Author: Ken Dropiewski

CVRx to Report Second Quarter 2024 Financial and Operating Results and Host Conference Call on July 29th, 2024

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MINNEAPOLIS, July 15, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, today announced that it plans to release second quarter 2024 financial and operating results after market close on Monday, July 29th, 2024. The Company will host a conference call to review its results at 4:30pm Eastern Time the same day. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on the developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact:Laura O’NeillFinn Partners212-867-1762laura.oneill@finnpartners.com

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Sheba Startup Innovalve Bio Medical Ltd Acquired by Edwards Lifesciences Corporation

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RAMAT GAN, Israel – July 15, 2024 – ARC Innovation at Sheba Medical Center, Israel’s largest medical center announced today another successful startup exit from within its innovation ecosystem with the acquisition of Innovalve Bio Medical Ltd by Edwards Lifesciences Corporation (NYSE: EW), a global leader in patient-focused medical innovations […]

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Life Seal Vascular Inc. Awarded Prestigious NSF SBIR Grant to Advance Innovative Endovascular Aortic Aneurysm Sac Management Technology

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More than $274,000 in NSF funding to develop breakthrough aneurysm sac management technologyCOSTA MESA, Calif., July 15, 2024 /PRNewswire/ — Life Seal Vascular Inc. (www.lifesealvascular.com), a pioneering company dedicated to revolutionizing endovascular treatment, is thrilled to announce that it has been awarded the highly competitive National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant. This funding will accelerate the development of Life Seal Vascular’s cutting-edge technology to improve patient outcomes and advance the field of endovascular aortic repair (EVAR).

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Life Seal Concept

“We are honored to receive this prestigious SBIR grant from the NSF. This funding is a testament to the innovative potential of our technology and our commitment to advancing EVAR care,” said Bob Mitchell, Executive Chairman of the Board at Life Seal Vascular Inc. “With this support, we are well-positioned to advance the development of our breakthrough aneurysm sealing solutions and make a significant impact on the lives of EVAR patients worldwide.”

The NSF SBIR grant will enable Life Seal Vascular to further develop its proprietary aneurysmal sac sealing technology. Designed as an adjunctive therapy to native endografts, Life Seal Vascular’s groundbreaking approach seals the entire aneurysmal sac potentially eliminating endoleaks, reducing reintervention rates and improving clinical outcomes for EVAR patients.
Dr. Michel Reijnen, a renowned vascular surgeon, commented on the significance of Life Seal Vascular’s technology, stating, “The advancements being made by Life Seal Vascular are truly remarkable. Their innovative solutions have the potential to revolutionize EVAR, offering patients safer and more effective treatment options. I am excited to see the positive impact this technology will have on the field and on patient care.”The NSF SBIR program is a highly competitive initiative that supports scientific excellence and technological innovation through the investment of federal research funds. Life Seal Vascular’s selection for this grant underscores the company’s dedication to advancing medical technology and its potential to deliver transformative healthcare solutions.This grant is supported by the U.S. National Science Foundation under award number 2407378.About Life Seal Vascular, Inc.Life Seal Vascular Inc. specializes in innovative sealing technologies for endovascular repair of aortic aneurysms. Their proprietary solutions has the potential to eliminate endoleaks, the main cause of reinterventions in Endovascular Aneurysm Repair (EVAR). By completely sealing the aneurysm, Life Seal Vascular’s devices ensure predictable deployment and do not interfere with imaging, thereby enhancing the effectiveness and safety of endovascular repair procedures.For more information about Life Seal Vascular Inc. and its groundbreaking technology, please visit [www.lifesealvascular.com](http://www.lifesealvascular.com).About U.S. National Science Foundation Small Business ProgramAmerica’s Seed Fund powered by the U.S. National Science Foundation Small Business programs focuses on transforming scientific and engineering discoveries into products and services with commercial and societal impact. The deep technologies that are funded show promise, but their success hasn’t yet been validated. And, each year, the NSF awards $200+ million in research and development (R&D) funding to about 400 startups across the United States. America’s Seed Fund is a program within the National Science Foundation and housed within the Directorate for Technology, Innovation and Partnerships.Media Contact:Bob MitchellExecutive Chairman of the BoardLife Seal Vascular Inc.Hannah Friend602-618-3377[email protected]SOURCE Life Seal Vascular, Inc.

