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Business Wire
6 days ago
- Business
- Business Wire
GenSight Biologics Announces an Additional Financing Amounting to Approximately EUR 500,000 from Existing Shareholder
PARIS--(BUSINESS WIRE)--Regulatory News: This additional financing provides valuable flexibility as we execute our operational roadmap through October 2025. NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN AND SOUTH AFRICA GenSight Biologics (the " Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced a financing through a capital increase reserved to an existing shareholder by the issuance of new shares with warrants attached, for a total gross amount of EUR 499,999.92 (excluding the future net proceeds related to the exercise of the warrants) (the " Reserved Offering"). The subscription price for one ABSA is EUR 0.17 (the " Offering Price"). This follows the approximately EUR 4 million financing announced on July 1, 2025 (the ' Early July Financing '). The Offering Price of the ABSA and the terms and conditions of the warrants, including their exercise price, are identical to those included in the Early July Financing. " We are delighted to receive this additional support from an existing shareholder, as we continue to pursue GenSight's strategic direction and LUMEVOQ's potential, ' commented Laurence Rodriguez, Chief Executive Officer of GenSight Biologics. " This supplementary funding, combined with our recent EUR 4 million financing, strengthens our position as we advance toward the anticipated opening of the French AAC program in Q4 2025 and prepare for our global Phase III RECOVER study." The New Shares (as defined below) represent less than 30% of the total number of the Company's ordinary shares already admitted to trading on Euronext Paris. The admission to trading of the New Shares on Euronext Paris is therefore exempted from the obligation to prepare a prospectus. Use of Proceeds The proceeds of the Reserved Offering will supplement the funds raised in the Early July Financing. Together, they are intended to be used principally to finance the continued development of LUMEVOQ ®, the Company's most advanced drug candidate, currently in Phase III. In particular, the funds raised will help ensure the Company's operational continuity, support the finalization of manufacturing transfer activities and secure the preparations for the anticipated opening of compassionate use access in France as well as the initiation of the Phase III study RECOVER. The balance will be used to meet certain financial obligations of the Company. This will extend the Company's cash runway from mid-July 2025 before the Early July Financing to early-October 2025 initially and now to mid-October 2025. " This additional financing provides valuable flexibility as we execute our operational roadmap through October 2025, ' noted Jan Eryk Umiastowski, Chief Financial Officer of GenSight Biologics. " We believe the support of UPMC Enterprises reflects the attractiveness of our investment proposition. We remain focused on achieving key regulatory milestones that will establish a sustainable revenue pathway, beginning with the AAC program." Terms and Conditions of the Reserved Offering The Reserved Offering, for a total of EUR 499,999.92 (share issue premium included), was carried out through the issuance of 2,941,176 ABSA (as defined below) via a capital increase without shareholders' preferential subscription rights reserved to a category of persons satisfying determined characteristics, pursuant to Article L. 225-138 of the French Commercial Code, through the issuance of new shares of a per value of EUR 0.025 (the " New Shares"), to which are attached 1 warrant for 1 new share (the " Warrants", together with the New Shares, the " ABSA" and with the new shares of the Company resulting from the exercise of the Warrants, the " Warrant Shares"). The launch of the Reserved Offering was decided on July 16, 2025 by the Chief Executive Officer, pursuant to the delegation of competence granted to her by the Company's board of directors (the ' Board of Directors ') on June 19 and June 30, 2025. The Board of Directors acted pursuant to the delegation of competence granted to it under the 24 th resolution of the Company's shareholders on May 13, 2025 (the ' General Meeting '). The EUR 0.17 issue price on one ABSA represents a facial premium of EUR 0.0492 to the closing price of the GenSight shares on Euronext Paris on the day of the determination of the issue price, i.e., EUR 0.1208 on July 16, 2025. The exercise price of the Warrants is EUR 0.21. The Warrants will be exercisable at any time from their issue date until July 21, 2030. The exercise of a Warrant