BRENTWOOD, Tenn. & AUSTIN, Texas–(BUSINESS WIRE)–Heartvue.ai, a cardiac imaging AI company founded by cardiologists, and Innolitics, a medical device software and regulatory consultancy, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance (K260811) for Heartvue.Proton, Heartvue’s machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance (MR) images. Innolitics guided Heartvue from initia
Regulatory
Innova Vascular Completes Enrollment in Trust IDE Study Evaluating the Laguna Thrombectomy System for Pulmonary Embolism
IRVINE, CA, UNITED STATES, August 31, 2026 /EINPresswire.com/ — Innova Vascular, Inc., a medical technology company developing innovative endovascular solutions for the treatment of vascular thromboembolism, today announced the completion of patient enrollment in the TRUST pivotal Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy […]
Perfuze Announces Final MARRS Results: Strong Reperfusion and First-Pass Performance in Pivotal Stroke Trial
GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company advancing stroke treatment through next-generation catheter technology, today announced publication of the final results of the MARRS pivotal study in the Journal of Neurointerventional Surgery. The trial met its primary endpoint, with successful reperfusion mTICI 2b-3 achieved in 89% of patients without rescue therapy – exceeding the prespecified performance goal. The study also demonstrated a 75% first-pass effect mTICI 2c-3
Cadrenal Therapeutics Announces Positive Outcome from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005 in Heparin-Induced Thrombocytopenia
FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity PONTE VEDRA, Fla., Aug. 31, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots. In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue. During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms. “We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency’s recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies.” The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications. The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com
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
Sentante takes physical AI to market, beginning commercial rollout in vascular surgery and interventional radiology
Following its May 2026 CE mark, Sentante is deploying first in the specialties its platform was built to serve, and where the multi-modal data that trains endovascular physical AI accumulates from the first commercial case KAUNAS, Lithuania, Aug. 25, 2026 /PRNewswire/ — Sentante, the…
Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs
CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus’ growing cardiovascular portfolio, expanding the company’s suite of next-generation AI products aimed at ide
Pulnovo Medical Announces First Two U.S. Patients Enrolled in PULSE-LHD IDE Clinical Trial of Pulmonary Artery Denervation in Treating Pulmonary Hypertension Associated with Left Heart Disease
NEW YORK, Aug. 23, 2026 /PRNewswire/ — Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), today announced the enrollment of the first two patients in its PULSE-LHD clinical trial, conducted under a U.S. Food and Drug…
Baird Medical Expands Global Microwave Ablation Footprint with Additional Product Registrations in Pakistan
Registrations cover the BD-GT Microwave Ablation System and T-1610 Disposable Microwave Ablation NeedleNEW YORK, Aug. 20, 2026 (GLOBE NEWSWIRE) — Baird Medical Investment Holdings Ltd. (NASDAQ: BDMD) (“Baird Medical” or the “Company”), announced that the BD-GT Microwave Ablation System and T-1610 Disposable Microwave Ablation Needle have received product registrations from the Drug Regulatory Authority of Pakistan (“DRAP”), further supporting the Company’s commercial activities in the country. The registrations build on Baird Medical’s existing presence in Pakistan, where the Company announced regulatory approvals and initial commercial availability at the Armed Forces Institute of Radiology & Imaging (“AFIRI”) in January 2026. The latest registrations further expand the regulatory foundation supporting the availability and use of Baird Medical’s microwave ablation technology in the market. MWA is increasingly being utilized as a minimally invasive treatment approach for benign and malignant soft tissue tumors, offering physicians the ability to precisely ablate targeted tissue while potentially reducing the burden associated with more invasive surgical procedures. As awareness and adoption of image-guided ablation continue to develop in the United States and internationally, Baird Medical is focused on expanding the regulatory, commercial and clinical infrastructure supporting broader physician and patient access to its technology. “Building a meaningful global presence requires more than entering new markets. Establishing the infrastructure to support sustained clinical adoption of our technologies is critical to our long-term success,” said Haimei Wu, Chairwoman and CEO of Baird Medical. “Our progress in Pakistan reflects the broader global strategy we are executing at Baird Medical: expanding access to our technology, supporting physicians as they incorporate MWA into clinical practice, and building a commercial presence across markets where we see meaningful opportunities for long-term adoption. Furthermore, it provides expanded access to patients who are searching for an effective and minimally invasive solution for the treatment of their tumor. As we continue to build our global presence, our objective is to establish Baird Medical as a leading platform for minimally invasive ablation.” The registrations represent continued progress in Baird Medical’s international expansion strategy as the Company advances regulatory and commercial development of its minimally invasive ablation technologies across key global markets. The Company has established a commercial footprint, while continuing to further establish its presence in the United States. Earlier this year, physicians in Vietnam and Argentina successfully completed their first microwave ablation procedures using Baird Medical’s technology, demonstrating the progression from market entry to clinical utilization. The additional registrations in Pakistan further support this momentum as Baird Medical works to broaden physician and patient access to MWA technology across global markets. About Baird Medical Baird Medical is a global, pioneering medical device company specializing in minimally invasive ablation technologies for a range of solid tumors. The Company’s lead product, a microwave ablation (MWA) system, is FDA-cleared for soft tissue ablation and is being launched in the U.S. primarily for the treatment of benign thyroid nodules. In addition, the Company is expanding its minimally invasive technology portfolio, including IRE-based products and an AI-powered robotic ablation system. Baird Medical’s MWA solutions have been adopted by a growing number of leading U.S. institutions and private practice groups, including the Mayo Clinic, Columbia University Medical Center, and The George Washington University Hospital. The company is rapidly expanding its global commercial footprint, with sales now reaching markets across multiple continents. Forward-Looking Statements This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Baird Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “could”, “should”, “expect”, “intend”, “might”, “will”, “estimate”, “anticipate”, “believe”, “budget”, “forecast”, “intend”, “plan”, “potential”, “predict”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Baird Medical and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Baird Medical does not undertake any duty to update these forward-looking statements. Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors, including, without limitation: (1) the risk that Baird Medical may not be successful in expanding its business in China or the United States; (2) changes in general economic conditions; (3) regulatory conditions and developments; (4) changes in applicable laws or regulations; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings instituted against Baird Medical or others; and (6) other risks and uncertainties from time to time described in the Registration Statement relating to the Business Combination and the transition report, including those listed under the sections titled “Risk Factors” therein, and in ExcelFin’s other filings with the SEC. The foregoing list of factors is not exclusive. Additional information concerning certain of these, and other risk factors is contained in ExcelFin’s most recent filings with the SEC and in the Registration Statement described above filed by Baird Medical in connection with its business combination with ExcelFin. All subsequent written and oral forward-looking statements concerning Baird Medical, the business combination described herein, or other matters attributable to Baird Medical or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Baird Medical expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Contact: Lee RothBurns McClellan for Baird MedicalLroth@burnsmc.com
PercAssist Announces First Patient Enrolled in AVANXA Clinical Feasibility Study using the eVAD™ System for Biventricular Mechanical Circulatory Support
SANTA CLARA, Calif.–(BUSINESS WIRE)–PercAssist, Inc., a medical device company developing innovative technology for extravascular Biventricular Mechanical Circulatory Support to provide hemodynamic improvements for patients in cardiogenic shock (CS), today announced the first patient enrollment for the AVANXA Feasibility Study was successfully conducted in São Paulo, Brazil. “I am thrilled to share the successful clinical use of the PercAssist eVAD System in a patient with SCAI Stage D CS,” s


