TELA Bio® Announces New Data on Use of OviTex in a Range of Hernia Repair Applications, Including Novel ReBAR (Reinforced Biologic Augmented Repair) Technique
September 13 2021 - 7:00AM
TELA Bio, Inc. (NASDAQ: 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 details of the clinical
research presented last week at the Society of American
Gastrointestinal and Endoscopic Surgeons (SAGES) meeting in Las
Vegas, Nevada.
Two poster presentations revealed new data, while a third video
presentation demonstrated a novel surgical technique that leverages
the unique properties of OviTex® Reinforced Tissue Matrix.
Robotic Assisted ReBAR of 111 Inguinal Hernias, presented by Dr.
Cory Banaschak, DO and Dr. Paul Szotek, MD, MBA, FACS, Medical
Director of the Indiana Hernia Center, revealed a 2.7% recurrence
rate, a 1.8% surgical site occurrence rate, and no infections in
patients with at least one year of follow-up. The authors concluded
that robotic transabdominal preperitoneal (rTAPP) inguinal hernia
repair with OviTex presents a viable and more natural repair
alternative in minimally invasive surgery, an approach typically
reserved for permanent synthetic meshes. Dr. Szotek stated, "The
Reinforced Biologic Augmented Repair, or the ReBAR technique,
applies sound hernia surgery principles while leveraging the
benefits of a reinforced biologic material with a low synthetic
foreign body burden. Our initial goals in adopting OviTex were to
lower recurrences while decreasing the amount of synthetic foreign
body implanted. That's what patients are increasingly looking for,
and it makes a lot of clinical sense if you can achieve it. With
over five years of experience utilizing the ReBAR technique with
OviTex, it appears that we are on the way to achieving these
goals."
Additional data on hernia repairs performed by Drs. Szotek and
Banaschak employing the ReBAR technique was recently highlighted in
an article entitled, Minimizing Retained Foreign Body in Hernia
Repair Using a Novel Technique: Reinforced Biologic Augmented
Repair (ReBAR) published in the Journal of Clinical and Medical
Research. In this prospective study of 619 implants using the ReBAR
technique for a variety of open and minimally invasive inguinal and
abdominal hernia repairs the authors reported an overall recurrence
rate of 1.3%.
Use of Ovine Reinforced Tissue Matrix in Bridged Incisional
Hernia Repair, presented by Dr. DeNoto III, MD, FACS, Director of
General Surgery at St. Francis Hospital in New York, analyzed
recurrence rates in the treatment of abdominal hernias that require
reinforcement in the absence of a primary repair. "These are some
of the most complex and challenging patients to reduce the
potential of a future hernia recurrence," said Dr. DeNoto. In this
series, patients with bridged repairs using OviTex had a 14%
recurrence rate. "To put the results of our study in perspective,
at similar time points we have seen recurrence rates more than
double when repaired with human or porcine mesh products. This is a
major reason why patients presenting with bridged repairs are so
difficult to treat and why an effective reinforcement option is
much needed."
For more information on the SAGES poster presentations, visit
https://epostersonline.com/sages2021/
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
StatementsThis 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 and the
development of new variants of COVID-19, such as the delta variant,
including but not limited to 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, our ability
to enhance our product offerings, that data from studies related to
our products may not be replicated in later studies or indicative
of future data, development and manufacturing problems, capacity
constraints or delays in production of our products, maintenance of
coverage and adequate reimbursement for procedures using our
products, and 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.
Investor ContactGreg
Chodaczek347-620-7010ir@telabio.com
Media ContactAlyson
Kuritz908-892-7149alyson@0to5.com
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