Disclosures. Disclosures 5/28/18. Amniotic Membrane In the Optometric Practice Workshop. Douglas K. Devries, O.D. Disclosures

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Consultant for ophthalmic companies: Alcon Bausch + Lomb Crystal PM Di

1 Amniotic Membrane In the Optometric Practice Workshop Peter Cass, O.D. Walter O. Whitley OD., FAAO, MBA Douglas K. Devries, O.D. Disclosures Peter J. Cass, OD Beaumont Family Eye Care Beaumont Texas Board Member TOA, Chair Health Information Technology Committee AOA Health Information Exchange Workgroup Partner, Optometric Business Solutions Consultant for ophthalmic companies: Alcon Bausch + Lomb Crystal PM Diopsys Solution Reach Katena Shareholder Essentia Douglas K. Devries, O.D. Disclosures Alcon Advisory Board Allergan Advisory Board and Speakers Bureau Akorn Advisory Board Bio Tissue Speakers Bureau and Advisory Board Bruder Advisory Board BVI Medical Advisory Board and Speakers Bureau B & L Advisory Board and Speakers Eyes 4 Lives Lumenis Johnson & Johnson Vision OcuSoft Advisory Board and Speakers Bureau TearLab Advisory Board and Speakers Bureau Tear Science Advisory Board RPS Stockholder Revision Optocs Advisory Board RySurg Advisory Board Science Based Health Shire Advisory Board and Speakers Bureau Sun Pharmaceutical OcuSoft - Speakers Bureau Ophthalmic Resources Founding Partner Disclosures Walter O. Whitley Consultant or Speakers Bureau for: Alcon Allergan Bausch & Lomb BioTissue BVI Ocusoft TearLab Science Based Health Shire Advanced Recalcitrant PEK In Ocular Surface Disease Amniotic Membrane 1

Inflammation is the Hallmark of All Ocular Surface Diseases Inflammation s Effect on Healing Corneal Inflammation Ocular

hallmark symptom of all ocular surface diseases Uncontrolled inflammation leads to: Chronic pain and discomfort/irritation

Keratitis Conjunctivitis Blepharitis Non-Resolved Inflammation Tissue Damage Controlling Inflammation is Key to Preventing

The Amniotic Membrane Maternal Birth Tissues Anatomy The amniotic membrane is the innermost lining of the placenta (amnion)

2 Inflammation is the Hallmark of All Ocular Surface Diseases Inflammation s Effect on Healing Corneal Inflammation Ocular Surface Disease Conjunctival Inflammation Eyelid Inflammation Inflammation: the first sign of wound healing & is also the hallmark symptom of all ocular surface diseases Uncontrolled inflammation leads to: Chronic pain and discomfort/irritation Delayed healing, more tissue damage Vision-threatening complication, e.g., scar/haze Effective control of inflammation is an important strategy to promote healing and minimize the risk of scar/haze Keratitis Conjunctivitis Blepharitis Non-Resolved Inflammation Tissue Damage Controlling Inflammation is Key to Preventing Tissue Damage! The Amniotic Membrane Maternal Birth Tissues Anatomy The amniotic membrane is the innermost lining of the placenta (amnion) Amniotic membrane shares the same cell origin as the fetus Stem cell behavior Structural similarity to all human tissue Uterus Placenta Amniotic Fluid Amnion Membrane Umbilical Cord 15 What is Human Amniotic Membrane? Studies show amniotic membrane enhances the wound healing process: It reduces pain It reduces inflammation It reduces scar formation Contains essential growth factors for cell growth and diversification Biological Scaffolding Helps initiate an active healing process by providing proteoglycans and growth factors Collagens, fibronectin and lamilin Cryopreserved membrane contains heavychain hyaluronic acid Inhibits proinflammatory cells Suppress T Cells 2

Technology Highlights Normal Adult Wound Healing

on its own Impressive regenerative platform that

Anti-scarring Anti-angiogenic Therapeutic actions:

Promotes cellular migration Expedites recovery

-HA/PTX3 Orchestrates the Regenerative Healing

Immune Response Facilitates Neutrophil Apoptosis

PATIENT HISTORY NEOX TREATMENT & OUTCOME Patient

Patient brought to the OR for sharp debridement and

Now the patient has formed a applications placed in

wounds nearly healed to date (10 weeks).

