Additive Manufacturing

Why we believe in 3D printing:
More and Less

More

  • We can create cellular structures / surface roughness that help to enhance cell biology, bony ingrowth, solid bony fusion. Osteoconductive and osteoinductive properties can achieved without additional coatings and surface treatments
  • Better use of space – more robust structures – product safety
  • Functional implants (expandable, integrated fixation) printed as one piece

Less

  • Lower manufacturing cost - No assembly – fewer parts, less risk of complaints / better traceability
  • Reduced time to scale-up and faster market access in initial Product-Launch phase

Expandable Cages

We suppose that the only reason why static cages are still used in the vast majority of cases (in particular in Europe) is COST. Typically the manufacturing costs of expandable cages are at least 2-3 times higher than regular static cages.

Expandable Cages make perfect sense because of

  • Realtime control of cage configuration
  • Support of MIS approach, navigation and robotics
  • Reduction of collateral damage during insertion
  • No hammering
  • Perfect sizing, height restoration and spinal realignment
  • Reduction of implant inventory and instrument set complexity
  • Reduction of processing cost

We suppose that the only reason why static cages are still used in the vast majority of cases (in particular in Europe) is COST. Typically the manufacturing costs of expandable cages are at least 2-3 times higher than a regular static cages.

BLUE OCEAN SPINE WILL CHANGE THIS.

Our benchmark is the “ideal cage” – not competition

We combine vast OR experience and close KOL interaction with medical device engineering expertise.

3D printing technology opens up new frontiers and design opportunities to achieve both - better products AND improved cost efficiency.

Our thoughts on design of the perfect expandable cage

MATERIAL

  • Improved fusion potential
  • Osteoconductive
  • Osteoinductive
  • Lattice structure (bony ingrowth / throughgrowth)
  • No artefacts (MRT/CT)

INSERTION

  • No hammering, no forceful impaction
  • Precise placement
  • Reduce nerve root -and dural sac retraction

ACCESS

  • Avoid exiting nerve root
  • Meets demands in open and MIS procedures
  • Tubular retractors / MIS retractors
  • Limited exposure (scaring)
  • Reduction of approach related morbidity
  • ATP (lateral cage)
  • Reduction of muscle damage

TRIALING / SIZING

  • No sequencial trialing, less retractor time
  • Adjustable trials (H/L/Angle)
  • Solid fitting, individual precise height adjustment

STRUCTURAL CORRECTION

  • Surgeon controlled realtime changes in shape / angle / height
  • Preservation of disc height
  • Selective placement of cage and expansion
  • Sagittal / coronal place correction
  • Separated adjustment of height and lordosis
  • Stepless adjustment
  • Indirect decompression
  • High expansion factor / lordosis angles

SAFETY

  • Reduced risk of expulsion
  • Intraperative reviseability, enable repositioning
  • Correction of position
  • Endplate preservation
  • Ease of use, steep learning curve
  • Intuitive instrumentation
  • Reduced OR time and blood loss

SET EFFICIENCY / COST

  • Maximised variability with low number of implant sizes
  • One cage adapts to multiple size configurations
  • High expansion factor
  • Minimized inventory (implants and instruments)
  • Adjustable trial instruments

FUSION QUALITY

  • Graft backfilling
  • Filling of expanded volume
  • Filling of concave disc space
  • Grafting through insertion instrument

Integrated Fixation

We do what makes the most sense.

Status

Current products and treatment concepts are often either too complex and too expensive or designs and solutions that are driven by IP restrictions, US regulary hurdles (no suitable predicate devices), or reimbursement codes – not always focused on clinical needs.

We strive for solutions that make sense for the patient and the surgeon AND comply with regulations and financial business models

Integrated Fixation

  • Easy expansion of anchors once cage is placed
  • Reduced cage migration
  • Comparable biomechanical stability (compared to integrated screws)
  • Improved safety
  • Reduction of surgical steps
  • MIS approach (tubes) possible clinical study in preparation
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