Saatva Coupons for July 2025
Loom & Leaf: Loom & Leaf is Saatva's most luxurious option. This memory foam bed is handcrafted in the US from eco-friendly materials, and is designed to contour to your body to relieve pressure on aching joints. In our testing we found it worked wonders on her back pain.
Latex Hybrid: The Saatva Latex Hybrid is built with non-toxic, natural and sustainable materials. The Latex offers some of the body-contouring feel of memory foam, but tends to sleep cooler, and there's a spring layer for a little bounce, too.
Memory Foam Hybrid: This is the cheapest of Saatva's two memory foam models. Unlike the Loom & Leaf, this one has a large spring layer, which should help with breathability as well as adding a touch of bounce. The top layers still deliver the soothing hug of memory foam.
Saatva HD: The Saatva HD is one of the best mattresses for heavy people, with a design that combines natural latex and memory foam, along with coils. It's pretty firm, with extra support around the lumbar area to ensure your spine stays properly aligned. Saatva promises no sagging edges, which will make getting up and out of bed nice and easy.
Not sure which mattress is right for you? Check out our comparison of the Saatva Classic vs Latex Hybrid vs Loom & Leaf.
Saatva offers free shipping on all bedding orders. Purchases are shipped via FedEx with free 45-day returns if you're not happy with your purchase.
Saatva offers free white glove delivery on all mattress, furniture, and rug purchases. Saatva's delivery partners will call you with a four-hour time window on the day before your purchase is scheduled to be delivered. If you need to cancel, you will not be charged a fee. Additionally, this service includes free in-room delivery and setup.
All mattress purchases at Saatva include free mattress and foundation removal. Note: You must select this option when purchasing your new Saatva mattress.
Saatva offers a 365-night sleep trial with all of its mattresses, foundations, and furniture. If after your trial you're unhappy with your purchase, Saatva will let you return or exchange your mattresses. Note: You'll receive a full refund less a $99 processing fee. Mattress toppers include a 180-night trial.
Saatva offers an unprecedented lifetime warranty, which they call the Friends for Life warranty. For the first 2 years of the Friends for Life warranty, Saatva will replace your mattress with a new one at absolutely no charge to you. Starting in year 3 and for as long as you own your mattress, Saatva will completely repair and re-cover your Saatva mattress. You will be responsible only for a $149 processing fee.
Saatva offers numerous ways to get in touch with them. You can start a live chat on the website or if you have questions about a product you can call 877-597-0583.
Shop Saatva deals online: Saatva is no stranger to deals and its products can be found on sale year-round. Naturally, the best Saatva deals will be found during major holidays like the 4th of July and Black Friday. However, you can still find deals any time of the year. Make sure to follow our Saatva mattress sales guide for the latest discounts and exclusive Saatva promo codes.
Get a Saatva professional discount: Saatva offers a year-round discount of $225 off purchases of $1,000 or more to military, healthcare professionals, first responders, government employees, students/teachers, and seniors. However, this offer is not stackable with any Saatva sales. If a current promo is greater than the Saatva discount program, then only the better discount will be applied.
Sign up to receive newsletter promos: Saatva will e-mail or text you its latest sales when you sign up for its newsletters. (You can sign up via the Saatva homepage).
Take advantage of that 1-year sleep trial: Saatva's 365-night home trial is one of the most generous trials we've seen. All of the company's mattresses include that trial, so you have plenty of time to decide whether a bed is right for you. If you aren't completely satisfied, you can return for a full refund less a $99 processing fee.
Shop Saatva's bundle deals: Some of the biggest discounts are offered when you buy a mattress bundle. Sure, you'll pay slightly more for the mattress and foundation, but the discount will likely be greater and you may even get some freebies thrown in like free pillows or bed sheets.
1. Select one of our Saatva promo codes you want to use and click "Get Discount".
2. You'll be taken to the Saatva website, where you'll see all the available discounts.
3. Add the items you want to your basket as you go, then clip on your shopping cart to review your order when you want to buy.
4. Check your discounts are applied to your order total, then proceed through the checkout as normal to place your order.
The coupons you'll find on Tom's Guide have been sourced by our dedicated coupons team, who use the web, our relationships with retailers, & our affiliate networks to find the latest codes. The offers on each coupon page are updated every few days to ensure we feature the freshest ways to save, and our commercial team (based in London) also sources exclusive codes and sales info directly from some of the biggest retailers around.
