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Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

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Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,2” said Matt Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” “Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels,3” said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. “By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.” Once approved, the new Tina-quant® test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy. About Lp(a)Globally, as many as one in five people have elevated Lp(a),1 where lifestyle interventions such as diet and exercise have no significant impact. While Lp(a) levels can be influenced by non-genetic factors including menopause, kidney and liver disease and hyperthyroidism, they are predominantly ( >90%) determined by genetic variations in the LPA gene.4 Raised Lp(A) is particularly prevalent among women, and people of African descent.5,6 High levels of Lp(a) have been shown to promote the buildup of lipids in artery walls, leading to the development of plaques, and have been associated with an increased risk of cardiovascular (CV) events4. Lp(a) testing is therefore an important tool for clinicians, enabling them to make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the coming years. Professional bodies around the world, including the National Lipid Association, Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology, and the Beijing Heart Society have recommended that Lp(a) measurement should be considered at least once in every adult person’s life. As Lp(a) has no single, defined molecular weight, there is a consensus in the scientific community that, ideally, Lp(a) levels should be measured in terms of the number of molecules per litre of blood (nmol/L). This contrasts with widely available tests that measure the molecular weight of Lp(a) in the blood (mg/L). About Tina-quant® Lp(a) RxDx assay The FDA has granted Breakthrough Device Designation to the Tina quant Lp(a) RxDx assay for use in selecting patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a) lowering drug. A lipoprotein (a) test involves a routine blood draw during which a small sample of blood is used for measurement. This test measures the number of Lp(a) molecules per litre in a person’s bloodstream, which paves the way for Lp(a) to serve as an actionable biomarker in future. If approved, it will be available on selected cobas® platforms. Currently, there is no FDA authorised Lp(a) assay measuring Lp(a) in nmol/L available in the US. This assay will be part of Roche’s wider portfolio of tests for cardiovascular diseases. Together, these tests provide healthcare professionals the opportunity to make informed decisions, allowing patients to access new and innovative treatments. About Breakthrough Device DesignationThe Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.  About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946 ​​ https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019[2] Beaglehole, R., Reddy, S., Leeder, S.R. (2007). Poverty and human development: the global implications of cardiovascular disease. Circulation 116, 1871–1873.[3] Zheng W, Chilazi M, Park J, et al. Assessing the Accuracy of Estimated Lipoprotein(a) Cholesterol and Lipoprotein(a)‐Free Low‐Density Lipoprotein Cholesterol. Journal of the American Heart Association. 2022;11(2). d oi: 10.1161/jaha.121.023136[4] Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946, https://doi.org/10.1093/eurheartj/ehac361[5] Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR, Nordestgaard BG. Sex differences of lipoprotein(a) levels and associated risk of morbidity and mortality by age: The Copenhagen General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi: 10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID: 35803767.[6] Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM, Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022 May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID: 35606075. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25  Simon GoldsboroughPhone: +44 797 32 72 915  Karsten KleinePhone: +41 79 461 86 83  Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262  Yvette PetillonPhone: +41 79 961 92 50 Dr. Rebekka SchnellPhone: +41 79 205 27 03   Roche Investor Relations Investor Relations North America
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Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out

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A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation

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LeMaitre to Present at the Jefferies Global Healthcare Conference

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BURLINGTON, Mass., May 21, 2024 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that George W. LeMaitre, Chairman & CEO, will present at the 2024 Jefferies Global Healthcare Conference on Thursday, June 6, 2024, at 11:00 AM ET at the Marriott Marquis in New York City. About LeMaitre LeMaitre is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. Additional information can be found at www.lemaitre.com.

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BioCardia Announces Reverse Stock Split

