McDermott and Bull executive Search
 

Other News

Cardiawave Announces First Routine Treatments Performed with Valvosoft® Following CE Mark Approval and Accelerates Its Deployment

Cardiawave Announces First Routine Treatments Performed with Valvosoft® Following CE Mark Approval and Accelerates Its Deployment After demonstrating its safety and performance in more than 100 patients during clinical development, Valvosoft®, the first non-invasive ultrasound technology designed to treat severe symptomatic aortic stenosis, is now being used in routine clinical practice across several European centers.This innovation makes it possible to repair the valve rather than replace it in patients who cannot immediately undergo a valve replacement procedure. Levallois-Perret, France, June 15, 2026 – Cardiawave, a French medtech pioneer in non-invasive ultrasound therapies for the treatment of aortic stenosis, has reached a major milestone. Following the CE marking1 of Valvosoft® at the end of 2025, the Company today announces the first patients treated in routine clinical practice in Europe with Valvosoft®, marking the beginning of the deployment of this innovation across France, the Netherlands, and Germany. A Breakthrough Innovation: Repairing the Valve Rather Than Replacing It Valvosoft® is the first non-invasive medical device developed for the treatment of severe symptomatic aortic stenosis. The technology is intended for patients for whom immediate valve replacement (TAVR or SAVR) is not recommended, or who decline surgical intervention. “The rollout of Valvosoft® following CE mark approval represents a major milestone for Cardiawave and for patients suffering from severe symptomatic aortic stenosis. We can now offer a non-invasive treatment option to patients for whom immediate valve replacement is either not feasible or not desired. This achievement also marks Cardiawave’s transition into a new phase of growth, driven by the deployment of Valvosoft® across several European countries and our ambition to become a leading player in the non-invasive treatment of aortic stenosis,” said Carine Schorochoff, Chief Executive Officer of Cardiawave. Aortic stenosis is a degenerative disease caused by the progressive calcification of the aortic valve leaflets, leading to valve stiffening and reduced oxygenated blood flow to the body’s organs. The consequences include chest pain, shortness of breath, heart failure, and an increased risk of sudden cardiac death. The condition affects approximately 2% of people over the age of 65 and 12.4% of those over 75234. Without treatment, life expectancy drops to 2.3 years in patients with severe symptomatic aortic stenosis, with a significant risk of sudden death5. Valvosoft® offers a unique approach worldwide: restoring the mobility of the native valve without surgery or implantation. The technology uses high-intensity ultrasound pulses to fragment calcifications on the valve leaflets while preserving surrounding tissues. The result is a sustained improvement in valve opening and hemodynamic performance, without the need for general anesthesia. Twelve-month results from the Valvosoft® First-in-Human (FIM) Study and the Valvosoft® Pivotal Study, presented at EuroPCR 20256 (100 patients treated across 12 European centers), confirmed both the safety of the technology and its effectiveness in improving cardiac function and patients’ quality of life. “Severe symptomatic aortic stenosis remains a life-threatening condition with a poor prognosis if left untreated. Valvosoft® introduces a unique approach: restoring the mobility of the native valve without surgery or implantation. Clinical study results obtained in 100 patients confirm the feasibility, efficacy, and safety of this non-invasive therapy for patients who previously had no therapeutic option available,” said Professor Emmanuel Messas, Interventional Cardiologist at HEGP (AP-HP) and Clinical Investigator of the study. Deployment in Europe and Global Expansion Prospects CE mark approval paves the way for large-scale deployment of Valvosoft®. Since May 2026, several Valvosoft® systems have been placed into clinical use, with a progressive rollout across multiple hospital centers in France and throughout Europe. Distribution agreements are currently under discussion across Europe, the United Kingdom, the Middle East, and India. Cardiawave is initially targeting approximately 300,000 patients in Europe and the United States who are either ineligible for immediate aortic valve replacement (AVR) or unwilling to undergo such procedures. In the longer term, the technology could benefit several million patients suffering from moderate forms of the disease. The global addressable market for aortic stenosis exceeds €10 billion. Building on its European success, the Company is preparing its entry into the U.S. market through the submission of an Investigational Device Exemption (IDE) application. At the same time, Cardiawave is strengthening its manufacturing capabilities in collaboration with French industrial partners to meet growing demand. To support these ambitions, Cardiawave has launched a financing round that will accelerate Valvosoft® production, support ongoing clinical studies in Europe and the United States, and advance the development of additional therapeutic applications. For more information : https://vimeo.com/1172170018/f7bf449742?share=copy&fl=sv&fe=ci Press contact  : Florence PORTEJOIE / FP2COM + 33 (0)6 07 76 82 83 – fportejoie@fp2com.fr  About Cardiawave Founded in 2014 by Mickaël Tanter, Mathieu Pernot, Emmanuel Messas, Mathias Fink, and Benjamin Bertrand, Cardiawave develops innovative non-invasive ultrasound therapies for cardiovascular diseases. Valvosoft® is a CE-marked medical device in the European Union and currently remains an investigational device outside Europe, intended solely for clinical research purposes. The device is based on Cardiawave’s proprietary Non-Invasive Ultrasound Therapy (NIUT) technology, developed in collaboration with leading academic institutions, including the Langevin Institute, Inserm Physics for Medicine, and HEGP. The Company has built a strong intellectual property portfolio comprising 10 patent families. 1 https://cardiawave.com/valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking/ 2 Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI:10.1093/eurheartj/ehy107) 3 Lindman B, et al. Calcific Aortic Stenosis. Nature Reviews Disease Primers 2, Article number: 16006. March 03, 2016. (DOI: 10.1038/nrdp.2016.6) 4 Osnabrugge R., et al. Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. Journal of American College of Cardiology, Volume 62, Issue 11, Pages 1013-1014. September 2013. (DOI: 10.1016/j.jacc.2013.05.015) 5 Malaisrie S, et al. Transcatheter Aortic Valve Implantation Decreases the Rate of Unoperated Aortic Stenosis. European Journal of Cardio-thoracic Surgery, Volume 40, Issue 1, Pages 43-48. July 2011. (DOI:10.1016/j.ejcts.2010.11.301) 6 https://cardiawave.com/wp-content/uploads/2025/05/Cardiawave-Announces-Positive-12-Month-Results-May-22nd-2025.pdf
Attachment

