Carlsmed Announces U.S. Launch of its aprevo® Technology Platform for Cervical Fusion Surgeries at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting

Rhea-AI Summary

Carlsmed (Nasdaq: CARL) announced the U.S. commercial launch of its aprevo® Technology Platform for cervical fusion on December 3, 2025, and will present early clinical experience at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting, December 3–6, 2025.

The aprevo® Cervical Interbody System pairs AI-driven preoperative planning with 3D-printed, patient-specific implants. Carlsmed reported its first 50+ cervical cases, noting efficient workflow integration, precise implant fit with maximized endplate coverage, and an ability to achieve planned sagittal and coronal alignment versus stock implants.

Carlsmed referenced prior aprevo® lumbar results showing lower complication rates and fewer revision surgeries, cited 370,000 U.S. cervical fusions performed this year as market context, and will hold a CSRS lunch workshop on Dec 4, 2025 at 12:30 PM EST.

Positive

• U.S. commercial launch of aprevo cervical platform on Dec 3, 2025
• Completed 50+ initial cervical cases in clinical evaluation
• CSRS presentation of early clinical observations Dec 3–6, 2025; workshop Dec 4

Negative

• None.

News Market Reaction

+12.44% 2.5x vol

29 alerts

+12.44% News Effect

+7.5% Peak Tracked

-11.7% Trough Tracked

+$50M Valuation Impact

$456M Market Cap

2.5x Rel. Volume

On the day this news was published, CARL gained 12.44%, reflecting a significant positive market reaction. Argus tracked a peak move of +7.5% during that session. Argus tracked a trough of -11.7% from its starting point during tracking. Our momentum scanner triggered 29 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $50M to the company's valuation, bringing the market cap to $456M at that time. Trading volume was elevated at 2.5x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cervical cases: 50+ cases U.S. cervical fusions: 370,000 surgeries CSRS Annual Meeting: 53rd meeting +2 more

5 metrics

Cervical cases 50+ cases Initial cervical aprevo clinical experience cited in launch release

U.S. cervical fusions 370,000 surgeries Estimated annual U.S. cervical fusion surgery volume in article

CSRS Annual Meeting 53rd meeting Cervical Spine Research Society conference where data presented

CSRS meeting dates Dec 3–6, 2025 Conference window for early cervical clinical data presentations

Lunch workshop time 12:30–1:30 pm EST Scheduled CSRS lunch workshop for early adopters’ presentations

Market Reality Check

Price: $11.67 Vol: Volume 53,487 is about 0....

low vol

$11.67 Last Close

Volume Volume 53,487 is about 0.64x the 20-day average, indicating muted trading activity before this news. low

Technical Shares at $13.13 were trading below the $13.53 200-day MA and 23.62% under the 52-week high.

Peers on Argus

Peers showed mixed moves, with names like NRC, OPRX, SPOK, and TALK up between 0...

Peers showed mixed moves, with names like NRC, OPRX, SPOK, and TALK up between 0.46% and 3.37%, while SY was down 4.6%, suggesting CARL’s setup was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Dec 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Product launch	Positive	+12.4%	U.S. launch of aprevo cervical platform and early clinical experience data.
Nov 19	Conference participation	Neutral	-0.2%	Announcement of CEO presentation at major healthcare investor conference.
Nov 06	Earnings and guidance	Positive	-1.7%	Strong Q3 growth, higher guidance, CMS NTAP and cervical launch timing update.
Oct 23	Earnings date set	Neutral	+3.6%	Scheduling of Q3 2025 earnings call and webcast details.
Sep 29	Management change	Positive	-1.6%	Appointment of experienced Chief Legal Officer to support post‑IPO growth.

Pattern Detected

Recent history shows strong positive price response to this cervical launch news, but mixed to negative reactions around earnings and leadership changes, indicating investors have not consistently rewarded fundamentally positive updates.

Recent Company History

Over the last few months, Carlsmed reported Q3 2025 results with revenue of $13.1M (up 98% year over year), raised full‑year guidance to $49.0–$50.0M, and highlighted >50 cervical procedures ahead of this commercial launch. It also expanded debt capacity up to $50M and added a Chief Legal Officer as it scaled post‑IPO. Conference participation and today’s aprevo cervical launch at CSRS build on this trajectory of commercialization and platform expansion.

Market Pulse Summary

The stock surged +12.4% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +12.4% in the session following this news. A strong positive reaction aligns with the stock’s prior response to this same cervical launch news, which previously saw a 12.44% gain. Recent history shows investors sometimes faded strong fundamentals, such as robust Q3 growth and guidance. With shares still 23.62% below the 52‑week high and trading under the 200-day MA, investors may weigh commercialization progress against execution and financing risks highlighted in recent filings.

Key Terms

cervical fusion, interbody system, ai-driven preoperative planning, 3d-printed, +3 more

7 terms

cervical fusion medical

"U.S. commercial launch of its aprevo® Technology Platform for cervical fusion surgeries."

A cervical fusion is an operation that permanently joins two or more bones in the neck so they heal into a single, stable piece — think of it like welding two links of a chain so they stop moving independently. Investors care because the procedure drives demand for implants, surgical tools, hospital and rehab services, and is affected by things like device approvals, insurance coverage and clinical outcomes, all of which influence sales and profitability in healthcare companies.

interbody system medical

"The aprevo® Cervical Interbody System expands Carlsmed’s personalized spine platform..."

An interbody system is a medical implant and accompanying hardware used in spinal surgery to replace a damaged disc and hold two vertebrae apart so bone can grow between them and stabilize the spine. Think of it as a small spacer or building block placed between two vertebrae to restore height and alignment; its safety, effectiveness, regulatory approval, and insurance coverage matter to investors because they directly affect sales, market adoption, and liability risks.

ai-driven preoperative planning technical

"combines AI-driven preoperative planning with 3D-printed, patient-specific implants..."

