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TELA Bio begins commercialization for Large Size OviTex® Reinforced BioScaffolds for Hernia Repair and Abdominal Wall Reconstruction after Aroa Biosurgery receives 510k clearance.10 Jan 2019

1,000 cm2 device now commercially available in the U.S. rounds out portfolio of surgical mesh for full range of complex surgical procedures

MALVERN, P.A. and Auckland NZ– January 10, 2019 – TELA Bio®, Inc. and Aroa Biosurgery, the joint developers of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market large sizes of OviTex RBS. The OviTex Permanent product line is now commercially available in United States from TELA Bio in sizes up to 25x40 cm (1,000 cm2), which is a 150% surface area increase over currently available devices.

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TELA Bio® Announces Initial Data from BRAVO Study of OviTex® Reinforced BioScaffolds for Ventral Hernia Repair7 Jun 2018

Early outcomes from post-market clinical study presented at Abdominal Wall Reconstruction Conference in Washington, DC.

MALVERN, Pa., June 7, 2018 /PRNewswire/ -- TELA Bio®, Inc., a surgical reconstruction company leading the development and commercialization of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that early outcomes from the company's post-market BRAVO (BioScaffold Reconstruction of Abdominal wall and Ventral hernia defects with Open or laparoscopic repair) study evaluating OviTex 1S Permanent for the treatment of ventral hernias are being presented at the 2018 Abdominal Wall Reconstruction Conference taking place June 7 – 9 at the Grand Hyatt Washington in Washington, DC.

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TELA Bio® Announces Plans to Launch OviTex® Reinforced BioScaffolds in Europe31 May 2018

MALVERN, Pa., May 31, 2018 /PRNewswire/ -- TELA Bio®, Inc., a surgical reconstruction company leading the development and commercialization of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced that its partner Aroa Biosurgery, a soft-tissue repair company based in New Zealand that develops and manufactures medical products to improve healing, has been granted EC Certification (CE Mark) allowing for the commercial launch of OviTex RBSs in the European Union (EU).

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