Cardiawave_PR_First_traitments_aortic_Stenosis

Medtronic completes acquisition of Scientia Vascular, seamlessly integrating access and therapeutic portfolios for neurovascular care

Acquisition delivers simplicity and access, supporting physicians across the full procedural workflow GALWAY, Ireland, June 12, 2026 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has completed its acquisition of Scientia Vascular,…

Tempus Announces Multi-Center Validation of AI-Enabled ECG Model for Predicting Atrial Fibrillation Risk Published in Heart Rhythm

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced publication of successful multi-site validation of its software, which received U.S. Food and Drug Administration clearance in 2024 for predicting the one-year risk of atrial fibrillation or flutter (AF). The study, titled “Multi-Center Validation of an Artificial Intelligence-Enabled ECG Model to Predict 1-Year Risk of Atrial Fibrillation or Fl

RadNet Secures $250 Million Incremental Term Loan to Fund Strategic Growth Opportunities and Reduces the Interest Rates on its Credit Facility by 0.25%

LOS ANGELES, June 10, 2026 (GLOBE NEWSWIRE) — RadNet, Inc. (NASDAQ: RDNT) (“RadNet”), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of outpatient imaging centers and a premier developer of radiology digital health solutions, today announced that it has entered into Incremental Amendment No. 3 (the “Third Amendment”) to its Third Amended and Restated First Lien Credit and Guaranty Agreement, as amended (the “Existing Credit Agreement” and, as amended by the Third Amendment, the “Credit Agreement”).

Tectonic Therapeutic Completes Enrollment in TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients

APEX 24-week Phase 2 trial is evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF)APEX Phase 2 trial enrolled 191 patients across 14 countries, with approximately 72% of patients in the enriched population of CpcPH with a pulmonary vascular resistance (PVR) >3 WU at baselineTX45 APEX Phase 2 topline results expected in early Q1 2027 WATERTOWN, Mass., June 10, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced the completion of enrollment for the APEX trial, a 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”). The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”) >3 Wood Units (“WU”) at baseline. “Reaching full enrollment in our APEX Phase 2 clinical trial represents a critical milestone for our TX45 clinical development program and brings us one step closer to potentially delivering a much-needed therapeutic option to patients suffering from PH-HFpEF,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “We are deeply grateful to the clinical investigators, study coordinators, and, most importantly, the patients and their families whose participation makes this vital research possible. The strong momentum we experienced during enrollment underscores the significant unmet medical need in PH-HFpEF, especially in patients with CpcPH. With the trial now fully enrolled, we look forward to the upcoming topline results for APEX, expected in early Q1 2027, which will help further characterize the therapeutic profile of our candidate and guide our strategy moving forward.” The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR >3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. In the APEX clinical trial, the mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR >3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Tectonic expects topline results from the APEX clinical trial in early Q1 2027. The APEX Phase 2 clinical trial is a global, randomized, double-blind, placebo-controlled, proof-of-concept trial designed to evaluate the safety and efficacy of two dose regimens of TX45 administered subcutaneously (“SC”) in patients with PH-HFpEF, enriched for patients with CpcPH. Patients were randomized to receive 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC every other week of TX45, or a placebo. Change from baseline in PVR in the PVR >3 WU population is the primary endpoint of the trial. ¹ Baseline characteristics are preliminary and subjective to change. About Group 2 Pulmonary Hypertension in HFpEFThe World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About TectonicTectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow us on LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and expected results of current clinical trials of Tectonic’s product candidates, including the ongoing APEX Phase 2 clinical trials for its lead product candidate, TX45, in patients with PH-HFpEF. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended March 31, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: Investors:Dan FerryLifeSci Advisors(617) 430-7576 Media:Kathryn MorrisThe Yates Network(914) 204-6412 CONTACT: daniel@lifesciadvisors.com, kathryn@theyatesnetwork.com