

The partnership reflects a growing shift towards brand presence within culturally rooted narratives
India, June 06: Omnigel, Cipla Health’s leading pain relief brand, has announced its in-film association with Peddi, a highly anticipated Telugu sports film featuring Ram Charan and Janhvi Kapoor.
Set in 1980s rural Andhra Pradesh, Peddi brings to life a powerful story of sport, resilience and community. Reflecting these themes, Omnigel has been integrated into the film’s narrative through contextual and natural placements, aligning the brand closely with moments of performance, recovery and endurance.
Omnigel is integrated into the film across several moments, reflecting its presence within a sport-led setting. It is also seen during the film’s central sports sequence, aligning with the broader themes of performance and resilience.
This association builds on Cipla Health’s ongoing efforts to explore formats beyond traditional media, with a sharper focus on platforms that are more culturally rooted and locally relevant. In the case of Peddi, the choice of a regional, sport-led film allows the brand to be part of a narrative that reflects everyday resilience and performance, rather than communicate through conventional advertising formats.
Commenting on the strategic association, Mr. Shivam Puri, MD & CEO, Cipla Health Limited, said: “Pain and recovery are strongly connected to how people live their daily lives, whether through sports or routine activities. At Cipla Health, our key focus with Omnigel has been to build solutions that support sustained movement. Peddi, with its grounding in sport and resilience, reflects this reality in a very natural way, making it a relevant context for us to be part of. Through this association, we are also looking at newer ways of engaging with audiences, where the brand can be present within the environments and stories they relate to.”
With sport at the centre of the film, Omnigel’s presence aligns with the physical demands and recovery associated with it. It also reflects the brand’s relevance in everyday movement and activity.
Omnigel is the leading player in pain relief brand offering solutions for everyday muscle and joint pain. It is designed to provide quick relief and help individuals stay active in their daily lives.
BURLINGTON, Mass. — June 4, 2026: Azara Healthcare, the four-time Best in KLAS provider of population health and value-based care solutions for the safety net, today announced that it has acquired Advocatia, a digital-first public benefits enrollment platform. The combination delivers the first end-to-end Medicaid coverage retention solution — pairing the Azara DRVS platform’s ability to identify and engage at-risk individuals with Advocatia’s strengths in guiding them through application, documentation, and initial enrollment or renewal of Medicaid coverage and other public benefits programs.
Together, the combined solution enables clients to:
– Identify and prioritize patients at risk of losing coverage using Azara DRVS registries and risk stratification
– Engage patients at scale through automated, multi-channel outreach
– Guide patients through the enrollment and renewal process in 75 languages via Advocatia’s self-service digital platform
– Capture documentation and income verification to support redeterminations and new work requirement reporting
– Provide health center staff and navigators real-time visibility into patient progress and completion rates alerting and allowing them to intervene when additional help is needed
The move comes as community health centers, hospitals, and other safety-net providers prepare for one of the most significant coverage shifts in a generation. Under the One Big Beautiful Bill Act (HR.1), more than 7.6 million Americans are projected to lose Medicaid coverage by 2034, and 80-hour monthly work requirements take effect in January 2027. The financial stakes for safety-net organizations are immediate. Hospitals are estimated to have delivered over $36 billion in uncompensated care to uninsured patients in each of the past 3 years, underscoring the growing pressure on providers caring for vulnerable populations. Compounding the challenge, the National Association of Community Health Centers (NACHC) projects HR.1 will reduce community health revenue by $7 billion annually due to increased uncompensated care — a level of strain that could force 1,800 site closures and 34,000 job losses nationwide.
“Our clients have been telling us the same thing for months: they need help ensuring that all patients still eligible for Medicaid coverage successfully re-enroll before deadlines and coverage loss,” said Jeff Brandes, President and CEO of Azara Healthcare. “Integrating Advocatia into the Azara platform closes that last mile by providing a single, connected workflow which moves a patient from identification, to outreach, to completed application, to coverage. That’s a meaningful step forward for the millions of patients who rely on safety net organizations for care.”
