The Latest Cardiac and Vascular News
June 20, 2024 06:32 AM Eastern Daylight Time TEL AVIV & ZURICH & NEW YORK–(BUSINESS WIRE)–SHL Telemedicine Ltd. (NASDAQ: SHLT, SIX: SHLTN;) (“SHL” or the “Company”), a leading provider and developer of advanced personal telemedicine solutions, has clarified today that it is in discussions with Discount Capital Ltd. the investment […]
MIAMI, June 18, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced the closing of its previously announced exercise of certain existing warrants to purchase an aggregate of 1,697,891 shares of its Class A common stock having an exercise price of $2.35 per share, originally issued in April 2024. The resale of the shares of Class A common stock issuable upon exercise of the existing warrants is registered pursuant to an effective registration statement on Form S-1 (File No. 333-278995). The gross proceeds to the Company from the exercise of the existing warrants were approximately $4.4 million, prior to deducting placement agent fees and estimated offering expenses payable by the Company. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. In consideration for the immediate exercise of the existing warrants for cash and the payment of $0.125 per new warrant, the Company issued new unregistered warrants to purchase up to an aggregate of 3,395,782 shares of Class A common stock. The new warrants are immediately exercisable at an exercise price of $2.50 per share and have a term of twenty-four months from the date of issuance. The Company intends to use the net proceeds from the transaction for its ongoing clinical and regulatory development of Lomecel-B™ for the treatment of several disease states and indications, including HLHS and Alzheimer’s disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. The new warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of Class A common stock issuable upon exercise of the new warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of Class A common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of Class A common stock issuable upon the exercise of the new warrants. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential for Lomecel-B™ to be a beneficial treatment for patients with HLHS and include, but are not limited to, the anticipated use of proceeds from the private placement. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, market and other conditions, adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor ContactDerek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com
SOUTH JORDAN, Utah, June 18, 2024 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today that it will release its financial results for the quarter ended June 30, 2024, after the close of the stock market on Thursday, August 1, 2024. Merit will hold its investor conference call on the same day (Thursday, August 1, 2024) at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific). To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck can be accessed using this link. A link to both register for the conference call and view the webcast will be made available at merit.com. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 people worldwide.
New analysis of the pivotal Phase 3 SOLOIST-WHF trial demonstrates INPEFA cost-effectiveness Findings consistent with another study recently published in the Journal of Comparative Effectiveness Research THE WOODLANDS, Texas, June 18, 2024 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the peer-reviewed Journal of the American College of Cardiology: Heart Failure has published a research paper concluding that INPEFA® (sotagliflozin) is cost-effective for people with diabetes and recent worsening heart failure using commonly accepted willingness-to-pay thresholds. “Our research team believes that this study is an important contribution to the economic evaluation of sotagliflozin, a novel SGLT inhibitor, from the perspective of the U.S. healthcare system. Our results demonstrated that in people with diabetes and recent worsening heart failure, sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds,” said William S. Weintraub, MD, MACC, FAHA, FESC, director of Population Health Research at MedStar Health Research Institute, and the lead author of the research paper. The analysis was conducted from a U.S. healthcare sector perspective, in accordance with Consolidated Health Economic Evaluation Reporting Standards. Results from this study showed that lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in the INPEFA and placebo groups, respectively. In another study, “Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure,” recently published in the Journal of Comparative Effectiveness Research, the research team used published real-world data to derive baseline event frequencies and SOLOIST-WHF study data to estimate the efficacy of INPEFA. According to the research results, the use of INPEFA led to a net gain in QALYs of 0.425 for INPEFA versus standard of care. The investigators concluded that INPEFA is a cost-effective addition to standard of care for patients hospitalized with heart failure and comorbid diabetes. “The data published in these two peer-reviewed journals reinforce our position that in addition to providing meaningful clinical benefits to heart failure patients, INPEFA provides significant financial value for payors and the U.S. healthcare system,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. The Journal of the American College of Cardiology: Heart Failure manuscript 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
Acquisition adds innovative technology for stroke prevention to vascular portfolio
MARLBOROUGH, Mass., June 18, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Silk Road Medical, Inc. (Nasdaq: SILK), a medical device company that has developed an innovative platform of products to prevent stroke in patients with carotid artery disease through a minimally invasive procedure called transcarotid artery revascularization (TCAR). The purchase price is $27.50 per share, reflecting an enterprise value of approximately $1.16 billion.i
Carotid artery disease is the cause of one-third of all strokes and a condition in which the carotid arteries in the neck become narrowed or blocked due to the buildup of plaque.ii Treatment options for this disease include medical therapy management, placement of a stent, or surgery to reduce the risk of stroke. The TCAR procedure involves accessing the carotid artery through a small incision in the neck and temporarily reversing blood flow away from the brain to prevent plaque from dislodging and causing a stroke. A stent is then placed at the site of the blockage for long-term plaque stabilization and future stroke prevention.
