Net loss for Fiscal Q3 2026 was $6.3 million (Fiscal Q3 2025 – $3.6 million) reflecting continued investment in research and development activities of $4.4 million (Fiscal Q3 2025 – $3.2 million) Ended Fiscal Q3 2026 with $0.9M in cash and cash equivalents (Fiscal Q4 2025 – $5.8 million) and on August 12, 2026 closed $10 million public offering Received $1.25 Million Ontario Life Sciences Scale-Up Fund Milestone PaymentAchieved U.S. FDA 510(k) Clearance for Next-Generation Hybrid IVUS-OCT Imaging SystemAdded to Clinical Evidence Supporting Hybrid IVUS-OCT Imaging TORONTO, Aug. 27, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today reported financial results and provided an operational update for the fiscal quarter ended June 30, 2026 (“Fiscal Q3 2026”). “Fiscal Q3 was an important quarter for Conavi with FDA 510(k) clearance for our next-generation hybrid IVUS-OCT system,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “FDA clearance was a major milestone for the Company and allows us to move forward with commercialization in the U.S. We believe there is a real clinical need for a system that gives physicians the benefits of both IVUS and OCT in a single platform. The case reports published to date, with additional publications expected, add to the clinical evidence supporting hybrid imaging and demonstrate how access to both modalities can support physician decision-making in complex coronary procedures. With the subsequent completion of our $10 million financing, we are now focused on completing the transfer to production and expect our first U.S. clinical placement in H2 2026.” Fiscal Q3 2026 Financial HighlightsAll amounts are in Canadian dollars unless otherwise noted. Net loss for Fiscal Q3 2026 was $6.3 million, compared to a net loss of $3.6 million in the prior-year period. For the nine months ended June 30, 2026, net loss was $13.8 million compared to $13.7 million in the prior-year period. Licensing and R&D services revenue for Fiscal Q3 2026 was $0.1 million compared to $0.1 million in the prior-year period. For the nine months ended June 30, 2026, total revenue was $0.5 million compared to $8.8 million in the prior-year period. The prior-year period included milestone revenue under the Company’s technology transfer and licensing agreement with East Ocean Medical that did not recur in Fiscal 2026. Total operating expenses for Fiscal Q3 2026 were $6.5 million compared to $4.7 million in Fiscal Q3 2025. The increase primarily reflected higher research and development spending associated with Novasight 3.0 and transfer-to-production activities, as well as higher general and administrative expenses. Research and development expenses were $4.4 million compared to $3.2 million in the prior-year period. Cash and cash equivalents were $0.9 million as of June 30, 2026, compared to $5.8 million as of September 30, 2025. Subsequent to quarter end, the Company completed the $10 million public offering described below. For additional information regarding the Company’s financial performance, including management’s discussion and analysis, readers are encouraged to review Conavi Medical’s filings on SEDAR+ and on the Company’s website at www.conavi.com. Fiscal Q3 2026 Business and Operational HighlightsFDA 510(k) Clearance of Next-Generation Hybrid Imaging SystemOn April 20, 2026, Conavi received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation Novasight Hybrid™ intravascular imaging system. The system combines intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) to enable simultaneous and co-registered imaging of coronary arteries within a single workflow. Following clearance, Conavi has focused on completing transfer to production and preparing for a targeted market release at U.S. hospitals in calendar H2 2026. Commercial readiness activities include manufacturing readiness, reliability studies, early inventory build and finalization of production transfer documentation. $1.25 Million Ontario Life Sciences Scale-Up Fund Milestone PaymentOn June 29, 2026, Conavi received a $1.25 million milestone payment from the Province of Ontario through the Life Sciences Scale-Up Fund (“LSSUF”). The payment was triggered by the Company’s achievement of U.S. FDA 510(k) clearance. Including this payment, Conavi has received $1.75 million under the program to date and remains eligible to receive additional funding under the agreement, which provides for up to $2.5 million based on the achievement of specified milestones. Funding under the program is intended to support commercialization initiatives, manufacturing scale-up and other eligible costs associated with the launch of Conavi’s hybrid imaging system. Peer-Reviewed Publication Adds to Clinical Evidence Supporting Hybrid IVUS-OCT ImagingOn July 8, 2026, subsequent to quarter end, Conavi announced the publication of a case report in the Journal of the Society for Cardiovascular Angiography & Interventions (“JSCAI”) titled “Versatility of Hybrid OCT and IVUS Imaging Enhances Contrast-Sparing Management of Eruptive Calcified Nodules.” The case report featured Conavi’s hybrid IVUS-OCT imaging system in a