EPISURF Aktie

 

Episurf Medical (NASDAQ: EPIS B) today announces an update on the process for US market clearance for the company's Episealer® MTP big toe implant. Episurf Medical has during the spring got interactive feedback from the US FDA on the company's 510(k) submission for market clearance, that has been addressed. Progress has been made, but there are certain validation activities that are not yet fully accepted by the FDA. The company will follow the advice by the FDA on the path forward, and the company has a concrete plan for how the final questions shall be addressed. Episealer® MTP is a...

Episurf Medical (Nasdaq: EPIS B) today announces that the abstract “SURVIVORSHIP AND CLINICAL OUTCOMES OF A NOVEL PERSONALIZED METAL IMPLANT FOR THE TREATMENT OF CARTILAGE LESIONS OF THE KNEE”, by Dr Francesca de Caro has been accepted for presentation at the ISAKOS (International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine) congress in Munich, Germany, on June 8-11, 2025. The abstract with up to 10 years' follow-up reports on high implant survival and good clinical outcomes for 34 patients who were treated with Episurf Medical's individualised implant Episealer®...

Episurf Medical AB (publ) announces that the company's CEO, Pål Ryfors, has been appointed interim CFO as of 19 May 2025 in addition to his current role as CEO. This follows the departure of Veronica Wallin from her position as CFO, as previously communicated. The recruitment process for a new CFO is ongoing....

Episurf Medical AB (publ) (“Episurf” or the “Company”) held its Annual General Meeting (the “Meeting”) on Thursday, 10 April 2025 in Stockholm. The income statements and the balance sheets for the Company and the group were approved and the Board of Directors and the CEO were discharged from liability for the financial year 2024. The Meeting resolved, in accordance with the proposal of the Board of Directors, that the Company shall not pay dividends for the financial year 2024. The Meeting resolved to approve the remuneration report for the financial year 2024. Sebastian...

Episurf Medical AB (NASDAQ: EPIS B): During the period 10 February 2025 up to and including 24 February 2025, shareholders exercised 1,586,850 warrants (TO13B). The number of shares has increased by 1,586,850 B-shares, and the number of votes has increased by 1,586,850. The remaining warrants (TO13B) have expired. The total number of shares amounts to 653,064,692, where 473,357 are A-shares, and 652,591,335 are B-shares. The total number of votes after the conversions amounts to 654,011,406....

Episurf Medical (Nasdaq: EPIS B) will attend Redeye Theme Event: Commercialization in Life Science which is held on March 20th, 2025. The event is arranged by Redeye and Episurf will be represented by its CEO Pål Ryfors. The format will be a 12-minute pitch followed by an 8-minute Q&A. The presentation will be streamed live at 10:10 CET at: https://www.redeye.se/events/1073684/redeye-theme-commercialization-in-life-science-2 and will also be made available afterwards on our website www.episurf.com. Location: Redeye, Mäster Samuelsgatan 42, Stockholm....

Veronica Wallin, Episurf Medical's CFO since June 2017 and previously Head of Finance since August 2016, has today announced her resignation from Episurf for a new opportunity.   "It's almost 9 years since I started at Episurf, and I'm extremely proud of everything we've achieved together. Episurf has a continued exciting journey ahead but now is a good time for me to take on a new challenge. I will ensure a good handover to the next CFO and continue to follow the company from a distance", says Veronica Wallin, outgoing CFO of Episurf Medical.   "Veronica is a highly valued and...

This English translation of the notice is an unofficial translation of the Swedish original. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail. The shareholders in Episurf Medical AB (publ), 556767-0541 (“Episurf” or the “Company”), are hereby summoned to the Annual General Meeting (the “Meeting”) on Thursday, 10 April 2025, at 16:30 (CEST) at the Company's office at Karlavägen 60, SE-114 49 Stockholm, Sweden. Entry and registration begin at 16:15 (CEST). The Board of Directors has, pursuant to Chapter 7, Section 4 a of the...

Episurf Medical's annual report for 2024 is available as of today at the company's website, www.episurf.com.  Episurf Medical has of environmental and cost reasons chosen not to print the annual report. A printed version of the annual report will be distributed to shareholders and others who made such request. The annual report can also be ordered from Episurf Medical on the following address: Episurf Medical AB, Karlavägen 60, 114 49 Stockholm, Sweden or by email: ir@episurf.com....

THIS PRESS RELEASE MAY NOT BE MADE PUBLIC, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, THE UNITED KINGDOM, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, ISRAEL, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION WHERE SUCH DISTRIBUTION WOULD REQUIRE ADDITIONAL PROSPECTUS, REGISTRATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW, IS PROHIBITED, OR OTHERWISE IS UNLAWFUL OR CANNOT BE MADE WITHOUT THE APPLICATION OF AN EXEMPTION FROM SUCH ACTION. REFER TO THE SECTION "IMPORTANT...

