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LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy

LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy

Business Wire07-05-2025
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA). At 12 months of therapy, the treatment arm responder rate was 65% with responders defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20. The study features a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS), which utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and providing customized titration.
'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova.
In , the company announced that OSPREY met its primary and secondary endpoints following six months of therapy. Study patients in the treatment arm of OSPREY have since shown continued improvement. When comparing baseline median values to six and 12 months of therapy (assessed at the seven- and 13-month follow-up visits, respectively), OSPREY subjects showed significant reductions in AHI and oxygen desaturation index (ODI) over time:
AHI reduced by 68% when the median at baseline of 34.3 is compared to the median of 11.0 at 12 months (versus the median of 11.6 at six months).
ODI reduced by 68% when the median at baseline of 34.9 is compared to the median of 11.1 at 12 months (versus the median of 12.8 at six months).
Further, after 12 months of treatment, OSPREY subjects in the device stimulation group experienced clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ). ESS and FOSQ as compared to baseline are secondary outcome measures within the study. ESS is a patient questionnaire that assesses how likely the patient is to fall asleep during the day and FOSQ is a patient questionnaire that assesses the effects of fatigue on daily activities.
"OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation. Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time,' said Dr. Atul Malhotra, lead investigator for the study, who is also a professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at UC San Diego Health. 'Responder rates in the treatment group were strong throughout the first year with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark. In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.'
Dr. Malhotra will present the OSPREY six-month results and 12-month top-line data at the American Thoracic Society International Conference on Tuesday, May 20, at 9:51 a.m. PDT in San Francisco.
OSPREY baseline values of OSA severity and body mass index (BMI) were representative of the general OSA population. Relative to other large-scale trials of hypoglossal nerve stimulation (HGNS) in support of U.S. Food and Drug Administration (FDA) approval, OSPREY included patients with greater OSA severity and higher BMI. Plus, OSPREY was designed to include patients with complete concentric collapse (CCC). Based on a recently presented predictive algorithm 1, it was determined that the OSPREY study enrolled patients at increased risk of CCC at a ratio aligned with the general OSA population seen in clinical practice. Response rates and AHI reductions at month 12 for patients in OSPREY with predicted risk for CCC were consistent with the results for the full study population, demonstrating the robustness of the therapeutic response 2.
'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation, including those with severe obstructive sleep apnea, elevated body mass index, and high risk of complete concentric collapse,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and strategic growth opportunity ahead, we are eager to bring this innovation to patients.'
LivaNova recently completed its premarket approval submission to FDA for the aura6000 System based on meeting OSPREY's primary safety and efficacy endpoints following six months of treatment. LivaNova has also provided FDA with interim 12-month results from the OSPREY study and intends to share the full 12-month dataset with FDA during its review.
The aura6000 System is an investigational implantable proximal hypoglossal neurostimulator undergoing clinical evaluation for the treatment of adult patients with moderate to severe OSA. There were no serious adverse device-related or procedure-related events reported during OSPREY.
References
The PREDICTOR algorithm was presented at the 2024 International Surgical Sleep Society Educational Update in Miami (https://surgicalsleepmeeting.org/educational-update-meeting/). The presentation occurred on Friday, Sept. 27, 2024, with the lecture being delivered by Jordan Weiner, MD (https://surgicalsleepmeeting.org/wp-content/uploads/2024/09/16253-ISSS-2024-Educationl-Agenda-22.pdf).
CYB-03127-R1
About OSPREY
OSPREY is a prospective, multi-center, randomized controlled open-label trial evaluating the safety and efficacy of the aura6000™ System versus a no stimulation control in subjects with moderate to severe OSA who have failed or are unwilling to use positive airway pressure treatment. CAUTION—the aura6000 System is an investigational device. Limited by Federal (or United States) law to investigational use.
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the OSPREY study, the aura6000™ System, and presentations at upcoming conferences. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
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The 3 Things That Matter for CRISPR Therapeutics Now
The 3 Things That Matter for CRISPR Therapeutics Now

