Partnership and Exclusive Worldwide Licensing Agreement With a World-Class International Leader in Regenerative Medicine
Since 2017, XCell Biologix has partnered with the Wake Forest Institute for Regenerative Medicine (WFIRM), a world-class, innovative research and development institute. WFIRM was established in 2004 by Anthony Atala, M.D., and his research team as the first regenerative medicine institute with primary-appointed, multi-disciplinary faculty under one roof.
WFIRM is a leader in translating scientific discovery into clinical therapies. Physicians and scientists at WFIRM were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Today, this interdisciplinary team is working to engineer more than 40 different replacement tissues and organs and to develop healing cell therapies - all with the goal to cure, rather than merely treat, disease.
Globally Advancing Wound Care & Severe Burn Platform Technologies
XCell Biologix signed an exclusive worldwide license agreement with WFIRM to develop, manufacture and distribute their mammalian derived amnion amniotic membrane technology portfolio. XCell Biologix has 12 patents issued or pending globally for its Solubilized Amnion Membrane (SAM) product portfolio in the US, Canada, Europe, Australia, Japan and South Korea. The technology was initially funded by a $1,240,000 grant from the U.S. Department of Defense to WFIRM to develop a technology to treat US soldiers suffering from severe burns and wounds inflicted on the battlefield. There have been 14 published research articles and numerous podium presentations at scientific meetings focused on the XCell Biologix' amnion technology or hyaluronic acid technology platforms by the inventors and their team from WFIRM.
Product Development & Manufacturing
Since 2018, XCell Biologix has partnered with the Viscus Biologics. Founded in 2012, Viscus Biologics LLC specializes in product realization from ideation to high volume production. In 2018, the company relocated to a dedicated high-capacity manufacturing facility and received ISO 13485 certification in 2016. The company manufactures components, devices, and products with natural polymer and extracellular matrix materials that fulfill patient and market needs, improve people’s quality of life, and restore tissue to a healthy, functioning, and durable state. Viscus Biologics is headquartered in Cleveland, OH and has a pre-clinical research facility in Dublin, Ireland.
XCell Biologix has worked with Arnall Golden Gregory LLP since our founding. Arnall Golden Gregory (AGG) is an Am Law 200 law firm with 180 attorneys in Atlanta, GA and Washington, D.C. For more than seven decades, AGG has established a strong record of helping growing enterprises become industry leaders. Today their team of attorneys, who practice in 30+ areas of law, continues to expand AGG’s reputation for helping public and private companies successfully grow their business.
Since XCell Biologix was established, we have worked with Frazier & Deeter, LLC. Frazier & Deeter is one of the largest and fastest-growing accounting firms in the U.S. They have won many awards including Best of the Best, Best Firm for Women, Fastest Growing, Best Firm to Work For, Practice Innovation, and Most Admired. Frazier & Deeter have been in business for 40 years. They have offices in six locations in the US and two offices in locations in the United Kingdom.
Quality Assurance & Regulatory Services
XCell Biologix works with REGSolutions for QA & Regulatory expertise. REGSolutions, LLC provides strategic consulting for medical device regulatory affairs, quality and clinical needs, including registrations for market entry in the USA and European (EU), regulatory rescue, quality system builds, and clinical registrations (IRB, IDE). XCell Biologix uses the cloud-based Greenlight Guru Quality Management System software. Over 800 of the world's leading MedTech companies use the Greenlight Guru platform.