“The TCAR platform developed by Silk Road Medical is a notable advancement in the field of vascular medicine, which has revolutionized stroke prevention and the treatment of carotid artery disease,” said Cat Jennings, president, Vascular, Peripheral Interventions, Boston Scientific. “We believe the addition of this clinically differentiated technology to our vascular portfolio demonstrates our continued commitment to provide meaningful innovation for physicians who care for patients with peripheral vascular disease.”
The TCAR system gained U.S. Food and Drug Administration approval in 2015 and is supported by several clinical studies demonstrating a reduced risk of stroke and other complications associated with traditional open surgery. The products sold by Silk Road Medical are the only devices commercially available for use during the TCAR procedure.
Boston Scientific expects to complete the transaction in the second half of 2024, subject to customary closing conditions. Silk Road Medical has guided to net revenue of approximately $194-198 million in 2024, representing 10-12% growth over the prior fiscal year.iii The impact to Boston Scientific adjusted earnings per share is expected to be immaterial in 2024 and 2025, and accretive thereafter. We expect the impact to GAAP earnings per share to be less accretive, or dilutive, as the case may be, due to amortization expense and acquisition-related net charges.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
Cautionary Statement Regarding Forward-Looking Statements
This press release 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. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding financial and business impact of the transaction and anticipated benefits of the transaction, the closing of the transaction and the timing thereof, business plans and strategy, product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the forward-looking statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Risks and uncertainties that may cause such differences include, among other things: economic, political, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions and the market acceptance of those products; market competition for our products; expected pricing environment; expected procedural volumes; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Silk Road Medical’s operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including receipt of the required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this press release.
CONTACTS:Blake RouhaniMedia Relations(763) 494-2268[email protected]
Jon MonsonInvestor Relations(508) 683-5450[email protected]
i Enterprise value of approximately $1.16 billion based on approximately 46.0 million fully diluted shares (or approximately $1.26 billion for 100% of the equity) and $101 million net cash position as of March 31, 2024ii Weerd M Stroke 2010; Modus Health Group for 2022Vascularweb.org; Virani, Salim, et al. “Heart Disease and Stroke Statistics— 2020 Update.” American Heart Association, 3 Mar. 2020.iii https://investors.silkroadmed.com/news-releases/news-release-details/silk-road-medical-reports-first-quarter-2024-financial-results#:~:text=Silk%20Road%20Medical%20projects%20revenue,the%20Company’s%20prior%20year%20revenue.
SOURCE Boston Scientific Corporation
MIAMI, June 17, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, today announced that it has entered into definitive agreements for the exercise of certain existing warrants to purchase an aggregate of 1,697,891 shares of its Class A common stock having an exercise price of $2.35 per share, originally issued in April 2024. The resale of the shares of Class A common stock issuable upon exercise of the existing warrants is registered pursuant to an effective registration statement on Form S-1 (File No. 333-278995). The gross proceeds to the Company from the exercise of the existing warrants are expected to be approximately $4.4 million, prior to deducting placement agent fees and estimated offering expenses payable by the Company. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the existing warrants for cash and the payment of $0.125 per new warrant, the Company will issue new unregistered warrants to purchase up to an aggregate of 3,395,782 shares of Class A common stock. The new warrants will be immediately exercisable at an exercise price of $2.50 per share and will have a term of twenty-four months from the date of issuance. The offering is expected to close on or about June 18, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for its ongoing clinical and regulatory development of Lomecel-B™ for the treatment of several disease states and indications, including HLHS and Alzheimer’s disease, obtaining regulatory approvals, capital expenditures, working capital and other general corporate purposes. The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of Class A common stock issuable upon exercise of the new warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of Class A common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of Class A common stock issuable upon the exercise of the new warrants. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential for Lomecel-B™ to be a beneficial treatment for patients with HLHS and include, but are not limited to, statements regarding the completion of the private placement, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds from the private placement. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, market and other conditions, adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor Contact Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com
HONG KONG, June 17, 2024 /PRNewswire/ — Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, announced the publication of its audited financial results for the year ended December 31, 2023 (“the period”) on June 16, 2024. Additionally, the Company announced that it would resume trading on the Hong Kong Stock Exchange on June 17, 2024.
