A.D.A.M. develops an on-demand personalized implant manufacturing infrastructure with a full scope of related services, provided remotely or on site

ABOUT

In August, 2020, FDA confirmed 510(k) eligibility for A.D.A.M. biopolymer and bioceramic bone implants. No human trials are required. FDA clearance is expected in 2022

In August, 2020, FDA confirmed 510(k) eligibility for A.D.A.M. biopolymer and bioceramic bone implants. No human trials are required. FDA clearance is expected in 2022.

A.D.A.M. was founded in 2018 by 3D printing company Kwambio and WeFund Ventures in Ukraine. The initial vision of the company was to create a carshop-like infrastructure where any part of the human body can be treated like a replaceable part. A.D.A.M. team decided to start the development of the project with a focus on bone implants and have developed proprietary 3D printing technology and material composites for the implants. The first prototypes passed pre-clinical trials in wistar rats. Successful results of the trials allowed A.D.A.M. to file the Q-Submission to the FDA. In their response, the FDA confirmed A.D.A.M. biopolymer and bioceramic bone implants' 510(k) eligibility. Concurrently, the company moved its HQs to the Technology Incubation Program at University of Connecticut.

A.D.A.M. plans to complete the animal studies, required by the FDA, in 2021. Next, the company aims to receive regulatory clearance for bone implants and begin the sales stage in 2022.

Bone implants, however, are just the beginning - in the years to come A.D.A.M. aims to launch R&D of blood vessel, heart valve and bronchial implants.

MANAGEMENT TEAM

TEAM

Denys Gurak
CEO
Former top executive of industrial conglomerates; expert in global medical trials regulations
3D printing industry expert;
Techstarts accelerator program experience
Dmytro Skomorokhov
VP of Business Development
Ada Bovsunovsky
COO
Formerly an analyst at venture fund and a hedge fund
Mykhaylo Pluzhnik
R&D Project Manager
Arkadii Bohdan
Head of R&D
MD, practicing surgeon, researcher in 3D bioprinting, materials' patents author
Yuliya Shapovalova
Legal Counsel
Head of Ukraine office, startup manager in IT and investment projects
Dr. Andrew Pedtke
Chief Medical Officer
Orthopaedic Surgeon,
venture investor and entrepreneur in biotech
Markian Silecky, Esq.
General Counsel
Corporate Counsel; co-founder of multiple multinational entities
Engineer specializing in thermal processing and materials chemistry

ADVISORY BOARD

Dr. Phillip Karber
Chief Strategy Advisor
Associate Professor at UConn, expert in complex fluids and 3D printing
Former DARPA Director, expert in innovative research and development
Tamir Harosh
Business Development Advisor

Professional advisor, leads consulting teams for companies and individuals
Dr. Anson Ma
Chief Technology Advisor
Dr. Anthony Tether
Chief Scientific Advisor
Dr. Mark Horowitz
Chief Trials Advisor
Professor at the Dept of Orthopaedics & Rehabilitation at Yale School of Medicine
Internationally recognized entrepreneur in pharma and biotech industries
Dr. Adnan Mjalli
Chief Development Advisor
Strategic business advisor with expertise in law and go-to-market domains
Eugene Fedorchenko
Digital Strategy Advisor
Entrepreneur with executive and board positions in ICT and technology driven organizations
Den Burykin
Digital Strategy Advisor
President at Potomac Foundation, former Head of Strategy at Dept of Defense, strategic advisor to NATO

R&D TEAM

Vadim Volkov
Alex Dibrov

Hardware design engineer
Oleg Rogankov
Materials physics, production technology, technological control
Medical consulting,
bio-engineering

A.D.A.M. mailing list
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Project initiation
(legal structure, team)
Operational
milestones

TIMELINE

Clinical & Regulatory and milestones
Medical application
of materials initiation

Aug 2018

Laboratory set-up; QMS digital platform dev

Feb-May 2019

Digital platform completion, QMS certified

Oct 2019

Aug 2020

May 2021

R&D of heart valves, main blood vessels, bronchial implants start

Jun 2022

Market launch for bone implants
FDA clearance

Oct 2022

R&D: strength recoverability, bio-glass synthesis
August, 2020 — FDA confirmed 510(k) eligibility — no human trials required, 1 year to market launch (VS 4yrs through the PMA, the clinical trials track)

Sep 2020

Established HQ at TIP, UConn

Dec 2021

Advanced material composites R&D completed
Printers MVP

Sep 2022

Pre-Clinical Trials completion
FDA confirms 510(k) eligibility
Draft Protocol for Animal Studies sent to FDA

Jun 2021

Implant testing samples ready

Oct 2021

Animal studies commence
510(k) Submission to FDA

Dec 2022

PARTNERS

Long-established bioscience ecosystem
Technology Incubation Program at the University of Connecticut
Early-stage venture capital firm
Top-Tier law firm in the area of "FDA Law"
Largest commercial research center in North Carolina
Fortune 500 American manufacturer of industrial tools and household hardware
One of the biggest network of seed accelerators in US
Top 3D-printing company
Industry oriented center dedicated to pre-competitive research in additive manufacturing
Boutique investment bank, financing over $50b of public and private capital raises
UConn Technology Incubation Program
9 W Broad St
Stamford, CT 06902
93 Kanatna St
Odesa, Ukraine
65039

© 2021 ADAM • PRIVACY

3 Dorohozhytska St,
UnitCity B9, 2d floor
Kyiv, Ukraine
04078