Plastics

EVICEL Fibrin Sealant (Human)

Product Information

EVICELTM Fibrin Sealant (Human)PSR Sales Training Module

Training Road Map

• Biosurgicals Overview

• Fibrin Sealant Market Overview

• New Indication

• Promotional Roadmap & HCC

• EVICEL Product Training

• Procedural Targets

• Sales Tools

• EVICEL in Plastic Surgery Procedural Training

• Q&A

• Review Game

EVICEL*FIBRIN SEALANT

(HUMAN)

Biosurgicals Products

ORC(Oxidized Regenerated

Cellulose)

ORC(Oxidized Regenerated

Cellulose)GELATINGELATIN FLOWABLE

GELATIN

FLOWABLEGELATIN COLLAGENCOLLAGEN FIBRIN

SEALANT

FIBRINSEALANT

SURGICEL*Hemostats

SURGICELFIBRILLAR*Hemostats

SURGICELNU-KNIT*Hemostats

SURGIFOAM*GELATIN SPONGE

& POWDER Hemostats

INSTAT*

MICROFIBRILLARCOLLAGEN Hemostats

SURGIFOAM*POWDER Kit

SURGIFLO* Hemostatic Matrix

THROMBINTHROMBIN

EVITHROM* Thrombin, Topical

(Human)

Fibrin Sealant Market Overview

12%10%

78%

60%

13%

27%

*IMS Data, 2007

U.S. Fibrin Market

Vitagel

EVICEL

Tisseel

2006 Fibrin Market ($92 MM)

2007 Fibrin Market ($103 MM est.)

Total fibrin market grew by

12% in 2007

Source: IMS 2007

Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1

2005

$183,364

$847,628$1.2MM

$1.9MM$2.2MM $2.2MM

$3.1MM$3.6MM

$4.2MM

$5.3MM

Launched EVICEL

Launched CROSSEAL

Launched EVICEL

Vascular

EVICEL Performance

2006 2007

$6.1MM

$8.4 MM

$7.1 MM

$10.4MM YTD in 2007vs

$17.7MM YTD in 2008

70% growth over 2007!!!

Launched EVICELGeneral

Hemostasis

$8.8MM

2008

122%

-15%

37%

The Fibrin Sealants segment increased 18% over previous quarter and 14% over 4Q ’06 to $27.3M this quarter.

Evicel leads the growth, with almost $5M growth in the past year and $0.7M in the past quarter. Although Tisseel is down over the past year, it rebounded in 4Q ’07 after its drop in 3Q ’07.

Tisseel is cannibalizing its VH (nonfrozen) business with the newer frozen formulations which now account for 22% of its total dollar volume

US Biosurgicals Market: Fibrin SealantsDetailed Segment, Short-term Dollar Performance

3 Month Quarters, $ Volume, in Millions

Growth over

Pr. Yr.

Segment Volume (MM)

$3.9$5.8

$8.2 $8.3 $8.8

$17.0

$17.5$14.3

$11.4

$12.0

$3.5

$3.4

$2.9

$3.5$4.0

$-

$5

$10

$15

$20

$25

$30

4Q '06 1Q '07 2Q '07 3Q '07 4Q '07

$,

Mil

lio

ns

Evicel Tisseel Vitagel

Source: IMS HIS Data

Compiled by: Pinky Shaw, BIWW

1Q '07 2Q '07 3Q '07 4Q '07 1Q '08Change vs. Prior Year

Nonfrozen 17.5$ 14.3$ 10.5$ 11.3$ 8.6$ -51%Frozen -$ -$ 0.9$ 3.2$ 3.9$

100% 100% 92% 78% 69%0% 0% 8% 22% 31%

TISSEEL DEEP DIVE

Nonfrozen % of Total Tisseel Frozen % of Total Tisseel

Plastic/Burn Surgery Market Overview

Procedure VolumePotential Market

(100% Penetration)

Breast (Reconstruction, Lift, Reduction and augmentation) (5 mL)

735,000 $338MM

Massive Weight Loss Body Contouring (20 mL) 43,000 $86MM

Abdominoplasty (15 mL) 160,000 $240MM

Burn Surgery (10 mL) 100,000 $100MM

TOTAL 1,038,000 $764MM

**NOTE: As always, promotion only for on-label surgeries for hemostasis

Procedures to Target

• Breast Reconstruction (reimbursed) with Flaps (TRAM, Lat, etc.)