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Key Points CRISPR Therapeutics' gene-editing treatments are highly customized and shockingly expensive. The market is watching to see if the underlying science can be applied to treat many diseases. The company has plenty of money right now, but its expenses could grow quite a bit from here. 10 stocks we like better than CRISPR Therapeutics › Biotechnology outfit CRISPR Therapeutics (NASDAQ: CRSP) isn't a name on many investors' radar -- and understandably so. Its market capitalization is a mere $6 billion. The company remains in the red largely because it's barely got any revenue to speak of. It's not likely to swing to a profit in the immediate future, either. Still, if you've got room in your portfolio for a little more risk paired with above-average upside potential, this is a stock worth adding to your watchlist (if not your portfolio) with three key things in mind. But first things first. What's CRISPR Therapeutics? Although the company was founded back in 2013, most of its time since then has been spent refining the work first done by Jennifer Doudna, Ph.D., and co-founder Emmanuelle Charpentier, Ph.D., who jointly figured out how to "edit" defective genetic code in a strand of DNA. By using a protein called Cas9 to find and remove a damaged portion of a genetic sequence and then replace it using a gene-editing biotechnology based on clustered regularly interspaced short palindromic repeats -- or CRISPR -- medical science is now able to do what was once unthinkable. It's still early days for the science -- very early. In fact, the FDA only made its first-ever approval of a gene-editing therapy in December of 2023. That's Casgevy, for the treatment of sickle cell disease, which was approved in the U.K. only a month earlier. 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Three things to watch As time marches on, though, this stock's backstory is evolving from one broadly driven by an idea to one that increasingly hinges on some very specific factors. To this end, here are the three things that matter the most to current and prospective CRISPR Therapeutics shareholders right now -- and for the foreseeable future -- since they'll either drive the stock higher or let it slide into a sell-off. 1. Insurers and patients' acceptance of CRISPR-based medicine's cost While the science of using CRISPR to repair faulty cells is exciting, it's not exactly cheap or easy. See, Casgevy isn't a pill or an injection. It requires a sample of a patient's own blood stem cells to create a completely customized therapy, which is then infused back into that patient after he or she has undergone chemotherapy. All of this care can only be done at one of CRISPR's 65 authorized treatment centers. Total cost? A little over $2 million per patient. 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If the company can demonstrate its solution is at least as good as (if not better than) alternative cholesterol-fighting drugs, investors might continue to support this stock. This information is coming. The company posted encouraging early results of CTX310's phase 1 clinical trial late last month, and says it intends to offer more detailed data at a healthcare conference scheduled for later in the year. If it's compelling enough, it could tamp down worries over the high cost of any CRISPR-based treatment. 3. Liquidity Finally, you'll want to keep an eye on CRISPR Therapeutics' liquidity, or the amount of cash it has on hand to cover its operating costs while it continues to develop CTX310 at the same time it's looking to expand Casgevy's commercialization. As of the end of the first quarter, CRISPR was sitting on $1.86 billion in cash, which is a lot for a company of this size. 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The money it needs to spend just to get any meaningful degree of traction from Casgevy or maintain its clinical trials could far exceed any conceivable amount of revenue the newly approved drug might produce in the foreseeable future. Don't confuse what CRSP stock is So what's the call? There isn't one -- not this time. Buying or avoiding a stake in CRISPR Therapeutics is entirely up to you, depending on your risk tolerances and your ability to manage such a holding. If you're strictly a buy-and-hold investor, there's probably not enough certainty here yet to latch onto for the long haul. And there may never be. If you've got a speculative side that can tolerate risk in exchange for hype-driven reward, though, you could make a decent bullish case. Just don't confuse the two, or muddy the waters by trying to be both. The last thing you want to do here is talk yourself into a long-term position that requires you to ignore obvious red flags like the three potential ones discussed above. 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The Motley Fool has positions in and recommends CRISPR Therapeutics. The Motley Fool has a disclosure policy. The 3 Things That Matter for CRISPR Therapeutics Now was originally published by The Motley Fool Error 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

The 3 Things That Matter for CRISPR Therapeutics Now
The 3 Things That Matter for CRISPR Therapeutics Now

