TELA Bio Announces U.S. Commercial Launch of OviTex® PRS Long-Term Resorbable for Plastic and Reconstructive Surgery
August 16 2023 - 7:00AM
TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical
technology company focused on providing innovative soft-tissue
reconstruction solutions that optimize clinical outcomes by
prioritizing the preservation and restoration of the patient's own
anatomy, today announced the launch of their OviTex PRS Long-Term
Resorbable product. OviTex PRS Long-Term Resorbable is intended for
implantation to reinforce soft tissue where weakness exists in
patients requiring soft tissue repair or reinforcement in plastic
and reconstructive surgery. The device is supplied sterile and is
intended for one time use.
OviTex PRS Long-Term Resorbable supplements the
Company's existing OviTex PRS portfolio, which includes OviTex PRS
Permanent and OviTex PRS Short-Term Resorbable configurations. The
OviTex PRS portfolio is designed to improve outcomes by
facilitating functional tissue remodeling while controlling the
degree and direction of stretch. OviTex PRS Long-Term Resorbable
enhances the OviTex PRS portfolio with specific design features,
including bi-directional stretch and a fully resorbable, long-term
polymer for reinforcement.
“We are excited to offer expanded clinical
utility of the OviTex PRS portfolio to surgeons and patients in
plastic and reconstructive surgery,” said Antony Koblish, President
and CEO of TELA Bio. “OviTex PRS Long-Term Resorbable is an
important addition to the portfolio as it will allow surgeons to
address clinical indications that require longer term reinforcement
while avoiding the use of permanent materials.”
With 6,800+ implantations at over 400 healthcare
facilities, OviTex PRS is the only biologic reinforced with
interwoven polymer sutures designed specifically for plastic and
reconstructive surgery. This next-generation reinforced biologic is
purposefully designed for consistency in stretch, permeability, and
handling while facilitating functional remodeling. The OviTex PRS
portfolio provides multiple resorption, stretch, and shape
offerings to meet the unique needs of each patient.
“The OviTex PRS portfolio provides surgeons with
an innovative and effective platform for soft-tissue
reconstruction,” said Dr. Howard Langstein, MD, Professor of
Plastic Surgery University of Rochester Medical Center. “My
experience with OviTex PRS has been very positive and the addition
of a long-term resorbable reinforcement option further expands the
treatment options for my patients.”
To learn more, visit www.ovitexprs.com .
About TELA Bio, Inc.TELA Bio,
Inc. (NASDAQ: TELA) is a commercial-stage medical technology
company focused on providing innovative technologies that optimize
clinical outcomes by prioritizing the preservation and restoration
of the patient's own anatomy. The Company is committed to providing
surgeons with advanced, economically effective soft-tissue
reconstruction solutions that leverage the patient's natural
healing response while minimizing long-term exposure to permanent
synthetic materials. For more information, visit
www.telabio.com.
About OviTex PRSOviTex PRS
Reinforced Tissue Matrix is intended for implantation to reinforce
soft tissue where weakness exists in patients requiring soft tissue
repair or reinforcement in plastic and reconstructive surgery. The
device is supplied sterile and is intended for one-time use.
Do not use OviTex PRS in patients with a known
sensitivity to materials of ovine (sheep) origin. For prescription
use only. For additional important safety information, please see
the OviTex PRS Instructions for Use.
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, including with respect to the launch
of the OviTex PRS Long-Term Resorbable product. 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 from macroeconomic conditions,
including the ongoing response to the COVID-19 pandemic,
recessionary concerns, banking instability, and inflationary
pressures, potentially impacting our ability to market our
products, demand for our products due to the deferral of elective
procedures, the labor and staffing environment in the healthcare
industry, disruption in our supply chain, or pricing pressures
concerning our products or the procedures using our products; 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; that data obtained from clinical studies
using our product may not be indicative of outcomes in other
surgical settings; 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.
Investor ContactGreg
Chodaczek347-620-7010ir@telabio.com
Media ContactAlyson
Kuritz908-892-7149alyson@0to5.com
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