complex coronary procedure involving a patient with impaired renal function and demonstrated how the complementary information provided by IVUS and OCT supported lesion assessment, treatment planning, stent optimization and management of contrast use. The authors concluded that hybrid IVUS-OCT imaging may play an important role in patients with challenging plaque morphology, particularly in the setting of chronic kidney disease. Management believes the publication adds to the growing body of clinical evidence demonstrating the potential utility of having both IVUS and OCT available through a single hybrid imaging platform. Closed $10 Million Public Offering to Support U.S. CommercializationOn August 12, 2026, subsequent to quarter end, Conavi closed its previously announced public offering for aggregate gross proceeds of $10 million. The Company intends to use the net proceeds to support a targeted market release of its Hybrid IVUS OCT system in the United States, as well as for working capital and general corporate purposes. OutlookWith FDA 510(k) clearance secured and the $10 million financing completed subsequent to quarter end, Conavi is focused on executing its U.S. commercialization strategy. Near-term priorities include completing transfer to production, building initial inventory, initiating a targeted market release at U.S. hospitals and continuing to build clinical evidence supporting adoption of hybrid IVUS-OCT imaging. About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ platform combines intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single system, enabling simultaneous and co-registered imaging of coronary arteries. Conavi has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid intravascular imaging system and is advancing preparations for commercialization in the United States. For more information, visit conavi.com. Notice on forward-looking statementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging, the potential utility of hybrid IVUS-OCT imaging across a range of complex coronary procedures, and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory 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. CONTACT:Chief Financial Officer: Mark Quick, 416-483-0100Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com
Other News
Milestone Pharmaceuticals Announces Data Presented at ESC Congress 2026 on the Impact of Paroxysmal Supraventricular Tachycardia (PSVT) on Patients’ Daily Lives and Quality of Life Between Episodes
Research Shows that Patients with PSVT Experience a Substantial Burden Between Episodes, with Negative Impacts on Anxiety, Daily Activities, Sleep, and WorkMONTREAL and CHARLOTTE, N.C., Aug. 27, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced findings from a longitudinal study describing how paroxysmal supraventricular tachycardia (PSVT) affects patients’ daily lives and quality of life in the periods between episodes. The findings are being presented in a moderated ePoster session titled “The Impact of PSVT on Patients’ Daily Life and QoL in Between Episodes” at the European Society of Cardiology (ESC) Congress 2026 on August 30, 2026, 15:15-16:00 CET, Station 6, Research Gateway, Hall A1. “This study’s findings broaden our understanding of the patient experience with PSVT and show that its impact can extend well beyond the acute episode,” said Sean D. Pokorney, M.D., MBA, Assistant Professor of Medicine, Duke University Medical Center and the Duke Clinical Research Institute, and study presenter. “The changes patients reported in activities such as driving, travel and exercise, together with persistent anxiety between episodes, illustrate a burden that is not captured by looking at episode frequency or duration alone.” PSVT is a common heart rhythm disorder in which the heart suddenly beats very fast affecting an estimated two million people in the United States. The acute symptoms of a PSVT episode are well recognized. However, the impact of living with the condition between episodes has not been well established. This study assessed patient-reported outcomes over nearly a year, capturing how PSVT shaped participants’ activities, emotions, and quality of life outside of a healthcare setting. The results show that many people living with PSVT change their behavior, avoid everyday activities, and carry anxiety with them even when they are not having an episode. Key Findings Approximately two in three patients adjusted their lifestyle between episodes to avoid stress, and nearly 40% reduced their activity or exercise routine because of PSVT.73% of patients reported daytime activity interruption between PSVT episodes.Automobile driving (53%) and travel (43%) were the everyday activities for which avoidance between PSVT episodes was most frequently rated as bothersome or extremely bothersome (score of 6 or 7 on a 7-point scale).Anxiety persisted between PSVT episodes. Patients reported an average anxiety level of 3.1 on a 7-point scale; 26% of patients reported feeling extremely anxious at some point during the study, and 16% reported the maximum anxiety score at least once.Side effects of medications