“We are pleased to be reporting an exceptional year for Peijia and are eager for our investors to have access to the public markets once again,” said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. “The preliminary, unaudited results published on March 28, 2024 remain unchanged following the audit, reiterating revenue growth of 75.9% and significant increases to our operational efficiencies. Our success was driven by market share gains, product portfolio expansion and key strategic partnerships. I’m very proud of our team and all that we were able to accomplish in 2023 and look forward to leveraging that momentum for the remainder of 2024.”
On March 28, 2024, Peijia announced a delay in the filing of the Company’s 2023 Annual Report as a result of the auditor’s work on certain financial assets, specifically related to the valuation of a prior HK$80million investment by the Company. On April 2, 2024, trading in Peijia shares was suspended pending publication of audited results. According to the Company’s announcement on June 16, 2024, the audit of the 2023 Annual Results have been completed in accordance with International Standards on Auditing issued by the International Auditing and Assurance Standards Board and the Company’s auditor, PricewaterhouseCoopers, have expressed unqualified opinion in the independent auditor’s report.
Trading resumed on June 17, 2024.
Financial Highlights
During the period, the Company recorded an operating revenue of RMB441.1 million, representing an increase of 75.9% year-over-year. The increase in revenue was mainly attributable to:
(i) the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed the Company to achieve an over 20% share of the Chinese TAVR market;
(ii) first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals;
(iii) sales volume of coil products increased significantly as a result of the implementation of VBPs in the provinces where the Company had won bids, especially the 21-province alliance VBP led by Jilin province;
(iv) sales volume of our existing and newly approved ischemic and vascular access products increased significantly as a result of the professional marketing activities and the quick penetration of neurointerventional procedures following the construction of stroke centers.
During the period, the Company recorded a gross profit of RMB325.4 million, representing an increase of 84.7% over the prior year, driven by continuous cost improvement measures throughout the business. 2023 gross profit margin of 73.8% increased by 350 basis points over the prior year. Expense ratios for selling and distribution, administrative costs, and research and development improved year over year by 22.7%, 17.1% and 82.2%, respectively.
Financial and Business Results by Segment:
Transcatheter Valve Therapeutic (“TVT”) Business:
During the period, the TVT Business recorded revenue of RMB185.6 million, representing an increase of 72.9% year-over-year. Gross profit increased 86.0% to RMB159.0 million year-over-year. The segment’s gross profit margin was 85.7%, representing an increase of 6.0% year-over-year, driven by supply chain optimization and yield rate improvement. TVT selling and distribution expenses, administrative expenses and research and development expenses ratios decreased by 32.5%, 25.9% and 169.5%, respectively. The segment loss narrowed by 13.5% year-over-year.
With the recovery of procedure volume in the market and the increase in unit production of the sales team, implantation volume of the Company’s TAVR products have increased significantly, leading to further gains in market share. During the period, the Company’s first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals. During the year, the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed us to achieve an over 20% share of the Chinese transfemoral TAVR market.
During the period, the Company made significant progress in the research and development of pipeline products.
In aortic valve product line, the Company expedited the registration clinical trials for TaurusTrio the in-licensed JenaValve Trilogy Transcatheter Heart Valve (“THV”) System designed for pure aortic regurgitation (AR), and TaurusNXT, the Company’s internally developed third-generation durability-enhanced TAVR product. As of June 16, 2024, patient enrollment has been completed for both trials and patient follow-up is ongoing. Specially, in July 2023, the Company launched the multi-center registration clinical trial for TaurusTrio, enrolling a total of 116 AR patients in six months and finished ahead of enrollment schedule targets. In addition, the Company has successfully completed the technology transfer from JenaValve and established local manufacturing facilities at its new headquarters in Suzhou to produce the product independently.
