REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural...

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Transcript of REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural...

Page 1: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard
Page 2: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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REINTRODUCING AMNIOVISCTM

Novel, Targeted Regenerative Therapeutic

• The most studied amnio viscosupplement to date

• 275-patient study

• Excellent outcomes - lasting safe pain relief

• Less adverse events than standard of care Hyaluronic Acid (HA) viscosupplements

• Patent pending

Page 3: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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OTHER OSTEOARTHRITIS (OA) THERAPIES

TYPE EFFICACY TOXICITY

Oral

Acetaminophen Limited Pain Relief Liver / GI

NSAIDs Limited Pain Relief GI / Cardiovascular

COX II inhibitors Limited Pain Relief Cardiovascular

Duloxetine Limited Pain Relief Suicidality / Liver

Opioids Limited Pain Relief Addiction, Fracture (elderly),

Cardiovascular, Mortality

Intra-articular

(joint

injections)

Steroids Pain Relief ends

after 2-4 weeks Generally well tolerated

*Synthetic Hyaluronic Acid

(HA) Visco Supplements

Similar to placebo in

controlled clinical studies Generally well tolerated

*American Academy of Orthopedic Surgeons guidelines (2013): “cannot recommend using HA” for “lack of efficacy”¹

Inadequate options and many serious side effects

Page 4: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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AMNIOVISCTM BENEFITS

The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints

• Step Change Improvement over standard of care Hyaluronic Acid (HA) viscosupplements

• Longer lasting

• More pain relief: 54% pain reduction at 6 months vs. only 32% with Synvisc

• Better for the diseased joint. HA + essential nutrients, 4 anti-inflammatory cytokines, and ability to restore the joint’s natural PH

• Immune-privileged amniotic fluid - no inflammatory reaction

• Single injection

• Lower adverse events profile than standard of care HA

• Value proposition: same procedure, same dose, a viscosupplement - BUT longer, better, safer pain relief

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AMNIOVISCTM IRB-CONTROLLED STUDY

Protocol-Driven Clinical Study

AmnioVisc Clinical Study (n=275) 4ml, single-dose knee injection

23 clinical sites in the U.S.

Study Objectives:

Determine whether AmnioViscTM is safe and well

tolerated and demonstrates superiority to

synthetic viscosupplements -- both in magnitude

and duration of pain relief at 6 months.

Pain Measurement (WOMAC Scale)

Pain: 0 = none / 500 = as bad as imaginable Pre-treatment Baseline Pain: 212

Stiffness: 0 = none / 200 = as bad as imaginable Pre-treatment Baseline Stiffness: 98

Difficulty: 0 = none / 1700 = as bad as imaginable Pre-treatment Baseline Difficulty: 733

Combined Scale: 0 - 2400 Pre-Treatment Baseline: 1051

• 30-day follow-up: n=241

• 90-day follow-up: n=162

• 180-day follow-up: n=63

• 4-Week Pain Diary: n=176

Page 6: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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AMNIOVISCTM PATIENT DATA

Suggests rapid, powerful and durable pain relief

0%

10%

20%

30%

40%

50%

60%

70%

80%

2 Weeks 30 days 90 days 180 days

29%

46% 44%

52%

61%

75% 78%

67%

44%

56% 48%

67%

78%

71%

WO

MA

C

% S

co

re I

mp

rove

me

nt

WOMAC Pain>75% Improved WOMAC Pain>40% Improved

WOMAC Stiffness>75% Improved WOMAC Stiffness>40% Improved

WOMAC

Pain WOMAC

Pain WOMAC

Pain WOMAC

Pain WOMAC Stiffness

WOMAC Stiffness

WOMAC Stiffness

Page 7: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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AMNIOVISCTM PATIENT DATA

Suggests rapid, powerful and durable pain relief

0.0% 12.5%

58.2%

63.2% 56.8%

0%

10%

20%

30%

40%

50%

60%

70%

80%

T-0 14 days 30 days 3 months 6 months

0.0%

47.7%

60.2%

60.1% 54.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

T-0 14 days 30 days 3 months 6 months

VAS % Average Pain Improvement WOMAC % Average Pain Improvement

Page 8: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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AMNIOVISCTM = LESS PAIN

Consistent across both WOMAC and VAS Scales

56.8% 58.3% 51.8% 51.0

[VALUE] [VALUE] [VALUE]

0

10

20

30

40

50

60

Baseline 30 days 3 months 6 months

0%

10%

20%

30%

40%

50%

60%

70%

VA

S S

co

re

Pe

rce

nt

Imp

rov

em

en

t Avg Improvement VAS Score

Time from Single Injection

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AMNIOVISCTM = LESS DIFFICULTY

0.0%

59.6% 60.2%

53.1%

[VALUE]

255 [VALUE] [VALUE]

-

100

200

300

400

500

600

700

Baseline 30 days 3 months 6 months

0%

10%

20%

30%

40%

50%

60%

70%Avg Improvement WOMAC Difficulty Score

WO

MA

C D

iffic

ulty

Sc

ore

Time from Single Injection

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AMNIOVISCTM STUDY EFFICACY RESULTS

Demonstrate advantages over SOC HA injections

0%

10%

20%

30%

40%

50%

60%

70%

80%

AmnioVisc MonoVisc OrthoVisc

78%

62%

50%

Percent of Patients with > 40%

Pain Improvement at 90 days

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

AmnioVisc SynVisc One

54.1%

33.8%

Average Pain Reduction at

6 Months WOMAC Score

TM TM

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PRICING RESEARCH AND COSTS

To patient/insurance for OA treatment SOCs

COMMONLY USED TREATMENTS FOR OSTEOARTHRITIS OF THE JOINTS

CLASS SELECTED PRODUCTS MONTHLY

COST 3-MONTH COST ANNUAL COST

NSAIDs Celecoxib (200 mg) $221.99 $ 665.97 $2,663.88

SNRIs Duloxetine (30mg) $215.37 $ 646.11 $2,584.44

HA Injections

Synvisc / Synvisc One

(3/1 injection(s)

/ 6 months) $96.98

$575.86

(6mo) $1,151.72

Opioids Celecoxib (200 mg) $221.99 $ 665.97 $2,663.88

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AMNIOVISCTM PRODUCTS AND PRICING

AmnioViscTM Products

PRODUCT # PRODUCT DESCRIPTION DETAILS

AV-0.5 AmnioViscTM 0.5ml

AV-1.0 AmnioViscTM 1.0ml

AV-2.0 AmnioViscTM 2.0ml

AV-2.5 AmnioViscTM 2.5ml

AV-4.0 AmnioViscTM 4.0ml

Page 13: REINTRODUCING A - Lattice Biologics4 AMNIOVISCTM BENEFITS The first regenerative, all natural viscosupplement for Osteoarthritis of ALL joints •Step Change Improvement over standard

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Lattice Biologics Ltd. 16701 N 90th Street, Suite 101, Scottsdale, AZ 85260

Guy Cook - CEO | [email protected]

Cheryl Farmer - CFO | [email protected]

Email to order: [email protected]

Call for more information: 1-855-286-8088 (TOLL FREE)