KNOXVILLE, Tenn., June 18, 2025 /PRNewswire/ — RADPAIR, a leading innovator in AI-powered radiology automation, and Lifetrack, a next-generation medical imaging platform, have announced a strategic partnership aimed at transforming radiology workflow, reporting efficiency, and global…
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Gradient Denervation Technologies Announces Acceptance into FDA’s Total Product Life Cycle Advisory Program for Development of its Pulmonary Artery Denervation System
PARIS, June 18, 2025 (GLOBE NEWSWIRE) — Gradient Denervation Technologies announced today that it has been accepted into the Total Product Life Cycle Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel technology intended to treat patients with pulmonary hypertension and associated heart failure. The TAP Pilot acceptance follows the Company’s recent announcement that the FDA granted Breakthrough Device Designation for the Gradient Denervation System.
Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) Investor Webinar with Presentation and Audience Q&A
TORONTO, June 18, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi Medical” or the “Company”), is pleased to invite investors and other interested parties to attend the Company’s upcoming live webinar presentation, audience Q&A and interview. CEO Tom Looby will discuss Conavi’s unique and market-leading imaging technology for minimally invasive cardiovascular procedures. The webinar will be a live, interactive online event where attendees can ask the presenters questions in real time. A recording will be available for those who cannot join the live event. Event: Radius Research Pitch, Deep Dive, and Q&A with Conavi Medical Corp. Presentation Date & Time: Tuesday, June 24th @ 4 PM ET / 1 PM PT Webcast Registration Link: https://us02web.zoom.us/webinar/register/9717496764316/WN_FVNRHuMeRAqlOSq-U3wkCA Radius Research gives individual investors access to in-depth CEO interviews with deep-dive institutional-level discussion and Q&A. Radius Research is part of Market Radius Capital, Inc. and hosted by Martin Gagel, a former top-ranked sell-side technology and special situations analyst. About Conavi Medical Corp.: Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first system to combine both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries. The Novasight Hybrid System has 510(k) clearance from the U.S. Food and Drug Administration; and regulatory approval for clinical use from Health Canada, China’s National Medical Products Administration, and Japan’s Ministry of Health, Labor and Welfare. For more information, visit conavi.com. Cautionary Statement Regarding Forward-Looking Information This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws, which reflect the current expectations of management of Conavi’s future growth, results of operations, performance and business prospects and opportunities. Forward-looking statements are frequently, but not always, identified by words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions, although these words may not be present in all forward-looking statements. Forward-looking statements that appear in this release may include, without limitation, references to Conavi’s plans for the commercialization of its Novasight Hybrid™ System. These forward-looking statements reflect management’s current beliefs with respect to future events, and are based on information currently available to management that, while considered reasonable by management as of the date on which the statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in actions, events, conditions, results, performance or achievements to be materially different from those projected in the forward-looking statements. Forward-looking statements involve significant risks, uncertainties and assumptions and many factors could cause Conavi’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Such factors and assumptions include, but are not limited to, Conavi’s ability to retain key personnel; its ability to execute on its business plans and strategies; and other factors listed in the “Risk Factors” sections of the joint information circular of Conavi dated August 30, 2024 and in the final short form prospectus of Conavi dated April 15, 2025 (each of which may be viewed at www.sedarplus.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions and Conavi has attempted to identify important factors that could cause actual actions, events, conditions, results, performance or achievements to differ materially from those described in forward-looking statements, Conavi cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Conavi expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Accordingly, investors should not place undue reliance on forward-looking statements. All the forward-looking statements are expressly qualified by the foregoing cautionary statements. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. Contacts Stefano Picone Chief Financial Officer (416) 483-0100
Conformal Medical Strengthens Intellectual Property Portfolio with Issuance of Additional Patents
The company holds 29 issued patents worldwide, covering key structural innovations in Left Atrial Appendage Occlusion (LAAO) technology, including implant design and conformability features. NASHUA, N.H., June 17, 2025 /PRNewswire/ — Conformal Medical, Inc. announced the issuance of two…
Mineralys Therapeutics Announces Positive Topline Results from Phase 2 Explore-CKD Trial of Lorundrostat for the Treatment of Hypertension in Subjects with CKD and Albuminuria
– Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks – – Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p6.0 mmol/L)0/59 (0%)3/58 (5%) BP, blood pressure; UACR, Urine albumin-to-creatinine ratio; TEAE, Treatment-emergent adverse event* Primary endpoint. ** Cystatin-C formula, a surrogate biomarker of renal function not subject to MATE1 transport and elimination in the glomeruli of the kidney.*** Per protocol Systolic BP, UACR, and eGFR estimates and p values from Mixed Effects Model for a crossover trial with multiple baselines. Serious Adverse Events were reported in two subjects (3%) during the lorundrostat treatment period and none during the placebo treatment period. TEAEs leading to discontinuation occurred in one subject (2%) during the placebo treatment period and in two subjects (3%) during the lorundrostat treatment period. During lorundrostat treatment, one subject discontinued treatment due to elevation of potassium associated with reduced eGFR and one subject discontinued treatment due to reduction in eGFR alone. During the lorundrostat treatment period, an anticipated, modest decrease in mean eGFR was observed (-6.8% lorundrostat, -4.6% mL/min/1.73m2 placebo-adjusted). Reduction in eGFR is also seen with other renin-angiotensin-aldosterone pathway inhibitors, including ACE inhibitors, ARBs and mineralocorticoid receptor antagonists (MRAs). This is the result of a reduction in the deleterious over-perfusion of glomeruli due, in part, to reduced blood pressure. These findings add to a growing body of evidence supporting the efficacy and safety of aldosterone synthase inhibitors (ASIs) in addressing the underlying mechanisms of hypertension, including in individuals with comorbid CKD. The reduction in UACR observed in this trial is consistent with the potential of lorundrostat to have renal protective effects. “Prolonged elevations in blood pressure in patients with compromised renal function can damage the small blood vessels in the kidneys, further reducing their ability to function properly,” said Dr. Matthew Weir, Director of the Division of Nephrology at the University of Maryland Medical Center and Professor of Medicine at the University of Maryland School of Medicine. “The evidence generated from this trial demonstrates the unique mechanism of action and benefit of lorundrostat in lowering systolic blood pressure and UACR. Lorundrostat shows significant potential in the management of hypertension and related kidney disease.” The Explore-CKD trial was designed to provide data that augments the antihypertensive profile of lorundrostat by evaluating the efficacy and safety of lorundrostat in subjects with compromised renal function. The Company had already completed three trials of lorundrostat for the treatment of subjects with uncontrolled hypertension (uHTN), including resistant hypertension (rHTN); the pivotal Phase 3 Launch-HTN and Phase 2 Advance-HTN trials, and the Phase 2, dose-ranging, Target-HTN trial, which demonstrated clinically meaningful reductions in systolic BP and a favorable safety and tolerability profile. The Company continues to study lorundrostat in the ongoing, open-label Transform-HTN extension trial, which is evaluating long-term efficacy, safety, and tolerability. Additionally, the Explore-OSA trial, initiated in the first quarter of 2025, continues to enroll subjects with OSA and uncontrolled hypertension. Conference Call The Company’s management team will host a conference call today, June 17, 2025, at 8:00 a.m. ET. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website (click here). About Explore-CKD The Explore-CKD trial (NCT06150924) was a randomized, double-blind, placebo-controlled, two-period, two-sequence (2×2) crossover trial. This Phase 2 trial was designed to evaluate BP reduction and safety of 25 mg QD lorundrostat when added to background treatment with an ACEi or ARB and an SGLT2 inhibitor for the treatment of hypertension in subjects with CKD subjects with an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 and albuminuria (UACR of 200-5,000 mg/g). The primary efficacy endpoint of the trial was change from baseline in systolic BP at week four in the active versus placebo treatment period. Exploratory endpoints included change from baseline in UACR and eGFR at week four in the active versus placebo treatment period. About CKD CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (approximately 37 million) U.S. adults have CKD, and approximately 22 million people in the United States are living with both hypertension and CKD.1 The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. 2 When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly.3 Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation, and fibrosis, contributing to both uncontrolled BP and kidney injury. 4,5 Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated.6 Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk, and improve long-term outcomes.4 Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.7 About Hypertension Having sustained, elevated BP (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States.8 In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. 9 Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.10 Less than 50% of hypertension patients achieve their BP goal with currently available medications.6 Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.11 About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that ASIs with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN, Launch-HTN and Explore-CKD may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. References 1National Kidney Foundation. High Blood Pressure and Chronic Kidney Disease | National Kidney Foundation. Accessed June 2025.2Ku E, Lee BJ, Wei J, Weir MR. Hypertension in CKD: Core Curriculum 2019. Am J Kidney Dis. 2019;74(1):120-131.3Tonelli M, et al. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006;17(7):2034-2047.4Bomback AS, et al. Potential of aldosterone synthase inhibition in CKD and hypertension. Kidney Int. 2022;102(1):18-27.5Luther JM. Effects of aldosterone on the kidney and cardiovascular system. Nat Rev Nephrol. 