TELA Bio(TELA)

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TELA Bio to Participate in the 2025 Jefferies Global Healthcare Conference
GlobeNewswire· 2025-05-22 20:05
MALVERN, Pa., May 22, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced that the Company will participate in the 2025 Jefferies Global Healthcare Conference. TELA’s management is scheduled to present at the 2025 Jefferies Global Healthcare Conference at 11:05 am ET on June 5th, 2025. Interested parties can access the live and archived webcast at ir.telabio.com. About TELA ...
TELA Bio, Inc. (TELA) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-08 22:50
TELA Bio, Inc. (TELA) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.21. This compares to loss of $0.23 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -19.05%. A quarter ago, it was expected that this company would post a loss of $0.23 per share when it actually produced a loss of $0.23, delivering no surprise.Over the last four quarters, the company has not been able to ...
TELA Bio(TELA) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:30
TELA Bio (TELA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Good afternoon, ladies and gentlemen, and welcome to the TELA Bio First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. Following the prepared remarks, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Louisa Smith from Gilmartin Group. Speaker1 Thank you, Gerald, and good a ...
TELA Bio(TELA) - 2025 Q1 - Quarterly Report
2025-05-08 20:30
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-39130 TELA Bio, Inc. Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Exact name of registrant as specified in its charter) Delaware (State or othe ...
TELA Bio(TELA) - 2025 Q1 - Quarterly Results
2025-05-08 20:15
Exhibit 99.1 TELA Bio Reports First Quarter 2025 Financial Results MALVERN, PA, May 8, 2025 -- TELA Bio, Inc. ("TELA Bio"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today reported financial results for the first quarter ended March 31, 2025. Recent Highlights "We are pleased with the strong performance in the first quarter of 2025 following the realignment and optimization of our sales organization," said Antony Koblish, President an ...
TELA Bio Reports First Quarter 2025 Financial Results
GlobeNewswire· 2025-05-08 20:05
MALVERN, Pa., May 08, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA Bio"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today reported financial results for the first quarter ended March 31, 2025. Recent Highlights Delivered revenue of $18.5 million in the first quarter 2025, representing growth of 12% over the prior year period and sequential growth of 5% over the fourth quarter of 2024;Increased demand for OviTex® and OviTex PRS Reinf ...
TELA Bio to Announce First Quarter 2025 Financial Results
GlobeNewswire· 2025-04-17 20:05
Core Viewpoint - TELA Bio, Inc. is set to report its first quarter 2025 financial results on May 8, 2025, and will host a conference call and webcast to discuss these results and provide a corporate update [1]. Group 1: Financial Reporting - The first quarter 2025 financial results will be reported on May 8, 2025 [1]. - A conference call and webcast will take place at 4:30 p.m. ET on the same day to discuss the financial results [1]. Group 2: Company Overview - TELA Bio, Inc. is a commercial-stage medical technology company focused on innovative soft-tissue reconstruction solutions [3]. - The company aims to optimize clinical outcomes by preserving and restoring the patient's own anatomy while minimizing long-term exposure to synthetic materials [3].
TELA Bio Announces U.S. Commercial Launch of Larger Sizes of OviTex® PRS for Plastic and Reconstructive Surgery
Newsfilter· 2025-03-31 11:00
To learn more, visit ovitexprs.com. About TELA Bio, Inc. MALVERN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ:TELA), a commercial- stage medical technology company focused on advancing soft-tissue reconstruction solutions, today announced the U.S. launch of larger sizes of OviTex PRS Reinforced Tissue Matrix, the only tissue-based device reinforced with polymer suture embroidery specifically engineered for plastic and reconstructive surgery. Designed for consistency in thickness, stretch, ...
