stemmatters, biotecnologia e medicina regenerativa lda avepark - parque de ciência e tecnologia...

Stemmatters, Biotecnologia e Medicina Regenerativa LdaAVEPARK - Parque de Ciência e Tecnologia S.A.

Zona Industrial da Gandra | S. Cláudio do BarcoAPARTADO 4152 | 4805 CALDAS DAS TAIPAS

E-mail: [email protected]: www.stemmatters.com

Stem cells and materials technologiesStem cells and materials technologies

Group 16 - Biomaterials and waste treatment

Ciência 2009, 29-30th July 2009, Lisbon




Strategic IntentStrategic Intent

To target clinical needs through the integration of advanced adult stem cell biology and novel biomaterials into

innovative therapeutic products for tissue regeneration




HistoryHistory

Academic spin-off of the 3B’s Research Group Created in November, 2007

Installed since September 2008 at the European Institute of Excellence for Tissue Engineering and Regenerative Medicine Research, Guimarães, Portugal.

Equipped with a future cGMP compliant facility for the processing of human tissue and cells (2003/94/EC Directive): 300 m2 of clean room (classes B, C and D);

250 m2 of R&D and QC laboratories.

1st funding round estimated to be finished by Sept, 2009 Start of operations estimated by Oct, 2009

Reception/

RegistrationRoom

Class B

Sample ProcessingRoom

Class B


Class B


Class B

Sample ExpansionRoom

Class C

Sample reception/

CentrifugationRoom

Centrifuge Room

Class D

CryopreservationRoom

Changing Room

Small Stock Room

One-way material/sample direction

Two-way material/sample direction

Personal way In through the control to the Dressing

Room

Personal way In to Class B Room

Personal way In to Class A Room

Personal way Out to the Undressing room / EXIT

Access to the cryopresevation room

Changing Clothes Passage

The material will be prepared, sterilized and packed in the “Washing room” and transfered to the near Class C pre-chamber when needed...

The workers will bring out all wastes/garbage with them to deposit at the garbage room before entering the Undressing room.All the wastes/garbage will be handled by an external company.

The workers will enter the Facilities through the “Reception Room” and according to the sample type, they will pick the necessary materials from the “Sterile Material Stock” Room and pass it to the “Material” Room near the “Dressing Room”.After changing clothes, they will enter the “Class C” corridor, if they go to one of the processing rooms or to the “Class D” corridor, if they go to the “Centrifugation Room”, taking the respective and pre-deposited material for that effect.

Dressing Room

Washing Room

Garbage




CSO: Rui L. Reis, CEng., MSc., PhD. (n. 1968) – Founder, President and Chief Scientific Officer: is an Associated Professor at the Department of Polymer Engineering and Director 3B’s Research Group. Editor in Chief of the Journal of Tissue Engineering and Regenerative Medicine, John Wiley and Sons Inc. He is author or co-author of more than 900 scientific publications.

CEO: Rui A. Sousa, CEng., MBA., PhD. (n. 1974) – Chief Executive Officer: is a senior researcher

at the 3B’s Research Group. Possesses business experience in several industrial and consultancy domains. He is author or co-author of more than 90 scientific publications and communications.

Dulce Costa Luísa Pereira João Oliveira Adrian Popa

TeamTeam




Social ContextSocial Context

The WHO estimates that more than 600 million people are aged above 60, being estimated that this number reaches the 2 billion by 2050.

Growing impact of degenerative or traumatic conditions due to demographic evolution, more dynamic lifestyles, and increased physical activities.




Regenerative Medicine

Overall MarketOverall Market

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Use of stem cells from adipose tissueUse of stem cells from adipose tissue

More than 1.6 billion people are overweight, of which 400 million are considered obese, with treatment costs between 2 and 8% of total health costs.

Steep increase in aesthetical surgical procedures, being Europe responsible for about one third of this global market.




Business PortfolioBusiness Portfolio

Stemmatters Therapeutics

Stemmatters Biomedical

Stemmatters Life Banking




Stemmatters TherapeuticsStemmatters Therapeutics




The Market for Cartilage Regeneration

Current MarketsCurrent Markets StemmattersTherapeutics

Prevalence of articular cartilage related lesions in Europe Nearly 250.000 traumatic incidents occur; About 7 million cases of treatable arthrosis occur each year.

High market potential for cartilage regeneration Among the biggest markets for connective tissues, being estimated between 1

to 5 billion €/year in Europe alone. Very high penetration of traditional treatment approaches Arthroscopic lavage and debridement, microfracture and mosaicplasty rule the

treatment of cartilage lesions. Cell based therapies with reasonable track record in this area ACT and MACI procedures are considered market references.




