ONE Retreats' Transformative Psilocybin Wellness Initiative Addresses Mental Health Conditions for Veterans
SEAL Future Foundation joins forces to expand safe access to psychedelic-assisted therapies
'Guidance Integration Platform' to provide integration resources for the patient community
RUNAWAY BAY, Jamaica, Feb. 26, 2025 (GLOBE NEWSWIRE) -- In a bold move to combat the mental health crisis facing veterans, ONE Retreats Jamaica, a premier psilocybin-assisted retreat provider, is currently offering a specialized Psilocybin Wellness Program for veterans. Designed to directly tackle PTSD, TBI, depression, anxiety, and suicidality, the program offers a structured, expert-led healing experience that blends cutting-edge science with time-honored therapeutic practices.
As Jamaica's leading psychedelic retreat provider, ONE Retreats is committed to safety, personal growth, and transformative healing. Since launching in 2023, it has hosted 8 veteran-focused retreats, welcoming 80 veterans and numerous civilians on their journey to wellness. Of those who have attended, 90% have reported significant relief and lasting benefits.
A key component of the program is the 'Guidance Integration" platform'—a first-of-its-kind online community offering ongoing integration, coaching, peer support, and educational resources to ensure lasting healing, long after participants return home. ONE Retreats also leads rigorous data collection efforts to advance research on psilocybin's effectiveness in treating mental health conditions.
'With 22 veterans tragically taking their own lives every day, it's clear that the conventional approach and traditional treatments are not adequately addressing the root causes of deep-seated emotional trauma,' said Kevin Bourke, co-founder of ONE Retreats. "Our Psilocybin Wellness Program represents a crucial step forward in addressing the urgent mental health needs of veterans. By combining our psilocybin expertise with ONE Retreats' transformational approach, we're offering veterans a real, sustainable path to healing."
"The transformative power of psilocybin therapy, when combined with proper preparation, setting, and integration support, can create profound breakthroughs for those struggling with trauma," said Vernise Cardillo, Retreat Operations Chief of ONE Retreats. "Drawing from my extensive experience in curating healing journeys worldwide, we've created a sanctuary where veterans can safely explore these treatments alongside expert facilitators who understand their unique challenges. Our program's success rate speaks to the critical importance of providing alternative healing modalities to those who've served our country."
Backed by the SEAL Future Foundation (SFF), a dedicated organization supporting Navy SEAL veterans, ONE Retreats is bridging the gap between breakthrough psychedelic therapies and those who need them most.
Participants begin with personalized consultations to ensure readiness before embarking on a six-day immersive retreat in Negril, Jamaica. The experience includes two psilocybin-assisted therapy sessions in a safe, legally regulated setting, supported by medical professionals and trained facilitators. Post-retreat, the Guidance Integration Platform provides long-term support for continued growth.
"For far too long, there has been a significant gap between effective mental health treatments and the veterans who desperately need them. At SEAL Future Foundation, our mission is to provide Navy SEALs a foundation that supports their well-being, education and careers to continue a life of service within their communities,' said Patrick Regan, veteran and volunteer Washington DC Forward Operating Base Lead of SEAL Future Foundation. 'Our members who participated in ONE Retreats experienced the profound impact of this therapy firsthand. The resounding sentiment from all participants is that they would undergo psilocybin therapy again and recommend it to others that are struggling, or simply working on personal improvement."
Jamaica's forward-thinking approach to psychedelics offers a legal, secure setting for this evidence-based mental health treatment. Building on the success of its Jamaica-based retreats, ONE Retreats is strengthening its data-driven research and expanding to the U.S. By 2026, licensed psilocybin-assisted therapy programs in Oregon and Colorado will make these transformative treatments more accessible to veterans who cannot travel internationally.
Veterans and organizations interested in participating in the Psilocybin Wellness Program can learn more at ONE Retreats. To donate to the SEAL Future Foundation, visit https://sealff.org/donate/.
About ONE RetreatsONE Retreats Jamaica is a premier provider of transformative psilocybin-assisted therapy retreats, offering safe, supportive environments for healing and personal growth. By blending traditional wisdom with modern therapeutic practices, our retreats help participants—both civilians and veterans—navigate mental health challenges, trauma, and self-discovery. Through guided psilocybin therapy and structured integration support, ONE Retreats is committed to making psychedelic healing more accessible while fostering a strong community of support and long-term well-being.
