The document outlines plans to develop and launch a line of medical devices and mobile applications to treat sensorineural hearing loss and tinnitus using a proprietary technology called Audioselective Transcranial Electric Stimulation (ATES). Clinical trials showed ATES improved hearing in 67-89% of patients and reduced tinnitus symptoms in 91% of patients. The proposed business model and market analysis indicate the ATES devices could generate over $21 million in sales revenue within 6 years by targeting the growing markets for hearing aids and mobile medical devices.
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1. TES MOBILE
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Development, creation and
international launch of a line
of medical devices
to treat sensorineural hearing loss
and tinnitus
2. SUMMARY
Project aim: Development, certification and international market
launch of a line of medical devices and a procedure to treat
sensorineural hearing loss and tinnitus.
Essence of the innovation: Implementing unique patented
technology for selective transcranial electric stimulation of the brains
protective mechanisms with an impulse current combined with
acoustic influence by tonal signals.
To be created during project realization: Professional and
individual device versions; the latter will be in the form of a mobile
application (for download and periodic update) and a special headset
connected to users mobile platform (smartphone or tablet PC).
Project budget (24 months): $ 1 335K
Looking for: Partners for product promotion.
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3. MEDICAL PROBLEM
About 10 % of the worlds population suffer from hearing disorders
In 2015 the number of patients will reach 700 million and there will be
900 million patients in 2020
85-90 % of patients have sensorineural hearing loss and 50 % have
tinnitus
This equals 30 million patients in the US, 80 million in Europe
and 13 million in Russia
Hearing loss and tinnitus have no specific treatment at present!
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4. THE SOLUTION
Audioselective Transcranial Electric Stimulation
Audio stimuli of variable Transcranial Electric
frequency and intensity Stimulation
The biophysical basis is the proven positive impact of re-education in the
treatment of acoustic neuronal disorders
Professional
Individual
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5. PROTOTYPE AND RESULTS
Prototype device TRANSAIR-07.
Course 10-15 procedures, every other day.
Results:
Hearing improved in 89 % of patients with
acute/sudden hearing loss and in 67 %
of those with chronic hearing loss (regardless of
etiology)
Tinnitus stops or becomes milder in 91 % of patients
Tonal hearing thresholds are stably decreased by 10-
35 dB
Percentage of patients with improved hearing ATES effects on subjective tinnitus
in acute and chronic SNHL
9%
36% 55%
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Tinnitus stopped
Tinnitus decreased in intensity
Tinnitus remained unchanged
6. COMPETITIVE TECHNOLOGIES
Traditional drug and Tinnitus Retaining
Cochlear implants
physical therapy Therapy (TRT)
These implants consist
Histamine-like Use of special hearing devices of wearable (external) and
medicines, retroauricular procaine combined with white noise implanted (inner) parts. The costs
blocks, laser therapy, stimulation generator. Widely used in the of an operation start from USD
with fluctuating current, quantum West, with a sales volume (therapy 30,000. The market has topped
hemotherapy, plasmapheresis, ho courses) in 2011 exceeding USD 87 USD 960 million and will reach
meopathic medicines, etc. million. USD 2.3 billion in 2017. The USA
accounts for 40 % of the market.
Does not treat the Invasive hearing
Aimed to inhibit disease
disease, but teaches the restoration applicable
progression, not to treat
patient in severe hearing loss
it
to ignore it only
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7. BUSINESS MODEL:
Individual ATES
purchase
recommendation
4P
Insurance
coverage
Purchase of SW
updates fee
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8. BUSINESS MODEL:
Professional ATES
Equipment
and
service consumables
at wholesale
price
sale
Equipment and
consumables at market
price
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9. MARKET AND SALES
The market for hearing aids grows by 10-15 % a year, to reach USD 26.2
billion in 2017*
USA, Europe, Canada, and Japan account for 80 % of sales. Within the last 5
years, the mobile device market in the US tripled (from USD 2.7 billion to
9.6 billion); 15 million devices were sold**
Sales volume in 6yr. (est.) $ 21,6M
1.4 % 0.1 % 仂亟舒亢舒 亳仆亟亳于亳亟舒仍仆 丐亅弌 (弍亠亰coverage)
Sales of individual ATES (without insurance
舒仂于仂亞仂 仗仂从亳)
Sales of individual ATES (with insurance coverage)
仂亟舒亢舒 亳仆亟亳于亳亟舒仍仆 丐亅弌 (仂
舒仂于仄 仗仂从亳亠仄)
23.1 % 亠舒仍亳亰舒亳 仗仂亠亳仂仆舒仍仆 丐亅弌
Sales of professional ATES
34.4 %
仂仄亳亳 仍亞亳 仗仂 仍亠亠仆亳 弌丐 亳
Fees per services in SNHL and tinnitus treatment
亳仆仆亳舒
仂亟舒亢舒 仂弍仆仂于仍亠仆亳亶 for individual ATES
Sales of software updates 亟仍
37.0 %
亳仆亟亳于亳亟舒仍仆仂亞仂 丐亅弌
3.9 % 仂亟舒亢舒 舒仂亟仆 仄舒亠亳舒仍仂于 亟仍
Sales of consumables for professional ATES
仗仂亠亳仂仆舒仍仆仂亞仂 丐亅弌
* - Audiological Devices - Global Strategic Business Report
** - HIMSS Analytics
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10. THE TEAM
Alexander Malygin CEO, co-founder, Candidate of Technical Science, MBA,
20 years of business experience. He headed the organization of serial production,
certification and technical testing of TRANSAIR and DOKTOR TES devices, participated
in creating a sales and service network for the device. During his job, more than 5,000
and over 40,000 TRANSAIR and DOKTOR TES devices respectively have been sold and
10 regional agencies have been founded.
Prof. Valeriy Lebedev Research Director, MD, co-founder, member of the Russian
Academy of Natural Sciences. He discovered TES effects on protective systems in the
brain of animals and humans. The author of 98 articles and 115 theses on TES therapy.
An Honored Science Worker of the Russian Federation
and Head of Applied Neurophysiology at the I.M. Sechenov Saint Petersburg Society of
Physiologists, Biochemists and Pharmacologists.
Anna Belimova physical therapist and audiologist, Candidate of Medicine,
10 years of experience in SNHL treatment. She has personally performed all clinical
trials, arranged and partly performed instrumental testing, carried out ATES procedures
in SNHL patients, and studied changes in hearing after ATES.
Dmitry Tseitlin Business Development Director, MD, Candidate of Medicine,
20 years of experience in international marketing and technology commercialization in
Russia, Israel and Germany. Business Coach at the Skolkovo Industrial Park.
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