Financial

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

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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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Adona Medical, a Shifamed Portfolio Company, Raises $33.5 Million in Series C Financing

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Funding to support next stage of product development and early clinical experience of company’s novel interatrial shunt and remote monitoring solution for patients with heart failure LOS GATOS, Calif., July 10, 2024 /PRNewswire/ — Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced today it has secured $33.5 million in Series C financing. The funds will be used to further product development and to initiate clinical use of the company’s adjustable interatrial shunt with integrated bi-atrial pressure monitoring. The financing was led by Cormorant Asset Management and TCP Health Ventures, with participation from Excelestar Ventures, the PA MedTech VC Fund II, Unorthodox Ventures, AMED Ventures, and other new and existing investors.

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The Adona Medical interatrial shunt features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter.

“Heart failure is a complex condition that benefits from an individualized treatment paradigm, yet many of the device-based treatment options available today offer a one-size-fits-all approach,” said Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center, Minneapolis Heart Institute Foundation. “Adona’s innovative shunt and sensor pairing aims to provide a more individualized management strategy and is designed so that shunt flow can be adjusted to best suit the needs of each individual patient, both initially and as their condition evolves over time. I look forward to working with the Adona team as they move into clinical use later this year.”

“Despite advancements in heart failure therapies, challenges remain that limit patient applicability and physician adoption with first-generation devices,” said Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “We are pleased to lead this round as we believe Adona’s technology has the potential to disrupt the field and benefit the millions of patients suffering from heart failure.”
The Adona device includes a shunt that features a flow channel with an adaptable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter. In addition, the implantable device features integrated sensors designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings can provide physicians with a more complete understanding of a patient’s hemodynamic status and can augment shunt therapy by enabling more informed medical management. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally.1″Adona is committed to improving outcomes for patients with heart failure. We’ve developed multiple innovative technologies that we believe will elevate the impact that is achievable with device-based interventions,” commented Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. “The team has made tremendous progress in advancing our solution for heart failure management and we are grateful for the strong ongoing support from our investors as we take the next steps in our journey.”About Adona Medical, Inc.Adona Medical, a privately held portfolio company of Shifamed, LLC, is a pre-clinical stage medical technology company developing next-generation interatrial shunting and remote patient monitoring solutions for patients with advanced heart failure. The Adona Medical heart failure management platform is an investigational device and is not approved for use in the U.S. or anywhere in the world. To learn more, please visit www.adonamed.com.About Shifamed, LLCFounded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.MEDIA CONTACT:Jennie KimSPRIG Consulting, LLC[email protected]References:
Benjamin et al. Circulation 2018.
SOURCE Adona Medical

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R3 Vascular Appoints Josh Smale as its Vice President of Global Clinical and Scientific Affairs

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MOUNTAIN VIEW, Calif., July 09, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs. Prior to joining R3 Vascular, Mr. Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio. Prior to his tenure at BD, Mr. Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV. He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV. Mr. Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University. He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents. Commenting on the appointment of Mr. Smale, Christopher M. Ownes, President and CEO of R3 Vascular, said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs. Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education. Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold. We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.” Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD). R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.” Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO). In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round. About R3 Vascular Inc.R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com. Media Contact:David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c861cb09-8ed9-4401-8f89-6e69934fd0d3

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Octagos Health Secures Over $43 Million Investment to Advance AI-Driven Cardiac Device Monitoring

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HOUSTON, July 9, 2024 /PRNewswire/ — Octagos Health, an industry-leading provider of AI-driven cardiac device monitoring solutions, today announced a successful equity raise of over $43 million in investment capital. The Series B investment round was led by funds managed by Morgan Stanley Expansion Capital, with continued participation from Mucker Capital and other strategic investors. This funding will accelerate Octagos Health’s mission to use artificial intelligence to revolutionize cardiac care and provide comprehensive patient monitoring services. 

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Octagos Health provides an AI-driven platform that offers continuous monitoring and data analysis for patients with cardiac devices (pacemakers, defibrillators, ambulatory monitors, consumer wearables, and other modalities). Atlas AI, the company’s proprietary technology, ensures high accuracy and sensitivity in detecting clinically relevant events, automating physician workflows, and enabling healthcare providers to make informed decisions and improve patient outcomes. The platform’s comprehensive capabilities include seamless integration with electronic health records (EHR) and customizable reporting features, making it a preferred choice for cardiology practices. 

“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics.”

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“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics. The funding will help us accelerate our growth across the US and expand into other critical areas of cardiac care, including ambulatory monitors, consumer wearables, and sleep.  Our goal is to build a comprehensive AI-based clinical decision support engine for healthcare. We are thrilled to have Morgan Stanley Expansion Capital as our lead investor and the continued support of Mucker Capital. In a short period, we have grown from first servicing my cardiology clinic to becoming one of the largest cardiac remote monitoring companies that provides software and services,” said Dr. Shanti Bansal, cardiologist, CEO of Octagos Health and Houston Heart Rhythm. 
“This investment will enable us to accelerate enhancements to our platform, in addition to scaling our commercial team and operations. We are currently the only company that helps cardiology practices migrate their historical data from legacy software providers and fully integrates with any EHR system. We do this while enabling customized reporting supported by patient and practice decision-support analytics,” said Eric Olsen, COO of Octagos Health. “We are excited to partner with Octagos Health and support their vision of transforming cardiac care,” said Melissa Daniels, Managing Director of Morgan Stanley Expansion Capital. “Octagos Health has demonstrated exceptional growth and innovation in a critical area of healthcare. We believe their platform and vertically integrated software and services significantly improve patient care and streamline cardiac monitoring processes for healthcare providers.” “Octagos Health is poised for scale – industry leading gross margins, a very sticky product that doctors and clinical staff love, and a market ready for disruption with artificial intelligence. This is the new wave for diagnostic care,” said Will Hsu, Co-Founder and Partner at Mucker Capital. “This funding will help Octagos Health continue to add additional data sources from various diagnostic and consumer devices and further differentiate their offering.” About Octagos Health Octagos Health is a leading provider of cardiac monitoring solutions, dedicated to improving patient outcomes through advanced technology and comprehensive monitoring services. The company’s AI-driven platform offers continuous monitoring and data analysis for patients with implantable cardiac devices, enabling healthcare providers to make informed decisions and deliver timely care. Octagos Health’s solutions are designed to seamlessly integrate with electronic health records and provide customizable reporting features, making it an essential tool for modern healthcare institutions. For more information, please reach out to [email protected]. You can also follow us on LinkedIn. About Morgan Stanley Expansion Capital Morgan Stanley Expansion Capital is the growth-focused private investment platform within Morgan Stanley Investment Management. Morgan Stanley Expansion Capital targets growth equity and credit investments within technology, healthcare, consumer, and other high-growth sectors. For nearly four decades, Morgan Stanley Expansion Capital has successfully pursued growth investment opportunities and has completed investments in over 200 companies, leveraging the global brand and network of Morgan Stanley.About Mucker Capital Founded in Santa Monica, CA in 2011, Mucker Capital provides Pre-Seed, Seed, and Series A capital and support for startups in Southern California and in other, similarly underfunded ecosystems outside Silicon Valley.SOURCE Octagos Health, Inc.

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Neha Motwani Elected to Longeveron® Board of Directors

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MIAMI, July 09, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company’s recent Annual Meeting of Stockholders. “I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. “Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B™, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-B™ has the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.” Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University. “I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Company’s clinical development,” said Ms. Motwani. “I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-B™ for the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.” About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. The Lomecel-B™ HLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Investor Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00f0eb5c-76f5-49b1-9994-ee363513547b

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