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For a glimpse into the future of orthopedic care, it’s always best to check on the startup scene. The following five orthopedic companies are at various stages of bringing innovative solutions to market under the direction of forward-thinking executives with an entrepreneurial spirit. We’re looking forward to tracking their accomplishments over the coming months and years as they advance the ways that surgeries are performed and how well patients heal.
1. Proprio
In April, the Seattle-based company received FDA 510(k) clearance for the Paradigm surgical navigation platform. The system is reportedly the first to use light field technology to create real-time 3D views of the surgical field during spine surgery.
Unlike traditional surgical navigation, Paradigm allows surgeons to remain focused on the patient during the procedure without disrupting surgical workflows.
Proprio says the system limits the need for intraoperative scans, a factor that reduces the surgical team’s exposure to radiation during surgery and shortens case times by up to 30 minutes. Paradigm also collects 250GB of clinical data per hour, information that will inform Proprio’s development of the platform’s future generations.
“We are very enthusiastic about the potential for Paradigm to enable clinicians to revolutionize spine surgery,” said Gabriel Jones, CEO and Co-Founder of Proprio. “We’re reimagining how surgery is done, rather than reconfiguring legacy tools.”
Jones believes that artificial intelligence and machine learning will help spine surgeons make more informed clinical decisions, and said Proprio aims to collect and analyze data from several sources during surgery. “Our platform will harmonize that information and allow surgeons to filter it so they get only what they want when they want it,” he added.
Proprio began placing Paradigm platforms in hospital ORs around the U.S. this year in a non-clinical capacity to capture real-time surgical data. The company is planning a broader commercial release in 2024.
2. Monogram Orthopaedics
In March, Monogram’s founder Douglas Unis, M.D., used the company’s robotic platform to perform the world’s first fully remote total knee replacement. Dr. Unis replaced a cadaver’s knee at the company’s headquarters in Austin, Texas, while controlling the robot from New York City.
It was a headline-grabbing step in the company’s efforts to personalize joint replacement through a combination of innovative implants and robotics.
Monogram signed a conditional purchase order in July with a global distributor to initiate a pilot program that will test its robotic platform with the distributor’s implants. The conditional purchase order allows the shipment of Monogram’s robotic platform to an international healthcare provider by November 30, 2023. The evaluation could involve surgeries performed on live patients.
Monogram believes this international commercialization strategy and a successful evaluation outside of the U.S. involving live patient data could help the company gain FDA 510(k) clearance of its robotic system.
Monogram became a publicly traded company on NASDAQ (with the symbol MGRM) and raised $17.2 million through the sale of shares earlier this year.
“We believe that Monogram can make significant improvements to the current state of the art in ortho-robotics,” said Co-Founder and CEO Ben Sexson. “We expect continued headwinds for robot pricing, and we hope to apply pressure on robot surgical times.”
3. Abanza
The company received FDA 510(k) clearance in December 2022 to market the WasherCap soft tissue fixation system for primary or revision anterior cruciate ligament (ACL) reconstruction.
“FDA clearance is exciting because it offers orthopedic surgeons a highly trusted solution for soft tissue graft fixation, which is especially valuable for young and female patients and revision procedures,” said Juan Abascal, COO at Abanza. “The device helps to secure a stronger and more rigid tibial fixation, which will support a better surgical outcome.”
The device provides reliable and accurate soft tissue graft fixation that’s independent of cancellous bone quality and makes it easy for surgeons to control and adjust the graft tension. A device-specific instrument set provides surgeons with the tools and supplies they need to implant WasherCap safely and easily.
Abanza wants to raise up to $15 million from investors and is looking for a strong medtech partner to help the company reach its $50M annual revenue goal by 2027.
4. Premia Spine
The company received Breakthrough Device Designation from FDA in March 2021 for the TOPS facet arthroplasty system, the only facet joint replacement system made for the lumbar spine. TOPS was designed to relieve lower back and leg pain in patients with spinal stenosis and spondylolisthesis while maintaining stability and preserving motion without the fusion of spine segments.
TOPS features two cross bars that attach to pedicle screws and a central motion mechanism that’s placed after bilateral facetectomies. This design stabilizes spondylolisthesis and preserves motion in all ranges of movement.
Premia announced FDA premarket approval of TOPS in June after undergoing rigorous testing and an Investigational Device Exemption study. The company’s FDA trial demonstrated that the device outperformed spine fusion at two years post-op in the treatment of grade 1 degenerative spondylolisthesis with stenosis. TOPS is the first lumbar spine implant to be labeled by FDA as superior to lumbar fusion.
The first U.S. surgeries were performed with TOPS days after it received FDA approval. Premia seeks to make inroads in the spinal stenosis market, which the company says is a $4.3 billion opportunity. The company plans a limited U.S. launch of TOPS in 2023 and a full launch in 2024.
“Spinal stenosis and spondylolisthesis patients now have access to a lumbar motion device that is superior to fusion,” said Ron Sacher, CEO of Premia Spine. “We’re excited to see what the future holds as we continue to drive advancements in spine care.”
5. Nanochon
This Washington, D.C.-based startup wants to enter the estimated $2 billion cartilage repair market in the U.S. with an off-the-shelf 3D-printed biomaterial device designed to replace and regrown knee cartilage. Chondrograft integrates with natural tissue by absorbing blood and supporting stem cell attachment to form new cartilage over time. Surgeons place the implant arthroscopically without disrupting their normal surgical workflow and can mold its shape to fit the patient’s specific anatomy while preserving more healthy tissue.
Chondrograft is an FDA premarket approval device, which Nanochon views as a platform technology that could be applied to the ankle, hip and shoulder. The company has received interest from investors in the small joint and hand and foot subsegments, according to Nanochon CEO Benjamin Holmes, Ph.D. He said the company plans to bring the device to market in 2027.
Nanochon is considering an international go-to-market strategy and will conduct Chondrograft’s first in-human procedure in Australia, according to Dr. Holmes. He said the company is focused on developing an instrument set or kit to maximize clinical delivery of the implant to enter the cartilage restoration market with an implant that surgeons like to use.
“Our device offers a lower-cost, off-the-shelf opportunity,” Dr. Holmes added. “Ultimately, our main competitor is surgical technique. We want to replace microfracture knee surgery as the go-to standard of care. We’re looking at a long pathway to get to market, but there’s a pot of gold at the end of the rainbow. There’s a large, well-validated need for this technology within the sports medicine niche.”