Yahoo

timean hour ago

  • Yahoo

The 3 Things That Matter for CRISPR Therapeutics Now

Key Points CRISPR Therapeutics' gene-editing treatments are highly customized and shockingly expensive. The market is watching to see if the underlying science can be applied to treat many diseases. The company has plenty of money right now, but its expenses could grow quite a bit from here. 10 stocks we like better than CRISPR Therapeutics › Biotechnology outfit CRISPR Therapeutics (NASDAQ: CRSP) isn't a name on many investors' radar -- and understandably so. Its market capitalization is a mere $6 billion. The company remains in the red largely because it's barely got any revenue to speak of. It's not likely to swing to a profit in the immediate future, either. Still, if you've got room in your portfolio for a little more risk paired with above-average upside potential, this is a stock worth adding to your watchlist (if not your portfolio) with three key things in mind. But first things first. What's CRISPR Therapeutics? Although the company was founded back in 2013, most of its time since then has been spent refining the work first done by Jennifer Doudna, Ph.D., and co-founder Emmanuelle Charpentier, Ph.D., who jointly figured out how to "edit" defective genetic code in a strand of DNA. By using a protein called Cas9 to find and remove a damaged portion of a genetic sequence and then replace it using a gene-editing biotechnology based on clustered regularly interspaced short palindromic repeats -- or CRISPR -- medical science is now able to do what was once unthinkable. It's still early days for the science -- very early. In fact, the FDA only made its first-ever approval of a gene-editing therapy in December of 2023. That's Casgevy, for the treatment of sickle cell disease, which was approved in the U.K. only a month earlier. The thing is, Casgevy is CRISPR Therapeutics' treatment, underscoring how well developed this biotech outfit's science is, and perhaps indirectly underscoring the fact that many rival drug developers are still well behind. Casgevy isn't the company's proverbial big Kahuna, however -- it's merely proof that gene editing can be successfully done. The heavy hitters in CRISPR's developmental pipeline are CTX310 for the treatment of certain cardiovascular diseases, and CTX131 and CTX112, both of which are taking aim at cancer using the very same CRISPR science. Although all of these drugs still have years of developmental work ahead of them, again, the underlying gene-editing technology works. Its potential applications are enormous. That's why CRISPR has a dozen or so others in clinical or pre-clinical trials also underway at this time. Three things to watch As time marches on, though, this stock's backstory is evolving from one broadly driven by an idea to one that increasingly hinges on some very specific factors. To this end, here are the three things that matter the most to current and prospective CRISPR Therapeutics shareholders right now -- and for the foreseeable future -- since they'll either drive the stock higher or let it slide into a sell-off. 1. Insurers and patients' acceptance of CRISPR-based medicine's cost While the science of using CRISPR to repair faulty cells is exciting, it's not exactly cheap or easy. See, Casgevy isn't a pill or an injection. It requires a sample of a patient's own blood stem cells to create a completely customized therapy, which is then infused back into that patient after he or she has undergone chemotherapy. All of this care can only be done at one of CRISPR's 65 authorized treatment centers. Total cost? A little over $2 million per patient. That's pretty steep for any therapy, but particularly for sickle cell disease, which at least has a handful of more affordable treatment options. The cost of treating life-threatening cancer is less of a stumbling block, even for insurers that may occasionally see bills nearly this size for even the most conventional of oncology treatment regimens. The price tag of this and any other future CRISPR-based therapy, however, is likely to remain in this ballpark, where payers may well balk. 2. The ongoing development of CTX310 Again, while Casgevy is approved to treat sickle cell disease, it's really more of a proving ground for the other drugs in CRISPR Therapeutics' developmental pipeline. This, of course, includes CTX131 and CTX112, but the company itself is putting the spotlight on CTX310 as a treatment for ANGPTL3 (angiopoietin-like 3), which is often associated with poorly regulated cholesterol, lipids, and triglycerides. If the company can demonstrate its solution is at least as good as (if not better than) alternative cholesterol-fighting drugs, investors might continue to support this stock. This information is coming. The company posted encouraging early results of CTX310's phase 1 clinical trial late last month, and says it intends to offer more detailed data at a healthcare conference scheduled for later in the year. If it's compelling enough, it could tamp down worries over the high cost of any CRISPR-based treatment. 3. Liquidity Finally, you'll want to keep an eye on CRISPR Therapeutics' liquidity, or the amount of cash it has on hand to cover its operating costs while it continues to develop CTX310 at the same time it's looking to expand Casgevy's commercialization. As of the end of the first quarter, CRISPR was sitting on $1.86 billion in cash, which is a lot for a company of this size. It's working through this money pretty quickly, though, shelling out nearly $150 million in operating expenses in Q1 alone. That doesn't include a full quarter's worth of the sort of costs the phase 1 trial of CTX310 is incurring now, or any other trials it starts or expands in the foreseeable future. Continued revenue growth from Casgevy should seemingly help offset some of this spending, even if not all of it. Indeed, the analyst community expects CRISPR's top line to soar from less than $50 million this year to more than $400 million in 2027, even if these same analysts believe the company will still be well in the red then. A few years' worth of losses isn't exactly unusual for a young biotech start-up. CRISPR Therapeutics would still lack much-needed scale even after such growth, though. The money it needs to spend just to get any meaningful degree of traction from Casgevy or maintain its clinical trials could far exceed any conceivable amount of revenue the newly approved drug might produce in the foreseeable future. Don't confuse what CRSP stock is So what's the call? There isn't one -- not this time. Buying or avoiding a stake in CRISPR Therapeutics is entirely up to you, depending on your risk tolerances and your ability to manage such a holding. If you're strictly a buy-and-hold investor, there's probably not enough certainty here yet to latch onto for the long haul. And there may never be. If you've got a speculative side that can tolerate risk in exchange for hype-driven reward, though, you could make a decent bullish case. Just don't confuse the two, or muddy the waters by trying to be both. The last thing you want to do here is talk yourself into a long-term position that requires you to ignore obvious red flags like the three potential ones discussed above. Should you buy stock in CRISPR Therapeutics right now? Before you buy stock in CRISPR Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and CRISPR Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $636,628!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $1,063,471!* Now, it's worth noting Stock Advisor's total average return is 1,041% — a market-crushing outperformance compared to 183% for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of July 28, 2025 James Brumley has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends CRISPR Therapeutics. The Motley Fool has a disclosure policy. The 3 Things That Matter for CRISPR Therapeutics Now was originally published by The Motley Fool

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