Development, creation and international launch of a line

of medical devices to treat sensorineural hearing

loss and tinnitus

TES MOBILE1

SUMMARY

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• Project aim: Development, certification and international market launch of a line of medical devices to treat sensorineural hearing loss and tinnitus.

• Essence of the innovation: Implementing unique patented technology for selective stimulation of the endorphin system combined with acoustic impact on the organ of hearing by tonal signals.

• To be created during project realization: Professional and individual device versions in the form of medical gadget with a mobile application and a special headset connected to user’s mobile platform (smartphone or tablet PC).

• Project budget (24 months): $ 1 335K

• Looking for: Both investors and partners for product promotion.

MEDICAL PROBLEM

• About 10 % of the world’s population suffer from hearing disorders

• In 2015 the number of patients will reach 700 million and there will be 900 million patients in 2020

• This equals 13 million in Russia, 30 million patients in the US, 80 million in Europe

• Hearing loss and tinnitus have no specific treatment at present!

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THE SOLUTIONAudioselective Transcranial Electric Stimulation

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The biophysical basis is the proven positive impact of re-education in the treatment of acoustic neuronal disorders

Audio stimuli of variable frequency and intensity

Transcranial Electric Stimulation

Indiv

idu

al

Pro

fess

ion

al

PROTOTYPE AND RESULTSPrototype device – TRANSAIR-07.Course – 10-15 procedures, 30 min, 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 decreased by 10-35 dB

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36% 55%9%

ATES effects on subjective tinnitusPercentage of patients with improved hearing

in acute and chronic SNHL

– Tinnitus stopped

– Tinnitus decreased in intensity

– Tinnitus remained unchanged

COMPETITIVE TECHNOLOGIES

Traditional drug and physical therapy

Histamine-like medicines, retroauricular procaine blocks, laser therapy, stimulation with fluctuating current, quantum hemotherapy, plasmapheresis, homeopathic medicines, etc.

Aimed to inhibit disease progression,

not to treat it

Tinnitus Retaining Therapy (TRT)

Use of special hearing devices combined with white noise generator. Widely used in the West, with a sales volume (therapy courses) in 2011 exceeding USD 87 million.

Does not treat the disease, but teaches the

patient to ignore it

Cochlear implants

These implants consist of wearable (external) and implanted (inner) parts. The costs of an operation start from USD 30,000. The market has topped USD 960 million and will reach USD 2.3 billion in 2017. The USA accounts for 40 % of the market.

Invasive hearing restoration applicable in severe hearing loss

only

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BUSINESS MODEL:Individual ATES

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purchasefee

recommendation

Purchase of SW updates fee

purchase

4 P

Insurance coverage

BUSINESS MODEL: Professional ATES

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advertise

mentfee

service

sale

Equipment and

consumables at wholesale

price

Equipment and consumables at market

price

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 6 yr. (est.) – $ 21,6M

* - Audiological Devices - Global Strategic Business Report** - HIMSS Analytics

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23.1 %

37.0 %

3.9 %

34.4 %

1.4 % 0.1 % Продажа индивидуальных АТЭС (без страхового покрытия)

Продажа индивидуальных АТЭС (со страховым покрытием)

Реализация профессиональных АТЭС

Комиссия с услуги по лечению СНТ и тиннитуса

Продажа обновлений ПО для индивидуального АТЭС

Продажа расходных материалов для профессионального АТЭС

Sales of individual ATES (without insurance coverage)

Sales of individual ATES (with insurance coverage)

Sales of professional ATES

Fees per services in SNHL and tinnitus treatment

Sales of software updates for individual ATES

Sales of consumables for professional ATES

THE TEAMAlexander 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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