• Abdominoplasty

• Massive Weight Body Contouring Procedures

Plastic Procedures

Background & New Indication

J&J Collaboration Framework

• Create a unified J&J presence and set of product-based solutions to the Plastic Surgery community

EVICEL General Hemostasis Indication Expected in January 2008

• Background on “General Hemostasis”– Fibrin Sealants regulated as a biologic product by the

FDA– Historically, an RCT required per indication (specific

surgical site and application)– FDA revised guidance to allow for a “general

hemostasis” claim if efficacy could be demonstrated in a “variety of surgical settings”

– General hemostasis does not include sealing, tissue/prosthetic attachment or adhesion prevention specific trials needed for these indications

New Opportunities in Plastic Surgery

• Expanded indication provides opportunity for promotion in Plastic Surgery for hemostasis

• Fibrin sealants (largely TISSEEL) used in breast reconstruction and augmentation, massive weight loss body contouring (MWLBC)

• Specific applications include hemostasis (on-label), sealing, tissue attachment, and adhesion prevention

EVICEL Selling Cycle

• Surgeon trial & usage in OR necessary to drive adoption• Reps train nurses and surgeon on preparation & application

and support materials management for handling product• May require P&T committee review and/or new product

committee via materials management• Typical cycle may be ~1-3 months• 3 purchases good indicator of a conversion• New account conversions driving growth• Current focus on share capture from Tisseel

New Indication for EVICELTM

EVICELTM Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for patients

undergoing surgery when control of bleeding by standard surgical techniques is ineffective or

impractical

* Pending final labeling from FDA

Does the surgeon operate on the

liver?

Sales rep can also respond to a training request

Sales rep or Medical Affairs * can respond to request for clinical

info.

Yes

YesYou and the customer can

initiate questions on EVICEL Fibrin Sealant (Human) for the

approved indication

Can you (sales rep) initiate conversation

on EVICEL Fibrin Sealant (Human) for the approved indication?

Can you (sales rep) respond to clinical questions on EVICEL

Fibrin Sealant (Human) for the approved indication?

Yes

Only customers can initiate questions

on EVICEL Fibrin Sealant (Human)

No

Only Medical Affairs * can respond to request for off-label clinical

information on fibrin glue

Sales rep could provide proper usage instructions upon request (including indications & safety information) to

customers who decide to use the product

Can you (sales rep) respond to off-label clinical questions on EVICEL Fibrin Sealant (Human)?

Can you (Sales rep) initiate conversation on EVICEL Fibrin

Sealant (Human)?

No

No

Training should include Indications, Contraindications, Precautions, Warnings, and the technical aspects of the product.

EVICEL™ Fibrin Sealant (Human)Original Promotional Road Map


Does the surgeon operate on the liver or perform vascular surgery?

Sales rep can also respond to a training request

Sales rep or Medical Affairs * can respond to request for clinical

info.

Yes

YesYou and the customer can

initiate questions on EVICEL Fibrin Sealant (Human) for the

approved indication


on EVICEL Fibrin Sealant (Human) for the approved indication?

Can you (sales rep) respond to clinical questions on EVICEL

Fibrin Sealant (Human) for the approved indication?

Yes

Only customers can initiate questions

on EVICEL Fibrin Sealant (Human)

No

Only Medical Affairs * can respond to request for off-label clinical

information on fibrin glue

Sales rep could provide proper usage instructions upon request (including indications & safety information) to

customers who decide to use the product


Can you (Sales rep) initiate conversation on EVICEL Fibrin

Sealant (Human)?

No

No


EVICEL™ Fibrin Sealant (Human)Vascular Promotional Road Map


Sales rep or Medical Affairs can respond to request for clinical

info.

Yes

Yes

You and the customer can initiate questions on EVICEL for the approved

indication


on EVICEL for the approved indication?

Can you (sales rep) respond to clinical questions on EVICEL for the approved

indication?

Only customers can initiate questions on EVICEL for off-label uses

No, cannot promote for off-label uses, such as sealing and fixation

Only Medical Affairs can respond to request for off-label clinical

information on fibrin glues


Can you (Sales rep) initiate conversation on off-label uses?

No

No


Promote On-label for Hemostasis?

Does the surgeon perform surgery?

Yes

EVICEL™ Fibrin Sealant (Human)General Hemostasis Promotional Road Map


Customer Requests for Clinical Information

• Utilize Medical Affairs for specific requests for:

– Off-Label uses for EVICEL™ (Sealing, Gluing, Fixation, etc..)

– Requests for Clinical Data for specialties that were not studied in our 3 clinical trials (Liver, Vascular & Soft Tissue)

• Customer can request clinical information by:

– Filling out Post Card (Lit Depot code: DHM0045)

– Calling: 800-888-9234, ext 3800

– E-mail: [email protected]

• Off-Label examples:

– Does EVICEL reduce seromas?

