Nalu Medical Achieves National Payer Milestone with Aetna Coverage for PNS Therapy
This policy shift moves Nalu from its prior classification of 'Investigational/Experimental' to 'Medically Necessary' for eligible patients—opening access to more than 22 million additional covered lives across the U.S.
'Aetna's recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,' said Tom West, Chief Executive Officer of Nalu Medical. 'We've built a robust body of clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain, as well as healthcare economic data that demonstrates use of Nalu PNS results in significant cost savings. We're proud to see a leading payer like Aetna acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.'
Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) 1 that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu Neurostimulation System has been repeatedly recognized for its revolutionary technology, including being named as one of the world's top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.
About Nalu Medical, Inc.
Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu Neurostimulation System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.
[1] Data on file, Nalu Medical, Inc. 2025.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
3 hours ago
- Business Wire
NEL Animal Cardiovascular Center Performs World's First Surgical Treatment of Canine Infective Endocarditis
ANYANG, South Korea--(BUSINESS WIRE)--The NEL Animal Cardiovascular Center said that its NEL Animal Heart Surgery Team has achieved the world's first surgical success in treating canine infective endocarditis (IE) in a dog. 'This case is the first to prove that surgical treatment can be a viable option for canine infective endocarditis, a condition previously considered inoperable. It is a result of our cumulative experience in over 50 successful mitral valve surgeries." Share The South Korean veterinarian team led by Chief Veterinarian Dr. Taeheum Um has conducted a complex procedure using cardiopulmonary bypass (CPB) to resect and reconstruct a heart valve damaged by infection, in a case where conventional medical treatment had proven insufficient. This case marks the world's first successful surgical intervention for canine infective endocarditis. The patient, an 8-year-old, 6.2 kg Spitz, was a high-risk case with a medical history of Protein-Losing Enteropathy (PLE) and prolonged antibiotic use. The first surgery addressed a degenerative mitral valve damaged by myxomatous changes, significantly reducing regurgitation. The patient recovered well without the need for ongoing medication. However, approximately four weeks post-op, a bacterial infection developed on the valve. Detailed diagnostics confirmed the presence of infective endocarditis caused by the multi-drug resistant bacterium Enterococcus faecium. The infection was likely due to intestinal barrier damage linked to chronic enteritis and long-term antibiotic treatment. Despite six weeks of intravenous antibiotic therapy, severe structural damage to the valve necessitated a second surgery. In the second operation, the team performed anterior mitral valve leaflet patch augmentation, extending the shortened anterior leaflet using a bovine pericardial patch. This is a highly advanced technique borrowed from human cardiac surgery — and this marks the first time it has ever been applied to a dog. The nine-hour procedure was successful, and the patient was able to discontinue all cardiac medications and diuretics. Now, over three months post-surgery, the dog is living a normal life without any syncope episodes. Considering the average survival period for dogs with infective endocarditis is around 70 days, this case — with the patient surviving and improving over 10 months post-onset — is a landmark achievement demonstrating the potential of surgical treatment. Dr. Taeheum Um, lead surgeon of the NEL Animal Heart Surgery Team, stated, 'This case is the first to prove that surgical treatment can be a viable option for canine infective endocarditis, a condition previously considered inoperable. It is a result of our cumulative experience in over 50 successful mitral valve surgeries. We will continue to monitor the case and publish our findings in academic journals.' Building on this success, the team aims to expand the clinical scope of treatment for complex canine heart diseases and contribute critical data to the global veterinary cardiology community. About NEL Animal Cardiovascular Center The NEL Animal Cardiovascular Center is a 24-hour specialty veterinary hospital with expertise in heart surgery and intensive cardiac care. It also offers services in neurology (disc treatment), advanced diagnostics (CT/MRI), stem cell therapy, and orthopedic surgeries such as cruciate ligament and patella luxation repairs. NEL is the only private animal hospital in South Korea capable of performing both mitral valve surgery and open-heart surgery. The center also operates a specialized heart screening program for early detection and management of cardiac diseases.
