Development and Productization of Orthopedic

Trauma 3D Implants

1. Company

Skolkovo Foundation Resident No. 414Skolkovo Industrial Park Resident No. 14 Sarov Industrial Park ResidentPh: +7 (495) 28-0000-1 p5070Ph: +7 (495) 7-43-43-45

Company information on the Internetwww.3d-medicina.ruwww.sk.ru to search for company information, enter "ABC" in the search fieldwww.community.sk.ru/net/1120077/www.community.sk.ru/technoparkwww.community.sk.ru/technopark/p/residents.aspxwww.миц технопарк.рф/sobytija/news/229/‐www.facebook.com/#!/groups/MICtp/www.itechnopark.ru/residents/www.nptechnopark.ru/store_of_innovations/

2. Innovative Project Summary (hereinafter - Project)

Product: All-purpose, anatomic, three-plane 3D implants made of

titanium alloy for surgical treatment of human bone fractures, which have no analogues in the world;

Project Objectives: Improving health, quality and the duration of human life; Active introduction of the innovative development of Russian

scientists and health professionals – high-tech 3D implants – on the market of medical trauma and orthopedic implants;

Creating a range of competitive fixators; Making a profit and educating financial reserves in order to

promote active business development; Expansion into international markets.

2. Innovative Project Summary (hereinafter - Project)

Current Project Status:• So far, one of the products planned for production and sale –

"3D Crab" plate – has been introduced. • "3D Crab" plate has been developed based on the model

of comminuted intraarticular fractures of the distal humeral metaepiphysis.

• Fixator was centrally purchased: in Arkhangelsk Region, by the N.V. Sklifosovsky Research Institute of Emergency Medicine (Moscow), and N.I. Pirogov City Clinical Hospital No. 1. (Moscow). It is also being used at the clinic of the Traumatology, Orthopedics and Field Surgery Department at the Moscow State University of Medicine and Dentistry (City Clinical Hospital No. 59, Moscow), and at the Russian Railways, LLC Hospital at the Lyublino Station (Moscow).

• Project commercialization is planned to begin 12 months after obtaining financing.

3. Target Market and Competition

Competitive Advantages: Product uniqueness lies in the possibility of reducing the disability times for

patients with fractures (3-5 times shorter) and the risk of disability by 30-70%.

Comparison with competitive products (SYNTHES; KONIGSEE; STRYKER; ChM; OSTEOSYNTHESIS): competitive retail price; strength (kN) is 2 times higher; the number of screws needed for fixation is 2 times smaller; surgeries are 30-90 minutes shorter; minimum need for modeling; recovery period is 3-5 times shorter; patient disability period is 3-5 times shorter; the risk of disability in patients is 30-70% lower.

3. Target Market and Competition

Productname

Manufacturer RF market share

countryPrice (RUB)

Strength (kN)

No. of screws

Surgery time (min)

Recovery period

(weeks)

Modeling

+ + + + +

Plates with angular

stability

Osteosynthesis 62% of the

marketRussia

48 35 16 120 - 180 10-14 + + + + +

SYNTHES21% of the RF

marketSwitzerland

59 29 16 120 - 180 8-14 + + +

KONIGSEE7% of the RF

marketGermany

53 25 12 120 - 180 10-14 ++

3D implantsABC

TechnologiesRussia

50-98 65 8 60 - 90 2-4 -

Comparison with competitors' products on the key parameters:

3. Target Market and Competition

Similar product development:Currently, there are no analogues in the world;Existing products on the market are not 3D implants;Virtually 100% of the market is occupied by regular linear and pre-

modeled plates.

Potential consumers of 3D implants are: Patients and their relatives; Orthopedic trauma hospitals; Private clinics and surgical centers; Departmental agencies; Army.

