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3D OSTEO LIFE
«Development and commercialization of orthopedic
          traumatology 3D implants»
1. Company



Skolkovo Foundation Resident No. 414
Skolkovo Industrial Park Resident No. 14
Sarov Industrial Park Resident
Ph: +7 (495) 28-0000-1 p5070
Ph: +7 (495) 7-43-43-45
e-mail: abc@3d-medicina.ru

Company information on the Internet:
www.3d-medicina.ru




                  Development and commercialization of orthopedic traumatology 3D implants
PROBLEMS OF PATIENTS WITH COMPLEX FRACTURES

                                                                            Unstable
                                                                        fixation in 60%
             Duration of disability
             patients with complex
              fractures of the 3-9
                    months

                                                                           The bones
                                                                         deformation in
                                                                              30%
                With traditional
              implants, the risk of
              becoming disabled is
                  up to 60%


         Development and commercialization of orthopedic traumatology 3D implants
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;
 Expansion into international markets.

             Development and commercialization of orthopedic traumatology 3D implants
3D PLATES (IMPLANTS).                                                          ABSOLUTE ANATOMICAL
THE MAIN ADVANTAGES:                                                           -developed on the natural
                                                                               human bones;
 HIGH BIOCOMPATIBILITY                                                         -symmetrical to the right and
 The use of special medical titanium Ti6Al7Nb provides high                    left parts of the skeleton;
 biocompatibility implant tissues of the human body without                    -differ by gender patients
 the risk of the onset of tissue oxidation (metallosis) and the                (male and female);
 development of chronic intoxication with heavy metals.                        -vary in height of the patient


 Reducing the time and complexity of surgery plates
 previously modeled, reducing the time of surgery for 30 -
 60 minutes depending on the type of fracture.

 Possibility of early function, reduced disability time by 2-3
 times, reducing the risk of invalidity

 No need to apply plaster after surgery

 Frame shape of the plates and anatomical geometry
 retaining elements provide stability to reconcile fracture
 consolidation period to the period of rehabilitation
 patients, which is an effective measure to prevent the
 disabling contractures and ankylosis.


                     Development and commercialization of orthopedic traumatology 3D implants
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).



               Development and commercialization of orthopedic traumatology 3D implants
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.




                Development and commercialization of orthopedic traumatology 3D implants
3. Target Market and Competition

   Comparison with competitors' products on the key
                    parameters:
            Manufacturer                                                                              Model
                                                                          Surgery          Recovery
Product      RF market                        Strength       No. of                                    ing
                                Price ($)                                  time              period
 name          share                            (kN)        screws                                    +++
                                                                           (min)            (weeks)
              country                                                                                  ++

            Osteosynthesis
              62% of the                                                                              +++
                                    1,6           35            16        120 - 180         10-14
                market                                                                                 ++
                Russia
 Plates       SYNTHES
  with      21% of the RF
angular                             1,9           29            16        120 - 180          8-14     +++
               market
stability    Switzerland
              KONIGSEE
             7% of the RF
                                    1,7           25            12        120 - 180         10-14      ++
                market
               Germany

                ABC
  3D
            Technologies            2-5           65            8          60 - 90           2-4        -
implants
               Russia



                Development and commercialization of orthopedic traumatology 3D implants
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.


               Development and commercialization of orthopedic traumatology 3D implants
3. Target Market and Competition



Commercialization scheme:
• 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
• 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)




               Development and commercialization of orthopedic traumatology 3D implants
4. Project Geography


     China                                                                                  EU
1,349,718,000 €                                                                       502,000,000 €
     India                                                                               Russia
1,222,172,000 €                                                                       143,000,000 €
      USA                                                                                 Japan
 313,328,000 €                                                                        127,000,000 €
   Indonesia                                                                             Mexico
 245,612,000 €                                                                        112,000,000 €
    Brazil                      Annual market volume                                     Vietnam
195,962,000 €                      7,000,000,000 €                                     90,500,000 €
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.
                 Average implant price = 1,000 €
                 Development and commercialization of orthopedic traumatology 3D implants
5. SWOT Analysis – Strengths – Russia


  Preferences in                      NO TAXES                         GR and PR resource
  national sales                     Benefits for                      Skolkovo Foundation
 under the brand                      Skolkovo                               YIC Sarov
 name “Made in                       participants                      Russian Association
    Skolkovo”                                                           of Industrial Parks