– Does EVICEL seal or fixate tissue?

Leverage our Broad GH Indication

Retroperitoneal Bleeding/Soft Tissue

(3)

Peripheral Vascular Surgery(2)

Liver Resection Surgery(1) General

Hemostasis IndicationStudied in 3

different tissue types

Soft Tissue Study Highlights

ENDPOINTS / CONCLUSIONS

• 135 subjects (11 pediatric) in 18 sites

• Time to hemostasis (TTH) – target bleeding site at 4, 7 & 10 mins

• 95.5% vs. 81.2% achieved hemostasis by 10 min

— Confirming that EVICEL™ is superior to SURGICEL (p<0.05)

• 75.8% vs. 53.6% achieved hemostasis by 4 min


Competitive Overview

Product Indication Statements

Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical1

TISSEEL (Fibrin Sealant)

Pre-Filled Syringe (Frozen) (Baxter)

TISSEEL is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; TISSEEL is a satisfactory hemostasis agent in fully heparinized patients undergoing cardiopulmonary bypass; TISSEEL is not indicated for the treatment of massive and brisk arterial or venous bleeding

TISSEEL has been shown to be an effective sealant as an adjunct in the closure of colostomies2

ARTISS (Fibrin Sealant)

(Baxter)

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and pediatric populations

ARTISS is not indicated for hemostasis2

1, 2 - Sources: US FDA Approved Package Inserts for Tisseel, EvicelTM & Artiss

Note: Information from respective prescribing information derived from separate clinical studies - not intended to convey comparative safety or efficacy.

US Indications Differ by Fibrin Sealant Brand

General PV CV Urology GYN Plastics Burns Ortho

Adjunct to hemostasis for use in patients undergoing surgery

TISSEEL

•.Adjunct to hemostasis in

patients undergoing

surgeries to treat splenic injuries due

to blunt or penetrating trauma

•Sealant as adjunct in closure of colostomies

Adjunct to hemostasis in

patients undergoing surgeries involving Cardio-

pulmonary bypass

ARTISS Not indicated for hemostasis

Sources: US FDA Approved Package Inserts for Tisseel, EvicelTM & Artiss

Note: Information from respective prescribing information derived from separate clinical studies - not intended to convey comparative safety or efficacy.

Indications by Fibrin Sealant

To adhere autologous skin grafts to

surgically prepared

wound beds resulting from

burns

*EVICELTM Fibrin Sealant (Human) Artiss & Tisseel Fibrin Sealant Package Inserts1. Sierra D. Fibrin sealant adhesive systems: a review of their chemistry, material properties and clinical applications. Journal of Applied Biomaterials. Vol.3. 1992: 147-151.Note: Not intended to convey comparative safety or efficacy.

Fibrinogen & Thrombin Content*

• Thrombin

– 800-1200 IU/mL

• Fibrinogen

– 55-85 mg/mL

• Thrombin– 400-625 IU/mL

• Fibrinogen– 67-106 mg/mL

• Aprotinin

– 2250-3750 KIU/mL

EVICELTM Fibrin Sealant TISSEEL Fibrin Sealant

• Thrombin– 2.5-6.5 IU/mL

• Fibrinogen– 67-106 mg/mL

• Aprotinin

– 2250-3750 KIU/mL

ARTISS Fibrin Sealant

EVICELTM does not contain aprotinin and does not

expose patients to the risks associated with aprotinin

EVICELTM does not require an antifibrinolytic stabilizer (ex: aprotinin) agent due to the removal of plasminogen from its formulation

Normal fibrin clot is produced with approximately 2–5 mg/mL of fibrinogen1

Longevity of the EVICELTM Fibrin Sealant (Human) clot in vivo is comparable to that of CROSSEAL* Fibrin Sealant, and other marketed fibrin sealants such as Tisseel

*Johnson & Johnson Wound Management Data on File, Data from in vitro animal model

Clot Longevity Comparison*

EVICELTM Product Training

Think EVICELTM for your Plastic Surgery Procedures

EVICELTM is the first and only fibrin sealant approved for general hemostasis in surgery1

TRAM Flap Abdominoplasty

Think

1. Full Prescribing Information.

INDICATION: An adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical

• Not indicated for the treatment of severe and brisk arterial bleeding.

• EVICELTM is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products.

• Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeld-Jakob (CJD) agent.

• Anaphylactic reactions may occur.

• In liver surgery, bradycardia occurred more frequently in the fibrin sealant group.