3. Target Market and Competition

Commercialization scheme:• Centralized implant sales (within p. 94 of the Federal Act) to orthopedic trauma

institutions. Innovative 3D implants are automatically placed in the HTMC (High-Tech Medical Care) Program as they are used for reconstructive artroplastic surgeries. Due to the fact that ABC Technologies is a resident of the Skolkovo Foundation, all the company's innovative products will be recommended for purchase in all regions of the Russian Federation by the Foundation;

• Maintaining a competitive market value of the product;• Creating Sales Offices with a complete set of the necessary equipment to ensure

individual design and development of implants in all major cities of the Russian Federation;

• Creating an Internet Sales Center to possibly provide free on-line consultations with the leading traumatologists using scanned images or 3D CT scans;

• Company's product range allows us to satisfy more than 60% of the consumer needs.

• Sale of technology (license) of the leaders of the market (SYNTHES; KONIGSEE; STRYKER)

9

4. Project Geography

The project has a broad geographical application as trauma care is provided in all major cities of the World. According to statistics, every year one out of 1,000 people receives bone implant.

China1,349,718,000 €

India1,222,172,000 €

USA313,328,000 €

Indonesia245,612,000 €

Brazil195,962,000 €

EU502,000,000 €

Russia143,000,000 €

Japan127,000,000 €

Mexico112,000,000 €

Philippines102,000,000 €

Annual market volume7,000,000,000 €

Average implant price = 1,000 €

Preferences in national sales

under the brand name “Made in

Skolkovo”

5. SWOT Analysis – Strengths – Russia

GR and PR resource Skolkovo Foundation YIC Sarov Russian Association of

Industrial Parks

Authority of the developers and

positive image of the product

75% R&D

Reducing surgery duration and

traumatic effectby half

HIGH SOCIAL IMPORTANCE

Development

strategy

Implants: ups and downs

NO TAXES Benefits for

Skolkovo participants

Sales to RF Government

3D implants included in HTMC

Program

5. SWOT Analysis – Possibilities – Russia

Competitive priceDealers network

(bulk sale)

Internet Sales Center in all major languages of the

World

MATERIALBioinert titanium

OUTSOURCING implant blank

production to NGO

"AVANGARD"

LICENSE TO MANUFACTURE

MEDICAL PRODUCTS

PRODUCT RANGE

3D, 2D and 1D implants and

screws

MEDICAL EDUCATION

Lack of material and technical base

5. SWOT Analysis – Weaknesses and Threats – Russia

Presence of foreign competitors in the

market

Dependence on third-party

production capacity – NGO "Avangard"

Competitors with unfair marketing

policy (kickbacks)

6. Technology and Intellectual Property

Innovation Description: 3D implants are anatomic and solid in structure and can provide

even distribution of appendicular bone joints weight bearing thanks to multiplane fixation (screws are inserted in all 3 planes - x, y and z - of the three-dimensional coordinate system);

Angular stability in 3 planes ensures absolute stability of fracture fixation. Plates are symmetrical for left and right skeleton regions, have six standard sizes, are differentiated by gender and race depending on the width of metaepiphyseal regions, and combine all the positive features of the traditionally used fixators (diaphyseal, metaphyseal, reconstruction plates, etc.).

Patents obtained• RF Patent PM No. 66183 "Fixator for osteosynthesis of

distal humeral fractures," • RF Patent PM No. 104445 "Fixator for tibia

osteosynthesis."• RF Patent PM 116335 "Fixator for treatment of fractures

of the distal radial metaepiphysis."• RF Patent PM 116340 "Fixator for osteosynthesis of

proximal tibia fractures"Patent applications• Application for RF patent PM No. 2011145082 dated

11/8/2011 "Fixator for osteosynthesis of distal humeral lateral fractures (outer epicondyle and trochlea of humerus)";

• Application for RF patent PM No. 2011145083 dated 11/8/2011 "Fixator for osteosynthesis of proximal femoral fractures (basilar, pertrochanteric and subtrochanteric fractures)";

• Application for RF patent PM No. 2011146436 dated 11/17/2011 "Fixator for osteosynthesis of fractures of the proximal humeral metaepiphysis";

6. Technology and Intellectual Property

7. Project Team

Aleksej Valeryevich Babovnikov Director GeneralM.D.,Professor - Traumatology, Orthopedics and

Field Surgery Department at the Moscow State University of Medicine and Dentistry