In the mitral and tricuspid valve product lines, the Company has been steadily advancing the research and development progress of each product. The registration clinical trial for GeminiOne, the Company’s internally developed Transcatheter Edge-to-Edge Repair device, was progressing as planned with patient enrollment completed in May 2024. In addition, in October 2023, the early clinical findings of GeminiOne and the novel TTVR product MonarQ were presented at the 2023 Transcatheter Cardiovasvular Therapeutics (“TCT”) conference with preparations now being made to conduct early feasibility studies in the United States.
Operationally, in December 2023, TVT production facilities were relocated to new headquarters, increasing the current manufacturing capacity by three times.
Neurointerventional (“NI”) Business:
During the period, the NI Business recorded revenue of RMB255.6 million, representing a better-than-expected year-over-year increase of 78.1%. Gross profit for the segment increased 83.4% year-over-year to RMB166.4. Gross profit margin improved to 65.1% for the full year, an increase of 190 basis points over 2022. Hemorrhagic, ischemic and vascular access products accounted for 32.0%, 33.6% and 34.1% of the segment revenue, a much more balanced product sales mix over 2022 with 39.4%, 27.6% and 32.9%, respectively. With the increasing sales of ischemic products, the segment’s gross profit margin increased to 67.1%, an increase of 3.5% over the prior year. These gains were driven by coil products winning bids and quick market penetration of new and existing ischemic products.
Selling and distribution expenses, administrative expenses and research and development expenses ratios improved year-over-year by 14.2%, 9.9% and 15.7%, respectively. Also, due to the increase in revenue and gross profit, and the Company’s long-term efforts in cost reduction and efficiency improvement, the segment loss significantly narrowed by 98.8% year-over-year, with the expectation of reaching profitability in 2024.
About the Company
Peijia Medical (09996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has two generations of TAVR systems and sixteen neurointerventional devices commercialized in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about.
SOURCE Peijia Medical
– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV – – BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine – DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, Human Acellular Vessels (HAVs) at commercial scale, today announced the issuance of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services (CMS) ICD-10 Coordination and Maintenance (C&M) Committee. These codes, effective for hospital discharges beginning October 1, 2024, cover procedures for replacing arteries in the upper or lower extremities using Humacyte’s HAV. Humacyte also announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the “acellular tissue engineered vessel” (ATEV). The CMS ICD-10 C&M Committee issues ICD-10-PCS codes to facilitate accurate classification and tracking of procedures. The ICD-10-PCS is a classification for procedures performed during inpatient hospital admissions1. The codes are widely used by hospitals and insurers to support data collection, payment, and monitoring. Obtaining these codes marks a significant milestone as Humacyte advances toward submission of a New Technology Add-on Payment (NTAP) application to CMS planned for later in 2024. Obtaining an ICD-10-PCS code is necessary to file an NTAP application. The newly issued codes are: X2R50WA: Replacement of Right Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R60WA: Replacement of Left Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R70WA: Replacement of Right Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R80WA: Replacement of Left Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 The ATEV is designed for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. ATEVs, which are bioengineered human tissues, are under investigation as universally implantable vascular replacements that resist infection and do not require immune suppression. The ATEV is intended to be readily available – “off-the-shelf” – with the potential to save valuable time for surgeons, thereby improving patient outcomes and reducing complications. Humacyte has extensive experience with the ATEV, accumulating over 1,200 patient-years of worldwide use in clinical trials for vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The company’s manufacturing facilities are capable of producing ATEVs at commercial scale to meet the potential needs of thousands of patients. The Prescription Drug User Fee Act (PDUFA) date for the FDA’s regulatory decision on Humacyte’s Biologics License Application (BLA), is August 10, 2024. This is based on a Priority Review which was granted by the FDA. The BLA submission was supported by positive results from the V005 Phase 2/3 clinical trial, and real-world evidence from the treatment of wartime injuries in Ukraine. In these studies, Humacyte’s ATEV demonstrated higher patency (blood flow) rates and lower amputation and infection rates as compared to historic synthetic graft benchmarks. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings, acceptances and approvals, including the BLA for our V005 clinical trial and the NTAP application to CMS; timing, scope, and rate of reimbursement for our ATEVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com ________________________1 Centers for Medicare & Medicaid Services. (2024). ICD-10-PCS Official Guidelines for Coding and Reporting 2025. Retrieved from https://www.cms.gov/files/document/2025-official-icd-10-pcs-coding-guidelines.pdf
