Randy Hubbell

Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc. Acquisition to expand the neuromodulation offerings for people living with chronic pain MARLBOROUGH, Mass., Oct. 17, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Nalu Medical, Inc., a privately held medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic pain. The transaction consists of an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific. On a 100% basis before consideration of Boston Scientific's current equity ownership in Nalu Medical, Inc. and other closing adjustments, the transaction price consists of an upfront cash payment of $600 million. The Nalu Neurostimulation System is designed to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin, including areas such as the shoulder, lower back and knee, through peripheral nerve stimulation (PNS). Nalu Medical received U.S. Food and Drug Administration 510(k) clearance for the Nalu system in 2019. In the COMFORT and COMFORT 2 randomized controlled trials, evaluating the safety and efficacy of PNS, the system demonstrated significant and sustained pain relief for patients. In COMFORT, 87% of participants reported more than a 50% reduction in pain at 12 months,i while in COMFORT 2, 79% of patients reached an average pain relief of 64% at six months.ii Real-world data from more than 2,000 individuals reinforced these findings, with 94% of patients achieving clinically meaningful improvement across a broad range of chronic peripheral nerve pain conditions.iii "Peripheral nerve stimulation is an exciting field with a significant unmet patient need," said Jim Cassidy, president, Neuromodulation, Boston Scientific. "Adding the highly differentiated Nalu Medical technology complements our existing therapies—including spinal cord stimulation, basivertebral nerve ablation and radiofrequency ablation—enabling us to deliver advanced pain relief options to a wider variety of patient populations." Boston Scientific expects to complete the transaction in the first half of 2026, subject to customary closing conditions. Nalu is expected to generate sales in excess of $60 million in 2025 and to deliver year-over-year growth in excess of 25% in 2026. On an adjusted basis, the transaction is expected to be immaterial to adjusted earnings per share (EPS) in 2026, slightly accretive in 2027, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges.

360

18 Comments

MedTech Innovation at TCT 2025 🚀 Honored to join the opening session of the MedTech Innovation Forum at TCT 2025, alongside visionary leaders Andrew Cleeland Jan Garfinkle Josh Makower Todd Brinton, MD Amr Salahieh. The session — “So, You Want to Be an Innovator: Master the Process, Channel the Genius” — offered timely reflections on how MedTech innovation must evolve to stay relevant and sustainable. 💡 Key takeaways: 1️⃣ MedTech funding is shifting. The cost of innovation is rising — driven by inflation, higher expectations, and reimbursement delays — making exits slower and returns smaller. Venture capital has shifted toward later-stage, de-risked ideas, creating new challenges for early innovators. 2️⃣ Innovation is a disciplined process, not a stroke of genius. The idea is only a small piece of the puzzle; history is written by those who show up. Unmet clinical needs are abundant, but the most promising ones are often latent—unseen yet impactful. Uncovering them is what leads to truly disruptive innovation. 3️⃣ Innovation thrives on meaning. For physicians, purpose (vs financial gain) is the most powerful motivator. However, deeper understanding and skillful navigation of the complex innovation ecosystem are needed to turn that purpose into lasting impact. In the end, meaningful innovation requires a convergence of insight, discipline, and purpose. #TCT2025 #MedTech #Innovation #MedicalDevices #Biodesign Mayo Clinic Fogarty Innovation Cardiovascular Research Foundation Juan Granada Shai Ran Sapir Lisa Carmel Charanjit (Chet) Rihal Stanford Mussallem Center for Biodesign

196

7 Comments

Technology is revolutionizing how and where patient care is delivered, shifting care beyond traditional medical settings and into homes, including those of the 48% of caregivers in the U.S. who provide care to a patient living in their own home.   At BD, we are at the forefront of this transformative shift and our innovations are enabling care to be delivered in new settings, helping patients – and their caretakers – manage conditions at home. BD® Purewick™ Urinary incontinence platform is both transforming the lives of patients suffering from urinary incontinence, but also the lives of caregivers who may provide care at home, allowing them to focus on what truly matters – spending quality time with their loved ones.  https://lnkd.in/evsnj3z7

