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MagnetOs for predictable fusions

Grow bone with MagnetOsTM

Growing bone with MagnetOs gives surgeons confidence where it matters most – delivering predictable fusion outcomes.1

In a Level I human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate of autograft (79% vs. 47%) in posterolateral fusions (PLFs).1 Among active smokers – who made up 1 in 5 patients – the fusion difference between MagnetOs and autograft was even more dramatic.*†1,2

MagnetOs grows bone on its own thanks to NeedleGripTM – a proprietary submicron surface technology that harnesses the immune system to stimulate bone growth, without added cells or growth factors.‡§3-5

Ready-to-use, easy to mold, and reliably staying put, MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures.||6-11

What makes MagnetOs different?

One word – NeedleGripTM

 

Fusion starts at the surface, where MagnetOs gets a grip on non-unions with NeedleGrip surface technology. Explore how NeedleGrip makes a difference – watch the magnification zoom video below at 25x, 50x, and 20,000x.

Zoomed video of MagnetOs under scanning electron microscopy (SEM)



NeedleGrip: harnessing the immune system to stimulate bone growth

The science behind NeedleGrip is called osteoimmunology – a field dedicated to understanding the relationship between the immune system and the skeletal system.3 As the immune system’s ‘first responders’, monocytes react to their environment by differentiating into different cell types.12

 

M1 pro-inflammatory pathway:
Macrophages polarize to the M1 phenotype, which are proinflammatory and promote fibroblast proliferation, often leading to scar tissue.12

M2 pro-healing pathway:
Macrophages polarize to the M2 phenotype, which are pro-healing and upregulate stem cells to create bone.12,13 MagnetOs NeedleGrip surface technology enhances the pathway to M2 macrophages.‡§3,5



Animation of the MagnetOs NeedleGrip mechanism of action

Kuros Biosciences MagnetOs mechanism of action animation
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Transcript

The number of spinal fusions performed each year in the United States is predicted to reach 876,000 by 2022. However, independent research by spinal surgeons has shown that the current failure rate for spinal fusions is 17.7%, which will result in 149,000 failed fusions and 92,000 revision surgeries per year.

A failed fusion is often associated with the presence of scar tissue at the intended site of bony repair rather than mature bone. The body’s natural response to surgery is the upregulation of macrophages. The pro-inflammatory M1 phenotype is responsible for promoting fibroblast proliferation, fibrous tissue formation, and, in sites of chronic inflammation, the development of scar tissue.

The pro-healing M2 genotype, associated with the later stages of wound repair and tissue remodeling, are anti-inflammatory. M2 macrophages upregulate mesenchymal stem cells both directly and indirectly, leading to the formation of new bone.

Immediately following spinal fusion surgery, the undifferentiated macrophage population will respond predominantly with the M1 scar tissue-forming phenotype during a phase of acute inflammation. After this key juncture, inflammation and proliferation of M1 at the expense of the M2 phenotype will result in fibrous tissue formation, ultimately causing the fusion to fail. However, if the M2 phenotype becomes dominant, bone formation will occur, resulting in a successful outcome.

Curos Biosciences have developed MagnetOs granules, a bone graft with a unique submicron surface topography. MagnetOs granules are available in a moldable putty, allowing the surgeon to sculpt the graft accurately to bony defects. Once implanted, the polymeric binder is rapidly resorbed, leaving the granules in place to take effect.

MagnetOs granules are designed to mimic the porous trabecular structure of cancellous bone. Unlike first-generation bone grafts with conventional surface architecture, the advanced surface of MagnetOs has needle-shaped features that are submicron in size and ideal for the attachment and spreading of macrophages.

When the patient macrophages are exposed to the submicron surface topography of MagnetOs, they are reliably polarized to the M2 phenotype. Macrophages of the M2 phenotype have been shown to perform several functions in bone. They remove debris from sites of bone repair and restore the extracellular matrix by promoting secretion of collagen by osteoblasts.

Cellular signaling results in mesenchymal stem cells being freed from the surrounding tissues and being drawn to the submicron surface of MagnetOs. Here they attach and differentiate to osteoprogenitor cells. Signaling also results in mesenchymal stem cells being recruited from the infiltrating vascular system.

