Biolux Research - Evaluation Program 082014

Transcription

OrthoPulse
TM
Light Accelerated Orthodontics
Evaluation Program
Copyright Biolux Research Holdings Ltd @ 2014
All Rights Reserved - Confidential & Draft
QUICK START
1
How to Use OrthoPulse™
2
Registering as an Evaluator
3
Familiarizing yourself with the
Evaluation and Documents 4
The OrthoPulse™ App
!
5
Starting Patients with OrthoPulse™
!
OrthoPulse™
6
Sharing Clinical Data with Biolux
7
Clinical Recommendations
2
5 STARTING PATIENTS WITH ORTHOPULSE™
1
Add new patient to the app
The patient will receive an email instructing
them on how to download and use the app
!
3
!
Ensure OrthoPulse™ is fully
charged
We recommend to charge OrthoPulse™
for a minimum of 3 hours before assigning to
a patient and before using.
!
2
Fill in all required patient
information
!
!
OrthoPulse™
!
!
4
!
Demo how to use OrthoPulse™,
walk through the Quick Start &
User Guide, and introduce
status light definitions to your
patient
!
!
!
3
5
Have the patient complete
one full treatment
5 minutes upper and 5 minutes lower,
while in the chair.
!
7
Pulsing purple indicates OrthoPulse™ is syncing
!
!
Click Settings and select Pair
Device.
!
!
!
!
6
Place the device on the
charging case to initiate
Bluetooth
!
OrthoPulse™
8
!
Check to see that the
treatment was logged
Swipe the screen on the app to the left to
show the Treatment Log.
!
4
Let patient know that they
should have received the
OrthoPulse™ Welcome email.
9
11
We recommend you to help the patient
download and sync the device at your practice.
Remind the patient to consult
Quick Start & User Guide
when they get home. !
!
!
!
!
10
! patient does not have
If the
access to an iOS7 device,
instruct them to bring their
OrthoPulse™ to every
appointment so that it may be
synced.
12
Devices have a limited memory and can store
data for up to approximately 60 days. Syncing
is crucial for archiving complete treatment
history and tracking compliance.
!
OrthoPulse™
!
!
!
!
!
Remind the patient to contact
[email protected]
if they have any questions or concerns about
OrthoPulse™ or the app. We also welcome
their suggestions. Their comments are
considered, immediately, and extremely
helpful.
!
!
!
!
!
!
5
6 SHARING CLINICAL DATA WITH ORTHOPULSE™
1
Login to your
OrthoPulse™ Profile
page
!
orthopulse.com/profile
Once a patients is added to the app, they will automatically be added to the
OrthoPulse™ Profile page, providing you with the ability to upload photos and
x-rays so these may be shared with Biolux Research. !
!
!
2
Add initial, intermediate and
! records
final photos and
as each patient! progresses
through treatment. !
Successful uploads will be indicated by a checkmark. !
!
OrthoPulse™
6
7 CLINICAL RECOMMENDATION
OrthoPulse™ treatment accelerates the
biology of orthodontic tooth movement. For optimum reduction of treatment time, light and continuous forces
should be maintained throughout orthodontic treatment.
• This may require clinical protocol and appointment scheduling modifications. !
!
OrthoPulse™
7
ORTHOPULSE™
LIGHT ACCELERATED ORTHODONTICS
OrthoPulse™
8
KNOWN PHOTOBIOMODULATION MECHANISMS
1
Mitochondrial chromophores
(inc. Cytochrome C Oxidase)
!
absorb photons, proton
pumping and ATP production
!
2
3
Increased energy available to the cell ->
increased / normalized metabolism
!
Reactive Oxygen Species
!
(ROS) production and
!
mitochondrial signalling
Stimulates/suppresses transcription factors, DNA/RNA synthesis ->
plethora of tissue/cellular activity
Inducible Nitric Oxide (NO)
production through
!
absorption of !photons by
Nitric Oxide Synthase
!
!
!
Increased micro and regional blood flow and osteoclastic activity
!
!
Download the OrthoPulse™ Clinical and Scientific Dossier
orthopulse.com/dossier.pdf
OrthoPulse™
9
PHOTOBIOMODULATION AND ENHANCEMENT
OF ORTHODONTICS IN ANIMAL MODELS (54+ ARTICLES)
!
