| | DEC - JAN 202119elective Cesarean delivery with maternal consent. "PalinGen® Flow is comprised of amniotic fluid-derived elements including extracellular material and proteins, and micronized amnion membrane, yielding a fluid allograft for subcutaneous injection. This jump-starts the healing process," Macal mentions. He mentions that the amniotic tissues are procured through qualified and trained recovery partners who follow stringent screening and recovery protocols in a highly controlled processing environment. "We have upgraded our manufacturing processes. This has helped us to make our product more consistent and effective while dealing with different sets of tissues," Macal elucidates.Such focus on quality has enabled Amnio Technology to receive authorization from FDA to proceed with a Phase II clinical trial under an Investigational New Drug (IND) application for its amniotic tissue-based product, PalinGen® Flow. The prospective, multicenter, randomized, controlled clinical study will investigate the efficacy of PalinGen® Flow treatment in adults with chronic ulcers of the lower extremities due to venous stasis or diabetic etiologies. Amnio Technology has confidence that this Phase II trial will demonstrate the safety, tolerability, and preliminary effectiveness of PalinGen® Flow as wound care therapeutic. Macal confirms, "We are pleased the FDA has authorized Amnio Technology to proceed with our PalinGen® Flow study in the treatment of severe chronic ulcers of the lower extremities due to venous stasis or diabetic etiologies." The PalinGen® Flow study will enroll patients with moderate-to-severe non-healing wounds at multiple clinical sites across the U.S. Amnio Technology in partnership with PharPoint Research, an award-winning clinical research organization, expects to commence trial recruitment and subject enrollment in the next 30 days.Macal believes that patients with diabetic wounds and associated infections need to be treated with novel therapies, and PalinGen® Flow is going to be a game-changer in such cases due to the subcutaneous approach and an acceptable safety profile based on documented human case studies. "The efficacy of amniotic tissue in wound healing has been recognized years back. Our goal is to drive regenerative medicine to new heights and relieve those patients suffering from complex and chronic wounds with our innovative amniotic tissue allografts and technologies," Macal concludes. We are pleased the FDA has authorized Amnio Technology to proceed with our PalinGen® Flow study in the treatment of severe chronic ulcers of the lower extremities due to venous stasis or diabetic etiologies
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