Barostim Device & Clinical Trial Results - Barostim improves exercise capacity in HFrEF patients, showing a 19%-20% improvement versus the control arm in clinical trials[19, 37] - The BeAT-HF pivotal trial demonstrated a clinically meaningful improvement of 60 meters in exercise capacity and a -14 point change in quality of life for Barostim patients[27, 28] - The BeAT-HF pivotal trial showed a 25% reduction in NT-proBNP levels with Barostim, which is considered clinically meaningful[34] Market Opportunity & Patient Identification - The initial annual market opportunity for Barostim in the U S and the five largest EU countries is estimated at $2 9 billion[44] - The U S market consists of 6 3 million patients, while the 5 EU countries have 8 6 million patients[42] - The initial addressable patient incidence rate is 55,000 patients per year in the U S and 61,000 patients per year in the 5 EU countries[42] - Patient identification for Barostim is straightforward, based on NYHA II/III symptoms, LVEF ≤ 35%, and NT-proBNP < 1600pg/ml[47] Commercial Strategy & Financial Performance - The company aims to add 3 new account managers every quarter to create new territories and activate implanting centers[58] - The goal is to have 5 active implanting centers per territory, with each center implanting 12 Barostim units per year[58] - Full year 2022 revenue was $7 0 million - $7 1 million, with US HF revenue at $5 9 million (+118%)[67] - The company projects total revenue between $35 0 million and $38 0 million for the full year of 2023[68]

Market Opportunity & Disease Burden - Heart failure affects over 6 million people in the U S [9], leading to over 1 1 million hospital discharges and over 1 3 million emergency room visits annually [11] - The annual costs associated with heart failure are expected to reach $70 billion by 2030 in the U S [11] - The U S annual net addressable market for Barostim is estimated at $2 2 billion, assuming an average selling price (ASP) of $29,000 [37] Barostim Therapy & Clinical Evidence - Barostim is presented as a neuromodulation therapy designed to improve heart failure symptoms [8] - Barostim implantation is a 60-minute procedure with a 97% freedom from major complications [46, 48] - Real-world evidence demonstrates an 85% relative reduction in hospital visits per year post-Barostim implant (average 1 92 years) compared to pre-implant (12 months) [67] Financial Performance & Guidance - Worldwide revenue for 2024 was $51 3 million, representing 31% growth [87, 88] - The gross margin for 2024 was 84% [87, 88] - The company's revenue guidance for full year 2025 is $55 0 – $58 0 million, with a gross margin of 83% – 84% and operating expenses of $95 0 – $98 0 million [90]

1.3 million patients are hospitalized annually in the U.S. from acute heart failure and it is the #1 cause of hospitalization in patients >65 years old If istaroxime is approved in the US for acute heart failure, this patent would provide protection to 2039 WARRINGTON, Pa., July 02, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries is pleased to announce that the United State ...

Core Insights - CVRx is a pioneering medical device company focused on treating advanced heart failure with its FDA-approved therapy [1] - The company is currently unprofitable due to significant investments in US sales and support infrastructure [1] Company Overview - CVRx operates in the medical device industry, specifically targeting advanced heart failure treatment [1] - The company has received FDA approval for its therapy, indicating regulatory validation of its product [1] Financial Performance - Despite its innovative approach, CVRx has not yet achieved profitability [1] - Heavy investments in infrastructure are a key factor contributing to the company's current financial status [1]

CVRx (CVRX) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Standby, your program is about to begin. Good day, everyone, and welcome to today's CVRx Q1 twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Mike Valley fro ...