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OSTEOPORE LIMITED — Investor Presentation 2021
Mar 21, 2021
65512_rns_2021-03-21_edc37b30-b002-4282-9a61-0582cab7d679.pdf
Investor Presentation
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INVESTOR PRESENTATION M A R C H 2 0 2 1
I N V E S T O R P R E S E N T A T I O N
O S T E O P O R E . C O M
DISCLAIMER
This presentation has been prepared by Osteopore Limited and its related entities (the “Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not treat the contents of this presentation, or any information provided in connection with it, as financial advice, financial product advice or advice relating to legal, taxation or investment matters.
No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness or reasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection with it, or any omission from this presentation, nor as to the attainability of any estimates, forecasts forecasts or projections set out in this presentation.
This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your own independent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at any time in its absolute discretion (without incurring any obligation to do so).
Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entity arising out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and Investments Commission Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expressly disclaimed and excluded.
Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be used in isolation as a basis to invest in the Company.
Future matters
This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company. Those intentions, expectations, future plans, strategy and prospects may or may not be achieved. They They are based on certain assumptions, which may not be met or on which views may differ and may be affected by known and unknown risks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside the control of the Company. No representation or warranty, express or implied, is made by the Company, or any of its directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved either totally or partially or that any particular rate of return will be achieved. Given the risks and uncertainties that may cause the Company’s actual future results, performance or achievements to be materially different from those expected, planned or intended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that the actual results, performance or achievements will be as expected, planned or intended.
US Disclosure
This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of any “US person” as defined in Regulation S under the US Securities Act of 1993 (“Securities Act”). The Company’s shares have not been, and will not be, registered under the Securities Act or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States or to any US person without being so registered or pursuant to an exemption from registration including an exemption for qualified institutional buyers.
O S T E O P O R E . C O M 2
I N V E S T O R P R E S E N T A T I O N
TRANSFORMATIVE BONE REGENERATION PRODUCTS
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BREAKTHROUGH TECHNOLOGY
Unique 3D printed implants that
facilitate vascularisation to accelerate
bone and tissue regeneration
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BREAKTHROUGH TECHNOLOGY IMPROVES LIVES REVENUE INCREASING
Extremely low probability of issues Revenue is growing as surgeons
Unique 3D printed implants that
facilitate vascularisation to accelerate after surgery compared to bone grafts increasingly switch from traditional
and permanent implants products to Osteopore implants
bone and tissue regeneration
TARGETING THE SIGNIFICANTLY UNTAPPED US$3.9BN BONE GRAFT & US$100BN PERMANENT IMPLANT MARKET WITH SUPERIOR PRODUCTS
I N V E S T O R P R E S E N TAT I O N O S T E O P O R E . C O M 3
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Source for market size data: Allied Market Research, BCC Research
INVESTMENT HIGHLIGHTS
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41%
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GROWTH $1.1m
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CY19
REGULATORY CLEARANCE
Osteopore’s products are cleared by
the US FDA, Australian TGA and some bear the CE mark of conformity $1.5m
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GROWING REVENUE
AUD$1.5 million in revenue for the twelve
month period to 31 December 2020, with around 50,000 successful treatments to date
CY20
SCALABLE BUSINESS MODEL
High margin products with low manufacturing capital intensity provide significant opportunity to scale the business and enter new markets
HIGHLY CREDENTIALED TEAM
The Company has a highly credentialed, collaborative and experienced team to progress the commercialisation and expansion of the Company’s technology
O S T E O P O R E . C O M 4
I N V E S T O R P R E S E N TAT I O N
ROBUST CASH POSITION TO DRIVE GROWTH
Shares on Issue[A] 117.2m Total Options on Issue[B] 13.1m Market Cap @ $0.44c[C] $51.5m $42.5m EV @ $0.44[C] CASH BALANCE[D] $9.0m FY20 Average Quarterly ($388k) Net Operating Cash Used
A: Shares on Issue includes 16.0m placement shares in August 2020.
B: 9.7m options with an exercise price of $0.25 and an expiry date of 30 June 2022, 0.4m options with an exercise price of $1.00 and an expiry date in December 2022, 3m options with exercise price of $1.20 and expiry August 2023. Option incentives held by executive management, directors & advisors.