AI-driven preoperative planning uses artificial intelligence to analyze patient scans and medical records to create customized surgical plans and simulations before an operation. It matters to investors because it can reduce procedure time, lower complication risks, and improve outcomes—like using a smart GPS and flight simulator before a trip—potentially cutting costs, increasing demand for related devices and software, and altering reimbursement or regulatory risk profiles.

3d-printed technical

"combines AI-driven preoperative planning with 3D-printed, patient-specific implants..."

3d-printed describes an object made by a machine that builds it up layer by layer from a digital design, like making a sculpture by stacking very thin slices instead of carving from a block. For investors, 3D printing matters because it can cut production time and costs, enable rapid prototyping and bespoke or small-batch runs, and change supply chains — all of which can affect a company’s margins, capital needs and competitive edge.

endplate medical

"precise implant fit with maximized endplate coverage, and, when compared with stock implants..."

An endplate is a specialized interface where two different tissues meet in the body — commonly either the tiny patch where a nerve connects to a muscle (motor endplate) or the thin surface where a spinal vertebra meets an intervertebral disc (vertebral endplate). Investors should care because these small, delicate structures are often the targets or constraints for drugs, medical devices and imaging; their condition can determine treatment success, regulatory risk, and market demand much like a socket determines whether a plug fits safely and reliably.

sagittal medical

"ability to achieve planned sagittal and coronal alignment goals."

Sagittal describes an imaginary vertical plane or view that divides the body into left and right portions, often used to describe the orientation of medical images or surgical approaches. For investors reading clinical or device news, knowing something is described as sagittal helps clarify how a scan, implant or procedure was positioned or measured—think of it like describing which way a loaf of bread was sliced, which can affect how results are interpreted and compared.

coronal alignment medical

"ability to achieve planned sagittal and coronal alignment goals."

Coronal alignment describes how a limb or the spine lines up when viewed from the front — essentially whether bones form a straight vertical line or lean inward or outward, like wheels on a car that are properly tracked or misaligned. For investors, it matters because poor alignment can change patient outcomes, increase the need for corrective surgeries or device replacements, affect product durability and follow‑up costs, and influence reimbursement, sales and liability risks in orthopedics and spine care.

AI-generated analysis. Not financial advice.

First 50+ cervical cases completed; observations on initial clinical experience to be presented by early adopters at the Carlsmed CSRS Lunch Workshop

CARLSBAD, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the U.S. commercial launch of its aprevo^® Technology Platform for cervical fusion surgeries. Surgeons involved in the clinical evaluation will also present early clinical data at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting in Washington, D.C., December 3-6, 2025.

The aprevo^® Cervical Interbody System expands Carlsmed’s personalized spine platform, which combines AI-driven preoperative planning with 3D-printed, patient-specific implants tailored to each patient’s anatomy and pathology. The cervical system builds upon the success of the aprevo^® lumbar platform, which to date has demonstrated lower complication rates and fewer revision surgeries compared to standard stock implants.

With over 370,000 cervical fusion surgeries performed in the U.S. this year, the need for technologies that support improved alignment and anatomical fit in patients with poor bone quality continues to grow. Early clinical experience shows efficient workflow integration, precise implant fit with maximized endplate coverage, and, when compared with stock implants, an ability to achieve planned sagittal and coronal alignment goals.

“We are excited to bring the aprevo^® platform to cervical fusion procedures, representing an important milestone in our mission to transform spine surgery,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “With positive clinical feedback from our first 50+ cases, strong reimbursement support and accelerating demand, we believe our cervical system has the potential to redefine the standard of care in cervical spine surgery.”

“Personalization represents the next frontier in cervical spine surgery,” said Dr. Andrew Chan, MD, at Columbia University / New York-Presbyterian Och Spine Hospital. “With aprevo^® Cervical we’re able to preoperatively plan in three dimensions and deliver a device that’s matched to each patient’s unique anatomy. That level of precision enhances how we correct alignment while helping broaden access to anterior cervical procedures for more complex patients.”

CSRS Lunch Workshop Details

Date: Thursday, December 4, 2025
Time: 12:30-1:30 pm EST
Room: Meeting Room 8 - Meeting Level
Panel Presenters: Andrew Chan, MD, Columbia University / New York-Presbyterian Och Spine Hospital, Deb Bhowmick, MD, Duke University, Department of Neurosurgery, and Venu Nemani, MD, PhD, Virginia Mason Medical Center

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, and demand for, the Company’s products, the Company’s expectations concerning the potential market size for its technology platform, 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

What did Carlsmed (CARL) announce on December 3, 2025 about cervical fusion?

Carlsmed announced the U.S. commercial launch of the aprevo® cervical technology platform for cervical fusion on December 3, 2025.

How many initial cervical cases has Carlsmed completed with aprevo®?

Carlsmed reported completing its first 50+ cervical cases during the clinical evaluation.

When and where will Carlsmed present early aprevo® cervical data (CARL)?

Early clinical observations will be presented at CSRS Dec 3–6, 2025, including a lunch workshop on Dec 4, 2025 at 12:30 PM EST.

What features does the aprevo® Cervical Interbody System offer for surgeons?

The system combines AI-driven 3D preoperative planning with 3D-printed patient-specific implants tailored to each patient’s anatomy and pathology.

Does Carlsmed claim clinical advantages for aprevo® cervical versus stock implants?

Early experience cited precise implant fit, maximized endplate coverage, and the ability to hit planned sagittal and coronal alignment goals versus stock implants.

What market context did Carlsmed (CARL) cite for cervical fusion demand?

Carlsmed noted about 370,000 cervical fusion surgeries performed in the U.S. this year as context for demand.