
Nuubu Deep Cleansing Foot Pads Under Review: Safe Natural Body Toxin Removal Option
New York, May 01, 2025 (GLOBE NEWSWIRE) —
In This Article, You'll Discover: Why subtle symptoms like fatigue, brain fog, and mood swings might point to internal toxin buildup
How Nuubu detox patches provide a natural, non-invasive way to support the body's detox process
provide a natural, non-invasive way to support the body's detox process The traditional Asian healing philosophy behind Nuubu foot patches
A detailed breakdown of Nuubu's natural ingredients including bamboo vinegar, tourmaline, and loquat leaf
including bamboo vinegar, tourmaline, and loquat leaf Who Nuubu herbal foot patches are best suited for—including wellness seekers, city dwellers, and people feeling 'off' without medical explanation
are best suited for—including wellness seekers, city dwellers, and people feeling 'off' without medical explanation Real-life benefits reported by users, such as improved sleep, mental clarity, better mood, and reduced tension
A step-by-step guide on how to use Nuubu for best results, including patch placement and frequency
for best results, including patch placement and frequency Current Nuubu pricing and discounts , with guidance on where to safely purchase
, with guidance on where to safely purchase Answers to frequently asked questions about Nuubu detox patches , including safety, results, and use cases
, including safety, results, and use cases Final verdict: Is Nuubu worth trying as part of your wellness and self-care routine?
TLDR – Nuubu Detox Patches: Natural Support for a Clearer, Balanced You
Nuubu detox patches offer a quiet yet powerful way to support the body's natural detox process without pills, chemicals, or complex routines. Rooted in traditional Asian medicine, this herbal foot patch leverages natural ingredients like bamboo vinegar, tourmaline, and loquat leaf to gently encourage toxin release through the soles of your feet while you sleep.
This in-depth Nuubu review explores how subtle symptoms—like unexplained fatigue, mental fog, or muscle tension—may stem from toxin overload, and how Nuubu foot patches aim to restore balance overnight. With easy application, no side effects for most users, and a growing base of positive feedback, Nuubu is becoming a go-to choice for people seeking natural detox support in their daily routine.
Whether you're a wellness enthusiast or simply looking for an easy way to feel more refreshed, Nuubu detox patches may offer the reset your body has been quietly asking for. Read on to learn how to use Nuubu , what makes it effective, and why it might be the gentle detox tool you've been missing.
Some symptoms don't show up in bold. They creep in quietly. You might feel a little more tired than usual, but you brush it off. Maybe it's just a long week. Your mind feels cloudy, but you figure it's the screens or lack of sleep. Then come the muscle aches, the mood swings, the strange restlessness that lingers even when there's nothing stressful happening. One by one, the signs appear. Not sharp enough to alarm you, but just enough to disrupt how you feel in your own skin.
And when nothing seems wrong on the outside, you start to wonder why you feel this way.
What if your body is trying to get your attention? Not with illness, but with quiet overload.
Today, our bodies are exposed to more toxins than ever from the air we breathe, the food we eat, even the stress we carry. And while our systems are designed to keep us balanced, they are not always equipped to handle the constant buildup of these invisible burdens. Over time, this internal clutter can leave you feeling off-balance, mentally drained, and physically sluggish.
That's why more people are looking beyond pills and quick fixes. They are returning to older traditions that trust the body's natural intelligence. One such tradition uses a surprisingly simple tool, a soft herbal patch placed on the soles of your feet. It works while you sleep, using ancient plant wisdom to support your body's own process of letting go.
This simple approach is what makes Nuubu different.
What Is Nuubu and How Does It Work?
Nuubu is a herbal foot patch made to support the body's natural detox process. Inspired by traditional Asian healing practices, it's based on the idea that the feet hold powerful connection points to the rest of the body. In many cultures, the soles of the feet are believed to reflect internal organs and energy channels. That's why Nuubu works by targeting these areas, helping the body release what it no longer needs through the skin's natural process, sweat.