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ASX: OSX SHARE PRICE PAST 12 MONTHS
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$0.80
$0.60
$0.40
$0.20
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MARCH APRIL MAY JUNE JULY AUG SEP OCT NOV DEC JAN FEB MARCH 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2021 2021 2021
C: Market Close, 1 March 2021
D: Cash balance at 31 December 2020
O S T E O P O R E . C O M 5
I N V E S T O R P R E S E N TAT I O N
HIGHLY CREDENTIALED TEAM
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GOH
KHOON
SENG
CEO
30-year career spanning both start-ups
and global multinational corporations
The last 20 years were at Medtronic Inc
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- The last 20 years were at Medtronic Inc Inc and Edwards Lifesciences Asia
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TEOH
SWEE
HIN
Non-Exec Director
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- Co-founder of Osteopore
Prof. Teoh has deep research experience in load bearing scaffolds for tissue regeneration and remodeling
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BRETT
SANDERCOCK
Non-Exec Chairman
Current CFO of Resmed (ASX:RMD / NYSE: RMD)
Senior executive at Norton Abrasives (Saint-Gobain)
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Senior executive at Norton Abrasives (Saint-Gobain)
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GEOFF
POCOCK
Non-Exec Director
20 years corporate finance and technology
commercialisation experience
Formerly Managing Director of Hazer Group
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- Formerly Managing Director of Hazer Group Ltd (ASX:HZR) and Non-Executive Director of ASX listed and private companies
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STUART
CARMICHAEL
Non-Exec Director
Partner of Ventnor Capital
Non-Executive Chairman and Director
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Non-Executive Chairman and Director of various ASX listed entities
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CARL
RUNDE
Chief Financial Officer
Former Vice President Corporate Systems and
FP&A at ResMed (NYSE:RMD / ASX:RMD)
Over 20 years of international experience as a finance
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Over 20 years of international experience as a finance business partner in commercial, R&D, and manufacturing functions in the medical device industry
O S T E O P O R E . C O M 6
I N V E S T O R P R E S E N TAT I O N
-
BREAKTHROUGH BIORESORBABLE
-
PRODUCTS FOR MULTIPLE APPLICATIONS
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Implant that is used to fill the
Implant that is used for
void following a craniotomy
covering Burr Holes (holes
(the surgical removal of part of
in skull) after neurosurgery
the bone from the skull to
expose the brain)
REGULATORY APPROVAL SALES GENERATING
REGULATORY APPROVAL SALES GENERATING
DENTAL
Dental plug which promotes
Implant used in craniofacial
vertical bone growth in the jaw
surgery to repair bone in the
following tooth removal
skull, neck and jaw, including
repairing orbital floor fractures
REGULATORY APPROVAL SALES GENERATING REGULATORY APPROVAL * SALES GENERATING
ORTHOPAEDIC
OSTEOPORE PSI
A scaffold used in a range of
Custom-designed patient
orthopaedic procedures, where
specific implants used
significant lengths of long bones
throughout the body
have been damaged
SALES GENERATING INVESTIGATIVE DEVICE SPECIAL ACCESS SALES
I N V E S T O R P R E S E N T A T I O N O S T E O P O R E . C O M 7
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*Regulatory approval in Singapore
HOW OUR IMPLANTS FACILITATE BONE GROWTH
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BURR HOLE IS DRILLED
Patients needing surgical repair for skull fractures usually receive a “burr hole” during surgery, which is drilled into the skull to relieve pressure often resulting from hemorrhage
IMPLANT DRAWS IN BLOOD
Osteopore’s proprietary 3D printed polymer scaffold is is made up of biomimetic microstructures that allow blood to be drawn into the implant before inserting
BONE GROWS ON SCAFFOLDS
Once in the skull the scaffold attracts cells and blood vessels, facilitating bone growth in-between the microstructures
IMPLANT DISSOLVES
The implants naturally and predictably dissolve over a period of 18-24 months to leave only natural healthy bone
8
I N V E S T O R P R E S E N TAT I O N
O S T E O P O R E . C O M
- SUPERIOR PRODUCTS FOR LARGE GLOBAL MARKETS
~~TRADITIONAL PROCEDURES~~
BONE GRAFT US$3.9bn A surgical procedure where bone material is harvested from the Bone Graft Substitutes patient’s own body and applied to Market by 2025 the area to promote bone healing Potential for infection and lasting pain at harvest site Potential for body to completely absorb the graft with no bone regeneration PERMANENT IMPLANTS Used for a wide variety of different US$100bn bone replacement / repair applications Permanent Implant Sales and are made from metal, ceramic and polymeric materials Non-biodegradable with a high potential for post surgical complications Difficult to micro-adjust for a better fit during the surgical procedure
I N V E S T O R P R E S E N TAT I O N
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Highly customisable Proven to be to biomimic different effective in ~50k bone types procedures
Naturally dissolves Leaves only over a predictable healthy bone time frame tissue Extremely low post Unlikely surgery complication inflammation rates to date or infection Implants can be easily modified during surgery for a more custom fit O S T E O P O R E . C O M 9
Source for market size data: Allied Market Research, BCC Research
Osteopore’s current market penetration is evident in its annual revenue figures announced on 26 Feb 2021 and in subsequent financial reporting. Osteopore cautions investors that there are regulatory barriers and unique access challenges associated with entry into new markets, which may adversely impact entities’ ability to access such markets.
