TELA Bio Announces 12-Month Analysis from BRAVO Study of OviTex® for Ventral Hernia Repair
March 18 2021 - 6:00AM
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 announced the results of the 12-month
analysis from the company's post-market BRAVO study evaluating the
clinical performance of OviTex Reinforced Tissue Matrix for the
treatment of ventral hernias. The data have been submitted to a
medical journal for publication and demonstrate minimal
postoperative surgical complications and hernia recurrence rates at
12-months with interim results up to 24-months.
"These results continue to be outstanding and compare very
favorably to results published for synthetics, resorbable
synthetics, or biologics," said Antony Koblish, President and CEO
of TELA Bio. "We look forward to the completion of the BRAVO trial
later this year and the presentation of our full two-year dataset,
which we believe will demonstrate the clinical benefits of OviTex
for use in the treatment of ventral hernias."
The analysis includes the full patient cohort at the 12-month
follow-up and an interim cohort at the 24-month follow-up. The
final 12-month analysis includes 76 patients, of whom two patients
experienced a recurrence, both adjacent to the original repair,
with the OviTex repairs remaining intact. Fifty-one (51) patients
reached the 24-month follow-up, with none experiencing a
recurrence.
"The data from the BRAVO study continues to demonstrate that
Ovitex is an excellent choice for the treatment of ventral
hernias," said Principal Investigator Dr. George DeNoto III, MD,
FACS, Director of General Surgery at St. Francis Hospital in New
York. "We are encouraged by the results of the complete data set of
the BRAVO study that reveal the long-term outcomes and durability
surgeons are seeking when choosing a material to use in hernia
repair."
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 patients 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 the 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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