854

17 Comments

Avvio Medical Receives FDA Breakthrough Device Designation for Enhanced Lithotripsy System (ELS) We’re proud to share that the Avvio Enhanced Lithotripsy System (ELS) has received Breakthrough Device Designation from the FDA — recognizing its potential to advance the treatment of ureteral stones through microbubble‑enhanced acoustic cavitation lithotripsy. This technology is designed to simplify stone treatment by enabling care outside the operating room, supporting outpatient and ASC workflows, and expanding access for the Medicare‑aged population disproportionately affected by stone disease. It is designed to be used without routine general anesthesia and post-operative stents and our ongoing pivotal US IDE study has already validated patient tolerability of the procedure with oral anxiolytics and topical analgesic gel. We plan to submit a DeNovo for market clearance in early 2026 and a new dedicated category III CPT 0991T code will be effective in January. This milestone validates years of science, teamwork, and commitment to making stone treatment safer, simpler, and more accessible. #AvvioMedical #BreakthroughDevice #KidneyStones #Urology #Lithotripsy #MedicalDevices #Innovation #MinimallyInvasive #UreteralStones #Cavitation #ASC #MedicareAccess https://lnkd.in/gc2bRFsK

128

15 Comments

Late breaking clinical science data, presented at #ESCCongress 2025 by Jacob Møller, MD and simultaneously published in NEJM Group, confirms the long-term survival benefit of the Impella CP heart pump. The groundbreaking DanGer Shock RCT continues to deliver impactful data that will improve outcomes for thousands of patients globally each year by demonstrating that at up to 10 years, when compared to standard care, routine use of Impella CP in patients who have had a heart attack with STEMI cardiogenic shock leads to an absolute mortality reduction of 16.3%. When compared to the control arm at 10 years, Impella CP patients gained an average of 600 additional days alive.    Thank you to Dr. Møller, his team, and the study investigators for their continued commitment to these patients! https://lnkd.in/ehp6-Sbz

404

4 Comments

This is a great quote from BD's Dr. Jeff Andrews, MD, FRCSC, discussing with Contemporary OB/GYN the new ASCCP guidelines for cervical cancer screening and the role of the BD Onclarity™ HPV assay: “While other assays exist, BD’s data and precision offer greater clarity in aligning test results with clinical recommendations. These advancements enhance the precision medicine approach, particularly as self-collection methods become more widespread in the United States over time.” #GuidelinesGamechanger #WomensHealth #CervicalCancer #GetScreened https://lnkd.in/eWpujS29

63

Our entire team is still buzzing from last week's expanded FDA indication for SIR-Spheres® Y-90 resin microspheres, making it the first and only radioembolization therapy in the U.S. approved to treat both unresectable HCC and metastatic colorectal cancer (mCRC) of the liver! I've had countless conversations with staff and physicians about this milestone and am humbled by the support and positive feedback everyone has shared. At Sirtex Medical Limited, we don't just innovate for the sake of innovation. We innovate to solve real-life problems that physicians are facing so that they can provide the best patient care possible. That's exactly why we've built the SIR-Spheres® infrastructure to be flexible by enabling physicians to treat patients with the activity they need, when they need it. See how SIR-Spheres® stands out amongst other radioembolization therapies: https://lnkd.in/giM-PBPv

149

3 Comments

Cordis recently unveiled new data from two significant peripheral studies showcasing its Selution SLR drug-eluting balloon. The company, headquartered in Miami Lakes, Florida, disclosed the 12-month outcomes from the SUCCESS PTA study at the esteemed Charing Cross Symposium in London. Additionally, it presented the SELUTION SFA Japan three-year findings at the Japan Endovascular Treatment Conference in Osaka. The findings from these studies, as per Cordis, validate the enduring effectiveness and safety of Selution SLR in addressing complex peripheral artery disease (PAD). Notably, the balloon demonstrated consistent efficacy and safety profiles across varied real-world patient cohorts, as highlighted in a recent news release. Cordis emphasized that the balloon's performance aligns favorably with top-tier benchmarks set by paclitaxel-eluting technologies.

44

1 Comment