Full Press Release Details
Bio Initiates BRAVO II Study of OviTex for the Robotic Repair of Ventral Hernias
MALVERN, PA, May 19, 2021 -- TELA Bio, Inc. ("TELA"), a commercial-stage
medical technology company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet
needs in soft tissue reconstruction, today launched the company's second post-market study, BRAVO II, to evaluate the clinical performance
of OviTex Reinforced Tissue Matrices in the robotic repair of ventral hernias. The first patient was enrolled at St. Lukes's Hospital
in Overland Park, Kansas.
"We continue our commitment to developing
and providing surgeons with advanced soft tissue repair materials," said Antony Koblish, President and CEO of TELA Bio. "With
the continued success of our original BRAVO study and the ongoing evolution in robotic procedures for more complex ventral hernia repair,
we are excited to demonstrate the efficacy and durability of the expanded OviTex portfolio in robotic hernia repair through our BRAVO
II study. This study will include the addition of OviTex LPR, which has been designed specifically for optimal robot compatibility."
The company expects to enroll up to 100 subjects
in the BRAVO II study at up to seven US-based sites, with patient follow-up at 90 days, 12 months, and 24 months. Study researchers will
primarily monitor the incidence of early postoperative surgical site occurrences, wound-related events, and other complications within
three months of surgery. Secondarily, researchers will monitor the incidence of true hernia recurrence, surgical site occurrences, and
other complications occurring after three months post-surgery. Patient reported outcomes will be evaluated and recorded using quality
of life and pain assessments.
"The use of reinforced tissue matrix
allows surgeons to offer patients a strong and safe robotic natural hernia repair while decreasing the amount of permanent mesh that is
placed in the abdomen," said Geoffrey Slayden, MD, of Saint Luke's Surgical Specialists in Overland Park, Kansas. "This technology
allows us to maximize the advantages of both the permanent and remodeling aspects of the mesh."
To learn more about Core, LPR, and 1S, the OviTex Reinforced Tissue
Matrix configurations that will be used in the BRAVO II study, visit telabio.com/ovitex.
About TELA Bio, Inc.
TELA Bio Inc. (NASDAQ: TELA) is a commercial-stage medical technology
company focused on designing, developing, and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue
reconstruction. The company is committed to providing patients with advanced, economically effective biologic material repair solutions
to minimize long-term exposure to permanent synthetic materials and improve clinical outcomes. TELA Bio's OviTex and OviTex PRS
Reinforced Tissue Matrix products are purposefully designed to address the shortcomings of existing reinforcement materials in hernia
repair, abdominal wall reconstruction, and plastic and reconstructive surgery. For more information, visit www.telabio.com.
OviTex Reinforced Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material
to obtain the desired surgical outcome. Do not use OviTex in patients known to be sensitive to materials of ovine (sheep) origin.
For prescription use only. For additional important safety information, please see the OviTex Reinforced BioScaffold Instructions for
The statements made or results achieved by TELA Bio customers described
herein were achieved in their specific setting. Due to variations in clinical experience and technique, there is no guarantee that these
results are typical. A surgeon must use his or her own clinical judgment when deciding which products are appropriate for treatment of
a particular patient. Always refer to the package insert, product label, and/or instructions for use before using any TELA Bio product.
Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual
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meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will,"
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impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption
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accurately forecast and meet customer demand, our ability to compete successfully, that data from earlier studies related to our
products and interim data from ongoing studies may not be replicated in later studies or indicative of future data, our ability to
enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products,
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risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the
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on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release,
and TELA assumes no obligation to update forward-looking statements whether as a result of new information, future events or
otherwise after the date of this press release, except as required under applicable law.
Chief Financial Officer