Product PipelineProduct Pipeline

ATMPs (Advanced Therapy Medicinal Products)

G01AT110C | pre-clinical | RECART Hydrogel/Adipose derived adult stem cells

G01AT300A | research | Hydrogel/Vascular stromal fraction derived cells

MDs (Medical Devices)

G01MD210B | research | Injectable filler for soft tissue applications

G01MD250B | research | Injectable filler system for maxillofacial applications

Products Under Development

StemmattersTherapeutics

Types of products currently under development:





Stemmatters Therapeutics | RECART Hydrogel/Adipose derived adult stem cells

Combined advanced therapy medicinal product (1394/2007 Regulation, CBMP EMEA guideline)

Polysaccharide hydrogel as an active implantable device Exopolysaccharide produced by microbial fermentation:

• Straight chain of repeating glucose, rhamnose and glucuronic acid units;

• Potential injectable system for minimally invasive surgeries;

• Processing under physiogical conditions without any reagents;

• Used in vivo for human ophthalmic applications and oral veterinary drug delivery.

Adipose derived adult stem cells Isolated from harvested adipose tissue:

• Dedicated or non-dedicated harvest procedure;

• Subpopulation isolated from the stromal vascular fraction;

• Good cell yield avoids previous cell expansion.






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Novel hydrogel system for TE applications





1 WEEK 2 WEEKS 3 WEEKS

No clear macroscopic change after 3 weeks of implantation. Extremely good integration with the surrounding tissues with a residual and thin fibrotic capsule.

Good performance upon subcutaneous implantation

Product PipelineProduct Pipeline StemmattersTherapeutics




col 1 col 2 aggrecan sox 90

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• Col1 was not detected after 8 weeks

Col2 increased ≈ 400 fold from 2-8 weeks

Aggrecan increased ≈ 35 fold from 2-8 weeks

Sox9 decreased close to zero from 2-8 weeks

house-keeping gene: GAPDH

8 WEEKS


Human chondrocytes form hyaline-like cartilage in vitro







ADIPOSE TISSUE FROM THE INTRASCAPULAR

REGION

ARTICULAR CARTILAGE FROM THE JOINTS

CHONDROGENIC PRE ≠ MEDIUM WITH TGF-Β1 + BMP-2

BASIC MEDIUM WITH NO PRE ≠

PROLIFERATION INDUCING MEDIUM WITH FGF-2







Macroscopic observation

Histology (H&E for cell morphology and tissue formation and alcian blue for cartilage ECM formation)

Histological scoring (Pineda score)

Real-time PCR analysis (Sox9, Collagen type I, Collagen type II, and Aggrecan)

Articular cartilage full-thickness defectSubchondral drill

(Ø 1 mm)

Implantation site Rabbit articular cartilage

(4 mm x 2-3 mm thickness)

+

+

+Study groups

Autologous approach

Total implantation time: 8 weeks

[Cells]=10x106 cells/mlCharacterization

A. Gellan + adipose tissue derived cells with pre differentiation period (ASC + GF*)

B. Gellan + adipose tissue derived cells with no pre differentiation period (ASC)

C. Gellan + articular chondrocytes (AC)

D. Gellan alone (GELLAN)

E. Empty defect (EMPTY)

*TGF-Β1 + BMP-2

J.T. Oliveira et al, Patent Application







4 weeks4 weeks 8 weeks8 weeks0 weeks0 weeks

Patent Application/Priority date: 01.2008J.T. Oliveira et al, Patent Application


Combination of hydrogel with ASCs is able to regenerate focal cartilage lesions






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Advantages of the cartilage repair strategy include: Potential therapeutic performance

Minimally invasive system to be administered arthroscopically

Avoids the need for a cartilage biopsy

Shorter time to therapy (TTT)

Competitive cost as compared to traditional ACT and MACI procedures





CompetitionCompetition

Cartilage applicationArthro Kinetics, BioTissue Technologies, Cellgenix,

co.don, Curasan, Educell, Fidia Advanced Biopolymers, Geistlich Surgery, Genzyme

Biosurgery, Histogenics, Interface Biotech, Karocell Tissue Engineering, Orthogen, TIGenix,

TETEC, Verigen Transplantation Service International

Cartilage: applicationStemmatters (Autologous)

Cartilage applicationco.don, Educell, Geistlich Surgery, Genzyme

Biosurgery, Interface Biotech, TIGenix, TETEC

Cartilage applicationOsiris Therapeutics (Allogeneic)

Skin applicationOrganogenesis, BioTissue Technologies, Advanced

BioHealing, Inc., Genzyme Biosurgery, Fidia Advanced Biopolymers, Intercytex, Celltran,