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Milestone Pharmaceuticals Refreshes Board of Directors

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– Two New Independent Directors, Stuart Duty and Andrew Saik, Appointed – Third New Independent Director to Be Appointed to Board in Near Term MONTREAL and CHARLOTTE, N.C., July 15, 2024 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (“Milestone” or the “Company”), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced steps to refresh its Board of Directors (“Board”). Stuart Duty and Andrew Saik have been appointed to its Board, effective immediately, and will stand for election at the Company’s 2024 Annual Meeting of Shareholders (the “Annual Meeting”). The Company will appoint a third independent director to its Board in the near term. In conjunction with the announcement, the Company entered into a Cooperation Agreement (the “Agreement”) with Alta Fundamental Advisers LLC (“Alta”), one of the Company’s shareholders. Mr. Duty has over 30 years of experience in investment banking and operations primarily in the biotechnology and specialty pharmaceuticals sectors. Most recently, he served as a Senior Managing Director at Guggenheim Securities, LLC from 2012 to 2023 where he advised senior executives and boards on a range of financing activities and strategic transactions. Mr. Saik has over 25 years of accounting and finance experience, including as Chief Financial Officer of biopharmaceutical companies Arvinas, Inc., Intercept Pharmaceuticals, Vyne Therapeutics Inc., PDS Biotechnology, Inc. and Vertice Pharma, LLC, where he has led numerous capital structure transformations. “We welcome Stuart and Andrew to our Board and look forward to benefitting from their varied perspectives and experiences,” said Robert J. Wills, PhD, Chairman of the Milestone Board of Directors. “We believe Stuart and Andrew will provide important insights to the Board and are great additions as we approach this particularly exciting time for Milestone.” The Company also announced that Debra K. Liebert and Richard C. Pasternak, MD, will not stand for reelection at the Annual Meeting. Dr. Wills added, “We want to thank Debra and Richard for their years of service and significant contributions as members of the Board. Their invaluable insights in the boardroom brought us closer to realizing our mission of providing a new treatment option for patients with paroxysmal supraventricular tachycardia and atrial fibrillation. We wish them all the best for the future.” Pursuant to the Agreement, Alta has agreed to customary standstill, voting and other related provisions. The Agreement will be included as an exhibit to the Company’s current report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission (the “SEC”). About Stuart Duty Stuart Duty brings over 30 years of experience in investment banking and operations primarily in the biotechnology and specialty pharmaceuticals sectors. Mr. Duty most recently served as a Senior Managing Director at Guggenheim Securities, LLC from 2012 to 2023, where he advised senior executives and boards on a range of financing activities and strategic transactions, including significant in-country and cross-border transactions in the U.S., Japan, China, Canada and many European countries. Prior to joining Guggenheim, he was a Managing Director, Co-Head, Healthcare Investment Banking at Piper Jaffray from 2007 to 2012, returning to the firm after serving in the same role from 1999 to 2002. Mr. Duty served as Chief Operating Officer of Oracle Partners from 2002 to 2007. Earlier in his career, he served as a Managing Director, Healthcare Investment Banking at Montgomery Securities, as Director, Business Development at Curative Technologies and as a healthcare investment banking analyst at Kidder Peabody. Mr. Duty has served on the board of directors of Achieve Life Sciences, Inc. (Nasdaq: ACHV) since March 2023, where he serves as the chair of the audit committee and sits on the nominating and corporate governance committee, and on the board of directors of EyePoint Pharmaceuticals (Nasdaq: EYPT) since November 2023, where he sits on the audit committee. Mr. Duty holds a BA in Biochemistry from Occidental College and an MBA from Harvard Business School. About