Larry Macal, Chief Operating Officer
Regenerative medicines generate biological substitutes and improve tissue functions while reducing the chances of undergoing limb replacement surgeries. That’s why amniotic tissues today are being studied extensively for its regenerative properties. Being naturally rich in growth factors, cytokines, amino acids, carbohydrates, hyaluronic acid, extracellular matrix (ECM) proteins, and cellular components, such tissues provide an immune-privileged barrier for complex and limb-threatening wound healing. Also, they play a vital role in preventing inflammation and scar tissue generation.
Founded in 2013, Amnio Technology is working dedicatedly to optimize the regenerative capability and clinical use of these amniotic tissues. Today, the company has emerged as a global leader in developing and distributing amniotic tissue allografts. “Our products are made from human amniotic membrane and fluid, which is essentially the innermost layer of the placenta and the liquid that surrounds the baby until it’s born. Just as these tissues act as a physical barrier to cover and protect the fetus during pregnancy, the Amnio Technology line of products provides a biological, physiological and physical overlay to support and protect an injury in the body,” says Larry Macal, Chief Operating Officer of Amnio Technology. “It also is an alternative for steroid shots that can lead to potential side effects, including temporary bruising or a collection of blood under the skin, flushing of the face for a few hours, inflammation, to name a few.”
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
Amnio Technologies’ PalinGen®
Flow is an amniotic tissue allograft that it recovers during elective 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.