Inflammatory Macrophages -HA PTX3 -HA -HA 1.

0 cm length x 5 mm depth Debridement 4 WEEKS After

& Th17 Lymphocyte Activation Promotes Regenerative

Scarless Fetal Wound Healing Speed & Quality of

Patient Presents 8 Days after Chemical Burn

first day of treatment Day 3 Day 5 Day 7 Day 17

-HA 3 months Day 10 Day 12 Day 15 Day 17 Limbal

3 Technology Highlights Normal Adult Wound Healing Our body does not achieve state-of-the-art healing on its own Impressive regenerative platform that possesses natural growth factors and optimal scaffolding properties within a complex extracellular matrix that are: Anti-inflammatory Anti-scarring Anti-angiogenic Therapeutic actions: Promotes Stem Cell Expansion Suppresses pain Promotes cellular migration Expedites recovery RESIDUAL HAZE PROLONGED INFLAMMATION SCAR FORMATION -HA/PTX3 Orchestrates the Regenerative Healing Process By Modulating the Innate and Adaptive Immune Response Facilitates Neutrophil Apoptosis (Cell Death) -HA Diabetic Foot Ulcer DIAGNOSIS & PATIENT HISTORY NEOX TREATMENT & OUTCOME Patient suffering from a chronic diabetic wound open Patient brought to the OR for sharp debridement and for 5 years; failed serial debridement, wound vacs, first NEOX application. Second and third NEOX and allografts. Now the patient has formed a applications placed in the first 4 weeks with both contralateral ulcer. wounds nearly healed to date (10 weeks). Changes M1 Inflammatory Macrophages to M2 Anti- Inflammatory Macrophages -HA PTX3 -HA -HA 1.0 cm width X 2.0 cm length x 5 mm depth Debridement 4 WEEKS After Cryopreserved Umbilical Cord #1 & #2 Suppresses Th1 & Th17 Lymphocyte Activation Promotes Regenerative Healing Umbilical Cord #3 10 WEEKS Chemical Burn Scarless Fetal Wound Healing Speed & Quality of Healing Count! Patient Presents 8 Days after Chemical Burn Complete Epithelium Damage PROKERA is placed on first day of treatment Day 3 Day 5 Day 7 Day 17 Giant neck mass resection at 26 weeks in-utero PTX3 -HA 3 months Day 10 Day 12 Day 15 Day 17 Limbal Stem Cell Expansion Begins Limbal Stem Cell Expansion Continues -HA -HA -HA Complete Scarless Healing -HA/PTX3, found naturally in amniotic membrane, is the critical biologic component responsible for scarless fetal wound healing. Courtesy of fetal surgeon, Michael Harrison, M.D. (UCSF) 3

- HA H C PTX3 - HA - HA - HA 5/28/18 Common Corneal Pathologies Associated with Dry Eye Superficial Punctate

Sjogren s Syndrome DRY EYE SYNDROME FILAMENTARY KERATITIS RECURRENT CORNEAL EROSION PROKERA PROMOTES REGENERATIVE

Understanding the Significance of the Processing Method Many things start off the same Difference Between Dehydrated

including -HA/PTX3 PTX3 -HA -HA Breaks down -HA/PTX3 to proinflammatory low molecular weight HA; the structural

LMW-HA LMW-HA LMW-HA -HA LMW-HA PROKERA ACCELERATE LASTING HEALING IN DRY EYE BY PROMOTING CORNEAL NERVE

manipulation from fresh AM). Thus, our products: 1.

Retain meaningful quantities of -HA/PTX3 to activate regenerative healing 3.