Andrew Saik Andrew Saik brings over 25 years of accounting and finance experience at biopharmaceutical companies. Mr. Saik is currently Chief Financial Officer at Arvinas, Inc. (Nasdaq: ARVN). Prior to joining Arvinas, Mr. Saik served as Chief Financial Officer at Intercept Pharmaceuticals from 2021 to 2023, where he led a restructuring of the company’s balance sheet that included the sale of its international business and recapitalization of the company’s debt. Mr. Saik served as Chief Financial Officer of Vyne Therapeutics Inc. from 2020 to 2021. He was Chief Financial Officer and served on the board of directors of PDS Biotechnology, Inc. (formerly Edge Therapeutics) from 2017 to 2020. Before joining PDS, he was Chief Financial Officer at Vertice Pharma, LLC, a Warburg Pincus-backed company, from 2015 to 2017. Mr. Saik was Chief Financial Officer of Auxilium Pharmaceuticals, Inc. from 2014 to 2015, where he helped lead the execution of Auxilium’s growth strategy culminating in the sale of the company. Before joining Auxilium, he was Senior Vice President, Finance and Treasurer at Endo Pharmaceuticals from 2013 to 2014. Earlier in his career, Mr. Saik served in senior financial management roles with increasing responsibility at Valeant Pharmaceuticals International from 2001 to 2012, including as Senior Vice President, Finance. He was a Finance Manager at Nexgenix from 1999 to 2001 and began his career at Atlantic Richfield as Finance Consultant from 1996 to 1999. Mr. Saik holds a BA from the University of California, Los Angeles and an MBA from the University of Southern California. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws (“forward-looking statements”). Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of upcoming clinical trial milestones and related data; the company’s cash runway; and the company’s plans to maintain a dialogue with its shareholders. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with SEC and the Canadian securities regulatory authorities, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the SEC and the Canadian securities regulatory authorities, which is available under Milestone’s profile on EDGAR at www.sec.gov and on SEDAR at www.sedarplus.ca. Except as may be expressly required by applicable law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available or based on future events or otherwise. Participants in the Solicitation This press release is neither a solicitation of a proxy or consent nor a substitute for any proxy statement or other filings that may be made with the SEC and Canadian securities regulatory authorities. Milestone, its directors, certain of its executive officers, and other members of management and employees may be deemed under U.S. securities laws and Canadian securities laws to be participants in the solicitation of proxies with respect to a solicitation by Milestone. Information about Milestone’s executive officers and directors and other participants in the solicitation, including their respective interests, by security holdings or otherwise, is available in the Company’s proxy statement on Schedule 14A for its 2023 annual meeting of shareholders, filed with the SEC on April 28, 2023 (available here). To the extent holdings of Milestone securities reported in the proxy statement have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC and if applicable, on the System for Electronic Disclosure by Insiders (“SEDI”) in accordance with insider reporting requirements of Canadian securities laws. Updated information regarding the identity of potential participants and their direct or indirect interests, by security holdings or otherwise, in Milestone will be set forth in the Company’s definitive proxy statement for the Annual Meeting and other documents to be filed with the SEC and Canadian securities regulatory authorities, when they become available. These documents are or will be available free of charge at the SEC’s website at www.sec.gov and either through the Company’s profile on SEDAR at www.sedarplus.ca or updated filings on SEDI at www.sedi.ca. Contact:Kim Fox, Vice President, Communications kfox@milestonepharma.com 704-803-9295  Investor RelationsChris Calabrese, ccalabrese@lifesciadvisors.comKevin Gardner, kgardner@lifesciadvisors.com