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Tom's Guide
2 days ago
- Tom's Guide
Tom's Guide Awards 2025: Our favorite mattresses, pillows and more
Actually getting a good night's sleep can make such a difference the following day, when you wake up feeling refreshed and energized. Whether it be your mattress or your pillow, using the wrong bedding for your preferred sleeping position can leave you feeling groggy with aches and pains all over. From hybrid mattresses to memory foam ones or even more affordable 'in a box' style mattresses, you have plenty of options when it comes to upgrading your bedding to get the kind of rest your body deserves and we've tried them all. Our team of experts has tested and reviewed all of the latest mattresses, pillows and other bedding gear for the Tom's Guide Awards 2025. Below, we highlight our favorite mattresses, toppers, protectors, pillows and more from the last 12 months that have transformed the quality of our sleep. We've been testing mattresses for nearly five years at Tom's Guide and the Saatva Classic has been our top-recommended bed for nearly as long. In fact, this is the fourth year in a row we've crowned the Classic our overall winner. After retesting it from top to base, we awarded it 5 out of 5 stars, praising the stunning balance of comfort versus support. Our Managing Editor of Sleep, Claire Davies, who slept on the Classic for seven months, declared that it revolutionized her sleep. 'Post-pregnancy left me with ongoing hip and lower back pain that got worse whenever I tried to lie down,' she said. 'I just couldn't get comfy for long enough on any bed or mattress topper I tried, until I started sleeping on the Saatva Classic. From the first night on the Saatva, all that discomfort melted away. It was such a relief to feel comfy in bed again.' Get instant access to breaking news, the hottest reviews, great deals and helpful tips. 2025 has seen the arrival of some very strong Saatva rivals (the Helix Midnight Luxe and the Brooklyn Bedding Copperflex Pro being two), but so far none of them are the whole package like the Saatva Classic. To us, it is still the best mattress you can buy for superb comfort and support, tailored to your exact sleeping position and body weight, and made from natural and organic toxin-free materials right here in America. The DreamCloud is another repeat Tom's Guide Award Winner, earning the title of the best mattress in a box for the second year in a row. Updated for 2025, the DreamCloud Classic offers exceptional support and comfort at an affordable price (roughly $699 for a queen), outperforming many expensive rivals in our lab-based tests. At 12' tall and with a soft-touch quilted cover, it also looks the part; more a hotel-style mattress than a budget-friendly boxed bed. One of the big attractions with the DreamCloud is the use of therapeutic foam that contours your body to relieve pressure points. You don't normally get this level of pressure relief from a cheaper mattress, making the DreamCloud a unicorn in the affordable bed market. The benefits (a forever warranty and year's sleep trial) are also relatively unheard of for a sub-$700 queen mattress. Add all of that up and there's no doubt as to why the DreamCloud Classic has taken home this award once again. The Saatva Classic is our overall mattress winner for the Tom's Guide Awards 2025 and our best hybrid mattress of the year too. Why? Because it comes in three firmness levels and two heights it's easy to match it to your sleeping position and body weight, making it one of the most customizable beds on the market. But there's much more... The large majority of our testing panel also awarded the Saatva Classic top marks for lumbar support, pressure relief (no more sore points across your body), and how it doesn't cling on to excess heat and turn your bed into an inferno at night. We loved sleeping on the 11.5' Luxury Firm version of the Classic and found it hard to fault (see our Saatva Classic mattress review for our full testing notes). The slightly bouncy feel makes it easier to move around on, and the edge support is the strongest we've tested – you could park a truck on the edge of this bed and it would not fall off. (Ok, maybe not a truck, but the edge support is so superb you can sleep on every inch to maximize space.) Even with a recent $40 price hike due to mattress tariffs the Saatva Classic is still good value for a luxury handcrafted hybrid bed made from non-toxic, premium materials – a comparable mattress sold in store would cost lots more. So when you add this to the unbeatable performance, high hotel-style build quality, and generous benefits (year's sleep trial, lifetime warranty and free White Glove Delivery), it's easy to see why the