Global Spine Congress delegate, are you ready to move the needle?

More spinal fusions are taking place each year, with >470,000 fusion procedures in top 5 EU territories.
But pseudarthrosis/non-union rates have not improved enough in the past 20 years to reduce the overall number of revision cases:

17%

the current % rate of non-unions

80,000 Non-unions per year
>10%

the current % rate of revisions

>49,000 Revisions per year
Learn More

So how can we move the needle on reducing non-unions?

According to published research from spine surgeons, which of the following is the most effective way to improve spinal fusion rates? Please select one of the answers below.

Training: Continued Education

0%

0% improvement in fusion outcomes following 35-40 procedures of learning curve under controlled conditions.9

Technique: Surgical Approach

6%

6% incremental gain in fusion outcomes with a new and improved approach and/or hardware system.10

Technology: Choice of Bone Graft

60%

Using the most effective bone graft can improve fusion outcomes by up to 60%.2,10,11

0%

0% improvement in fusion outcomes following 35-40 procedures of learning curve under controlled conditions.9

6%

6% incremental gain in fusion outcomes with a new and improved approach and/or hardware system.10

60%

Using the most effective bone graft can improve fusion outcomes by up to 60%.2,10,11

Let’s evaluate your options

What is your bone graft of choice today?

Bioglass

e.g., Bonalive™, Novabone™, Fibergraft®

Did you know that...

  • Bioglass is a more ‘foreign’ material than calcium phosphate because its composition is less close to physiological bone.
  • Its mechanism of action has been demonstrated in vitro but has never been translated to improved spinal fusion outcomes in patients.7,8
  • In both pre-clinical and clinical studies, bioglass has led to non-unions, resorption, and adverse immune response.7-10

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft that offers you a viable and proven alternative to bioglass. In a head-to-head study of standalone bone grafts in a clinically-relevant sheep model of posterolateral fusion, MagnetOs reached equivalent fusion outcomes to the ‘gold standard’ autograft; while fusion with bioglass was 0% (100% non-union).7

Allograft

e.g., fresh-frozen/freeze-dried allograft, cancellous chips, pastes, strips

Did you know that...

  • Allograft has proven to have a very low efficacy when used as a standalone bone graft in both pre-clinical and clinical studies of spinal fusion.6,11
  • Sterilisation treatments of allografts reduce their mechanical and biological properties.12
  • Allografts carry a risk of transmission of disease or infection from a donor. The risks are small, but serious cases have been reported.13

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft with advanced surface technology. Unlike allograft, MagnetOs is osteoinductive and can form bone throughout the graft. When used as a standalone bone graft, MagnetOs has consistently demonstrated equivalence to the ‘gold standard’ of autograft in a clinically-relevant sheep model of posterolateral fusion.7,14

BMPs

e.g., InductOsTM

Did you know that...

  • The intended use of BMPs in the spine is restricted to lumbar interbody fusion.
  • BMPs carry a risk of complications in both on-and-off-label use, including undesired ectopic bone formation in adjacent tissues, bone resorption and inflammation.15
  • Delivery of BMPs in a collagen sponge carrier has been shown to produce a burst release of BMP-2, which can result in inflammation and ectopic bone.6-18

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft, and like BMPs has an osteoinductive claim in EU. Because MagnetOs induces bone formation locally at its surface without the risk of undesired ectopic bone formation, it doesn’t carry the same risk of complications as BMPs, which can leach into adjacent tissues. Used as a standalone bone graft, MagnetOs has consistently demonstrated equivalence to the ‘gold standard’ of autograft in a clinically-relevant sheep model of posterolateral fusion.7,14

DBMs

e.g., DBX®, GraftonTM

Did you know that...

  • The amount of osteoinductive factors and osteoconductive scaffold in DBMs varies between products and from lot-to-lot; resulting in unreliable fusion outcomes in pre-clinical models.19,20
  • DBMs are not terminally sterilised because this reduces their biological properties, leading to a risk of disease transmission.13,21
  • Pre-clinical and clinical studies of DBM in spinal fusions have reported low fusion rates.22,23

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft with advanced surface technology. As a synthetic bone graft, MagnetOs’ performance doesn’t depend on donor characteristics, as DBMs do. MagnetOs, used as standalone bone graft, has consistently demonstrated equivalence to the ‘gold standard’ of autograft in a clinically-relevant sheep model of posterolateral fusion.7,14

PepGen P-15

e.g., i-FACTORTM

Did you know that...

  • The osteoconductive scaffold in PepGen P-15 is bovine bone, which is a technology first introduced in the 1950s.
  • Four different preclinical and clinical studies have reported migration of PepGen P-15 from posterolateral and interbody sites.24-27
  • Fusion rates with PepGen P-15 were inferior to allograft in a sheep model of posterolateral fusion.