Each patch is infused with a blend of time-tested ingredients like bamboo vinegar, tourmaline, loquat leaf, and vitamin C. When placed on the bottom of clean feet before sleep, the patch begins to interact with the body's warmth and moisture. As you rest, the herbs in Nuubu gently support circulation and perspiration. By morning, the patch darkens a visual sign that the patch has absorbed moisture, possibly including impurities the body has released during the night.
While results can vary from person to person, many users say they wake up feeling a little lighter, clearer, and more refreshed than before. There's no complicated routine or overwhelming detox protocol. Just a patch, a quiet night's rest, and a chance for your body to do what it does best is restore balance on its own.
And to understand how that's even possible, it helps to take a closer look at the natural ingredients Nuubu is made from.
What's Inside Nuubu? A Look at Its Herbal Components
Nuubu isn't made with harsh chemicals or synthetic fillers. Instead, it relies on a carefully chosen mix of natural elements, drawn from centuries-old Asian healing traditions. These herbal components work together to gently support your body's own ability to release toxins and restore balance. Here's what each one brings to the patch:
Loquat Leaf
This soft, velvety leaf has been used in traditional remedies to help calm the body and ease discomfort. Known for its soothing and anti-inflammatory qualities, it may help reduce tension and support overall wellness while your body goes through the detox process.
Bamboo Vinegar
A natural liquid produced from heated bamboo, this vinegar is believed to help with digestion and promote healthy microbes in the body. On the skin, it may encourage gentle sweating and open the pores, supporting the release of impurities through the feet.
Vitamin C
Famous for its immune-boosting and antioxidant power, vitamin C helps protect against the effects of daily stress and toxins. It may also support skin health and recovery as your body cleanses itself naturally overnight.
Wood Vinegar
Similar to bamboo vinegar, this wood-derived liquid is believed to help absorb moisture and unwanted waste through the skin. It's one of the key components that give the patch its drawing power and may assist in clearing out built-up residue.
Tourmaline
A mineral valued in traditional medicine, tourmaline is believed to help with energy flow and circulation. Some say it slightly warms up on contact with skin, encouraging better detox through gentle stimulation of the feet's pressure points.
Chitin
Derived from natural sources like shellfish, chitin is known for its protective and purifying qualities. In the patch, it may help improve absorption and shield the skin from irritation as the detox process unfolds.
Houttuynia Cordata Thunb
Often used in herbal medicine for its natural cleansing effects, this plant may help reduce inflammation and support the body's ability to calm itself. It plays a quiet but important role in soothing the skin during detox.
Dextrin
A type of plant-based fiber, dextrin helps bring everything together. It acts as a carrier and stabilizer, making sure the patch works smoothly, stays in place, and lets the other herbal components do their job.
Together, these gentle elements form the heart of Nuubu, working silently and steadily as you sleep, helping your body feel clearer, calmer, and more balanced with each passing night.
Ready to wake up feeling lighter, clearer, and more refreshed—without swallowing pills or enduring strict routines? Try Nuubu detox patches tonight and discover how this gentle, natural foot patch can help your body release what it doesn't need while you sleep.
Who Is Nuubu For?
Nuubu is designed for people who feel out of balance and want a natural way to support their body's detox process. It's especially helpful for: People feeling mentally foggy or unfocused: If your thoughts feel cloudy or you're easily distracted, Nuubu may offer gentle clarity by helping the body feel lighter.
If your thoughts feel cloudy or you're easily distracted, Nuubu may offer gentle clarity by helping the body feel lighter. Those who feel tired even after sleeping: If rest isn't refreshing you the way it used to, your body might be working harder than you realize. Detox support could help you feel more restored.
If rest isn't refreshing you the way it used to, your body might be working harder than you realize. Detox support could help you feel more restored. Anyone dealing with mood swings or irritability: Emotional ups and downs can sometimes be linked to how your body is processing stress and toxins.