4 - HA H C PTX3 - HA - HA - HA 5/28/18 Common Corneal Pathologies Associated with Dry Eye Superficial Punctate Keratitis Filamentary Keratitis Recurrent Corneal Erosion Corneal Ulcers Neurotrophic Keratitis Exposure Keratitis Sjogren s Syndrome DRY EYE SYNDROME FILAMENTARY KERATITIS RECURRENT CORNEAL EROSION PROKERA PROMOTES REGENERATIVE HEALING WITHOUT SCARRING TO ACCELERATE VISION RECOVERY Confidential property of tissuetech inc. Do not distribute. Understanding the Significance of the Processing Method Many things start off the same Difference Between Dehydrated and Cryopreserved Amniotic Tissue -HA Preserves meaningful quantities of all extracellular matrix components, including -HA/PTX3 PTX3 -HA -HA Breaks down -HA/PTX3 to proinflammatory low molecular weight HA; the structural integrity is lost. LMW-HA LMW-HA LMW-HA -HA LMW-HA PROKERA ACCELERATE LASTING HEALING IN DRY EYE BY PROMOTING CORNEAL NERVE REGENERATION CRYOTEK cryopreservation method allows us to preserve AM at -80ºC without forming ice (minimal manipulation from fresh AM). Thus, our products: 1. Maintain the structural and biological integrity of the membrane 2. Retain meaningful quantities of -HA/PTX3 to activate regenerative healing 3. Retain the original tensile strength of AM, facilitating ease of handling during surgery The processing method is the key to retaining potency. A prospective, controlled study to compare self-retained amniotic membrane (ProKera Slim, Bio- Tissue, Miami, FL) and conventional treatment in patients with moderate to severe DED (DEWS 2-4). Twenty subjects were enrolled and randomized to receive ProKera Slim (PKS) or conventional treatment. Changes in signs and symptoms, corneal topography, corneal sensitivity, and corneal nerve density were evaluated at John baseline, et al, Ophthalmol, submitted, month and 3 months. Dr. Thomas John 4

5 RAPID REDUCTION OF SYMPTOMS, PAIN, AND CORNEAL STAINING PROKERA PROMOTING A LASTING EFFECT BY INCREASING CONREAL NERVE DENSITY * * P< P< STUDY BASELINE Corneal Nerve Density ( m m/mm 2 ) ** P=0. * P= * * Corneal Nerve Density P< P<0.005 CONTROL BASELINE BEFORE PROKERA 8000 Baseline 1 Month 3 Months * P< * P< MONTH 1 MONTH * P< * P< AFTER PROKERA 3 MONTHS * * P< P< MONTHS John et al, Ophthalmol, submitted, 2017 John et al, Ophthalmol, submitted, 2017 PROKERA S LASTING EFFECT IN DRY EYE IS REPRODUCED IN DREAM STUDY ACCELERATE HEALING, REDUCE TIME, BETTER OUTCOME (HSV KERATITIS) 62 patients (75 eyes) with mod/ severe dry eye (DEWS 3-4) despite maximal medical treatments. Single PROKERA placement for 5 ± 2 days, 59 (95%) patients demonstrated improved ocular 4.0 surface that last for 3 months DEWS Scores /5/ /9/ /12/ F H/O HSV, RE, for 20 years. Ø 12/5/16: Resolving Sty Ø 12/9/16: 3 EDs TX: acyclovir 200 mg 5 times daily Ø 12/12/16: Dendritic HSV TX: Debridement + PROKERA Ø 12/15/16: Clear cornea 12/15/ Baseline 1 wk 1 M 3 M Confidential property of tissuetech inc. Do not distribute. Confidential property of tissuetech inc. Do not distribute ACCELERATE HEALING, BETTER OUTCOME, REDUCE COST/ VISITS ACCELERATE HEALING, BETTER OUTCOME, REDUCE COST/VISITS 12/7/ /14/ F lost LE to Glaucoma and C/O Painless progressive loss of vision, RE, but unsuccessfully managed by primary care for 3 months Ø 11/18/2016: presented to a corneal specialist with PED despite artificial tears qid, preforte qid, timolol bid Ø 12/7/2016: seen by Dr. Tseng with Corneal Ulcer and VA dropped to CF TX: corneal scraping and culture and started on Vigamox qid Ø 12/9/2016: No worsening, Inserted PROKERA plus Ø 12/14/2016: Ulcer healed with VA:20/400; Culture + Pseudomonas Confidential property of tissuetech inc. Do not distribute. 4 mont hs 5 days 5

PROKERA utilizes the proprietary CryoTek cryopreservation process that maintains the active extracellular matrix of the amniotic membrane

PROKERA is the only FDA-cleared therapeutic device that both reduces inflammation and promotes scar less healing Contraindications Not to

PROKERA can be used for a wide number of ocular surface diseases with severity ranging from mild, moderate, to severe Insertion of

