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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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2 years ago

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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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LEAP Group Relaunches HumanView, a Growth Intelligence System Built to Explain Why Customers Behave the Way They Do

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4 hours ago

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October 24, 2026

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Reimagined from the ground up, HumanView pairs statistical modeling with expert analysts to turn millions of real-world customer signals into business decisions

LOUISVILLE, Ky., Oct. 23, 2026 /PRNewswire/ — LEAP Group today announced the relaunch of HumanView, its growth intelligence service. The new version has been rebuilt from the ground up and now has a dedicated home at leapgroupnetwork.com/humanview.

HumanView analyzes what customers say and do across social platforms, e-commerce sites, review platforms, search behavior and user-generated content, including signals from Reddit, TikTok, YouTube, Meta, Amazon and Walmart+ that general AI tools cannot always access. Because the data reflects unprompted, real-world behavior, it avoids the response bias built into surveys and focus groups.

The service works in three layers. HumanView captures signals at scale, decodes millions of records through validated statistical models such as regression, correlation and clustering, and then relies on experienced analysts to interpret the patterns. Clients receive clear, human-validated insights instead of another dashboard.

“Machines find the patterns. Humans find the point,” said Alan Gilleo, CEO at LEAP Group. “The first version of HumanView showed us how much customers reveal when nobody is asking them questions. This version is built to explain why they act the way they do, and to put those answers in front of everyone making decisions, from product to service to marketing.”

HumanView focuses on three areas:

Growth Intelligence: customer motivations and how people perceive a brand and its competitors

Market and Category Intelligence: product pain points, service friction, unmet needs and competitive gaps

Audience Intelligence: new segments, positioning opportunities and gaps in the market

Every model is designed and validated by data scientists and benchmarked before it informs a recommendation.

To learn more about HumanView, visit leapgroupnetwork.com/humanview.

About LEAP Group
LEAP Group is a boutique marketing agency holding company with offices in Louisville, Indianapolis, Cincinnati and Chicago. Guided by the belief that brands should “Market Less. Matter More.,” LEAP gives clients access to specialized experts across its entire network. Learn more at leapgroupnetwork.com.

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SOURCE LEAP Group

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STEPHEN A. SMITH ADDRESSES WHITE HOUSE DINNER ATTENDANCE, REAFFIRMS COMMITMENT TO HBCUs AND PROTECTING CORPORATE INVESTMENT IN BLACK EDUCATION

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5 hours ago

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October 24, 2026

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NEW YORK, Oct. 23, 2026 /PRNewswire/ — Stephen A. Smith, media mogul, New York Times bestselling author, and proud 1991 graduate of Winston-Salem State University, is addressing the public discussion surrounding his decision to attend a White House dinner with President Donald Trump, emphasizing his commitment to the long-term financial stability of Historically Black Colleges and Universities (HBCUs).

For Smith, the decision was rooted in a commitment to institutions that have educated generations of Black leaders, professionals, entrepreneurs, and public servants.

“I will always advocate for HBCUs and the students whose futures depend on them,” Smith said. “My reason for attending the White House dinner was to discuss the challenges these institutions face in securing long-term funding and to make the case that corporate America must continue to invest in them.”

Smith acknowledged federal support through the FUTURE Act while expressing concern that political tensions surrounding diversity, equity, and inclusion (DEI) could discourage private companies from supporting HBCUs. He maintains that these institutions deserve sustained corporate partnerships, philanthropic contributions, and public investment.

“If we truly believe in free-market capitalism, businesses should be able to support educational institutions and charitable causes without fear of criticism or repercussions,” Smith said. “HBCUs have made extraordinary contributions to this country. They deserve sustained public and private investment.”

Ashley Christopher, Esq., Founder and CEO of the HBCU Week Foundation, recognized Smith’s advocacy and decision to engage with the administration.

“Stephen A. Smith has been a powerful advocate for HBCUs, using his platform and influence to shine a national spotlight on our institutions,” expressed Christopher, “His continued support of HBCU Week helps advance our mission of connecting students with life-changing educational opportunities, and we are proud to have him as our ambassador.”

Since Smith became an HBCU Week Ambassador in 2019, the initiative has facilitated more than 15,000 on-the-spot college acceptances and raised and awarded more than $150 million in scholarships, according to the HBCU Week Foundation.

As public discussion continues, Smith is emphasizing the importance of ensuring HBCUs have the resources and partnerships needed to educate future generations and expand opportunities for students.

CLICK HERE to watch Smith’s full response to his White House visit.

MEDIA CONTACT:

media@mrsasinc.com

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SOURCE Straight Shooter Media

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Advantex Announces Completion of Financing and Extension of Maturity Date of Previously Issued Debentures

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5 hours ago

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October 24, 2026

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TORONTO, Oct. 23, 2026 /CNW/ — Advantex Marketing International Inc. (CSE: ADX) (“Advantex”), a leader in the merchant cash advance and loyalty marketing products for merchants, today announced the completion of a $250,000 secured debt financing. Advantex issued a $250,000 non-convertible debenture which bears an interest rate at 12% per annum and matures December 15, 2027. The proceeds raised from this issuance of the Debenture will be used for working capital purposes.

Advantex has also extended the maturity of its existing $700,000 in 12% secured debentures from October 10, 2026 to December 15, 2027.

About Advantex Marketing International Inc.

Advantex provides working capital to merchants. Advantex also provides specialized marketing programs that enable members of Aeroplan to earn Aeroplan points at participating merchants.

Advantex shares trade on the Canadian Securities Exchange under the symbol ADX. For more information go to Advantex’s profile on www.sedar.com

Forward-Looking Information

This news release contains “forward-looking statements” within the meaning of applicable securities laws relating to the future business and operations of Advantex. Actual results and developments may differ materially from those contemplated by these statements. The business and operations of Advantex described herein is dependent on a number of factors and is subject to a number of risks and uncertainties. Factors that could cause actual results to differ material include, but are not limited to, changes in Advantex’s economic and competitive conditions including but not limited to the industry sectors in which Advantex operates.

The statements in this news release are made of the date of this release. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made and Advantex undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable law.

SOURCE Advantex Marketing International Inc.

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