Plastic Surgery Commercially Available

• Plastic & Orthopedic Surgery – Soft tissue repair indications

• Acute trauma• Post surgery closure• Difficult to heal wounds• No donor site surgery required

91 y/o patient with Melanoma on top of right hand.

One week post surgery, full thickness remodeling initiated.

Patient exhibits minimal inflammation and pain.

Two months post surgery, full thickness remodeling near completion.

Patient has complete range of motion.

What is an Extracellular Matrix (ECM)• ECM occupies the space between cells

– Is part every organ of every species

• Xenogenic transferability

• Universal among species

• Complex infrastructure

– Collagen types

– Proteoglycans

– Hyaluronic acid, laminin, fibronectin

– Glycoproteins

• Mediates cell-to-cell interactions

– Proliferation and differentiation

– Modulates biological activities of growth factors

MatriStem (UBM) Peer Reviewed Publications (39)

Technology Properties• Basement membrane components of UBM• Antibacterial properties of UBM• Material Properties of UBM• Cell migration and proliferation

Technology Forms• Gel form of UBM• Mechanical properties of Multi-laminante• Characterization of UBM Powder

Orthopedic   • Chemoattraction of Progenitor Cells in Achilles tendon• UBM injectable in dogs with osteoarthritis, an RCT   

Thoracic Wall Reconstruction• Repair of thoracic wall, including ribsEsophageal Remodeling• Esophageal Reconstruction• Reinforcement of esophagusCardiac Remodeling• Reconstruction of myocardium• Inductive scaffold for myocardiumTunica Repair• Corporal tissue function maintainedUrinary Incontinence• Particulate for treatment of UIHybrid Design• Biodegradable elastomer and UBM

Scientific AdvisorsAnthony A. Atlala, M.D. • Director of the Wake Forest Institute for Regenerative Medicine and the William Boyce

Professor and Chair of the Department of Urology at Wake Forest University School of Medicine

Thomas W. Gilbert, Ph.D. • Research Assistant Professor in the Department of Surgery at the University of Pittsburgh,

McGowan Institute for Regenerative Medicine

Christopher D. Prevel, M.D. • Founder of the Plastic Surgery Institute of Florida • Clinical Associate Professor of Surgery at the University of South Florida School of Medicine

Alejandro Nieponice, M.D. • Research Assistant Professor of the department of surgery at University of Pittsburgh and

faculty of the McGowan Institute for Regenerative Medicine• Surgical associate and director of the Clinical Translation Unit at the Austral University

Hospital in Buenos Aires, Argentina.

Dr. Jeff Wood, Dr. William Rose, Dr. Rick Mitchell, Dr. Cooper Williams and Dr. Nicolai Jarlov are advisors of ACell and practicing veterinarians who have conducted pioneering research with various applications of UBM for animals such as horses and dogs.

FDA Clearances And Pathway

.

Cleared 510(k)sApplications

Cleared 510(k)sApplications

Planned PMA and 510(k)Applications

Partial & Full Thickness Topical Wounds

Trauma Lacerations 2nd degree burns Ulcers Diabetic Venous PressureSurgical closure Donor site Moh’s surgery Cancer surgeryPlastic surgery Surgical incision closure Body wall contouring Breast reconstruction

Soft Tissue Reinforcement & Repair

General surgery Body wall repair Hernia Breast reconstruction Trauma ReconstructionUrological Pelvic floor, Bladder sling IncontinenceGI tract Esophageal repair Rectal Fistula repair

Minimally Invasive Injectable Treatments Orthopedics Arthritic joints Tendon & ligament Facial cranial bone Bone augmentation Rotator cuff Tendon wrap Nerve guide Interposition tendon graft Plastic surgery : Dermal injectable Lip augmentation Facial augmentation strand Hair transplantation

ACell Vet (UBM)• Basement membrane porcine urinary bladder

• ACell Vet is ACellular

• Non-crosslinked

• Biphasic design

– Basement membrane layer

– Tunica propria layer

• Promotes angiogenesis

• Recruitment of progenitor (adult) stem cells

• Gradual scaffold degradation

• Antibacterial properties

• Tissue remodeling instead of scarring

• Returns body to normal state and function

Complex Structural Composition

• Collagen

– Types: I, II, III, IV, VII

• Bioactive Components

– GAGs

– Proteoglycans

• Growth Factors

– VEGF, BMP4, PDGF-BB, KGF, TGFbeta1, IGF, bFGF, EGF, TGFalpha

• Glycoproteins

– Laminin, Elastin, Fibronectin

• Anti-Infective Peptides

– 18 AMP’s have been identified in porcine tissue

• Porcine defensin pBD-1

Badylak, et. al. The basement membrane component of biologic scaffolds derived from extracellular matrix. Tissue Eng. 2006 Mar;12(3):519-26.

Atala, et. al. Identification and Characterization of Bioactive Factors in Bladder Submucosa Matrix. Biomaterials. 2007 Oct;28(29):4251-6.

Badylak, et. al. Antibacterial activity within degradation products of biological scaffolds composed of extracellular matrix. Tissue Eng. 2006 Oct;12(10):2949-55.

What is ACell Vet ?

•Extracellular Matrix (ECM)•Scaffold to Promote Site Specific Host Cells to Infiltrate

•Naturally derived (porcine)

•ACell-ular•No Immune System Rejection

•Totally Resorbable•Completely Replaced By Healthy Host Tissue

•Not Chemically Crosslinked•No Additional Chemicals to Promote Rejection

How ECMs Work

Site Specific Constructive Remodeling

of Host Tissue by recruitment of

Peripheral

and

Bone Marrow Derived Progenitor Cells.

ACell Vet Applications

• Wound Care• Corneal Ulcers• Dental Applications• Tendon & Ligament

Repair• Fracture Repair• Gastrointestinal

Surgery• Osteoarthritis

• Body wall, soft tissue repair

• Cancer reconstruction• Urological procedures

including Incontinence• Dura Repair• Cranial Cruciate

Regeneration

Dudley – Degloving Injury

•Classic degloving injury after HBC

•Single layer ACell Vet applied 10/11/02

•Day 3 - initial formation of granulation bed apparent. ACell Vet reapplied.

Dudley – Degloving Injury

•Day 11 - excellent granulation bed and vascularization.

Dudley – Degloving Injury

•Day 17 – progressing nicely

•Day 30 – almost closed

Dudley – Degloving Injury

•Day 66 – Wound barely visible and regrowth of hair proceeding nicely.

Classy• Wound was unresponsive

to treatment for 2 years

• Skin defect 12 x 14 cm.

• Bone defect 10 x 7 cm.

• Treated with ACell and surgery

• 8 months later

• Little scar

Bilateral CHDIntra-articular Injection

Study Abstract : Canine Joints

Jeff Wood, DVM– Arthritic Hip Controlled Study

• 20 dogs

– Study Length• 168 days

– Single Injection• Effective for 6 months on treatment group

• Effective up to 12 months in some dogs

– No Adverse Effects

Regenerative Medicine

• Cost Effective

• Reduced Treatment Time

• Easy to Use

• Predictable Results

• Better Healing…Naturally!