M2 macrophages have been shown to express BMP2 and cross-talk with stem cells via the prostaglandin PGE2 pathway. The recruited progenitor cells in turn differentiate to osteoblasts. These cells then begin the work of laying down collagen that will soon mineralize to form new bone.

Unlike conventional osteoconductive bone grafts, for which there is a greater risk of fibrous tissue formation and scarring, bone formation takes place throughout MagnetOs simultaneously without the need for added cells or growth factors, resulting in a uniform, solid, stable, and reliable fusion that is equivalent to the gold standard of autograft.

MagnetOs:
the evidence

MagnetOs is supported by an extensive blend of peer-reviewed scientific, pre-clinical and clinical studies through Project Fusion: our global research program, where science and clinical evidence meet.

Explore the vast body of evidence behind MagnetOs.

What surgeons are saying about MagnetOs

Dr. Patel, Northwestern Center for Spine Health, Chicago, IL

Dr. Poelstra, The Rothman Institute, Jersey City, NJ

Dr. Sama, HSS Spine, New York, NY

Dr. Sandhu, MedStar Georgetown University Hospital, Washington, D.C.

Dr. Allen, UC San Diego Health, San Diego, CA

Mr. Tucker, Great Ormond St, London

Mr. Tucker, Great Ormond St, London

Mr. Tucker, Great Ormond St, London

Dr. Patel, Northwestern Center for Spine Health, Chicago, IL

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My name is Alpesh Patal. I’m the Head of Orthopedic Spine Surgery at Northwestern. I’m fellowship trained in orthopedic spine surgery and neurosurgical spine surgery. I am a spine surgeon, and my practice specializes in cervical spine surgery as well as minimally invasive spine surgery.

So the most appealing part of MagnetOs is that it’s a product that started by trying to solve a fundamental problem that we see as spine surgeons, which is getting a reliable, predictable fusion. And it started with that problem and it solved for that problem.

As spine surgeons, we’re familiar with the link between the immune system and bone healing or bone biology. That field is called osteoimmunology. MagnetOs takes the immune system and harnesses the power of the immune system to promote bone healing. It does so through its unique submicron needle-like structure, and that surface topography polarizes macrophages away from M1 phenotype towards M2 phenotype. And it’s those M2 macrophages that create an environment that promotes bone healing, prevents inflammation, and helps us achieve a more successful spinal fusion.

So that unique aspect of MagnetOs is what separates it from other bone graft products. The catalyst for me in my practice that led towards full adoption were the results that I saw in my patients—the great clinical outcomes, the successful fusions that I saw in those more complex, challenging fusion environments convinced me that MagnetOs can deliver on its promise that it can promote bone healing and enhance spinal fusion.

This is a case I’m happy to share with you. This is a 60-year-old female that I had taken care of. She had presented to our hospital after an injury. She was having quite severe neck pain, and she had an unstable C2 fracture involving the lateral masses, the pedicles of C2, and also had a fracture at C4.

On the pre-surgical imaging, we see what appears to be an odontoid fracture but is actually a much more complex, unstable C2 fracture involving the pedicles of C2, and that is what I thought was driving and creating her severe neck pain symptoms.

The surgical plan that I had for the patient was a posterior C1 to C4 instrumented fusion, a reduction of her fracture, and then a posterior lateral bone grafting consisting of local autograft bone, but then also MagnetOs as a bone graft extender.

The post-surgical x-rays show me very good restoration of alignment. Very pleased with the implants in terms of how they’re positioned. More impressively, as I look down the road—for this patient, she had a very good clinical outcome. At about eight months after surgery, she had a CT scan done of her cervical spine, and on the still images, I can see a really robust amount of fusion in that posterior lateral space from C1 all the way down to C4.

So in a really relatively challenging fusion environment, we can see really good bone formation at the eight-month mark. More impressively than the still images is, as we rotate through and as we slide through all of the sagittal slices and then the axial slices, we can see that the fusion we’re obtaining with MagnetOs is not a spot fusion. It’s not just occurring in a few spots here and there. It’s a really robust amount of bone confluently forming along the entire posterior space from C1 all the way down to C4.