With a mission to redefine what gene therapy can do, Spur is optimizing every component of its product candidates to develop a new generation of gene therapies Spur is advancing two potentially life-changing gene therapy candidates in clinical trials and a bold research strategy to move gene therapy beyond rare diseases into more prevalent conditions Lead program FLT201 for Gaucher disease poised to enter Phase 3 development in 2025 Acquired SwanBio, adding Phase 1/2 program for adrenomyeloneuropathy to its clinical-stage pipeline and strengthening CNS expertise Founding investor Syncona commits additional $50 million to support development of pipeline LONDON, June 17, 2024 (GLOBE NEWSWIRE) — Spur Therapeutics, formerly Freeline Therapeutics, today announced a new name and brand to reflect its focus on developing a new generation of gene therapies and advancing the practice of genetic medicine. Building on compelling data for its lead program FLT201, a highly differentiated gene therapy candidate for Gaucher disease, Spur is pursuing an ambitious research strategy to unlock the promise of gene therapy for more prevalent chronic conditions, starting with Parkinson’s disease and certain forms of cardiovascular disease. “At Spur Therapeutics, our mission is to redefine what gene therapy can do,” said Michael Parini, Spur’s Chief Executive Officer. “Our new name and new brand reflect our determination to alter the course of a disease with a single dose of genetic medicine and change the course of people’s lives. By optimizing every component of our product candidates to get just the right expression, packaged and delivered to the body in just the right way, we are working to develop a new generation of therapies that spur gene therapy forward to transform the lives of even more patients.” Spur today also announced its acquisition of SwanBio Therapeutics, which adds a potential first-in-class gene therapy program for adrenomyeloneuropathy (AMN), a devastating neurodegenerative disease, to its clinical-stage pipeline, as well as strengthened capabilities in central nervous system (CNS) disorders that can be leveraged across both its AMN and Parkinson’s disease programs. The AMN program, SBT101, is currently in a Phase 1/2 clinical trial, and Spur plans to report an initial safety update from the higher-dose cohort in this trial in the first half of next year. There are no approved treatments for AMN, and SBT101 is the only gene therapy candidate in development for the disease. Syncona Ltd., the founding shareholder in both Freeline and SwanBio and a leading life science investor focused on creating, building and scaling global leaders in life science, has committed an additional $50 million (£40 million) to support development of the expanded pipeline. Syncona Executive Partner and former SwanBio Executive Chair John Tsai has joined Spur’s Board of Directors. “We see great promise across Spur’s broadened pipeline, with a highly differentiated lead clinical program backed by compelling data and a second potentially first-in-class clinical asset,” said Chris Hollowood, CEO of Syncona Investment Management Limited and Chairman of the Board of Directors of Spur. “Building on its work, Spur has an exciting opportunity to become a leading gene therapy company developing one-time treatments for debilitating chronic diseases, potentially setting new standards of care and changing lives.” Spur expects to initiate a Phase 3 trial for FLT201 in 2025 in Gaucher disease. There is no cure for Gaucher disease, and even with current treatments, many patients continue to experience debilitating symptoms. Recently reported data from its Phase 1/2 GALILEO-1 trial highlight FLT201’s potential to set a new standard of care for Gaucher disease. The data show that a single dose of FLT201 resulted in dramatic reductions in the toxic buildup of glucosylsphinogsine (lyso-Gb1), one of the best predictors of clinical response and disease severity in Gaucher disease, in patients who have had persistently high levels despite years of treatment on currently approved therapies. Early signs of clinical improvement in fatigue and bone marrow burden were also observed. FLT201 has demonstrated a favorable safety and tolerability profile. Building on its work in Gaucher disease, Spur’s research program in Parkinson’s disease is focused on a subset of patients with mutations in the GBA1 gene, the same gene implicated in Gaucher disease. The program leverages the same transgene as FLT201. Spur is further optimizing the transgene for expression in the brain and identifying the best capsid and route of administration to deliver its proprietary GBA1-85 transgene to key areas of the brain affected by Parkinson’s disease. Spur expects to select a development candidate later this year to progress into preclinical studies designed to support the program’s advancement into clinical trials. No disease-modifying therapies