EVOLUTION of
DENTAL IMPLANTS
The

February 2014
Ti Foam™ is a porous titanium
nanotechnology dental implant
that is created by a joint research
and development project by
National Research Council of
Canada Industrial Materials
Institute a Canadian government
supported SME incubator system
in conjunction with
Dr. Mislav Pavelic
Founder/CEO, DDS, FICOI
25 years of Industry experience
with over 10,000 real world
surgeries
2 previous successful start-ups
with industry buyouts
2/11/2014

Open Cell BioMed Merging Proprietary
Biomedical Materials with Human Cell Biology

2
2/11/2014

Open Cell BioMed Merging Proprietary
Biomedical Materials with Human Cell
Biology

3
Opencell’s
Healing
times
reduced

MONTHS

DAYS

Candidates
2X
with poor bone
increased
candidate pool

2/11/2014

Technology

Structure mimics bone
(the scaffold) +
(molecular enhancer)
Nanotechnology = 3D
super charged bone
growth bone growth

Open Cell BioMed Merging Proprietary
Biomedical Materials with Human Cell Biology

4
BIOMIMETIC SCAFFOLD
High porosity (70%-85%)
Permeability (i.e. pore size
between 50-400 µm)
Foaming creates 20X the
surface area for attachment

BONE
Structures and properties
mimic those of Trabecular
bone facilitating bone
growth and grafting

Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology
2/11/2014

5
BONE MORPHOGENIC PROTEINS
(BMP-2) INCREASE OSTEOBLAST
PROLIFERATION

IMBEDDING ANTIBIOTICS
(FLAGYL®
METRONIDAZOLE)
DRASTICALLY REDUCING
RISK OF INFECTION
Nano surface modifier's of the
Ti Foam™ porous titanium
scaffold; etching
processes, hydrophilic
agents, ionizers, hydroxyl
apatite's and phosphates Cell BioMed Merging Proprietary
Open

= super charged
bone growth

2/11/2014

Biomedical Materials with Human Cell
Biology

6
Video showing 3-Dimensional growth of Bone into Ti Foam™

http://www.youtube.com/watch?v=hdsc
nna5r1Q

2/11/2014

Open Cell BioMed Merging Proprietary
Biomedical Materials with Human Cell
Biology

8


The Opportunity



Dental Implant Market



$3.5 BILLION







High growth market over the
period 2010–2017, rising from $2.6
billion in 2010 to about $5 billion
in 2017,
aging population ,
emerging markets are currently only
a bleep in this market
Noble, Straumann, Biomet, and
Zimmer are all Billion dollar
companies
Numerous dental implant
companies – market is primed for
M&A activity
In 2010, Danaher purchase of Implant
Direct, an innovative fast-growing dental
implant company founded in 2004. The
value of the deal was $240 mil , or 4x
sales.

Open
2/11/2014 Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology

9
Competition / Customer / Acquirer
Company

Worldwide % of
Implant Market

20
20
19
9
8

Other

24

In 2012, Zimmer Dental
Inc., announced the launch of
their Trabecular Metal Dental
Implant (a product similar to TiFOAM – but not titanium) in the
U.S. and select global markets.
While segmented numbers are
not available for this particular
product, the company has said
that sales growth has been
strong. This product uses a
different manufacturing process
and does not incorporate
nanotech growth inducers or
antibiotics.

The EVOLUTION of
2/11/2014
Merging Proprietary Biomedical Materials with
Human Cell Biology

1.

Proprietary Technology – Strong IP -the foaming process is

developed by National Research Council of Canada Industrial Materials Institute
and exclusively licensed to our company for the use on dental implants.
Additionally the company has patents pending on the manufacturing process for
a Titanium foamed surface coated dental implant and a fully Titanium foamed
dental implant as well as design patents for a Titanium foamed surface coated
dental implant and a fully Titanium foamed dental implant.
2.

Process and design –2 Other companies (Biomet-3i and Zimmer) have
porous titanium from other manufacturing processes (chemical treatments)but
have not been able to utilize it on a dental implant design

3.

