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Total joint replacement has become the standard of care for millions of orthopedic patients each year. The startup 3Spine seeks to increase that number even more with the introduction of MOTUS, the first-ever total joint replacement implant for the lumbar spine. The technology has the potential to shift the paradigm of spine care by prioritizing replacement and motion preservation over fusion.
“From a clinical perspective, we can’t continue to justify spending billions of dollars on technology that has improved outcomes only 5% to 10%. Patients still undergo repeat surgeries at a significant rate,” said Scott Hodges, D.O., Co-founder and Medical Director at 3Spine. “We need to invest in technology that moves the needle.”
Dr. Hodges and his fellow 3Spine Co-founders Craig Humphreys, M.D., and Marc Peterman, Ph.D. have spent decades developing the MOTUS implant and lumbar total joint replacement procedure. The encouraging results from its three clinical pilot studies helped the company secure FDA Breakthrough Device Designation and Investigational Device Exemption (IDE) for a pivotal clinical trial, which is currently enrolling patients across the U.S.
“The most common question I get from people is, why hasn’t somebody done this before? It’s so logical,” said Dr. Peterman, the company’s CEO. “The answer is simple. It’s hard. You’re trying to replace very small structures adjacent to nerves. There’s not a lot of bone to hang on to, and you’re in a highly loaded part of the body. It’s hard, which is why it’s the last joint in the body to be replaced.”
Total Joint Replacement for the Spine
Total joint replacement for the spine aims to address underlying pathologies, restore natural balance and maintain range of motion — similar to the goals of knee and hip replacements. 3Spine’s procedure is a bilateral, balanced approach that replaces the function of the disc and facet joints.
The company believes the technology has a broad indication for adults aged 21 to 80 years old who have any combination of spinal stenosis, facet degeneration and disc degeneration. The label it’s seeking is biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1.
“We are addressing all pain generators, which is the reason we’ve achieved a level of success with MOTUS,” Dr. Hodges said. “The outcomes of current artificial disc replacement are extremely positive, but facet issues, stenosis, and instability will continue to limit ADR indications. On the other hand, if you replace the facets but leave the degenerative disc, patients can still experience pain from the bad disc. Also, in both of those situations, you are not correcting alignment problems. Our big advantage comes from treating all pain generators and correcting segmental alignment issues.”
3Spine’s procedure is a bilateral, balanced approach that replaces the function of the disc and facet joints.
Technology in the Making
Drs. Hodges and Humphreys came up with the idea for the three-column total joint replacement MOTUS after going through disc replacement training in the late ’90s. Medtronic purchased their intellectual property in 2004 and Dr. Peterman, an engineer by training, led the original program at Medtronic as Manager of the Thoracolumbar Dynamic Stabilization group.
In 2014 the program was spun out of Medtronic to access private capital for what was projected to be a 10-year, $100-million-dollar IDE cycle. 3Spine has since become an independent, single-product company focused on FDA approval.
“From a technical standpoint, we would not have been able to do this 20 years ago,” Dr. Peterman said. “The industry has developed around us. We had to let materials, surgical techniques and knowledge of biomechanics catch up. We now have access to highly advanced antioxidant Vitamin E Poly, which allows us to make a small bearing that will hopefully last a lifetime. Power tool techniques are now common and allow us to perform a very controlled, careful correction of the patient’s spine. All these advancements helped us develop and introduce the product that we have today.”
Shifting Mindsets
3Spine believes that their procedure will dramatically change the $10 billion spine market, and they’re taking cues from other total joint replacement segments.
Dr. Humphreys, who serves as Research Director, noted that hip replacement initially had strict age criteria for patients over 65. Now the market has broadened, and surgeries are commonly performed on patients younger than 60 to stave off additional arthritis and restore movement.