Forticell Bioscience, Cambrex

Bone application Aastrom Biosciences (Autologous),

Osiris Therapeutics (Allogeneic)

Several applications:Advanced Cell Technologies, Geron, ES Cell International, Stem Cell Sciences, Aastrom Biosciences, Aldagen, Angioblast Systems,

Athersys , BrainStorm Cell Therapeutics, Cardio3, Cellerant Therapeutics, Cognate Therapeutics ,

Gamida-Cell, Mesoblast , Neuronyx, Osiris Therapeutics, AdiStem, Bioheart, Cellerix, Cognate

Therapeutics, Cytori Therapeutics , ReNeuron Group Plc, Tengion, PharmaFrontiers , Tissue

Genesis, Inc , Gamida-Cell, Saneron CCEL Therapeutics, ViaCell

Primary cellsPrimary cells Progenitor cellsProgenitor cells

Other Cell Based Therapies

Other Cell Based Therapies

Tissue Engineering Products

Tissue Engineering Products






RECART Hydrogel/Adipose derived adult stem cells

R&D and non-clinical development

Clinical development MA Applic.

Marketing Authorization

In VivoTesting

Biomaterial R&D

In vitro testing

GMP grade

Phase I

Phase II

Phase III

2007-20102007-2010 2010-20182010-2018 20192019 20202020

Phase IV






RECART Hydrogel/Adipose derived adult stem cells

R&D and non-clinical development

Clinical development MA Applic.

Marketing Authorization

In VivoTesting

Biomaterial R&D

In vitro testing

GMP grade

Phase I

Phase II

Phase III

2007-20102007-2010 2010-20182010-2018 20192019 20202020

Phase IV

Stemmatters Life BankingStem cell isolation and storage services

Stemmatters BiomedicalProducts and services for R&D





Rui A. SousaCEO

Tel. +351-253-540100Fax. +351-253-540199

E-mail: [email protected]

ContactsContacts




Stemmatters Life BankingStemmatters Life Banking




Current MarketsCurrent Markets

Main application markets for stem cells

Current uses of stem cells are made in 3 distinct medical related markets:

Cell banking;

Therapeutic development;

Cell therapies.

(source: Frost & Sullivan).

StemmattersLife Banking




Current OfferingCurrent Offering

Stemmatters Life Banking | Stem cell isolation and storage services

Bone marrow (onstem service – B2C); Adipose tissue (adstem service – B2C):

The treatment of tissues and biological residues generated in surgical procedures assures a cell banking opportunity not yet addressed.

Market potential for the isolation and storage of adipose derived adult stem cells for autologous application is estimated to worth:

• 75 million €/year for Spain, France, Germany, UK, Italy and Portugal;

• 120 million €/year for EU15.

Assures a polyvalent platform for regenerative technologies; Assures positive cash flow and supports leveraging of R&D pipeline.






CompetitionCompetition StemmattersLife Banking






Acquisition Drivers Increased value of the surgical procedure; Potential application in future autologous regenerative therapies; Allows for off the shelf availability of personalized regenerative products; Decreases time for clinical delivery of therapy.

Current applications of adipose derived adult stem cells Radiation Necrosis

Breast Reconstruction

Heart Attack

Chronic Heart Disease

Crohn’s Disease

Tracheal Fistula Healing

Calvarial Repair

Marrow Transplant Complications

Diabetes





Stemmatters BiomedicalStemmatters Biomedical




Stemmatters Biomedical | Products and services for R&D


Isolation and processing services of human cells: Human stromal vascular fraction isolated from adipose tissue

containing human adipose derived stem cells (all samples are characterized for cell number and viability);

Human adipose derived stem cells (all samples are characterized for cell number and viability, as well as multipotent mesenchymal stem cell markers: CD29, CD105, CD34 and CD45);

• Pre-clinical research in regenerative medicine accounts for a market volume of about 700 million €/year.

Cell culturing products; Hydrogel support systems for 3D cell culturing;

• Very high R&D visibility among the potential buyer community;

• The global market potential for the commercialization of 3D supports for non-clinical R&D is estimated to worth between 7 and 35 million €/year.

Device for dynamic cell seeding and culturing.

StemmattersBiomedical




Corporate StrategyCorporate Strategy

R&D Stemmatters Therapeutics



Trade sale

Licensing

Spin-off




Corporate StrategyCorporate Strategy

R&D

Time to Market

Time inCorporate

Portfolio



Stemmatters Therapeutics

Technology

OtherCompany




Financial projectionsFinancial projections




Financial ProjectionsFinancial Projections

2009-2016

stemmatters, biotecnologia e medicina regenerativa lda avepark - parque de ciência e tecnologia...

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