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New Published Data Highlights Potential Cost-Savings of INPEFA® (sotagliflozin) for Heart Failure

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New analysis of the pivotal Phase 3 SOLOIST-WHF trial provides additional evidence of positive economic impact on hospitals participating in various alternative payment models (APM) Findings consistent with two peer-reviewed studies published in June 2024 THE WOODLANDS, Texas, July 15, 2024 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the Journal of Managed Care + Specialty Pharmacy (JMCP), the peer-reviewed journal of the Academy of Managed Care Pharmacy, has published a research paper concluding that the use of INPEFA® (sotagliflozin) for the treatment of patients hospitalized for heart failure (HF) and suffering from comorbid diabetes leads to significant positive impact on provider health system financial outcomes, largely due to bonus payments through alternative payment models (APM). Researchers quantified the one-year financial impact on US provider health systems of adopting sotagliflozin relative to standard of care (SoC) across three common APMs, also known as value-based purchasing agreements: the Bundled Payments for Care Improvement-Advanced program (BPCI), Medicare Shared Savings Program for Accountable Care Organizations program (ACO), and the Hospital Readmissions Reduction Program (HRRP). HRRP is a Medicare value-based purchasing program designed to encourage hospitals to reduce the 30-day risk of unplanned readmissions for six procedures or conditions, including HF. “Our analysis demonstrated that sotagliflozin use reduced the frequency of patient hospital readmissions and emergency department visits, leading providers to receive larger value-based bonus payments under these alternative payment models,” said Jason Shafrin, Ph.D., Center for Healthcare Economics and Policy at FTI Consulting, and the lead author of the research paper. The study population matched that of the SOLOIST-WHF trial: adult patients aged 18 to 85 years who had been hospitalized for a HF event and were also diagnosed with diabetes. Researchers modeled the total costs of rehospitalization, emergency department visits, drug costs, and adverse events between sotagliflozin and SoC from the perspective of a median sized U.S. community hospital and concluded that substantial positive financial impacts were realized with sotagliflozin when participating in any of the three studied APMs. On a per admission basis, sotagliflozin adoption resulted in a $4,720 margin increase for HRRP, $1,200 margin increase for BPCI, and $1,078 margin increase for ACO. Sotagliflozin adoption also produced significant cost savings when measured on a total health system basis. The model estimated that a median sized U.S. community hospital would realize a $305,604 annual margin increase for HRRP, $100,106 margin increase for BPCI, and $31,029 margin increase for ACO by adopting sotagliflozin. “There is a growing body of evidence that the use of INPEFA for patients hospitalized with heart failure who suffer from diabetes leads to significant value for payors and clinical institutions,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “This analysis provides additional evidence that as more health systems adopt APMs, often more than one at a time, there is potential to realize important clinical and financial advantages with the use of INPEFA.” The Journal of Managed Care + Specialty Pharmacy manuscript can be accessed here. These findings are consistent with two peer-reviewed studies published in June 2024, “Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF” in the Journal of the American College of Cardiology: Heart Failure can be accessed here and “Cost–effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure” in the Journal of Comparative Effectiveness Research can be accessed here. About Lexicon Pharmaceuticals   Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.  About INPEFA® (sotagliflozin)  Discovered using Lexicon’s unique approach to gene science, INPEFA® (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.  INDICATION  INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:  heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors   IMPORTANT SAFETY INFORMATION  Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA.  INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.  Contraindications: INPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components.  Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM).  Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors.  The risk of ketoacidosis may be greater with higher doses.  There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors.  Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis.  Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.  INPEFA is not indicated for glycemic control.  Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level.  If suspected, discontinue INPEFA, evaluate, and treat promptly.  Monitor patients for resolution of ketoacidosis before restarting INPEFA.  Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine.  There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors.  Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.  Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.  Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections.  Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.  Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia.  INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue.  Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.  Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors.  Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement.  Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.  Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections.  Monitor and treat as appropriate.  Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors.  Use alternative testing methods to monitor glucose levels.   Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.  Drug Interactions:  Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.  Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations.  Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.  Use in Specific Populations:  Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding. Geriatric Use: No INPEFA dosage change is recommended based on age.  No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.  Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension. Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR

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Acarix Shares Begin Trading on the US-based OTCQB Market

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NEW YORK, July 15, 2024 /PRNewswire/ — Acarix, a leader in rapid AI and acoustics-based cardiac diagnostics, is pleased to announce that the Acarix shares (OTCQB: ACIXF) begin trading today on the OTCQB Market in the US. Acarix´s shares will in parallel to its current Nasdaq First North Growth market listing in Stockholm, be traded with a US ticker symbol and a share price in USD.