“In spine, when we see one-level degeneration, we wait until it gets really bad because nobody wants a fusion,” Dr. Humphreys said. “But if one level collapses at 80%, it’s already not moving normally, and the levels above it start to break down due to abnormal force. If you get to that level sooner, you can protect the other levels, and you get better outcomes because your device moves — just like with hip and knee replacement. We need to switch our mindset to think the way joint surgeons do. If we fix a vertebral level sooner, we can protect the spine.”
The 3Spine founders believe that MOTUS will create opportunities to treat patients who seek an alternative to spine fusion and will cater to spine surgeons who seek to specialize in motion preservation. The company is planning significant training courses and considering certification for surgeons interested in the procedure.
“We will follow the total joint model, where it’s better for a surgeon to perform five hip replacements per week than for five surgeons to do one hip replacement per week,” Dr. Hodges said. “We see the same thing happening in spine. Surgeons who are interested in motion-preserving surgery get trained in the technique, perform it repeatedly and have better outcomes and fewer complications.”
Next Steps
3Spine is currently enrolling patients in its IDE study and working on its commercial strategy. The company secured a CPT code for total joint replacement and approximately $60 million in private funding to date.
Although the company’s leaders have achieved numerous critical milestones, they know there is still clinical, regulatory and commercial work ahead of them.
“We came up with the idea of taking patients to Grand Cayman for our third clinical pilot, because we wanted to really refine the indications, rehab program, and technique prior to the IDE,” Dr. Hodges said. “We got to know our pilot patients well during the five days we would spend with them on the island. They were passionate about their outcomes, and they returned to normal life activities better than any of my regular fusion patients. These pioneers still provide the daily inspiration to keep moving forward. Every time we run into a wall — and as a startup, we run into a lot of them — we think back to the early days and are reminded of just how far we have come. Lumbar total joint replacement isn’t just a new implant, it’s a totally new surgical specialty. The work is similar to developing the total hip. No big advancement in care comes easily, but it can be done. We are 100% patient-focused, and we are getting there.”
Total joint replacement has become the standard of care for millions of orthopedic patients each year. The startup 3Spine seeks to increase that number even more with the introduction of MOTUS, the first-ever total joint replacement implant for the lumbar spine. The technology has the potential to shift the paradigm of spine care by prioritizing...
Total joint replacement has become the standard of care for millions of orthopedic patients each year. The startup 3Spine seeks to increase that number even more with the introduction of MOTUS, the first-ever total joint replacement implant for the lumbar spine. The technology has the potential to shift the paradigm of spine care by prioritizing replacement and motion preservation over fusion.
“From a clinical perspective, we can’t continue to justify spending billions of dollars on technology that has improved outcomes only 5% to 10%. Patients still undergo repeat surgeries at a significant rate,” said Scott Hodges, D.O., Co-founder and Medical Director at 3Spine. “We need to invest in technology that moves the needle.”
Dr. Hodges and his fellow 3Spine Co-founders Craig Humphreys, M.D., and Marc Peterman, Ph.D. have spent decades developing the MOTUS implant and lumbar total joint replacement procedure. The encouraging results from its three clinical pilot studies helped the company secure FDA Breakthrough Device Designation and Investigational Device Exemption (IDE) for a pivotal clinical trial, which is currently enrolling patients across the U.S.
“The most common question I get from people is, why hasn’t somebody done this before? It’s so logical,” said Dr. Peterman, the company’s CEO. “The answer is simple. It’s hard. You’re trying to replace very small structures adjacent to nerves. There’s not a lot of bone to hang on to, and you’re in a highly loaded part of the body. It’s hard, which is why it’s the last joint in the body to be replaced.”
Total Joint Replacement for the Spine
Total joint replacement for the spine aims to address underlying pathologies, restore natural balance and maintain range of motion — similar to the goals of knee and hip replacements. 3Spine’s procedure is a bilateral, balanced approach that replaces the function of the disc and facet joints.
The company believes the technology has a broad indication for adults aged 21 to 80 years old who have any combination of spinal stenosis, facet degeneration and disc degeneration. The label it’s seeking is biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1.