taken chronically (e.g., daily) for PSVT were frequently reported as burdens. Fatigue and weakness were each rated as bothersome or extremely bothersome (6 or 7 on a 7-point scale) by 65% of patients.Sleep (30%) and capacity for work (22%) were the most commonly reported areas of lifestyle dissatisfaction (score of 1 or 2 on a 5-point scale). Conclusions PSVT imposes a substantial quality-of-life burden between episodes, affecting anxiety, daily activities, sleep, and work. Medication side effects and activity avoidance further contribute to this burden, underscoring that the impact of PSVT extends beyond acute symptomatic episodes and highlighting an unmet treatment need.The authors call for future research to evaluate the quality-of-life impact of at-home, self-administered treatments to terminate PSVT episodes. The prospective, longitudinal, web-based survey study enrolled 247 adults in the United States and United Kingdom with a self-reported diagnosis of PSVT and no history of catheter ablation at enrollment. Participants completed a baseline survey in February 2019, weekly tracking surveys through December 2019, and a closing survey. During weeks without a PSVT episode, participants completed quality-of-life assessments, including the World Health Organization Quality of Life–Brief Version (WHOQOL-BREF), and answered questions about lifestyle changes, avoidance behaviors, emotional symptoms, and anxiety. Participants had a mean age of 52 years, 72% were female, and the population carried a substantial comorbidity burden. The study was funded by Milestone Pharmaceuticals. “Better understanding the impact of PSVT on the patients’ daily lives – including between acute events – is important as we consider the management and treatment options which can more fully address the needs of people living with this condition,” said David Bharucha, M.D., PhD, FACC, Chief Medical Officer of Milestone Pharmaceuticals. About Paroxysmal Supraventricular Tachycardia (PSVT) An estimated two million people in the United States are currently diagnosed with PSVT, which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many healthcare providers are dissatisfied with the lack of effective treatment options, with patients often electing to pursue prolonged, burdensome, and costly trips to the emergency department or even undergo invasive cardiac ablation procedures. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/ Contact:Investor RelationsKevin Gardner, kgardner@lifesciadvisors.com Media RelationsRebecca Novak, rnovak@milestonepharma.com
Cardurion Pharmaceuticals Announces Late-Breaking Presentation of Phase 2 Results for Tovinontrine (CRD-750), a PDE9 Inhibitor, in Heart Failure
Results from two Phase 2 clinical trials assessing tovinontrine in both major types of chronic heart failure will be presented at the Heart Failure Society of America annual scientific meetingBURLINGTON, Mass., Aug. 27, 2026 (GLOBE NEWSWIRE) — Cardurion Pharmaceuticals, Inc. (“Cardurion”), a clinical-stage biotechnology company discovering and developing new therapeutic approaches for the treatment of patients with cardiovascular diseases, today announced that the Company will present results from the Phase 2 CYCLE clinical trials evaluating tovinontrine (CRD-750), a novel phosphodiesterase-9 (PDE9) inhibitor, in chronic heart failure. The results will be presented in late-breaking presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona taking place on October 9–12, 2026. Tovinontrine is an orally administered PDE9 inhibitor that represents a new mechanism to enhance the natriuretic peptide signaling (NPS) pathway, a clinically validated pathway for the treatment of patients with heart failure. Cardurion is the first company to bring a PDE9 inhibitor into clinical development for the treatment of chronic heart failure. “We look forward to sharing the exciting results from our CYCLE trials, which represent the first time that robust Phase 2 data have been completed for PDE9 inhibition in heart failure. Despite current standard of care, a large unmet medical need remains, and patients with chronic heart failure continue to experience high rates of morbidity and mortality,” said Howard Surks, MD, Chief Medical and Scientific Officer of Cardurion. “It is a major milestone for our company to successfully complete this large, global clinical program in both major types of heart failure, and the results of the CYCLE studies will guide the next stage of clinical development for tovinontrine as we move closer to our goal of bringing this novel PDE9 inhibitor to patients with chronic heart failure.” The presentations at HFSA in October will describe the results from Cardurion’s global, multi-center, Phase 2 clinical trials (NCT06215911 and NCT06215586) assessing the safety and efficacy of tovinontrine in the two major types of chronic heart failure: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Details for the presentations at HFSA are as follows: CYCLE-1 REF presentation title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine (CRD-750) in Patients With Chronic Heart Failure With Reduced