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In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE), as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology's annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO. 'Despite being a common manifestation of systemic lupus erythematosus, fatigue is a difficult-to-treat symptom that can severely impact a person's quality of life, and remains a challenge to address,' said Ioannis Parodis, MD, PhD, Associate Professor of Rheumatology, Karolinska University Hospital, Sweden. 'The results we observed in this Phase 3 study indicate that participants treated with dapirolizumab pegol have the potential to achieve consistent improvements in fatigue beyond the current standard of care.' In an analysis of the impact of DZP on patient-reported fatigue in people with SLE participating in the PHOENYCS GO study, individuals receiving DZP in addition to standard of care (SOC) treatment demonstrated improvements across two fatigue measurements: Improvements in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores were greater in the DZP group (change from baseline, 8.9), compared with SOC alone (5.2; nominal* p=0.0024) at Week 48. Using FATIGUE-PRO, a measure recently developed to capture the patient experience of fatigue in SLE, greater improvements from baseline (nominal* p<0.05) were observed in people receiving DZP compared with SOC alone in the Physical Fatigue (change from baseline difference between groups,7.6), Mental and Cognitive (5.6), and Susceptibility to Fatigue (7.8) scales at Week 48. 'Being able to address both fatigue and remission are areas of critical unmet need in lupus care, an important treatment goal is to improve the quality of life for patients as well as to reduce the long-term risk of organ damage through disease remission,' said Eric F. Morand, MBBS, Head of the Monash Health Rheumatology Unit, Monash University, Australia. 'In the PHOENYCS GO study, dapirolizumab pegol has shown meaningful impact in helping patients achieve remission and low disease activity, offering the exciting possibility for improved disease control while reducing exposure to glucocorticoids. 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An estimated 90% of people living with lupus are women; most begin to see symptoms between the ages of 15-55.3,4,5 Individuals from populations of African, Hispanic, Asian and Native American descent are at a greater risk of earlier onset and more aggressive disease.6,7 Pregnancy in women with SLE is high risk, with higher maternal and fetal mortality and morbidity than the general population.8,9 About Dapirolizumab PegolDapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment. 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About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient's lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Forward looking statements UCBThis document contains forward-looking statements, including, without limitation, statements containing the words 'potential', 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'continue' and similar expressions. 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These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References: Tselios K, Gladman DD, Touma Z, et al. Disease course patterns in systemic lupus erythematosus. Lupus. 2019;28(1):114-122. Fanouriakis A, Tziolos N, Bertsias G, et al. Update οn the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis. 2021;80(1):14-25. doi:10.1136/annrheumdis-2020-218272 Petri M. Epidemiology of systemic lupus erythematosus. Best Pract Res Clin Rheumatol. 2002;16(5):847-58. Epub 2002/12/11. doi: 10.1053/berh.2002.0259. PubMed PMID: 12473278. Rees F, Doherty M, Grainge M, Davenport G, Lanyon P, Zhang W. The incidence and prevalence of systemic lupus erythematosus in the UK, 1999-2012. Ann Rheum Dis. 2016;75(1):136-41. Epub 2014/10/01. doi: 10.1136/annrheumdis-2014-206334. PubMed PMID: 25265938; PubMed Central PMCID: PMCPMC4717400. Pons-Estel GJ, Ugarte-Gil MF, Alarcón GS. Epidemiology of systemic lupus erythematosus. Expert Rev Clin Immunol. 2017;13(8):799-814. Carter EE, Barr SG, Clarke AE. The global burden of SLE: prevalence, health disparities and socioeconomic impact. Nat Rev Rheumatol. 2016;12(10):605-20. Epub 2016/08/26. doi: 10.1038/nrrheum.2016.137. PubMed PMID: 27558659. Kheir JM, Guthridge CJ, Johnston JR, Adams LJ, Rasmussen A, Gross TF, et al. Unique clinical characteristics, autoantibodies and medication use in Native American patients with systemic lupus erythematosus. Lupus Sci Med. 2018;5(1):e000247. Epub 2018/03/14. doi: 10.1136/lupus-2017-000247. PubMed PMID: 29531773; PubMed Central PMCID: PMCPMC5844376. Mehta B, Luo Y, Xu J, Sammaritano L, Salmon J, Lockshin M, et al. Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis. Ann Intern Med. 2019;171(3):164-71. Epub 2019/07/10. doi: 10.7326/M19-0120. PubMed PMID: 31284305. Bitencourt N, Bermas BL. Pharmacological Approach to Managing Childhood-Onset Systemic Lupus Erythematosus During Conception, Pregnancy and Breastfeeding. Paediatr Drugs. Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford).2021;60(11): 5397-407. (NCT04294667). A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS GO) 2023 [cited August 2024] Available at: Retrieved July 25, 2024. MEDIA CONTACTS:UCBAdriaan Snauwaert+32 497 70 23 BiogenJack Cox+1 781 464 INVESTOR CONTACTS:UCBAntje Witte+32 2 559 Power+ 1 781 464 2442IR@
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More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch. Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives. 'We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,' said Mesoblast Chief Executive Dr. Silviu Itescu. 'We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch. We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.' About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@