Strategic Partnerships – Our strategic relationships with National
Research Council of Canada Industrial Materials Institute and participating
universities build barriers of entry for our competition

4.

Proprietary Surgical Technique - Bone Graft Surface Impaction
Technique®

5.

Low Regulatory Risk – Class 2 Medical Device – gets to market
quickly
11
2/11/2014

Completed Stage 4 in our R&D project
namely FDA 510K requirements
1-Development and optimization of the design
2-Validation of the performances
(structure, microstructure, composition, implantation, Fatigue
Testing ISO14801 Testing completed- Results show the foam
holds up to and beyond the forces of mastication*
3-Optimization of the fabrication process

The project cost 1 million to complete with $500,000.00 in
seed capital from the principal and The Canadian
Government contributed its facilities and Labour force to
the tune of $500,000.

The company is now ready to commercialise its unique first
product line of Ti Foam™ nanotechnology coated
threaded dental implant system.
Merging Proprietary Biomedical Materials with Human Cell Biology
12
Near-term Regulatory Clearance
• Ti-FOAM™ NT Threaded Implant System is fully developed
• U.S. – Class 2 device following 510k Pre-market Notification
application process (demonstrate equivalence with approved
device – clinical trials NOT required)
• Completed:
• Development and optimization of design
• Validation of performance
• Optimized fabrication process

• Required:
Preparation of Application (estimate)

60 days

FDA Clearance Time for Dental Implant (allows for marketing)

90 days

ESTIMATED TIME TO “APPROVAL”
The EVOLUTION of

150 days
Merging Proprietary Biomedical Materials with Human Cell Biology

online worldwide ordering system
offer a low cost end user dental implant
numerous up sell possibilities

Focus on emerging markets

Revenue Sources
• Dental Implant Systems

• Attachments
• Surgical Instrumentation
• Biologics
• Education and Practice growth strategies

2/11/2014

14
POROUS TITANIUM SCAFFOLD



SEM View of the
TI-FOAM™
Threaded Dental
Implant

NANOTECH GROWTH INDUCERS
2/11/2014

15





TI-FOAM™ Full Foam Design dental implant
(designed and tested – undeveloped)
TI-FOAM™ Full Foam threaded dental implant
Biologics –graft material
Hip, knee and shoulder designs

Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology
2/11/2014

16
Merging Proprietary Biomedical Materials with Human Cell Biology

Getting the word out

Build a Doctor sales force by making their
practice a Center for Excellence.
Focus on the Ultimate Decision Makers
“Patients” Through web based and viral

marketing campaigns t
Trade Show exhibits and Conferences are the
most common and effective forms of getting
information and awareness to the Doctors
that are using dental implants already or may
want to use our product
2/11/2014

17
Direct To Consumer Advertising is the
future of Healthcare marketing


Direct to consumer multi-media blitz –
emphasis on Ti Foam™ ‘s patient
benefits/Patients wants: Fast
procedures, Minimally invasive
procedures, Long lasting results and
Good aesthetics



Medical, pharmaceutical and now
dental advertising is on the increase



Consumer awareness of dental
implants is increasing



Patients seek more information
regarding treatment and they will
increasingly use the resources of the
internet and social media

2/11/2014

18
Merging Proprietary
Biomedical Materials with
Human Cell Biology

2/11/2014

Mislav Pavelic Founder/CEO, DDS, FICOI
25 years of Industry experience with over 10,000 real world surgeries
2 previous successful startups with industry buyouts
William Simmons COO 30 years operational experience in
manufacturing and design of dental implants
Stefan Kim VP Marketing /Sales New Media Guru
Ragan Mengal CFO 15 years in finance
19







Capital expenditures
Regulatory,
documentation
/administration
Operations
Marketing
R&D
.
Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology

2/11/2014

20
Seeking Funding to commercialize the product line
Series A funding of 1.5 million -preferred shares
 Distributor – selling rights sold per area – sales
Seeking $1.5 million
FDA & split Canada Marketing Applications 20%
Health on commission basis
$500,000
PatentJoint Ventures – negotiable - M&A
$100,000
 expenses (incl. additional applications)


