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  • Pål Ryfors

    CEO


    Karlavägen 60, 114 49 Stockholm
    0709623669
    http://www.episurf.com
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    Episealer® technology to be presented at international scientific congress

    Episurf Medical (Nasdaq: EPIS B) today announces that the Episealer® technology will be presented at the 7th ICRS (International Cartilage Regeneration & Joint Preservation Society) Summit in Catania, Italy, on September 25-27, 2024. The Episealer® technology will be presented at two sessions as part of the scientific program. Dr. Gary Levengood of Sports Medicine South, part of the Northside Health System, GA, USA, has been invited to present his experience using the Episealer® Patellofemoral System, introduced on the US market in 2023. This is the first time usage of the Episealer®

    Episurf Medical: Strategy update to take the next commercial steps and improve financial results

    Episurf Medical (Nasdaq: EPIS B) today announces that the company is implementing a strategic focus that brings an increased focus on the US market, as well as a transition to a distributor model for other key markets. The company sees great opportunities for continued commercialization within selected market segments. The strategic focus means: · Operational measures to significantly improve the company's financial position and running costs. · Accelerate the path towards, and increase transparency for, operational profitability. · Increased focus on distributor sales and

    Episurf Medical’s first US VAC approval

    Today, Episurf Medical (Nasdaq: EPIS B) announces the first approval for its Episealer® Patellofemoral System from a hospital Value Analysis Committee (VAC). Value analysis committees allow hospitals to make informed decisions regarding the selection of medical devices, technologies, and services within their facility. They review factors such as clinical efficacy, patient outcomes, safety, cost-effectiveness, and overall value proposition of the products and services under consideration. Approval from a hospital’s VAC is a near-mandatory step required by every hospital or hospital system

    Episealer® Patellofemoral System available in United Arab Emirates

    Episurf Medical (NASDAQ: EPIS B) today announces that the Ministry of Health & Prevention in the United Arab Emirates has issued a classification letter for the company’s implant technology Episealer® Patellofemoral System, allowing sales in the United Arab Emirates market. The classification follows after a review process. “As soon as we got the Episealer® Patellofemoral System clearance in the United States, we started the regulatory work of bringing the technology to other markets. The United Arab Emirates is now the second country that cleared the product for sale, and we are

    Episurf Medical receives FDA 510(k) clearance for Episealer® Patellofemoral System

    Episurf Medical (NASDAQ: EPIS B) today announces that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Episealer® Patellofemoral System. The Episealer® Patellofemoral System is an implant system with two opposing implants, intended for patients with osteoarthritis limited to the distal patellofemoral joint in the knee. It is based on Episurf Medical’s proprietary individualised implant technology. Episurf Medical will now prepare for the market launch of the company’s first product on the US market. “Episurf has received US market

    Episurf Medical submits 510(k) application for Episealer® Patellofemoral System

    Episurf Medical (NASDAQ: EPIS B) today announces that the company is now filing a 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The application is ready for filing and following certain administrative steps, it is expected that it is submitted within the next days. The application will undergo a review process.  Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. The system is based on Episurf Medical’s proprietary implant technology with

    Episurf Medical: Update on Episealer® Patellofemoral System for the US market

    Episurf Medical (NASDAQ: EPIS B) today announces that the development of the company’s Episealer® Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. Simultaneously, the company is preparing for a commercial

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