KDB Competitive
`
`Trabectome/Goniotome {MST}
`
`Patent Owner Ex. 2005-0001
`NE W WORLD MEDICAL
`
`
`
`Trabectome/Goniotome {MST}
`
`Patent Owner Ex. 2005-0001
`NE W WORLD MEDICAL
`
`
`
`Agenda
`Combating the competition: Trabectome/Goniotome MST}
`
`Company Overview
`
`Product Overview
`
`Rei mbursement Landscape
`
`Messaging
`
`Resources
`
`- Medical Affairs {Internal FYI- Data Review}
`
`- Medical Education {Internal Use &Customer Facing}
`
`-Marketing {Sales to Customer Facing}
`
`Patent Owner Ex. 2005-0002
`NE W WORLD MEDICAL
`
`
`
`MST �Microsurgical Technology)
`Combating the competition: Trabectome/Goniotome MST}
`
`i
`
`T:_
`
`At a glance...
`
`• Portfolio caters to Cataract surgeons &
`procedures that require additional
`technologies (loose zonules, floppy iris,
`Micro instruments}
`
`• Likely to leverage cataract surgeon
`relationships
`
`• May add sleeve to Goniotome to help
`maintain anterior chamber during
`procedure.
`
`Patent Owner Ex. 2005-0003
`NE W WORLD MEDICAL
`
`
`
`Trabectome
`Combating the competition: Trabectome/Goniotome MST}
`
`TRABECTO ME
`
`micro-surgical monogement of oduit & infontrle gioucomo
`
`Conversation points
`
`• Ramp to do it right
`• Trabectome/Goniotome DO NOT have a ramp to lift ,
`stretch, and precisely excise the TM.
`
`• Intuitive technology
`• No additional staff or capital equipment investment
`needed to utilize the Kahook Dual Blade
`
`• Trabectome leaves behind bigger leaflets and runs the risk of
`the remaining leaflets to fibrose'. In addition, Trabectome is
`also a cumbersome technology because it requires
`attachment to capital equipment, which takes additional
`time for proper set-up.
`
`IRi$atiDn port
`
`aore��
`
`tootp�ate
`
`'� Aspiration port
`Return electrode
`Active electrodB
`
`Patent Owner Ex. 2005-0004
`NE W WORLD MEDICAL
`
`
`
`Goniotome Overview
`Co mbating the co mpetition: Trabectome/Gonioto me MST}
`
`Width of footplate
`Width of each
`blade2
`
`Kahook Dual Blade
`230 microns
`12.7 microns
`
`Goniotome*
`345 microns (1.5X larger)
`47.5 microns (3.7X larger}
`
`• Goniotome has serrated blades which are 3.4X larger
`than the dual blades for KDB which is designed specifically
`for precise excision of trabecular meshwork. Goniotome blades
`can result in imprecise cuts, as the blades cross the TM upon
`insertion into the canal and so the cutting happens before any
`lifting and stretching of the TM.
`
`• Trabectome leaves behind bigger leaflets and runs the
`risk of the remaining leaflets to fibrose' . In addition ,
`Trabectome is also a cumbersome technology because it
`requires attachment to capital equipment, which takes
`additional time for proper set-up.
`
`Patent Owner Ex. 2005-0005
`NE W WORLD MEDICAL
`
`Kahook Dual Blade*
`
`47.5
`
`Goniotome*
`
`
`
`Goniotome
`Combatinc the competition: Trabectome/Goniotome {MST}
`
`�*�•
`Conversation points 4� ���
`
`• The Irrigation/Aspiration {I/A) feature may cause AC instability,
`iris billowing, and may not open the angle to a degree that
`makes visualization adequate.
`
`• Goniotome has serrated blades which are 3.4X larger than the
`dual blades for KDB which is designed specifically for precise
`excision of trabecular meshwork. Goniotome blades can
`result in imprecise cuts, as the blades cross the TM upon
`insertion into the canal and so the cutting happens before
`any lifting and stretching of the TM.
`
`• Goniotome + I/A is also a cumbersome technology because it
`requires attachment to capital equipment, which takes
`additional time for proper set-up.
`
`• Trabectome/Goniotome DO NOT have a ramp to lift ,stretch,
`and cleanly excise the TM.
`
`GONtOTOME +l/A
`
`Goniotome with Irrigation & Aspiration as well as serrated dual blade cleanly excise
`TrafJeCular Meshwork (TM) and aspirates TM, while maintaining a clear anterior chamber
`with its Irrigation and Aspiration, creating ideal angle visualization during surgery.