Ejection Fraction: The Cycle-1 REF TrialCYCLE-2 PEF presentation title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess the Safety and Effectiveness of Tovinontrine (CRD-750) in Patients With Chronic Heart Failure With Preserved Ejection Fraction: The Cycle-2 PEF Trial About PDE9 InhibitionPhosphodiesterase (PDE) 9 is an enzyme whose elevated activity in patients with heart failure reduces the beneficial effects of the natriuretic peptide signaling (NPS) pathway. The NPS pathway plays an important and protective role in cardiac function, and its activation has been shown to confer outcomes benefit for patients with heart failure. PDE9 is significantly upregulated in patients with chronic heart failure, causing disruption in the NPS pathway. Cardurion is the first company to demonstrate clinical proof-of-mechanism for PDE9 inhibition in patients with chronic heart failure with its PDE9 program. About Heart FailureHeart failure is a prevalent and growing condition that is responsible for substantial morbidity and mortality. Approximately 6.7 million adults in the United States suffer from heart failure, and approximately 50 percent of these patients die from the condition within five years of diagnosis. One in five patients with heart failure are hospitalized annually, and approximately 25 percent of these patients are re-admitted within a month of discharge. Approximately half of all patients with chronic heart failure have reduced ejection fraction (HFrEF) and half have preserved ejection fraction (HFpEF), categorized as different diseases based on the pumping ability of the heart. Significant unmet medical needs remain in heart failure, despite the reductions in morbidity and mortality from currently approved treatments for heart failure. About Cardurion PharmaceuticalsCardurion Pharmaceuticals is a clinical-stage biotechnology company discovering and developing new therapeutic approaches to address cardiovascular diseases. Cardurion has extensive expertise in cardiovascular biology, signaling pathways and drug discovery and development, and it translates that expertise into potentially groundbreaking therapeutics with the promise to address the unmet needs of patients. Cardurion’s clinical-stage pipeline consists of product candidates targeting phosphodiesterase-9 (PDE9) and calcium/calmodulin-dependent protein kinase II (CaMKII). Cardurion is the first company to advance product candidates against these novel and important targets into clinical testing for the treatment of cardiovascular disease. Cardurion is headquartered in Burlington, Massachusetts, with discovery sciences and research facilities in Shonan, Japan. For more information, please visit Cardurion’s website at https://cardurion.com and follow us on LinkedIn. CONTACT: Contacts
Investors:
Charlie Newman
Chief Business & Operating Officer
charlie.newman@cardurion.com
Media Contact:
Kathryn Morris
The Yates Network LLC
kathryn@theyatesnetwork.com
Catheter Precision Achieves Major Commercial Milestones with Cardinal Health, Johns Hopkins and the placement of the First VIVO System in Germany
Received First LockeT Purchase Order Through Cardinal Health which serves approximately 90% of U.S. Hospitals though its Medical Products business Johns Hopkins Hospital, a world-renowned academic medical center, Places First Order for LockeT, VTAK’s suture retention device Places its first VIVO 3D Imaging System with a hospital in Germany, one of the largest electrophysiology markets in Europe. FORT MILL, S.C., Aug. 27, 2026 (GLOBE NEWSWIRE) — Catheter Precision, Inc.’s (NYSE American: VTAK) medical device business unit specializing in cardiac electrophysiology solutions, today announced significant commercial growth across its LockeT and VIVO product lines, marked by new U.S. distribution channels, premier hospital adoption, and international expansion. Key Commercial Highlights: Cardinal Health Strategic Reach: Catheter Precision received its first purchase order for LockeT via Cardinal Health. As one of the nation’s largest distributors—servicing roughly 90% of U.S. hospitals—Cardinal Health provides LockeT a massive streamlined supply chain network across the U.S. healthcare market.Johns Hopkins Adoption: The Company secured its first purchase order for LockeT from Johns Hopkins in Baltimore MD, validating the clinical value of the device within one of the world’s premier academic medical institutions.German VIVO System Placement: Expanding its European footprint, Catheter Precision signed a new placement contract for its VIVO System in Germany, continuing its strategy to grow international use. “These achievements highlight tangible progress across both our LockeT and VIVO product portfolios,” said David Jenkins, Chief Executive Officer of Catheter Precision. “Securing our first Cardinal Health order grants us immediate access to an extensive domestic distribution network to drive broader market adoption. Concurrently, our milestone order with Johns Hopkins validates our clinical offering, while our new VIVO contract in Germany underscores steady international demand.” Jenkins added, “We are beginning to