Regenity is leading the regenerative medicine industry, driving growth and innovation to support improved patient care and outcomes.
The future of healthcare is promising, with growth and innovation led by advancements in regenerative medicine. Companies like Regenity Biosciences are pioneering advancements in regenerative science and transforming bioabsorbable materials into life-changing solutions.
An Explosion of Growth in Regenerative Medicine
The regenerative medicine market is rapidly expanding, driven by the rising prevalence of chronic
conditions, demand for personalized therapies, and an aging population. With 1 in 6 U.S. adults over
65 , there’s a growing need for innovative treatments that go beyond symptom management to enable 1
true healing.
This need for advanced solutions has been met with stem cell therapy and tissue engineering breakthroughs like Regenity’s FDA-cleared RejuvaKneeTM, a collagen-based meniscal implant that facilitates the regeneration of native meniscal tissue instead of cutting or replacing it . This marks a 2 shift from the standard of care with the potential to improve patients’ quality of life.
Gaining a Competitive Edge with a Regenerative Medicine CDMO
Medtech companies have a unique opportunity to enter the high-growth regenerative medicine market
with support from contract development and manufacturing organizations (CDMOs) like Regenity,
offering expertise, efficiency, and scalability in key areas:
- Manufacturing Expertise
Regenerative medicine products often require complex, specialized manufacturing processes. CDMOs ensure the highest quality and regulatory compliance through advanced capabilities in material sourcing, tissue engineering and proprietary biomaterial processes. Regenity’s end-to-end approach delivers unmatched quality, consistency, and efficiency for end products made from collagen, synthetic polymers, and other biomaterials. - Regulatory Support
CDMOs provide critical support navigating complex regulatory landscapes, ensuring compliance with local and global standards. With 27+ years of experience, Regenity has 60 510(k) clearances, 24 CE marks, 2 China certificates, and approvals in 85+ countries on behalf of its customer base. This experience matters when it comes to supporting customers’ regulatory submissions, claims development, and clinical study design for regenerative devices. - Scalability and Flexibility
Scaling production for commercial success requires flexibility, quality and consistency. CDMOs can offer seamless transitions from clinical trials to full-scale manufacturing. Regenity’s state-of-the-art facilities—spanning over 70,000 square feet in the U.S. and EU— provide immediate scalability in ISO Class 7 environments with established regulatory certifications.
Looking Ahead
Regenerative medicine is transforming healthcare, empowering medtech companies to innovate, stay
competitive, and ultimately serve more patients. With CDMOs like Regenity providing expertise and
scalability, companies can efficiently bring groundbreaking tissue engineering solutions to market,
shaping the future of healthcare.
- Caplan, Z. (2023, May 25). U.S. Older Population Grew From 2010 to 2020 at Fastest Rate Since 1880 to 1890. Census.gov. https://www.census.gov/library/stories/2023/05/2020-census-united-states-
older-population-grew.html - Regenity Data on File, 2024