currently exist for Parkinson’s disease, and this program could be a first step toward a gene therapy for hundreds of thousands of people with GBA1 Parkinson’s worldwide. Additionally, Spur has a research program, leveraging a suite of promising cardioprotective proteins to develop gene therapy candidates for cardiovascular diseases, starting with a severe subset of chronic heart failure. About Spur TherapeuticsSpur Therapeutics is a clinical-stage biotechnology company focused on developing life-changing gene therapies for debilitating chronic conditions. By optimizing every component of its product candidates, Spur aims to unlock the true potential of gene therapy to realize outsized clinical results. Spur is advancing a breakthrough gene therapy candidate for Gaucher disease and a potential first-in-class gene therapy candidate for adrenomyeloneuropathy, as well as a research strategy to move gene therapy into more prevalent diseases, including forms of Parkinson’s, dementia, and cardiovascular disease. Expanding our impact, and advancing the practice of genetic medicine. Toward life-changing therapies, and brighter futures. Toward More™ For more information, visit www.spurtherapeutics.com or connect with Spur on LinkedIn. Media Contact:Naomi Aokinaomi.aoki@spurtherapeutics.com+ 1 617 283 4298 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e68ddce-d346-46c3-b5bf-d03686e6d5e9
SAN FRANCISCO, June 14, 2024 /PRNewswire/ — Avive Solutions, Inc., a Brisbane, CA-based manufacturer of lifesaving Automated External Defibrillators (AEDs) has been recognized as a Top 3 winner of the 2024 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.
Select employers from the Bay Area were named winners of the awards at a celebratory event on June 13th, 2024 in San Francisco. These winning organizations were honored for having created exceptional workplaces with collaborative, supportive workplace cultures that their employees value highly.
Award applicants were evaluated and ranked across 5 categories according to the number of Bay Area employees. The rankings find companies in the region whose employees rate them as the highest on such values as fun, collaborative culture, solid compensation, benefits offerings and other amenities, as well as management practices. The rankings were unveiled on June 14th, 2024 in the San Francisco Business Times and the Silicon Valley Business Journal.
“We are honored and thrilled to be named to the 2024 list of Bay Area Best Places to Work,” said Jess Koenig, Head of People at Avive. “With so many fantastic, established companies with amazing culture and perks located in the region to choose from, we are proud to know that our employees value our culture, lifesaving mission, and workplace environment so highly and are excited to come to work every day at Avive.”
Co-founder and CEO Sameer Jafri added, “I’m proud of our team’s commitment to attracting and retaining exceptional talent that connects with our mission to save lives, contributes positively to our culture, and is driven to do what it takes to push our company forward to new heights. We’re building something special here, and the tremendous emphasis we place on building a great culture has, and continues to pay off. It’s humbling to be recognized with this award, and we are committed to Avive continuing to be one of the best places to work in the Bay Area for many years to come.”
About Avive Solutions, Inc.Avive Solutions is a new kind of AED company. We are revolutionizing Sudden Cardiac Arrest response with our innovative platform that brings together a 21st-century AED device and first-of-its-kind software solutions. With our award-winning product, the Avive Connect AED, we are the first new company to bring an AED to market in the U.S. in over 20 years. Focused on portability, accessibility, and connectivity, the Avive Connect AED is one of the most advanced products in the industry. Additionally, our software solutions not only make owning and managing AEDs simple, they also deliver a comprehensive cardiac arrest response solution to communities, with the goal of increasing bystander intervention, decreasing time-to-defibrillation, and getting valuable data to the people who need it, when they need it. Founded in 2017, we are on a mission to empower bystanders, first responders, and 911 telecommunicators to provide lifesaving care as quickly and easily as possible. Our versatile platform is designed to meet the needs of all types of industries – schools, gyms, places of worship, any size business and even your home. Join us on our mission to save lives and learn more at avive.life.
About 2024 Bay Area Best Places to Work Best Places to Work is an innovative publication and awards program produced by the San Francisco Business Times and the Silicon Valley Business Journal. The rankings were determined by surveys that went directly to employees who answered a series of questions. The survey was administered online by the employers and through a service provided by Quantum Workplace, our research partner. The rankings are numeric based on Quantum’s scoring process. By ranking companies and sharing best practices we facilitate idea sharing and help other companies learn from the best.
Media Contact:Kyle Noble[email protected](415) 287-6881
SOURCE Avive Solutions, Inc.