Episurf Medical (NASDAQ: EPIS B) today announces that a response to the US FDA, addressing a request for additional information on the company's Episealer® MTP implant, has been filed. This is a step in the process for the 510(k) submission for market clearance of the Episealer® MTP implant for the big toe. The FDA review has been on hold while waiting for Episurf to submit this additional information.   “Getting us to this milestone is a great team effort and an important step in our work towards market clearance for Episealer® MTP. We have performed an extensive work together with...

Episurf Medical (NASDAQ: EPIS B) has during the last year received seven additional patent approval notifications. The United States Patent and Trademark Office (USPTO) has issued three notices of allowance. Two of them relate to positioning features to ensure correct implantation of the company's Episealer® implants, while the third relates to a system for customising an implant for treatment of damage in an anatomical joint. The Indian patent office Intellectual Property India has granted the company three new patents in India. One patent covers design automation as part of Episurf'...

Episurf Medical (Nasdaq: EPIS B) today announces several recent permissions granted from health systems' Value Analysis Committees (VACs) within the United States. While typical sales cycles begin with interest from an orthopaedic surgeon, review and access to begin doing surgeries must almost always first be granted by individual VACs. Recently, among others, the company has received approval to initiate surgeries within facilities at: · Vail Health System (affiliated with the Steadman Clinic) – Vail, Colorado · The Hospital for Special Surgery – New York, New York · Dartmouth...

Episurf Medical (Nasdaq: EPIS B) will attend Redeye Technology & Life Science Day which is held on December 3rd, 2024. The event is arranged by Redeye and Episurf will be represented by its CEO Pål Ryfors. The format will be a 2-minute pitch followed by a 16-minute Q&A session. The presentation will be streamed live at 09:00 CET at: https://www.redeye.se/events/1038747/redeye-technology-life-science-day and will also be made available afterwards on our website www.episurf.com. Location: Sergelkonferensen, Mäster Samuelsgatan 42 (Sveavägen 9), Stockholm....

Episurf Medical (Nasdaq: EPIS B) will attend Redeye Medtech & Diagnostics Event which is held on November 13th, 2024. The event is arranged by Redeye and the company will be represented by its CEO Pål Ryfors. The format will be a 12-minute presentation followed by an 8-minute Q&A Session. The presentation will be streamed live at 09:50 CET at https://www.redeye.se/events/1016182/redeye-theme-medtech-diagnostics-3 and will also be made available afterwards on our website www.episurf.com. If you would like to attend the event in person, you can register at https://crm.redeye.se/events/...

In accordance with the decision by the Annual General Meeting, Episurf Medical's Nomination Committee shall consist of four members. The members are selected by the three largest shareholders in the company that wish to participate in the committee. In addition, the Chairman of the Board is to be appointed to the Nomination Committee. The members of the Nomination Committee shall agree on a chairman/woman of the committee. In accordance with the above principles, the Nomination Committee consists of the following four members: · Ulf Grunander, Chairman of the Board Episurf Medical...

In order to facilitate settlement of an acquisition of 9,526,170 Class B shares in Episurf Medical AB (publ) (“Episurf” or the “Company”) by Sacajo Investments LLC (“Sacajo”), a trust with the Company's Senior Advisor Niles Noblitt as first member, Sacajo and Pål Ryfors, CEO of Episurf, have agreed that Pål Ryfors shall hold the shares during an interim period. Consequently, Pål Ryfors will acquire 9,526,170 Class B shares in Episurf from Sacajo for a purchase price of SEK 2,286,280.80, corresponding to SEK 0.24 per share. Payment for the shares is made by Pål Ryfors issuing a promissory...

Episurf Medical (Nasdaq: EPIS B) today provides an update on the company's 510(k) application to the US FDA, for market clearance of the company's implant for treatment of osteoarthritis in the so-called 1st MTP joint in the big toe. During this process, the company has exchanged information with the FDA, and this process will continue shortly. "We are pleased to have come this far in the process. We have in-depth experience of interacting with the FDA, and we know that it is difficult to forecast these processes accurately, but we certainly feel that we are moving forward. We will not...

Episurf Medical (Nasdaq: EPIS B) to present at Pareto Securities Healthcare Conference on September 19, 2024. The event is arranged by Pareto and the company will be represented by its CEO Pål Ryfors. Time: 11:05-11:25 CEST Format: 20 minutes including Q&A Location: Studio 8, Downtown Camper, Drottninggatan 28, 111 51 Stockholm The presentation slides will be made available afterwards on our website www.episurf.com....

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®...