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Acarix Shares Begin Trading on the US-based OTCQB Market

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Acarix Shares Begin Trading on the US Based OTCQB Market

OTC Markets Group operates financial markets for 12,000 US and global securities. OTCQB is a trading platform in the US operated by the OTC Markets Group, as an alternative to listing on Nasdaq New York and NYSE. Cross-trading on OTCQB helps satisfy an increasing interest from US investors and increase accessibility to the US capital market. Companies on OTCQB meet high financial standards, follow best practice corporate governance, demonstrate compliance with US securities laws, and have a professional third-party sponsor introduction.

“We’re excited to begin trading on the OTCQB Market in the US and expand the reach beyond our Nasdaq Stockholm listing. Acarix has a strong base of international shareholders and with the US being our most important commercial market, we now welcome the ability for more investors to join our journey,” comments Aamir Mahmood, CEO of Acarix.
“We are pleased to welcome Acarix to the OTCQB Best Market,” said Joe Coveney, Vice President of OTC Market Group’s Corporate Services. “Acarix will trade alongside other leading life science and medical device companies that utilize a ‘list local, trade global’ strategy to leverage their home market filings and disclosures to publicly trade in the US and expand their global investor base.”About AcarixAcarix is a Swedish medical device company that innovates solutions for rapid rule out of coronary artery disease (CAD) at point of care. The CE-approved and FDA DeNovo-cleared Acarix CADScor System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive, and costly diagnostic procedures. The CADScor System has been used on more than 29,000 patients. Acarix recommends CADScor System as a first-line diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow to rule out significant coronary artery disease (CAD), with at least 96% certainty at point of care. Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ticker: ACARIX). Carnegie Investment Bank is the Certified Advisor of Acarix. For more information, please visit www.acarix.comMedia Contact:Jennifer Anderson720-471-4625[email protected]SOURCE Acarix

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Lexeo Therapeutics Announces Positive Interim Phase 1/2 Clinical Data of LX2006 for the Treatment of Friedreich Ataxia Cardiomyopathy

