said Sharokin Badal, SVP, Director of Deposit and Treasury Services at First Pacific Bank. “With Finastra, our customers will benefit from additional payment offerings, enabling better cash flow and financial management. The modernity and scalability of Payments To Go, along with its seamless integration with our existing vendors, make it the ideal solution.”

Deployed on Microsoft Azure cloud, Payments To Go provides the bank with the agility needed to offer new and innovative payments rails, including FedNow Service. As one of the first software providers in the industry to complete certification for the FedNow Service and ISO 20022 compliance, Finastra is well-positioned to provide financial institutions with the ability to deliver instant payment services around the clock, with more than 200 customers across the US able to launch FedNow Service through its solutions.

“Our payments as a service solution provides First Pacific Bank with a modern infrastructure that enables scalability and an enhanced customer experience,” said Radha Suvarna, Chief Product Officer, Payments at Finastra. “We’re pleased that the bank selected us to not just prepare them for regulatory and compliance requirements, but to support the team as they meet the moment to unlock new opportunities in payments innovation.”

“Readiness for both ISO 20022 messaging standards for Fedwire and the FedNow Service are critically important for community-based financial institutions to stay competitive and compliant as the instant payments space continues to evolve,” said Erika Baumann, Director Commercial Banking and Payments at Datos Insights. “By aligning with global standards and embracing new payment rails, community banks are well positioned to improve their offerings.”

To learn more about Payments To Go, visit Finastra at Sibos 2024 on stand G30.

About Finastra
Finastra is a global provider of financial services software applications across Lending, Payments, Treasury and Capital Markets, and Universal (retail and digital) Banking. Committed to unlocking the potential of people, businesses and communities everywhere, its vision is to accelerate the future of Open Finance through technology and collaboration, and its pioneering approach is why it is trusted by ~8,100 financial institutions, including 45 of the world’s top 50 banks. For more information, visit finastra.com.

About First Pacific Bank
First Pacific Bank is a wholly owned subsidiary of First Pacific Bancorp (OTC Pink: FPBC) and is a growing community bank catering to individuals, professionals, and small-to-medium sized businesses throughout Southern California. With a history that spans 17 years, the Bank offers a personalized approach, access to decision makers, a broad range of solutions, and a commitment to delivering an exceptional customer experience. First Pacific Bank operates locations in Los Angeles County, Orange County, San Diego County, and the Inland Empire. For more information, visit firstpacbank.com or call 888.BNK.AT.FPB.

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View original content:https://www.prnewswire.co.uk/news-releases/first-pacific-bank-expands-its-instant-payments-offerings-with-finastra-driving-growth-302254356.html

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