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Episurf Medical (EPIS-B)

Its 5 bequerel, not great, not terrible

Hvis emisjonen går i boks som planlagt tror jeg denne være grei å sitte med om man har tålmodighet til å ri stormen ut (som en liten del av en diversifisert portefølje).

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Episurf Medical (Nasdaq: EPIS B) today announces that results from a clinical study with follow-up of the 30 first patients from nine Swedish clinics show good implant safety and significantly improved patient-reported outcome scores. Follow-ups of the patients are now completed, and the principle investigator will compile the results for submission to a scientific journal. In total, 30 patients are included in the study and the average follow-up time is 55 months (24 - 86 months).

The Episealer Knee implant is intended for treatment of focal cartilage and osteochondral defects on the femoral side of the knee joint. These defects often imply severe pain, which significantly can impact the patients quality of life. Cartilage has a very limited ability to heal and the self-repairing mechanism decreases further as we age. Current standard of care, which includes various biological treatment alternatives, have shown limited effectiveness, especially with increasing age.

The Episealer Knee implant is fully tailored to fit each patients unique curvature of the joint surface, the size and shape of the lesion, and underlying bone conditions. In addition to providing an individualised implant, individualised surgical instrumentation is also provided to enable correct position of the implant. The associated imaging technology visualises chondral and osteochondral defects and provides the surgeon with support in the decision making as well as being a surgery planning tool.

The objective of the prospective consecutive cohort study is to assess subjective short-term outcome and possible longer-term risks of the intervention. The study performed at Capio Artro Clinic, Stockholm, reviews the clinical outcome of 30 patients, from nine Swedish clinics, who have received an Episealer Knee implant during the years 2012 - 2017. The mean follow-up time is 55 months. Of the 30 patients, one patient has undergone revision to a partial knee prosthesis. The patient-reported outcome scores EQ5D, VAS (EuroQoL Visual Analogue Scale), VAS-pain (Visual Analogue Scale) and KOOS (Knee injuries and Osteoarthritis Outcome Score) all show significant improvements.

This is the third clinical study from which we see clinical results. To date, only one of them have been published, but as previously communicated, we are expecting plenty of activity from this field during 2020. We are very happy to hear about the positive results from this independent study. The results are in line with the strong data presented from an ongoing European multicentre study, and further, confirms the results we get reported from individual surgeons who follow their patients. It takes time to get long term results and we have now come to a time point when these anticipated results can be presented, and hopefully, soon published, says Pål Ryfors, CEO Episurf Medical.

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Episurf Medical AB (publ) (Episurf Medical or the Company) held an extraordinary general meeting in Stockholm on 10 March 2020 where it was resolved to approve the resolution adopted by the board of directors on 7 February 2020 on a new share issue with preferential rights for the shareholders (the Rights Issue) and a directed new share issue with deviation from shareholders preferential rights (the Directed Share Issue), as well as to amend the Companys articles of association.

Issue of shares with preferential rights for shareholders

The board resolution approved by the extraordinary general meeting mainly entails that the Company shall carry out an issue of class B shares corresponding to a total subscription amount of up to approximately SEK 51.1 million before transaction related expenses, with preferential rights for the shareholders of the Company to subscribe for new shares in proportion to their previous shareholding. In summary, the resolution on the Rights Issue means the following:

  • Each share previously held will entitle the shareholder to receive three (3) subscription rights of class B. Eight (8) class B subscription rights entitles to subscription for one (1) new class B share at a price of SEK 1.50 per new share. If fully subscribed, a total of 34,099,033 new class B shares will be issued, and the total proceeds will amount to SEK 51,148,549.50.

  • The Companys share capital shall be increased with no more than SEK 10,238,368.76 by a new issue of no more than 34,099,033 class B shares.

  • The record date for participation in the Rights Issue is 16 March 2020.

  • The subscription period in the Rights Issue takes place between 19 March 2020 and 2 April 2020.

If not all shares issued in the Rights Issue are subscribed for with preferential rights, the board shall decide on the allotment of new class B shares subscribed for without subscription rights in accordance with the principles set out in the resolution on the Rights Issue.