Azara’s solutions, including the Azara DRVS platform, Azara Care Connect (ACC), and Azara Patient Outreach (APO), already help more than 1,000 safety-net provider organizations identify and engage patients who are at risk of falling off the Medicaid rolls during reenrollment periods. Clients include community health centers, rural and critical access hospitals, primary care associations, clinically integrated networks and health plans across all 50 states. Advocatia adds the final, essential layer. Its digital, guided enrollment experience walks patients through enrollment in Medicaid, SNAP, and more than 1,000 additional public benefit programs, with built-in tools for document collection, application completion, and follow-up.
Advocatia brings a decade of experience working with hospitals, providers, and health plans, with more than 5 million patients having accessed the platform. The company reports industry-leading metrics including 93% application submission rate among users who begin the process, 86% approval rate on submitted applications, and 33% reduction in application completion time.
“Advocatia was built on the simple belief that no one should lose coverage because the process is too hard to navigate,” said Ryan Brebner, Co-Founder and CEO of Advocatia. “Joining Azara lets us deliver on that mission at a scale we couldn’t reach alone. Azara already has trusted relationships with the safety-net providers and health plans serving the communities we’re built to help, and together, we can make sure those individuals don’t just get identified but stay covered.”
The combined Azara and Advocatia solution is available to Azara clients immediately, with several additional capabilities planned throughout 2026 and into 2027.

Core-collapse supernovae are thought to be powered by neutrino-driven energy transport. Now, researchers in Japan have shown that neutrino fast flavor conversion can either enhance or suppress supernova explosions depending on the progenitor star. Using advanced multiangle neutrino radiation hydrodynamics simulations, the team demonstrated that the mass accretion rate is the key factor governing this bifurcated behavior, offering new insight into the evolution and death of massive stars.
Our universe, filled with galaxies and stars, is full of mysteries. Over the centuries, astronomers have observed and documented supernova—the catastrophic explosion of stars—as some of the brightest and most energetic events in the universe. In particular, at the end of their lives, massive stars explode into core-collapse supernovae (CCSNe). Scientists believe these explosions to be mainly facilitated by neutrino-mediated energy transport. However, the effects of collective neutrino oscillations known as fast flavor conversion (FFC) on the CCSN explosion mechanism remain largely unclear.
Previous studies attempted to investigate the role of FFC in CCSNe using approximate “truncated moment” methods. However, these approaches cannot reliably capture the angular neutrino distributions needed to determine where FFC occurs.
A new study instead employs a multiangle treatment, allowing the researchers to directly model the angular behavior of neutrinos in momentum space.
The team of researchers, led by Assistant Professor/Junior Researcher Ryuichiro Akaho from the Faculty of Science and Engineering at Waseda University, Japan, along with co-authors Dr. Hiroki Nagakura from the National Astronomical Observatory of Japan and Professor Shoichi Yamada from Waseda University, has carried out CCSN simulations with multiangle neutrino transport to elucidate the impact of neutrino FFC on CCSNe.Their insightful findings were made available onlineon May 11, 2026, and have been published inVolume 136, Issue 19 ofthe journal Physical Review Letters on May 15, 2026. The paper was also selected as a “Featured in Physics” article by the journal editors, recognizing its significance and broad interest to the physics community.
In this study, the team combined a quantum kinetic theory-based FFC model with multidimensional Boltzmann neutrino radiation hydrodynamics simulations. Their framework directly identifies where FFC occurs using neutrino angular distributions calculated during the simulation itself. Akaho remarks: “We deploy our first-ever Boltzmann radiation hydrodynamics code that implements an FFC subgrid model, judge the occurrence of FFC directly from angular distributions obtained in simulations, and ascertain neutrino flavor states via physics-based quantum kinetic methodsimplemented through the Bhatnagar-Gross-Krook relaxation scheme. Crucially, we have already demonstrated this extended framework of neutrino transport in our previous work.”
The CCSN simulations presented in this study encompass successful as well as failed explosions, various progenitor models with zero-age main sequence masses of 9, 12, 16, and 20M⊙, and three different nuclear equations of state (EOSs), namely, variational method-based Furusawa-Togashi EOS, Dirac-Brückner-Hartree-Fock technique, and chiral effective field theory.
