How Evergen combines world-class biomaterials with a patient-first mindset to solve challenges within re-generative medicine

As a world-class global contract development and manufacturing organization (CDMO), Evergen works closely with innovators and OEMs to develop and deliver life-changing regenerative medicine technologies. Prioritizing patients, Evergen’s innovation begins by identifying complex challenges, then manufacturing solutions that promote healing, accelerate recovery and help prevent complications to enhance patients’ lives.

Kevin Breeden, COO
Kevin Breeden, COO

The company began in 1998 as a spin-off of the University of Florida Tissue Bank but has since expanded its biomaterials capabilities through several acquisitions. Today, Evergen provides customized services with high-quality allograft and xenograft biomaterials, specializing in the growing clinical segments of plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac. In 2024, Evergen rebranded from RTI Surgical to better reflect the strategic evolution of the company into regenerative medicine. Under its new brand, the company has strengthened its commitment to understanding patient needs and developing customized solutions in high-growth clinical segments.

Kevin Breeden, COO, explains more about Evergen and how its solutions enhance patients’ lives. “Our customers range from large blue-chip companies, to challengers and innovators in our respective markets,” he opens. “As we have a diverse customer base, they have varying needs; some might need a biomaterial solution, others need outsourced CDMO services to improve product development and speed to market, or some need to fill capability gaps like biomaterial procurement or regulatory submission. With our extensive portfolio of biomaterials, capabilities, and technical expertise, we help our customers to build scalable solutions in global markets.

“While we have business metrics like yield attainment, cycle times and on-time delivery to help us run efficiently, our top priority is always to align the decisions we make with the benefits they will have on a patient or for the clinician. Every process we design, every validation we run, and every record we complete is done with a patient-centric mindset. Knowing that we improve people’s lives every day is a privilege. In the allograft side of the business, for instance, we process human donated tissue; these are gifts of life, and we take that responsibility very seriously.”

R&D

This patient-centric approach also extends to Evergen’s R&D operations. “Innovation always begins with the patients and the procedures,” Kevin states. “We listen to our OEM customers to learn about their challenges and the unique clinical needs of the patients, and once we understand the problem, we identify the best biomaterial in the ideal form for each procedure. This collaborative nature is the defining strength that enables us to develop customized solutions . We bring development and manufacturing together early in the processes, leveraging our expertise in technical R&D, biomaterials, and manufacturing processes. We also apply risk management and quality by design principles to ensure innovations aren’t just new ide-as but products that consistently and reliably perform.”

In terms of manufacturing, Evergen operates sites across the US, Europe, and New Zealand, each with the necessary specialized equipment, processes, and infrastructure to facilitate each biomaterial. “We maintain quality and reliability by adhering to our rigorous quality systems, which include strong process controls, validated equipment, robust training, and data integrity,” Kevin explains. “In recent years, we’ve also invested in automation and digital tools to improve consistency, traceability, and speed to market. At our Alachua facility in Florida, for instance, we’ve implemented AI-powered image processing software developed in partnership with the University of Florida. This software enhanced the analysis of a CT bone graft scan, which is used to assess bone density structure, to identify how we can best use the graft.

a cientist's focus is on a piece of laboratory equipment, specifically a cylindrical rack or holder that contains several test tubes or vial

In contrast to conventional systems that typically require multiple technicians to assess the graft, this system uses AI to analyze hundreds of images and processes reports in under ten seconds, enabling us to make quick da-ta-driven decisions.”

From our conversation, Kevin’s expertise and commitment to patient care shines through. Thinking about his career and the wider industry, Kevin shares: “I have more than 30 years of experience in the medtech industry, and I became enamored with the tissue side of the sector. It fascinates me to take tissue, whether it’s animal-based xenograft or human-based allograft, and transform it into life-enhancing products. I’ve been at Evergen for two years now, and it’s amazing to be part of a business that’s a new kind of partner for the industry – one that focuses on developing biomaterial solutions that address unmet clinical needs. What makes Evergen unique is that we don’t advocate a specific biomaterial over another, but instead work with clinicians, OEMs, and surgeons to understand their challenges and demands. As Evergen continues to transform, I’m proud to drive our unwavering commitment to quality and continuous improvement.”

With an extensive portfolio of biomaterial solutions and an unrivaled commitment to patient care, Evergen is redefining what it means to be a partner in the medtech industry. As talk turns to the future, Kevin shares Evergen’s strategy: “We’re seeing increased demand across all clinical segments, especially for soft tissue in the sports medicine and plastic surgery and reconstructive surgery clinical segments. To meet in-creased demand, we’re increasing our capabilities at several of our facilities and working to improve our operational efficiency. This includes finding new ways to implement AI within manual processes that not only allow us to be more efficient, but also to be more thoughtful about the products and processes we conduct.

“The last couple of years have seen us focus on integrating our acquired companies, but 2026 is about execution and scaling our CDMO platform while maintaining the quality we’re known for and consistently delivering for our customers. We strive to be a reliable and committed partner with a patient-first mindset, which means we’re always keen to progress and engage in innovative product development.

“From concept to commercialization, I want Evergen to be recognized as the key CDMO partner in regenerative medicine, known for world-class quality, dependable supply, and an ability to help customers develop life-enhancing biomaterial solutions,” Kevin concludes. “Strategically, we’ll continue to expand our capabilities and bring our biomaterial solutions to more patients around the world while never compromising our standards.”

www.evergenbio.com

 

!-- Impression Tag --> Ad