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Osteopore implants do not require any
major changes to current clinical procedures
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IMPROVED PATIENT OUTCOMES & LOWER HEALTHCARE COSTS
Osteopore products address an unmet clinical need by providing readily adaptable implants and reducing complication rates after surgery
Provides hospitals, clinicians and patients with a proven solution that expediates recovery and lowers costs that may occur with traditional procedures in the event of complications
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6 – 19% [1,2,3]
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Bone Graft
REPORTED COMPLICATION RATES
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25 – 33% [4,5,6]
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Permanent Implants
REPORTED COMPLICATION RATES
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0.01%
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1 0
I N V E S T O R P R E S E N TAT I O N
O S T E O P O R E . C O M
Sources located in in Appendix slide
SCALABLE & CUSTOMISABLE MANUFACTURING
All Osteopore products are fabricated in-house using proprietary 3D printing technology
Rapid design, manufacturing and delivery of implants to anywhere in the world
Unique low cost manufacturing process
Ability to print autonomously at scale
Increase or decrease production depending on global demand for different surgeries
Maintains IP advantage and keeps trade secrets within the company
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• Expanded manufacturing space by 100% in 2020 • Increased the number of printers from 8 to 14 to meet growing demand
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• Increased the depth and breadth of expertise at all organisational levels
1 1
I N V E S T O R P R E S E N T A T I O N
O S T E O P O R E . C O M
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3 INNOVATE
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Undertaking a number of early-
stage, low-capital intensity
development projects with
large potential upside
COMPANY
VALUE
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2 DIVERSIFY
PRODUCT RANGE
Osteopore is undertaking
a number of development
#1 ACCELERATE programs to launch new
REVENUE GROWTH products and expand the
scope of bone regeneration
applications
Revenue growth from our current
product range is the highest corporate
and commercial priority and will
remain the focus throughout the
COMPANY
lifecycle of the company
VALUE
TIME FRAME
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COMMERCIAL STRATEGY THAT BUILDS VALUE
O S T E O P O R E . C O M 1 2
I N V E S T O R P R E S E N TAT I O N
ACCELERATE REVENUE GR WTH
I N V E S T O R P R E S E N T A T I O N
1 3
O S T E O P O R E . C O M
4X CONSECUTIVE QUARTERS OF REVENUE GROWTH
Revenue providing a solid commercial foundation to build from, with the strategy in place to scale
Achieving sales growth (41% cc YOY) despite healthcare and hospitals being disrupted due to COVID-19
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$500,000
$429k
$407k
$400,000
$354k
$341k
$313k
$300,000
$279k
$228k
$200,000
$164k
$100,000
Q1 Q2 Q3 Q4
CY 2019 CY 2020
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O S T E O P O R E . C O M 1 4
I N V E S T O R P R E S E N TAT I O N
REVENUE GROWTH STRATEGY
23 DISTRIBUTION PARTNERS PARTNERS SECURED IN 13 2020
EXPANDING DISTRIBUTION NETWORK
CURRENTLY TARGETING ~1.1 million[7] CRANIAL PROCEDURES GLOBALLY
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North America Europe
(293k [] ) (272k) APAC
(435k)
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Leverage distribution partnerships in the key markets to accelerate revenue growth
Ensure sales teams and surgeons are educated and supported to drive adoption and sales
Leverage early adopters in sales and marketing campaigns to achieve product sales momentum
Increase underlying revenue through a mix of geographic expansion and adjacent clinical applications
O S T E O P O R E . C O M 1 5
I N V E S T O R P R E S E N TAT I O N
- In brackets, the number of cranial procedures undertaken in 2020.