Saatva Classic is still our most-recommended hybrid bed. The Nectar Premier is the slightly softer and more luxurious alternative to the Nectar Classic, the previous top ranking option in our best memory foam mattress guide and a prior Tom's Guide Award winner. The Premier has earned its spot in this year's Tom's Guide Awards by delivering that classic memory foam feel most of us love and crave: a full body 'hug' and a plush, contouring surface you just can't wait to sink into after a long, hard day. We found the Nectar Premier to be most comfortable for side sleeping, as the dense cushioning cradles the hips and shoulders to minimize numbness or aching. We enjoyed it for back sleeping too (there's good lumbar support here), making it a decent choice for combi sleepers who switch positions through the night. And while we're not saying that the Nectar Premier can put an end to your sleep divorce, the superb motion isolation is ideal for couples as the generous layers of foam eat up any movement from your partner for a more peaceful night's sleep. Side sleeping is the most popular and healthiest sleep position in the world but it isn't without its challenges. Chief among those is intense pressure on your shoulders and hips if you're lying on the wrong mattress for this sleeping position and your body weight. With the majority of our testing panel comprising side sleepers, we really know our stuff when it comes to recommending the best mattress for side sleepers. For us, the Helix Midnight Luxe is the cream of the side lying crop. This hotel-style bed is opulent from tip to toe, delivering bags of pressure relief (goodbye, painful pressure points) without hanging on to excess heat (yep, it's hot sleeper safe). The other big draw is motion isolation: as Nicola Appleton explains in our full review, you'll barely feel any movement from those you share a bed with. Expensive, but worth the price — and a worthy winner of this Tom's Guide Award. We know from rigorous testing that the best mattresses for stomach sleepers are all about support and that's something the Helix Dawn Mattress delivers by the bucketful. This hybrid bed has stared-down some tough competition in 2025 (the Plank Firm Mattress is a double-sided dream for stomach sleeping), but the Helix Dawn takes the win here by pairing immense support with a good value price. Tom's Guide Senior Sleep Writer Ruth Jones tested the Dusk Luxe and said that while stomach sleeping normally puts pressure on your back, she felt 'refreshed and rested' when sleeping on this mattress. The best mattress toppers aren't just for fixing up old mattresses. They're also good for softening hard beds, cooling hot beds, and enabling you to experience the comfort of a better mattress for a fraction of the price. For us, the Tempur-Pedic Tempur-Adapt + Cooling Mattress Topper does all that and more. We first tested the original 3' Tempur-Adapt topper and found it to provide cloud-like plushness, yet it had a tendency to trap body heat. We tested it again with a + Cooling upgrade (with cool-touch cover) for our review and the difference in sleep comfort was enormous. 'I spent two weeks sleeping on the Tempur-Adapt + Cooling Topper loved how it delivered Tempur Pedic's signature comfort without the usual heat retention,' said reviewer Alsion Barretta.'If you're not ready to invest in a new mattress, this topper is an easy, affordable way to add a big upgrade to your bed.' Since our new bedding writer Becky George joined our team last September we've been testing more pillows than ever. The one that stood out from the crowd as our top recommended pillow is the Coop Home Goods Adjustable Pillow, a foam and fiber fill design that uses an adjustable loft to appeal to all sleep styles. While the flat support of the Tempur-Pedic Tempur-Cloud pillow is perfect for stomach sleeping and the ergonomic build of the Nest Bedding Easy Breather Pillow suits side sleepers, the Coop Home Goods Adjustable Pillow can be made taller or smaller to suit your needs. Becky praised the 'feathery softness' of the fill and noted as a combination sleeper who tends to change sleep position, the Coop Home Goods Pillow kept her comfy in all of them. If ever there was a Goldilocks pillow, this is it. Mattress protectors might seem like a boring purchase at first, but in reality they make a huge difference to how long your bed lasts and how healthy you feel when sleeping on it. Fancy lying face to face with stale sweat, dust mites, body oils and more? No, we didn't think so. The Coop Home Goods Waterproof Mattress Protector is the number one rated product in our best mattress protectors guide and our top-recommended option for all sleepers. It takes home this Tom's Guide Award because we feel it offers