MALVERN, Pa., March 18, 2021 (GLOBE NEWSWIRE) — TELA Bio Inc. (“TELA”), a commercial-stage medical expertise firm targeted on designing, growing, and advertising and marketing modern tissue reinforcement supplies to handle unmet wants in delicate tissue reconstruction, at the moment introduced the outcomes of the 12-month evaluation from the corporate’s post-market BRAVO examine evaluating the scientific efficiency of OviTex Bolstered Tissue Matrix for the remedy of ventral hernias. The information have been submitted to a medical journal for publication and exhibit minimal postoperative surgical issues and hernia recurrence charges at 12-months with interim outcomes as much as 24-months.
“These outcomes proceed to be excellent and examine very favorably to outcomes revealed for synthetics, resorbable synthetics, or biologics,” mentioned Antony Koblish, President and CEO of TELA Bio. “We sit up for the completion of the BRAVO trial later this yr and the presentation of our full two-year dataset, which we consider will exhibit the scientific advantages of OviTex to be used within the remedy of ventral hernias.”
The evaluation consists of the complete affected person cohort on the 12-month follow-up and an interim cohort on the 24-month follow-up. The ultimate 12-month evaluation consists of 76 sufferers, of whom two sufferers skilled a recurrence, each adjoining to the unique restore, with the OviTex repairs remaining intact. Fifty-one (51) sufferers reached the 24-month follow-up, with none experiencing a recurrence.
“The information from the BRAVO examine continues to exhibit that Ovitex is a wonderful selection for the remedy of ventral hernias,” mentioned Principal Investigator Dr. George DeNoto III, MD, FACS, Director of Normal Surgical procedure at St. Francis Hospital in New York. “We’re inspired by the outcomes of the whole information set of the BRAVO examine that reveal the long-term outcomes and sturdiness surgeons are searching for when selecting a cloth to make use of in hernia restore.”
About TELA Bio, Inc.
TELA Bio Inc. (NASDAQ: TELA) is a commercial-stage medical expertise firm targeted on designing, growing, and advertising and marketing modern tissue reinforcement supplies to handle unmet wants in delicate tissue reconstruction. The corporate is dedicated to offering sufferers with superior, economically efficient biologic materials restore options to sufferers to attenuate long-term publicity to everlasting artificial supplies and enhance scientific outcomes. TELA Bio’s OviTex® and OviTex PRS Bolstered Tissue Matrix merchandise are purposefully designed to handle the shortcomings of current reinforcement supplies in hernia restore, stomach wall reconstruction and plastic and reconstructive surgical procedure. For extra info, go to www.telabio.com.
OviTex Bolstered Tissue Matrix is meant to be used as a surgical mesh to strengthen and/or restore delicate tissue the place weak spot exists. Indications to be used embody the restore of hernias and/or stomach wall defects that require the usage of reinforcing or bridging materials to acquire the specified surgical end result. Don’t use OviTex in sufferers identified to be delicate to supplies of ovine (sheep) origin. For prescription use solely. For extra necessary security info, please see the OviTex Bolstered BioScaffold Directions for Use.
The statements made or outcomes achieved by TELA Bio prospects described herein had been achieved of their particular setting. As a result of variations in scientific expertise and approach, there isn’t a assure that these outcomes are typical. A surgeon should use his or her personal scientific judgment when deciding which merchandise are applicable for the remedy of a specific affected person. At all times seek advice from the bundle insert, product label, and/or directions to be used earlier than utilizing any TELA Bio product. Merchandise is probably not accessible in all markets as a result of product availability is topic to the regulatory and/or medical practices in particular person markets
Warning Relating to Ahead-Trying Statements
This press launch accommodates forward-looking statements throughout the which means of The Personal Securities Litigation Reform Act of 1995. Phrases akin to “could,” “may,” “will,” “ought to,” “consider,” “anticipate,” “anticipate,” “estimate,” “proceed,” “predict,” “forecast,” “venture,” “plan,” “intend” or comparable expressions, or statements relating to intent, perception, or present expectations are forward-looking statements and mirror the present beliefs of TELA’s administration. These statements usually are not ensures of future efficiency and are topic to sure dangers, uncertainties and different components that might trigger precise outcomes and occasions to vary materially and adversely from these indicated by such forward-looking statements together with, amongst others, the affect to our enterprise of the continuing COVID-19 pandemic, together with any affect on our potential to market our merchandise, demand for our merchandise as a result of deferral of procedures utilizing our merchandise or disruption in our provide chain, our potential to realize or maintain profitability, our potential to achieve market acceptance for our merchandise and to precisely forecast and meet buyer demand, our potential to compete efficiently, that information from earlier research associated to our merchandise and interim information from ongoing research is probably not replicated in later research or indicative of future information, our potential to boost our product choices, improvement and manufacturing issues, capability constraints or delays in manufacturing of our merchandise, upkeep of protection and enough reimbursement for procedures utilizing our merchandise, product defects or failures. These and different dangers and uncertainties are described extra totally within the “Danger Components” part and elsewhere in our filings with the Securities and Alternate Fee and accessible at www.sec.gov, together with in our Annual Report on Kind 10-Ok and Quarterly Experiences on Kind 10-Q. Any forward-looking statements that we make on this announcement communicate solely as of the date of this press launch, and TELA assumes no obligation to replace forward-looking statements whether or not because of new info, future occasions or in any other case after the date of this press launch, besides as required below relevant regulation.
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