Business Insider
4 hours ago
- Business Insider
GSK provides update on US FDA advisory committee review of Blenrep
GSK (GSK) notes that the U.S. FDA Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the July 23 PDUFA date. GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
8 hours ago
- Yahoo
Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and the collapse of the company's share price this year. In a statement Monday, Sarepta said it plans to cut approximately 36% of its staff and pause research on several drug programs. The company expects the two moves together will result in more than $400 million in annual cost savings in 2026. On a conference call held Wednesday afternoon, Sarepta CEO Doug Ingram said that "failure to adapt" to recent setbacks "would risk our long-term viability as an organization and decrease the opportunity to bring the greatest benefit to the greatest number of patients living with rare disease." Sarepta employed 1,372 people as of the end of last year, according to a regulatory filing. Shares in the company rose in after-hours trading on the news. For Sarepta, the layoffs reflect, in part, uncertainty around the future of Elevidys, its gene therapy for Duchenne muscular dystrophy. Elevidys is the product of many years of research into the deadly neuromuscular condition and, in 2023, became the first and currently only gene therapy for the disease approved in the U.S. The Food and Drug Administration's clearance was controversial. While Elevidys initially won approval for a narrow group of patients, the agency expanded its OK the following year even though study results were mixed and left the therapy's ultimate benefits unclear. But the broader OK sent Sarepta's share price soaring and demand for Elevidys climbing. Some Wall Street analysts predicted sales might top $2 billion in 2025. However, in March and in June, Sarepta disclosed two Elevidys-treated patients died after experiencing acute liver failure. The individuals were older and could no longer walk because of their disease's progression. In response, Sarepta stopped selling the treatment to these older, non-ambulatory patients, who it judges are at higher risk of treatment-induced liver damage. The company also paused a study meant to confirm Elevidys' benefits in these patients, and convert the therapy's current 'accelerated' approval in these patients to a traditional one. Sarepta is working on a new regimen of immune-suppressing drugs to manage the safety risks, and plans to soon share its findings with the FDA. Sarepta has suspended its financial forecasts in the meantime. The company's share price is lower by more than 80% this year amid concerns about Elevidys' future and the chance new FDA leadership might restrict its use. The company also has $1 billion in senior notes coming due in 2027. Ingram had hinted cuts could be coming on a conference call in June 'We're going to have to look at our cost structure to make sure that we remain financially disciplined,' he told analysts then. Sarepta became profitable in 2024, and believes it can stay in the black even if Elevidys only draws revenue from ambulatory patients, executives said on that June call. On Wednesday, Sarepta shared that the FDA is adding a black box warning about the risk of liver failure or injury to Elevidys' label, which Sarepta said should resolve any agency concerns with the therapy's use in that group. However, "more dialogue is required' with the FDA about Elevidys' use in non-ambulatory patients, Ingram said on the Wednesday call. Sales of the gene therapy were approximately $282 million in the second quarter, Sarepta disclosed Wednesday, lower than the $375 million it recorded the first quarter. The company believes sales in ambulatory patients are likely to annualize at a minimum of $500 million annually through 2027. Three other 'exon-skipping' drugs Sarepta sells for Duchenne could bring in about $900 million per year over that period, the company added. Sarepta also has a gene therapy for limb-girdle muscular dystrophy it plans to submit for approval later this year, too, although it is pausing research on other treatments for that condition. Aside from the Duchenne medicines it sells, Sarepta intends to focus resources moving forward on a group of RNA-based medicines it's developing with Arrowhead Pharmaceuticals. Among them are treatments for spinocerebellar ataxia, Huntington's disease and facioscapulohumeral muscular dystrophy. In its statement, Sarepta said those drugs have 'tremendous near-term potential.' Editor's note: This story has been updated with additional details and commentary from Sarepta executives. Recommended Reading Second Duchenne patient dies after receiving Sarepta gene therapy 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