 Authority of the
 developers and                                                             HIGH SOCIAL
positive image of                                                           IMPORTANCE
   the product


  Development                                                          Reducing surgery
    strategy                                                             duration and
   Implants:                           75% R&D                         traumatic effect
 ups and downs                                                              by half

              Development and commercialization of orthopedic traumatology 3D implants
5. SWOT Analysis – Possibilities



                                      MEDICAL                          Competitive price
                                     EDUCATION                         Dealers network
                                                                          (bulk sale)


 Internet Sales                                                            LICENSE TO
  Center in all                                                           MANUFACTURE
major languages                                                             MEDICAL
  of the World                                                             PRODUCTS


PRODUCT RANGE
 3D, 2D and 1D                        MATERIAL
  implants and                         Bioinert
    screws                             titanium

              Development and commercialization of orthopedic traumatology 3D implants
5. SWOT Analysis – Weaknesses and Threats




Lack of material and                                                  Presence of foreign
   technical base                                                     competitors in the
                                                                           market




 Competitors with
 unfair marketing
 policy (kickbacks)

             Development and commercialization of orthopedic traumatology 3D implants
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.).




                Development and commercialization of orthopedic traumatology 3D implants
6. Technology and Intellectual Property

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
•  pplication for RF patent PM No. 2011145082 dated
  A
  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";




                   Development and commercialization of orthopedic traumatology 3D implants
PLATE «CRAB 3D»




        We have developed and successfully introduced into clinical practice innovative implant
"Crab plate 3D". This clip has reduced the period of rehabilitation of patients with fractures of the distal
 humerus in 5 times (14-20 days instead of 70-100 days). Successfully carried out more than 50 surgery.


                   Development and commercialization of orthopedic traumatology 3D implants
Development and commercialization of orthopedic traumatology 3D implants
Clinical example: patient S-ova O.S., 40 years old (case number 4988/10, Moscow City
Clinical Hospital № 59). Diagnosis: internal multisplintered metaepifizarny fracture of
the distal part of the left humerus with displacement of bone fragments - Type 13 C 3
(AO / ASIF).