excellent quality for the money, it's breathable, quiet (no annoying crinkly noises here), and fully waterproof. In short, the Coop Home Goods Waterproof Mattress Protector delivers everything you need to keep your mattress safe from stains, spills, allergens, and other nasties. Our Managing Editor of Sleep, Claire Davies, uses it on her mattress and wouldn't be without it now. TikTok favorite the Hatch Restore 3, aka our best sunrise alarm clock of the year, packs a whole load of functionality into one sleek device. We're talking authentic sunrise simulation, 60+ sleep soundtracks, and a sundown setting to help you chill out and drop off. All that, plus a variety of alarms and cheerful sunrise settings to get you out of bed fast and raring to go in the morning – a godsend during the depths of winter. The Hatch Restore 3 is our top pick for anyone who needs a hand creating a consistent bedtime routine and wake-up time, both of which will improve your sleep health and your overall wellbeing in turn. 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Associated Press
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- Associated Press
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USA Today
07-07-2025
- USA Today
ALS Community Files Citizens' Petition asking FDA to Approve NurOwn Stem Cell Therapy
New and Unprecedented Survival, Respiratory, and Biomarker Data Prove that NurOwn Helps People with ALS Live Longer and Live Stronger On July 4, 1939, Lou Gehrig delivered his iconic 'luckiest man' speech, announcing his retirement from the New York Yankees. On that day, ALS ended his Hall of Fame career. Less than two years later, ALS ended his life at just 37 years old. In the last 86 years, the lethal outcome has not changed. ALS is a cruel, paralyzing and 100% fatal disease. But today, the ALS community has hope. A coalition of ALS patients and family members has filed a Citizens' Petition with the FDA, requesting the approval of NurOwn, a neurotrophically-enhanced stem cell therapy. Backed by a decade of real-world data from the NurOwn trials and Expanded Access Program (EAP), the 309-page Citizens' Petition details the unprecedented survival, respiratory, and biomarker data for the FDA's consideration. The new evidence is supported by testimony from top ALS neurologists who were the trial's principal investigators, and the 'totality of the evidence' from the Phase 3 trial. And, it aligns with real-world evidence where trial participants (now-unblinded) and their treating neurologists have proclaimed that NurOwn improves how people with ALS 'feel, function and survive.' NurOwn: A Revolutionary Approach to ALS Treatment Developed by BrainStorm Cell Therapeutics , NurOwn combines the restorative potential of autologous mesenchymal stem cells with the regenerative power of neurotrophic factors, which are like 'Miracle-Gro' for dying motor neurons. NurOwn uses a patient's own stem cells that work like a FedEx truck, delivering nano-packages of neurotrophic factors and immunomodulatory cytokines directly to damaged motor neurons. The results are profound. Within days, trial participants reported halting of symptoms like fasciculations, cramping and clonus; and some improvements in function. With additional doses, the EAP data confirm NurOwn's ability to slow lethal ALS progression, improve function, restore breathing, and extend survival – offering a lifeline to those battling this 100% fatal and paralyzing disease. Unprecedented Survival and Respiratory Data Survival data have long been the gold standard for FDA approvals; and as Commissioner Makary has emphasized: 'gold standard science and common sense' will guide this FDA's decisions. To that end, Petitioners have submitted survival data derived from their own real-world evidence over the past decade. These survival data are unprecedented in ALS clinical trial history. Five-Year Survival: 100% in NurOwn EAP vs. 20% in ALS natural history. All EAP participants (n=10) achieved five-year survival without tracheostomies. Extended Tracheostomy-Free Survival (TFS): 7-year median tracheostomy-free survival (range from 5 to 8.5 years), far surpassing the 2.5- to 3-year median in ALS natural history data. Progression-Free Survival (PFS): When patients received NurOwn, they experienced PFS ranging from a few months up to 17 months. ( See Petition's Emergent Fact section C at pg 19-33). At the FDA Advisory Committee meeting for NurOwn in 2023, Dr. Anthony Windebank of Mayo presented the clinical trial data and shared his expert opinion about the progression-free survival that he and other experienced trial investigators had witnessed – unprecedented in their prolific 40+ year neurology practices: 'I think this data is compelling & it should be approved…. While