AUSTIN, Texas, January 12, 2021 (Newswire.com) - Direct Biologics, LLC, an industry leader in extracellular vesicle technology, announced today that the company has launched AmnioWrap™ placental-based sheet allografts for clinical use. AmnioWrap™ is a unique, tri-layer graft intended for applications in acute and chronic wounds. The allograft contains a collagen extracellular matrix and a wide array of regulatory proteins including growth factors, cytokines, and chemokines - known key factors for healing and tissue regeneration.
"Our management team commands extensive commercial, scientific and clinical experience in amniotic allografts, including Adam McQueen who is leading this endeavor," noted Joe Schmidt, Co-Founder and President. "Adding AmnioWrap tri-layer allograft to our portfolio is a natural expansion of our remarkable regenerative therapeutic platform. We are delivering 2021 solutions for patients in need of the newest generation of therapies to augment healing."
McQueen, Division Vice President of Amniotic Products, added, "I'm excited to bring this revolutionary tri-layer allograft to market. Amniotic tissue has proven to be one of the more comprehensive regenerative products and is backed by extensive clinical and scientific research." AmnioWrap™ is available in a wide variety of sizes to support treatment in multiple surgical applications, such as in plastic surgery reconstruction, orthopaedic and spine, surgical wounds, as well as chronic wounds, burn and ocular injuries or conditions.
Mark Adams, Co-Founder and Chief Executive Officer, stated, "We're excited to add yet another exceptional technology to our product assortment to meet the needs of clinicians across a broad range of therapeutic disciplines. Placental allografts represent an important and fast-growing segment of the skin and dermal substitute market."
"It's important for clinicians to have multiple biotherapeutic tools at hand in order to treat patients based on their specific clinical need," added Chief Medical Officer, Vik Sengupta, MD. "The AmnioWrap™ product line offers another option to help heal wounds and aid in limb salvage, reduce potential surgical complications, and improve quality of life for patients."
Direct Biologics is also enrolling patients in EXIT COVID-19, its national multi-center, Phase II, placebo controlled, randomized clinical trial investigating the use of ExoFlo™ for COVID-19 associated acute respiratory distress syndrome (ARDS).
AmnioWrap™ is a dehydrated, sterilized human amniotic/chorionic membrane allograft intended for homologous use in the repair, replacement, reconstruction, or augmentation of human tissue. It contains key components found in human placental tissues including an intact extracellular matrix (ECM), regulatory growth factors and cytokines. AmnioWrap™ is easy to handle and apply and has been used topically for surgical applications, wounds, burns, soft tissue injuries, and over tendons and ligaments.
ExoFlo™ is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo™ provides natural bioactive signals that have been shown to modulate inflammation and direct cellular communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with a recently expanded R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The company was created to expand the science of regenerative healing by delivering cutting-edge biologic technologies. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of its extracellular vesicle biologic products through the FDA's investigational new drug application process. For more information visit http://www.directbiologics.com.
Source: Direct Biologics