!
!
!
•
Kawasaki and Shimizu, 2000 concluded that the low energy laser irradiation can accelerate
tooth movement accompanied with alveolar bone remodelling in the rat model.
!
•
The same effects were observed when the LLL therapy was applied to the rabbit model.
Zhu et al, 2001
!
•
Fujita et al, 2008 demonstrated that laser irradiation stimulates the velocity of tooth
movement via induction of RANK and RANKL in rats.
!
•
Increased expression of fibronectin and Type I collagen in LLL tooth movement in rats.
Kim et al, 2008
!
•
LLLT accelerates the velocity of tooth movement via stimulation of the alveolar bone
remodelling in rats. Yoshida et al, 2009
!
•
OrthoPulse™
LLLT facilitates the velocity of tooth movement and MMP-9, cathepsin K, and integrin
subunits of alpha(v)beta3 expression in rats. Yamaguchi at al, 2010
10
POSITIVE EFFECTS OF PHOTOBIOMODULATION
ON HUMAN ORTHODONTIC TOOTH MOVEMENT
!
!
!
!
•
Increased velocity (by 2.0 fold) of canine movement (N=15) and decreased pain in lased
group (809nm). 0,3,7,14 day exposure monthly. Youssef et al. (2008).
!
•
Significantly higher acceleration (by 1.3 fold) of the retraction of treated (780nm)
canines (N=11). 0,3,7,14 exposure monthly. Cruz et al. (2004).
!
•
Laser irradiated canines moved significantly faster (by 1.9 fold) than that of the nonirradiated group (p<0.05). Sousa et al. (2011).
!
•
OrthoPulse™
An average increase (by 30%) in the rate of tooth movement found for the low-intensity
laser therapy group (p<0.05). Mehta & Patil (2012).
11
PUBLISHED in vivo EVIDENCE
✓ 46% acceleration of tooth movement in 620nm treated animals
✓ 80% less root resorption in 620nm treated animals
Ekizer et al. Effect of LED-mediated-photobiomodulation therapy on orthodontic tooth movement
and root resorption in rats. Laser Med Sci., 2012 Aug 29.
!
✓ Significantly more mature bone in expanded suture of LED treated rats
Ekizer A et al. Light-emitting diode photobiomodulation: effect on bone formation in
orthopedically expanded suture in rats-early bone changes. Lasers Med Sci., 2012 Nov 9.
!
✓ Significantly lower failure rate of immediately loaded TADs with 620nm
Uysal T et al. Resonance frequency analysis of orthodontic miniscrews subjected to light-emitting
diode photobiomodulation therapy. European Journal Orthodontics 2012 Feb; 34(1):44-51.
!
OrthoPulse™
!
12
ORTHOPULSE™ in vivo EVIDENCE
SUBMITTED FOR PUBLICATION - UNDER REVIEW
!
!
!
!
Photobiomodulation-induced tooth movement using extra-oral
transcutaneous phototherapy utilizing Red LED (625nm) radiation
versus nIR-Laser (855nm) radiation on the rat periodontium and on
orthodontic tooth movement
!
!
Susanne Chiari1,2, Susan S. Baloul1,3, Emilie Goguet-Surmenian1, Thomas E. Van
Dyke1, Alpdogan Kantarci1
!
1
Boston University Goldman School of Dental
! Medicine,
Department of Periodontology and Oral Biology, Boston MA USA
!
2
!
3
36 healthy CRL-CD male rats:
• 5 groups of 6 rats (experimental)
• 1 group of 6 rats (baseline)
OrthoPulse™
University of Vienna, Department of Orthodontics, Vienna, Austria
Boston University Goldman School of Dental Medicine,
Department of Orthodontics, Boston MA USA
✓ Light treated animals showed 2.8 - 3.7 fold increase in
tooth movement compared to control
13
ORTHOPULSE™ (EXTRA-ORAL PROTOTYPE) PUBLISHED CLINICAL EVIDENCE
✓ 2.3x faster alignment rate versus control
Kau et al. Photobiomodulation accelerates orthodontic alignment in the early phase of
treatment. Progress in Orthodontics 14:30. 2013
!
✓ No negative effect on root resorption
Nimeri et al. The effect of photobiomodulation on root resorption during orthodontic
treatment. Clin Cosmet Investig Dent. 6:1-8.