realize the returns on our commercial infrastructure investments. Our focus remains on driving multi-channel growth through expanded U.S. distribution, direct enterprise hospital relationships, and targeted international expansion. Catheter Precision remains committed to scaling its global footprint across top-tier health systems, physicians, and global distribution partners.” About Catheter Precision, Inc.Catheter Precision, Inc. (NYSE American: VTAK) is an innovative medical device company focused on developing breakthrough solutions for cardiac electrophysiology procedures. Its core product portfolio includes the VIVO™ system, a non-invasive 3D imaging platform designed to assist electrophysiologists in mapping cardiac arrhythmias, and LockeT, a suture retention device designed to assist in vascular closure post-procedure. About LockeTCatheter Precision’s LockeT® is a suture retention device indicated for wound healing by distributing suture tension over a larger area in conjunction with standard-of-care closure techniques. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. LockeT is a sterile Class I product registered with the FDA and has received CE Mark approval. About VIVOCatheter Precision’s VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias prior to an electrophysiology procedure, potentially streamlining procedural workflow. VIVO has received marketing clearance from the U.S. FDA and carries the CE Mark. About Catheter PrecisionCatheter Precision, Inc. (NYSE American: VTAK) is an innovative U.S.-based medical device company focused on developing and commercializing technologies designed to improve the treatment of cardiac arrhythmias. The Company’s primary commercial products include the VIVO System and LockeT. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of applicable federal securities laws. Forward-looking statements include statements regarding the potential commercial adoption of LockeT and VIVO, expansion of distribution channels, future product sales, hospital adoption, international expansion and the potential impact of the Company’s commercial strategy. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Readers are encouraged to review the Company’s filings with the Securities and Exchange Commission, including its Forms 10-K and 10-Q, for additional information regarding these risks. ContactInvestor RelationsIR@catheterprecision.com973-691-2000
NYU Langone Health Names Sunil Rao, MD, Director of the Leon H. Charney Division of Cardiology and Welcomes Susheel Kodali, MD, to Lead Interventional Cardiology
NEW YORK, Aug. 27, 2026 /PRNewswire/ — NYU Langone Health has appointed Sunil Rao, MD, an internationally recognized clinician-investigator whose work has introduced new approaches to treating patients with complex cardiovascular conditions, as director of the Leon H. Charney Division of…
Cardio Diagnostics Report Identifies Growing Rural Cardiovascular Care Gap Amid Ongoing Workforce Shortages and Access Challenges
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics has released a new edition of the company’s rural health report: The State of Rural Hospitals and Cardiovascular Care.
BridgeBio Announces First Participant Dosed in ASCEND-ATTR, a Phase 3b/4 Study Evaluating the Long-Term Effects of Acoramidis on Disease Regression in ATTR-CM
– The ASCEND-ATTR study builds on the Phase 3 ATTRibute-CM CMR substudy results previously shared here, which indicated treatment with acoramidis may improve cardiac structure and function with evidence of amyloid regression in a subset of patients – ATTR-CM has long been treated as a disease where progression can be slowed, but these findings raise the possibility that acoramidis may be capable of reversing progression and actively restoring heart health. TTR stabilization with acoramidis may allow the body’s natural amyloid clearance mechanisms to outpace amyloid formation, thereby enabling cardiac remodeling and functional recovery – ASCEND-ATTR will determine whether long-term acoramidis treatment is associated with sustained improvement in cardiac structural disease damage, function, and amyloid burden – Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the ESC Congress 2026 PALO ALTO, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today that the first participant has been dosed in ASCEND-ATTR, a Phase 3b/4 study designed to further characterize the long-term effects of acoramidis on the improvement of cardiac structure, function, and amyloid burden in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer. “Serial cardiac imaging from the ATTRibute-CM CMR substudy gave us the first real signal that TTR stabilization can do more than slow disease progression, it may allow the heart to recover function and remodel favorably over time,” said Ahmad Masri, M.D., M.S. of Oregon Health and Science University. “ASCEND-ATTR will allow us to study these structural and functional changes prospectively and in far greater depth, across a notably larger patient cohort and with two complementary imaging modalities, to better understand the extent to which favorable remodeling can be achieved