not everyone responds to the treatment, there are clearly a significant number who do. I have clearly seen some people stabilize in a way that I have never seen in any other trial . In fact, in the small number of people who participated in EAP and received 6-9 treatments, there were people who stabilized while on NurOwn in the trial. In the interval before they were in the EAP – which was over a year or more in some cases – these participants deteriorated, then again stabilized in the additional [EAP] treatment period. There were some who IMPROVED their score. Other investigators who have been working 'hands on' with the participants in the trial have seen similar responses….' Dr. Windebank's testimony underscores the unprecedented impact of NurOwn on people with ALS. And the NurOwn survival data is buttressed by other compelling efficacy data also detailed in the Citizen's Petition: Long-term Preservation of Respiratory Function : A 5- to 8-year delay in the need for non-invasive ventilation (NIV) over a 15-month natural history; and significant stabilization or improvement in Forced Vital Capacity (FVC), both key predictors of ALS survival. ( See Emergent Fact section D at pg 34-44). Long-term Slowing of ALS Progression: Up to an 85% slowing in ALS progression rate, from a trial qualification of a minimum loss of 1 point per month to 0.15 points per month after receiving NurOwn. ( See Emergent Fact section F at pg 44-46). Biomarker Evidence: 23 CSF biomarkers demonstrate statistically significant changes and NurOwn's target engagement across pathways of neuroprotection, neuroinflammation, and neurodegeneration. ( See Fact section M at pgs 156-166). Real-World Evidence and Patient Experiences Our Citizens' Petition also leverages real-world evidence (RWE) and real-world data (RWD) from the EAP and Right to Try – consistent with the Congressional intent of the 21st Century Cures Act. Multiple trial participants testified, submitted Public Comments and shared their RWE, which aligns with the type of efficacy evidence specified in the ALS Guidance Document and 21st Century Cures. At the time of the advisory committee meeting in 2023, many trial participants reported tangible improvements in how they felt and functioned, and hence, an improved quality of life. (See sections H & I, pgs. 91-127). Their testimony was supported by video evidence documenting those improvements and by the opinions from multiple treating neurologists outside the clinical trial. For example, neuromuscular specialist Dr. Danielle Geraldi-Samara submitted a Public Comment to the FDA about what she observed in many of her patients participating in the NurOwn Phase 3 trial and EAP: 'The real world evidence could not be more striking. I have known patients nearly immobile who gained some functionality in their gait, patients with severe dysarthria become intelligible, patients who could not manage the fine motor skill needed to button or zipper, finally able to dress independently. I have patients with solid plateaus [in ALSFRS-R scores] over the course of a year.' Her clinical observations of progression-free survival after the NurOwn trial mirror those of Dr. Windebank and the other investigators during the trial and EAP. Now that the Phase 3 trial has been unblinded, multiple trial participants have confirmation that NurOwn halted their lethal progression and helped some people regain function. Our lived patient experiences now have both validation and vindication. When people are becoming paralyzed, it's common sense that we know when a therapy helps us function. Our lived patient experiences aren't anecdotal hyperbole; they are evidence. And as Commissioner Makary recently said at the Gene and Cell Therapy Forum, there is value in learning from 'n of 1' cases. Combined, the EAP 'n of 10' and the right to try 'n of 1' illustrate compelling and consistent, dose-dependent evidence of efficacy. Reinforcing the efficacy data, Navy pilot Matt Bellina shared the RWE and RWD contained in his VA medical records in his blog and on social media . Matt too experienced unprecedented clinically meaningful improvements after receiving 7 doses of NurOwn via Right to Try. Although he was a slow progressor, diagnosed in 2011, Matt's ALS had progressed significantly. He was choking on food, using NIV to breathe at night; had little use of his hands; and could not stand without assistance. His data are informative, supporting evidence of efficacy because he is the only person in the US who received 6 consecutive doses; because he was the only 'slow progressor' to receive NurOwn; and because his baseline score was 21/48 on the ALS Functional rating scale. Matt's large magnitude, dose-dependent improvement in function was immediate and