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