!
✓ ~35% reduction in overall treatment time
!
OrthoPulse™
Multi-centre trials IP (N=30) (in progress)
!
!
!
!
14
CURRENT CLINICAL STUDIES AND TRIALS IN PROGRESS
Investigator / Institution!
TS1.5 Tim Shaughnessy
Suwanee, GA, USA!
Completed
(n=11 of 11)!
Pilot: Non-extraction. Alignment and total Tx time, (CTB and SLB) Adolescent
& Adult. Submitted for publication. Under review.!
TS2 Tim Shaughnessy
Suwanee, GA
Univ Alabama and Forsyth Institute,
USA!
IP (n=26 of 30)!
RCT Pivotal: Non-extraction. Alignment and total Tx time, Root integrity & Pain
evaluation. Sham Controls. (CTB) Adolescent.!
EUC2 Said Samara & Don Ferguson Completed
European University College Dubai, (n=60 of 60)!
UAE!
RCT: Extraction. Velocity of space closure in en-masse retraction. (Passive
SLB) Adolescent & Adult. Manuscript in preparation.!
MC Peerapong Santiwong
Mahidol Univ., Bangkok, Thailand !
IP (n=42 of 45)!
RCT: Non-Extraction. Alignment and total Tx time, Bone Quality and Root
integrity eval CBCT (Passive SLB) Adult and Adolescent.!
TS3 Tim Shaughnessy
Suwanee, GA, USA
IP (n=25 of 30)!
Case series. Total Tx time. Adolescents and Adults. (Mixed brackets and
mechanics)!
KHU1 Young Guk Park & Min Ki Noh, IP (n=40 of 45)!
Kyung Hee U., South Korea
OrthoPulse™
Clinical Trials
Focus of Study!
Status /
Enrolled
RCT: Effect of OrthoPulse™ on the rate of retraction en-masse 6 anterior teeth!
15
CURRENT CLINICAL STUDIES AND TRIALS IN PROGRESS
Investigator / Institution!
OrthoPulse™
Clinical Trials
Focus of Study!
Status /
Enrolled!
BX8
Marc Lemchen, NYC, NY
Tito Norris, San Antonio, TX
Tim Shaughnessy, Suwanee, GA
!
IP (n= 55 of 100)! Case Series: Beta OrthoPulse™ evaluation and assess clinical effectiveness. !
TD1/TD2
Todd Dickerson, Phoenix, AZ!
!
Completed
(n=12 of 12)!
Pilot Study: Efficacy of OrthoPulse™ and Invisalign® treatments. !
Cross-over design.!
!
TD3
!
IP (n= 4 of 10)!
RCT: Effect of OrthoPulse™ on aligner change rate during Invisalign®
treatment. Cross-over design.!
TD4
IP (n= 2 of 28)!
RCT: Effect of OrthoPulse™ on total Invisalign® treatment time.!
UAB2 !
Chung How Kau, University of
Alabama at Birmingham, AL!
IP (n= 0 of 40!
RCT: Effect of OrthoPulse™ on treatment timeline with clear aligners.!
EUC3
Don Ferguson et al.
European University College Dubai,
UAE!
IP (n=0 of 40)!
RCT Pivotal: Non-extraction. Alignment and total Tx time, Root integrity & Pain
evaluation. Sham Controls. (CTB) Adolescent.!
!
16
INTRA-ORAL PHOTOBIOMODULATION INDUCED ORTHODONTIC TOOTH ALIGNMENT: PILOT FEASIBILITY STUDY
SUBMITTED FOR PUBLICATION (UNDER REVIEW)
!
!
!
!
Measure
Alignment
Rates
Days to
Alignment
Group Arch N Mean
SD
Min
Max Difference P-Value
10
0.20
0.19
0.83
Control
0.44
Intraoral
18
1.27
0.53
0.24
2.06
Control
10
104
55
42
204
Intraoral
18
48
39
17
164
Control
10
5.77
1.57
3.70
8.80
Starting LII
Intraoral
18
7.27
2.99
3.72
14.58
186.3%
53.6%
26.0%
0.0002
Intra-oral photobiomodulation induced orthodontic
tooth alignment: pilot feasibility study
!