Emotional ups and downs can sometimes be linked to how your body is processing stress and toxins. People experiencing muscle tension or restlessness: When toxins build up, some people feel it physically through tight shoulders, aching legs, or that buzzing, uneasy energy.
When toxins build up, some people feel it physically through tight shoulders, aching legs, or that buzzing, uneasy energy. Busy professionals and urban dwellers: City life, pollution, processed food, and daily stress can add to the body's burden. Nuubu may help give it a break.
City life, pollution, processed food, and daily stress can add to the body's burden. Nuubu may help give it a break. Those who prefer natural and traditional remedies: If you're someone who trusts plant-based, herbal solutions over synthetic ones, Nuubu's roots in traditional Asian medicine will likely appeal to you.
If you're someone who trusts plant-based, herbal solutions over synthetic ones, Nuubu's roots in traditional Asian medicine will likely appeal to you. Wellness seekers building a regular self-care routine: Even without major symptoms, many use Nuubu as part of a quiet, nightly ritual to help their body stay balanced.
If you've been feeling 'off' lately and don't know why, Nuubu offers a simple and natural place to start. Let's take a closer look at what kinds of benefits people say they notice when they use it consistently.
Benefits of Using Nuubu Detox Patches
Nuubu isn't loud or dramatic. It works quietly, in the background, giving your body a chance to reset without pills, side effects, or complicated routines. Below are the kinds of benefits many Nuubu reviews are experiencing, written from a place of empathy and simplicity.
Clearer Thinking and Better Focus
Many users notice that their mind feels sharper and more alert after using Nuubu for just a few nights. That heavy, cloudy feeling like you're always 'a few steps behind' starts to ease. For people who deal with brain fog, forgetfulness, or scattered thoughts, this gentle clarity can feel like a breath of fresh air. It's not a sudden jolt like caffeine, but more like your brain finally taking a deep, cleansing breath.
Deeper, More Restful Sleep
When the body is under stress or holding on to toxins, sleep can become shallow and broken. Nuubu may help by supporting the body's natural detox process overnight, allowing the nervous system to calm down. Many users say they fall asleep faster and wake up fewer times in the night. Over time, this can lead to more restorative sleep and a better sense of energy during the day.
Improved Mood and Emotional Balance
Toxins aren't just physical, they can also weigh on your mood. When the body is out of sync, emotions can swing without warning. With Nuubu, some users say they feel less irritable and more emotionally steady. It's not about being happy all the time, it's about regaining a sense of emotional balance, where small problems don't feel overwhelming anymore.
Relief from Muscle Aches and Tension
Stress doesn't just live in the mind. It settles in the body, in your neck, shoulders, back, and legs. That constant stiffness or soreness can drain you without realizing it. Nuubu's soothing herbs may help the body release that tension, especially overnight when the patch is in contact with your feet's key pressure points. The result? You may wake up feeling less tight, more comfortable, and ready to move through your day with ease.
Lighter, More Energized Mornings
You know that heavy, drained feeling you sometimes wake up like your body hasn't had a real break? Nuubu may help lift that weight. By gently supporting the body's effort to remove waste and buildup overnight, it allows you to feel more refreshed when the morning comes. Instead of dragging yourself out of bed, you may find yourself moving with a little more ease and clarity.
A Moment of Self-Care in a Busy Life
There's something quietly powerful about putting on a Nuubu patch at night. It's a small action that reminds you to care for yourself without guilt, pressure, or complexity. Just you, your breath, and a simple ritual that says, 'I'm choosing to feel better.' For many, that act alone is worth more than the patch itself. It becomes a grounding habit, a pause in an otherwise noisy world.
Visible Results You Can See Each Morning
One of the unique features of Nuubu is how the patch changes color after use. While the darkening is mostly due to sweat and moisture, many people find it satisfying to peel it off and see something has happened. It turns the invisible process of detox into something more tangible — a small bit of proof that your body is responding.