“We are addressing all pain generators, which is the reason we’ve achieved a level of success with MOTUS,” Dr. Hodges said. “The outcomes of current artificial disc replacement are extremely positive, but facet issues, stenosis, and instability will continue to limit ADR indications. On the other hand, if you replace the facets but leave the degenerative disc, patients can still experience pain from the bad disc. Also, in both of those situations, you are not correcting alignment problems. Our big advantage comes from treating all pain generators and correcting segmental alignment issues.”
3Spine’s procedure is a bilateral, balanced approach that replaces the function of the disc and facet joints.
Technology in the Making
Drs. Hodges and Humphreys came up with the idea for the three-column total joint replacement MOTUS after going through disc replacement training in the late ’90s. Medtronic purchased their intellectual property in 2004 and Dr. Peterman, an engineer by training, led the original program at Medtronic as Manager of the Thoracolumbar Dynamic Stabilization group.
In 2014 the program was spun out of Medtronic to access private capital for what was projected to be a 10-year, $100-million-dollar IDE cycle. 3Spine has since become an independent, single-product company focused on FDA approval.
“From a technical standpoint, we would not have been able to do this 20 years ago,” Dr. Peterman said. “The industry has developed around us. We had to let materials, surgical techniques and knowledge of biomechanics catch up. We now have access to highly advanced antioxidant Vitamin E Poly, which allows us to make a small bearing that will hopefully last a lifetime. Power tool techniques are now common and allow us to perform a very controlled, careful correction of the patient’s spine. All these advancements helped us develop and introduce the product that we have today.”
Shifting Mindsets
3Spine believes that their procedure will dramatically change the $10 billion spine market, and they’re taking cues from other total joint replacement segments.
Dr. Humphreys, who serves as Research Director, noted that hip replacement initially had strict age criteria for patients over 65. Now the market has broadened, and surgeries are commonly performed on patients younger than 60 to stave off additional arthritis and restore movement.
“In spine, when we see one-level degeneration, we wait until it gets really bad because nobody wants a fusion,” Dr. Humphreys said. “But if one level collapses at 80%, it’s already not moving normally, and the levels above it start to break down due to abnormal force. If you get to that level sooner, you can protect the other levels, and you get better outcomes because your device moves — just like with hip and knee replacement. We need to switch our mindset to think the way joint surgeons do. If we fix a vertebral level sooner, we can protect the spine.”
The 3Spine founders believe that MOTUS will create opportunities to treat patients who seek an alternative to spine fusion and will cater to spine surgeons who seek to specialize in motion preservation. The company is planning significant training courses and considering certification for surgeons interested in the procedure.
“We will follow the total joint model, where it’s better for a surgeon to perform five hip replacements per week than for five surgeons to do one hip replacement per week,” Dr. Hodges said. “We see the same thing happening in spine. Surgeons who are interested in motion-preserving surgery get trained in the technique, perform it repeatedly and have better outcomes and fewer complications.”
Next Steps
3Spine is currently enrolling patients in its IDE study and working on its commercial strategy. The company secured a CPT code for total joint replacement and approximately $60 million in private funding to date.
Although the company’s leaders have achieved numerous critical milestones, they know there is still clinical, regulatory and commercial work ahead of them.
“We came up with the idea of taking patients to Grand Cayman for our third clinical pilot, because we wanted to really refine the indications, rehab program, and technique prior to the IDE,” Dr. Hodges said. “We got to know our pilot patients well during the five days we would spend with them on the island. They were passionate about their outcomes, and they returned to normal life activities better than any of my regular fusion patients. These pioneers still provide the daily inspiration to keep moving forward. Every time we run into a wall — and as a startup, we run into a lot of them — we think back to the early days and are reminded of just how far we have come. Lumbar total joint replacement isn’t just a new implant, it’s a totally new surgical specialty. The work is similar to developing the total hip. No big advancement in care comes easily, but it can be done. We are 100% patient-focused, and we are getting there.”
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Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.