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SUNNYVALE, Calif., May 21, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that, following approval by the Company’s stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Time on Thursday, May 30, 2024. The Company’s common stock will begin trading on a split-adjusted basis when the market opens on Thursday, May 30, 2024. The Company’s common stock and warrants will continue to be traded on The Nasdaq Capital Market under the ticker symbols “BCDA” and “BCDAW,” respectively. The reverse stock split is intended to increase the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company, however, cannot assure that the price of its common stock after the reverse stock split will reflect the corresponding split ratio, that the price per share following the effective time will be maintained for any period of time, or that the price will remain above the pre-split trading price. At the effective time of the reverse stock split, every 15 shares of the Company’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Continental Stock Transfer & Trust Co., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares, and any payments in cash in lieu of fractional shares, if applicable. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise hold a fractional share of the Company’s common stock following the reverse stock split will receive a cash payment in lieu thereof at a price equal to that fractional share to which the stockholder would otherwise be entitled multiplied by the closing sale price of the common stock on The Nasdaq Capital Market, as adjusted for the reverse stock split, May 29, 2024. Proportional adjustments will be made to the number of shares of common stock issuable upon exercise or conversion of the Company’s equity awards and warrants, the applicable exercise or conversion price and the number of shares issuable under the Company’s equity plans. Following the reverse stock split, the Company’s common stock will have a new CUSIP number (09060U 606). The CUSIP number for the Company’s public warrants will not change. In connection with the reverse stock split, the Company will effect an adjustment to its authorized shares of common stock, such that the 100,000,000 authorized shares of common stock will be reduced to 50,000,000 authorized shares of common stock. The par value per share of common stock and number of authorized shares of preferred stock will not change. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on April 15, 2024, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at https://www.biocardia.com/investors/finanicals-filings/id/1021.   About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding the timing and effectiveness of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors,” and in its subsequently filed Quarterly Reports on Form 10-Q. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

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Aerovate Therapeutics Presents Baseline Data from the Phase 2b Portion of the IMPAHCT Trial at the American Thoracic Society 2024 International Conference

