Photo courtesy of Carlsmed.
Carlsmed is a graduate of the EvoNexus startup incubator program, it now employs 10 with plans to move into a new office in 2021.

Photo courtesy of Carlsmed. Carlsmed is a graduate of the EvoNexus startup incubator program, it now employs 10 with plans to move into a new office in 2021.

San Diego-based Carlsmed, a MedTech company focused on personalized implants used in complex spine surgeries, has raised $10 million in a Series A round.

The new funding was led by U.S. Venture Partners, a Silicon Valley-based firm alongside participating investors including Vertical Group, Cove Fund, and Wavemaker Three-Sixty Health, among others. Carlsmed previously raised $2.5 million in seed funding.

The 10-employee startup will use the money to further commercialize its “aprevo” implants for adult degenerative scoliosis, said Mike Cordonnier Carlsmed’s founder and chief executive officer.

Founded in 2018, by Cordonnier and Niall Casey. Carlsmed leverages machine learning technologies and prior outcomes data to personalize the treatment of complex adult spinal deformities.

In addition, its technology makes surgical plans and devices tailored to the precise medical situation of every individual patient.

“This round of financing comes at the perfect time to meet surgeon and patient demand for the newly launched breakthrough aprevo devices,” said Cordonnier. “We now have the access to capital that will allow us to continue to deploy our devices to patients that need it.”

Carlsmed has its eyes on commercial growth, after completing its preclinical phase.

3-D Printed Implants

In the U.S. alone, more than 6 million adults have mild to severe spinal deformity and less than 5% of those patients are being treated today — due to the high incidence of complications from current standard of care.

Carlsmed’s implants are designed for every patient individually, the team believes it can achieve better spinal alignment outcomes and avoid additional procedures.

In particular, surgeons using its technology could have optimal screw size and trajectory determined prior to an operation.

The company also said it could use digital imaging to create personalized, 3-D printed titanium implants for patients.

“Emerging technologies like aprevo are vital for improving healthcare efficiencies and patient satisfaction,” said Jenell Paul-Robinson VP of clinical value and provider relations at MedTech Innovator. “Solutions like aprevo bring significant efficiencies to the healthcare industry. Early adopter surgeons and hospitals will be positioning themselves as true trailblazers for this type of personalization in spine surgery.”

Receiving FDA Clearance

Last year, the U.S. Food and Drug Administration gave Carlsmed’s implant 510(k) clearance and the Breakthrough Device Designation for correction of adult spinal deformity.

“What’s spectacular about our breakthrough designation is that the FDA believes our devices can improve that standard of care for a much-needed patient population,” said Cordonnier. “We’re the first company to do anything like this.”

The company also expanded its team of executive officers by appointing Frank Fitzgerald, as vice president of sales. Fitzgerald will help build out Carlsmed’s U.S. sales and distribution channels.

Jonathan Root and Phil Young, both U.S. Venture Partners, will join Carlsmed’s board of directors. Kevin Sidow, former chief executive of St. Francis Medical Technologies, also will join the board.

Carlsmed is a graduate of the EvoNexus incubator program and is a Connect with San Diego Venture Group 2020 Cool Company. In 2021, the startup will open its first office with plans to grow its team significantly.

“We’re thankful to the San Diego community that supported us to get to this point, we have finally gotten over the hump as a startup,” said Cordonnier. “We’re now on a growth trajectory towards improving the standard of care for this much needed group, while also showing that patient-specific devices on a mass scale can decrease the cost of care for a broad group of patients.”