3D Printing BioTech Confirms FDA Eligibility for Streamlined Regulatory Pathway | A.D.A.M’s Patented Materials and Proprietary Technology Allows Lower-Cost Offering vs Competition

“A.D.A.M. is the first-ever opportunity to print organic bones.

The key reason for us to launch this project is to help people save their lives.

The global 3D Bioprinting Market is growing rapidly. According to research, it is going to develop very intensively up to 2024, achieving more than USD2.5 billion. We do believe in the potential of the team, which previously has launched successful 3D printing projects that already gained a lot of attention, and we hope that A.D.A.M. will bring this endeavour for innovations to the next level.”   

Denys Gurak, CEO & Co-Founder, A.D.A.M

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Executive Summary

A.D.A.M. (Advanced Development of Additive Manufacturing) is a biotech company that provides 3D-bioprinting services on demand. A.D.A.M. uses its proprietary 3D-printing technology and patented materials to manufacture bioresorbable patient-specific implants—primarily, bone implants.

The company currently focuses on orthopaedic implants, but in the future, A.D.A.M. intends to expand its product offerings to cover major blood vessels, heart valves, and bronchial implants.

Taking into account the company’s achievements over the last two years, the support received from experts on both the scientific and business sides of the project, and the positive response from the FDA, the company anticipates a relatively short and straightforward path to market approval.

Investment Highlights

Set for Rapid Industry Growth

  • 3D-Printed Implant Market in 2019: $1.12 billion Projected Market in 2027: $3.97 billion

Positive FDA Regulatory Pathway

  • The FDA’s positive response to A.D.A.M.’s Q-Submission regarding 510(k) eligibility means that no human trials are required and that there will be a decrease in time to market from 5 years to 1.5-2 years, indicating a straightforward and streamlined regulatory process.

Competitive Price Advantage

  • A.D.A.M.’s implants are less expensive to produce than titanium implants and other
    alternatives, and this cost efficiency sets an economic moat which directly benefits all stakeholders including patients, insurance companies, hospitals, and investors.

Accepted Into Academic Incubator

  • A.D.A.M was accepted into the Technology Incubation Program at University of Connecticut which offers them access to state-of-the-art research facilities and resources.

Investment Offering

A.D.A.M. is raising a maximum round size of $6 million for Series A preferred stock financing, and have already secured a lead investor for part of the round.

This series A round will be closing on July 31, 2021.

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