Preliminary time plan for the Rights Issue

12 March 2020 Last day of trading including the right to receive subscription rights

13 March 2020 First day of trading excluding the right to receive subscription rights

16 March 2020 Record date for participation in the Rights Issue

19 March - 31 March 2020 Trading in subscription rights

19 March - 2 April 2020 Subscription period

7 April 2020 Publication of the outcome in the Rights Issue

Directed issue of shares with deviation from preferential rights for shareholders

The board resolution approved by the extraordinary general meeting mainly means that the Company shall carry out an issue of up to 60,000,000 class B shares, corresponding to a total subscription amount of approximately SEK 90 million before transaction related expenses, directed to certain institutional investors who have expressed interest in subscription in advance, including among others the Fourth Swedish National Pension Fund, Nyenburgh Investment Partners, Rhenman Partners Asset Management and Strand Kapitalförvaltning Fonder. The reason for deviation from the shareholders preferential rights is to provide additional capital to the Company in order to finance its continued expansion, as well as to provide long-term institutional shareholders and thereby promote Episurf Medicals potential to develop the Company with the purpose of creating added value for all shareholders.

The subscription price per new class B share in the Directed Share Issue is 1.50 SEK, which has been determined through a book building procedure and according to the board corresponds to the market value of the shares. The Directed Share Issue increases the share capital with SEK 18,015,235.96.

Shares issued in connection with the Directed Share Issue are not eligible for participation in the Rights Issue.

Adoption of new articles of association

In order to enable the Rights Issue and the Directed Share Issue, the extraordinary general meeting resolved, in accordance with the proposal of the board of directors, to amend (i) § 4 in the articles of association of the Company regarding the limits of the share capital so that the share capital shall be no less than SEK 27,302,316.80 nor exceed SEK 109,209,267.20, and (ii) § 5 in the articles of association of the Company regarding the number of shares so that the number of shares in the company shall be no less than 90,930,755 and no more than 363,723,020.

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical

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Veldig bra dette :+1: Var litt bekymret for at de skulle prøve å prute ned prisen.

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Veldig sterkt, har vært en maraton men det blir ny epoke nå

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Episurf Medical (NASDAQ: EPIS B) today announces that the company has secured ethics approval for all European hospitals that are being prepared to take part in the companys clinical study EPIC-Knee: Episealer Knee System IDE Clinical Study. This includes approval from ethics committees in the UK (four sites), Germany (two sites) and Denmark (one site). Approval from the respective ethics committee is mandatory for the sites to initiate enrollment of patients into the study.

This is great progress for our IDE study. The randomised, controlled study includes hospitals in both the US and Europe, with a total number of 180 patients. In the US we have a number of sites totally ready for the study, and in Europe we have now finally gone through all ethic approval processes with favourable outcomes. We are looking forward to starting enrolling IDE patients in the UK, Germany and Denmark, comments Pål Ryfors, CEO, Episurf Medical.

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Episurf Medical (Nasdaq: EPIS B) will attend the investor conference Aktiedagen, held in Stockholm (Operaterrassen, Karl XII:s torg) on March 16 2020. The event is arranged by Aktiespararna, and the company will be represented by the CEO Pål Ryfors.

The presentation will be available live at 11:15 on aktiespararna.se/tv/live. The presentation will also be available after the conference at Aktiespararnas website, as well as on the companys website.

For full program, see link: https://www.aktiespararna.se/aktiviteter/aktiedagen-stockholm-16-mars.

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical

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Operasjoner av den typen episurf gjør er jo det første som går ut døren, selve definisjonen av “planlagt operasjon som ikke er livsnødvendig”.

Men det har ikke så enormt mye å si for selskapet, tid er en kritisk faktor i deres kliniske data så langt.

The Rights Issue in brief

The Rights Issue comprises up to 34,099,033 class B shares. The pre-emptive right to subscribe for new class B shares shall be in relation to the number of old class A and/or B shares that the shareholder owns per the record date, March 16 2020. Per eight (8) shares previously held will entitle a subscription for three (3) new class B shares. The subscription price is SEK 1.50 per share. Those who are not current shareholders can also subscribe for shares in the Rights Issue.

Preliminary timeline

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Greit dette her med garantert emisjon 50% over børskursen den siste tiden.

Helt sykt. De reddet seg i siste liten.