will give the right to subscribe to one (1) Warrant Share (the " Exercise Ratio"), it being specified that this Exercise Ratio may be adjusted following any transactions carried out by the Company on its share capital or reserves, as from the issuance date of the Warrants, in order to maintain the rights of the Warrants' holders. Impact of the Reserved Offering on the Company's Shareholding Following the issuance of the New Shares, the Company's total share capital will be EUR 3,891,473.45 (composed of 155,658,938 ordinary shares). If all the Warrants are exercised, and thus all the Warrant Shares issued, the Company's total share capital will be EUR 3,965,002.85 (composed of 158,600,114 ordinary shares). Please see sections 19.1.3 and 19.1.4 of the Company's 2024 Universal Registration Document and the press release dated July 1, 2025 relating to the Early July Financing for a description of the securities issued by GenSight and giving access to its capital. For illustration purposes, the impact of the issuance of the New Shares and the Warrant Shares on the ownership of a shareholder holding 1% of the Company's share capital prior to the Reserved Offering and not subscribing to it, is as follows: Impact of the Reserved Offering on Shareholders' Equity For illustration purposes, the impact of the issuance of the New Shares and the Warrant Shares on the Company's equity per share (calculation made on the basis of the Company's shareholders' equity as reflected in the consolidated financial statements as of December 31, 2024, adjusted for the capital increase of March 7, 2025, the conversion of 631,560 Heights convertible bonds into 1,930,195 new shares on April 1, 2025, in accordance with the amendment dated June 27, 2024 to the convertible bond agreement, and the capital increase of July 1, 2025) is as follows: Evolution of the Shareholding Structure following the Reserved Offering To the Company's knowledge, immediately prior to completion of the Reserved Offering, the breakdown of the Company's share capital was as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) 3 Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 4 35,795,627 23.4 % 53,106,527 20.4 % Invus 5 21,512,773 14.1 % 30,535,967 11.7 % UPMC Enterprises 6 10,158,364 6.7 % 12,487,477 4.8 % Heights 7 14,900,613 9.8 % 70,347,580 27.1 % BPI 3,877,591 2.5 % 5,355,501 2.1 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.2 % Other shareholders (total) 65,603,292 43.0 % 85,398,945 32.8 % Total 152,717,762 100.00 % 260,012,832 100.00 % Expand To the Company's knowledge, immediately after the completion of the Reserved Offering and the issuance of the New Shares, the breakdown of the Company's share capital will be as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 35,795,627 23.0 % 53,106,527 20.0 % Invus 21,512,773 13.8 % 30,535,967 11.5 % UPMC Enterprises 13,099,540 8.4 % 18,369,829 6.9 % Heights 14,900,613 9.6 % 70,347,580 26.5 % BPI 3,877,591 2.5 % 5,355,501 2.0 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.1 % Other shareholders (total) 65,603,292 42.1 % 85,398,945 32.1 % Total 155,658,938 100.0 % 265,895,184 100.0 % Expand To the Company's knowledge, after the completion of the Reserved Offering and the issuance of the New Shares and all Warrant Shares upon exercise of all Warrants, the breakdown of the Company's share capital will be as follows: Shareholders Shareholding (non-diluted) Shareholding (diluted) Number of shares and voting rights % of share capital and voting rights Number of shares and voting rights % of share capital and voting rights 5% Shareholders Sofinnova 35,795,627 22.6 % 53,106,527 20.0 % Invus 21,512,773 13.6 % 30,535,967 11.5 % UPMC Enterprises 16,040,716 10.1 % 18,369,829 6.9 % Heights 14,900,613 9.4 % 70,347,580 26.5 % BPI 3,877,591 2.4 % 5,355,501 2.0 % Directors and Officers 517,002 0.3 % 2,388,335 0.9 % Employees 352,500 0.2 % 392,500 0.1 % Other shareholders (total) 65,603,292 41.4 % 85,398,945 32.1 % Total 158,600,114 100.0 % 265,895,184 100.0 % Expand Admission to Trading of the New Shares and the Warrants Settlement-delivery of the Reserved Offering and the admission of the New Shares to trading on the regulated market of Euronext Paris are expected on July 21, 2025. The New Shares and the Warrant Shares will be subject to the provisions of the Company's by-laws and will be assimilated to existing shares upon final completion of the Reserved Offering. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company's existing shares under the same ISIN code FR0013183985 / SIGHT. The Warrants are expected to be admitted to trading on the Euronext Growth market in Paris (" Euronext Growth Paris") on July 21, 2025 on the same warrant listing line as the Company's existing warrants under the same ISIN code FR0014010IB4/SIGBS. The Warrant Shares will be admitted to trading on Euronext Paris as they are issued following the exercise of the corresponding warrants. Lock-up Commitments The benefit of the lock-up commitments agreed by the Company (45 days) and directors and officers of the Company (60 days) has been extended to UPMC Enterprises. Indicative Timetable July 16, 2025 Decision of the Chief Executive Officer setting the terms and conditions of the Reserved Offering. July 17, 2025 Publication of this press release. July 18 or 21, 2025 Publication of the Euronext notice of admission of the New Shares to trading on Euronext Paris. July 21, 2025 Settlement-delivery of the ABSAs - Detachment of the Warrants - Start of trading of the New Shares on Euronext Paris. Admission of the Warrants on Euronext Growth Paris Expand Risk Factors The Company draws the attention of the public to the risk factors relating to the Company and its business described in its 2024 Universal Registration Document, as updated in the Information Document made available in connection with the Early July Financing, which are available free of charge on the Company's website ( . In addition, the main risks specific to securities are as follows: The existing shareholders who do not participate in the Reserved Offering will see their shareholding in the share capital of GenSight diluted, and this shareholding may also be further diluted in the event of the exercise of the Warrants, as well as in the event of new securities transactions. The volatility and liquidity of GenSight shares could fluctuate significantly. The market price of the Company's shares may fluctuate and fall below the subscription price of the shares issued in the context of the Reserved Offering. The sale of Company shares may occur on the secondary market, after the Reserved Offering, and have a negative impact on the Company share price. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Disclaimer Not for release, directly or indirectly, in or into the United States of America, Canada, Australia, Japan or South Africa. This press release and the information contained herein do not contain or constitute an offer to subscribe or purchase, or the solicitation of an order to purchase or subscribe, for securities in the United States of America or in any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the Securities Act, or under the securities laws of any state or other jurisdiction of the United States of America, and may not be offered or sold in the United States of America except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with the securities laws of any state or any other jurisdiction of the United States. GenSight does not intend to make a public offering of the securities in the United States of America. The distribution of this press release may be subject to legal or regulatory restrictions in certain countries. Persons in possession of this press release should inform themselves of and observe any local restrictions. The information contained herein is subject to change without notice. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Reserved Offering; the anticipated cash runway of the Company; and future expectations, plans and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Reserved Offering and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the Autorité des marchés financiers from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. 1 The number of shares contained in the table includes 107,295,070 shares that may be issued by the Company further to the exercise of the remaining share warrants, founders share warrants, free shares and stock options outstanding, including the share warrants issued as part of the Early July Financing. 2 Idem. 3 Idem. 4 Sofinnova Partners: French management company located at 7-11 boulevard Haussmann, 75009 Paris, France, which manages Sofinnova Crossover I SLP. 5 Invus: a Bermudian company located at Clarendon House, 2 Church Street, Hamilton HM 11 Bermuda. Pursuant to the provisions of Article L. 233-9 I, 4° bis of the French Commercial Code, Invus has stated that they hold 6,360,058 shares of GENSIGHT BIOLOGICS S.A. as a result of holding "contracts for differences" ("CFDs") maturing on January 3, 2034, covering an equivalent number of GENSIGHT BIOLOGICS S.A. shares, to be settled in cash. 6 UPMC Enterprises: a non-profit organization located at 6425 Penn Avenue, Suite 200, Pittsburgh, Pennsylvania, United States of America. 7 Heights Capital: a Cayman Islands exempted company located at PO Box 309GT, Ugland House South Church Street, George Town Grand Cayman, Cayman Islands.