SCALABLE OPPORTUNITY
Osteopore has superior off-the-shelf products products that can be manufactured at scale and is used in over 1.1m procedures globally
Long shelf-life products that can be stocked in a hospitals inventory system
TOTAL NUMBER OF SURGERIES IN 2020[7]
SURGERY TYPE
Craniotomy / Craniotomy closure Burr hole for hematoma evacuation Craniectomy Burr hole for shunt placement 74,203 Endoscopic third ventriculostomy 65,730 Cranioplasty 51,247 Skull base repair 48,958 Burr hole for drain placement 46,413 Burr hole for biopsy 33,520 Cranial reconstruction 19,897 Craniosynostosis repair 11,588 USG guided external ventricular drain insertion 3,845 Burr hole for exploration 3,229 TOTAL 1,109,764
359,428
302,570 89,134 74,203
O S T E O P O R E . C O M 1 6
I N V E S T O R P R E S E N T A T I O N
Sources located in in Appendix slide
FOUNDATIONAL MARKETS
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ASIA
Well established and experienced distribution partner network in South Korea, Vietnam, Singapore and Australia 2020 constant currency year-on-year revenue growth of 39%
Expanded range of clinical applications, including aesthetic surgery
Emerging dental application sales in Singapore Orthopaedic application clinical trials underway in Singapore, Vietnam and Malaysia
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AUSTRALIA & NZ
Hired dedicated Business Development person in Sydney Australia
Signed Australian & NZ distribution agreement with LMT Surgical Education and training for LMT sales team
Achieve initial sales
Support clinical trial for dental application
O S T E O P O R E . C O M 1 7
I N V E S T O R P R E S E N T A T I O N
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Europe + UK
Signed German-Austrian Distribution Agreement with MTG Medizintechnik Göhl GmbH Initial stocking order for Osteopore products from MTG Medizintechnik Göhl GmbH Identify & engage with Key Opinion Leaders surgeons across broader Europe + UK Achieve initial stocking orders
PRIORITY MARKET EXPANSION CHINA USA Signed US Distribution Signed Co-operation Agreement with Bioplate agreement with Boao Yiling Life Care Centre in China First “stocking” order with Bioplate Establish a subsidiary in the Suzhou Industrial Park as the Education and training first step towards obtaining for Bioplate sales team Chinese regulatory approval Secure additional U.S. Prepare NMPA dossier for distribution partnerships regulatory approval
USA Signed US Distribution Agreement with Bioplate First “stocking” order with Bioplate Education and training for Bioplate sales team Secure additional U.S. distribution partnerships to cover more states Initiate 510k regulatory approval for dental and orthopedic products
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JAPAN
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Identify and engage KOL surgeons interested in adopting Osteopore products Identify potential distribution partners with strong ties to hospitals specialising in craniofacial procedures Develop the necessary education and training materials Achieve initial stocking order
O S T E O P O R E . C O M 1 8
I N V E S T O R P R E S E N TAT I O N
DIVERSIFYING PR DUCT RANGE
1 9
I N V E S T O R P R E S E N TAT I O N
O S T E O P O R E . C O M
DENTAL
Osteopore has developed an enhanced bioresorbable 3Dprinted dental plug which promotes bone growth in the jaw, reducing the likelihood of bone shrinkage after tooth extraction.
Currently, patients requiring dental implants have to wait 3-6 months for bone to grow in the tooth socket after extraction. Osteopore aims to deliver a shorter, reliable and less painful treatment process as the plugs are placed immediately after extraction, eliminating the need for bone grafts.[8, 9]
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Lab Development
Pre-Clinical Trials
Clinical Trials ongoing
Regulatory Approval Singapore
Sales
Singapore
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LIMITED SALES IN SINGAPORE
PURSUING TGA & USFDA
510K CLEARANCE & CE MARK
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US$1BN PA
DENTAL BONE GRAFT
ALTERNATIVES MARKET
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O S T E O P O R E . C O M 2 0
I N V E S T O R P R E S E N TAT I O N
Source for market size data: Allied Market Research, BCC Research
ORTHOPAEDIC
US$2BN PA Sales of orthopaedic alternatives
Osteopore has successfully conducted first in human trials using the Osteopore scaffold in a range of orthopaedic procedures, where significant lengths of long bones have been damaged or diseased.
The Osteopore scaffold has recently demonstrated significant clinical success in tibia regenerations in Australia and Germany.[8, 10]
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Lab Development
Pre-Clinical Trials Clinical Trials ongoing
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Regulatory Approval
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Sales
O S T E O P O R E . C O M 2 1
I N V E S T O R P R E S E N TAT I O N
Source for market size data: Allied Market Research, BCC Research
INN VATE
1 0
I N V E S T O R P R E S E N TAT I O N
O S T E O P O R E . C O M
REGENERATION OF OTHER TISSUE
Osteopore has successfully completed animal trials for knee cartilage regeneration, and the Osteopore scaffold may also potentially be used to assist with the regeneration of other tissue types
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VETERINARY MARKETS
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Osteopore has successfully completed multiple animal trials for a number of different surgical applications which could possibly translate into products for the veterinarian market
INNOVATE
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ACCELERATING BONE REGENERATION
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Osteopore is investigating the viability of incorporating compounds to produce novel polycaprolactone polymer composites which could be used development additional products for adjacent therapeutic and surgical areas
Osteopore is conducting several earlystage research initiatives with high quality institutions that could present significant commercial opportunities.
