Carlsmed aprevo® Lumbar 2-year Data Published in Global Spine Journal

Rhea-AI Summary

Carlsmed (Nasdaq: CARL) announced publication of a retrospective cohort study in Global Spine Journal showing that 3D preoperative planning plus patient-specific aprevo® interbody implants reduced 2-year mechanical-complication revision rates to 4.3% (n=115) versus 16.6% (n=997) with conventional stock implants (p<0.001), a 74% relative reduction. The comparator cohort came from the International Spine Study Group dataset of senior spine surgeons. Authors note improved restoration of distal lumbar lordosis and potential reductions in proximal junctional kyphosis, reoperations, and economic burden. The peer-reviewed article is available online in Global Spine Journal.

Positive

• 2-year revision rate of 4.3% with aprevo®
• 74% relative reduction vs stock implants (16.6% to 4.3%)
• Comparator cohort drawn from International Spine Study Group dataset
• Published peer-reviewed evidence in Global Spine Journal

Negative

• Study is a retrospective cohort, not randomized
• aprevo® cohort n=115 versus comparator n=997, unequal sizes
• Comparator cohort treated by highly experienced surgeons, may limit generalizability

Argus Jan 7 session

+2.94% close to close Open Argus

Details

News Market Reaction – CARL

On Jan 7, the first trading day after this news, CARL closed 2.94% above the previous close.

Data tracked by StockTitan Argus for the Jan 7 session.

Market Context

This announcement highlighted peer-reviewed 2-year lumbar data showing aprevo-treated patients had a...

Analysis

This announcement highlighted peer-reviewed 2-year lumbar data showing aprevo-treated patients had a 4.3% revision rate vs 16.6% with stock implants, a 74% relative reduction supported by p<0.001. The findings build on prior cervical launch news from Dec 3, 2025, reinforcing the broader aprevo platform story. Investors may track how such outcomes translate into adoption and revenue, alongside financial trends like Q3 2025 revenue of $13.1M and raised full-year guidance.

Key Figures

aprevo revision rate: 4.3% stock implant revision rate: 16.6% aprevo cohort size: 115 patients +5 more

aprevo revision rate

4.3%

2-year revision rate due to mechanical complications (n=115)

stock implant revision rate

16.6%

2-year revision rate due to mechanical complications (n=997)

aprevo cohort size

115 patients

Retrospective ASD cohort treated with aprevo implants

comparator cohort size

997 patients

International Spine Study Group ASD cohort with stock implants

p-value

p<0.001

Difference in mechanical complication-related revisions

relative reduction

74%

Relative reduction in revision rates vs stock devices

average 2-year revision rate

24.9%

Average mechanical complication revisions across four published studies

follow-up period

2 years

Duration over which revision rates were assessed

Historical Context

5 past events · Latest: Dec 16

5 events

1. Dec 16

   Conference participation

   24h Move

   +0.0%

   Announcement of J.P. Morgan 2026 Healthcare Conference participation and investor meetings.

2. Dec 03

   Product launch

   24h Move

   +12.4%

   U.S. launch of aprevo cervical platform with early clinical experience and large market context.

3. Nov 19

   Conference participation

   24h Move

   -0.2%

   Piper Sandler Healthcare Conference presentation and investor meetings announcement.

4. Nov 06

   Earnings results

   24h Move

   -1.7%

   Q3 2025 results with $13.1M revenue, strong growth, and raised full-year guidance.