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Baseline characteristics reflect a PAH population with significant disease Topline data from Phase 2b portion of IMPAHCT study to be released in June 2024 Enrollment into the Phase 3 portion of IMPAHCT continues at more than 120 sites globally WALTHAM, Mass., May 21, 2024 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presented a poster outlining baseline characteristics from all patients enrolled in the dose-ranging Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) at the American Thoracic Society (ATS) 2024 International Conference taking place in San Diego, CA. IMPAHCT is a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multinational trial evaluating the safety and efficacy of AV-101 in adults with pulmonary arterial hypertension (PAH). “These baseline characteristics reflect a patient population with significant disease despite treatment with two to three targeted PAH therapeutics. This underscores the unmet need for novel therapeutics with unique mechanisms of action that address the key drivers of PAH,” said Hunter Gillies, MBChB, Chief Medical Officer of Aerovate Therapeutics. “Coupled with our operationally seamless and adaptive IMPAHCT Phase 2b/Phase 3 trial design, we believe we are well positioned to move AV-101 forward efficiently through Phase 3 development without compromising the scientific rigor required to optimize the dose of a new investigational drug for patients.” The 202 adult patients in the Phase 2b portion of IMPAHCT are roughly split between World Health Organization functional classes II and III, with approximately 57% of patients on triple background therapy consisting of prostacyclins, endothelin receptor antagonists, and nitric oxide pathway targeting compounds. The baseline characteristics are similar to other recent studies in PAH for novel therapeutics and should support the ability to evaluate clear signals of efficacy, safety and tolerability of AV-101, a novel dry powder formulation of imatinib administered by inhalation. “We believe that we are at the beginning stages of a new era of therapeutics in PAH that have the potential to address the root cause of disease,” said Tim Noyes, Chief Executive Officer of Aerovate Therapeutics. “Our previous Phase 1 study in healthy adult volunteers demonstrated that direct delivery of lower doses of imatinib to the lung through dry powder inhalation resulted in lower systemic exposure than achieved with 400mg of oral imatinib with no serious adverse events reported. We are looking forward to providing our Phase 2b data in June and advancing AV-101 development to provide a novel antiproliferative treatment for patients with PAH who need more options.”      Aerovate expects to present topline Phase 2b data in June and continue Phase 3 trial enrollment globally. A copy of the conference poster presentation will be available in the “Events & Presentations” section of Aerovate’s website at ir.aerovatetx.com. About PAHPAH is a rare, progressive orphan disease with unmet medical need that affects approximately 70,000 people in the United States and Europe. PAH can cause strain on the heart, leading to limitation of physical activity, heart failure and reduced life expectancy. About AV-101AV-101 is an investigational, proprietary dry powder inhaled formulation of the antiproliferative drug imatinib. Developed specifically for pulmonary arterial hypertension (PAH), AV-101 is designed to target cellular hyperproliferation and resistance to apoptosis, driven by improper signaling in cells of the distal pulmonary arteries. By targeting the proliferation and accumulation of cells in the arteries of the lungs, we believe AV-101 has the potential to provide meaningful improvements for patients beyond the capabilities of currently approved therapies. AV-101 is designed for delivery by an easy-to-use dry powder inhaler, directly into the lungs to maximize potential clinical benefit and limit systemic adverse effects. Phase 1 results published in ERJ Open Research showed that AV-101 delivered by dry powder inhalation was generally well-tolerated by healthy adult volunteers with no serious adverse events reported. Aerovate has completed enrollment in the Phase 2b portion of the IMPAHCT clinical trial and is currently enrolling patients in the Phase 3 portion to evaluate the safety and efficacy of AV-101 in adults with PAH. About the IMPAHCT TrialIMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a multi-national, placebo-controlled Phase 2b/Phase 3 trial in adults with PAH that continuously enrolled patients from Phase 2b to Phase 3. The Phase 2b portion of the trial will evaluate three doses of AV-101 over 24 weeks, compared to placebo, to identify an optimal dose based on the primary endpoint, change in pulmonary vascular resistance (PVR), and safety, tolerability, and other clinical measures. The Phase 3 portion of the trial will compare patients taking the optimal dose of AV-101, selected from the Phase 2b data, to placebo. The primary endpoint of the Phase 3 portion of the trial will be change in six-minute walk distance (6MWD) over 24 weeks versus placebo. More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT05036135.About Aerovate Therapeutics, Inc.Aerovate is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. Aerovate’s initial focus is on advancing AV-101, its proprietary dry powder inhaled formulation of the drug imatinib for the treatment of patients with PAH. Learn more at aerovatetx.com or follow the Company on X (formerly known as Twitter) and LinkedIn. Available InformationAerovate announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts, the investor relations section of the Company website at ir.aerovatetx.com, and the Company’s X (formerly known as Twitter) account @AerovateTx in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” seek,” “strategy,” “should,” “target,” “will,” “would” and similar expressions regarding future periods. These forward-looking statements include, but are not limited to, statements regarding the baseline patient characteristics from the Phase 2b portion of the IMPAHCT trial and contribution of those characteristics to the evaluation of safety and efficacy measures; the clinical significance of similarities in baseline characteristics of patients in IMPAHCT as compared to prior-conducted trials, including third-party trials; our expectations regarding continuing patient enrollment for the Phase 3 portion of the IMPAHCT trial; therapeutic potential and clinical benefits of AV-101; and our anticipated timing for the release of topline data from the Phase 2b portion of the IMPAHCT trial. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the therapeutic potential, safety and clinical benefits of AV-101; the timing associated with the identification and activation of clinical sites, patient enrollment, initiation, delivery of drug supply and continuation of our Phase 2b/Phase 3 trial of AV-101 in PAH patients; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Media ContactPeg Rusconipeg.rusconi@vergescientific.com Investor ContactIR@Aerovatetx.com

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WearLinq Announces Acquisition of AMI Cardiac Monitoring, LLC, and Expands Clinical Services Nationwide with FDA 510(k) Cleared 6-Lead ECG Device

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SAN FRANCISCO–(BUSINESS WIRE)–WearLinq, a leading provider of wearable health monitoring and diagnosis solutions, today announced the acquisition of AMI Cardiac Monitoring, LLC, an established independent diagnostic testing facility (IDTF) with more than 33 years of expertise in ambulatory cardiac monitoring. This strategic acquisition will fuel WearLinq’s capacity to offer expansive clinical […]

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Cardio Diagnostics to Participate in the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Fee Schedule (CLFS) Annual Meeting to Secure Medicare Payment for Its Innovative Tests

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CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, today announced its participation in the Clinical Laboratory Fee Schedule (CLFS) Annual Meeting on June 25, 2024. At this meeting hosted by the Centers for Medicare & Medicaid Services (CMS), the Company will recommend pricing for its innovative clinical […]

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Studies Reveal Cell-by-Cell Changes Caused When Pig Hearts and Kidneys are Transplanted into Humans