The researchers remarkably found that the impact of FFC on CCSN explosion is bifurcated depending on the progenitors. While FFC promotes shock revival and boosts the explosion energy for the lowest-massprogenitor, it has an inhibitory impact for higher-mass progenitors. The mass accretion rate is the main determinant governing this bifurcated effect. For a high value of mass accretion rate, the contribution of FFC to neutrino heating turns out to be negative,since the concurrent reduction in neutrino luminosity dominates over the enhancement of heating efficiency through FFC-driven spectral hardening of electron-type neutrinos. In contrast, FFC contribution to neutrino heating becomes positive foralow mass accretion rate.
“Our present results highlight the limitations of approximate neutrino transport and show that a multiangle treatment is essential for accurately capturing FFC effects. Otherwise, important FFC signals may be overlooked or even falsely identified,” highlights Akaho.
Overall, this work provides a robust argument for the involvement of neutrino FFC in the explosion mechanism of CCSNe, improving our understanding of the lifecycle of massive stars and potentially serving as a theoretical guide for future CCSN observations.
Watchmen, domestic servants, street vendors, auto/cab drivers, security guards, and students are especially invited
Hyderabad, June 3: Lodge Keys No. 297, the city’s primary unit of Freemasonry, will organise a CPR Training Programme on June 6, 2026, from 2:00 PM to 5:30 PM at the Goshamahal Baradari Masonic Building, Goshamahal, in collaboration with GVK Green Health Services (formerly GVK EMRI).
The programme is part of Lodge Keys’ community outreach initiative, “Be a CPR Ambassador”, which aims to train 1,000 citizens in the life-saving skill of Cardiopulmonary Resuscitation (CPR).
CPR is a critical first-aid technique used when a person’s heart stops beating or when breathing ceases. Immediate CPR administered during the “golden minutes” before professional medical help arrives can significantly improve the chances of survival.
Over the past one-and-a-half years, Lodge Keys has successfully trained 758 citizens in CPR free of cost and is now just 242 participants away from achieving its target of 1,000 CPR Ambassadors. In addition, more than 1,400 people have been reached through awareness seminars, and the organisation aims to educate over 10,000 citizens through public awareness programmes eventually.
The June 6 programme will feature hands-on practical training conducted by certified trainers from GVK Green Health Services. Participants will practise CPR on mannequins, enabling them to gain confidence and develop the skills required to respond effectively during emergencies.
In addition to CPR, participants will also receive AED (Automated External Defibrillator) familiarisation training. An AED is a portable device used during sudden cardiac arrest. While CPR helps maintain blood circulation to the brain and other vital organs, an AED can analyse the heart’s rhythm and, when necessary, deliver an electric shock to help restore a normal heartbeat.
The AED module will cover: Recognition of sudden cardiac arrest, Safe operation of an AED, Correct placement of electrode pads, Understanding and following AED voice prompts, When to administer CPR and when to use an AED and How CPR and AED work together to improve survival outcomes
The organisers believe that CPR and AED training should be accessible to all sections of society. Therefore, individuals who can afford the training are requested to contribute a participation fee of ₹1,000. Those who are unable to pay will be accommodated free of cost.
“We do not want the ability to save a life to depend on one’s ability to pay. Anyone willing to learn CPR should have the opportunity to do so,” said the organisers.
Lodge Keys especially invites security guards, watchmen, auto and cab drivers, street vendors, domestic workers, housekeeping staff, students, and other community members to take advantage of this opportunity. Employers and institutions are also encouraged to nominate such individuals for free training.
Participation is limited to 40 persons on a first-come, first-served basis. Prior registration and confirmation are mandatory.
For registration and participation, please contact: D. Ramchandram – 98480 42020; P. Veerabhadrudu – 93910 39047; Arun Selgam – 98491 75197 and G. Ashok Kumar – 94402 26960
Individuals, NGOs, philanthropists, and corporations interested in supporting this life-saving initiative are encouraged to contact D. Ramchandram at 98480 42020 and partner with Lodge Keys to create more CPR Ambassadors.