Coronary/Structural Heart by Comments are Disabled

Achieved mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline >10% reduction in LVMI at 12 months in 75% of participants with elevated LVMI at baseline Sustained and consistent improvements in other key measures of cardiac status, including left ventricular wall thickness and troponin I, in majority of participants at 12 months Increased post-treatment frataxin expression above baseline in all participants evaluated via myocardial biopsy to date LX2006 was well tolerated with no treatment-related serious adverse events to date; proceeding to Cohort 3 in SUNRISE-FA, with one participant dosed in this cohort to date Company to host webcast today at 8:00 AM ET NEW YORK, July 15, 2024 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (NCT05302271), LX2006 was well tolerated with no treatment-related serious adverse events, and clinically meaningful improvements in cardiac biomarkers were observed with increasing improvement over time. “We are very encouraged by these data and the potential of LX2006 to treat FA cardiomyopathy, a devastating and fatal condition with no currently approved therapies,” said Dr. Eric Adler, Chief Medical Officer and Head of Research at Lexeo Therapeutics. “Based on the favorable safety profile and clinical benefits observed to date, we are excited to explore expedited clinical development of LX2006, including potential for accelerated approval of this possibly life-saving treatment.” “The interim data shared today demonstrate clinically meaningful improvements across multiple cardiac biomarkers of hypertrophy, a hallmark of FA cardiomyopathy,” said Dr. Sandi See Tai, Chief Development Officer at Lexeo. “Together with the increases in frataxin protein expression observed in SUNRISE-FA cardiac biopsies to date, these results further highlight the potential of LX2006 to positively impact outcomes for people with FA cardiomyopathy. I would like to thank the participants, caregivers, and investigators participating in these trials who have helped to achieve this important milestone.” FA cardiomyopathy is a devastating, rare, and progressive disorder caused by loss of function mutations in the frataxin gene. Thus far in participants in the SUNRISE-FA trial with cardiac biopsies, low levels of frataxin have been found in the heart at baseline, estimated to be 2% or less of normal. In terms of clinical presentation, FA cardiomyopathy is typically characterized by left ventricular hypertrophy ultimately progressing to heart failure, and cardiac dysfunction is the cause of death in up to 80% of individuals with FA. A new natural history subset analysis conducted by Lexeo showed elevated left ventricular mass index (LVMI) in adults with FA cardiomyopathy, and LVMI remained stable or increased with age without spontaneous improvement. Elevated LVMI is an indicator of left ventricular hypertrophy and correlated with mortality in multiple cardiovascular conditions including FA cardiomyopathy. Interim Safety Results LX2006 was well tolerated with no treatment-related serious adverse events to date in either studyNo signs of complement activation or other immunogenicity observedNo cardiac or hepatic safety signals observedAll adverse events were transient and resolvedNo participants discontinued from either study Interim Clinical Results (from 8 participants with > 6-months of follow-up) Left ventricular mass index (LVMI): Of participants with elevated LVMI at baseline, 75% achieved >10% reduction at 12 months (n=4). Of all participants, 50% achieved >10% reduction in LVMI at 12 months (n=6). Among the participants with elevated LVMI at baseline, mean reduction in LVMI was 11.4% at 12 months (n=4) and 18.3% at 18 months (n=2). Left ventricular (LV) lateral wall thickness: wall thickening, an early indicator of left ventricular hypertrophy, was reduced by 13.6% on average in all participants at 12 months (n=6).High-sensitivity Troponin I (hsTnI): troponin I, a biomarker of myocardial injury, was reduced by 53.3% on average in all participants at 12 months (n=5).Frataxin protein expression evaluated via myocardial biopsy: observed increased frataxin levels compared to baseline following treatment with LX2006 in all participants evaluated to date utilizing two distinct measurements: LCMS: frataxin increase observed in 3 of 3 evaluable participants.IHC: frataxin increase observed in 2 of 2 evaluable participants. Dosing Update and Next Steps As of July 15, 2024, 13 participants dosed to date across two trials: Cohort 1 (1.8x1011vg/kg): n=6Cohort 2 (5.6×1011 vg/kg): n=6Cohort 3 (1.2×1012 vg/kg): n=1 SUNRISE-FA independent Data and Safety Monitoring Board endorsed proceeding to Cohort 3 dose level (1.2x1012vg/kg). This cohort has started enrollment with 1 participant dosed to date and will include at least 3 participants.The Weill Cornell investigator-initiated trial is currently enrolling in Cohort 2.Lexeo expects to share further details of these interim results, including an additional cardiac biopsy from Cohort 2, at a scientific conference in Fall 2024. Corporate Webcast DetailsLexeo Therapeutics will host a webcast at 8:00 AM ET today, July 15, 2024. Analysts and investors can participate by accessing the webcast live here or on the News & Events page in the Investors section of Lexeo’s website, www.lexeotx.com. The webcast will be archived on the company’s website following the completion of the call. About the Clinical Studies SUNRISE-FA is a Lexeo-sponsored, multicenter, 52-week, open-label trial evaluating the safety and preliminary efficacy of LX2006 in people who have FA cardiomyopathy, with three ascending-dose cohorts. Investigators at Weill Cornell Medicine are conducting a Phase 1A study of AAVrh.10hFXN, known as LX2006 at Lexeo, in a single-site, 52-week, open-label trial evaluating the safety and preliminary efficacy in people who have FA cardiomyopathy, in two ascending-dose cohorts with five participants per cohort. About LX2006LX2006 is an AAV-based gene therapy candidate delivered intravenously for the treatment of FA cardiomyopathy, the most common cause of mortality in individuals with FA affecting approximately 5,000 people in the United States. LX2006 is designed to target the cardiac manifestations of FA by delivering a functional frataxin gene to promote the expression of the frataxin protein and restore mitochondrial function in myocardial cells. In preclinical studies, LX2006 reversed the cardiac abnormalities in FA disease models and showed improvement in cardiac function and survival while demonstrating a favorable safety profile. The FDA has granted Rare Pediatric Disease designation, Fast Track designation, and Orphan Drug designation to LX2006 for the treatment of FA cardiomyopathy. About Lexeo Therapeutics  Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs. Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations and plans regarding our current product candidates and programs, including statements regarding the potential benefits of LX2006 for the treatment of Friedreich ataxia cardiomyopathy and the timing for receipt and announcement of data from its clinical trials, and the timing and likelihood of potential regulatory approval. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward-looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, filed with the SEC on May 9, 2024, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Media Response:Janine Bogris (201) 245-6838 janine.bogris@inizioevoke.com Investor Response:Stephen Jasper(858) 525-2047stephen@gilmartinir.com