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NEW YORK, May 21, 2024 /PRNewswire/ — Surgical teams at NYU Langone Health performed the world’s first genetically modified pig kidney transplants into a human body in September and November 2021, and then transplanted two pig hearts in the summer of 2022. These procedures were done in patients declared dead based on neurologic criteria (decedents) and maintained on ventilators with the consent of their families. Demonstrating the field’s progress, NYU Langone in April 2024 transplanted a pig kidney into a living patient.
Now two new analyses, one published online on May 17 in Nature Medicine and the other May 21 in Med, reveal changes at the single-cell level in the organs and recipient’s bodies before, during, and just after the xenotransplantation surgeries in the decedents. Teams of scientists had worked alongside the surgeons, taking blood and tissue samples to analyze changes in tens of thousands of collected cells.
Led by researchers at NYU Grossman School of Medicine and the Broad Institute of MIT and Harvard, the Med paper tracked the genetic and cellular activity in the two pig kidneys transplanted into humans, and compared them against pig kidney samples that had not been translated. To do so, the research team used several techniques, including single-cell RNA sequencing, which determined the order (sequence) of the molecular letters making up the pig and human genes active in various cell types during the procedures.
The study showed that the transplanted pig kidneys, while not rejected outright by the recipients’ bodies (no immediate kidney failure), caused a strong reaction in human peripheral blood mononuclear cells (PBMCs). This set of immune cells can attack transplanted (foreign) organs much like they attack foreign invaders, such a viruses. While immediate rejection was not seen, in part due to treatment with medications that suppressed it, the new study found evidence of subtler reactions that could cause xenotransplants to fail over time.
Specifically, the pig kidneys were seen to trigger “antibody-mediated rejection” at the molecular level. As the body develops immune proteins called antibodies specific to a transplanted organ, they recruit natural killer cells, macrophages, and T cells that can injure it. The team also saw an uptick in pig kidneys of tissue repair mechanisms, where certain cells multiply as part of the growth involved in healing. Normal cells that transform into cancer cells also grow aggressively, so the mechanism bears watching. 
“We have detailed the cellular mechanisms that dictate how human immune cells react to a xenotransplant in the short term,” said Jef Boeke, PhD, a co-senior author on both studies, and director of the Institute for System Genetics at NYU Grossman School of Medicine. “These results give us new insights into how we might further engineer pig organs for transplant, or tailor immunosuppression treatments to improve tolerance of a foreign organ.”
By tracking the interplay between the kidneys and human system several times each day, the researchers found that pig kidney immune cells drove reactions right after the transplant, but that human immune cells infiltrated the pig organs by 48 hours to dominate signaling. Measuring the degree to which pig immune cells trigger the first wave of immune attack on xenotransplants will shape efforts to prevent irreversible cellular damage to them, say the study authors.
Transplanted Hearts
The other new paper, published in Nature Medicine, featured a “multiomics” analysis of pig hearts and surrounding human cells in decedents. This included analyses every six hours after transplant of gene activity (transcriptomics), as well of proteins (proteomics), lipids, and metabolites (intermediates in biological pathways) present in cells.
Rapid, massive increases in the number of certain cell types were also seen in decedents receiving pig hearts. In one of the decedents (designated D1) but not the other, activated T cell and natural killer (NK) cell populations within the PBMC group increased from about one percent 30 hours post-transplant to more than 20 percent of the entire PBMC population by 66 hours after the procedure. This dramatic immune reaction to the organ, a complication called perioperative cardiac xenograft dysfunction (PCXD), came with a damaging inrush of immune cells (inflammation), and misplaced healing attempts (tissue remodeling) that thicken tissue and can hinder function.
