DBS & Retinal Implant Market Analysis

1. Deep Brain Stimulation – DBS(腦深層電刺激)
1
DBS Therapy uses a surgically
implanted medical device to
deliver mild electrical pulses
to precisely targeted areas of
the brain to treat the
symptoms of movement
disorders and other
neurological conditions.
MDT’s Activa PC
Neurostimulator

2. Deep Brain Market – Growing Opportunities
2
•Parkinson’s Disease
•Dystonia
•Essential Tremor
•Epilepsy
•Obsessive
Compulsive
Disorder(OCD)
FDA APPROVED
INDICATION
EMERGING
INDICATION
FUTURE
INDICATION
•Obesity1
•Depression
•Stoke Recovery
•Alzhelmer’s Disease
•Anxiety
•Bulimia Nervosa(暴食
症)
•Tinnitus (耳鳴)
•Traumatic Brain Injury
•Tourette’s Disease
•Sleep Disorders(睡眠障
礙)
Research and clinical studies are currently focused on expanding the
applicability of DBS to new disorders and conditions.
t
REVENUE
x1 x10 >x10
1. WW 600M Obesity estimated in 2014 http://www.who.int/mediacentre/factsheets/fs311/en/
2020 2025

3. FDA-approved DBS Market
3
A rise in the world’s aging population increase the number of patients living
with neurological movement disorders which now are the main causes of
mortality globally.
Parkinson’s Disease
(PD)
As many as 10 million
people worldwide are
living with Parkinson’s
disease. Approximately
60,000 Americans are
diagnosed with
Parkinson’s disease each
year, and the risk of
developing Parkinson’s
increases with age.
10M@W
W
Essential Tremor
Essential Tremor, a
neurological disorder
affecting an estimated
10 million Americans,
causes shaking that can
significantly impact
activities of daily living;
less than 60% of people
with essential tremor
respond well to standard
oral medications.
Obsessive-Compulsive
Disorder (OCD)
OCD affects about 2.2
million American adults,
with direct and indirect
costs of $8.4 billion,
which is 5.7% of the
estimated $147.8 billion
cost of all mental illness.
Epilepsy
About 50 million people
worldwide have
epilepsy, 30% or more of
whom may not be
treatable with standard
oral medications.
10M@U
S
2.2M@U
S
>50M@w
w
XXX may take lead
with leading
technology
Source: http://multimediacapsule.thomsonone.com/file/download/1616/RelatedDocuments/673

4. DBS Device Market Revenue Forecast (for PD)
4
Source http://www.transparencymarketresearch.com/deep-brain-stimulator-market.html
The global deep brain stimulation devices market was valued
at USD 1.79 billion in 2013 and is expected to grow at a CAGR of
8.9% from 2014 to 2020, to reach an estimated value of USD 3.21
billion in 2020. (by Transparency Market Research, 2015/2)

5. DBS Competition : 5 Forces Analysis
5
Competitive
Rivalry
Suppliers
Buyers
New Entrants
Substitutes
The market is dominated by established key players (MDT, STJ, and BSX) that
conduct extensive research for technological advancements.
Demand for high quality products such as programmable stimulators and
implantable pulse generator (IPG) limits the choice of manufacturers to
supply at minimal cost.
Market is oligopolistic with three major players dominating the market. This
provides limited options for buyers and thus lowers their bargaining power.
Strict regulatory standards set by the FDA may create barriers for new
entrants
Innovation of alternative treaXXXnt therapies and high cost of DBS devices
elevates the level of threat from substitutes.

6. 1. Replace not only the battery, but the whole IPG
2. The cost of battery replacement in all systems is roughly 80% of the
initial surgery
3. The replacement surgery risks; lead-connection problems, damaged
leads, and further risk of infection.
4. Average age of DBS patient is 60-65 year old  BSX’s 25 year battery
life means no replacement needed!
Why is battery-life of DBS so important ?
(但醫院與醫生不喜歡, 因為收入減少…)
6
1. An AC power-supply unit to charge the recharger.
2. A Recharger (the remote she has in her hand).
3. One antenna that connects from the recharger /
remote to the IPG via a ‘wand’(under the round bit
over her collar bone.
4. A waist belt and shoulder belt
DBS IPG comes with 4 accessories:
https://www.linkedin.com/pulse/20140711074717-134569387-the-parkinson-s-dbs-paper

7. Product Benchmark
7
XXX Medtronic ST Jude
Boston
Scientific
NeuroPace
Product XXXXXX Activa Libra Versice RNS
Intended Use Epilepsy
PD, dystonia,
OCD, Essential
Tremor, Epilepsy
PD
PD, Dystonia,
Essential Tremor
Epilepsy
IPG implant Chest Chest Chest Chest Beneath Scalp
Lead Implant Depth + Planar Depth Depth Depth Depth + Planar
External
Programmer
YES YES
iPad mini
iPod touch
YES No
Closed-loop Open-Loop Open-Loop Open-Loop Closed-loop
Contact 16 8 N/A 16 4
Power Supply
Wireless charging +
rechargeable
Battery(10year)
Rechargeable
Battery (RC – 9
year)
Primary
Battery (7year)
Rechargeable
Battery(25year)
Primary
Battery
Price (device
+ surgery cost)
US$XXK US50K(RC)??? N/A N/A US$40K
Regulatory
Status
N/A
FDA Approval
(1997)
CE Mark
(2013)
CE Mark
(2013)
FDA Approval
(2013)

