1. 1 Making of new sapphire hip endoprosthesis. From science to business on October, 10 – 12, 2006 Kiev Doctor of medicine Vladimir Tankut Tel.: 8 (057) 704-14-66 E-mail: filippenko@valor.ua Sytenko Institute of Spine and Joint Pathology Ukrainian Academy of Medical Sciences Kharkov

2. 2 The creation of biologically inactive, wear-proof, inexpensive pair of friction in the hinge of endoprosthesis of joint hip is topical. What is needed in the market? Prevention of high concentrations formation of tension and increasing of operating reliability are the advantages of the offered construction.

3. 3 Brief technology description. The technology of endoprosthesis creation is based on the synthesis of scaffolding with following raising of sapphire crystal in laboratory conditions and its processing in order to create the spheres into hinge of artificial joint.

4. 4 Stage of development. Development types of hip endoprosthesis with sapphire- chirulene pair of friction are created, their preclinical appraisal was performed with positive results. In two years after operation

5. 5 It is annually executed operations of hip replacement Who needs it & how many will they need? The necessity in new working-out is very high. Patients with I1I-IV grade of hip arthrosis require operations of hip replacement. The amount of these operations is equal to 50 000 in Ukraine annually, whereas about 1 million in the whole world per year.

6. 6 What is my unique technology advantage? The complete process of product manufacturing (from the raw mining to the outlet of end product) is set up; there are customers for its forth putting.

7. 7 Competitive matrix. The cheapness (comparing with existing analogues), overstability and durability of material (sapphire), low coefficient of friction, biochemical inactivity and biocompatibility with human organism.

8. 8 How will I beat the competition? Plainness, cheapness, originality of endoprosthesis manufacturing. Opportunity for joint work. The work requires the participation of technologists and medical staff, for further improvement of endoprosthesiss working- out and their clinical appraisal.

9. 9 Proprietary information statement The technology material presented in this talk is available for licensing or joint product development. None of the slides contain any confidential or proprietary information which would prevent patenting the technology.

10. 10 Problem Description & Market Need Hip arthrosis is a severe chronic progressive disease of hip joint, which leads to severe disability in 70-80 % cases. The incidence of this disease among working population has increased on 40-60 % for the last 20 years. Dynamics of increase of coxarthrosis

11. 11 Long-Term Clinical Results Arthroplasty of the Hip Hip replacement is an effective and progressive method for the treatment of coxarthrosis. The pairs of friction in the hinge knot are imperfect in the existing constructions of endoprosthesiss, which lead to severe complication in 25% cases 10-12 years after joint replacement and require repeated revision operations. Problem Description & Market Need

12. 12 Total wear-out of Teflon socket after 3 years J.Charnley Low Friction Arthroplasty of the Hip 1979. The destruction of polymer in the knot of endoprosthesis friction Total wear-out of Chirulen socket after 3 years Sytenko institute of spine and joint pathology 2003 factor of destruction Problem Description & Market Need

13. 13 Brief technology description Advantages On a level with the highest world standards the new technologies of the production of pure furnace charge for the growing of crystals, optimal technologies for the processing of spheres and acetabulum of artificial joint made from sapphire, for the production of friction pair with minimal coefficient of friction in hinge will be worked out. New unique design of hip endoprosthesis using sapphire- sapphire friction pair in hinge will be worked out and the technique of operation will be improved. New pathogeneticaly grounded approach to the carrying out of clinical roentgenological and laboratory investigation of patients with hip pathology will be worked out: new criteria for the updating of indications for operation and rehabilitation period will be designed.

14. 14 Experimental results The change of coefficient friction for different connections of materials

15. 15 Stage of development (clinical tests if medical) and international patents Pre-productions models of hip endoprosthesiss with sapphire head and acetabulum are manufactured, pre-clinical trials are carried out. Clinical approbation of endoprosthesis with sapphire head was carried out on 5 patients, 5 years follow-up after first operation, the results are good. There 4 Declarative Patents of Ukraine, no international patents.

16. 16 Targeted Market Segment Patients with coxarthrosis of III-1V grade require hip replacement. Among these people are middle aged and able to work citizens who has the pathology of hip due to its disease or injury. About 15 000 of hip replacement are performed in Ukraine per year, and about 1million all over the world. The price of our endoprosthesis construction is about 1 000 Euro, whereas existent construction – 1500 - 2500 Euro.

17. 17 Competition Our competitors are firms that produce endoprosthesis (1 in Ukraine and about 30 all over the world). On the background of great experience in sapphire production, carrying out about 5 000 operations of primary and repeated joint replacement using different design of endoprosthesiss (including 5 with a sapphire head), presence of experienced highly qualified specialists we will work out an endoprosthesis with sapphire friction pair, that will be cheaper, more safety, solid and unsophisticated in manufacture in comparison with the analogues existing nowadays.

18. 18 Competitive Matrix Important product or technology characteristics Sytenko Institute of Spine and Joint Pathology Ukrainian Academy of Medical Sciences Kharkov DePuy USA Zimmer USA Endurance Saphire/saphire 0,02% per year Metal/polymer 2% per year Metal/polymer 2-3% per year Coefficient of friction Saphire/saphire 0,001 Metal/polymer 0,058 Ceramics/polymer 0,080 BiocompatibilityAbsolute Incomplete from formation of toxic particles of friction of materials Cost (euro) 10001800-30001500-2500

19. 19 Opportunities The necessity to create a modern high- technology manufacture of hip endoprosthesis with new design and sapphire friction pair in hinge. Carrying out of the design of endoprosthesis in order to get the European and world level. Approximate cost of project is equal to 300 – 400 thousands Euro.

20. 20 Contact information Doctor of medicine Vladimir Tankut Tel.: 8 (057) 704-14-66 Mob. Tel.: +38(066) 112-45-79 E-mail: filippenko@valor.ua Sytenko Institute of Spine and Joint Pathology Ukrainian Academy of Medical Sciences Kharkov new sapphire hip endoprosthesis