No Pills, No Fuss, No Guesswork
What makes Nuubu different is how simple it is. You don't need to swallow anything. You don't need to follow a complicated schedule. You just apply the patch to clean feet before bed and let it work overnight. It's wellness without the overwhelm — and that's what makes it so easy to stick with.
If even one of these benefits speaks to what you've been feeling lately, Nuubu may be worth trying. But how do you use it the right way?
Don't ignore the quiet signs your body is sending—fatigue, brain fog, and mood swings might be signals of toxin overload. Experience the power of traditional herbal detox with Nuubu foot patches and take your first step toward daily balance and inner calm.
How to Use Nuubu Detox Patches (Step-by-Step)
Using Nuubu is one of the simplest wellness habits you can add to your day. There's no prep work, no extra tools, and no need to change your routine. All you need is a few quiet minutes before bedtime and a willingness to let your body rest and reset. Here's how to use Nuubu the right way:
Step 1: Wash and Dry Your Feet
Before applying the patch, make sure your feet are clean and dry. This helps the patch stick properly and stay in place while you sleep. Washing also clears away any surface dirt so the ingredients can interact more effectively with your skin.
Step 2: Remove the Patch from Its Wrapper
Take one patch out of the packaging. You'll notice a soft, padded side — this is the side that goes directly on your skin. Nuubu uses a gentle herbal scent, not artificial perfume, so the smell should be earthy and clean.
Step 3: Apply the Patch to the Center of Your Sole
Place the patch on the middle of your foot, sticky side up against the sole. The center of your foot is believed to be one of the most important detox points in traditional wellness — it connects to different organs and energy channels throughout the body.
Step 4: Repeat on the Other Foot (Optional)
For best results, it's recommended to apply a second patch to your other foot. However, some people start with one patch to test how their body responds. Either way is fine — listen to your body and do what feels right for you.
Step 5: Leave the Patch On Overnight (6–8 Hours)
Once both patches are in place, head to bed. Let the herbal blend work quietly while you rest. Most people leave them on for 6 to 8 hours — basically, while they sleep. It won't interrupt your rest or cause discomfort.
Step 6: Remove the Patches in the Morning
When you wake up, slowly peel the patches off and take a look. You'll likely see dark spots or discoloration — this is a normal sign that the patch has interacted with sweat and moisture. While the color doesn't confirm exactly what's been removed, it's often seen as a visual cue that the process is working.
Step 7: Wash Your Feet Gently
After removing the patches, wash your feet with warm water and a mild soap. This removes any residue left behind and leaves your skin feeling fresh and clean.
How Often Should You Use It?
Many people start with a short 5-day to 10-day cycle to see how they feel. From there, some continue using Nuubu a few times a week, while others save it for when they feel off-balance. It's flexible and can be adjusted to your body's needs.
No pressure. No complicated instructions. Just a simple, soothing nightly ritual that helps your body feel a little more like itself again.
Affordability, Offers & Where to Buy Nuubu
Nuubu keeps things simple and surprisingly affordable. Here's what you need to know if you're thinking about giving it a try:
Current Offer: Up to 70% Off
Right now, Nuubu is available for as low as $17.95 (down from the regular $59.83). This limited-time deal makes it one of the most cost-effective wellness tools you can try — especially compared to pricey detox supplements or spa treatments.
What You Get in One Box
Each box typically contains 10 patches (5 pairs). That's enough for: A 5-day full detox using both feet nightly, or
A 10-day cycle using one patch per night.
Bulk Savings Available
Planning to use it longer or share with family? The official site often offers multi-box bundles at even better value. These packages can drop the per-box price even further.
Buy From the Official Website Only
To avoid counterfeit products and get access to the best pricing: Always buy directly from Nuubu's official website
This ensures product authenticity and gives access to their money-saving bundles
If your wellness routine feels incomplete, it might be missing this one simple, ancient remedy. Nuubu detox patches work overnight to support your body's natural cleansing process—without chemicals, stress, or fuss. Order today and feel the difference by morning.
Frequently Asked Questions About Nuubu
Q: What exactly are Nuubu patches used for?
