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INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis....

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I.CERAM Investors Presentation August 2018 INVESTOR PRESENTATION AUGUST 2018 « Ceramic excellence for the treatment of bone infections and bone tumors »
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Page 1: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

INVESTOR PRESENTATIONAUGUST 2018

« Ceramic excellence for the treatment

of bone infections and bone tumors »

Page 2: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Your contacts

André KERISITCEO, Founder

Christophe DURIVAULT

Financial Director

▪ 32 years of experience in orthopaedic devices

▪ Sales manager and Product developper

▪ Founder of 2 companies

2

Eric DENES, M.D

Scientific Director

Page 3: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Where do we come from?

3

Page 4: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Ambition: the whole skeleton

« Becoming the leader in bone

replacement for infection & cancer

with our innovative implants, made of porous alumina ceramic »

CE marked in July 2018

Our vision, our goal

Page 5: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Short-term investment plan

▪ Sternal prosthesis was CE marked in July

2018 ▪ → A. Commercialization investments for the EU market

including France

▪ → B. Investments, including a new production facility in the

Limoges area

▪ Next regulatory step to address U.S. markets▪ → C. Begin U.S. FDA approval process

5

Page 6: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

CERAMIC IMPLANT

(+ Active molecule)

DISEASED PART:

- Infection

- Cancer

6

Our technology: Summary

CERAMIC IMPLANT

(Mechanical properties)

Page 7: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Our technology:

Ceramil®

Alumina ceramic

Page 8: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018 8

Céramil® Cancellous bone

Bone mimicker

Page 9: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018 9

Main characteristics

Unique capacity of

bone integrationPorosity range from

100 to 900 μm

Proved

biocompatibility, inert

Mechanical strength

more than 20 MPa3 times cancellous bone

strength in compression

Radiolucency and

compatibility

with radiotherapy

Pure alumina Al2O3

Interconnected

porosity without

dead endA certain level of

resistance to

bacterial infection

Non resorbable

Page 10: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018 10

Ceramic track record

First implantation:1995

Several patents

CE mark since:1997

Renewed by I.CERAM

since 2006

Implantations:>6000

Knee wedges: >3000 (first pieces)

Cervical cages: >1700

Lumbar cages: >250

Trepan filling: >130

Various orther shapes

No infection No material vigilance

Page 11: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

▪ In vitro▪ Colony forming unit stuck to

several materials

▪ A : Staphylococcus aureus

▪ B : Pseudomonas aeruginosa

▪ Strains forming biofilm

Dr T.S Ouk, MCU-Ph - Laboratoire de Chimie des Substances Naturelles, University of Limoges

* : p<0,05

* : p<0,05

** : p<0,001

A

B

11

Low bacterial adhesion

**

**

Amount of S. aureus adherent to different materials

Page 12: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018 12

MC3T3-E1 cells. Nucleus marked with DAPI.

Great osseointegration

Bone cells colonize pores and secrete

and mineralize bone matrix

Histology of bone tissue observed at 2 different stages in 2 close

pores at M7

Mature bone (light pink area) New bone formation (dark pink area)

J3 J7

Page 13: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

The family tree

13

No more development but a strong basement:

> 6000 implantations without any complication

Investments

Joint

replacement

Every boneBone

Tumor

Bone

Infection

Antibiotic loading

Page 14: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Antibiotic loading

Our technology: Ceramil®

Page 15: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Material colonisation

H+2Adhesion

H+4Beginning of

biofilm formation

H+8Biofilm over all

the surface

H+24Bacteriarelease

15

Olson ME, et al. J Biomed Mater Res. 1988 Jun; 22: 485–95.

Page 16: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

In vitro release

16

Gentamicin Vancomycin

Page 17: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Natural antibiotic spectrums

17

S. aureus

S. epidermidis

Streptococcus ssp.

Page 18: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018 18

BoneDefect

INFECTION

•Native bone

•Prosthesis

CANCERAGENESIS

Page 19: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

- Unloaded sternum (Tumour & Agenesis)

- Antibiotic loaded sternum

- Antibiotic loaded bone flap

I.Ceram answers to clinical

challenges:

Page 20: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Sternal metastasis

Chest wall reconstruction after metastasis removal

Page 21: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Bone agenesis (Sternum)

9 year-old girl

Down syndrome

Cardiac neonate surgery

Surgery performed in

MarseilleDischarged on day 6

Page 22: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Deep sternal wound infection

after cardiac surgery

After 10 months of hospitalisation 1 week after surgery 3 weeks after surgery, day of discharge

Reportage : Magazine de la santé / 13 avril 2018 (M22 post opératoire)

Antibiotic (gentamicin) loaded device

Page 23: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Chronic OsteomyelitisResistant Staphylococcus (MRSA)

Bone fistula and diseased bone

Bone flap impacted and anchored

Bone fistula

Skin fistula

M11 Follow-up (June 2018)

Bacteriology samples:

All positive with MRSA

Loaded with gentamicin

Page 24: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

▪ Local dosages▪ Comparison with the required concentration for efficacy:

▪ Blood samples:▪ No or very low concentrations

▪ Reduced toxicity24

Device Loaded

gentamicine

dose

H1 H5 H24

Sternum * 320 mg1500 mg/L

> 175

395 mg/L

> 50

Sternum * 160 mg2100 mg/L

> 260

36,9 mg/L

> 4.6

Bone flap ** 160 mg184 mg/L

> 50

13 mg/L

> 4

* For an MIC of 1 mg/L

** MRSA MIC for

gentamicin < 0.5 mg/L

Concentration (mg/L)

