4 stories this morning, for surgeons and the people who support them.
- Carlsmed Q3 2026: revenue $21.6M (+65% from $13.1M); gross margin 77.3% (vs 75.9%); net loss $12.2M (vs $8.5M); cash and investments $80.3M; surgeon user base up more than 60%; FY26 revenue guidance raised to $78-80M from $74-78M; FY2027 IPPS with increased inpatient aprevo lumbar payment effective Oct 1; aprevo Lumbar Bi-lateral Posterior System launched in October (~30,000 US procedures/yr, company estimate); Tony Jarc named Chief Product and AI Officer — Carlsmed reported 65% third-quarter revenue growth on November 10 and raised its full-year revenue guidance; the new inpatient payment for aprevo lumbar procedures took effect October 1, after the quarter closed. Source
- FDA approves Bayer's asundexian (Sunharbo), the first factor XIa inhibitor, to reduce stroke risk after non-cardioembolic ischemic stroke or high-risk TIA, with antiplatelet therapy; OCEANIC-STROKE (n=12,327): recurrent stroke risk down 26%, no overall increase in major bleeding (higher in patients over 75 and in the first 90 days); 50 mg once daily; $748.50 list per 30 days — FDA approved asundexian on November 9 for secondary stroke prevention alongside antiplatelet therapy, based on the phase 3 OCEANIC-STROKE trial (also reported by Healio, https://www.healio.com/news/neurology/20261110/fda-approves-sunharbo-first-factor-xia-inhibitor-for-reducing-risk-for-secondary-stroke). Source
- Eur Spine J target trial emulation of NORDSTEN-DS, three Chinese teaching hospitals: 4,490 matched degenerative spondylolisthesis patients; >=30% ODI improvement at 2 years 81.2% decompression alone vs 82.2% decompression plus fusion (RR 0.99); fusion had more dural tears (13.9% vs 4.7%), wound infections (6.7% vs 2.1%), longer surgery (164 vs 85 min) and stay (13 vs 8 days), fewer reoperations (6.4% vs 10.5%); E-value 1.11 — An EHR-based target trial emulation published November 10 found similar two-year function after decompression alone and decompression plus fusion for degenerative spondylolisthesis, with more complications and resource use after fusion; the authors say it supports rather than confirms NORDSTEN-DS. Source
- NEJM, PEPPER trial: 18,883 hip and knee arthroplasty patients randomized to aspirin 81 mg twice daily, warfarin (INR 2.0) or rivaroxaban 10 mg for 30 days; death or symptomatic VTE at 6 months 1.26% / 1.23% / 0.94%; aspirin not noninferior to rivaroxaban or warfarin (margin 0.69 points); safety events 2.91% / 3.36% / 3.48%, warfarin and rivaroxaban not noninferior to aspirin for safety — The PCORI-funded PEPPER comparative-effectiveness trial, in the November 12 issue of NEJM with an editorial by John Eikelboom, found aspirin was not noninferior to rivaroxaban or warfarin for death or symptomatic VTE, while neither anticoagulant was noninferior to aspirin on bleeding, wound reoperation or MI. Source
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