Modules of the Modules of the components of a hip components of a hip

jointjoint

Authors: V. Lukyanchenko Lugansk A. SamoylenkoLLC «BES-T Manufacturing»

Presenter: Yulia Yakovleva Science and Technology Entrepreneurship Program“From Idea to Market”

February, 24, Kiev, UkraineNatalia Volodkova

SummaryObjective:Objective: decrease of the death rate among senile population of decrease 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 emergency oncology, orthopedics and surgical departments and emergency hospitals.hospitals.

Project duration:Project duration: 24 months 24 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 of transfer 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)

Steps of ProjectI.I. – – the certification procedure - $the certification procedure - $ 1414,,500 500 including including finishing - $ 6,300)finishing - $ 6,300) ((CCRDF costs RDF costs - $ - $ 5,700)5,700);;II.II. – – establishing the government and business partnership establishing the government and business partnership – –

$$ 11,,500 500 ((CCRDF costs RDF costs - $ 300- $ 300));;

III.III. – – promoting the production cooperationpromoting the production cooperation – – $$ 11,,260 260 ((CCRDF RDF costs costs - $ 1,200- $ 1,200));;

IV.IV. – – launching the advertizing campaignlaunching the advertizing campaign – – $$ 625 625 ((CCRDF costs RDF costs - $ 600- $ 600));;

V.V. – – preparing for the participation in public tender preparing for the participation in public tender procurements procurements ((Ministry of HealthMinistry of Health, , Regional Health Care Regional 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 and production 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 to of a batch to the children of war, according to the advertizing campaign and the rest of the batch will be given to the 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 realization Syeverodonets'k, Balakleya, Kharkiv, for commercial realization – – $$ 1717,,615 615 ((CCRDF costs RDF costs - $ 4,- $ 4,220000))..

The problem Production of reliable high-quality orthopedic implants Production 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.

Solution

Main products:Main products:

Modules of the Modules of the components of a hip components of a hip joint joint

(cemented and noncemented (cemented and noncemented fixation)fixation)

Main advantages:Main advantages:

Treatment at nonspecialized clinicsTreatment at nonspecialized clinics;;

Anatomical prosthetics (conchoidal Anatomical prosthetics (conchoidal shape of a headshape of a head)) is provided is provided;;

Heads can be coated with alumina Heads can be coated with alumina film, ceramic coatingsfilm, ceramic coatings;;

Alloy materials application, such as Alloy materials application, such as stainless steel, Co-Cr, Ti, Zr, Ta;stainless steel, Co-Cr, Ti, Zr, Ta;

Alongside with multivariant fabrication Alongside with multivariant fabrication of components (titanium, stainless of components (titanium, stainless steel);steel);

Cemented and noncemented fixationCemented and noncemented fixation..

These needs will be resolved:These needs will be resolved: Mitigation of pain, fast recovery of locomotive Mitigation of pain, fast recovery of locomotive

function;function;

Deformation correction, extremity length Deformation 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 district Advancing qualification of doctors in district hospitals;hospitals;

The reduction in mortality among patients with The 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 in Opportunity to purchase endoprosthesis in installments.installments.

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.

Why anatomical heads, for old people?Why anatomical heads, for old people?

less chance of less chance of dislocation;dislocation; a larger range of a larger range of motion;motion; less wear of the less wear of the insert;insert; more stability in the more stability in the joint.joint.

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

Our facilitiesOur facilities

Market OpportunityMarket volumeMarket volume

World marketWorld market:: ~~ 7-8 7-8 bln $/year bln $/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

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 — —

Modular designHeads and modular

adapters — —

Business ModelThe 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

Business ModelExisting production chainExisting production chain

Delivery Ti,

stainless steel

Individual design

Preparatory work

Metal work

Finishing processing

Coating

Installation

Marketingand Sales

TIME ≈ 10 DAYSTIME ≈ 10 DAYS

PackagingPackaging

- «Inmasters»,- «Delmed»

- “Institute of Surface Engineering"

- «Inmasters»

Financial ProjectionsPlanned sales Planned sales

and profitand profitFinancialFinancial

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 project Total 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

Road MapOur 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”

Certificate Certificate ISO 9001-ISO 9001-

2009 2009

In case of In case of successful the successful the project, we are project, we are planning to planning to expand production expand production that will allow go to that will allow go to foreign marketforeign market

The Team

LUKYANCHENKO, Volodymyr LUKYANCHENKO, Volodymyr Chief researcherChief researcher

SAMOYLENKO, Oleksandr SAMOYLENKO, Oleksandr Managing the coordination, Director “BES-T Manufacturing”

LLC

VOLODKOVA, NataliaVOLODKOVA, Natalia Structural design

ZYKOVA, GannaZYKOVA, Ganna

SAFONOV, Volodymir SAFONOV, Volodymir

Procurement of technical equipment required for the application of coatings onto products

THANK YOU!THANK YOU!

LLC «BES-T Manufacturing»LLC «BES-T Manufacturing»Oleksandr SamoylenkoOleksandr Samoylenko+38 050 294-50-83+38 050 294-50-83samoylenko@lds.net.uasamoylenko@lds.net.uadirector@inmasters.netdirector@inmasters.net

Developer: Developer: Yulia Yakovleva