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89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Financial by Comments are Disabled

SAN FRANCISCO, July 12, 2024 (GLOBE NEWSWIRE) — 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 125,000 shares of the Company’s common stock to six new employees (the “Inducement Grants”) on July 9, 2024 (the “Grant Date”). The Inducement Grants have been granted pursuant to the Company’s 2023 Inducement Plan (the “Plan”). The Inducement Grants were granted as an inducement material to these individuals entering into employment with 89bio in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grants have an exercise price per share that is equal to the closing price of 89bio’s common stock on the Grant Date. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 12 equal quarterly installments, subject to each employee’s continued employment with 89bio through the applicable vesting dates. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn. Investor Contact:Annie Chang89bio, Inc.investors@89bio.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com Media Contact:Sheryl SeapyReal Chemistrysseapy@realchemistry.com

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Sirnaomics Announces Completion of IND-Enabling Studies of Safety and Efficacy for STP125G with NHP Models, Targeting ApoC3 for Treatment of Cardiovascular Diseases

Regulatory by Comments are Disabled

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 12, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company”, Stock Code: 2257.HK, together with its subsidiaries, the “Group” or “Sirnaomics”), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, announced today that the Group has completed IND-enabling studies for STP125G, an siRNA therapeutics targeting Apolipoprotein C3 (ApoC3), based on its proprietary GalAhead™ mxRNA technology. The safety and efficacy results from the non-human primate (NHP) studies strongly support for an IND filing with the U.S. FDA for initiating a Phase I clinical study of STP125G for cardiovascular disease indications.
ApoC3 is a widely known player in triglyceride metabolism, and it has been recently recognized as a polyhedric factor which may regulate several pathways beyond lipid metabolism by influencing cardiovascular, metabolic, and neurological disease risk. High levels of triglycerides (TG) have been shown to be associated with increased risk of cardiovascular diseases. For severe hypertriglyceridemia (sHTG) patients whose TG level is more than 1000 mg/dL, the risk of developing acute pancreatitis is 5 to 10 times to that in the general population. Down-regulation of ApoC3 using siRNA or antisense oligonucleotides has been shown to be effective in lowering TG in sHTG patients.
During an efficacy evaluation of STP125G with non-human primate model (N = 4), we observed a dose-dependent silencing activity among 1 mg/kg, 3 mg/kg and 10 mg/kg doses with a strong safety profile. The maximum target silencing efficacy was achieved at 10 mg/kg dosage around week 4 and was maintained for an additional 9 weeks (the total length of this 13-week study). The safety evaluation of STP125G using non-human primate model (N = 4) demonstrated an excellent safety readout with a single subcutaneous administration at 50 mg/kg, 100 mg/kg or 250 mg/kg. The maximum target silencing efficacies were like the level of 10 mg/kg for all three high dosages.
“STP125G is the second drug candidate based on our GalAhead™ mxRNA technology that has shown excellent safety and potent efficacy results with the NHP models. Its long-lasting silencing activity against ApoC3 may provide better therapeutic benefit to patients suffering cardiovascular conditions, than those of antisense and other siRNA drugs.” Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, indicated. “Those data readouts further validated STP125G as a novel siRNA therapeutic candidate for treatment of hypertriglyceridemia and other cardiovascular diseases, using our proprietary GalAhead™-based delivery technology”.
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About ApoC3 and STP125G