Using science and evidence to drive decision-making on the choice of bone graft products is critically important. As we look outside of my practice, my institutional experience, we see the use of MagnetOs growing and spreading. We see more and more surgeons adopting the science that Curos brings, the solution that MagnetOs is, into their practice. And I’m convinced that we’re going to see better results for patients—both in terms of clinical outcomes but also more successful spinal fusions—as a result of it.

What I tell my fellow spine surgeons about MagnetOs as a product is that it reflects that strong foundation in science, and it accomplishes that goal of promoting bone healing and enhancing spinal fusion. Simply put, it works the way you want it to work. It works better than the other bone graft extenders that we’ve seen come to market, at least in the 15 years of my career, and I’m very, very pleased with the results.

Dr. Poelstra, The Rothman Institute, Jersey City, NJ

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My name is Cornelis Polstra. I work at the Nevada Spine Clinic and within the Nevada Spine Clinic, within the Robotic Spine Institute of Las Vegas, and I’m an orthopedic and neurological spine surgeon.

I was introduced to Curos probably around 2015, and the reason I was very interested in Curos—having a well-tested and safe material that underwent tremendously advanced surface modification by giving it sort of this needle grip texture—and suddenly allow this material then to attract monocytes out of the bloodstream and out of decorticated bone close to the fusion bed to become eventually bone-making cells, just to say it simply, and allow my local autograft mixed with this material to suddenly have an amplified ability to make bone, seemed to be like a no-brainer. So I was very impressed with it, and from there on the development has gone further.

All these white powders sort of look the same when they come to the operating room. It’s a white granular material, and you can’t really see microscopically what goes on on the surface. What Curos famously has done is create a surface modification and made this needle grip surface that really attracts the right kind of cells to the bone-making area. Subsequently, it turns them into a sort of pro-healing M2 macrophage, is what we call them, and that eventually initiates substantial amounts of bone formation out of the osteoprogenitor cells that go around in that site also. And eventually, that’s what stabilizes the patient and that delivers clinically high fusion rates and greater success for my patients.

We did a prospective data collection that we then retrospectively looked at in both the cervical spine as well as the lumbar spine. I treated a large variety of patients in my practice with very challenging comorbidities—obese patients, multi-level revision-type surgeries, patients that had not healed before and had pseudoarthroses, patients that were long-term smokers. And together with a lot of my colleagues, we have the ability to do clinical studies now to really show where the rubber meets the road, that this product is so much better than what we used to use.

So I think that Curos has a tremendous opportunity to expand upon their footprint already in the U.S., with the future development of this product as a backbone, because it is just simply so strong and backed by science. I think based on that, the next line of products are going to amplify even what they are doing. So I have tremendous hope for them. I think they’re going to do wonderful, and I can’t wait to see where they’re growing and what the next products are going to be for my patients.

I like to do evidence-based medicine, so every step of the way there is good evidence for what we’re actually doing and what I’m applying to my patients. And I feel comfortable that I don’t have these inflammatory side effects anymore that we used to see with the BMP, while still benefiting from tremendous efficacy of my product.

I think for all of us, when we try to start using a new bone graft material, we need to have some substantial data. So in my case, when I was introduced to it, I certainly looked at the basic science data—what’s happening at the surface—is this needle grip surface modification really doing something on a cellular level? And once that data was very clear, how much benefit this modification gave, we looked at animal data, large animal data, and eventually data in human. But then the only way to get data in human is also to contribute to it. So that’s the reason that I was excited for my prospective data collection on my patients and report also the great outcomes that we saw with MagnetOs.

I’m not exactly sure if I can quote you the exact number of the number of people that I’ve treated with MagnetOs, but it’s well over a thousand at this point. It is a well-proven bone graft extender. I think there is tremendous history already now and ongoing forward, and it is my number one bone graft extender for everything that I do—with, again, great clinical outcomes in the patient-reported data and the imaging studies that we obtain post-operatively.