TELA Bio(TELA) - 2024 Q4 - Annual Report
2025-03-21 20:05
Revenue Dependence and Sales Performance - Sales of OviTex products accounted for 66%, 67%, and 70% of total revenue for the years ended December 31, 2024, 2023, and 2022, respectively[254]. - The company expects that sales of OviTex products will continue to account for the majority of revenue for the foreseeable future[254]. - The company is highly dependent on the commercial success of its OviTex product line, which poses a risk to its financial condition if sales do not increase[254]. - The company’s ability to grow revenue will depend on increasing sales of OviTex products and successfully introducing new products[260]. - The company may experience lower than expected sales if there is a decrease in consumer spending or negative reactions to pricing[249]. - Approximately 15%, 10%, and 8% of the company's revenue for the years ended December 31, 2024, 2023, and 2022, respectively, came from sales in markets outside of the U.S.[273]. Regulatory Compliance and Risks - The company must comply with various regulatory requirements, including FDA clearances, to commercialize its OviTex products[281]. - The company may face enforcement actions from the FDA for non-compliance, which could result in fines, recalls, or delays in product sales[335]. - Compliance with EU MDR is essential for selling products in EEA, with CE mark obtained for OviTex products[348]. - Regulatory compliance failures could lead to significant penalties, including fines, product recalls, and operational restrictions[356]. - Changes in regulatory policies or new legislation could delay or complicate future product approvals and market entry[370]. - The transition period for compliance with the new MDR regulations ends on May 26, 2024, necessitating a quality management system[372]. - Ongoing regulatory scrutiny requires periodic safety and effectiveness reports to the FDA, with non-compliance risking enforcement actions[353]. - Future modifications to products may necessitate new regulatory clearances, impacting the timely introduction of enhanced products[348]. Intellectual Property and Competitive Position - The company owns twenty-three issued or allowed U.S. patents and has twelve pending U.S. patent applications, with rights to a total of twenty-five issued or allowed U.S. patents as of December 31, 2024[299]. - The company may face significant expenses to enforce or defend its intellectual property rights, which could harm its competitive position[298]. - The company may encounter ownership disputes regarding intellectual property developed by employees or contractors, which could interfere with its ability to capture commercial value[306]. - The company may face challenges in protecting its proprietary rights in non-U.S. countries, which could hinder its competitive position[304]. - Recent changes in U.S. patent laws could limit the company's ability to obtain and enforce patents, creating uncertainty regarding the value of existing patents[325]. Market and Competitive Landscape - The medical device industry is highly competitive, with larger competitors having greater market share and resources, which could hinder the company's ability to compete effectively[412]. - The company may struggle to renew contracts with Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs), affecting sales and operations[418]. - The commercial success of the company's products will depend on market acceptance among surgeons and medical professionals[255]. - The company may face challenges in maintaining market acceptance if competing products are introduced that are more cost-effective[258]. Supply Chain and Manufacturing Risks - The company relies on Aroa as the exclusive manufacturer and supplier of its OviTex and OviTex PRS products, which poses risks if Aroa fails to meet production demands[277]. - The company is dependent on the supply of ovine rumen sourced through Aroa in New Zealand, which may be vulnerable to disruptions[290]. - Any disruption in Aroa's manufacturing activities could materially affect the company's revenue and market acceptance of its products[287]. - Aroa expanded its manufacturing capacity by approximately 15,000 square feet in 2022 to meet anticipated demand[286]. Financial and Operational Risks - The company's financial results may fluctuate significantly due to various factors, making period-to-period comparisons less meaningful[406]. - Changes in political and regulatory environments could have a material adverse effect on the company's financial condition and operations[405]. - The company faces risks related to cybersecurity incidents that could disrupt operations and damage reputation[441]. - The company does not have redundant facilities, which poses risks of operational disruption due to natural or man-made disasters[440]. - Accurate forecasting of customer demand is critical, as mismanagement could lead to inventory issues and reputational damage[430]. Healthcare and Economic Environment - Rising inflation rates may negatively impact revenues and profitability, potentially leading to lower volumes of elective surgeries[249]. - Future healthcare reforms may limit government payments for healthcare products, potentially reducing demand and revenue for the company[400]. - The Affordable Care Act significantly impacts the healthcare industry by broadening access to health insurance and imposing new taxes on pharmaceutical manufacturers[398]. - Changes in healthcare laws, such as the Affordable Care Act, may increase the difficulty and cost of commercializing products[397]. Clinical and Market Research - The BRAVO study fully enrolled 92 patients to support the marketing of OviTex products, but long-term effects of certain products remain unstudied[425]. - Interim or preliminary data from clinical trials may change as more patient data become available, impacting business prospects[427].
TELA Bio(TELA) - 2024 Q4 - Earnings Call Presentation
2025-03-21 02:06
INVESTOR PRESENTATION March 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this document, including but not limited to statements regarding possible or assumed future results of operations, business strategies, development plans, regulatory activities, market opportunity competitive position, potential growth opportunities, a ...