spinal implants - cervical

Developed by RSB SPINEDeveloped by RSB SPINEmanufactured by mahemedicalmanufactured by mahemedical

InterPlateInterPlate® ® PlatformPlatform

Novel Plate-Interbody Combination Novel Plate-Interbody Combination Fusion Devices Fusion Devices

Developed by Robert S. Bray, Jr. MDDeveloped by Robert S. Bray, Jr. MD

COMPANY PROPRIETARYCOMPANY PROPRIETARYUS Patent 6,984,234US Patent 6,984,234

Other patents pending and applied forOther patents pending and applied for

Company InformationCompany Information

Date Incorporated: 2001(LLC) Date Incorporated: 2001(LLC)

Location: Cleveland, OHLocation: Cleveland, OH

Founder, President and CEO: John A. RedmondFounder, President and CEO: John A. Redmond

Co-Founder and Inventor: Robert S. Bray, Jr. M.D.Co-Founder and Inventor: Robert S. Bray, Jr. M.D.

COMPANY PROPRIETARYCOMPANY PROPRIETARY

Senior ManagementSenior Management

John A. Redmond-President and CEOJohn A. Redmond-President and CEO Robert S. Bray, Jr. M.D-Medical DirectorRobert S. Bray, Jr. M.D-Medical Director James M. Moran, D.Eng.-VP EngineeringJames M. Moran, D.Eng.-VP Engineering Lisa Hower-Operations ManagerLisa Hower-Operations Manager Mark Whiteaker-Senior Design EngineerMark Whiteaker-Senior Design Engineer


Major Competitors and Products

Atlas Spine xBiomet x SolitaireBlackstone xCentinel Spine STALIFDepuy xGlobus x IndependenceIST Spine xK2M xLDR ROI, MC+Life Spine xMedtronic x Prevail, IntrepidNuvasive xPioneer xRSB InterPlate C-Ti, C-P, L-Ti, L-PSpinal Elements x Mosaic, Magnum +Stryker xSynthes x SynFix, Zero PTheken x VU-APODVertebron xx Spine xZimmer x

Traditional Plates & Screws

PEEK Spacer or BoneSpacer/Plate/Screws Combined

Titanium or PEEKPEEK Spacer Other Anchoring Method

InterPlate is DifferentInterPlate is Different

C-Ti and L-Ti approved as a plate (can C-Ti and L-Ti approved as a plate (can code both 22851 and 22845)code both 22851 and 22845)

Most material and technique optionsMost material and technique options

Only stand-alone with built in subsidence Only stand-alone with built in subsidence controlcontrol



InterPlate

PLATESPLATES INTERBODY DEVICESINTERBODY DEVICES

AdvantageAdvantage DisadvantageDisadvantage AdvantageAdvantage DisadvantageDisadvantage

Graft retention ProfileProfile Low profile ExpulsionExpulsion

Load sharing (dynamic plates)

Remove to treat Remove to treat adjacent levelsadjacent levels

Minimal incision Stress shieldingStress shielding

Screw fixation to prevent expulsion

Incision lengthIncision length Not removed for subsequent surgeries

Load transfer Load transfer through screwsthrough screws

Loaded in compression

Subjected to Subjected to bendingbending

Inherently stable

Key Features/AdvantagesKey Features/Advantages

Lower profile than ACDF plateLower profile than ACDF plate Reduced dissection and faster than a plateReduced dissection and faster than a plate Can be implanted next to plate or artificial discCan be implanted next to plate or artificial disc Patented design facilitates increasing Patented design facilitates increasing

resistance to subsidenceresistance to subsidence Unique screw cover allows for multiple screw Unique screw cover allows for multiple screw

anglesangles Titanium or PEEK/cervical or lumbarTitanium or PEEK/cervical or lumbar Guide tube screw insertion or freehandGuide tube screw insertion or freehand


Key Features/Advantages (cont)Key Features/Advantages (cont)

Multiple SizesMultiple Sizes Cleared for use w/o supplemental fixation, C-Cleared for use w/o supplemental fixation, C-

Ti and L-Ti cleared as a plate (coding Ti and L-Ti cleared as a plate (coding advantage)advantage)