Mumbai , May 30 : The World Health Organization theme for the World No Tobacco Day 2026 is “Unmasking the Appeal – Countering Nicotine and Tobacco Addiction.” This global campaign aims to raise awareness about the evolving landscape of tobacco and nicotine products, including e-cigarettes, nicotine pouches and synthetic nicotine devices, and how these products may appeal to children and adolescents through flavours, product design and digital social media promotion.
Electronic nicotine delivery products can adversely affect children’s and adolescents’ health by exposing them to nicotine and other harmful substances during critical stages of growth and brain development. Such exposure may affect attention, learning, memory and impulse control, increase the risk of nicotine dependence, and contribute to respiratory and cardiovascular problems. Aerosols from these products may contain substances associated with lung disease and other long-term health risks. Despite decades of progress in tobacco control, newer nicotine products continue to gain visibility through attractive flavours, appealing designs and online promotion. WHO estimates that at least 15 million adolescents aged 13–15 years globally use e-cigarettes, and in countries with available data, children are more likely than adults to vape.
India has been a leader in prohibiting E-cigarettes through the Prohibition of Electronic Cigarettes Act -2019. However, as reported on 21st May 20126 by Press Information Bureau , Govt. of India, nearly 3 lakh e-cigarettes and vapes worth more than INR 120 crore were seized by the Directorate of Revenue Intelligence from a smuggling network operating across Maharashtra, Gujarat and other states.
The LifeFirst Programme, an initiative of Narotam Sekhsaria Foundation in collaboration with Salaam Bombay Foundation, is a tobacco dependence treatment programme working across schools, workplaces, healthcare settings and communities to support tobacco cessation and prevention among adolescents and adults.
As part of its school-based activities this year, LifeFirst sensitized more than 6,000 students in Grades 7 to 9 across 100 schools in Mumbai on the harms associated with tobacco, supari and other harmful products. During these sessions, e-cigarettes were observed to be used by adolescents, which are available through illegal routes. LifeFirst counsellors also observed that social media exposure, peer influence and perceptions of newer tobacco products as less harmful may contribute to experimentation among young people. Adolescents may perceive them as “cool”, fashionable, harmless or socially acceptable alternatives to conventional tobacco products. However, these products contain addictive nicotine and other potentially harmful substances that may pose health risks.
Protecting children and adolescents from nicotine addiction requires sustained awareness efforts, continued implementation of existing regulations, responsible communication around emerging nicotine products and engagement from parents, schools, communities and public health stakeholders.
On World No Tobacco Day 2026, Narotam Sekhsaria Foundation reiterates the importance of strengthening awareness and preventive efforts for children and adolescents to support healthier future of the country.
According to researchers at Semmelweis University, not only inflammation, but also sleep disorders, depression, obesity, and smoking may sustain persistent rheumatic symptoms. In their publications in the journals Nature Reviews Rheumatology and The Lancet Rheumatology, they also proposed a model that can help identify and treat the true causes of symptoms in time.
Researchers at Semmelweis University analyzed how depression, smoking, obesity, sleep disorders, and other health problems are linked to difficult-to-treat rheumatoid arthritis.
Rheumatoid arthritis is a chronic autoimmune disease in which the immune system attacks the joints, causing pain, swelling, and stiffness. It affects tens of thousands of people in Hungary only. Most patients respond well to treatment, but 6–28 percent belong to the so-called “difficult-to-treat” group because they do not achieve lasting remission despite therapy.
According to the publications in Nature Reviews Rheumatology and The Lancet Rheumatology, these factors may not only coexist with the disease but may also help maintain it.
For example, pain and depression may reduce physical activity, increase body weight, worsen sleep and mood – all of which can feed back into pain and everyday functioning, creating a difficult-to-break “vicious cycle.”

The researchers not only identified these patterns but also developed a new model that could improve the treatment of such difficult-to-treat patients. Under the currently used “treat-to-target” therapeutic approach, patients’ conditions are regularly monitored using measurable indicators, and if treatment does not sufficiently reduce inflammation, therapy is adjusted – for example by increasing the medication dose or switching to another drug. However, according to the researchers, this approach can function not only as a therapy but also as a kind of “early warning system”: it can quickly indicate when symptoms may not be caused solely – or at all – by inflammation.