2014;10(6):308-320.6Carey RM, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement from the AHA. Hypertension. 2018;72(5):e53-e90.7CDC. Chronic Kidney Disease in the United States, 2021. Accessed June 2025.8CDC. Facts About Hypertension. Centers for Disease Control and Prevention. Updated September 27, 2023. Accessed June 2025. 9CDC. Underlying Cause of Death, 1999–2022 Results. CDC WONDER Online Database. Accessed June 2025.10Centers for Disease Control and Prevention. Health and Economic Benefits of High Blood Pressure Interventions. National Center for Chronic Disease Prevention and Health Promotion. Updated November 20, 2023. Accessed June 2025. 11Brown JM, et al. Primary Aldosteronism and the Pathogenesis of Hypertension. Physiol Rev. 2018;98(1):103-137. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsLindsay RoccoElixir Health Public RelationsEmail: lrocco@elixirhealthpr.com
Lilly to acquire Verve Therapeutics to advance one-time treatments for people with high cardiovascular risk
Verve’s leading programs aim to deliver lifelong cardiovascular risk reduction with a single dose by targeting genes strongly linked to cardiovascular disease Lilly’s established capabilities in cardiometabolic disease and genetic medicines are highly complementary to Verve’s vision and…
Corvia Medical closes $55 million funding round to complete confirmatory trial and pursue FDA approval of Corvia Atrial Shunt
Existing investors provide funding to finish international RESPONDER-HF trial TEWKSBURY, Mass., June 17, 2025 /PRNewswire/ — Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, today announced the successful closure of a $55 million funding round from…
CathVision Advances Real-Time PFAnalyzer Software Into Clinic, Enhancing Electrophysiology Software Portfolio for Pulsed Field Ablation
COPENHAGEN, Denmark, June 16, 2025 /PRNewswire/ — CathVision, a leader in advanced cardiac electrophysiology (EP) technology, has developed a new algorithmic tool (PFAnalyzer) to help physicians assess durable lesion during Pulsed Field Ablation (PFA). The PFAnalyzer™ module allows the…
Inquis Medical’s AVENTUS Thrombectomy System Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism
Pioneering device combines precision clot removal with autologous blood reinfusion to address unmet needs in PE treatmentMENLO PARK, Calif., June 16, 2025 (GLOBE NEWSWIRE) — Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced that its AVENTUS Thrombectomy System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE). The AVENTUS System is a next-generation mechanical thrombectomy platform developed in close collaboration with physicians to address critical limitations of current technologies. “The FDA’s clearance of the AVENTUS System marks a major milestone for the company,” said Vahid Saadat, Co-CEO of Inquis Medical. “It validates the tireless efforts of our team and the deep partnerships we’ve built with our physicians, all focused on solving long-standing challenges in clot removal. AVENTUS is uniquely designed to meet the needs of physicians treating this life-threatening condition quickly, effectively, and safely.” The AVENTUS Thrombectomy System, which incorporates proprietary tissue-sensing technology to help operators distinguish the type of tissue in contact with the catheter tip in real time and guide precise clot removal, was previously cleared by the FDA for use in the peripheral vasculature. Additionally, the AVENTUS Clot Management System received FDA clearance for use with the AVENTUS Thrombectomy System to enable autologous blood transfusion, allowing reinfusion of filtered aspirated blood and supporting efficient, blood-conserving clot removal. This most recent clearance extends the platform’s indication to include the treatment of pulmonary embolism. “Treating PE requires both speed and precision,” said Mojgan Saadat, Co-CEO of Inquis Medical. “The AVENTUS platform is the only thrombectomy solution with integrated tissue-sensing technology that enables precision removal of large clot burdens while streamlining blood return and reducing procedural complexity, all in a single, integrated approach. Receiving this clearance in record time speaks to the strength of our clinical data, the quality of our regulatory submission, and the incredible work of the Inquis team. We’re thrilled to launch this technology and deliver a state-of-the-art solution to physicians on the front lines of saving lives.” This regulatory milestone follows the successful completion of the AVENTUS Pivotal Trial, the first U.S. Investigational Device Exemption (IDE) study to evaluate aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients. The trial demonstrated excellent safety and performance across a broad range of clinical settings, with no device-related major adverse events and rapid improvement in right heart strain. The results were presented as a late-breaking clinical trial at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions and were simultaneously published in the society’s peer-reviewed journal, JSCAI. About Inquis MedicalInquis Medical is a medical device company focused on peripheral vascular innovations. The company is developing next-generation thrombectomy technology that provides physicians with improved control and precision, enhances procedural efficiency, and minimizes blood loss. Founded in 2020, Inquis Medical is led by a seasoned executive team with decades of experience in developing, launching, and supporting novel medical devices that address unmet clinical needs and deliver lasting impact. For more information, visit our website or follow us on LinkedIn. Media Contact: John Weaverinfo@inquismedical.com888-526-7738
InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
MIAMI, June 13, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS.