PEEK spacers designed to fit C-Ti and L-Ti, PEEK spacers designed to fit C-Ti and L-Ti, can be inserted together or separatecan be inserted together or separate

Simple implantation instrumentsSimple implantation instruments Allows surgeons most choices compared to Allows surgeons most choices compared to

competition competition


InterPlate versus PlatesInterPlate versus Plates


InterPlate vs Plate profileInterPlate vs Plate profile



Platform/Implantation Platform/Implantation ConfigurationsConfigurations

Cervical or Thoraco-Lumbar sizesCervical or Thoraco-Lumbar sizes

Titanium InterPlate with PEEK spacer (C-Ti/CPS Titanium InterPlate with PEEK spacer (C-Ti/CPS and L-Ti/LPS), both attachable and separate and L-Ti/LPS), both attachable and separate implantation options. implantation options.

Titanium InterPlate with attachable cervical Titanium InterPlate with attachable cervical allograftallograft

Titanium InterPlate with autograft (C-Ti and L-Ti)Titanium InterPlate with autograft (C-Ti and L-Ti) All PEEK Cervical and Lumbar under All PEEK Cervical and Lumbar under

developmentdevelopment

Implantation OptionsImplantation Options


Placement OptionsPlacement Options



Unique Design Avoids Stress Shielding Unique Design Avoids Stress Shielding of Graftof Graft

Subsidence control Subsidence control withoutwithout stress shieldingstress shielding

Tapered teeth or wedge Tapered teeth or wedge control subsidence resistancecontrol subsidence resistance

Tooth height matches screw Tooth height matches screw traveltravel

At end of screw travel the plate At end of screw travel the plate bears on flat caudal surfacesbears on flat caudal surfaces

InterPlate C-TiInterPlate C-Ti


InterPlate C-Ti 2 levelInterPlate C-Ti 2 level


InterPlate C-PInterPlate C-P


InterPlate L-Ti 2 level lumbarInterPlate L-Ti 2 level lumbar



Current Product Status Current Product Status

InterPlate C-Ti (titanium cervical)InterPlate C-Ti (titanium cervical)

FDA ApprovedFDA Approved


Current Product StatusCurrent Product Status

InterPlate L-Ti (lumbar ALIF titanium)InterPlate L-Ti (lumbar ALIF titanium)

Approved as VBR, IFD and Plate, w/o supplementalApproved as VBR, IFD and Plate, w/o supplemental

fixation fixation



InterPlate C-PS spacerInterPlate C-PS spacer

FDA Approved FDA Approved



InterPlate L-PS spacer (lumbar)InterPlate L-PS spacer (lumbar)



InterPlate C-P (cervical)InterPlate C-P (cervical)



Cervical AllograftCervical Allograft


Regulatory StatusRegulatory Status



Intellectual PropertyIntellectual Propertyo Issued Patents:Issued Patents:

5,888,223 Anterior Stabilization Device5,888,223 Anterior Stabilization Device

6,235,034 Bone Plate and Bone Screw Guide Mechanism6,235,034 Bone Plate and Bone Screw Guide Mechanism

6,984,234 Bone Plate Stabilization System and Method for its Use6,984,234 Bone Plate Stabilization System and Method for its Use

7,985,255 Implant Subsidence Control7,985,255 Implant Subsidence Control

8,100,976 Implant Subsidence Control8,100,976 Implant Subsidence Control

1847240 EU1847240 EU

o Patent Applications:Patent Applications:

Implant Subsidence Control 11/248,651Implant Subsidence Control 11/248,651

Lateral Mount Implant Device 11/686,054Lateral Mount Implant Device 11/686,054

Spine Implants 11/735,723Spine Implants 11/735,723

Foreign applications pendingForeign applications pending

Manufacturing

RSB is certified to ISO 13485:2003 by TUV America

Design in-house using SolidWorks 3D CAD

Manufacturing outsourced to mahemedicalProduct inspected by vendor per RSB

work instructions and verified upon receipt

spinal implants - cervical

Technology

autograft cti

plate cancti

life spine x medtronic

different cti

stryker x synthes x

peek peek spacer

plate codingti

tititanium interplate