Business Wire
08-07-2025
- Business
- Business Wire
GenSight Biologics Reports Cash Position as of June 30, 2025
PARIS--(BUSINESS WIRE)--Regulatory News: "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics." Share GenSight Biologics (" GenSight Biologics" or the " Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of June 30, 2025. "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics. We successfully completed the technology transfer of LUMEVOQ's upstream manufacturing process to our new partner Catalent, secured the ANSM's agreement to consider opening the AAC program in France, and closed our private placement financing in July, ' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. ' We continue to actively pursue non-dilutive financing options to support our critical value-driving activities. With the AAC program launch planned for Q4 2025, we have established a clear financial pathway through H2 2026, when we expect to initiate our Phase III RECOVER trial and submit our marketing application to the MHRA of the UK." Cash position as of June 30, 2025 GenSight Biologics' cash and cash equivalents totaled €0.3 million as of June 30, 2025, compared to €0.9 million as of March 31, 2025. With the equity-with-warrants-attached and pre-funded warrants financing announced on July 1, 2025 (approximately €3.9 million) and the anticipated collection of approximately additional €0.2 million in Research Tax Credit (CIR) in September, and based on current operations, plans, and assumptions, this balance should fund operations until early October 2025. EUR 0.7 million of the proceeds from the financing has been used for the repayment in principal on the convertible bonds held by Heights Capital through offset against their subscription. The funds are insufficient to cover operational requirements for the next 12 months. However, the anticipated opening of the AAC program in France in Q4 2025 (targeted for October) will establish a clear cash pathway until H2 2026, when the company expects to initiate the RECOVER Phase III clinical trial and to submit the UK MHRA marketing application for LUMEVOQ ®. The company is pursuing strategic options that could generate funds for the Phase III trial and UK regulatory submission. These include: Licensing of LUMEVOQ outside Europe and the United States Exploring paid compassionate access programs in other countries Release of the second tranche of the EIB loan In the first quarter of 2026, the company will have a precise view of residual financing needs and will make a strategic decision on additional financing modalities. If necessary, GenSight Biologics may access financial markets. Options in the medium term include partnering or M&A arrangements. Recapitulation of Recent Milestones Regulatory Progress and Named Early Access Program (AAC) In June 2025, GenSight achieved a significant regulatory milestone when the ANSM agreed to consider opening the LUMEVOQ ® AAC program, contingent upon approval of a dose-ranging study. The Company has submitted a preliminary study design to the agency and expects to finalize the protocol in Q3 2025. Concurrently, GenSight is working with the ANSM to establish AAC program access for patients who may not qualify for the study but could benefit from early access to LUMEVOQ ®. The AAC program is targeted to launch by Q4 2025, with an anticipated opening in October 2025. Manufacturing Partnership and Scale-Up In June 2025, the Company successfully completed the transfer of LUMEVOQ ® 's upstream manufacturing process to its new manufacturing partner, Catalent, Inc. The technology transfer is expected to be finalized by the end of 2025, positioning Catalent to manufacture the drug product for both the planned global Phase III RECOVER trial and regulatory submission requirements. Number of outstanding shares As of July 8, 2025, GenSight Biologics' number of outstanding shares was 152,717,762 ordinary shares. Financial Agenda The Company will report its interim H1 financial results by the end of September 2025. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Private Placement; the anticipated cash runway of the Company; and future expectations, plans, and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Private Placement and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
Medscape
02-07-2025
- Health
- Medscape
Long COVID Rates Higher in Women: Evidence Grows