“When target values improve but the patient still suffers from pain and fatigue, it is worth taking a step back. In such cases, instead of automatically prescribing more medication, doctors should look for what is maintaining the symptoms – whether it is chronic pain syndrome, depression, sleep disorders, or obesity,” said Dr. György Nagy, head of the Department of Rheumatology and Immunology at Semmelweis University. The researchers themselves have observed that this approach can improve outcomes for difficult-to-treat patients, and in many cases it can also positively affect the doctor–patient relationship.

The researchers’ model has achieved major international recognition: the publications introducing the concept of “difficult-to-treat” disease and the related treatment strategy have already been cited more than a thousand times by other researchers. Moreover, the definition is now used worldwide not only in the context of rheumatoid arthritis but also in connection with other diseases.
Meanwhile, the team is already working on the next steps: alongside their own research, they are planning to join projects that would use artificial intelligence to develop even more effective therapies for people with rheumatoid arthritis.
“With AI-based pattern recognition, we could identify subgroups among patients, and with the help of these data we could create more effective, almost personalized treatment strategies for them,” explained Dr. Lilla Gunkl-Tóth, PhD student at Semmelweis University and first author of the publications.
Increasing interest in science-backed ingredients positions Singapore as a key gateway for European dairy innovation in Southeast Asia
SINGAPORE, May 29 - The European Union is strengthening its engagement with Singapore as a regional hub for advanced food manufacturing and nutrition innovation. This comes as demand for functional dairy ingredients accelerates across Southeast Asia.
Led by Bord Bia – The Irish Food Board, the initiative is part of the “European Dairy: Ireland, Where Nature Meets Science” campaign, a €3.2 million investment co-funded by the European Union to strengthen Asia’s nutrition pipeline and foster long-term trade partnerships. The campaign showcases sustainable farming and scientific research behind European dairy production.
Singapore is globally recognised as a hub for innovation, positioned at the heart of Southeast Asia’s food ecosystem, and has an important role in regional product development and distribution. Manufacturers across ASEAN are increasingly seeking high-quality science-backed ingredients, as demand for targeted life-stage nutrition, preventative health products and functional foods is increasing. This is largely driven by the fact that Southeast Asia’s population is growing and aging rapidly, particularly in Singapore, leading to increased demand for functional foods to support healthy aging and overall wellbeing. Given limited domestic dairy production in Singapore, F&B innovators and manufacturers are driven to rely on imports and seek trusted international partners.
Ms. Lorna Allen, South East Market Manager of Bord Bia, mentioned, “Singapore is a key gateway for European dairy engagement in Southeast Asia, particularly as demand for functional and science-backed nutrition continues to grow. Ireland has exported €276 million value of dairy products to Southeast Asia in 2025, a y-o-y increase of 16.4%. Through the EU-funded campaign, Bord Bia is supporting closer collaboration between European dairy producers from Ireland and regional food and nutrition innovators.”
Dr Kalpana Bhaskaran, Deputy Director, industry partnerships and Head, Glycemic Index Research Unit at Temasek Polytechnic, commented, “Dairy ingredients play a vital role across the life course. With protein‑fortified and functional dairy products gaining strong momentum, the opportunity to improve population health through evidence‑based dairy innovation has never been greater.”
European dairy from Ireland combines a natural grass-fed, pasture-based system with the support of advanced scientific research. This combination of natural production methods and scientific validation allows European dairy to meet the performance and quality requirements of manufacturers across Asia.
Dr. André Brodkorb, Senior Researcher, Teagasc Food Research Centre Moorepark, said, “Irish grass‑fed milk is scientifically proven to deliver superior nutritional benefits, with Teagasc research showing dairy cows who operate on an Irish grass-fed system, produced milk with higher percentages of omega-3 and conjugated linoleic (CLA) fatty acids compared to cows fed medium and low proportions of grass.”