0.0049
Tim
! Shaughnessy et al.1
1
! USA
Private practice, Suwannee, GA,
N.S
✓ OrthoPulse™ treated arches exhibit significantly faster alignment rates
(186% faster), and reduces days to alignment by over 50% when
compared to conventional methods.
OrthoPulse™
17
PILOT: OPTIMIZING INVISALIGN® AND ORTHOPULSE TREATMENT
PI: TODD DICKERSON, PHOENIX, AZ
!
!
INTERIM RESULTS
!
!
N=12
Design: Crossover Study
Method: Determine optimal aligner switching intervals based on patients’ subjective
daily analysis of pain, aligner fit and pressure and air gap presence.
!
Every day, patients assess:
A) pain levels: rated 1-3
B) aligner fit/pressure on teeth: rated 1-3
C) air gaps present: rated 1-3
!
Patients progress into the subsequent aligner when:
A) pain = 1
B) aligner fit = 1
C) no air gaps
!
!
!
!
OrthoPulse™
!
18
!
!
!
•
INTERIM RESULTS
!
Patients received intervention period of 10- and 20-minute OrthoPulse™
treatment a day while progressing through a number of aligners.
!
•
The average number of days in aligners for each OrthoPulse™ intervention is
determined .
!
•
% reduction of the average number of days in aligners is compared to
conventional Invisalign aligner change frequency
!
!
OrthoPulse™
19
INTERIM RESULTS
!
!
!
!
Days in Each Aligner for TD1-004 (OrthoPulse Intervention)
Aligner2525@@Day
Day88
88
Aligner
(OrthoPulse
iO X1 Intervention)
10min/day
15
Aligner
Day3232
Aligner
88
@@Day
(OrthoPulse
iO X2 Intervention)
20min/day
10
No Pain
7 7
6
5
Days in Aligner
Worst Imaginable Pain
6
5
5
4
4
3
4 4
3
0
4
4
4
4
4
3
2 2
1 1
5
3
2
1
1
22 2
2
1 1
4
3
3
2
1
2 2 2 2
3 3
2
1
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
Aligner #
OrthoPulse™
20
INTERIM RESULTS
!
!
!
!
9"
68"
99"
p-value
66%"
0.000"
69%"
0.000"
80.0
from standard
66%*%
69%*%
✓ OrthoPulse™ reduced aligner
switching durations 66-69% compared
to Invisalign® standard (p=0.000).
OrthoPulse™
0.0
20.0
OrthoPulse™,20min/day,
8"
# of
Percentage Reductions (%)
aligners
60.0
OrthoPulse™,10min/day,
Patient N
40.0
Intervention Type
100.0
Percent Reduction from Conventional Invisalign Prescription
Prescribed
Standard!
!
!
Means
iOx1
10min/day! !
!
!
iOx2
20min/day
+/- 1 Standard Deviation
* = p(z) < 0.05 two-tailed t-tests used to assess H0: Percentage Reduction = 1
21
OVERALL TREATMENT TIMES
COMPLETED ORTHOPULSE™ PATIENTS
!
!
!
!
Patient ID
Age
Sex
Est Tx Time
Actual Tx Time
% Reduction
Mechanics
TS1.5-001
13
M
24 mo
10 mo, 11 days
57%
Fixed
TS1.5-004
13
F
20 mo
13 mo, 12 days
33%
Fixed
TS1.5-010
13
F
20 mo
10 mo, 11 days
48%
Fixed
TS3-002
51
M
18 mo
11 mo, 15 days
39%
Fixed
TS3-006
30.9
F
30 mo
13 mo, 24 days
54%
Fixed
TS3-007
13.9
M
24 mo
13 mo, 1 day
45%
Fixed
TS2-004
13.8
F
21 mo
12 mo, 24 days
61%
Fixed
BX8ML-001
44
F
15 mo
5 mo, 23 days
62%
Invisalign
BX8ML-019
49.2
F
15 mo
4 mo, 24 days
68%
Invisalign
BX8RN-001
15
M
18 mo
5 mo, 21 days
63%
Fixed
BX8RN-002
39.4
M
20 mo
6 mo, 27 days
66%
Fixed
BX8RN-005
16.2
F
12 mo
7 mo, 9 days
39%
Fixed
BX8TD-011
24.1
F
18 mo
3 mo, 18 days
65%
Invisalign
19.6 mo
9.3 mo
54%
✓ OrthoPulse™ treated patients show average 54% reduction in overall
treatment time compared to estimated conventional treatment times.