Dr. Sama, HSS Spine, New York, NY

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My name is Andrew Sama. I practice at Hospital for Special Surgery in New York City. I’m a spine surgeon and the Co-Chief of the Spine Service at the hospital.

When I met the team at Curos, I was impressed by their scientific knowledge and the application of that science to the technology that they create. When I met with them, I felt more that it was a scientific discussion or an academic discussion rather than a sales pitch. So, I was impressed by their ability to be a science-based company rather than a sales-based company. They’ve created products such as MagnetOs that are fundamentally sound and can be applied by any surgeon for any patient with good outcomes.

I’m looking for a bone graft that’s commercially available with good handling properties and characteristics that works to achieve fusion. So, the great features of MagnetOs are that it maintains the shape that you mold it to. So when you place it into the fusion gutter, it prevents soft tissue from falling into that gutter, and it allows good hard trabecular bone to form as part of your fusion mass—and that’s a predictable event.

One of the cases that I used MagnetOs for was a 62-year-old male patient who had a history of Parkinson’s disease. He had severe back pain. He had what we would call neurogenic claudication, which is difficulty walking because of pressure on the nerves in the back. He failed to improve even though he had done physical therapy, he had modified his activities, he had done some injections into his back which gave him some temporary relief, but still was pretty debilitated by his condition.

So I felt he would benefit from an operation to decompress the nerves, realign the spine, and stabilize it. And that’s where something like MagnetOs is of paramount importance—because we’re going to mix the MagnetOs with his own bone that we remove when we take the pressure off, put it out there as a substrate, and his body will make bone that grows, gets matured, and then stabilizes that segment forever.

So here we have an anterior-posterior and a lateral projection of the patient’s lumbar X-ray. This shows a grade 1 degenerative spondylolisthesis of L4 and L5. With bending films—flexion-extension—there’s a minimal amount of reduction when the patient extends his spine, demonstrating that there is some segmental instability. We look at the CT scan with the patient in the supine position—he actually does reduce a fair amount, confirming the fact that he does have instability there. And you can see the degenerative nature of his facet joints on the axial cuts.

When you look at his MRI scan, he has spondylolisthesis as previously noted, and as a consequence of his facet hypertrophy and ligamentum hypertrophy, he has resulted in subarticular lateral recess stenosis.

During the operation, I concentrated on decompressing his nerves, accessing the disc space to restore the lost height of the disc space, and provide reduction of the spondylolisthesis. We placed pedicle screws with rods, and the bone graft that we created by his laminectomy we mixed with the MagnetOs, packed that into the intertransverse process gutters and in space allowed for the fusion mass to occur.

This is an AP and lateral X-ray of his lumbar spine one year post-operative. You can see that he has formed an excellent fusion mass in the intertransverse process gutters bilaterally. He has maintained his reduction of the spondylolisthesis, and he has maintained the height that was created for his disc space with no evidence of significant subsidence.

Fibrin PTH is one of the most exciting things that drew me to Curos as a company because I was fascinated by the concept of using parathyroid hormone—which we have used at our institution for patients with osteoporosis for more than 20 years—but taking advantage of the properties for the body to create and fortify bone locally by mixing it with fibrin and placing that in the fusion bed.

I would tell my colleagues that Curos is a company that is founded on strong scientific principles, with a group of scientists and leaders that really have the patient’s best interest at heart. I believe their products such as MagnetOs are reproducibly successful in achieving bone fusions in spine surgery.

Dr. Sandhu, MedStar Georgetown University Hospital, Washington, D.C.

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My name is Faheem Sandhu. I’m a Professor of Neurosurgery and Director of Neurosurgery at MedStar Georgetown University Hospital.
My practice is focused on adult degenerative conditions of the spine, and I also specialize in minimally invasive procedures to treat these disorders of the spine.

I’m looking for material that, one, doesn’t have a lot of side effects; two, gives maximal fusion; and three, is reliable and reproducible every time I use it. I’m someone who really needs to see the basic science before I switch and use something—and when I saw the preclinical data and animal studies on Curos, it was very compelling.

