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What if you could accelerate spinal fusion for your high-risk patients?

It’s time to address fusion speed.

Spinal fusion surgeries are becoming more complex with a higher risk of fusion failure.1

Decorative.

In 2023, there were an estimated 465K spinal fusion cases in the United States that used a bone graft replacement.2

Decorative.

The rate of spinal fusion surgeries has continued to drastically increase over time.2

Decorative.

Spinal fusion surgery has become more complex with an increased prevalence of patients with one or more comorbidities.1

Decorative.

Despite advances in surgical technique and implants, non-union remains a concern, especially among high-risk patients.

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Why does fusion speed matter?

It’s a race against time.

It’s a race against time.

What if new bone formation could be safely accelerated to achieve fusion in less time?

There is a need to reduce risk exposure for your patients in the surgery-to-fusion time gap.

  • •It can take up to 12 months for bones to fully fuse3
  • •The longer it takes, the higher the potential of risks such as hardware failure
  • •If this hardware failure happens before union, it may lead to pseudoarthrosis and the need for reoperation

In spinal fusion, extended time to fusion may escalate risks for patients.

What are the challenges with high-risk patients?

Patients with one or more comorbidities have an elevated risk of non-union.4

In the surgery-to-fusion time gap, these patients face increased levels of risk.

  • •BMI >30: patients with obesity have up to 2x higher risk of non-union4
  • •Diabetes: patients with diabetes have up to 13% higher probability of failed fusion4
  • •Smokers: patients who smoke have a 2x higher risk of non-union4
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Earlier clinical intelligence can help get your patients on the right healing trajectory sooner.

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There is a need to safely accelerate physiologic bone formation to achieve fusion sooner for these patients, too.

What is a bone growth accelerator (BGA)?

Despite over 350 spinal bone graft replacements (BGRs) on the market, none of them have demonstrated a substantial improvement in fusion speed.

You don’t need just another bone graft replacement (BGR). What if you could have a bone growth accelerator (BGA)?

Despite all the options, no bone graft replacement (BGR) has demonstrated a substantial improvement in fusion speed to mitigate risk during the surgery-to-fusion time gap.

WHAT COULD A BGA LOOK LIKE?

  • •
    Has high quality Level 1 evidence in humans.
  • •
    Evaluates fusion in high-risk patient populations (obesity, diabetes, smoking).
  • •
    Demonstrates a substantial improvement in fusion speed.
Current BGR options:

Class III drug-device combinations5,6

  • •
    Have high quality Level 1 evidence in humans.
  • •
    Some studies evaluated smokers and/or patients with diabetes; none reported patients with obesity.
  • •
    Fusion speed is comparable to autograft in Level 1 studies.
Current BGR options:

Demineralized bone grafts6,7

  • •
    Limited Level 1 evidence, mostly lower quality studies in humans/animals.
  • •
    Studies evaluated smokers; none reported patients with diabetes or obesity.
  • •
    Fusion speed has not been evaluated.
Current BGR options:

Cellular-based allografts (stem cells)6,8

  • •
    Limited amount of low quality evidence in humans, mostly animal and in-vitro cell studies
  • •
    Some studies evaluated smokers and/or patients with diabetes; none reported patients with obesity.
  • •
    Fusion speed has not been evaluated.
Current BGR options:

Synthetics6,9

  • •
    Limited Level 1 evidence, mostly lower quality studies in humans/animals.
  • •
    Studies evaluated smokers, none reported patients with diabetes or obesity.
  • •
    Fusion speed has not been evaluated.
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There is a need for a true bone growth accelerator (BGA) that can safely optimize early fusion without sacrificing bone quality for high-risk patients.

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REFERENCES: 1. Haik H, et al. Jama Intern Med. 2024;184(2):183-192. 2. Clarivate | Decision Resources Group. Bone Graft Substitutes. December 2022. 3. Gum JL, et al. JBJS Essent Surg Tech. 2016;6(2):e22. 4. Mariscal, et al., in preparation 5. Burkus JK, et al. J Spinal Disord Tech. 2002;15(5):337-349. 6. Abjornson C, et al. Int J Spine Surg. 2018;12(6):757–771. 7. Kang J, et al. Spine. 2012;37(12):1083-1091. 8. Wind J, et al. Neurol Int. 2022;14(4):875-883. 9. Lehr AM, et al. Spine. 2020;45(14):944-951.