Regenative Labs CEO predicts this will have significant implications to advance multiple fields.
PENSACOLA, Fla., July 8, 2022 /PRNewswire/ — Regenative Labs, a leading FDA-registered and HTC/P manufacturer, confirms that the Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM), an independent body which facilitates and validates regenerative and cellular medicine through collaborative and translational research, has approved its protocol for observational data of homologous use applications for Regenative’s products.
In noting receipt of the IRCM IRB letter, CEO Tyler Barrett observed that this is a key step in facilitating other studies for use of Regenative’s products. “We believe this will allow clinicians to explore new homologous use applications and make it easy to follow their patient outcomes,” he said, adding, “We are committed to advancing this field of research.”
The IRB letter confirms a key classification, known as 361, allowing Regenative to further studies for the use of its products.
“We are excited that this will allow us and our partner physicians to look for new uses,” said Barrett, pointing out that connective tissue is found throughout the body and that while the current use is heavily concentrated in addressing defects in the knee and specialties like orthopedics, Regenative has received queries and reports from specialties like podiatry and urology for cases of wound care and urinary incontinence.
In confirming receipt of the IRB’s letter, Regenative Labs confirmed their continued adherence to applicable state, local and federal regulations and requirements. They also look forward to a strong relationship with regulators.
The specific observational data collection approved is through MedngineTM of homologous use applications using ProTextTM, CryoTextTM,SecreTextTM, CoreTextTM and AmnioText.
Protocol number: RL-ME-002
IRB approval number: IRCM-2022-311
About Regenative Labs : Regenative Labs produces regenerative medicine products to address the root cause of a patient’s conditions using Wharton’s Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides effective, non-addictive, non-invasive options for patients. Regenative Labs has a laser-focused, expert product research and development team which follows FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines.
Link to Original Article: Institutional Review Board Approves Regenative Labs’ Protocol For Key Data Collection