5. Oct 23

   Earnings date notice

   24h Move

   +3.6%

   Scheduling of Q3 2025 earnings release and investor call details.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

3d preoperative planning, interbody implants, adult spinal deformity, proximal junctional kyphosis, +4 more

8 terms

3d preoperative planning medical

"3D preoperative planning combined with patient-specific, anatomically designed interbody implants"

3D preoperative planning is the use of three-dimensional medical images and computer models to map out a surgical approach before entering the operating room, like creating a detailed blueprint or GPS route for a complex job. It matters to investors because it can shorten surgery time, reduce complications and follow-up costs, and increase demand for specialized software, imaging services and guided surgical tools, all of which can affect clinical outcomes and revenue streams.

interbody implants medical

"anatomically designed interbody implants significantly reduces mechanical complication–related reoperations"

Interbody implants are medical devices placed between two spinal bones (vertebrae) to restore height, stabilize the spine, and encourage the bones to grow together into a single solid segment. Think of them as a structural spacer or small bridge that allows new bone to form and hold the spine in the correct position. Investors watch this product category because it drives sales for surgical-device makers, is sensitive to regulatory approvals and reimbursement rules, and often commands higher margins and recurring demand as surgical techniques and aging populations grow.

adult spinal deformity medical

"mechanical complication–related reoperations in complex adult spinal deformity (ASD) surgery"

Adult spinal deformity is a chronic condition where the spine develops abnormal curves or misalignment in adulthood, causing pain, difficulty standing or walking, and reduced quality of life. Investors watch it because treating the condition often requires long-term medical care, surgery, specialized devices or implants, and follow-up services; changes in technology, clinical outcomes, regulation, or reimbursement can materially affect the market size and revenue prospects for healthcare companies.

proximal junctional kyphosis medical

"decrease the risk of developing proximal junctional kyphosis, a significant and potentially devastating"

Proximal junctional kyphosis is a complication that can occur after spinal fusion surgery where the spine develops an abnormal forward bend at the junction just above the fused segment, sometimes causing pain, instability or need for further treatment. Investors should care because it affects clinical success, patient demand, regulatory reviews, warranty and revision-surgery rates, and therefore reimbursement and sales for devices and procedures—like a rigid beam that bends and requires costly repairs.

patient-specific interbody implants medical

"patient-specific interbody implants can facilitate a more harmonious and precise restoration"

Patient-specific interbody implants are spinal devices custom-made to match an individual’s anatomy and replace the cushion between two vertebrae during fusion surgery, like a bespoke part made to fit a particular machine. For investors, they matter because personalization can command higher prices, reduce repeat surgeries and improve outcomes, but also brings higher manufacturing costs, regulatory review and reliance on surgeon adoption and reimbursement policies.

lumbar lordosis medical

"precise restoration of distal lumbar lordosis, which has been shown to decrease the risk"

Lumbar lordosis is the natural inward curve of the lower spine; when that curve is larger or smaller than typical it can cause back pain, altered posture or mobility issues. Investors care because changes in how this condition is diagnosed, treated or reimbursed affect demand for related products and services—orthopedic devices, surgical procedures, rehabilitation programs and diagnostic imaging—so clinical data, regulatory decisions or new therapies can influence revenue and market value.

revision procedures medical

"reducing reoperations and lowering the overall economic burden associated with revision procedures"

Revision procedures are the formal steps a company or regulator follows to update, correct or reissue previously published documents, reports, forecasts or approvals. For investors this matters because revisions can change the facts or outlook that underlie investment decisions—similar to correcting a map after finding a wrong road, the update can alter how you navigate risk, value and timing of returns and may indicate operational or reporting problems.

personalized spine surgery medical

"Personalized Spine Surgery in Adult Deformity: Reoperation Rates and Mechanical Complications"

Personalized spine surgery is an approach that tailors the surgical plan, implants and tools to an individual patient’s anatomy and condition—often using detailed imaging, custom-made implants or patient-specific guides—rather than a one-size-fits-all procedure. For investors, it matters because personalized techniques can improve outcomes, shorten recovery and create demand for premium devices, software and services, which can shift market size, pricing and regulatory risk in the spine-care industry.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CARLSBAD, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the publication of a new retrospective cohort study in Global Spine Journal demonstrating that 3D preoperative planning combined with patient-specific, anatomically designed interbody implants significantly reduces mechanical complication–related reoperations in complex adult spinal deformity (ASD) surgery.