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Spennende å se hvor mange som blir med da, om flere kjøper seg opp istedenfor å tegne seg. Uansett sikret 90M da, som det poengteres her, til en fin pris.

Hehe, det som hadde vært downeren totalt nå var jo om de som hadde garantert for emisjonen plutselig ikke klarte å stille beløpet. Rarere ting har skjedd…

Redey: Nu inleds Episurf Medicals fullt garanterade företrädesemission

https://mailchi.mp/b8f9126c5ef1/acarix-fretrdesemission-nu-igng-teckningskurs-150-sek-1014119?e=bd1f07c108

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Episurf, Episurf, Episurf!

EPISURF

Episurfs riktade nyemission på 90 miljoner kronor blev fulltecknad (Finwire)

2020-03-20 09:29

Medicinteknikbolaget Episurf Medicals rikade nyemission blev fulltecknad och bolaget tillförs 90 miljoner kronor före emissionkostnader. Teckningskursen var 1,50 kronor per aktie. Det framgår av ett pressmeddelande.

Den riktade emissionen tecknades av ett begränsat antal institutionella investerare, inkluderat bland andra Fjärde AP-fonden, Nyenburgh Investment Partners, Rhenman Partners Asset Management och Strand Kapitalförvaltning Fonder.

Episurf har även en pågående nyemission med förträdesrätt för aktieägarna.

Henrik Öhlin
henrik.ohlin@finwire.se, 0703-21 06 99
Nyhetsbyrån Finwire

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Patentsamlingen her blir bare bedre og bedre:

Episurf Medical (NASDAQ: EPIS B) has received another Notice of Allowance from the United States Patent and Trademark Office (USPTO). The patent, entitled System, guide tools and design methods related thereto for performing osteochondral transplantation surgery in a joint, is within the area of devices and processes to facilitate treatment of joint lesions with osteochondral grafts.

This is a patent that shows how the companys medical imaging technology can be applied to a broader range of devices than the Episealer joint implants. 3D modelling, damage visualisation and individualised design here form the basis for a guide system developed for osteochondral transfer such as for example autograft and allograft surgery, says Katarina Flodström, COO, Episurf Medical.

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Episurf Medical (Nasdaq: EPIS B) will attend Digital Investor Forum on March 31 2020. The digital event is arranged by Redeye and the company will be represented by the CEO Pål Ryfors.

The presentation will be available live at 15:40 on https://www.redeye.se/live/IF-31-mars. The presentation will also be available after the conference at Redeyes website, as well as on the companys website.

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical

Episurf Medical (Nasdaq: EPIS B) today announces promising results from the study with the title X-ray fluoroscopic analysis of knee joint kinematic in open and closed chain activities in patients with Episealer Knee implants performed at Charité University Hospital, Berlin. Preliminary results show good patient satisfaction and good knee function.

The Episealer Knee implant is intended for treatment of focal cartilage and osteochondral defects on the femoral side of the knee joint. The Episealer Knee implant is fully tailored to fit each patients unique curvature of the joint surface, the size and shape of the lesion, and underlying bone conditions.

The objective of this retrospective study is to measure the knee function of patients who received an Episealer and compare with the knee function of patients who received a total knee prosthesis as well as with patients with healthy, untreated knees.

Knee replacement surgery is a significant and definitive procedure that often does not produce a perfectly functioning knee. For example, range of motion seldom becomes normal due to lack of anatomic precision. Hence, a comparative functionality study on Episurf Medicals individualised implant is valuable. Hypothetically, the Episealer should result in better functionality, and this is the conclusion that these preliminary results are pointing towards. These results add to previously reported strong clinical results, such as pain and activity scores says Prof. Leif Ryd, Senior Medical Advisor at Episurf Medical.

After recruitment and follow-up of 90% of the patients, the results are promising, showing good self-reported patient satisfaction (clinical questionnaires) as well as high passive and active knee joint flexion in line with the function of healthy, untreated knees. Preliminary qualitative analysis during the data processing shows an apparent physiological external rotation of the femur as well as signs of femoral rollback from extension until high flexion. Final quantitative analysis remains once all patients have been tested.

This is the first comparative study with patients who have received Episealer implants. We are very happy to hear that the preliminary results are in line with our expectations and that we actually restore the joint function, says Pål Ryfors, CEO Episurf Medical.

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