Project "Modules of the component of a hip joint" - LLC BES-T Manufacturing

1. Modules of theModules of the
components of a hipcomponents of a hip
jointjoint
Authors: V. Lukyanchenko Lugansk
A. Samoylenko
LLC «BES-T Manufacturing»
Presenter: Yulia Yakovleva Science and Technology Entrepreneurship Program
“From Idea to Market”
February, 24, Kiev, Ukraine
Natalia Volodkova

2. Summary
Objective:Objective: decrease of the death rate among senile population ofdecrease of the death rate among senile population of
Ukraine suffering from femoral neck fracture.Ukraine suffering from femoral neck fracture.
Modules of the components of a hip joint are used by traumatology,Modules of the components of a hip joint are used by traumatology,
oncology, orthopedics and surgical departments and emergencyoncology, orthopedics and surgical departments and emergency
hospitals.hospitals.
Project duration:Project duration: 24 months24 months
Funding:Funding: 12 000 $ + 24 500 $12 000 $ + 24 500 $ → 36 500 $→ 36 500 $
Expected results:Expected results:
received certificates ( 4Q 2014 year)received certificates ( 4Q 2014 year)
 supply system to all health facilitiessupply system to all health facilities
 party released hip endoprosthesis - 150 pcs.party released hip endoprosthesis - 150 pcs.
 transfer of 5% ( 10 pcs.) of the party's Charitable Fund children oftransfer of 5% ( 10 pcs.) of the party's Charitable Fund children of
War (“Fund surgical rehabilitation for older people”, Lugansk)War (“Fund surgical rehabilitation for older people”, Lugansk)

3. Steps of Project
I.I. –– the certification procedure - $the certification procedure - $ 1414,,500500 includingincluding
finishing - $ 6,300)finishing - $ 6,300) ((CCRDF costsRDF costs - $- $ 5,700)5,700);;
II.II. –– establishing the government and business partnershipestablishing the government and business partnership ––
$$ 11,,500500 ((CCRDF costsRDF costs - $ 300- $ 300));;
III.III. –– promoting the production cooperationpromoting the production cooperation –– $$ 11,,260260 ((CCRDFRDF
costscosts - $ 1,200- $ 1,200));;
IV.IV. –– launching the advertizing campaignlaunching the advertizing campaign –– $$ 625625 ((CCRDF costsRDF costs
- $ 600- $ 600));;
V.V. –– preparing for the participation in public tenderpreparing for the participation in public tender
procurementsprocurements ((Ministry of HealthMinistry of Health,, Regional Health CareRegional Health Care
SystemSystem) –) – $$ 375;375;
VI.VI. –– cooperation with insurance companiescooperation with insurance companies –– $$ 625;625;
VII.VII. –– production of a batch of hip implants in appropriate amount andproduction of a batch of hip implants in appropriate amount and
donating 5%donating 5% (10 pcs.)(10 pcs.) of a batch to the children of war, according toof a batch to the children of war, according to
the advertizing campaign and the rest of the batch will be given tothe advertizing campaign and the rest of the batch will be given to
hospitals in the cities of Izium, Lugansk, Cherkassy, Slavyanoserbsk,hospitals in the cities of Izium, Lugansk, Cherkassy, Slavyanoserbsk,
Syeverodonets'k, Balakleya, Kharkiv, for commercial realizationSyeverodonets'k, Balakleya, Kharkiv, for commercial realization ––
$$ 1717,,615615 ((CCRDF costsRDF costs - $ 4,- $ 4,220000))..

4. The problem
Production of reliable high-quality orthopedic implantsProduction of reliable high-quality orthopedic implants
- worldwide problem- worldwide problem
In Ukraine:In Ukraine:
operations are performed 5 000 if necessary
20 000 annually;
mortality after fracture 25-30%;
number of patients increased by 15% the last 15
years;
high prices for imported implants, for most 70%
population;
lack of Ukrainian manufacturer who can provide a
high level of technology and affordable prices;
Austin Moore prosthesis model has not changed
since 1939.

5. Solution
Main products:Main products:
Modules of theModules of the
components of a hipcomponents of a hip
jointjoint
(cemented and noncemented(cemented and noncemented
fixation)fixation)
Main advantages:Main advantages:
 Treatment at nonspecialized clinicsTreatment at nonspecialized clinics;;
 Anatomical prosthetics (conchoidalAnatomical prosthetics (conchoidal
shape of a headshape of a head)) is providedis provided;;
 Heads can be coated with aluminaHeads can be coated with alumina
film, ceramic coatingsfilm, ceramic coatings;;
 Alloy materials application, such asAlloy materials application, such as
stainless steel, Co-Cr, Ti, Zr, Ta;stainless steel, Co-Cr, Ti, Zr, Ta;
 Alongside with multivariant fabricationAlongside with multivariant fabrication
of components (titanium, stainlessof components (titanium, stainless
steel);steel);
 Cemented and noncemented fixationCemented and noncemented fixation..

