Company Presentation Advanced Development of Additive Manufacturing, Inc - twid creative studio
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Company Presentation Advanced Development of Additive Manufacturing, Inc. June 2021
Disclaimer
This presentation and the information contained herein (the “Presentation”) is being presented to a limited number of parties who may be interested in reviewing information
regarding the Company. This Presentation does not purport to be all-inclusive or to necessarily contain all the information that a prospective investor may desire to know
or need to know to evaluate the ADVANCED DEVELOPMENT OF ADDITIVE MANUFACTURING, INC. (the “Company”) or the merits of a future investment. The information contained herein
has been prepared solely to assist prospective investors in deciding whether to proceed with a further investigation of the Company and does not purport to be all-inclusive
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NOT LIMITED TO, LOSS OF ALL OR A SUBSTANTIAL PORTION OF THEIR INVESTMENT.
2
Investment Overview
• A.D.A.M. develops an on-demand personalized implant 3D-printing infrastructure with a full
scope of related services, provided remotely or on-site.
• A.D.A.M. bundles the following services in its TAAS model: medical data storage, implant 3D-modelling, on-demand 3D-printing
for bone implants using proprietary 3D-printing technique, and optional hardware installation at the POC
• Business model designed to decrease costs and to improve patient outcomes VS existing alternatives (i.e. titanium implants
and emerging alternatives)
• We have developed a superior technology and possess a strong IP Portfolio
• Developed two biodegradable material composites, superior to metals and plastics in biocompatibility and patient outcomes
• Currently developing upgraded BJP and FFF printers with proprietary advancements for high-quality, fast and cost—efficient
production
• IP Portfolio: 4 provisional patents (2 for materials and 2 for printers) in the U.S., 2 patents for materials in Ukraine
• Regulatory 510(k) pathway validated by FDA; Animal Trials to start Q3 2021
• FDA responded positively to A.D.A.M.’s Q-Sub regarding 510(k) eligibility requiring only successful animal studies (no human
trials) for the FDA 510(k) clearance
• Draft Protocol for Animal Studies to be submitted to the FDA in May 2021; animal studies to begin in September 2021
• FDA 510(k) Clearance expected in Sep 2022
• Potential to disrupt growing markets
• 3D printing for the medical industry - $1.8 billion (17% CAGR 2019-2029); segment – implantable devices (17% CAGR 2019-2029)
• Orthopedic implant market - $47B (2019) & $64B (2026); segments – 3D-printed bone implants ($3.8B in 2026)
• Growth in markets driven by ageing population, augmented incidence of orthopedic diseases. FDA endorsement of additive
manufacturing in healthcare industry
• Solid management team and advisors
• CEO with international medical trials regulations and defense applications expertise
• Strong Advisory Board of 9 professionals in Orthopedics, 3D-printing, Strategy, Business Development and Digitalization
• The Board of Directors consists of 3 officers with 2 seats open 3
Market Opportunity
problem • Orthopaedic market is currently dominated by technology video
titanium implants, which are costly, rarely
personalized, and typically require the click to play
second surgery to extract metal fixation
elements
• Implants made from alternative materials are
expensive and have long delivery times
solution On-demand personalized bone implant 3D-printing
infrastructure with a full scope of related
services, provided remotely or on-site
• 3D-printed patient-specific implants (PSI)
-> reduced surgical time and improved
surgical results
• Biodegradable and bioresorbable materials
-> no need for revision surgeries -> reduced
patient suffering and health costs
• Proprietary printers installed at the point
of care or at the company’s facilities
-> delivery time of 1-3 days
4
Market
3D Printing for Medical Devices market, $B • 3D-Printing for Implantable Device
Segment – 17% CAGR for 2019-2029
6.1 • Total addressable market for ADAM
not limited by $1.8B of 3D
5.2 printing for medical devices
4.5
market
4.0 • A.D.A.M. can target and disrupt
3.4 orthopedic implants market,
3.0 estimated at $47B in 2019
2.5 (expected $79.5B in 2030), 3D-
2.2
1.8 printed segment expected to reach
1.6
1.3 $3.8B in 2026
• Market growth driven by: ageing
population, augmented incidence of