When Brazilian scientist Letícia Soares contracted COVID-19 in April 2020, she was in the final stretch of her postdoctoral studies in disease ecology at a Canadian University. By August, she was bedbound. What began as piercing migraines quickly escalated into a cascade of long COVID symptoms — gastrointestinal distress, sleeplessness, joint and muscle pain, and crushing fatigue. For Soares and many other women with long COVID, it also included sudden menstrual changes that exacerbated her other symptoms. 'It just baffled me,' said Soares, now 40. 'It was debilitating.' Before COVID, she had a stable, predictable cycle while using a hormonal IUD — light cramping, mild abdominal swelling, and consistent, manageable bleeding. Then, after her infection, her period disappeared entirely. A couple of years later, the pattern reversed: prolonged, heavy bleeding returned, compounding her long COVID symptoms and triggering severe crashes from post-exertional malaise — one of the hallmarks of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a condition linked to post-viral illness. Cases like Soares's are leading scientists to spend more time trying to understand the biologic sex disparity in chronic illnesses such as long COVID that initially had all but been ignored. New research from the National Institutes of Health RECOVER initiative, the largest observational study to date, confirms what many have long suspected: Women face a significantly higher risk of developing long COVID than men. While men are more likely to experience severe acute illness and higher mortality, growing evidence suggests women are more vulnerable to chronic symptoms. Published in JAMA Network Open , the study analyzed data from over 12,200 participants who had been infected by COVID between 2021 and 2024. Even after adjusting for clinical and demographic factors, women had a 31%-44% higher likelihood of developing long COVID than men. The risk was especially pronounced among nonpregnant, nonmenopausal participants. This study is the first to examine risk across different groups assigned women at birth, revealing that age, pregnancy, and menopause all play a role in long COVID likelihood, said lead author Dimpy Shah, MD, PhD, assistant professor of population health sciences at The University of Texas Health Science Center at San Antonio. 'That is a very novel finding.' Five years into the pandemic, with hundreds of millions of people worldwide affected by lingering symptoms, this emerging research on biologic sex disparities highlights the complexity of long COVID and how it intersects with hormonal cycles and life stages. The study found that when adjusting for variables like age, race, and underlying health conditions, women had a 31% higher risk for long COVID. When only age and race were accounted for, the risk jumped to 44%, suggesting that other factors, including autoimmune conditions and post-viral illnesses, may influence the link between sex and long COVID. The RECOVER study revealed notable patterns: Pregnant women aged 18-39 years had a lower long COVID risk than their nonpregnant counterparts compared with men in the same age group. Similarly, menopausal women aged 40-54 years had a lower risk than nonmenopausal women in that age group. 'This could be due to hormonal changes and variations in inflammatory responses, which shift with age,' Shah explained. By identifying how biologic sex, pregnancy, and menopause affect long COVID risk, this study moves the field closer to understanding why some individuals experience prolonged illness — and how treatment strategies might be tailored accordingly. While the latest RECOVER study wasn't designed to analyze hormone levels, senior author Nora G. Singer, MD, director of Rheumatology at MetroHealth Medical Center in Cleveland, emphasized the need for future research in this area. 'If we understood better the biologic mechanisms contributing to sex specificity, I think the question is, could we better stratify who we're worried about developing long COVID? Could we target drugs? Are there ways we could manipulate things to make people less likely to get long COVID, and are there different levels of immune response at these different ages?' Emerging 'Menstrual Science' Could Be Key Expanding this research is critical as long COVID and similar chronic conditions remain largely overlooked in medical funding and study. 'These illnesses are underfunded and understudied relative to their disease burdens,' said Beth Pollack, a research scientist at the Massachusetts Institute of Technology, Cambridge, Massachusetts, who studies complex chronic illnesses. Addressing knowledge gaps, especially around sex differences, could significantly improve our understanding of complex chronic illnesses, said Pollack, who co-authored a 2023 literature review of female reproductive health impacts of long COVID. For example, several previous studies and surveys of female patients with long COVID report an increase in symptoms related to menstruation, which further suggests a possible link between sex hormone fluctuations and immune dysfunction in the illness. Sex Hormones and Immunity The pathologies