O S T E O P O R E . C O M 2 3
I N V E S T O R P R E S E N TAT I O N
2021 COMMERCIAL PRIORITIES
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ACCELERATE REVENUE GROWTH
Leverage cranial and maxillofacial products with
regulatory approval in significant Markets:
Asia USA Germany
Australia & NZ Scandinavia
Establish a presence in new markets with
a high volume of relevant procedures:
China UK Japan
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DIVERSIFICATION Leverage dental product regulatory approval in Singapore to drive sales in Asia Initiate a dental clinical trial in Australia as the basis for TGA product approval Initiate FDA approval for dental and orthopaedic products for sale in the USA Initiate regulatory approval for rhinoplasty in Korea
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INNOVATION
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Experiment with promising novel compound
combinations, including PCL-TCP and PCL-TCP-
Mg, facilitating bone and cell growth to
improve healing time and patient outcomes
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Engage with Terumo BCT to explore the opportunities to combine Osteopore’s resorbable biomimetic scaffolds with Terumo’s autologous biologics
Continuously improve manufacturing efficiency using proven technological improvements in 3D printing to cost effectively scale production
O S T E O P O R E . C O M 2 4
I N V E S T O R P R E S E N TAT I O N
APPENDIX
2 5
I N V E S T O R P R E S E N TAT I O N
O S T E O P O R E . C O M
GLOBAL REGULATORY APPROVAL
Osteopore is working towards necessary regulatory approval to expand sales in additional target jurisdictions including;
Current regulatory clearances Potential Future clearances
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Brazil
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Egypt
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Jordan
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China
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Israel
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UAE
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Colombia
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Japan
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UK
O S T E O P O R E . C O M 2 6
I N V E S T O R P R E S E N T A T I O N
SOURCES
-
1 Dimitriou, R., Mataliotakis, G. I., Angoules, A. G., Kanakaris, N. K., & Giannoudis, P. V. (2011). Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury , 42, S3-S15.
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2 Younger, E. M., & Chapman, M. W. (1989). Morbidity at bone graft donor sites. Journal of orthopaedic trauma , 3(3), 192-195.
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3 Arrington, E. D., Smith, W. J., Chambers, H. G., Bucknell, A. L., & Davino, N. A. (1996). Complications of iliac crest bone graft harvesting. Clinical Orthopaedics and Related Research ®, 329, 300-309
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4 Giese, H., Meyer, J., Unterberg, A., & Beynon, C. (2020). Long-term complications and implant survival rates after cranioplastic surgery: a single-center study of 392 patients. Neurosurgical Review , 1-9.
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5 Wiggins, A., Austerberry, R., Morrison, D., Ho, K. M., & Honeybul, S. (2013). Cranioplasty with custom-made titanium plates—14 years experience. Neurosurgery , 72(2), 248-256.
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6 Thien, A., King, N. K., Ang, B. T., Wang, E., & Ng, I. (2015). Comparison of polyetheretherketone and titanium cranioplasty after decompressive craniectomy. World neurosurgery , 83(2), 176-180.
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7 cetas healthcare (2020). Market research conducted for Osteopore on the global cranial procedure market.
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8 Sparks, D. S., Saifzadeh, S., Savi, F. M., Dlaska, C. E., Berner, A., Henkel, J., ... & Hutmacher, D. W. (2020). A preclinical large-animal model for the assessment of critical-size load-bearing bone defect reconstruction. Nature protocols , 15(3), 877-924.
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9 Zhang, Z., & Teoh, S. H. (2014). Novel 3D polycaprolactone scaffold for ridge preservation – a pilot randomised controlled clinical trial. Clinical Oral Implants Research , 26, 271-277.
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10 van Griensven, M., Biberthaler, P., & Rosado Balmayor, E. (2015). Clinical approaches to the healing of long bone defects. In Schantz, J-T. & Hutmacher, D.W. (2020), Advanced Therapies in Regenerative Medicine , Vol. 2, World Scientific, (pp. 217-231).
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