Bone Sample H1 H3 H6 H12 H24 H48

# 1 Sternum Blood < 0,5 < 0,5 < 0,5 < 0,5 < 0,5 < 0,5

# 2 Sternum Blood < 0,5 0,6 0,6 < 0,5 < 0,5

#3 Femur Blood < 0,5 < 0,5 < 0,5 < 0,5 < 0,5

#4 Sternum Blood < 0,5 < 0,5

In vivo

Page 25: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Focus on Sternum

▪ To date:▪ 13 implantations

▪ Of which 3 loaded with gentamicin

▪ Mean follow-up : 20 months

▪ First one : more than 3 years of follow-up

▪ CE marking obtained in July 2018

25

Page 26: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Partnerships for distribution

26

Page 27: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Scientific publications

▪ 2 articles accepted for publication in

international journals:▪ F. Bertin, E. Deluche, J. Tricard, A. Piccardo, E. Denes. First case of sternal replacement of bioceramic with

bioceramic prosthesis after radio-induced sarcoma. Curr Oncol. 2018

▪ F. Bertin, A. Piccardo, E. Denes, G. Delepine, J. Tricard. Porous alumina ceramic sternum: A reliable option for

sternal replacement. Annals of Thoracic Medicine. 2018

▪ Oral communications▪ Jérémy Tricard, Alessandro Piccardo, Nicolas Pichon, Denis Asselineau, François Bertin. Résultats des premières

implantations de la prothèse CERAMIL®, un nouveau dispositif de remplacement sternal - SFCTCV (Société Française de

Chirurgie Thoracique et Cardio-Vasculaire), Journées d'Automne 2016

▪ Posters▪ F. Bertin, E. Denes, G. Levêque, F. Fiorenza, J. Tricard, D. Setton, C. Mage, F. Sturtz. Sternum replacement by a porous

alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

▪ François Bertin, Jérémy Tricard, Claire Eveno, Eric Denes, Alessandro Piccardo. Porous alumina ceramic sternum as an

option for sternal replacement. About 7 cases - 25th European Conference on General Thoracic Surgery Innsbruck,

Austria, 28 – 31 May 201727

Page 28: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Presentation to surgeons

▪ International meetings attendance for sternum présentation▪ 26th European Conference on General Thoracic

Surgery (ESTS)

▪ 2018 – Ljubljana (Slovenia)

▪ 52nd Annual Meeting of the Association for European Paediatric and Congenital Cardiology

▪ 2018 – Athens (Greece)

▪ 71st Congrès de chirurgie thoracique et cardio-vasculaire

▪ 2018 – Lille (France)

▪ Vivatechnology – Paris 2018

28

Page 29: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Regulation

▪ Beginning of:▪ CE marking for the antibiotic loaded sternum

▪ Our objective: 2020

▪ Antibiotic file review: max 210 days

▪ FDA approval

▪ Mean time for class III (PostMarket Approval): 400 days

▪ Thus, our objective: 2021

▪ Submission cost: ~250,000 $

▪ Global budget: 1,000,000 $

Page 30: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Same bone, different diseases

Infection

Cancer

30

AgenesieI.Ceram :

The solution

Agénésie

Infection

Cancer

: One solution for all sternal pathologies

Page 31: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Participation in 3D printing

company

▪ Minority shareholder (49%)

▪ For single use ancillaries

▪ Metal and plastic 3D printing

31

Page 32: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

The future

32

Main

axes

• New shapes, volumes & structure

• Loaded sternum CE marking

• FDA

• Other molecules

• Worldwide distribution

Page 33: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

Financial figures

Page 34: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

I.Ceram stock

▪ Listed in Paris

▪ Market Place:

Euronext Growth

▪ Mnemonics:

ALICR

▪ Average daily

volume: 2,600

Page 35: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

I.Ceram Shareholding

35

André

KERISIT

50%

Xale

Finance (Belgium)

36,5%

Ernée

Gestion (Luxembourg)

13,5%

Private investors

43,5%

Investissement Développement

56,5%

SA I.CERAM

ADDIDREAM

49%

I.Ceram PT

(Portugal)

100%

I.Ceram SRO

(Czeck

Republic)

100%

I.Ceram

South Africa

33%

Limousine de

Brevet

100%

I.Ceram UF

(SASU)

100%

3D Printing Commercial/Business IP New factory

project

Page 36: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

P&L

K€Year 2017

Audited

Year 2016

Audited

Turnover 1 479 1 506

Ebitda -1 385 -1 198

Operating profit -2 125 -1 716

Financial profit 53 -126

Exceptional profit - 85 - 53

Yearly Net Loss -2 157 -1 895

Page 37: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

2016 Dec. 31st

Balance Sheet (K€)

Assets

Short Term

Receivables

3 191

1 300

11 219 K€

Liabilities

11 219 K€

Assets

8 688

Available Cash

2017 Dec. 31st

3 573

3 606

Equity

Loans1 858

9 586 K€

Liabilities9 586 K€

Assets

6 514

2 407

Equity

Loans

4 057

3 971

Other debtsOther debts1 214 1 231

Page 38: INVESTOR PRESENTATION - I.CERAM€¦ · Sternum replacement by a porous alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule

I.CERAM

Investors Presentation

August 2018

To summarize the pitch

▪ A disruptive technology protected by patents

and secrets

▪ It’s just the good time to adress new big markets

▪ A complete and complementary team

▪ A complete in-house business model for the

greatest value for shareholders


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