Carlsmed announces successful first cervical surgery using its AI-enabled aprevo® device, advancing personalized spine treatment.
Quiver AI Summary
Carlsmed, Inc., a medical technology company focused on AI-driven personalized spine surgery solutions, announced the successful completion of its first cervical procedure using the aprevo® system on July 14, 2025, performed by Dr. Joseph Osorio at UC San Diego Health. The aprevo® devices are uniquely tailored to each patient's anatomy and alignment needs, leveraging Carlsmed’s AI surgical planning and production capabilities. Dr. Osorio highlighted the innovation's ability to enhance alignment in cervical fusion compared to traditional implants, marking a significant advancement for spine surgery. Following its IPO, Carlsmed's CEO, Mike Cordonnier, expressed enthusiasm for this milestone and its potential to improve surgical outcomes while aiming for a U.S. commercial launch of the aprevo® cervical system in 2026, having received FDA Breakthrough Device designation.
Potential Positives
- Successful completion of the first aprevo® cervical procedure signifies a significant advancement in the company's surgical technology and demonstrates its practical application in a clinical setting.
- FDA granted Breakthrough Device designation for aprevo® cervical, which can expedite its development and commercialization process, highlighting its potential impact in the medical field.
- Partnership with UCSD Health and Dr. Osorio indicates strong collaboration with reputable medical professionals, enhancing credibility and potential market acceptance of the technology.
- Anticipation of a U.S. commercial launch in 2026 positions Carlsmed to capitalize on market needs and expand its offerings in personalized spinal surgery solutions.
Potential Negatives
- Carlsmed's expected US commercial launch of aprevo® cervical in 2026 indicates a delayed entry into the market, which could hinder their competitive position against other available solutions.
- The need for a "Breakthrough Device designation" may suggest that existing treatments are inadequate, potentially undermining confidence in the spinal surgery market overall.
- The reliance on forward-looking statements introduces uncertainty about the future success and viability of the aprevo® cervical system, which may concern investors and stakeholders.
FAQ
What is aprevo® cervical?
aprevo® cervical is a medical device designed for personalized cervical spine surgery, utilizing AI-powered surgical planning for optimal alignment.
Who performed the first aprevo® cervical procedure?
The first aprevo® cervical procedure was performed by Dr. Joseph Osorio, Chief of Spine Surgery at UC San Diego Health.
When is the US commercial launch of aprevo® cervical expected?
Carlsmed expects to launch aprevo® cervical commercially in the United States in 2026.
What advancements does aprevo® cervical offer?
aprevo® cervical allows for greater customization and alignment in cervical surgeries compared to traditional implants, improving surgical outcomes.
What designation did the FDA grant to aprevo® cervical?
The FDA granted aprevo® cervical Breakthrough Device designation, highlighting its potential to improve patient outcomes in spine surgery.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CARL Insider Trading Activity
$CARL insiders have traded $CARL stock on the open market 6 times in the past 6 months. Of those trades, 6 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $CARL stock by insiders over the last 6 months:
- ROBERT II MITTENDORFF purchased 1,333,333 shares for an estimated $19,999,995
- CAPITAL GROUP MANAGEMENT, L.P. B purchased 1,333,333 shares for an estimated $19,999,995
- JONATHAN D ROOT purchased 466,666 shares for an estimated $6,999,990
- PHILIP M YOUNG has made 2 purchases buying 59,999 shares for an estimated $899,985 and 0 sales.
- KEVIN SIDOW purchased 13,333 shares for an estimated $199,995
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Full Release
CARLSBAD, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the successful completion of the first aprevo ® cervical procedure on July 14, 2025 by Joseph Osorio, MD, PhD, Chief of Spine Surgery in the Department of Neurological Surgery at UC San Diego (UCSD) Health in San Diego, CA.
The aprevo ® devices are designed to match the unique anatomical and alignment needs of each patient through Carlsmed’s proprietary AI-powered surgical planning platform and digital production system.
Dr. Osorio, who has extensive experience utilizing the aprevo ® platform for lumbar spine fusion procedures, noted, “Leveraging the aprevo ® system for cervical fusion surgery allows a level of alignment which I believe is not achievable with traditional implants. The ability to customize each device to the patient’s unique pathology and anatomy represents a meaningful advancement for my practice.”
“On the heels of our IPO, this first cervical procedure represents an exciting milestone as we expand our personalized surgical solutions to the cervical spine,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “We are proud to partner with Dr. Osorio and UCSD Health to bring this breakthrough technology to patients. Our goal is to reduce the need for revision surgeries, improve outcomes, and enhance value across the healthcare system as we work toward establishing a new standard of care.”
Carlsmed was granted Breakthrough Device designation for aprevo ® cervical by the FDA and expects a US commercial launch in 2026.
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 Company’s current expectation of launching aprevo ® cervical in the United States in 2026 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 the 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.
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