Please see sales representative for Full Prescribing Information

Important Safety Information

EVICEL™ Fibrin Sealant (Human)

A safe and effective all-human fibrin sealant that doesn’t require an antifibrinolytic agent, while maintaining clot stability

1. Full Prescribing Information.2. Data on File. ETHICON, INC.


• EVICELTM is the first and only fibrin sealant approved as a general adjunct to hemostasis in patients undergoing surgery

• EVICELTM does not contain aprotinin or bovine derivatives1 and does not expose patients to the risks associated with aprotinin2

• Needle-free device eliminates the risk of needle-stick injuries

• Double-viral inactivation / removal procedure designed to reduce the risk of viral transmission1

Hemostasis can begin quickly with lesspreparation time and minimal clogging

Triple-lumen tip — resists clogging

1. Full Prescribing Information.2. Data on File. ETHICON, INC. Thaws within 10 minutes at 370C; within 1 hour at 200C to 250C (room temperature); or within 1 day at 20C to 80C (refrigerator).


• Ready to use in less than one minute after thawing1,2

• Clog-resistant triple lumen catheter design eliminates the inconvenience of switching tips

• Standard 7cm, 45cm and 35cm Rigid Tips designed to resist clogging

Designed to keep you focused on your procedure– Clear and stable clot1

1. Full Prescribing Information, see EVICELTM Package Insert2. Data on File. ETHICON, INC.


• Forms an elastic clot that anchors firmly to the bleeding site2

• Sprays or drips for broad or targeted application1

• 5 mL provides 100 cm2 coverage area1

• Provides clear visibility of the bleeding site so you can quickly assess hemostasis2

• EVICELTM maintains clot stability over time comparable to other fibrin sealants, without the need for an antifibrinolytic agent2

Can be stored at:• -18°C or colder for up to 2 years• 2°- 8°C for 30 days• Room temperature for 24 hours.

Can be thawed in:• 10 minutes in 37°C water bath • 1 hour at room temperature• 1 day at 2°- 8°C in refrigerator


Biologics – Thrombin & BAC21

Device Overview2 luer locks for easy removal and

attachment of accessory tips

Triple lumen 7cm

clog resistant applicator tip

Optional 35cm Rigid Tip

Can be sprayed or dripped from the same device

35 cm Rigid Tip Overview

EVICEL 35 cm Rigid TipPackaging (3 per box)

Ready to sprayor drip

One-Handed delivery

Atraumatic & clog-resistant tip (triple lumen runs throughout

tip)

Attaches easilyto the device

EVICELTM Fibrin Sealant (Human) should be sprayed using an air pressure of 20–25 psi measured by air flow*

* EVICELTM Fibrin Sealant (Human) Pressure Regulator Instructions for Use

Pressure Regulator

Preparation Video

EVICEL™ Fibrin Sealant (Human) Summary1

• All Human, manufactured human plasma-derived components, aprotinin & bovine-free

• Easy preparation with no reconstitution required

• Ready to use in less than a minute

• Spray or drip with same device

• Clear elastic clot

• Tri-lumen tip, clog resistant applicator


Plastic Surgery Sales Tools

NOW the only fibrin sealant approved for

general hemostasis in

surgery

Updated Main Sales Aid

New Effective Bullet:Proven Rapid Hemostasis

in vascular, urologic, gynecologic and general surgery

New Soft Tissue Study

data in general,

gynecologic and urologic

surgery

* Pending final labeling from FDA; Draft Piece-Subject to change

New Plastics Slim Jim

Plastics Images(Breast

Reconstruction)Hemostatic Efficacy(New Soft

Tissue Study Data) in general,

gynecologic and urologic

surgery

Experience the clear choice for

your plastic surgery procedures

Spray or drip EVICEL™ to achieve hemostasis during

reconstructive procedures, including: breast reconstruction,

abdominoplasty, facial reconstruction

and vascular anastomoses

* Subject to FDA Review* Pending final labeling from FDA; Draft Piece-Subject to

change

Customer Requests for Clinical Information

• Utilize Medical Affairs for specific requests for:

– Off-Label uses for EVICEL™ (Sealing, Gluing, Fixation, etc..)