of long COVID currently focus on four hypotheses: persistent viral infection, reactivation of dormant viruses (such as common herpes viruses), inflammation-related damage to tissues and organs, and autoimmunity (the body attacking itself). It's this last reason that holds some of the most interesting clues on biologic sex differences, said Akiko Iwasaki, PhD, a Yale University, New Haven, Connecticut, immunologist who has led numerous research breakthroughs on long COVID since the start of the pandemic. Women have two X chromosomes, for example, and although one is inactivated, the inactivation is incomplete. Some cells still express genes from the 'inactivated genes' on the X chromosome, Iwasaki said. Those include key immune genes, which trigger a more robust response to infections and vaccinations but also predispose them to autoimmune reactions. 'It comes at the cost of triggering too much immune response,' Iwasaki said. Sex hormones also factor in. Testosterone, which is higher in men, is immunosuppressive, so it can dampen immune responses, Iwasaki said. That may contribute to making men more likely to get severe acute infections of COVID but have fewer long-term effects. Estrogen, on the other hand, is known to enhance the immune response. It can increase the production of antibodies and the activation of T cells, which are critical for fighting off infections. This heightened immune response, however, might also contribute to the persistent inflammation observed in long COVID, where the immune system continues to react even after the acute infection has resolved. Sex-Specific Symptoms and Marginalized Communities Of the more than 200 symptoms people with long COVID experience, Iwasaki said, several are also sex-specific. A draft study by Iwasaki and another leading COVID researcher, David Putrino, PhD, at Mount Sinai Health System in New York City, shows hair loss as one of the most women-dominant symptoms and sexual dysfunction among men. In examining sex differences, another question is why long COVID rates in the trans community are disproportionately high. One of the reasons Iwasaki's lab is looking at testosterone closely is because anecdotal evidence from female-to-male trans individuals indicates that testosterone therapy improved their long COVID symptoms significantly. It also raises the possibility that hormone therapy could help. However, patients and advocates say it's also important to consider socioeconomic factors in the trans community. 'We need to start at this population and social structure level to understand why trans people over and over are put in harm's way,' said J.D. Davids, a trans patient-researcher with long COVID and the co-founder and co-director of Strategies for High Impact and its Long COVID Justice project. Where It All Leads The possibility of diagnosing long COVID with a simple blood test could radically change some doctors' false perceptions that it is not a real condition, Iwasaki said, ensuring it is recognized and treated with the seriousness it deserves. 'I feel like we need to get there with long COVID. If we can order a blood test and say somebody has a long COVID because of these values, then suddenly the diseases become medically explainable,' Iwasaki added. This advancement is critical for propelling research forward, she said, refining treatment approaches — including those that target sex-specific hormone, immunity, and inflammation issues — and improving the well-being of those living with long COVID. This hope resonates with scientists like Pollack, who led the first National Institutes of Health-sponsored research webinar on less studied pathologies in ME/CFS and long COVID, and with the experiences of individuals like Soares, who navigates through the unpredictable nature of both of these conditions with resilience. 'This illness never ceases to surprise me in how it changes my body. I feel like it's a constant adaptation,' said Soares. Now living in Salvador, Brazil, her daily life had dramatically shifted to the confines of her home. While her condition limits many aspects of her life, working remotely allows her to stay involved in disability advocacy as a co-lead and researcher at the international Patient-Led Research Collaborative. Understanding sex differences in long COVID could also transform care for millions. From a public health perspective, new research could improve diagnosis in clinics, inform targeted therapies for high-risk groups, and encourage women to take their symptoms seriously. 'Because they are at potentially higher risk for long COVID, if they're not feeling well, they should definitely talk to their primary care or internal medicine physicians,' said Shah, reflecting on the latest RECOVER study's findings. 'It's a call to action.'
