TELA Bio Initiates BRAVO II Study of OviTex® for the Robotic Repair of Ventral Hernias
19 May 2021 - 9:00PM
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.
About OviTexOviTex 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 Use.
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 markets
Caution Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Words such as "may," "might," "will," "should," "believe,"
"expect," "anticipate," "estimate," "continue," "predict,"
"forecast," "project," "plan," "intend" or similar expressions, or
statements regarding intent, belief, or current expectations are
forward-looking statements and reflect the current beliefs of
TELA's management. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties and
other factors that could cause actual results and events to differ
materially and adversely from those indicated by such
forward-looking statements including, among others, the impact to
our business of the ongoing COVID-19 pandemic, including any impact
on our ability to market our products, demand for our products due
to deferral of procedures using our products or disruption in our
supply chain, our ability to achieve or sustain profitability, our
ability to gain market acceptance for our products and to
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, maintenance of coverage and adequate
reimbursement for procedures using our products, product defects or
failures. These and other risks and uncertainties are described
more fully in the "Risk Factors" section and elsewhere in our
filings with the Securities and Exchange Commission and available
at www.sec.gov, including in our Annual Report on Form 10-K and
Quarterly Reports 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.
TELA Bio ContactNora BrennanChief Financial
OfficerTELA Bio, Inc.484-320-2930Investor
ContactGreg Chodaczek347-620-7010 ir@telabio.com
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