6. These needs will be resolved:These needs will be resolved:
 Mitigation of pain, fast recovery of locomotiveMitigation of pain, fast recovery of locomotive
function;function;
 Deformation correction, extremity lengthDeformation correction, extremity length
restoration;restoration;
 Recovery and fast rehabilitation of aged people;Recovery and fast rehabilitation of aged people;
 Minimize the cost of quality care and rehabilitation;Minimize the cost of quality care and rehabilitation;
 Advancing qualification of doctors in districtAdvancing qualification of doctors in district
hospitals;hospitals;
 The reduction in mortality among patients withThe reduction in mortality among patients with
traumas and injuries of the hip joint;traumas and injuries of the hip joint;
 Improving the quality of life for patients;Improving the quality of life for patients;
 Opportunity to purchase endoprosthesis inOpportunity to purchase endoprosthesis in
installments.installments.

7. Technological Advantage
Power of new technologies,Power of new technologies, due to:due to:
High corrosion resistance;
High hardness and wear resistance;
The low elastic modules and optimal hardness
to the module;
Jung, which increase flexibility of the coating;
Optimal ratio Hardness Young's modulus;
Low coefficient of friction in
the air and body fluids;
The high surface energy (hydrophilicity)
compared with metal materials;
Biocompatibility of tissues and body fluids.

8. Why anatomical heads, for old people?Why anatomical heads, for old people?
 less chance ofless chance of
dislocation;dislocation;
 a larger range ofa larger range of
motion;motion;
 less wear of theless wear of the
insert;insert;
 more stability in themore stability in the
joint.joint.

9. Why anatomical heads, for old people?Why anatomical heads, for old people?
Patient K., 75 year old (Patient K., 75 year old (Clinical aprobationClinical aprobation))
After operation
2 years later
Patient S., 67 year oldPatient S., 67 year old
After operation
2 years later

10. Our facilitiesOur facilities

11. Market Opportunity
Market volumeMarket volume
World marketWorld market:: ~~ 7-87-8 bln $/yearbln $/year
Ukrainian market:Ukrainian market: ~36 mln $/year~36 mln $/year
Potential customers:Potential customers:
 Specific doctors: - surgeonsSpecific doctors: - surgeons
- orthopedists- orthopedists
 Patients and their relatives;Patients and their relatives;
 Administration of district hospitals;Administration of district hospitals;
 Public regional and local administrations.Public regional and local administrations.
Our planes
CIS market & Middle EastCIS market & Middle East

12. Competition ComparisonComparison
Indicator
destination
parameters Indicators destination parameter values
and characteristics
The product Famous analogues
Analog 1 Analog 2
Coating Ceramic coating AL2O3,
Zr and ZrO2
— —
Reliability of use, lack
of resected bone
destruction
Three-dimensional wedge-
shaped leg, notrotation
guides ribs
Several rows of
rectangular fins —
Anatomical
construction
Head spherical, with a
hollow — —

13. Business Model
The main stages assist patientsThe main stages assist patients
Transfer data
(Internet)
Data
processing
Model
products
Manufacturing
of products
Deliver to
the customer
Payment
or
loan

14. Business Model
Existing production chainExisting production chain
Delivery
Ti,
stainless
steel
Individual
design
Preparatory
work
Metal
work
Finishing
processing
Coating
Installation
Marketing
and Sales
TIME ≈ 10 DAYSTIME ≈ 10 DAYS
PackagingPackaging
- «Inmasters»,
- «Delmed»
- “Institute of Surface
Engineering"
- «Inmasters»

15. Financial Projections
Planned salesPlanned sales
and profitand profit
FinancialFinancial
The main sources of income:The main sources of income:
✔ Substitution to foreign total
prostheses by the Ukrainian
unipolar
✔ Related Services (new workplaces)
✔ Profit from manufacturing &
selling
YearYear 2014 2015
Total sales,
items
50 100
Gross
income, UAH
2 800 000 5 600 000
Expense categoryExpense category Total projectTotal project
value, $value, $
Individual financial support 12,000
Equipment, services &
supplies
7,875
Certification 14,500
Advertisement 2,125
Total budgetTotal budget 36,50036,500

16. Road Map
Our partners and progressOur partners and progress
In Ukraine:In Ukraine:
- “INMASTERS” LLC;
- “DELMED” LLC;
- “Institute of Surface
Engineering", LLC
In USA:In USA:
- J. McLloy President “Accutek
Testing Laboratory”,;
- D. McGowan “Spine and
Orthopedic Surgery Associates”
CertificateCertificate
ISO 9001-ISO 9001-
20092009
In case ofIn case of
successful thesuccessful the
project, we areproject, we are
planning toplanning to
expand productionexpand production
that will allow gothat will allow go
to foreign marketto foreign market

17. The Team
LUKYANCHENKO, VolodymyrLUKYANCHENKO, Volodymyr
Chief researcherChief researcher
SAMOYLENKO, OleksandrSAMOYLENKO, Oleksandr
Managing the coordination,
Director “BES-T Manufacturing”
LLC
VOLODKOVA, NataliaVOLODKOVA, Natalia
Structural design
ZYKOVA, GannaZYKOVA, Ganna
SAFONOV, VolodymirSAFONOV, Volodymir
Procurement of technical
equipment required for the
application of coatings onto
products

18. THANK YOU!THANK YOU!
LLC «BES-T Manufacturing»LLC «BES-T Manufacturing»
Oleksandr SamoylenkoOleksandr Samoylenko
+38 050 294-50-83+38 050 294-50-83
samoylenko@lds.net.uasamoylenko@lds.net.ua
director@inmasters.netdirector@inmasters.netDeveloper:Developer:
Yulia Yakovleva