8. Retinal Implant (人工視網膜晶片植入)
8
The Retinal Implant is
meant to partially restore
useful vision to people
who have lost their vision
due to degenerative eye
conditions such as retinitis
pigmentosa (RP)
or macular degeneration
By providing with low
resolution images by
electrically stimulating
surviving retinal cells, users
can restore specific visual
abilities, such as light
perception and object
recognition.
Second Sight’s Argus II solution

9. Retinal Degeneration – Cause of Blindness
9
Dysfunction or destroyed photoreceptor cells
Light

10. Targeting Retinal Diseases
10
Retinitis Pigmentosa - RP
(色素性視網膜炎 )
Age-related Macular
Degeneration –AMD
老年黃斑[視網膜中心視覺區]退化症
• Hereditary Genetic Disease
• Peripheral Rods degenerate
• Gradually progresses towards center of eye
• Spares the foveal region
• Tunnel vision results
•Genetically Related
•Cones in Macula region degenerate
•Loss or damage of central vision
•Peripheral Retina spared
•Common among old people
Loss of visual field
of 3-13% per year

11. Epi-retinal vs. Sub-retinal Stimulation
11

12.  High Social Cost of Blindness: Researchers at NORC at the University of
Chicago came out with a report that the cost of vision problems will
increase 376% from $150 billion today to $717 billion by 2050 in the
United States alone. 1
 Unfulfilled Requirement : Second Sight estimates the number of people
who are considered legally blind from RP, AMD and others in 2015 2, but
only with around 100 cases implanted in 2015.
Opportunity of Retinal Implant Market
121: http://www.preventblindness.org/cost-vision-problems-reach-717-billion-2050
2. http://seekingalpha.com/article/3069126-a-recent-ipo-with-a-medical-breakthrough-for-blindness-worth-billions &
http://www.forbes.com/sites/greatspeculations/2015/06/05/why-reimbursement-wins-for-argus-ii-keep-me-bullish-on-second-sight/

13. VisOn Product Benchmark
13
XXX
Second
Sight
Pixium Vision
Retina
Implant
Nano
Retina
Origin Taiwan US France German Israel
IPO TBD 2014/11 2014/6 N/A N/A
Market Cap. TBD $450m €85.5m N/A N/A
Patent
XX(granted)
XX(pending)
300(granted)
150(pending)
N/A N/A N/A
Product XXXX Argus II IRIS PRIMA Alpha IMS Bio-retina
Pixel 256 60 50~150 5000(?) 16 576
Implement
Approach
Sub Epi Epi Sub Sub Epi
Regulatory
Status
N/A
CE Mark:
2011/2
FDA HDE:
2013/2
CE Mark:
2017/E
N/A
CE Mark:
2013/7
N/A
Power supply IR RF(Coil ) RF(Coil) IR RF(Coil) IR Laser
Pricing US$XXK US$145K1 US$110K N/A US$130K $60K
1. Reimbursement of Argus II is around 100K in France, German, US
Check patent search status
Needed

14. Clinical Training Center – Key Successful Factor for
Business Growth (or bottleneck?)
Regional Clinical
Training Center
Patient
Fulfillment
1. Surgery Capacity: Develop
sufficient amount of
practitioners/ doctors locally
2. Awareness / Promotion:
Increase public awareness of
biotech therapy and increase
adoption
3. Regional Clinical Trial: Local
hospital cooperation to
accelerate FDA approval
process
Asia
Pacific
EU
US

15. Summary : Winning Strategies of XXX
15
Innovations
 Leverage
Innovative IC
design &
manufacturing
resources in Taiwan
 Collaborate with
R&D research units
to focus on
creating innovative
products with long
battery life,
miniaturized
design, and no side
effect.
1
Manufacturing
Outsourcing
 Leverage qualified
manufacturing
services provided
by ODM/EMS in
Taiwan & China in
order to curb costs
while focusing on
the development
of new and
advanced
technologies.
2
Public & Professional
Awareness
 Arrange global and
local promotional
campaigns via
regional clinical
training centers
that especially
target healthcare
professionals,
practitioners,
doctors, primary
care physicians,
specialists,
economists, and
media.
3
WW Medical ecosystem
connection
 To accelerate
penetration in
established and
developed markets
with medical
ecosystem
connection via
government
support and
hospital
networking.
4

16. BACKUP
16

17.  Lift Labs專門開發供帕金森氏症病患使用的穩定裝置
 Google表示，Lift Labs所開發的消除顫抖的裝置能夠改善數百萬人們的生
活品質，Google準備研究該技術是否能有其他應用，以進一步了解及管理
有關神經退化性的各種疾病，Lift Labs團隊將加入發展各種新興技術的
Google X部門。
Google Buys Lift Labs in Further Biotech Push
(2014/9)
17
Source: http://bits.blogs.nytimes.com/2014/09/10/google-buys-lift-labs-in-further-biotech-push/?_r=0
Google has bought Lift Labs, a San Francisco company that makes a high-tech spoon
designed to make it easier for people with neurodegenerative tremors (e.g. Parkinson’s
Disease) to eat, the latest in a growing list of moves the search giant has made into
biotech.