Full Press Release Details
Bio Announces Interim Analysis from BRAVO Study of OviTex for Ventral
MALVERN, Pa., July 9, 2020 (GLOBE NEWSWIRE) -- TELA Bio, Inc.
("TELA"), a commercial-stage medical technology company focused on designing, developing and marketing a new category
of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced the results of an interim
analysis from the company's post-market BRAVO study evaluating the clinical performance of OviTex for the treatment of ventral
hernias. The data have been submitted to a medical journal for publication, and show low surgical complication and hernia recurrence
rates at various time points up to 24-months postoperatively.
continue to validate the effectiveness of OviTex in improving patient outcomes in ventral hernia repair," said Antony Koblish,
President and CEO of TELA Bio. "We remain confident that additional follow-up data will further establish OviTex as an optimal
treatment option to improve patient care and address surgeon needs."
The interim analysis
includes patient cohorts at the 90-day, 12-month and 24-month follow-up periods. At 90 days post-op, there were no recurrences,
reoperations, or implant removals among the 85 patients analyzed. At 12 months, 57 patients have been assessed, with only one
patient experiencing a recurrence. Notably, this recurrence occurred in a location adjacent to the original repair in an area
of abdominal weakness and the initial repair using OviTex remained intact. Of the 20 patients that have reached 24-month follow-up,
none experienced a recurrence or long-term complication.
to be encouraged by the compelling results from our BRAVO study," said Principal Investigator Dr. George DeNoto III, MD,
FACS, Director of General Surgery at St. Francis Hospital in New York. "The interim results highlight positive patient outcomes
with OviTex and the promise of this advanced biologic solution to provide a durable hernia repair as seen by low recurrence rates
at 12- and 24-month follow-up with no long-term complications to-date."
a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement
materials to address unmet needs in soft tissue reconstruction. TELA's products are designed to improve on shortcomings of existing
biologics and minimize long-term exposure to permanent synthetic material. TELA's portfolio is supported by quality, data-driven
science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.
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 realted 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.
Vice President, Corporate
Development and Investor Relations