obvious. ( See section J at pgs 128-133). Matt has video documenting him standing out of a wheelchair unassisted – the first time in two years. He stopped choking on food . He i mproved his functional score by 6 points . His FVC stabilized and he stopped using NIV to breathe for more than 4 years. NurOwn interrupted Matt's lethal trajectory to death. Commissioner Makary has repeatedly offered that the FDA, under President Trump, 'believes in both the spirit and the letter of right to try. ' Thus, Petitioners hope that this FDA will consider and believe the RWE from the very veteran for whom President Trump's Right to Try law was named . Totality of Evidence Methodology for Rare Diseases To determine if a therapy can meet the approval threshold of 'substantial evidence,' the FDA asks if a therapy improves how people 'feel, function or survive.' Regulators look principally at the trial's primary endpoint at one fixed point in time at the end of the trial. But in heterogeneous rare diseases with small populations and short placebo-controlled trials, efficacy signals can be missed. Hence, it's much more likely to result in a Type II statistical error: delaying or denying approval of a drug that does work. In a terminal disease like ALS, Type II errors cause ongoing paralysis and death. Thus, the Citizens' Petition reasserts the propriety of the FDA's use of the 'totality of evidence' statistical methodology to assess NurOwn's efficacy. This approach – widely accepted in oncology for evaluating therapies in heterogeneous, rare populations – strengthens the case for NurOwn's approval by highlighting the consistent benefits in the subgroup of ALS patients earlier in ALS progression (akin to a drug working on stage I and II cancer patients). When including the trial population with the most advanced ALS (akin to stage III/IV cancer), the trial did not meet its endpoints. But when looking at the patients earlier in ALS progression, NurOwn met statistical significance. Using the 'totality of the evidence' methodology, renowned biostatistician and Wilkes Award winner, Dr. Lee-Jen Wei of Harvard / Dana Farber analyzed the multiple trial endpoints, across multiple functional scale domains, at multiple time points throughout the 28-week trial. He testified at the Advisory Committee meeting that these p-values were: 0.045, 0.021, 0.007 and 0.005; thus providing more supporting evidence of NurOwn's efficacy. Meeting FDA Approval Thresholds The Citizens' Petition asserts that NurOwn achieves the statutory thresholds for multiple FDA approval pathways: 1. Traditional Approval NurOwn's survival data, including the five-year survival, TFS, PFS and OS, meet the 'substantial evidence' threshold of one well-controlled trial plus supporting evidence. This conclusion aligns with the FDA's recognition that survival data are the gold standard in FDA approvals. Thus the diversity and magnitude of NurOwn's survival outcomes fulfills both the 'quality' and 'quantity' requirements of 'substantial evidence.' ( See Emergent Fact section C, pgs. 19-33). 2. Accelerated Approval NurOwn meets the 'reasonable likelihood' threshold for accelerated approval. The survival data from the 'n of 10' EAP are 'reasonably likely to predict' a favorable impact on irreversible mortality of the 32,000 people with ALS. This survival data far surpasses survival data supporting the accelerated approval of many cancer therapies. ( See comparison at Memorandum section I, pgs. 191-209 and Exs. A & B). NurOwn's respiratory data, including delays in time-to-tracheostomy, time-to-NIV, and improved FVC, are also reasonably likely to predict a favorable impact on mortality. ( See Emergent Fact section D, pgs. 34-43 and Memorandum II.C pgs. 219-222). NurOwn's CSF biomarker data are also reasonably likely to predict a 'clinically meaningful' effect. NurOwn caused statistically significant changes in first-in-class CSF biomarkers – regardless of disease severity and only in the NurOwn treatment arm. Of the 45 pre-specified biomarkers tested, 23 had statistically significant changes and 15/23 had p-values ≤0.001. These CSF biomarkers provide objective biological evidence of target engagement across pathways of neuroinflammation, neurodegeneration, and neuroprotection. ( See Petition Facts section M, pgs. 156-166 and Memorandum section II.C pgs. 219-222). Additionally, Brainstorm Cell has shared neurofilament light biomarker data in a poster presentation at the 2024 NEALS conference. As the FDA has acknowledged, as ALS progression advances, harmful NfL increases, reflecting more diseased and dying motor neurons. At the end of the Phase 3 trial, there was a 9.4% delta between the NurOwn and placebo arm (p=.037). But in those 10 from EAP who were earlier in progression