The worse outcomes experienced by the one decedent may be partly because this heart was smaller than anticipated for the recipient’s size, and required an extra procedure to compensate for it, the researchers said. These factors may have cut off blood flow and the oxygen supply to the heart for longer, which is known to cause ischemia reperfusion injury when the supply is restored. The research team observed that PCXD-related immune reactions to the pig organ got worse in the presence of this recipient’s reperfusion injury.
“This study demonstrated that multiomics can be used to reveal a broad picture of what is happening in the recipient of a xenograft,” said Brendan Keating, PhD, a co-senior author on both studies and faculty in Department of Surgery at NYU Grossman School of Medicine. “The team that did the xenotransplant had several theories about why the first decedent was having more issues, but multiomics helped to define the complications, and may be used to counter them moving forward.”
Robert Montgomery, MD, DPhil, the H. Leon Pachter chair of the Department of Surgery at NYU Langone Health was a co-senior author of the kidney paper. This study was also led by co-senior study author Bo Xia, PhD, a graduate student at the time of the study at NYU Grossman School of Medicine, who is now a principal investigator at the Broad Institute of MIT and Harvard. Co-first-authors were Wanqing Pan and Binghan Zheng of Dr. Xia’s group at the Broad Institute, and Weimin Zhang of the Institute for Systems Genetics (ISG) at NYU Grossman School of Medicine. Also a Broad Institute author was Jiangshan Bai. Other NYU Langone study authors were Brendan Camellato and Yinan Zhu at ISG; Jeffrey Stern, Elaina Weldon, Jacqueline Kim, Karen Khalil, Massimo Mangiola, and Adam Griesemer in the NYU Langone Transplant Institute; Adriana Heguy and Peter Meyn in the Genome Technology Center; Ziyan Lin and Alireza Khodadadi-Jamayran of the Applied Bioinformatics Laboratories, and Philip Sommer in the Department of Anesthesiology, Perioperative Care & Pain Medicine.
Along with Dr. Keating, a corresponding author of the Nature Medicine heart study, co-first authors were Eloi Schmauch and Dr. Xia, Brian Piening of the Providence Cancer Center in Portland, Maedeh Mohebnasab of the Division of the University of Pittsburgh Medical Center, Chenchen Zhu of Stanford University, Dr. Stern, and Weimin Zhang, of the ISG. Also NYU Langone authors were Jacqueline Kim, David Andrijevic, Karen Khalil, Ian Jaffe, Simon Williams, Elaina Weldon, Mercy Williams, Qian Guo, Sophie Widawsky, Vasishta Tatapudi, Massimo Mangiola, Navneet Narula, Nader Moazami, Harvey Pass, Adam Griesemer in the Transplant Institute; Brendan Camellato, Larisa Kagermazova, and Yinan Zhu in the ISG; Feng-Xia Liang, and Joseph Sall in Department of Cell Biology, Adriana Heguy in the Department of Pathology, and Han Chen and Ramin Herati in the Department of Medicine.
Additional authors were from the University of Pennsylvania, Stanford University, University of Oxford, Broad Institute, Imam Abdulrahman bin Faisal University in Saudi Arabia, the Paris Institute for Transplantation and Organ Regeneration, Cleveland Clinic, University of Eastern Finland, 10x Genomics, United Therapeutics (which provided funding), and Revivicor, Inc. All authors are listed in the study manuscript.
The authors would like to thank the families of the decedents for their generous donation to science, and LiveOnNY for providing end-of-life family support. The kidney work was supported in National Institute of Health grants RM1HG009491 and DP5OD033430. The heart work was supported by National Institute of Health grants R01 AI144522 and P30CA016087. Other funding sources of the heart study were the Orion Research Foundation, Yrjö Jahnsson Foundation; the Vilho, Yrjö and Väisälä Fund; Aarne Koskelon Foundation, and the Antti and Tyyne Soininen Foundation.
Dr. Boeke is a founder and consultant of CDI Labs, Inc., Neochromosome, Inc., and ReOpen Diagnostics. He serves or served on the scientific advisory boards of Logomix, Inc., Modern Meadow, Inc., Rome Therapeutics, Inc., Sample6, Inc., Sangamo, Inc., Tessera Therapeutics, Inc. and the Wyss Institute, all unrelated to the present work. Dr. Montgomery is on scientific advisory boards for eGenesis, Sanofi, Regeneron, CareDx and Hansa Biopharma, is a consultant to Recombinetics, and reports consulting fees from Hansa Medical, Regeneron, ThermoFisher Scientific, Genentech, CareDx, One Lambda, ITB Med, Sanofi and PPD Development, all unrelated to the present work. These relationships are being managed in keeping with the policies of NYU Langone Health.
Contact: Gregory Williams, [email protected] 
SOURCE NYU Langone Health System