OrthoPulse™
22
ORTHOPULSE™ CLINICAL ADVANTAGES
1
2
3
Photobiomodulation increases
energy production (ATP) in
stressed cells and tissue.
No change in Doctor’s
preferences or clinical
techniques
!
!
!
!
Photobiomodulation accelerates
bone and soft tissue
remodelling process.
There may be optimization
through the use of modified
mechanics and protocols
!
!
!
!
Non-specific: ALL cells and
tissues benefit
Non-invasive, drug-free and
extremely low risk profile
(Class II device)
!
!
4
5
6
7
!
Works with any orthodontic
system - technique independent
!
Scientifically proven effect and
mechanisms understood
!
8
!
!
OrthoPulse™
23
ORTHOPULSE™
OrthoPulse™
24
ORTHOPULSE™
✓ Microprocessor controlled
•
•
Continuous monitoring of internal device state (temps, errors etc.)
Logs all activity for upload and sync to App and Cloud
!
✓Made in Canada by global leader of medical and electronic
device manufacturer
•
•
•
!
OrthoPulse™
Ultrasonically welded parts
Highest durability and biocompatible implantable medical grade
silicone mouthpiece
Flexible and conforms to all dental arches
!
!
25
PATIENT BENEFITS
✓Easy, comfortable daily 10min intra-oral
treatment
!
✓Comfortable soft medical grade silicone
appliance
!
✓Lockable charging case with induction
charging for convenience and easy travel.
!
✓iOS app for patient tracking of Tx,
incentives for compliance
!
OrthoPulse™
26
ORTHODONTIST BENEFITS
✓No fitting or adjustments required
!
✓Ready to use “out of the box”, no device
set-up or assembly
!
✓Easily delegable to auxiliaries
!
✓Fast pairing of device with iOS app
!
✓Auto-compliance monitoring
!
✓Practice differentiator
!
!
OrthoPulse™
27
ORTHOPULSE™ APP
1
Distinct doctor app with
OrthoPulse™ patients’
compliance at a glance.
2
Tracking of the overall patient’s
treatment consistency and
percentage compliance.
!
OrthoPulse™
3
Detailed treatment log
to track individual selftreatment sessions
28
ORTHOPULSE™ APP
OrthoPulse™
29
LIGHT ACCELERATED ORTHODONTICS™
CLINICAL GUIDELINES
!
!
!
!
OrthoPulse™ treatment accelerates the
biology of orthodontic tooth movement.
For optimum reduction of treatment time
• Maintaining light, continuous forces throughout
orthodontic treatment may require clinical protocol
and appointment scheduling modifications.
!
!
OrthoPulse™
30
INVISALIGN®
CLINICAL GUIDELINES
!
!
!
!
•
OrthoPulse™ treatment accelerates the rate of orthodontic tooth movement so
aligners will become passive sooner, and tooth movement will stop.
!
•
Therefore requires patients advancing earlier to the next aligner.
!
•
Compliance is crucial
•
•
!
!
Invisalign® wear 22+ hours/day
Daily OrthoPulse™ treatment - no missed treatments
!
Rx: 7-day aligners
Rx: 14-day aligners
!
•
!
Recommend patients switch aligners
every 3 or 4 days
•
Recommend patients switch aligners
every 6 or 7 days
✓ Suggested guidelines are a subject to clinician’s discretion based on the individual patient
treatment plan, biology and confirmation of Invisalign® tracking.
OrthoPulse™
31
FIXED APPLIANCES
CLINICAL GUIDELINES
!
!
!
!
✓ Teeth move quicker, alignment occurs sooner, therefore to maintaining light
continuous forces throughout orthodontic treatment requires changing arch
wires more quickly and shorter intervals during the levelling and alignment phase.
Space closure
Intervals between orthodontic visits
!
!
•
During rapid alignment phase, recommend
more frequent visits every 2-3 weeks in
order to advance to next larger wire size.
•
!
•
Once alignment is achieved you can go to
your customary treatment visits.
!
Sliding mechanics optimal. Closing loops to be
avoided as accelerated tooth movement will
decrease focus rapidly and become passive
unless you activate more frequently.
