Regenative Labs announces groundbreaking Wharton's Jelly research demonstrating HCT/P compliance after processing

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PENSACOLA, Fla., Aug. 15, 2022 /PRNewswire/ -- Regenative Labs, a leading HCT/P manufacturer, has co-authored a pioneering paper together with experts from The Institute of Regenative Medicine and the Department of Pharmacology and Chemical Biology, Baylor College of Medicine.

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Retrieved on: 
Monday, August 15, 2022
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FDA, Baylor College of Medicine, Multimedia, Association, American Association, Literature, Regenerative medicine, Intervertebral disc, Technology, Spine, American Association of Tissue Banks, 361, Hospital, Research, Spinal fusion, Pain, Department, Compliance, SEM, Institute, AATB, Patient, ECM, Health, Degenerative disc disease, Foot, Scanning electron microscope, Cartilage, Wake Forest Institute for Regenerative Medicine, IRB, Connective tissue, Physician, Knee, Ankle, Hip, Wharton, Shoulder, Labs, Public sector banks in India, DDD, Microscope, Pharmaceutical industry, Medical device, Ibuprofen, Pharmacology, Medicine
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FLORIDA, NEW YORK CITY
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REGENATIVE LABS, THE INSTITUTE OF REGENATIVE MEDICINE, BAYLOR COLLEGE OF MEDICINE
Summary
Key Points: 
  • Regenative Labs has pioneered the use of perinatal tissue allografts and is pleased that this paper supports our current homologous use practices, consistent with our 361 status.
  • 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.
  • Regenative Labs's expert product research and development team compliesFDA guidelines of minimal manipulation for homologous use.


Regenative Labs announces groundbreaking Wharton's Jelly research demonstrating HCT/P compliance after processing

This includes the analogous nature of articular cartilage, muscle fascia, and intervertebral disc confirmed by way of comparative Scanning Electron Microscope analysis

PENSACOLA, Fla., Aug. 15, 2022 /PRNewswire/ -- Regenative Labs, a leading HCT/P manufacturer, has co-authored a pioneering paper together with experts from The Institute of Regenative Medicine and the Department of Pharmacology and Chemical Biology, Baylor College of Medicine.

"This paper is a market disruptor and will be our most significant paper released to date. This is the first literature that we are aware of to utilize Scanning Electron Microscope (SEM) images of actual tissue samples to objectively demonstrate on a qualitative and quantitative basis that collagen structural tissue matrices in our post-processed Wharton's Jelly allografts and those in articular cartilage, muscle fascia, and intervertebral discs are analogous," said Regenative Labs CEO, Tyler Barrett.

This research highlights our commitment to the Regenerative Medicine community. We believe the combination of our IRB-approved observational studies, peer-reviewed publications, ISO-certified laboratory processes, and our commitment to compliance with FDA and American Association of Tissue Banks (AATB) standards, sets the standard for HCT/P manufacturers. Regenative Labs has pioneered the use of perinatal tissue allografts and is pleased that this paper supports our current homologous use practices, consistent with our 361 status.

Currently, the treatments for the Intervertebral Disc (DDD) range in cost and effectiveness from an $8 bottle of Ibuprofen to $150,000 for spinal fusion (1). Neither of these treatment options target the foundational issue of ECM cartilage breakdown in the intervertebral discs. By age 35, 30% of people show signs of DDD; by age 60, this increases to 90% (2). That we are aware of, this is the first perinatal tissue allograft in the medical marketplace that may be applied in a homologous fashion per FDA 361 guidelines to replace or supplement missing or damaged connective tissue. All other non-surgical paradigms focus on symptom management and do not address the disc's collagen structural degeneration. In collaboration with medical providers across the country, we are actively investigating additional homologous use applications for this technology in tissue defects associated with the load-bearing joints of the knee, hip, shoulder, spine, ankle, and foot.

Billions of dollars are spent annually on the surgical care and treatment of patients suffering from degeneration of load-bearing joints and intravertebral discs. We are honored to offer patients evidence-based and structural tissue defect-specific non-surgical applications on a global scale.

Additional Sources:

  1. How much does degenerative disc treatment cost? CostHelper. (n.d.). Retrieved August 10, 2022, from https://health.costhelper.com/degenerative-disc.html
  2. Degenerative disc disease. Columbia Neurosurgery in New York City. (2021, July 21). Retrieved August 10, 2022, from https://www.neurosurgery.columbia.edu/patient-care/conditions/degenerative-disc-disease#:~:text=Most%20people's%20spinal%20discs%20degenerate,does%20not%20necessarily%20cause%20pain.

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 daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs's expert product research and development team complies FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: www.regenativelabs.com 

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SOURCE Regenative Labs

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