ApoC3 is an important emerging target linking hypertriglyceridemia with cardiovascular disease (CVD). ApoC3 is a potent modulator of many established CVD risk factors, and is found on chylomicrons, VLDL, LDL, and HDL particles. Many studies show that in humans, apoC3 levels are an independent risk factor for CVD, and its presence on lipoproteins may promote their atherogenicity. Recent findings of the role of ApoC3 has been implicated in HDL metabolism and in the development of atherosclerosis, inflammation, and ER stress in endothelial cells. ApoC3 has been recently considered an important player in insulin resistance mechanisms, lipodystrophy, diabetic dyslipidemia, and postprandial hypertriglyceridemia (PPT). The emerging evidence of the involvement of ApoC3 in the pathogenesis of Alzheimer’s disease open the way to further study if modification of ApoC3 level slows disease progression. Furthermore, ApoC3 is clearly linked to cardiovascular disease (CVD) risk, and progression of coronary artery disease (CAD) as well as the calcification of aortic valve and recent clinical trials has pointed out the inhibition of ApoC3 as a promising approach to manage hypertriglyceridemia and prevent CVD. Several evidences highlight the role of ApoC3 not only in triglyceride metabolism but also in several cardio-metabolic pathways. STP125G is a single-stranded siRNA therapeutics targeting ApoC3 mRNA, based on Sirnaomics proprietary GalAhead™ mxRNA technology.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Group’s GalAhead™ mxRNA technology, is currently in Phase I development. STP125G is the second siRNA therapeutics based on Sirnaomics proprietary GalAhead™ mxRNA technology, targeting ApoC3 mRNA for cardiovascular disease treatment. STP237G is the first dual-targeted drug based on a GalAhead™ muRNA technology and is in the late stage of preclinical evaluation. The Group has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the expansion of the Group’s clinical pipeline and establishment of the Group’s manufacturing facility, Sirnaomics focuses on a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.
SOURCE Sirnaomics

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HeartSciences Announces Allowance of U.S Patent for AI-ECG Assessment of Left Ventricular and Right Ventricular Heart Dysfunction

Rhythm by Comments are Disabled

Southlake, Texas, July 11, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that intellectual property (IP) exclusively licensed to HeartSciences has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the detection of left ventricular (LV) and/or right ventricular (RV) dysfunction using deep learning, further strengthening the Company’s AI-ECG IP portfolio. Heart failure (HF) is a growing worldwide public health issue affecting 64 million people annually1 and is associated with high mortality, lower quality of life and reduced physical capacity while placing substantial costs on the healthcare system. Low-cost testing for heart failure has not been readily available for front-line physicians. With the development of AI-ECG algorithms, HeartSciences improves the early identification of patients that need additional testing, allowing earlier treatment and improved patient outcomes. Andrew Simpson, Chief Executive Officer of HeartSciences, stated, “This patent allowance further expands our extensive AI-ECG IP portfolio. AI-ECG is set to change the detection of heart disease and this latest patent further bolsters value to HeartSciences and our stakeholders.”  1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018;392:1789–1858. About HeartSciences Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical utility. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and is developing AI-ECG solutions to be made available on either a hardware agnostic cloud-based platform or its proprietary MyoVista® wavECG™ device, to help identify cardiovascular disease in any care setting worldwide in a manner to best suit different care providers. HeartSciences’ first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. For more information, please visit: https://heartsciences.com/. X: @HeartSciences Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2024, filed with the SEC on March 14, 2024 and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Contacts: HeartSciencesGene Gephart+1-682-244-2578 (US)info@heartsciences.com Investors: Gilmartin GroupVivian Cervantesinvestorrelations@heartsciences.com

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