– Requests for Clinical Data for specialties that were not studied in our 3 clinical trials (Liver, Vascular & Soft Tissue)

• Customer can request clinical information by:

– Filling out Post Card (Lit Depot code: DHM0045)

– Calling: 800-888-9234, ext 3800

– E-mail: [email protected]

Product Preparation Poster

New Cling-zee OR Wall Poster

Easy preparation:No mixing required

New easy-to-see images

Preparation instructions for the

35 cm Rigid Tip

EVICEL Product Codes

New Customer In-service Deck(Updated with new indication & modular device)

New Updated Website(New specialty tabs in Ortho, Burns & Plastics)

New Blackberry Videos(3 new videos in Ortho, Burns & Plastics)

EVICEL in Plastic Surgery Overview

Plastic & Burn Specialty Overview

Why I Use Fibrin Sealants Hemostasis: (on-label)1. Bleeding most common complication after most plastic

surgical procedures2. Hematoma can be devastating complication 3. Can lead to skin flap loss, loss of skin graft, thrombosis

of vascular anastamosis

Sealant: (off-label- Must send requests to Med Affairs)1. Oozing from tissue bed can lead to seroma formation

– Lymphatics– Capillaries and small vessels

2. Seroma can lead to infection, cosmetic deformity, reoperation

Where I Use Fibrin Sealant

1. Under all skin grafts to prevent shearing

2. Underneath all flaps prior to inset for better flap adherence

3. Under flap donor sites

4. On top of skin graft donor site prior to dressing placement

5. Any large open raw surface area where bleeding / oozing is a concern

1. Incision 1. Incision

Abdominoplasty

Steps of Procedure & Bleeding Challenges

Steps of Procedure & Bleeding Challenges

AbdominoplastySteps of Procedure & Bleeding Challenges1. Incision

2. Dissection of skin from abdominal wall tissue– Oozing from tissue bed– Large number of lymphatics and small vessels

transected3. Abdominal muscles tightened4. Excess skin is excised 5. New naval opening created6. Drains placed7. Application of EVICEL™ Fibrin Sealant

(Human) and closure

Breast Reconstruction – FlapSteps / Bleeding Challenges1. TRAM flap donor site very similar to

abdominoplasty2. Latissimus dorsi flap leaves large surface area

cavity in upper back

3. Flap incision4. Dissection of skin from abdominal wall or back5. Elevation of muscle from its normal anatomic

position and rotation up onto chest to create breast6. Fascia closed7. Drains placed8. New naval opening created9. Application of EVICEL™ Fibrin Sealant (Human)

and closure

Breast Reconstruction – Implant

Steps / Bleeding Challenges1. Usually immediately after

mastectomy so incision not needed

2. Pectoralis muscle elevated, pocket created

3. Implant placed

4. Pectoralis closed – primary or graft

5. EVICEL™ Fibrin Sealant (Human) placed under pectoralis muscle

6. Drains placed

7. EVICEL™ and skin closure

Facial SurgerySteps / Bleeding Challenges

1. Head and neck extremely vascular

2. Facelift, Craniofacial surgery

3. Incision

4. Thin facial skin flap elevated – hematoma devastating

5. Muscle layer elevated and plicated – parotid gland

6. Extra skin excised

7. Drain placed

8. EVICEL™ Fibrin Sealant (Human) and skin redraping and closure

Scar Revision

1. Small scar turns into large surface area wound when scar excised

1. Small scar turns into large surface area wound when scar excised

Bleeding ChallengesBleeding Challenges

Scar RevisionSteps1. Incision and excision of scar2. Grafts harvested – donor

sites sprayed with EVICEL™ Fibrin Sealant (Human) and dressing placed

3. Graft or skin substitute placed edges stapled down in strategic spots

– EVICEL™ applied under graft

– Complete stapling process– Dressings placed

For Internal Use Only

Scar Revision

Surgery Videos

Breast Reconstruction

Q&A

Thank You!

Back-up slides

Develop new customers and

markets(Ortho, Plastics &

Burns)

HOW?1. Take share from Baxter

2. Target & convert Tisseel accounts

3. EVICEL is a different product:

All human formulation

Bovine and aprotinin free

Easy to prepare & use

Broadest indication with new General Hemostasis indication

Capture competitivemarket share

Capture competitivemarket share

Create new marketsCreate new markets

Protect our existing business

Protect our existing business

Maintain & Protect our existing

business

2008 Goals

- Main Sales Aid - Product Monograph - FDA approval letter - Press Release

- Plastics Slim Jim

- Burn Slim Jim - Ortho Slim

Jim

Sales Tools:

Sales Tools:

- Contracting Strategy - Main Sales Aid

Sales Tools:

Burn SurgerySteps / Bleeding Challenges1. Large volume blood loss from burn wound excision

and donor sites alike

2. Traumatic wounds similar to burn

3. Burn excised with tangential excision

4. Hemostasis usually with thrombin/epinephrine

5. Grafts harvested – donor sites sprayed with EVICEL™ Fibrin Sealant (Human) and dressing placed

6. Graft meshed

7. Grafts applied to burn wound – Edges stapled down in strategic spots

– EVICEL™ applied under graft

– Complete stapling process– Dressings placed

Date post:	22-Jun-2015
Category:	Education
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