Packaging and labeling

$200,000

Marketing and Sales

$200,000

Salaries and Administration

$500,000

2/11/2014

21

Nrc slides

  • 1.
  • 2.
    Ti Foam™ isa porous titanium nanotechnology dental implant that is created by a joint research and development project by National Research Council of Canada Industrial Materials Institute a Canadian government supported SME incubator system in conjunction with Dr. Mislav Pavelic Founder/CEO, DDS, FICOI 25 years of Industry experience with over 10,000 real world surgeries 2 previous successful start-ups with industry buyouts 2/11/2014 Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2
  • 3.
    2/11/2014 Open Cell BioMedMerging Proprietary Biomedical Materials with Human Cell Biology 3
  • 4.
    Opencell’s Healing times reduced MONTHS DAYS Candidates 2X with poor bone increased candidatepool 2/11/2014 Technology Structure mimics bone (the scaffold) + (molecular enhancer) Nanotechnology = 3D super charged bone growth bone growth Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 4
  • 5.
    BIOMIMETIC SCAFFOLD High porosity(70%-85%) Permeability (i.e. pore size between 50-400 µm) Foaming creates 20X the surface area for attachment BONE Structures and properties mimic those of Trabecular bone facilitating bone growth and grafting Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 5
  • 6.
    BONE MORPHOGENIC PROTEINS (BMP-2)INCREASE OSTEOBLAST PROLIFERATION IMBEDDING ANTIBIOTICS (FLAGYL® METRONIDAZOLE) DRASTICALLY REDUCING RISK OF INFECTION Nano surface modifier's of the Ti Foam™ porous titanium scaffold; etching processes, hydrophilic agents, ionizers, hydroxyl apatite's and phosphates Cell BioMed Merging Proprietary Open = super charged bone growth 2/11/2014 Biomedical Materials with Human Cell Biology 6
  • 7.
    Video showing 3-Dimensionalgrowth of Bone into Ti Foam™ http://www.youtube.com/watch?v=hdsc nna5r1Q 2/11/2014 Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 8
  • 8.
     The Opportunity  Dental ImplantMarket  $3.5 BILLION    High growth market over the period 2010–2017, rising from $2.6 billion in 2010 to about $5 billion in 2017, aging population , emerging markets are currently only a bleep in this market Noble, Straumann, Biomet, and Zimmer are all Billion dollar companies Numerous dental implant companies – market is primed for M&A activity In 2010, Danaher purchase of Implant Direct, an innovative fast-growing dental implant company founded in 2004. The value of the deal was $240 mil , or 4x sales. Open 2/11/2014 Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 9
  • 9.
    Competition / Customer/ Acquirer Company Worldwide % of Implant Market 20 20 19 9 8 Other 24 In 2012, Zimmer Dental Inc., announced the launch of their Trabecular Metal Dental Implant (a product similar to TiFOAM – but not titanium) in the U.S. and select global markets. While segmented numbers are not available for this particular product, the company has said that sales growth has been strong. This product uses a different manufacturing process and does not incorporate nanotech growth inducers or antibiotics. The EVOLUTION of
  • 10.
    2/11/2014 Merging Proprietary BiomedicalMaterials with Human Cell Biology 1. Proprietary Technology – Strong IP -the foaming process is developed by National Research Council of Canada Industrial Materials Institute and exclusively licensed to our company for the use on dental implants. Additionally the company has patents pending on the manufacturing process for a Titanium foamed surface coated dental implant and a fully Titanium foamed dental implant as well as design patents for a Titanium foamed surface coated dental implant and a fully Titanium foamed dental implant. 2. Process and design –2 Other companies (Biomet-3i and Zimmer) have porous titanium from other manufacturing processes (chemical treatments)but have not been able to utilize it on a dental implant design 3. Strategic Partnerships – Our strategic relationships with National Research Council of Canada Industrial Materials Institute and participating universities build barriers of entry for our competition 4. Proprietary Surgical Technique - Bone Graft Surface Impaction Technique® 5. Low Regulatory Risk – Class 2 Medical Device – gets to market quickly 11
