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Carlsmed Announces First aprevo® Bi-lateral Posterior Lumbar Interbody Fusion Procedure

MWN-AI** Summary

Carlsmed, Inc. (Nasdaq: CARL) recently announced a significant milestone in spine surgery with the successful completion of the first Bi-lateral Posterior Lumbar Interbody Fusion procedure utilizing its aprevo® Lumbar Bi-lateral Posterior System. The operation was performed by Dr. CJ Kleck at the University of Colorado Hospital in Denver, Colorado. This achievement reinforces Carlsmed’s commitment to leading the field of personalized, data-driven spine solutions, aimed at enhancing surgical precision, improving patient outcomes, and minimizing the risk of costly revision surgeries.

Mike Cordonnier, the Chairman and CEO of Carlsmed, emphasized the company’s innovative approach, highlighting the integration of artificial intelligence (AI) in their surgical strategies. The new procedure adds to their personalized surgery portfolio, showcasing the versatility and effectiveness of the aprevo® technology. Dr. Kleck expressed confidence in the ability to customize treatments for patients based on specific anatomical and pathological considerations, enhancing the precision of surgical outcomes.

The Bi-lateral Posterior Fusion System is designed to work seamlessly with Carlsmed’s broader aprevo® platform, which utilizes proprietary AI-enabled software and clinical intelligence. This integration aims to offer tailored surgical strategies and preoperative planning for various spinal conditions. The commercial launch of this new system is anticipated within this year, expanding the availability of advanced surgical options to patients and healthcare providers.

Carlsmed is dedicated to transforming the landscape of spine surgery through AI-driven personalized solutions, ultimately aiming to improve healthcare outcomes while reducing costs. However, the company advises caution regarding forward-looking statements about future expectations and potentials, as actual results may differ due to various risk factors.

MWN-AI** Analysis

Carlsmed, Inc. (Nasdaq: CARL) has recently made headlines with the successful completion of its first Bi-lateral Posterior Lumbar Interbody Fusion procedure, utilizing its innovative aprevo® Lumbar Bi-lateral Posterior System. This development positions Carlsmed as a significant player in the evolving landscape of personalized spine surgery, particularly as it prepares for a commercial launch later this year.

Investors should consider the implications of this advancement, especially in the context of the growing demand for precision healthcare solutions. The AI-enabled technology that Carlsmed is pioneering not only stands out due to its personalization capabilities but also addresses critical pain points in surgical outcomes, such as alignment and the risk of revision surgeries. As healthcare expenditures continue to rise, solutions that emphasize improved patient outcomes and reduced costs are likely to gain traction among hospitals and healthcare providers.

Moreover, the endorsement from noted orthopedic surgeon Dr. CJ Kleck adds credibility to the efficacy and utility of the aprevo® system. His positive feedback highlights the adaptability of the technology across a spectrum of patients, which could lead to broader market acceptance and adoption.

As Carlsmed gears up for its full commercial rollout, attention must be paid to the competitive landscape, including other emerging technologies in spinal surgery and their clinical outcomes. Potential investors should closely monitor the upcoming commercial phase, paying attention to market penetration strategies and any partnerships that might enhance distribution capabilities.

While the announcement is a bullish sign for Carlsmed’s growth potential, it’s important to remain cautious of the inherent risks associated with market launches in the medical technology sector. Investing in Carlsmed requires balancing optimism stemming from its innovative offerings with due diligence on execution risks. Overall, greater patient demand for personalized surgery solutions suggests a positive outlook for Carlsmed.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

CARLSBAD, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the successful completion of the first posterior lumbar spine surgery using the Company’s aprevo® Lumbar Bi-lateral Posterior System. The procedure was performed by Orthopedic Spine Surgeon CJ Kleck, M.D. at the University of Colorado Hospital in Denver, Colorado.

“This clinical milestone strengthens our position as a leader in personalized, data-driven spine solutions designed to help surgeons plan with greater precision, improve patient outcomes, and reduce costly revisions. The addition of the aprevo® Bi-lateral Posterior Lumbar Interbody Fusion procedure to our personalized surgery procedure portfolio further demonstrates the power and versatility of our personalized, AI-enabled approach to spine surgery,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “We look forward to our full commercial launch this year to provide this personalized procedural option to patients, surgeons, and hospital systems on a larger scale.”

“Carlsmed’s aprevo® technology is integral to my pre-operative, intra-operative, and post-operative workflow, and extending its use across additional lumbar fusion approaches allows me to more precisely tailor treatment to each patient,” said Dr. Kleck. “Being able to personalize procedures based on each patient’s anatomy and pathology gives me greater confidence in achieving alignment goals. Adding a Bi-lateral posterior system to the list of procedures addressable with aprevo® will enable me to utilize this technology across a broader range of patients.”

Carlsmed’s Bi-lateral Posterior Fusion System integrates seamlessly with the Company’s broader aprevo® platform technology, which combines proprietary AI-enabled software and clinical intelligence to deliver personalized surgical strategies and preoperative planning across a range of spinal pathologies. The Company expects to commercially launch the system later this year.

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 timing of the commercial launch of the Company’s Bi-Lateral Posterior Fusion System, the potential of the Company’s products, the ability of the Company’s products to improve patient outcomes and reduce revision surgeries, 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**

How does the integration of Carlsmed Inc. CARL's aprevo® technology impact patient outcomes compared to traditional spinal surgery methods?

The integration of Carlsmed Inc.'s aprevo® technology enhances patient outcomes by providing personalized surgical solutions that reduce recovery time, minimize complications, and improve overall effectiveness compared to traditional spinal surgery methods.

What specific advantages does Carlsmed Inc. CARL's Bi-lateral Posterior Fusion System offer to surgeons like Dr. Kleck during the surgical process?

Carlsmed Inc.'s Bi-lateral Posterior Fusion System offers advantages such as improved precision in spinal alignment, reduced surgical time, enhanced visualization, and minimized patient trauma, enabling surgeons like Dr. Kleck to achieve better outcomes and faster recovery for patients.

What are the projected timelines for the full commercial launch of Carlsmed Inc. CARL’s Bi-lateral Posterior Fusion System, and how will this impact market competitiveness?

Carlsmed Inc.'s Bi-lateral Posterior Fusion System is projected for full commercial launch in early 2024, which is expected to enhance market competitiveness by offering innovative solutions and potentially capturing a significant share of the spinal fusion market.

What risks does Carlsmed Inc. CARL identify that could hinder the success of the aprevo® technology and its commercial launch in the spine surgery market?

Carlsmed Inc. identifies risks such as regulatory challenges, market competition, technological adoption by surgeons, reimbursement issues, and the potential for clinical performance under real-world conditions that could impede the success of the aprevo® technology in the spine surgery market.

**MWN-AI FAQ is based on asking OpenAI questions about Carlsmed Inc. (NASDAQ: CARL).

Carlsmed Inc.

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