Nuubu patches are used to support your body's natural detox process. They're believed to help release toxins through the soles of your feet while you sleep, leaving you feeling clearer, calmer, and more refreshed.
Q: How often should I use Nuubu?
You can use Nuubu daily for the first 5 to 10 days. After that, some people continue using it 2–3 times a week as part of their wellness routine. It really depends on how your body feels.
Q: Does the patch turning dark mean it's working?
The patch often turns dark due to moisture, sweat, and heat from your feet. While this isn't a lab test for toxins, many people take it as a visual sign that the patch has absorbed something during use.
Q: Will I feel something while wearing the patch?
Most people don't feel anything dramatic, just a comfortable patch on their feet. Some report a mild warmth or tingling, but it's usually very gentle and relaxing.
Q: Are there any side effects?
Nuubu is made from natural herbs and minerals. It's generally well-tolerated, but if you have sensitive skin or allergies, it's a good idea to test it on a small area first or check with a healthcare provider.
Q: Can I use Nuubu on other parts of my body?
Yes, some people apply the patches to areas like the back, shoulders, or knees, especially where they feel tension. But the soles of the feet are the most common spot because of their link to energy and detox points.
Q: Is it safe for older adults or teens?
Yes, many older adults and teens use Nuubu without issues. As with any wellness product, it's best to use common sense and check with a doctor if you have any health concerns.
Q: Does Nuubu have a strong smell?
Nuubu has a light, natural herbal scent. It's not perfumed or artificial, and most people find it pleasant and earthy.
Q: Will it leave stains or residue on my bed?
After overnight use, the patch may be moist and dark, but it usually doesn't leak or stain bedding. Just be sure it's securely attached and placed properly before sleeping.
Q: Where can I buy Nuubu safely?
The safest place to buy Nuubu is directly from the official website. That way, you know you're getting the real product and can take advantage of current discounts and bundle deals.
The Final Verdict: Nuubu Review
If your body has been sending quiet signals like constant fatigue, mood swings, brain fog, or muscle tension, and you've been ignoring them, maybe it's time to listen.
Nuubu doesn't promise miracles. It won't change your life overnight. But what it offers is something refreshingly simple in a world of noise, a natural, low-effort way to support your body's own ability to rebalance and renew. No pills. No drastic changes. Just a gentle patch, rooted in traditional herbal wisdom, working quietly while you sleep.
It's affordable. It's non-invasive. And for many people, it becomes more than just a detox patch, it becomes a small act of self-care in a routine that's been missing it.
So if you're tired of feeling 'off' and want to take a gentle first step toward feeling clearer, lighter, and more in control of your own wellbeing…Nuubu might be exactly where you start.
Your body knows how to heal—it just needs the right support. Nuubu helps activate that wisdom with herbal ingredients trusted for centuries. Apply the patch tonight, and let your body detox while you rest. Your future self will thank you. Company : Nuubu
: Nuubu Address : 354 Downs Blvd, Suite 101A Franklin, TN 37064 USA
: 354 Downs Blvd, Suite 101A Franklin, TN 37064 USA Email : [email protected]
: [email protected] Order Phone Support :
: (US) +1 (667) 284-7014(UK) +442080891401(DE) +498004009820(FR) +33644656863(PL) +48800005495
(SV) +46103371611
Disclaimers and Disclosures
The information provided in this article is for general informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment. Individuals should not use the information herein to diagnose or treat a health or wellness problem or condition without consulting a qualified healthcare provider. The content is not intended to replace professional medical advice, nor should it be relied upon as such.
Nuubu detox patches and the claims associated with their use have not been evaluated or approved by the Food and Drug Administration (FDA). These products are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. The benefits described are based on user testimonials and traditional wellness practices, which modern clinical studies may not support.
This article may contain references to third-party products, websites, or offers. Any and all such references are provided for informational purposes only. No content provider, syndication partner, or publisher assumes responsibility for the content, accuracy, availability, or performance of such third-party materials or products. Readers are encouraged to perform their own research and due diligence before purchasing any product or service mentioned.