  • 11.
    2/11/2014 Completed Stage 4in our R&D project namely FDA 510K requirements 1-Development and optimization of the design 2-Validation of the performances (structure, microstructure, composition, implantation, Fatigue Testing ISO14801 Testing completed- Results show the foam holds up to and beyond the forces of mastication* 3-Optimization of the fabrication process  The project cost 1 million to complete with $500,000.00 in seed capital from the principal and The Canadian Government contributed its facilities and Labour force to the tune of $500,000.  The company is now ready to commercialise its unique first product line of Ti Foam™ nanotechnology coated threaded dental implant system. Merging Proprietary Biomedical Materials with Human Cell Biology 12
  • 12.
    Near-term Regulatory Clearance •Ti-FOAM™ NT Threaded Implant System is fully developed • U.S. – Class 2 device following 510k Pre-market Notification application process (demonstrate equivalence with approved device – clinical trials NOT required) • Completed: • Development and optimization of design • Validation of performance • Optimized fabrication process • Required: Preparation of Application (estimate) 60 days FDA Clearance Time for Dental Implant (allows for marketing) 90 days ESTIMATED TIME TO “APPROVAL” The EVOLUTION of 150 days
  • 13.
    Merging Proprietary BiomedicalMaterials with Human Cell Biology online worldwide ordering system offer a low cost end user dental implant numerous up sell possibilities Focus on emerging markets Revenue Sources • Dental Implant Systems • Attachments • Surgical Instrumentation • Biologics • Education and Practice growth strategies 2/11/2014 14
  • 14.
    POROUS TITANIUM SCAFFOLD  SEMView of the TI-FOAM™ Threaded Dental Implant NANOTECH GROWTH INDUCERS 2/11/2014 15
  • 15.
        TI-FOAM™ Full FoamDesign dental implant (designed and tested – undeveloped) TI-FOAM™ Full Foam threaded dental implant Biologics –graft material Hip, knee and shoulder designs Open Cell BioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 16
  • 16.
    Merging Proprietary BiomedicalMaterials with Human Cell Biology Getting the word out Build a Doctor sales force by making their practice a Center for Excellence. Focus on the Ultimate Decision Makers “Patients” Through web based and viral marketing campaigns t Trade Show exhibits and Conferences are the most common and effective forms of getting information and awareness to the Doctors that are using dental implants already or may want to use our product 2/11/2014 17
  • 17.
    Direct To ConsumerAdvertising is the future of Healthcare marketing  Direct to consumer multi-media blitz – emphasis on Ti Foam™ ‘s patient benefits/Patients wants: Fast procedures, Minimally invasive procedures, Long lasting results and Good aesthetics  Medical, pharmaceutical and now dental advertising is on the increase  Consumer awareness of dental implants is increasing  Patients seek more information regarding treatment and they will increasingly use the resources of the internet and social media 2/11/2014 18
  • 18.
    Merging Proprietary Biomedical Materialswith Human Cell Biology 2/11/2014 Mislav Pavelic Founder/CEO, DDS, FICOI 25 years of Industry experience with over 10,000 real world surgeries 2 previous successful startups with industry buyouts William Simmons COO 30 years operational experience in manufacturing and design of dental implants Stefan Kim VP Marketing /Sales New Media Guru Ragan Mengal CFO 15 years in finance 19
  • 19.
         Capital expenditures Regulatory, documentation /administration Operations Marketing R&D . Open CellBioMed Merging Proprietary Biomedical Materials with Human Cell Biology 2/11/2014 20
  • 20.
    Seeking Funding tocommercialize the product line Series A funding of 1.5 million -preferred shares  Distributor – selling rights sold per area – sales Seeking $1.5 million FDA & split Canada Marketing Applications 20% Health on commission basis $500,000 PatentJoint Ventures – negotiable - M&A $100,000  expenses (incl. additional applications)  Packaging and labeling $200,000 Marketing and Sales $200,000 Salaries and Administration $500,000 2/11/2014 21