!
!
!
!
!
OrthoPulse™
32
CLINICAL INVESTIGATOR TIPS AND TECHNIQUES
✓ Set expectations for patients early.
!
✓ Be sure patients fully understand that the compliance is crucial. If they “fall off the wagon” and do not use
OrthoPulse™ and their appliances they may be dismissed from the evaluation.
!
✓ Take photos of aligners in the mouth if they start not to track.
!
✓ Mention that the treatment is safe and has been used in orthopaedics and wound healing.
!
✓ Patient selection - choose highly motivated patients.
!
✓ Take photos more frequently of patient’s progress.
!
✓ If your patients experience OrthoPulse™ device issues as bugs can occur on occasion with any new
technology, please contact Biolux as we would like to avoid interruption in treatment progress.
[email protected]
OrthoPulse™
33
ORTHOPULSE™ SSG1 EVALUATION TIMELINE
Doctor Registration
Doctor license copy and a
CV are required for ethics
approval by IRB Services Inc.
to register for SSG1
evaluation.
Patient Enrolment
3 patients to be enrolled
within 30 days of receiving
the devices.
!
3 Patients
to be added to the
OrthoPulse™ app
Welcome Email to register
and download the app
August
Webinar
Post webinar, all
participants will receive
a welcome email to
register for an
OrthoPulse™ doctor
profile.
OrthoPulse™
Analytics
Data collection and analysis
!
!
Doctor & Patient Surveys
to be completed
est.
2015 Q1
September
!
3 OrthoPulse™ Devices
at no charge
Records
for each case to be submitted
Devices at no charge
Initial, interim, final records
Upon completion of the
registration, Biolux will send
the doctor 3 devices.
!
Using your doctor profile web page
submit your patient records.
!
FDA Approval
Sales in the U.S.
!
!
34
MARKET SURVEYS - AJO DO
URIBE F, PADALA S, ALLAREDDY V, NANDA R. AM J ORTHOD DENTOFACIAL ORTHOP. 2014 APR;145(4 SUPPL):S65-73
!
!
!
!
Patients’, parents’, and orthodontists’ perceptions of the need for
and costs of additional procedures to reduce treatment time.
• Electronic surveyed 683 AAO members 70%
orthodontists interested in adopting procedures
to reduce treatment time
!
• 50% reduction in treatment time, the majority
were willing to pay 50% more in treatment fees
!
!
!
OrthoPulse™
35
MARKET SURVEYS - IPSOS - ASI
ONLINE QUANTITATIVE SURVEY - MAY 2014
!
!
!
!
3
groups
•
•
all 3 groups were very interested in OrthoPulse™ 10 minutes
per day self-treatment at home.
most respondents are interested because of the convenience
of OrthoPulse™ being quick and simple
!
!
$1,000$2,000
• respondents were willing to pay based on 50% or 67%
reduction in time
• > 50% would prefer to pay a monthly payment for the
OrthoPulse™ premium
• 86% considering ortho treatment expect to use clear aligners
Survey sampling
•
•
•
•
N=252
Group 1: Considering orthodontic treatment
Group 2: Currently in orthodontic treatment
Group 3: Completed orthodontic treatment
in last 5 years or less
!
OrthoPulse™
18-34
• undergoing treatment are more willing to pay $2,000
premium for the time reduction
years old
36
ORTHOPULSE™ NET PRICE / PATIENT PREMIUM
• Post FDA Approval commercial product
!
• OrthoPulse™ online ordering: www.orthopulse.com
!
• OrthoPulse™ $979 net price includes:
1) OrthoPulse™ App – Patient Motivation / Compliance Tracking System
2) FedEx Just-in-Time delivery
• Two day FedEx
• Shipping included
!
• OrthoPulse™ Patient Premium up to $500.00
!
• Orthodontic fee for fixed or clear aligners + $1495 = _____
!
!
!
!
!
!
OrthoPulse™
37
QUESTIONS & ANSWERS
OrthoPulse™
38
THANK YOU!
Contact:
John Nabors
VP of Global Sales and Marketing
!
[email protected]
orthopulse.com
!
Support
[email protected]
!
!
OrthoPulse™
39

Biolux Research - Evaluation Program 082014

Transcription

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