Business Wire
04-06-2025
- Business
- Business Wire
LivaNova Initiates Process with U.S. Centers for Medicare and Medicaid Services for Reconsideration of National Coverage for VNS Therapy for Treatment-Resistant Depression
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it has initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) to seek reconsideration of national Medicare coverage for VNS Therapy™ in unipolar patients with treatment-resistant depression (TRD). The first step in the process for making a National Coverage Determination (NCD) is the submission of a draft formal request for CMS reconsideration. "We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. Five critical articles featuring outcomes from in-depth data analyses on primary and select secondary endpoints in the RECOVER study have recently been published in or accepted by peer-reviewed journals, and the totality of data presented in these articles serves as the basis of the Company's request to CMS. The company believes these articles satisfy the Coverage with Evidence Development (CED) requirement of sharing peer-reviewed, publicly accessible results of pre-specified outcomes measured in the RECOVER study. In addition to the five articles, the request for coverage reconsideration includes strong 24-month clinical outcomes from the unipolar cohort of the RECOVER clinical study that demonstrate the substantial retention of benefits and the durability of VNS Therapy over time. 'We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'Our follow-on analyses of the RECOVER unipolar data demonstrate that symptoms alone may not be the sole source upon which to gauge the clinical impact of treatment. Instead, symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness. We are eager to review this powerful data with CMS during the reconsideration process.' Final Articles in Critical Series Analyze RECOVER Primary and Select Secondary Endpoint Data Two new in-depth analyses 1,2 on primary and select secondary endpoints in the RECOVER trial have recently been published and a third accepted by peer-reviewed journals. Prior to these articles, two initial articles were published in Brain Stimulation 3,4 in December 2024, completing the series of five critical articles in total. Collectively, the articles highlight the significant unmet need of this markedly ill population with TRD. The RECOVER data demonstrates that VNS Therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS. Depressive symptoms, daily function, and quality of life taken together, as a novel composite metric, present a more complete picture of treatment effectiveness than symptoms alone. The fifth and final critical publication utilizes this composite metric and demonstrates favorable response to VNS Therapy in TRD patients who had previously failed multiple treatments, including interventional therapies. Researchers found that patients with previous ECT or TMS treatment had statistically significant and clinically meaningful benefits with active VNS Therapy. Notably, VNS Therapy is the only treatment that has demonstrated therapeutic effects in patients who previously failed ECT. 24-Month VNS Therapy Data Show Durability, Increasing Response Across All Outcome Measures New top-line 24-month data from the RECOVER study show that, across all outcome measures, VNS Therapy patients in the active arm of RECOVER experienced a substantial durability of benefit from month 12 to month 24. Of those patients who at 12 months had achieved clinically meaningful benefit, the median durability of benefit was 81.3% across all outcome measures at the 24-month assessment. This is considerable durability for these unipolar patients who, at baseline in the RECOVER study, had failed more than 13 antidepressant treatments on average. Observing all VNS Therapy patients in the active treatment arm of the RECOVER trial from month 12 to month 24, researchers also found improvement in all outcome measures, with the median rate of response, or clinically meaningful benefit, increasing from 40.2% at month 12 to 51.6% at month 24. 'There is no clinical evidence to demonstrate that there are any other therapies, including pharmacotherapies and interventional therapies such as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), that can claim this profound level of sustained durability and increasing benefit,' said A. John Rush, M.D., Professor Emeritus at Duke-National University of Singapore Medical School who has spent 25 years researching VNS Therapy for TRD and served as Chief Consultant on the RECOVER trial. 'These are critical findings that offer hope to treatment-resistant depression patients and their loved ones, who have struggled for years to find effective options. Patients not only stay better – they also continue to get better.' Improvement in suicidality shows statistically significant separation as early as month three LivaNova conducted additional in-depth analyses specifically evaluating suicidality for the active treatment arm of RECOVER through the first 12 months of therapy. Using a composite suicidality measure 5, results showed an estimated 43% higher odds of achieving meaningful improvement in suicidal ideation symptoms versus the control arm. Of specific interest, there was separation between the active and control arms on the composite suicidality metric as early as month three. Additionally, the observed separation was consistent throughout the initial 12 months. 