Integra LifeSciences Holdings Corp. Plainsboro, NJ 860 employees 3 divisions: - Integra LifeSciences - Integra NeuroSciences - Integra Padgett Instruments.

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Presentation transcript:

Integra LifeSciences Holdings Corp. Plainsboro, NJ 860 employees 3 divisions: - Integra LifeSciences - Integra NeuroSciences - Integra Padgett Instruments INTEGRA® Dermal Regeneration Template

Financials Publicly traded since 1995 on NASDAQ (IART) For FYE 12/03 revenues increased 58% to $185.6 M FY 2003 net income $26.8 M Stock price $31.87 on 4/12/04 Web site:

IART, LIFC, and NASDAQ (1 yr)

INTEGRA® Dermal Regeneration Template Bilayer skin replacement used for treating full-thickness or deep partial- thickness burns FDA approved Marketed by Ethicon, Inc. (J&J) Dermal layer and temporary epidermal layer Temporary epidermis replaced with ultra-thin autograft (0.003 – 0.005”)

INTEGRA® Dermal Regeneration Template

INTEGRA® Dermal Regeneration Template: Dermal layer Porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) Manufactured with a controlled porosity and defined degradation rate Permits infiltration of fibroblasts, macrophages, lymphocytes, and capillaries derived from the wound bed. Endogenous collagen matrix is deposited by fibroblasts; simultaneously, the dermal layer of INTEGRA® Dermal Regeneration Template is degraded

INTEGRA® Dermal Regeneration Template: Epidermal layer Temporary synthetic polysiloxane polymer (silicone) Upon adequate vascularization of the dermal layer and availability of donor autograft tissue (usually 7-14 days), the temporary silicone layer is removed and a thin, meshed layer of epidermal autograft is placed over the "neodermis." Cells from the epidermal autograft grow and form a confluent stratum corneum, thereby closing the wound reconstituting a functional dermis and epidermis.

Clinical Studies 149 burn patients Median take for INTEGRA®: 80% conventional autograft: 95% Acceptable to investigators Epidermal autograft take 90% vs. 95% for conventional autograft Wounds with INTEGRA® and meshed epidermal autograft less likely to show meshed and spread pattern than meshed conventional autograft

Clinical Studies No significant difference in healing time between INTEGRA® and temporary wound covers Healing time with thin autograft comparable to conventional autograft Donor sites of thin autografts healed faster and allowed more cycles for reharvesting than conventional donor sites

Clinical Studies Physician and patient assessment of cosmetic and functional outcome: - Patients preferred INTEGRA® over control - Physicians favor INTEGRA® in terms of scarring and cosmesis - Donor 12 months favored thin epidermal autograft over conventional

Integra NeuroSciences NeuraGen Peripheral Nerve Guide Absorbable collagen tube Conduit for axonal growth across a nerve gap Axons of severed peripheral nerves regenerate spontaneously, but will not establish functional connections unless the nerve stumps are surgically reconnected Rapid method for rejoining severed peripheral nerves, in contrast to conventional microsurgical techniques

NeuraGen Peripheral Nerve Guide

Cartilage Regeneration Template Damaged cartilage on the knee The site is debrided and prepared for the cartilage matrix implant The cartilage matrix is implanted into the damaged area of the knee Cartilage begins to regenerate Healthy, completely regenerated cartilage

Integra Collagen Products Bone regeneration - Resorbable sponge used with BMP-2 - Medtronic Sofamor Danek spinal applications Dental - Guided tissue regeneration in periodontal surgery - Hemostasis in dental surgery - Sulzer Dental Neurosurgical - DuraGen® Dural Graft Matrix

Genzyme Biosurgery Cambridge, MA One of 3 divisions of Genzyme Corporation Epicel® cultured epidermal autografts Carticel® autologous cultured chondrocytes

Financials Publicly traded on NASDAQ since 2001 (was GZBX; now GENZ) FYE 12/02 revenues increased 2% to $240.1 M FY 2002 operating loss $24.5 M For Q1-03 revenue $65.6 M Stock price (GZBX) $1.96 on 4/30/03 GENZ $47.49 on 4/12/04

GZBX, IART, LIFC, NASDAQ (1 yr)

Epicel® First introduced in 1987 Used in treatment of burns From postage-stamp sized biopsy to entire body surface area in 16 days 75 patients per year 600 patients worldwide Ship product to U.S., Europe or Japan

Epicel® Autologous keratinocytes co-cultured with irradiated murine cells to form cultured epidermal autografts (CEA) 2 to 8 cell layers thick Each sheet attached to a petrolatum gauze backing with stainless steel surgical clips. Each autograft is approximately 50 cm 2 and is individually packaged in sterile, buffered, serum free Dulbecco's Modified Eagles Medium (DMEM). The murine cells used in the culture process have been extensively tested for the presence of infectious agents.

Epicel® Clinical Database Survival displayed by TBSA burned (n=478) TBSA (%) Survived n (%) Died n (%) < 4034 (89.5)4 (10.5) 40<TBSA<60134 (92.4)11 (7.6) 60<TBSA<70100 (90.1)11 (9.9) 70<TBSA<8094 (85.5)16 (14.5) 80<TBSA<9088 (82.2)19 (17.8) >9028 (68.3)13 (31.7)

Carticel® Autologous cultured chondrocytes Began marketing in 1995 Used to repair symptomatic cartilage defects of the femoral condyle caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure Not for patients with osteoarthritis Covered by most insurance plans

Carticel® Raisin-sized biopsy during arthroscopic procedure; shipped to Genzyme Chondrocytes expanded in culture to millions of cells; shipped back to surgeon Periosteum from lower leg sutured over the defect like a patch to hold the cells in place Patients back to full weight bearing in 6-8 weeks; resume physical activity within one year Over 6000 patients treated since 1995

Carticel® Clinical Experience Defect Resumed all activities Some improvement No improvement Total Femoral condyle 7 (29%)8 (33%)9 (38%)24 Femoral condyle plus other non- cartilage repair 4 (25%)9 (56%)3 (19%)16 Total 11 (28%)17 (42%)12 (30%)40

Carticel II® (in development) Three-dimensional autologous cartilage graft that may be delivered arthroscopically Treat larger defects, permit early weightbearing and allow for significantly quicker return to function than the current product.