TELA TELA Bio Inc

TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the European launch of OviTex Inguinal Reinforced Tissue Matrix, the only reinforced tissue matrix specifically engineered for laparoscopic and robotic-assisted inguinal hernia repair.

This milestone follows the successful U.S. launch of OviTex Inguinal in 2024, where it has achieved over $1 million in sales in its first year and has seen growing adoption by surgeons seeking a tailored, more natural alternative to synthetic mesh for inguinal hernia procedures.

OviTex Inguinal is available in two configurations in Europe, consisting of a three- or four-layer anatomically shaped device, to provide surgeons with a variety of options to address unique patient, technique or procedure-related characteristics. Each configuration has been designed for trocar-compatibility to enhance use of these products in laparoscopic and robotic procedures.

OviTex Inguinal builds on the existing OviTex portfolio, a next generation reinforced tissue matrix that utilizes layers of ovine (sheep) rumen interwoven with just enough polymer for added strength, designed to minimize permanent polymer footprint​. OviTex has over 8 years of clinical experience with more than 69,000 implantations and over 40 published or presented works globally demonstrating its clinical efficacy in hernia repair, based on sales and internal data.

This data includes a prior retrospective study, Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair (ReBAR), examining OviTex Core Permanent in a variety of hernia repair techniques and indications. The study, led by Dr. Paul Szotek, Medical Director of the Indiana Hernia Center, included the analysis of 259 patients who underwent robotic inguinal hernia TAPP repair using the ReBAR technique and demonstrated a low 1.2% recurrence rate with an average follow up of 1.5 years.

“As the adoption of robotic-assisted procedures continues to expand across Europe, there is great opportunity for naturally derived devices that support healing and have strong clinical data,” said Bill Allan, President of TELA Bio’s Europe Operations. “OviTex Inguinal is purpose-built to address that need. In the European market—where shared decision-making between surgeons and patients is a hallmark of surgical planning, this product is an ideal fit. We believe it offers European surgeons a compelling option that is designed to deliver on both clinical performance and patient expectations.”

OviTex Inguinal will be showcased this week at the European Hernia Society (EHS) Annual Congress in Paris, France, where the TELA Bio team will highlight the product’s design features and clinical history.

To learn more about OviTex Inguinal, visit www.telabio.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 and OviTex Inguinal DevicesOviTex 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. OviTex Inguinal is intended for use as a surgical mesh to reinforce and/or repair tissue where weakness exists. Indications for use include the repair of inguinal hernias that require the use of reinforcing material to obtain the desired surgical outcome.​

Do not use OviTex/OviTex Inguinal in patients with a known sensitivity to materials of ovine (sheep) origin. Use of OviTex/OviTex Inguinal in this patient population may result in an allergic or immunological reaction.

The following adverse events have been reported for surgical repair of hernias (with or without a surgical mesh): pain, infection, dysphagia, hernia recurrence, dehiscence, abscess, adhesion, bowel obstruction, bleeding, fistula, seroma, perforation, mesh migration, and mesh contraction.

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 OviTex Inguinal Reinforced Tissue Matrix in Europe. 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 recessionary concerns, banking instability, increasing market interest rates, monetary policy changes, changes in trade policies, including tariffs and trade protection measures, and inflationary pressures, potentially impacting our ability to market our products; demand for our products related to changes in volumes or frequency of surgical procedures, including due to outbreak of illness or disease, cybersecurity events impacting hospital operations, potential hospital closures, labor and hospital staffing shortages, supply chain disruptions to critical surgical and hospital supplies, pricing pressures or any other applicable adverse healthcare economic factors; 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; product 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 ContactLouisa Smithir@telabio.com