6 PROKERA utilizes the proprietary CryoTek cryopreservation process that maintains the active extracellular matrix of the amniotic membrane which uniquely allows for regenerative healing. PROKERA is the only FDA-cleared therapeutic device that both reduces inflammation and promotes scar less healing Contraindications Not to be used with patients with glaucoma filters! Allergies to Ciprofloxacin or Amphotericin B! PROKERA can be used for a wide number of ocular surface diseases with severity ranging from mild, moderate, to severe Insertion of Cryopreserved Amniotic Tissue Open package exposing contained Membrane Rinse with saline liberally (prevents stinging from preservation media Apply topical anesthesia Hold upper lid and have patient look down Insert into superior fornix Slide under lower eyelid Check for centration 6

Post-Treatment Protocol Continue medications Apply Temporary Tarsorrhaphy (PRN) - Tape - Tegaderm - Breathe-Right nasal strips CONFIDENTIAL AND PRIVILEGED

! Possible Tape Tarsorrhaphy How Long to Keep Membrane On Ideal 7 days 4 Days at mimimum Schedule on Monday Remove when VA clears How Long Do the Results Last?

Remember, 81% said that they would agree to have it again! What Does the Literature Say? Cheng, A., Zhao, D., Chen, R., et al.

7 Post-Treatment Protocol Continue medications Apply Temporary Tarsorrhaphy (PRN) - Tape - Tegaderm - Breathe-Right nasal strips CONFIDENTIAL AND PRIVILEGED Property of Bio-Tissue, Inc. Do not reproduce or distribute.! Possible Tape Tarsorrhaphy How Long to Keep Membrane On Ideal 7 days 4 Days at mimimum Schedule on Monday Remove when VA clears How Long Do the Results Last? v Mild cases: months v Moderate cases: 6-12 months v Severe cases: 3-6 months Set the patient s expectations that the procedure may need to be repeated. Remember, 81% said that they would agree to have it again! What Does the Literature Say? Cheng, A., Zhao, D., Chen, R., et al. Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane. Ocul Surf Jan;14(1): Chen, H. Pires, R. and Tseng, S. Amniotic membrane transplantation for severe neurotrophic corneal ulcers. Br J Ophthalmol Aug; 84(8):

PROKERA Removal Dehydrated Amniotic Membrane Topical Anesthetic

or forceps Ask the patient to look down Slide the PROKERA out with

Property of Bio-Tissue, Inc. Do not reproduce or distribute.

Spec the eyelids Apply topical anesthesia Denude 1-2 mm of

8 PROKERA Removal Dehydrated Amniotic Membrane Topical Anesthetic Pull the lower eyelid Lift the lower edge of PROKERA using a Q-tip or forceps Ask the patient to look down Slide the PROKERA out with gentle pressure on the upper eyelid CONFIDENTIAL AND PRIVILEGED Property of Bio-Tissue, Inc. Do not reproduce or distribute. Dehydrated Amniotic Membrane Technique Patient in supine position Spec the eyelids Apply topical anesthesia Denude 1-2 mm of epithelium surrounding defect with gentle blade or wek cell Step 1: Prep and Denude 8

Step 2: Placement of AmbioDisk Maintain dry ocular surface

traction, counter traction 1-2 mm over peripheral conj

18, 16 or 14mm BCL Non tooth forceps Center lens over

remove speculum Request several blinks Disregard small

Alternate Step 1: Prep and Denude Patient seated Apply topical

wek sponge < 10 minute procedure Alternate Step 2: Placement

surface of CL Center graft on CL Place IOP up Gently smooth

9 Step 2: Placement of AmbioDisk Maintain dry ocular surface Center graft on cornea Place IOP down Gently smooth using traction, counter traction 1-2 mm over peripheral conj Disregard small creases and bubbles Step 3: Placement of Lens 18, 16 or 14mm BCL Non tooth forceps Center lens over AmbioDisk Maintain centration of disk over cornea Gently remove speculum Request several blinks Disregard small bubbles, creases Apply appropriate meds Step 4: Finish Alternate Step 1: Prep and Denude Patient seated Apply topical anesthesia Denude 1-2 mm of epithelium surrounding defect with wek sponge < 10 minute procedure Alternate Step 2: Placement of AmbioDisk Alternate Step 3: Placement of Lens Dry back surface of CL Center graft on CL Place IOP up Gently smooth Disregard small creases and bubbles 18, 16 or 14mm BCL Insert CL w/ AmbioDisk Maintain centration over cornea 9