The publisher of this article may receive compensation or commissions through affiliate links provided within the content. This means that if a reader clicks on a link and makes a purchase, the publisher may earn a commission at no additional cost to the consumer. This affiliate relationship does not influence the editorial integrity of the information provided.
While every effort has been made to ensure the accuracy of the information contained in this article at the time of publication, errors, omissions, or outdated content may occur. The publisher, content providers, and syndication partners disclaim any liability for typographical errors, inaccuracies, or any misunderstanding arising from the content.
All trademarks, service marks, and product names referenced in this article are the property of their respective owners. Use of these names does not imply any endorsement.
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Global Fatty Liver Day 2025: Elevating Liver Health in the Metabolic Health Conversation
Global Liver Institute Calls for Urgent Action as Fatty Liver Disease Prevalence Surges Worldwide Today is Global Fatty Liver Day Washington, D.C., June 11, 2025 (GLOBE NEWSWIRE) -- On the second Thursday in June, Global Fatty Liver Day (formerly International NASH Day) spotlights one of the most widespread yet under-addressed health threats of our time: fatty liver disease, increasingly referred to as steatotic liver disease (SLD) in clinical settings. Hosted annually by Global Liver Institute (GLI), this public awareness campaign raises awareness of this silent epidemic and its deep roots in global metabolic health liver disease, including metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated alcohol-related liver disease (MetALD), impacts millions globally—yet most remain undiagnosed and untreated. Once considered rare, fatty liver disease has surged in parallel with rising rates of obesity, diabetes, and other metabolic estimated 30.2% of the global population now lives with MASLD, with rates soaring to 57.5% among adults with obesity. In the United States alone, more than 122 million adults are projected to be affected by R. Holden, President and CEO of Global Liver Institute, states, 'The liver is no longer the silent organ. Fatty liver disease is now one of the clearest and most urgent signs of global metabolic dysfunction. On Global Fatty Liver Day, we call on healthcare leaders, policymakers, and the public to recognize the liver's central role in preventing not just liver disease—but cardiovascular disease, diabetes, and other non-communicable diseases (NCDs). Liver health must rise to the top of public health agendas globally.'Fatty liver disease develops when excess fat accumulates in the liver, often without symptoms in its early stages. Left unaddressed, it can progress to inflammation, fibrosis, cirrhosis, liver cancer, and even death. In fact, MASH is now one of the leading causes of liver transplantation in the fatty liver disease doesn't occur in isolation: Up to 75% of people with type 2 diabetes also have MASLD Over 70% of people with MASLD also live with obesity Between 20% and 80% of individuals with high cholesterol or triglycerides are also affected by fatty liver disease 'Fatty liver disease is not just about the liver—it's about the entire metabolic ecosystem,' said Sharon Jaycox, PhD, Fatty Liver Disease Program Director at GLI. 'If we fail to address it, we miss a major opportunity to detect and treat metabolic dysfunction early. We must educate patients and providers alike, embed liver screening in diabetes and obesity care, and drive equitable access to diagnostics and care.' GLI urges coordinated action across health systems, communities, and governments to: Incorporate liver screening into routine care for those with obesity, diabetes, and other metabolic risks Educate the public and clinicians about MASLD, MASH, and MetALD as part of integrated metabolic care Expand access to affordable, noninvasive diagnostic tools Support policies and funding that reflect the scale and urgency of the fatty liver disease crisis As GLI continues to lead this global awareness effort, we invite stakeholders to join us in bringing liver health into every metabolic health to learn more, access resources, and take action on Global Fatty Liver Day. Attachment Today is Global Fatty Liver Day CONTACT: Christine Maalouf Global Liver Institute cmaalouf@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 hours ago
- Yahoo
Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD
NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD). In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication. Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. 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@
Yahoo
4 hours ago
- Yahoo
Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD
NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD). In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication. Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. 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@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data