with long-term acoramidis treatment.” ASCEND-ATTR is a single-arm, prospective, longitudinal, open-label study that will enroll approximately 150 participants with ATTR-CM. Cardiovascular magnetic resonance (CMR) and cardiac echocardiography will be performed annually over 36 months. The primary efficacy endpoint is responder status at Month 36 by CMR, based on improvement from baseline in LV systolic function. Secondary endpoints include CMR measures of cardiac function, structure, and amyloid burden at Month 36, along with echocardiographic measures, circulating biomarkers, and imaging assessments at Months 12 and 24. This study reflects BridgeBio’s relentless pursuit in advancing care and addressing the unmet needs of the ATTR-CM community. The previously presented CMR substudy of ATTRibute-CM found treatment with acoramidis suggested disease improvement across multiple measurements of cardiac structure and function through month 30, including mean improvement from baseline in Left Ventricular Mass Index (LVMi), Left Ventricular Stroke Volume Index (LVSVi), and Left Ventricular Ejection Fraction (LVEF) with evidence of amyloid regression in a subset of patients. TTR stabilization with acoramidis may allow the rate of innate amyloid clearance mechanisms to exceed the rate of amyloid formation, thereby enabling cardiac remodeling and functional recovery. These findings suggest acoramidis may be capable of altering the trajectory of this otherwise progressive disease and actively restoring heart health. Additional data from the CMR substudy of ATTRibute-CM and its open-label extension compared to a natural history cohort will be shared at the European Society of Cardiology (ESC) Congress 2026. More information on ASCEND-ATTR (NCT07695701) can be found here on clinicaltrials.gov. About Attruby™ (acoramidis)INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATIONAdverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBio Pharma, Inc.BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. BridgeBio Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the data regarding acoramidis, including the potential for acoramidis to improve cardiac structure and function, promote cardiac remodeling and functional recovery, alter or reverse the progression of ATTR-CM, and restore heart health; the potential for TTR stabilization with acoramidis to allow innate amyloid clearance mechanisms to exceed the rate of amyloid formation and thereby enable cardiac remodeling and functional recovery; the design, conduct, enrollment, timing, endpoints and anticipated ability of ASCEND-ATTR to further characterize the long-term effects of acoramidis on cardiac structure, function and amyloid burden, including whether long-term treatment with acoramidis is associated with sustained improvement in cardiac structural disease damage, function and amyloid burden; and BridgeBio’s plans to present additional data from the CMR substudy of ATTRibute-CM and its open-label extension at future medical meetings. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s clinical trials not being indicative of final data; the design, enrollment, conduct, timing and success of ongoing and planned clinical trials, including ASCEND-ATTR; the risk that results from subgroup analyses or other analyses may not be predictive of future clinical outcomes or treatment effects; that observed improvements in cardiac structure, function or amyloid burden may not be replicated in additional analyses or studies or translate into improved long-term clinical outcomes; that mechanistic interpretations of observed data, including the potential relationship between TTR stabilization, innate amyloid clearance, cardiac remodeling and functional recovery, may not be borne out by further analyses or additional data; that ASCEND-ATTR may not demonstrate sustained improvement in cardiac structure, function or amyloid burden or otherwise confirm the findings or therapeutic implications suggested by prior analyses; that plans to present additional data may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact: Kaitlyn Reilly, Director, Communicationscontact@bridgebio.com (650)-789-8220 BridgeBio Investor Contact: Kristen Kelleher, Director, Investor Relations ir@bridgebio.com
Kestra Appoints Curtis Kopf as Senior Vice President of Customer Experience
KIRKLAND, Wash., Aug. 26, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today announced the appointment of Curtis Kopf as Senior Vice President of Customer Experience. In this newly created role, Mr. Kopf will lead the patient experience from approval of a patient order through completion of therapy and device return, aligning the people, processes and technology that support providers and their patients throughout the use of the ASSURE® WCD. “Our mission is to provide innovative, intuitive medical technologies to protect and support at-risk patients. That mission guides both the technology we create and the experience we deliver, helping patients begin therapy with confidence and remain engaged, connected, and protected throughout their care,” said Brian Webster, President