Alternate Step 4: Finish Additional steps

bubbles, creases Apply appropriate meds Fill

Demonstration AmbioDisk : Management Follow

healing Absorption: 7-14 days Rx: Doctor

Burn Clinical Case: Thermal Burn Presentation

10 Alternate Step 4: Finish Additional steps Request several blinks Disregard small bubbles, creases Apply appropriate meds Fill out paperwork < 10 minute procedure Video Demonstration AmbioDisk : Management Follow up: 48 hours AmbioDisk dissolves during healing Absorption: 7-14 days Rx: Doctor discretion, judgment Clinical Case: Thermal Burn Clinical Case: Thermal Burn Presentation 68 YO WM Hit in eye with hot welding rod Severe lineal thermal burn over central corneal 24 hours later Membrane in place Significant healing Patient pain free 10

Clinical Case: Thermal Burn Clinical Case: Corneal

completely resolved Minimal haze and scaring 20/25

corneal ulcer infection after work injury Hypopion

Case: Corneal Ulcer Clinical Case: Corneal Ulcer 2

Vision normalizing 20 day follow up Membrane

Case: Alkali Burn Clinical Case: Alkali Burn

clean a building Severe alkali burn Affecting 99%

re-epithelialized Small piece of membrane visible

11 Clinical Case: Thermal Burn Clinical Case: Corneal Ulcer 5 day follow up Membrane removed Wound completely resolved Minimal haze and scaring 20/25 uncorrected Presentation 54 YO HM w/ Severe corneal ulcer infection after work injury Hypopion Stromal haze Large defect Heavy staining Clinical Case: Corneal Ulcer Clinical Case: Corneal Ulcer 2 day follow up Membrane in place Haze clearing Vision normalizing 20 day follow up Membrane removed day 5 Haze cleared Vision normal Clinical Case: Alkali Burn Clinical Case: Alkali Burn Presentation 48 YO HM Using a pressure washer to clean a building Severe alkali burn Affecting 99% of cornea 11 day follow up Almost re-epithelialized Small piece of membrane visible upon removal of bandage lens Rinsed well Mild edema and swelling Minimal pain Near normal vision 11

28 day follow up Nearly resolved Minimal SPK 20/30 uncorrected acuity Clinical Case: Alkali Burn Self Retaining Amniotic Membrane Cost of Pro Kera Approximately $675 to $950 Cost of Bio Optix

12 28 day follow up Nearly resolved Minimal SPK 20/30 uncorrected acuity Clinical Case: Alkali Burn Self Retaining Amniotic Membrane Cost of Pro Kera Approximately $675 to $950 Cost of Bio Optix Approximately $600 Medicare Allowable Nevada $1520 Self Retaining Amniotic Membrane Sample Billing & Coding Per Patient CPT Bundled with supply V2790 supple code for non CMS Initial visit: (14)... $ $ PROKERA Procedure visit: First Eye: $1, Second Eye: $1, Follow-up (3 wks): $ Total $3, (Ophthalmological services): Medical examination and evaluation with initiation of diagnostic treatment program; comprehensive, new patient, one or more visits (Ophthalmological services): Medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, one or more visits Refraction External ocular photography with interpretation and report for documentation of medical progress (e.g., close-up photography, slit lamp photography, stereo-photography) (Ophthalmological services): Medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; intermediate, established patient. 0 Day Global CPT Code has a Zero Day Global Period What You Will Need Gloves Saline Solution Remove Protective Covering Retention Ring Rinse with Retaining Ring in Place Remove ProKera Rinse in Gloved Hand Determine Right Side Up Douglas K. Devries, O.D. Eye Care Associates of Nevada DrDevries@NVEyeLaser.com 12

Amniotic Membrane Workshop. Amniotic Membranes. Amniotic Membrane - Profile 5/9/2016. Advanced Recalcitrant PEK In Ocular Surface Disease

Amniotic Membrane Workshop. Amniotic Membranes. Amniotic Membrane - Profile 5/9/2016. Advanced Recalcitrant PEK In Ocular Surface Disease Amniotic Membrane Workshop William Townsend, OD, FAAO Walter O. Whitley, OD, MBA, FAAO Virginia Optometric Association Annual Meeting June 10-12, 2016 Advanced Recalcitrant PEK In Ocular Surface Disease