The MagnetOs fusion was identical to the autograft bone fusion side. There was solid bone formation and robust bone formation on both sides—they were almost indistinguishable. Seeing is believing in terms of the fusion.

The Project Fusion is a comprehensive look at all the evidence that supports MagnetOs use in clinical settings. There are a number of prospective, Level 1 studies being conducted comparing MagnetOs to autograft bone, which is the gold standard.

I started using it about three years ago, and I’ve been very pleased that the results have matched what I saw in the science. I’ve seen excellent fusion results, and I have a number of patients now who are more than one year out from long fusion constructs—and I’ve seen CT scans that show excellent fusion throughout the construct.

I had one case in particular that was very challenging. It was a lady with a hemivertebra and a tethered cord-type presentation due to the deformity in her spine. I performed a thoracolumbar fusion on her. Her bony anatomy was altered because of this congenital defect, so having a reliable fusion was something I was concerned about.

The surgery went fine, but about six weeks afterward, she developed a seroma at the site of the surgery—a fluid collection we saw on CT scan. There were no signs of infection, but she was experiencing a lot of discomfort due to muscle stretching. So I took her back to the operating room and washed out the seroma, which turned out to be sterile.

At that time, I was able to inspect the fusion mass, and I initially thought I might have to reinforce it. But even at just six weeks, the MagnetOs material had solidified—it was literally rock hard. I could not chip away at it. It was very reassuring and impressive to see such solid fusion so early after surgery.

I recommend MagnetOs to my colleagues because I’ve found it to be extremely reliable and reproducible. I’ve shown them pictures and discussed cases that demonstrate fusion in various settings, and the response I’ve received has been very positive. Most of them are very intrigued, and I usually get a, “Wow, that’s pretty impressive fusion,” based on the timeframe and the setting of the fusion.

Dr. Allen, UC San Diego Health, San Diego, CA

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My name is Richard Todd Allen. I’m a board-certified orthopedic surgeon working at UC San Diego Health. I’ve been in practice now for about thirteen and a half years following my fellowship. My area of expertise is in reconstructive procedures for adult deformities, including scoliosis and tumors. I also perform a significant number of upper cervical spine and cervicothoracic deformity cases, utilizing both open and minimally invasive techniques.

One feature that stood out to me when reviewing the ovine study—and later seeing the transition in my own practice with the use of MagnetOs—was the surface architecture of the material. The “needle-grip” surface of MagnetOs is biologically active, and implants with such altered surface features may provoke a favorable bone response and yield better fusion outcomes compared to prior materials.

These implants are placed under compression, and what really caught my attention in the ovine model was its ability to promote fusion even in the intertransverse space—a biologically challenging environment. That gave me more confidence to begin using it in my most difficult patients.

My hope is that the higher-level studies MagnetOs is undertaking, particularly through Project Fusion, will demonstrate in Level 1 comparisons how this product stands apart. Many of the currently available bone grafts rely on minimal data—often just 510(k) pathway data—which doesn’t necessarily translate to complex academic patients. These are patients with limited soft tissue envelopes, prior infections, or other complicating factors, and improving their quality of life means dealing with very challenging fusion environments.

What I’ve already seen in my own practice is encouraging. I’ve been impressed by the predictability and reliability of the fusion outcomes—even in revision surgeries or in patients presenting with proximal junctional kyphosis. I’ve had several cases recently where the durability and consistency of the fusion results with MagnetOs stood out.

In one particular case, I had a patient with adjacent segment disease and proximal junctional failure. At about eight months post-op, I obtained a CT scan and could clearly identify the area where I had placed MagnetOs. The granules had matured into a robust, solid fusion mass. I was truly impressed by the durability and strength of the fusion, especially in such a challenging case.

I’m not seeing broken rods or failed fusions like I have in the past. The posterior fusion bed, the vascularity of the area, and the soft tissue envelope often create a limited environment for bone fusion. But MagnetOs has performed consistently. When I place it, I know I’m generating a biologic response that leads to predictable results.

What sets MagnetOs apart is its surface architecture modification—a concept we’ve already seen validated in implant technology. The ability to trigger a biologic response at the tissue level is exactly what I’m looking for in a bone graft.