'The composite suicidality outcome is especially encouraging because we can see a separation between the active and control arms so early in the study,' said Charles Conway, M.D., director of the Washington University Resistant Mood Disorders Center at Washington University School of Medicine in St. Louis. Conway is the RECOVER study's lead investigator. 'We're eager to further evaluate the suicidality data beyond 12 months and, in the context of the overall durability story of VNS Therapy, determine whether this benefit also continues to improve over time.' While not included in the initial submission to CMS, the suicidality data will be provided in detail to the agency upon publication in a peer-reviewed journal. RECOVER launched in 2019 as part of a CED framework per the CMS NCD process. For the unipolar cohort of RECOVER, enrollment was completed in March 2023, and the 12-month follow-up for those patients was completed in March 2024. No new safety issues were identified in the study. About RECOVER LivaNova's VNS Therapy™ System has been approved for the treatment of depression since earning CE Mark in 2001 and premarket approval (PMA) from the U.S. Food and Drug Administration in 2005. RECOVER stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression. The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. About VNS Therapy for Depression The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug Administration-approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. The most commonly reported side effects are voice alteration or hoarseness, prickling or tingling in the skin, increased coughing, shortness of breath, and sore throat. Infection is the most common complication of the surgical procedure. Important safety information is available at References Conway CR, et al. An examination of symptoms, function, and quality of life as conjoint clinical outcome domains for treatment-resistant depression. Journal of Mood & Anxiety Disorders. April 14, 2025. DOI: 10.1016/ Sackeim HA, et al. Characterizing the effects of vagus nerve stimulation on symptom improvement in markedly treatment-resistant major depressive disorder: A RECOVER trial report. July 1, 2025. DOI: 10.1016/ Conway CR, et al. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ Rush AJ, et al. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ The composite suicidality metric was created by adding a suicidality-specific question from each of MADRS, Quick Inventory of Depressive Symptomology–Self Report, or QIDS-SR, and Quick Inventory of Depressive Symptomology–Clinical, or QIDS-C. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the RECOVER study, the VNS Therapy™ System, Symmetry™, and the likelihood that the Company is successful in obtaining national Medicare coverage for its VNS Therapy™ System. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
Time of India
29-05-2025
- Health
- Time of India
Infants prone to sleep, appetite issues in long Covid; preschoolers to dry cough: US study
New Delhi: Infants under two-years-old, suffering from long Covid are more likely to experience trouble sleeping, fussiness, poor appetite, stuffy nose, and cough, while children aged three to five are more likely to have a dry cough and tiredness, according to a new study in the US. "Children with these symptoms often had worse overall health, lower quality of life, and delays in development," co-first author Tanayott Thaweethai, associate director of biostatistics research and engagement at Massachusetts General Hospital, US, said. Long Covid refers to symptoms that persist well beyond having recovered from an acute COVID-19 infection. The findings, published in the Journal of the American Medical Association (JAMA) Pediatrics, are the latest from the US National Institutes of Health's 'RECOVER' initiative, aimed at understanding and preventing long Covid. An earlier analysis by the team in August 2024, found that children aged six to 11 displayed brain- and stomach-related symptoms such as headache, trouble focussing and sleeping, while teenagers experienced a loss of smell and taste, fatigue and physical pain. Notably, teens were found to display long Covid symptoms more similar to adults -- who often report brain fog and fatigue -- than to children. This study is "important because it shows that long COVID symptoms in young children are different from those in older children and adults," Thaweethai said. "Infants (or) toddlers (0-2 years) with infection history were more likely to experience trouble sleeping, fussiness, poor appetite, stuffy nose, and cough, and preschool-aged children (3-5 years) were more likely to experience dry cough and daytime tiredness (or) sleepiness or low energy," the authors wrote. The researchers examined 472 infants and 539 preschoolers, of which 278 infants and 399 pre-schoolers had previously suffered from COVID-19. The participants were enrolled between March 2022 and July 2024. Among those with a history of infection, 40 infants (14 per cent) and 61 pre-school children (15 per cent) were identified as having long Covid. Symptoms lasting at least 90 days after COVID infection for both age groups were analysed -- 41 symptoms in the infant group and 75 in preschoolers. Parts of India, including Delhi-NCR, West Bengal and Karnataka, are seeing an uptick in COVID-19 cases, which have been attributed to Omicron sub-variants. Severity of infections as of now is generally mild and there is no cause for worry, the Indian Council of Medical Research (ICMR) had said on May 26.>
