BIOHEAL THERAPEUTICS: A World-Class Leader in Regenerative Medicine
Since 2017, BIOHEAL THERAPEUTICS has partnered with the Wake Forest Institute for Regenerative Medicine (WFIRM), a globally recognized leader in regenerative medicine. Established in 2004 by Dr. Anthony Atala and his research team, WFIRM was the first institute to bring together multi-disciplinary faculty under one roof, dedicated to advancing regenerative medicine.
Pioneers in Regenerative Medicine
WFIRM is renowned for its groundbreaking work in translating scientific discoveries into clinical therapies. Highlights include:
- World's First Laboratory-Grown Organs: Successfully engineered and implanted into humans.
- Ongoing Projects: Engineering over 40 different replacement tissues and organs, and developing cell therapies aimed at curing diseases.
Advancing Wound Care and Severe Burn Technologies Globally
BIOHEAL THERAPEUTICS holds an exclusive worldwide license agreement with WFIRM to develop, manufacture, and distribute amnion-derived technology. Our innovations include:
- 12 Global Patents: Covering the Solubilized Amnion Membrane (SAM) product portfolio in the US, Canada, Europe, Australia, Japan, and South Korea.
Product Development and Manufacturing Excellence
Since 2018, we have partnered with Viscus Biologics, enhancing our manufacturing capabilities. Key achievements include:
- Dedicated High-Capacity Facility: Relocated in 2018.
- ISO 13485 Certification: Achieved in 2016, ensuring the highest standards in quality management.
Trusted Legal Representation
BIOHEAL THERAPEUTICS has been supported by Arnall Golden Gregory LLP (AGG) since its founding. AGG, a Law 200 firm with 180 attorneys in Atlanta, GA, and Washington, D.C., has a proven track record of helping growing enterprises become industry leaders over the past seven decades.
Reliable Financial Services
Since our inception, Frazier & Deeter, LLC have provided robust financial services. They operate from six locations in the US and two in the UK.
Commitment to Quality Assurance and Regulatory Compliance
We partner with REGSolutions for expert QA and regulatory services. Our company utilizes the cloud-based Greenlight Guru Quality Management System software, trusted by over 800 leading MedTech companies worldwide.
Conclusion
BIOHEAL THERAPEUTICS continues to lead the way in regenerative medicine through strategic partnerships, innovative product development, and a steadfast commitment to quality and compliance. Our collaboration with WFIRM and other industry leaders ensures we remain at the forefront of advancing wound care and regenerative therapies globally.