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BioSig Technologies Chief Executive Officer Mr. Anthony Amato Issues the Following Letter to Shareholders

Financial by Comments are Disabled

Westport, CT, May 21, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or “Company”), a medical technology company delivering unprecedented accuracy and precision to intra-cardiac signal visualization, has today issued the following Letter to Shareholders: Dear Shareholders, As the new CEO of BioSig, I am committed to keeping our shareholders updated to the best of my ability on the progress of our Company. Our new management team is firmly committed to both restoring and creating lasting shareholder value and we believe our recent progress is the beginning of a successful foundation for growth. Over the past two months, BioSig has realized important and material progress with respect to several corporate initiatives. The Company is pleased to introduce its newly assembled Board of Directors, comprised of five highly qualified and talented individuals with decades of experience in their respective fields, including three independent directors, and the Company has fully constituted each committee of the Board of Directors (Audit, Compensation, and Nominating and Corporate Governance). The Company is also in the process of assembling a revamped Business Advisory Board, which will evaluate specific business opportunities as well as possible mergers & acquisitions. It is the Company’s strong belief that by attracting quality people, the best results will be achieved. While the Company’s operations were impacted for a brief period by the changes in both the CEO position and the Board, the Company continues to focus on its core business, the ongoing operations of its PURE EP™ Biomedical Signal Processing Technology. The Company still maintains active partnerships with some of the largest well-known institutions in the electrophysiology space.  The Company is working with great urgency to demonstrate the value proposition of its internal PURE EP platform, to both its stakeholders and shareholders. In addition, the Company believes that it has compelling opportunities with other owned assets including, but not limited to, the Artificial Intelligence (“AI”) space, specifically relating to generative data compilation and potential commercialization through proprietary algorithms specific to the interventional cardiology sector. The Company, during the summer of 2023, issued a number of press releases relating to AI initiatives and potential partnerships. The Company owns multiple assets that management is currently working towards potential monetization. Additionally, the Company presented to the Nasdaq Hearings Panel on Tuesday, May 7, 2024 as was previously disclosed to shareholders.  Representing the Company was a top advisory firm well known for working on Nasdaq compliance matters.  Prior to the hearing, the Company was informed by Nasdaq Listing Qualifications staff that it had regained compliance with the minimum bid price requirement as set forth in Listing Rule 5550(a)(2).  The Company addressed, at the hearing, the remaining compliance issues and will update shareholders once the Company receives further communication from the Nasdaq Panel. I want to reiterate my commitment to restoring shareholder value and will work tirelessly to achieve specific goals I set prior to accepting the CEO position. I want to thank our supportive shareholders for their patience and understanding as we move forward. Sincerely, Anthony AmatoChief Executive Officer About BioSig Technologies, Inc. (NASDAQ: BSGM) BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; and (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see Biosig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Quarterly Report on Form 10-Q, filed with the SEC on May 20, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

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Merit Medical Launches basixSKY™ Inflation Device

Peripheral/Endo by Comments are Disabled

SOUTH JORDAN, Utah, May 21, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced the US commercial release of the basixSKY Inflation Device. BasixSKY is the latest addition to Merit’s comprehensive inflation device portfolio, which includes both digital and analog devices. The basixSKY is available as a standalone solution and in kits with Merit Angioplasty Packs, configured to offer complementing AccessPLUS™, Honor®, and PhD™ hemostasis valves. Designed with ease of use in mind, the new device is simple and highly responsive, creating an efficient approach to inflation. Rotational torque and handle revolutions to reach pressure are minimized, and a comfort-grip feature enables one-handed preparation. Learn more about the basixSKY Inflation Device. Endovascular interventions, such as balloon angioplasty and stent placement procedures used to widen narrowed or blocked coronary and peripheral arteries, utilize an inflation device. These are minimally invasive techniques that can restore blood flow through diseased vessels and minimize damage to surrounding tissue. In 2024, it is estimated that 1.79 million coronary balloon and stent placement procedures will be performed in the United States.1 “We are pleased to broaden our portfolio of inflation devices,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “With high-quality digital and analog solutions and custom kit options, we remain a leader in the inflation device market. We’re proud of that. We look forward to continuing to serve our healthcare partners, helping them to provide the best patient care.” ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 people worldwide.  TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTS PR/Media Inquiries Sarah Comstock Merit Medical +1-801-432-2864 | sarah.comstock@merit.com  INVESTOR INQUIRIES Mike Piccinino, CFA, IRC Westwicke – ICR +1-443-213-0509 | mike.piccinino@westwicke.com 1. Clarivate DRG, Market Insights ǀ Interventional Cardiology Devices ǀ United States ǀ 2023, December 29, 2022 (Clarivate, 2022).

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