Carlsmed
Overview
Carlsmed is a medical technology company focused on advancing personalized spine surgery through its innovative AI-enabled solutions. Founded by Mike Cordonnier, Claude Hooton, and Jim Fitzsimmons, it is based in Carlsbad, California. Carlsmed has been influential in revolutionizing spine surgery by providing patient-specific surgical plans and devices, particularly through their trademarked aprevo® platform. As of 2024, Carlsmed has raised significant capital, including a $52.5 million Series C funding round, positioning itself as a leader in the field of personalized spine surgery.
Recent Developments
- October 2024: Carlsmed announced the addition of Kevin O’Boyle to its Board of Directors. He will serve as the Chair of the Audit Committee, bringing extensive experience in medical technology businesses.
- August 2024: Carlsmed received favorable Medicare reimbursement decisions for its customized spinal fusion devices. This development positions Carlsmed's technology at the forefront of reimbursable spine fusion procedures by categorizing these under the most favorable Medicare Severity-Diagnosis Related Groups (MS-DRGs).
- March 2024: The company closed a $52.5 million Series C funding round designed to propel the commercialization of their aprevo® platform and further development of cervical fusion devices set to release in 2025. The funding round was co-led by U.S. Venture Partners and B Capital.
- January 2024: Carlsmed published compelling clinical data in the Global Spine Journal showcasing the efficacy of its aprevo® technology, indicating significant improvements in surgical outcomes and alignment.
- September 2023: The FDA granted Breakthrough Device Designation to Carlsmed's technology for the treatment of cervical spine disease, further endorsing the company's innovative approach and expanding its solutions to cervical spine applications.
Company Information
| Attribute | Information |
|---|---|
| Founding Date | 2018 |
| Headquarters | Carlsbad, California, USA |
| Founders | Mike Cordonnier, Claude Hooton, Jim Fitzsimmons |
| Revenue | Not publicly disclosed |
| Profits | Not publicly disclosed |
| Key Investors | B Capital, U.S. Venture Partners |
| Industry | Medical Technology, Personalized Spine Surgery |
| Number of Employees | Estimated 100+ |
Early History
Carlsmed was founded in 2018 with the aim of personalizing spine surgery. The founders, Mike Cordonnier, Claude Hooton, and Jim Fitzsimmons, leveraged their experience in the medical technology sector to innovate solutions tailored to individual patient needs. Early on, the company garnered attention by achieving FDA clearance for their patient-specific spine surgery platform, aprevo®. This pivotal step allowed Carlsmed to position its technology as a trailblazer in personalized healthcare, creating a niche in the spine surgery market.
Company Profile and Achievements
Carlsmed operates within the medical technology sector, specializing in spine surgery. Its hallmark product, the aprevo® platform, uses advanced AI algorithms and 3D modeling to craft personalized surgical plans and devices tailored to the unique anatomical needs of each patient.
Key achievements and milestones include:
- FDA Breakthrough Device Designations: Carlsmed has been recognized with multiple breakthrough device designations by the FDA, underscoring its pioneering technology for both lumbar and cervical spine diseases.
- Funding Milestones: Having raised over $82 million in funding through various investment rounds, Carlsmed has equipped itself with the resources to scale rapidly.
- Customized Solutions: The aprevo® devices are notable for their ability to match each patient's specific spinal structure, thereby improving surgical outcomes and reducing postoperative complications.
- Clinical Validation: Published studies substantiate the effectiveness of Carlsmed’s devices in achieving optimal alignment during surgery, which is critical for successful long-term outcomes.
Current Operations and Market Position
Carlsmed is positioned at the forefront of the personalized medical device industry, focusing on spine surgery. The company’s innovative use of AI in the creation of personalized surgical plans places it ahead of traditional spine surgery methods. Carlsmed continues to expand its market reach by enhancing its product offerings and expanding into cervical spine applications with anticipated new launches. The company’s strong investor backing and strategic collaborations have facilitated its growth, enabling it to capture a significant share of the spine surgery market.
Conclusion
Carlsmed stands out in the medical technology sector for its pioneering approach to spine surgery through personalized, AI-driven solutions. By increasing precision and personalization, Carlsmed is not only enhancing patient outcomes but also redefining industry standards. With substantial funding and regulatory achievements behind it, Carlsmed is poised to expand its influence in the healthcare sector, particularly as personalized medical devices become increasingly integral to improving complex surgical outcomes. As the company anticipates further product releases and geographical expansion, its impact on the spine surgery landscape is set to grow considerably.