Carlsmed Aims for $100M+ IPO, Advancing Personalized Spine Surgery with AI and 3D Printing

Carlsmed, a pioneering artificial intelligence-powered spine surgery developer, has announced plans for an initial public offering (IPO) on the Nasdaq, aiming to raise over $100 million. The company, which specializes in personalized fusion procedures using 3D-printed titanium spinal implants, is offering at least 6.7 million shares priced between $14 and $16 each.

AI-Driven Surgical Planning and Custom Implants

Founded in 2018, Carlsmed's aprevo platform leverages artificial intelligence to revolutionize spinal fusion surgery. The system incorporates preoperative surgical planning based on CT scans, custom manufacturing of implants, intraoperative alignment visualization, and postoperative analysis.

The company's approach to matching implants to the unique curvature of patients' vertebrae has shown promising results. Carlsmed reports a 50-fold increase in total contact area between the implant and the spine, with a 94% average graft contact observed after one year. Notably, the revision surgery rate for procedures using Carlsmed's technology is less than 2%.

Regulatory Milestones and Market Expansion

Carlsmed has made significant strides in obtaining regulatory clearances for its innovative technology. In December 2024, the company received FDA clearance for its aprevo cervical interbody implants, following a breakthrough designation from the agency. This approval builds upon the earlier green light for lumbar procedures, including anterior, lateral, and transforaminal approaches, which was granted in late 2020.

Financial Backing and Manufacturing Advancements

The company's growth has been supported by substantial venture capital funding. In March 2024, Carlsmed secured $52.5 million in a Series C round co-led by B Capital and U.S. Venture Partners. This financial boost was followed by the launch of a digital production line in November 2024, enabling the delivery of sterile, custom-made implants to hospitals within a 10-day timeframe.

As Carlsmed prepares for its public debut under the ticker "CARL," the company's potential $430 million market valuation reflects growing investor confidence in personalized medical device technologies. With over 500 patients already treated using its hardware, Carlsmed is positioned at the forefront of the personalized spine surgery market, promising to reshape patient outcomes in spinal fusion procedures.