Bord Bia brought leading European dairy suppliers from Ireland to Food & Hospitality Asia (FHA) in Singapore last April. Industry professionals attending FHA Singapore were invited to explore partnership opportunities and discover how European dairy from Ireland is supporting the next generation of nutrition solutions in Asia. Bord Bia focused on:
Functional dairy ingredients designed for sports nutrition, healthy ageing, life-stage nutrition, and foodservice.
Solutions that support product innovation for Asian consumers.
Opportunities to connect directly with suppliers for sourcing and collaboration.
As part of the European Union’s engagement in Singapore, Bord Bia is also facilitating a closed-door industry session bringing together stakeholders from research, development, and manufacturing. This reflects ongoing collaboration between European dairy stakeholders and regional partners, including organisations such as Temasek and Teagasc, to support innovation and knowledge exchange in functional nutrition.
New data from AMFM Healthcare reveals a convergence of financial pressure, sleep disruption, and environmental stressors signaling a shift in how Americans experience and manage mental health
ORANGE COUNTY, Calif. (May 28, 2026) – AMFM Healthcare on Wednesday released findings from a new national survey of 2,000 U.S. adults, revealing that nearly three in four Americans (72.7%) feel stressed on a regular basis, and that many are turning to a mix of healthy, harmful, and emerging digital behaviors to cope.
The survey found that stress is being driven by a convergence of pressures. More than 82.2% of adults say the cost of living is a major source of stress, while 77.1% report that stress has negatively affected their sleep quality. At the same time, 58.5% say feelings of loneliness have increased, reinforcing broader concerns about how mental health challenges are showing up in everyday life.
The data also points to a less commonly discussed, but increasingly relevant, contributor to mental health strain: environmental conditions. More than half of Americans (53.0%) say weather negatively affects their mental health, suggesting that stress is not only emotional and financial, but also shaped by daily surroundings and lived conditions.
“Stress today isn’t coming from one place, it’s layered,” said Ted Guastello, CEO, AMFM Healthcare. “Financial pressure, poor sleep, and loneliness are already taking a toll, and when environmental factors like weather are added in, it helps explain why stress can feel so persistent and difficult to manage.”
The survey also reveals a shift in how Americans are coping. While 69.2% say they use exercise to manage stress, nearly half (46.7%) report using alcohol or cannabis. Meanwhile, 50.8% say social media increases their stress or anxiety, highlighting how some coping behaviors may actually be making stress worse.
One of the most notable findings is the role of technology in emotional coping. Nearly one in three respondents (31.5%) say they have used AI tools or chatbots to cope with stress, reflecting a growing trend as people look for support that is immediate, accessible, and available around the clock.
“We’re seeing people fill gaps in care however they can,” said Guastello. “AI tools are accessible and available 24/7, which makes them appealing, but they’re not a replacement for human care. This reflects a bigger issue: people are looking for support, but the system isn’t always meeting them where they are.”
To better understand whether stress is being experienced differently across the country, the survey findings were also analyzed by region. The results suggest that while stress is widespread nationwide, the factors shaping it, and the ways people experience it, can vary depending on where they live.
In the Midwest, 60.2% say weather affects their mental health, the highest of any region, alongside widespread sleep disruption (76.7%). In the Northeast, stress appears to be more closely tied to isolation, with the highest reported increase in loneliness (60.6%) and a strong share of respondents (59.6%) also citing weather as a factor.
In the South, stress remains closely connected to financial strain, with 73.4% reporting regular stress and 81.6% citing cost of living as a major source of stress. The region also saw the highest share of respondents (52.1%) saying social media contributes to their stress. In the West, economic pressure is even more pronounced, with a nation-leading 84.3% citing cost of living, alongside elevated digital stress (52.0%) and fewer respondents (47.4%) pointing to weather as a factor.
“These regional differences tell an important story,” added Guastello. “Stress may be a national issue, but it doesn’t look exactly the same everywhere. Where people live, how they connect, and what pressures they face all influence how stress shows up, which is why support needs to be flexible, accessible, and responsive to real-life needs.”
Despite widespread need, many Americans still face barriers to care, including cost, long wait times, and stigma, leaving millions to manage stress on their own.
The AMFM Healthcare Local Stress Forecast surveyed adults 18+ across all 50 states to better understand how stress is evolving, and what it will take to address it.