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft with advanced surface technology. Unlike PepGen P-15, MagnetOs is osteoinductive - and can form bone throughout the graft. MagnetOs, used as a standalone bone graft, has consistently demonstrated equivalence to the ‘gold standard’ of autograft in a clinically-relevant sheep model of posterolateral fusion.7,14

1st Gen Synthetics

e.g., Osteoset™, Vitoss™, Chronos®, Pro-osteon™, Nanobone™, Mastergraft™

Did you know that...

  • 1st Gen Synthetics are solely osteoconductive and do not have osteoinductive potential.
  • Resorption of certain 1st Gen Synthetics (e.g., β-TCP and Calcium Sulfate) occurs faster than the rate of bone ingrowth, which may cause a suboptimal tissue response.28, 29
  • Other 1st Gen Synthetics have a very slow resorption rate (e.g., Hydroxyapatites), which may reduce the rate of complete healing and impair assessment of radiological fusion.30

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft with advanced surface technology. Unlike first-generation synthetics that are merely osteoconductive, MagnetOs is osteoinductive - and can form bone throughout the graft with an optimal resorption rate. Used as standalone bone graft, MagnetOs has demonstrated equivalence to the ‘gold standard’ of autograft in a sheep model of posterolateral fusion.14, 29

Silicated Calcium Phosphate

e.g., Actifuse®

Did you know that...

  • Si-CaP bone grafts are highly crystalline hydroxyapatite which resorb very slowly. This may reduce the rate of complete healing and impair assessment of radiological fusion.31
  • The effects of silicon substitution have not been translated to superior results in humans.32-34
  • Clinical fusion rates for Si-CaP are mixed and often below reported fusion outcomes for other bone graft substitutes in the same indication.35-40

Have you heard of MagnetOs?

MagnetOs is our next-generation synthetic bone graft with advanced surface technology. Unlike Si-Cap, MagnetOs is osteoinductive - and can form bone throughout the graft. MagnetOs, used as a standalone bone graft, has demonstrated equivalence to the ‘gold standard’ of autograft in a sheep model of posterolateral fusion.7,14

Let’s look at some RWE

Proving how we move the needle on reducing non-unions:

From pre-clinical studies to real-world evidence.

Ontwerp zonder titel (2)
Dr. Kees Poelstra, MD, PhD
The Robotic Spine Institute
Las Vegas, Nevada

In 2018, Dr. Kees Poelstra performed an investigator-led, retrospective cohort study using MagnetOs in 52 cases of lumbar interbody spinal fusion, to evaluate its efficacy in a real-world patient population.41

Indication
  • 1-4 level interbody fusion (ALIF)
  • Degenerative and deformity
Cohort
  • 52 patients (97 levels)
  • Mean age 60.9
  • Mean BMI 29.6
Bone Graft
  • MagnetOs Putty combined with Allograft & BMA
Outcomes
  • Fusion: Flex-ex radiographs and CT
  • Clinical: Modified PROLO score
  • Follow-up: ≥ 6 months, average 7.5 months
Fusion outcomes reported between 3-12 months post-operatively
table

Pseudoarthrosis was observed in 3 out of 97 levels (3.1%).

Fusion Clinical outcome was assesed using a modified prolo scale (0-20) and clinical evaluation
graph-and-pie

Patient reported outcomes showed a substantial improvement in pain and functional grade.

Learn more
Magnetos Video Screenshot

Getting a grip on non-unions with NeedleGrip surface technology.

We’ll help you move the needle with MagnetOs

MagnetOs isn’t like any other synthetic bone graft. It’s osteoinductive thanks to our unique NeedleGrip™ surface technology which provides traction for our body’s vitally important ‘pro-healing’ immune cells (M2 macrophages).*42

This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft.7,14,43

The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more efficient and predictable fusion.*

 

SO are you ready to move the needle?

It’s time to move the needle with MagnetOs

Contact us to:

  • learn how to reduce non-unions
  • receive the latest publication from Van Dijk et al. eCM. 2021.
  • receive Dr. Poelstra's case study.

*MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion. Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please refer to the Instructions for Use for a full list of indications, contraindications, precautions, and warnings.

MagnetOs and NeedleGrip are trademarks of Kuros Biosciences. Actifuse is a registered trademark of Baxter International Inc. Allovance is a registered trademark of Australian Biotechnologies Pty Ltd. Attrax is a trademark of NuVasive Inc. Bonalive is a trademark of Bonalive Biomaterials Ltd. Fibergraft is a registered trademark of Prosidyan, Inc. i-FACTOR is a trademark of Cerapedics, Inc. Novabone is a trademark of NovaBone Products, LLC. Vitoss is a trademark of Orthovita, Inc. ViviGen is a registered trademark of LifeNet Health. Osteoset is a trademark of Wright Medical Group N.V. Nanobone is a trademark of Artoss GmbH. Mastergraft, InductOs and Infuse are trademarks of Medtronic Plc. Pro-osteon is a trademark of Interpore International. Chronos is a registered trademark of DePuy Synthes Companies. Fibergraft is a registered trademark of Prosidyan, Inc. DBX is a registered trademark of MTF. Grafton DBM is a trademark of Osteotech, Inc.

 

PROMO_MAG_EU_063-21 Aug '21