at the start of the Phase 3 trial, the delta between the NurOwn and placebo arms was more apparent. At the end of Phase 3, the 4/10 on placebo had a 37% increase in harmful NfL whereas the 6/10 on NurOwn had a 4% decrease in NfL. With the additional dosing in EAP, the 4/10 in the placebo-crossover group finally experienced a 5% decline in harmful NfL, whereas people on NurOwn maintained a 36% decrease from baseline. Not surprisingly, those who received the most doses of NurOwn and received it earliest in ALS progression had the largest magnitude functional changes and as well as the largest decrease in NfL levels – with two people who received 9 total doses having a decrease of ≥60% in harmful NfL levels. ( See table in section II.C.2.a on page 222). As such, the changes in CSF biomarkers are reasonably likely to predict a clinically meaningful benefit, and thus, the third way that NurOwn can meet the threshold for accelerated approval. 3. Conditional Approval NurOwn aligns with Commissioner Makary's proposed 'plausible mechanism of action' threshold for conditional approval. Both stem cell technology and neurotrophic factors are plausible mechanisms of action in ALS; and NurOwn's CSF biomarker data confirms biological plausibility. ( See Petition Fact section N, pgs. 173-176 and Memorandum section II.G at pgs. 234-241). A Call for De Novo Review and Expedited Action The Citizens' Petition requests a de novo review by the FDA. The Center for Biologics Evaluation and Research (CBER) has not ever considered the EAP survival, respiratory, or biomarker data, nor has it considered the Right to Try data from Navy pilot Matt Bellina, nor the unblinded and now corroborated RWE/RWD from people who have benefitted from NurOwn since 2011. The Petitioners also request that CBER use the Commissioner's new Priority Voucher to expedite review. The Citizens' Petition also proposes that FDA consider the far-reaching benefits of a Phase 4 post-marketing study, including a biorepository and natural history/exposome database, which aligns with the FDA Priorities outlined by Doctors Makary and Prasad. A Historic Moment for the ALS Community At the recent 2025 Gene and Cell Therapy Forum , Secretary Kennedy shared that the FDA will do everything it can to 'accelerate approvals for rare diseases.' And in their Joint OpEd for JAMA Viewpoints , Commissioner Makary and Director Prasad said the FDA is committed to 'rapidly usher to market new products with transformational potential.' In furtherance of that commitment, Director Prasad told the rare disease community that the FDA will: 'approve anything that is an incremental advancement' accelerate therapies by 'taking action at the first sign of promise for rare diseases' and at the 'earliest sign of statistical evidence' monitor people post-market to 'ensure people live longer, stronger.' The Citizens' Petition argues that NurOwn has more than transformational potential . Rather, the survival and respiratory data, along with 8 years of RWE, demonstrate its already transformational impact on people living with ALS. Thus, the ALS community calls on the FDA to approve NurOwn, honoring its commitment to marry 'gold standard science and common sense.' ALS is stealing decades from our lifespans. Just as the FDA acts with urgency for people with terminal cancer, the Citizens' Petition asks the FDA to act with the same urgency as ALS is killing our motor neurons. Please don't let another generation of people with ALS die waiting when we know a stem cell therapy can help us live. About ALS ALS is a 100% fatal, heterogeneous, rare neurodegenerative disease. As motor neurons die, the brain can no longer communicate with the voluntary muscles, which slowly become paralyzed. For reasons researchers don't fully understand, ALS impacts only the motor neurons, not the sensory neurons. Thus, people with ALS still feel cramping, sensations, fasciculations and pain, but they can't move to respond to them. Ultimately, people lose the ability to walk, talk, move, eat, drink, swallow, and eventually, breathe. About the Petitioners The Petitioners are a coalition of people who received NurOwn and others with ALS who could not. We are committed to advancing research, treatment access, and policy changes for ALS. Petitioners: Nicholas Warack, Esq. Matt Klingenberg – Phase 3 & EAP Eric Stevens – Phase 3 & EAP Joshua Smith – Phase 3 & EAP Estate of Roberto Muggli – Phase 3 & EAP Lesley Krummel – Phase 3 Estate of Kade Simons – Phase 3 Estate of Justin Rogers – Phase 3 Terri Pickering Saenz – Phase 2 Tara Collazo Mayuri Saxena Estate of Jamie Rose Berry Estate of Patricia Manhardt Shahriar Minokadeh, MD Contact: SOURCE: NurOwn Citizen's Petition View the original press release on ACCESS Newswire