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029
orthopedic diseases, FDA
3D Printing for Medical Devices endorsement of 3D-printing in
healthcare
Source: Report “3D Printing for the Medical and Dental Industry 2019-2029”, Technology, Market Opportunities and Outlook, Dr Bryony Core and
Dr Nadia Tsao, IDTechEx, 2020
5Therapeutic Target Markets
Orthopedic Oncology CMF, neuro-,
surgery and plastic
surgery
6Product Overview
Technology-As-A-Service
Model
charging medical centers a fee for implant production and system usage
Materials Printers Digital Platform QMS
▪ Bioceramic and ▪ BJP and FDM printers ▪ MVP developed for ▪ Quality Management
biopolymer with proprietary medical data cloud System in place from
composites developed advancements under storage the start of R&D
for flat and tubular development ▪ Features under ▪ ISO certification
bone implants ▪ 2 provisional development: implant
▪ 2 provisional patents in the U.S. 3D-modelling,
patents in the U.S.; medical staff
2 patents in Ukraine training
7Technology Validation
Histological sections of the implantation into the
soft tissue of wistar rats
▪ No hematoma, edema, scarring,
degenerative changes, tumors,
tissue necrosis and other
abnormalities were detected
Ceramic implant Connective
Connective tissue
tissue capsule capsule
▪ Implants are biocompatible
▪ In the fourth week, due to the
porous structure of the ceramic
Ceramic implant
material, cell migration and
germination of the connective
tissue (T) deep into the implant
was observed; in the twelfth
week the process has intensified
4 week observation 12 weeks observations
after implantation after implantation
8Implants and Intellectual Property
Bioceramic Bone Implants Biopolymer Bone Implants
Application: non-weight-bearing bones Application: weight-bearing bones
reconstruction replacement
Material: ceramic bio-glass composite Material: modified biopolymer
• Highly bioactive • Imitates natural bone structure
• High porosity • High level of strength and
• Stimulates osteogenesis recoverability
Printing Technique: BJP Printing Technique: FFF
• Proprietary printing powder • Proprietary sterilization system
compression system feature feature
Intellectual Property
• 2 provisional patents for materials (US)
• 2 provisional patents for novel FFF and BJP printers (US)
• 2 permament patents for 3D-printed hernia meshes creation method (Ukraine)
A.D.A.M. plans to to file all patents under the PCT (Patent Cooperation Treaty) with a focus on
primary markets in EMEA and APAC regions in Q2 2022.
9Benefits VS Alternatives
• Production speed is substantially higher while price of finished product
is substantially lower
• No need for re-operation to extract metal fixation elements
• No need to traumatize a patient for the purpose of bone marrow
autoplasty
• Implants stimulate osteogenesis processes
• Sufficient strength indicators to withstand implant loads for use in
maxillofacial surgery
• The components from which the implant is made do not have allergic,
toxic, teratogenic properties
• 3D modeling technique allows printing individualized implants for each
specific clinical case
10Customer Lifecycle
John needs no
Medical team revision
John is orders John’s surgeries, the
admitted to implant from implant degrades
the hospital A.D.A.M. while John’s own
with a bone facilities or bone tissue
fracture prints it on-site regrows
John has his Medical team Surgeon
MRI/CT scans models an operates John
stored on individualized on the same day
A.D.A.M. implant for with improved
Digital John’s accuracy and
Platform specific case speed
11Next Product Lines
Heart Valve Bronchial Major Blood
Implants Implants Vessel Implants
12Product Development and Clinical Timeline
Product Development Timeline
R&D of heart
Lab Advanced Material
Project Digital platform Established HQ at valve, blood Market Launch for
set-up; QMS Printers MVP Composites R&D
initiation MVP TIP at UCONN vessel, bronchial Bone Implants
launch Completed
implants launch
| | | | | | | |
Aug 2018 Feb-May 2019 Oct 2019 Sep 2020 Nov 2021 Dec 2021 Jun 2022 Oct 2022
Clinical Timeline
Draft Protocol
FDA Confirms
Pre-Clinical Trials for Animal Implant Testing Animal Studies 510(k) Submission to
510(k) FDA Clearance
completed Studies sent to Samples Ready Kickoff FDA
Eligibility
FDA
| | | | | | |
Oct 2019 Aug 2020 May 2021 June 2021 Sep 2021 May 2022 Sep 2022
13Competitive Landscape
• Majority of competitors are highly
specialized on system, software, materials,
or services segment whereas A.D.A.M.
develops a holistic TAAS model.