and Chief Executive Officer. “Curtis brings the vision and experience to lead that journey end to end, harnessing data and automation to scale patient support, strengthen performance at every stage, and extend the impact of the ASSURE WCD and the broader Cardiac Recovery System platform to more patients.” Mr. Kopf has extensive experience leading customer experience, digital transformation, and large-scale service operations. Most recently, he served as Group Vice President, Global Customer Experience at Insulet Corporation, where he led a global organization of more than 1,000 employees across digital, customer service, and customer success and helped advance the adoption of artificial intelligence across a large-scale service organization. Previously, he served as Chief Experience Officer and Chief Digital Officer at REI, where he led customer experience, digital, analytics, innovation, and service organizations. “Every interaction is an opportunity to build confidence, remove friction, and help patients stay connected throughout their cardiac recovery,” said Mr. Kopf. “Kestra has built a powerful combination of differentiated technology and deeply committed patient support. I look forward to working with the team to anticipate patient needs, simplify each step of the journey, and scale that experience while preserving the human connection that matters most.” The appointment of Mr. Kopf comes as Kestra invests in its commercial capabilities, including multiple artificial intelligence initiatives designed to drive operating leverage across its customer-facing operations. These investments are expected to position Kestra for its next stage of growth by advancing the technology that protects patients and the experience that supports them. About Kestra Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Investor contact
Neil Bhalodkar
neil.bhalodkar@kestramedical.com
Nanox to Report Second Quarter 2026 Financial Results on September 9, 2026
PETACH TIKVA, Israel, Aug. 25, 2026 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will report its financial results for the quarter ended June 30, 2026, before market open on Monday, September, 9, 2026. Erez Meltzer, Chief Executive Officer and Acting Chairman, and Guy Nathanzon, Chief Financial Officer, will host a conference call to review these results and provide a business update beginning at 8:30 a.m. ET. Interested parties may register for the conference call using the following link: Nanox Q2 2026 Conference Call The live webcast of the conference call may be accessed by using the following link: Nanox Q2 2026 Webcast The webcast link will also be posted in the Investor Relations section of the Nanox website at Events and Presentations. About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT, which combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit www.nanox.vision Contacts Investor ContactMike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com Media ContactICR HealthcareNanoxPR@icrinc.com
Incuvate Files Patent Infringement Lawsuit Against Penumbra
Complaint alleges Penumbra’s THUNDERBOLT™ system infringes five Incuvate patents covering blood-clot detection technologyIRVINE, Calif., Aug. 25, 2026 (GLOBE NEWSWIRE) — Incuvate, LLC today announced that it has filed a patent-infringement lawsuit against Penumbra, Inc. in the U.S. District Court for the Northern District of California. The lawsuit, filed August 19, 2026, alleges that Penumbra’s recently launched THUNDERBOLT™ Neurovascular Thrombectomy System and related components infringe five Incuvate patents directed to real-time aspiration monitoring technology used in catheter-based thrombectomy procedures. Incuvate’s patents cover technology that uses pressure sensors, microprocessors, and pre-set pressure thresholds or differentials to provide real-time visual and audible feedback during aspiration procedures. Incuvate alleges that this technology helps distinguish between clot engagement and blood flow and provides clinicians with valuable information during thrombectomy procedures. The complaint identifies Penumbra’s THUNDERBOLT system, Penumbra ENGINE vacuum source, THUNDERBOLT tubing and module, and associated RED Reperfusion Catheters as accused products. Incuvate alleges that these products use patented technology to detect flow conditions, including the presence of clot, and provide users with feedback regarding flow status. Through this lawsuit, Incuvate seeks to hold Penumbra accountable for what Incuvate alleges is Penumbra’s unauthorized and willful infringement of the technologies embodied in the asserted patents. Incuvate is seeking damages, injunctive relief, and other remedies described in the complaint. A copy of the complaint is available through PACER Monitor in Incuvate, LLC v. Penumbra, Inc., Case No. 4:26-cv-08658. About IncuvateIncuvate works with medical device entrepreneurs to develop early-stage concepts into innovative products and leads them to market via new companies it finances, builds, and manages. Learn more at incuvatellc.com Media ContactLance CapelDirector of Strategy & External Relationslancemcapel@gmail.com