For more information on AMFM Healthcare’s programs, please visit our websites at amfmtreatment.com, missionprephealthcare.com, and missionconnectionhealthcare.
MELVILLE, N.Y., May 26 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX,” or the “Company”) (Nasdaq:BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today announced that the last patient has been dosed in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for the treatment of chronic lumbar disc disease (cLDD), completing treatment administration in the Company’s lead clinical program and advancing the study into the next stage of blinded follow-up ahead of expected topline safety and efficacy data in Q2 2027.
The prospective, randomized, double-blind, sham-controlled, single-disc Phase 2 study enrolled approximately 99 patients across U.S. clinical sites and is designed to evaluate the safety and preliminary efficacy of BRTX-100 in patients with painful chronic lumbar disc disease. Subjects were randomized in a 2:1 ratio to receive either BRTX-100 or control treatment. The primary safety endpoints for the trial include the frequency and severity of adverse events and serious adverse events, as well as imaging-related findings. The primary efficacy responder endpoint is defined as at least a 30% improvement from baseline in both pain — as measured by the Visual Analog Scale — and function –as measured by the Oswestry Disability Index, at week 52. Study follow-up assessments are being conducted at weeks 2, 12, 26, 52 and 104, with MRI evaluations at baseline, week 52 and week 104.
“Completion of dosing in our Phase 2 BRTX-100 trial represents an important transition point for BioRestorative,” said Lance Alstodt, BioRestorative Chief Executive Officer. “We have now completed treatment administration in a rigorously designed, randomized, double-blind, sham-controlled study of our lead regenerative spine candidate, and the program is moving through blinded follow-up toward the 52-week efficacy assessment and expected topline safety and efficacy data in the second quarter of 2027. Importantly, this milestone also comes as we continue Phase 3 readiness activities following our Type B meeting with the FDA, where the agency did not raise clinical safety concerns and provided alignment on key elements of the late-stage development pathway.
“With Phase 2 dosing now complete, we believe BioRestorative is positioned to advance the next phase of BRTX-100 development while reducing expenses and redirecting operational focus and resources toward additional value-creation priorities, including the continued commercialization of our BioCosmeceutical platform,” Mr. Alstodt continued. “Our objective is to build from this milestone with discipline, clinical rigor and a clear focus on advancing our regenerative medicine platform across both therapeutic and commercial opportunities.”
BRTX-100 is BioRestorative’s proprietary autologous, hypoxically cultured mesenchymal stem cell therapy designed for delivery into the harsh, low-oxygen, low-nutrient environment of the intervertebral disc. Patients in the trial received a single intradiscal injection of BRTX-100 consisting of 40 x 10^6 cells administered in approximately 1.5 cc through a minimally invasive outpatient procedure.
Eligible patients enrolled in the study were required to have chronic low back pain persisting for at least six months, failure of conservative therapy for at least six months, MRI-confirmed single symptomatic lumbar disc disease and minimum baseline pain and disability thresholds. Major exclusion criteria included prior lumbar surgery at the index level and prior biologic or cellular disc interventions.
BioRestorative has previously reported favorable blinded safety and preliminary efficacy data from the ongoing Phase 2 trial, including sustained improvements in pain and functional measures across multiple follow-up periods and MRI findings suggestive of potential disc remodeling in certain subjects. In previously disclosed blinded datasets, the Company reported clinically meaningful improvements across pain and function measures, including Visual Analog Scale, Oswestry Disability Index, Roland-Morris Disability Questionnaire and Functional Rating Index assessments. To date, the Company has reported no dose-limiting toxicities or serious adverse events related to BRTX-100 in the safety cohorts evaluated. These blinded findings have been presented at scientific and industry conferences and disclosed through prior Company announcements.
BRTX-100 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of chronic lumbar disc disease. BioRestorative previously announced a positive outcome from a Type B meeting with the FDA regarding key elements of a potential Phase 3 program and a pathway toward future BLA-enabling activities. The Company expects to continue advancing Phase 3 preparation activities while blinded follow-up in the Phase 2 study continues, with topline safety and efficacy data expected in Q2 2027.