CARLSMED RAISES $10M TO BRING CUSTOM IMPLANTS TO SPINE SURGERIES
FDA last week approved titanium devices to treat adult degenerative scoliosis
San Diego’s Carlsmed, which received reg ulatory clearance last week for personalized implants used in complex spine surgeries, has raised $10 million in a Series A round of venture capital funding.
The 10-employee startup will use the money to further commercialize its “aprevo” implants for adult degenerative scoliosis. The condition results in cur vature of the spine that can lead to lower back and leg pain, among other things. It affects about 6 million adults in the U.S.
Carlsmed has developed patented, machine-learning technolog y that takes patient imag ing, prior outcomes data and other information to design
personalized implants for surgeries to straighten the spine, said Mike Cordonnier, chief executive and cofounder of Carlsmed.
The company then taps 3D printers to manufacture the customized implants, which are made of medical grade titanium.
Last week, 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.
According to Cordonnier, conventional spinal implants come in a variety of shapes, and it is up to surgeons to find the best fit through a trial-and-error process.
If the implant doesn’t fit a patient’s anatomy quite right, it can result in complications, including possibly revision surgery, he said.
Because Carlsmed’s implants are designed for every patent individually, the company believes it can achieve better spinal alignment outcomes and avoid additional procedures.
“We create the exact device for that patient, build it on demand, package and sterilize it, and deliver to the operating room so when the surgeon is there, they have confidence to know exactly what to expect f rom the procedure,” said Cordonnier.
This round of financing is led by Silicon Valley’s U.S. Venture Partners. Vertical Group, Cove Fund, and Wavemaker Three-Sixty Health also participated, among others.
Founded in 2018 by Cordonnier and Niall Casey,
Carlsmed previously raised $2.5 million in seed funding. The company is a graduate of the EvoNexus startup incubator program in Southern California.
San Diego is home to a cluster of medical device companies that supply spine surgeons, including NuVasive, SeaSpine Inc. and Alphatec Spine.
With the new funding, Dr. Jonathan Root and Phil Young, who are associated with 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.