                Development and commercialization of orthopedic traumatology 3D implants

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Abc 19 06-07 en

  • 1. 3D OSTEO LIFE «Development and commercialization of orthopedic traumatology 3D implants»
  • 2. 1. Company Skolkovo Foundation Resident No. 414 Skolkovo Industrial Park Resident No. 14 Sarov Industrial Park Resident Ph: +7 (495) 28-0000-1 p5070 Ph: +7 (495) 7-43-43-45 e-mail: abc@3d-medicina.ru Company information on the Internet: www.3d-medicina.ru Development and commercialization of orthopedic traumatology 3D implants
  • 3. PROBLEMS OF PATIENTS WITH COMPLEX FRACTURES Unstable fixation in 60% Duration of disability patients with complex fractures of the 3-9 months The bones deformation in 30% With traditional implants, the risk of becoming disabled is up to 60% Development and commercialization of orthopedic traumatology 3D implants
  • 4. 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;  Expansion into international markets. Development and commercialization of orthopedic traumatology 3D implants
  • 5. 3D PLATES (IMPLANTS). ABSOLUTE ANATOMICAL THE MAIN ADVANTAGES: -developed on the natural human bones; HIGH BIOCOMPATIBILITY -symmetrical to the right and The use of special medical titanium Ti6Al7Nb provides high left parts of the skeleton; biocompatibility implant tissues of the human body without -differ by gender patients the risk of the onset of tissue oxidation (metallosis) and the (male and female); development of chronic intoxication with heavy metals. -vary in height of the patient Reducing the time and complexity of surgery plates previously modeled, reducing the time of surgery for 30 - 60 minutes depending on the type of fracture. Possibility of early function, reduced disability time by 2-3 times, reducing the risk of invalidity No need to apply plaster after surgery Frame shape of the plates and anatomical geometry retaining elements provide stability to reconcile fracture consolidation period to the period of rehabilitation patients, which is an effective measure to prevent the disabling contractures and ankylosis. Development and commercialization of orthopedic traumatology 3D implants
  • 6. 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). Development and commercialization of orthopedic traumatology 3D implants
  • 7. 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. Development and commercialization of orthopedic traumatology 3D implants
  • 8. 3. Target Market and Competition Comparison with competitors' products on the key parameters: Manufacturer Model Surgery Recovery Product RF market Strength No. of ing Price ($) time period name share (kN) screws +++ (min) (weeks) country ++ Osteosynthesis 62% of the +++ 1,6 35 16 120 - 180 10-14 market ++ Russia Plates SYNTHES with 21% of the RF angular 1,9 29 16 120 - 180 8-14 +++ market stability Switzerland KONIGSEE 7% of the RF 1,7 25 12 120 - 180 10-14 ++ market Germany ABC 3D Technologies 2-5 65 8 60 - 90 2-4 - implants Russia Development and commercialization of orthopedic traumatology 3D implants
  • 9. 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. Development and commercialization of orthopedic traumatology 3D implants
  • 10. 3. Target Market and Competition Commercialization scheme: • 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 • 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) Development and commercialization of orthopedic traumatology 3D implants
  • 11. 4. Project Geography China EU 1,349,718,000 € 502,000,000 € India Russia 1,222,172,000 € 143,000,000 € USA Japan 313,328,000 € 127,000,000 € Indonesia Mexico 245,612,000 € 112,000,000 € Brazil Annual market volume Vietnam 195,962,000 € 7,000,000,000 € 90,500,000 € 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. Average implant price = 1,000 € Development and commercialization of orthopedic traumatology 3D implants
  • 12. 5. SWOT Analysis – Strengths – Russia Preferences in NO TAXES GR and PR resource national sales Benefits for Skolkovo Foundation under the brand Skolkovo YIC Sarov name “Made in participants Russian Association Skolkovo” of Industrial Parks Authority of the developers and HIGH SOCIAL positive image of IMPORTANCE the product Development Reducing surgery strategy duration and Implants: 75% R&D traumatic effect ups and downs by half Development and commercialization of orthopedic traumatology 3D implants
  • 13. 5. SWOT Analysis – Possibilities MEDICAL Competitive price EDUCATION Dealers network (bulk sale) Internet Sales LICENSE TO Center in all MANUFACTURE major languages MEDICAL of the World PRODUCTS PRODUCT RANGE 3D, 2D and 1D MATERIAL implants and Bioinert screws titanium Development and commercialization of orthopedic traumatology 3D implants
  • 14. 5. SWOT Analysis – Weaknesses and Threats Lack of material and Presence of foreign technical base competitors in the market Competitors with unfair marketing policy (kickbacks) Development and commercialization of orthopedic traumatology 3D implants
  • 15. 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.). Development and commercialization of orthopedic traumatology 3D implants
  • 16. 6. Technology and Intellectual Property 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 •  pplication for RF patent PM No. 2011145082 dated A 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"; Development and commercialization of orthopedic traumatology 3D implants
  • 17. PLATE «CRAB 3D» We have developed and successfully introduced into clinical practice innovative implant "Crab plate 3D". This clip has reduced the period of rehabilitation of patients with fractures of the distal humerus in 5 times (14-20 days instead of 70-100 days). Successfully carried out more than 50 surgery. Development and commercialization of orthopedic traumatology 3D implants
  • 18. Development and commercialization of orthopedic traumatology 3D implants
  • 19. Clinical example: patient S-ova O.S., 40 years old (case number 4988/10, Moscow City Clinical Hospital № 59). Diagnosis: internal multisplintered metaepifizarny fracture of the distal part of the left humerus with displacement of bone fragments - Type 13 C 3 (AO / ASIF). Development and commercialization of orthopedic traumatology 3D implants
  • 20. Pictures in the surgery and after surgery radiograph the same patient Development and commercialization of orthopedic traumatology 3D implants
  • 21. Functional outcome in 10 days after surgery Control examination in 6 weeks after surgery Development and commercialization of orthopedic traumatology 3D implants
  • 22. Analysis of the traditional techniques of surgical treatment plate bone failure of union fracture fracture in fracture bone deformation unstable osteosynthesis Development and commercialization of orthopedic traumatology 3D implants
  • 23. 7. Project Team A  leksej Babovnikov of the contest of young scientists Director General – PhD (MK-2006) for the Grant M.D.,Professor - Traumatology, from the President of the Russian Orthopedics and Field Surgery Federation Department at the Moscow State Dmitri Rubekin University of Medicine and irector of Development D Dentistry Business angel uthor of 99 studies, 10 RF A Serial entrepreneur patents and 1 monograph; winner Development and commercialization of orthopedic traumatology 3D implants