`
`a Handpfece w/ indicat es
`6 Aspvoilon Connector
`c Mgatlon Connector
`
`Patent Owner Ex. 2005-0006
`NE W WORLD MEDICAL
`
`
`
`Product Comparison
`Combatinc the competition: Trabectome/Goniotome {MST} Supportive Comparative info
`
`Trabectome/ Goniotome Class 2 Device
`
`• Ramp to do it right :The ramp elevates and places
`the TM on stretch prior to a clean excision of
`diseased tissue.
`
`• Broad treatment opportunity : Excisional goniotomy
`with KDB can be performed as a stand-alone
`procedure or during cataract procedures. At a
`lower price point and established code for
`goniotomy.
`
`• Intuitive technology: KDB does not require
`additional capital equipment or staff to operate.
`
`• Trabectome &Goniotome DO NOT have a ramp to
`lift or stretch the TM
`
`• Goniotome &Trabectome + IA requires additional
`staff to operate capital equipment.
`
`• Capital equipment &support may be a barrier to
`adoption of the technology.
`
`Patent Owner Ex. 2005-0007
`NE W WORLD MEDICAL
`
`
`
`Reimbursement Landscape
`Combating the competition: Trabectome/Goniotome {MST}
`
`.
`�
`�' b �= �,
`
`• Established code 65820
`
`• Excisional goniotomy
`
`• Surgeon allowable � $769
`• ASC Allowable $1,772
`• Hospital allowable -$3610
`
`• Single use Manually Operated Instrument
`
`Trabectome/ Goniotome Class 2 Device
`
`• Utilizes 65820 cpt code
`
`• Goniotomy (Goniotome) w/o a ramp
`
`• Surgeon allowable � $769
`• ASC Allowable $1,772
`• Hospital allowable $3610
`
`• Single use Manually Operated Instrument (w/o IA)
`• Single Use Equipment assisted instrument (w/ IA)
`
`Patent Owner Ex. 2005-0008
`NE W WORLD MEDICAL
`
`
`
`Messaging
`Combatinc the competition: Trabectome/Goniotome {MST}
`
`Trabectome/ Goniotome Class 2 Device
`
`• The Irrigation/Aspiration (I/A) feature may cause AC instability, iris billowing,
`and may not open the angle to a degree that makes visualization
`adequate.
`
`• Goniotome has serrated blades which are 3.4X larger than the dual blades
`for KDB which is designed specifically for precise excision of trabecular
`meshwork. Goniotome blades can result in imprecise cuts, as the blades
`cross the TM upon insertion into the canal and so the cutting happens
`before any lifting and stretching of the TM.
`
`• Trabectome leaves behind bigger leaflets and runs the risk of the remaining
`leaflets to fibrose'. In addition, Trabectome is also a cumbersome
`technology because it requires attachment to capital equipment, which
`takes additional time for proper set-up.
`
`• Trabectome/Goniotome DO NIOT have a ramp to lift ,stretch, and cleanly
`excise the TM.
`
`'Goniotome is a trademark of Neomedix Corporation
`
`1.
`2.
`
`Seibold LK et al. Preclinical Investigation of Ab Interno Trabeculectomy Using a Novel Dual Blade Device. Am J Ophthalmol 2013.
`
`
`Data on file. New World Medical.
`
`Patent Owner Ex. 2005-0009
`NE W WORLD MEDICAL
`
`
`
`Objections &Barrier Handling
`Combatinc the competition: Trabectome/Goniotome {MST}
`
`Objection
`
`Response
`
`Closing reminders
`
`"I love the serrated blades of the Goniotome"
`
`" KDB doesn't have I/A Functionality"
`
`Kahook Dual blade is designed with excisional
`goniotomy in mind. the ramp lifts and stretches
`the TM allowing the dual blades to precisely
`excise the diseased tissue.
`
`Kahook dual blade does not require additional
`materials to perform a precise excisional
`goniotomy.
`
`The Kahook Dual Blade is designed to fit into
`Schlemm's canal and precisely excise
`diseased TM. Goniotome is larger.
`
`Kahook dual blade does not require
`additional costs of materials such as BSS,
`tubing or capital equipment. It also does not
`burden your OR staff with additional duties to
`complete the goniotomy procedure
`
`• I/A will require additional tubing and supplies;
`Kahook dual blade is designed to maneuver
`in the eye with no additional materials
`needed.
`
`"Goniotome excises the TM just like KDB"
`
`Kahook dual blade uses a ramp which lifts
`and stretches the TM allowing the dual blades
`to precisely excise diseased TM.
`
`You need the ramp to do it right. Placing the TM
`on stretch allows for a clean excision and helps
`prevent leaflets that can potentially scar over
`time.
`
`Patent Owner Ex. 2005-0010
`NE W WORLD MEDICAL
`
`
`
`D i s c u s si o n
`
`Trabectome/Goniotome {MST}
`
`Patent Owner Ex. 200 x0011
`NE W WORLD MEDICAL
`
`
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