Results from Studies of OviTex™ Reinforced BioScaffolds Presented at Abdominal Wall Reconstruction Conference
New class of surgical mesh demonstrates positive healing response, rapid graft integration in a non-human primate model.
MALVERN, Pa., June 15, 2016 /PRNewswire/ — TELA Bio, Inc., a surgical reconstruction company leading the development of Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that results from three studies of the company’s OviTex™ RBSs were presented at the Abdominal Wall Reconstruction (AWR) Conference held June 9-11 in Washington, D.C. OviTex RBSs combine synthetic and biologic materials by interweaving polymer through layers of intact extracellular matrix (ECM), a biologic building block derived from ovine rumen. Dr. Stephen Ferzoco, a Boston-based hernia surgeon, partnered with the company to evaluate OviTex RBSs.
In one study, OviTex RBSs were used to repair full thickness abdominal wall defects (3x7 cm) in adult Vervet monkeys and clinical tissue remodeling, inflammation, foreign body response, and seroma formation was analyzed macroscopically and histologically at 1, 3, and 6 months following implantation (n=3 per time-point). OviTex RBSs were shown to be well tolerated with no signs of inflammation, delamination, herniation or visceral attachments, and demonstrated a positive healing response and rapid graft integration into the host tissue.
A second non-human primate study evaluated the visual appearance including the size and shape of five different mesh materials used to repair full thickness abdominal wall defects (3x7 cm) in adult Vervet monkeys at 6 months following implantation (n=2 to 5 per material). Coated synthetic and synthetic resorbable mesh had shrunk and showed extensive pleating, while biologic implants showed less pleating but changed shape significantly. OviTex RBSs best maintained their shape and appeared most integrated in the abdominal defect.
A third study measured the biomechanical characteristics of OviTex RBSs compared to commercially available synthetic mesh materials through ball burst, uniaxial tensile, and suture retention testing using an Instron machine. OviTex RBSs matched or exceeded the strength of synthetic meshes currently used for ventral hernia repair.
“This new class of materials uses the strength and regenerative properties of a layered ECM scaffold, while simultaneously providing additional reinforcement via the polymer,” said Dr. Ferzoco. “Based on these results, OviTex RBSs represent a new option for surgeons looking for the benefits of both biologic and synthetic repair materials.”
About TELA Bio, Inc.
TELA Bio, Inc. is a privately owned company focused on bringing innovative, cost-effective, surgical reconstruction solutions to surgeons, hospitals and patients. The company’s OviTex™ Reinforced BioScaffolds (RBSs) products, designed for hernia repair and abdominal wall reconstruction procedures, integrate polymer and biologic materials through engineering design principles. The OviTex portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated the advantages of an RBS over commercially available materials. TELA Bio plans to launch OviTex in North America and the European Union, and is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in surgical reconstruction. To learn more about TELA Bio visit http://www.telabio.com.
Berry & Company Public Relations
SOURCE TELA Bio, Inc.
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