• All competitors have long delivery times (2
weeks on average VS A.D.A.M.’s 1-3 days)
• Most competitors offer implants made of
either biopolymer or bioceramic implants,
whereas A.D.A.M. offers both
• OPM, the market leader, does not offer
biodegradable materials
• A.D.A.M. bone implants can be used in
oncology applications (i.e. surgical
replacement of the damaged bone with the
implant)
• Due to the integrated approach of the
A.D.A.M. implant-manufacturing process, it
is expected that the final cost for patient
will be cheaper compared to the existing
and emerging alternatives
14Projected Budget
$4.93M (17 months financing) to reach FDA clearance and product readiness
for market launch.
$1.12M Product Development Completion of animal studies for bioceramic
and biopolymer bone implants
• R&D - $530k
• Software Development - $100k
• Platform Development - $120k
• Scientific Consulting - $240k 2 material composites and 2 printers ready
• IP - $130k for market launch
$1.46M Clinical
FDA 510(k) Clearance
• Animal Studies - $1.2M
• Regulatory Expenses - $260k
Global IP Coverage Secured
$0.18M Marketing
$2.17M OpEx Digital Platform Ready for Commercial Use
15Partners
Long-established Technology Incubation Boutique investment bank, Industry-oriented Top-Tier law firm
bioscience Program at the financing over $50 billion center dedicated to in the area of
ecosystem University of of public and private pre-competitive “FDA Law”
Connecticut capital raises, research in additive
restructurings, and mergers manufacturing
and acquisitions
Top 3D-printing One of the biggest Fortune 500 American Early-stage Largest commercial
company network of seed manufacturer of industrial venture capital research center in
accelerators in US tools and household hardware firm North Carolina
16Management
Denys Gurak Andy Pedtke, MD
CEO Chief Medical Officer
Formerly a top executive of industrial Practicing orthopaedic surgeon, founder
conglomerates; expert in global medical of innovative limb prosthetics company,
trials regulations advisor to startups, VC investor
Ada Bovsunovsky Arkadii Bohdan, MD
COO Head of R&D
Formerly an analyst at a VC firm Practicing surgeon, researcher in 3D
BA, Economics (Boston University), MSc bioprinting, writer of materials’
Finance (Bocconi University) patents
Dmytro Skomorokhov Mykhaylo Pluzhnik
VP of Business Development R&D Project Manager
3D printing industry expert; Techstars Engineer focusing on thermal processing,
accelerator program experience materials chemistry, project management
Markian Silecky, Esq. Yuliya Shapovalova
General Counsel Head of Ukraine Office, Legal
Corporate Counsel with over 30 years of Counsel
international experience; co-founder of Startup manager in IT and investment
various multinational entities projects; legal support
17Advisory Board
Dr. Anthony Tether Dr. Phillip Karber
Chief Scientific Advisor Chief Strategy Advisor
Former DARPA Director, expert in President at Potomac Foundation, former
innovative research and development Head of Strategy at Department of
Defense, strategic advisor to NATO,
governments and corporations
Dr. Mark Horowitz Tamir Harosh
Chief Trials Advisor Business Development Advisor
Professor at the Department of Professional advisor, leads the BD,
Orthopedics and Rehabilitation, Yale negotiations, and consulting teams for
University School of Medicine companies and individuals
Dr. Anson Ma Den Burykin
Chief Technology Advisor Digital Strategy Advisor
Associate Professor at UConn, site Experienced entrepreneur with executive
director at SHAP3D, expert in complex and board positions in ICT and
fluids and 3D printing technology driven organizations
Dr. Adnan Mjalli Eugene Fedorchenko
Chief Development Advisor Digital Strategy Advisor
Internationally recognized entrepreneur Strategic business advisor with over
in pharma and biotech industries decade of track record in management,
law and go-to-market domains
18Summary
• One-stop shop for implant production
• Potential to disrupt outdated healthcare models
and $47 billion orthopedic implant industry
• Advantages: reduction in costs for all Parties,
improved surgical outcomes and reduced patient
suffering
For more information,
• Pre-clinical trials successfully completed; please contact:
animal studies start in Q3 2021
• No human trials required
DENYS GURAK, CEO
• Expected time of FDA 510(k) clearance: September
2022
dg@adamproject.org
• Results-driven management team and strong
Advisory Board
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