By Melane Sampson
Closely-held Evergen, formerly RTI Surgical, is advancing innovative medical solutions across the cardiac, sports and orthopedics, plastic and reconstructive surgery, and neuro-spine clinical segments as the only contract development and manufacturing organization (CDMO) in regenerative medicine with a clinically proven, differentiated portfolio of both allograft (human donor) and xenograft (animal source) biomaterials at scale.
“Evergen is a global, world-class regenerative medicine CDMO uniquely positioned as an end-to-end resource—offering medical technology companies and healthcare professionals a comprehensive range of top-quality talent and capabilities, along with an integrated value chain that includes design, research and development, regulatory support, verification and validation, manufacturing, and supply chain management solutions,” Olivier Visa, Pharm.D., president and CEO of Evergen, says in an interview with BioTuesdays.
Dr. Visa points out that, in addition to being the only CDMO to offer customers both allograft and xenograft biomaterials, what sets Evergen apart is its patient-centered focus. The company, specializing in soft tissue, collaborates with a diverse range of original equipment manufacturers (OEMs) partners—from large multinationals to small start-ups—to identify and develop customized solutions addressing specific clinical challenges.
“Evergen starts the process with the patient, the surgeon, and the procedure, unlike other regenerative medicine CDMOs that start from the biomaterial,” Dr. Visa asserts. “Evergen helps healthcare professionals with the right surgical solutions and a choice of safe, reliable biomaterials they can trust for their patients and procedures. Our emphasis is on enhancing the lives of individual patients by enabling surgeons to better address their unique needs in repairing, replacing, and regenerating damaged tissues to restore normal function, leveraging the body’s natural healing process.”
According to Dr. Visa, Evergen recently completed a 5,000 sq. ft., $15 million Class III medical device facility in Alachua, Florida. The new clean room significantly expands the company’s proprietary Tutoplast tissue sterilization process, which provides high quality, safe, and consistent grafts. With this facility, Evergen is looking to support a growing customer demand for its processed implants beyond the 17 million patient lives the company has already served.
Moreover, the new clean room plays a key role in Evergen’s ongoing clinical study evaluating the safety and efficacy of Cortiva, an allograft dermis (ADM). “This expansion underscores our commitment to investing in innovation, quality, and scientific data in regenerative medicine,” Dr. Visa says. “It enhances our manufacturing capabilities and enables us to continue developing best-in-class solutions for patients, in partnership with our OEM customers.”
Cortiva, commonly used in soft tissue repair, undergoes Evergen’s Tutoplast tissue sterilization process. In 2023, the FDA granted Cortiva Investigational Device Exemption (IDE) approval to support clinical investigations in breast reconstruction. “The IDE approval was a significant milestone toward obtaining FDA pre-market approval for Cortiva ADM implants,” Dr. Visa notes. “It aligns with our strategic goal of becoming a leading medical device company in regenerative medicine by offering a diverse portfolio of clinically validated solutions.”
Dr. Visa outlines that Evergen’s growth strategy includes key acquisitions that expand its capabilities. In early 2024, the company acquired Cook Biotech, adding the porcine small intestinal submucosa (SIS) platform to its portfolio, which broadens its reach into new markets.
Continuing on its growth trajectory and strategic focus on soft tissue clinical segments, Dr. Visa highlights the company’s second acquisition in November 2024—Collagen Solutions. Collagen is a global supplier of engineered medical-grade collagen and xenograft tissue with specialized capabilities in bovine and porcine collagen materials. This acquisition further expanded Evergen’s comprehensive portfolio of allograft and xenograft biomaterials at scale.
“We’ve done a lot of transformation over the last four years to get to where we are today, with two acquisitions in 2024 alone, involving a tremendous amount of due diligence and integration, followed by a rebranding to Evergen in early 2025,” Dr. Visa asserts.
“The rebranding of RTI Surgical to Evergen marks a defining moment in our company’s evolution. Every decision we make begins with understanding patient needs and developing flexible, high-quality solutions that enable our customers to meet these needs effectively. As Evergen, we are positioned to lead a new era of regenerative medicine, becoming the trusted CDMO of choice for OEM partners,” he adds.
Looking ahead, Dr. Visa says Evergen aims to continue on its trajectory attracting the best talent, enhancing its capabilities, and identifying new growth opportunities to further embrace the patient-first mindset and deliver the best support to OEMs. “We have a robust portfolio of allograft and xenograft biomaterials but we need that third leg—resorbable biosynthetics—a new, upcoming focus in regenerative medicine and tissue engineering.”
Resorbable biosynthetics are man-made biomaterials that offer the advantage of being versatile and customizable, Dr. Visa explains. Allografts and xenografts absorb quickly into the body, while resorbable biosynthetics present a different resorption profile, offering surgeons resorption timelines that best fit the procedure and the individual patient’s needs.
“Because every patient and surgeon are unique, we believe a combined approach to reconstructive surgery is the way of the future—offering surgeons the choice of allografts, xenografts, and resorbable biosynthetics, or a combination of these options,” Dr. Visa concludes.
“Our mission at Evergen is to enhance patients’ lives by creating the best clinical outcomes, through innovative, high-quality medical solutions. In order for us to be truly patient-centric, we intend to continue to innovate, stay ahead of the curve, and evolve so we can fully answer as many relevant needs as possible.”
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