The study compared 2-year revision rates among ASD patients receiving Carlsmed’s aprevo^® personalized interbody implants with revision data from a similar patient cohort receiving conventional stock implants. The comparator cohort was drawn from the multicenter dataset of the International Spine Study Group, which is comprised of senior spine surgeons dedicated to advancing the treatment of adult spinal deformity. Patients treated with aprevo^® experienced significantly fewer revisions due to mechanical complications, showing a revision rate of 4.3% (n=115) compared with 16.6% (n=997) using stock devices (p<0.001), representing a 74% relative reduction.

“In complex deformity cases where alignment accuracy is critical, translating preoperative goals into postoperative outcomes remains a persistent challenge,” said Justin Smith, MD, PhD, Department of Neurosurgery, University of Virginia and the article’s lead author. “When paired with 3D preoperative planning, patient-specific interbody implants can facilitate a more harmonious and precise restoration of distal lumbar lordosis, which has been shown to decrease the risk of developing proximal junctional kyphosis, a significant and potentially devastating mechanical complication in ASD surgery.”

“Previously published clinical data has demonstrated that 3D surgical planning combined with patient-specific interbody implants help surgeons achieve the personalized alignment goals and endplate fit that are unique to each patient,” said Mike Cordonnier, Chief Executive Officer of Carlsmed. “These new findings further validate the clinical value of personalization in spine surgery, improving outcomes, improving quality of life, reducing reoperations and lowering the overall economic burden associated with revision procedures.”

Sigurd Berven, MD, Department of Orthopedic Surgery, University of California San Francisco and study author added, “The revision rates in the comparator cohort are already relatively low, as these patients were treated by highly experienced and renowned surgeons. Across four published studies noted in the paper, the average 2-year revision rate due to mechanical complications is 24.9%, which makes the improvement achieved with aprevo^® even more meaningful.”

The peer-reviewed article “Personalized Spine Surgery in Adult Deformity: Reoperation Rates and Mechanical Complications Following Customized Planning and Interbody Implant Use,” is available online at Global Spine Journal: https://journals.sagepub.com/doi/10.1177/21925682251409696.

Carlsmed’s aprevo^® Technology Platform combines AI-enabled preoperative planning with patient-specific interbody implants to enable predictable alignment tailored to individual patient anatomy and pathology, addressing alignment challenges and overcoming clinical and economic limitations inherent to traditional, stock implants.

About Carlsmed 

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. 

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects, including statements about the potential of the Company’s products, the ability of the Company’s products to improve patient outcomes, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in Carlsmed’s Registration Statement on Form S-1 on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations 
Caroline Corner, PhD 
IR@Carlsmed.com 

Media 
LeAnn Burton 
Senior Director Brand Marketing 
LBurton@Carlsmed.com 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Carlsmed (CARL) publish on January 6, 2026 regarding aprevo® outcomes?

Carlsmed announced a Global Spine Journal study showing aprevo® had a 4.3% 2-year revision rate versus 16.6% for stock implants (p<0.001).

How large was the revision-rate reduction reported for aprevo® in the Global Spine Journal study?

The study reported a 74% relative reduction in revisions due to mechanical complications versus stock devices.

Where can investors read the aprevo® 2-year study published by Carlsmed (CARL)?

The peer-reviewed article is available online in Global Spine Journal at the provided DOI link.

Does the study prove aprevo® is superior to stock implants for all spine surgeons?

The study is a retrospective cohort with comparator patients treated by senior surgeons, so results may not generalize to all settings.

What sample sizes were compared in the aprevo® study cited by Carlsmed (CARL)?

The aprevo® group was n=115 and the comparator stock-implant group was n=997.

What clinical benefits did authors attribute to 3D planning and aprevo® implants?

Authors reported improved distal lumbar lordosis restoration and reduced risk of proximal junctional kyphosis, lowering reoperations and economic burden.