New Business Models in Healthcare: Point-of-care 3D Printing of Surgical Implants

At its current stage of development A.D.A.M. focuses on orthopedic implants and have developed two proprietary material combinations and corresponding printers. In future, we are planning to modify the extrusion printing technology to be able to print other tissues and essentially move to 4D printing.

Our approach is to combine core competence (materials and printers), software and Quality Management system solutions in one platform that will serve as one-stop-shop for printing of implants on site in hospitals. This approach and the new technology-as-a-service model will allow for scaling 3D printing technologies in healthcare and thereby substantial cost saving, which is the main impediment for implementation of the existing technologies. Our data shows that only 5-10% of orthopedic surgeons in developed countries know and/or have used 3D printing in their practice, a lot of those who know a reluctant to utilize 3D printing in practice because of the high costs and lack of knowledge. We believe that our mission is to disrupt existing healthcare models and bring innovative solutions to patients is one of the main trends for the future of healthcare.

A presentation by Denys Gurak, CEO, A.D.A.M.

Interview

Question 1: What drives you?
Innovating and changing the healthcare industry on a scale

Question 2: Why should the delegate attend your presentation?
Opportunity to learn the dirt hand experience of building a complex digital and 3D printing workflow

Question 3: What emerging technologies / trends do you see as having the greatest potential in the short and long run?
3D bioprinting, human-machine interface, AI

Question 4: What kind of impact do you expect them to have?
Better patient outcomes and greater longevity

Question 5: What are the barriers that might stand in the way?
Conservatism of the healthcare industry and regulators; public opinion in different countries

About Denys Gurak
Denys Gurak is an experienced C-level manager and serial entrepreneur. He is a CEO and Co-Founder at A.D.A.M., a 3d bioprinting company with a primary focus on 3D-printed bones. Denys’s ultimate vision is to build an on-demand personalized tissue manufacturing platform that would be a one-stop shop for transplanted tissues and organs; and, hence, to cut barriers to medical treatment for millions.
Denys’s passion for biotech can be traced back to 2010, when he was leading the international relations and certification, along with EU legislation adaptation at the Ukrainian medicinal products regulatory authority (official position – director of the «GMP/GDP Center» of the State Administration of Ukraine on Medicinal Products (SAUMP).
In 2014 Denys joined the Ukrainian Defense Industry (a state defense conglomerate) in 2014 as the Deputy Director-General for foreign economic activity. During his time at the company, he managed the export-import operations that amounted to USD 1 billion yearly turnover. Furthermore, Denys represented Ukraine as the Head of Ukraine’s delegation to the NATO Industrial Advisory Group (NIAG), and led the industry transformation initiatives and international relations.
Denys is a Partner at WeFund Ventures, an early stage venture firm with a focus in disruptive IT, biotechnology, aerospace and security projects.

About A.D.A.M.
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.

Denys Gurak is speaker at the 2022 edition of the 3D BioPrinting Conference.

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