So, if you’re dealing with complex cases or need a graft that gives you that extra degree of confidence in biologically challenging environments, I think MagnetOs is a viable and compelling option to consider in your practice.

Mr. Tucker, Great Ormond St, London

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My name is Stuart Tucker. I’m a Consultant Spinal Surgeon, primarily working at Great Ormond Street Children’s Hospital in London, where I’ve been for just over 12 years. I’ve been a consultant for 21 years.

In treating adult degenerative spine conditions, I favor a combination of anterior and posterior surgery, as I believe this approach significantly increases the likelihood of achieving a solid spinal fusion. For all adult degenerative patients undergoing lumbar fusion, I routinely obtain a CT scan at six months postoperatively. I’ve been doing this consistently for the past 20 years, as it’s a valuable tool in assessing graft integration and determining whether a definitive fusion has been achieved.

It’s disheartening to see patients at six months with a failed fusion, which is why I believe it’s critical to provide a stable construct during the initial operation—supported by the most effective bone graft substitute to optimize the success of the procedure.

In posterior lumbar fusions, I prefer a pedicle screw construct, and I augment this with posterolateral bone grafting using MagnetOs Putty. One of the key advantages of MagnetOs Putty is that it remains where you place it—it doesn’t get washed away during the procedure. This characteristic is clearly visible in postoperative imaging. On coronal CT reconstructions at six months, we typically observe the replacement of the initial granular appearance of the graft with normal trabecular bone.

After two years of using MagnetOs across a range of spinal indications, I can confidently say that I would strongly recommend its use to other surgeons. Whether in primary or revision cases, I now feel comfortable using MagnetOs as my sole bone graft substitute.

Mr. Tucker, Great Ormond St, London

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My name is Stuart Tucker. I’m a Consultant Spinal Surgeon, and I work primarily at Great Ormond Street Hospital for Children in London, where I’ve been for just over 12 years. I’ve held a consultant position for 21 years.

At Great Ormond Street, one of the principal challenges we face is treating children with significant comorbidities. These are often very unwell patients with complex medical needs. In pediatric spinal surgery, the primary goal is to achieve a solid fusion—often across multiple levels—which makes the use of a reliable bone graft substitute essential.

While adherence to sound surgical technique is, of course, critical to achieving good outcomes, the choice of bone graft plays an equally vital role and should not be underestimated. It’s imperative that surgeons critically evaluate the grafts they use to ensure the highest possible potential for successful fusion.

In pediatric skeletal patients, I use a combination of bone dust—generated with a high-speed burr—mixed with MagnetOs. I see no clinical indication to harvest additional bone, such as from the spinous processes, as this compromises the muscle bed for reattachment and can lead to an unsightly widened scar.

A theoretical advantage of using a highly porous graft like MagnetOs is its ability to absorb the hematoma formed during the preparation of the fusion bed. This may help reduce the risk of a “wet wound” and, in turn, lower the chance of postoperative infection.

In scoliosis surgery, we aim to achieve multi-level fusion with a product that is safe and free from risks related to disease transmission. As a surgical team, we collectively made the decision to switch to MagnetOs—guided by clinical evidence and our commitment to achieving the best possible outcomes for our patients.

Based on our experience, I would strongly recommend MagnetOs to other surgeons, both in pediatric and adult spine surgery settings.

From the frontline of spine

“I like that MagnetOs has a history in surface architecture modifications with the ability to generate a pro-healing immune response to stimulate bone growth.”

R. Todd Allen, MD, PhD

Professor, Endowed Chair in Spinal Surgery and Spine
Fellowship Director, Department of Orthapedic Surgery
UC San Diego School of Medicine, San Diego CA
Kuros Strategic Advisory Board Member

“The excitement of the front-end science is strong; we apply it to patients for spinal fusion procedures, and we see really robust, solid fusion rates that we never saw with other products.”

Alpesh A. Patel, MD, FACS, MBA

Director of Othopedic Spine Surgery
Northwestern Medicine, Chicago, IL
Kuros Strategic Advisory Board Member

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