Author of 99 studies, 10 RF patents and 1 monograph; winner of the contest of young

scientists – PhD (MK-2006) for the Grant from the President of the Russian Federation

Dmitry Nikolaevich RubekinDirector of DevelopmentBusiness angelSerial entrepreneur

8. Project Financial Indicators (5-year horizon)

Project NPV at start47 897 354 €

Project PI15,89

Project payback period

27 months

Investment amount 3,715,000 €

Project IRR 202.5%

It is planned that the project will generate 3.97 € for each invested Euro in 5 years

8. Project Financial Indicators (5-year horizon)

Project NPV and undiscounted cash flow1

ме

с.

2 м

ес

.3

ме

с.

4 м

ес

.5

ме

с.

6 м

ес

.7

ме

с.

8 м

ес

.9

ме

с.

10

ме

с.

11

ме

с.

12

ме

с.

1 м

ес

.2

ме

с.

3 м

ес

.4

ме

с.

5 м

ес

.6

ме

с.

7 м

ес

.8

ме

с.

9 м

ес

.1

0 м

ес

.1

1 м

ес

.1

2 м

ес

.1

ме

с.

2 м

ес

.3

ме

с.

4 м

ес

.5

ме

с.

6 м

ес

.7

ме

с.

8 м

ес

.9

ме

с.

10

ме

с.

11

ме

с.

12

ме

с.

1 м

ес

.2

ме

с.

3 м

ес

.4

ме

с.

5 м

ес

.6

ме

с.

7 м

ес

.8

ме

с.

9 м

ес

.1

0 м

ес

.1

1 м

ес

.1

2 м

ес

.1

ме

с.

2 м

ес

.3

ме

с.

4 м

ес

.5

ме

с.

6 м

ес

.7

ме

с.

8 м

ес

.9

ме

с.

10

ме

с.

11

ме

с.

12

ме

с.

1 год 2 год 3 год 4 год 5 год

-500,000,000р

0р

500,000,000р

1,000,000,000р

1,500,000,000р

2,000,000,000р

2,500,000,000рNPV проекта и недисконтированный денежный поток

NPV проекта на момент его начала, руб. Недисконтированный денежный поток нарастающим итогом

НИОКР (R&D):Начало продаж 15 месяц

9. Calendar Plan prior to Sales

No. Work DescriptionTurnaround Time

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

  Month Number 1 2 3 4 5 6 7 8 9 10 11 12

1Developing 3D models in "Stl" format of the entire product range + + +                  

2 Developing promotional materials (branding) +                      3 Preparing technical documentation (TS) + +                    

4

Preparing documentation for obtaining a registration certificate from the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, including:

+ + + + + +            

4.1- Clinical trials (on paper)     + +                4.2- Bench tests     + +                4.3- Clinical trials (actual)     + + + + + + +      

5 Obtaining TS Certificate of Conformity           + +          

6Obtaining voluntary GOST R ISO 9001-2008 (ISO 9001:2008) Certificate of Conformity           + +          

7Obtaining license to manufacture medical products           + + + +      

8 Trademark registration + + +                  9 Office organization + +                    

10

Creating Internet Sales Center with online consultations from leading traumatologists and information on all governmental programs to receive free High-Tech Health Care

+ + + + + + + + + + + +

11 International patenting     + + + + + + + + + +12

Filing priority RF patent applications for unpatented products + + + +                

13

Organizing and supplying equipment for medical products manufacturing (renting premises, purchasing marking, packaging and technical equipment)

        + +            

14 Sale start                     + +

10. Commercial Offer

Requested investment amount 3,715,000 EUR

1.05 mln EUR - authorized capital contribution for 25.01% company shares, venture capital investments (non-return investments).

2.71 mln EUR - current assets (return on investment). After the completion of R & D (13 months) interest-free credit line for 2 years.

Investor project withdrawal options

o IPOo Company share buybacko Strategic sale of investor's share to a large biopharmaceutical company

The project team plans to attract non-returnable grant of the SKOLKOVO Foundation in the amount of 1 million euros on R&D stage of the project.