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Episurf Medical (EPIS-B)

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#906

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EPISURF
Start of a comparative investigator-initiated study of joint function of Episealer® patients (Cision)
2019-01-21 08:00

Episurf Medical (NASDAQ: EPIS B) today announces the start of a comparative investigator-initiated clinical study performed at the Julius Wolff Institute, Charité University Hospital, Berlin. 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” will follow up patients that have undergone an Episealer® procedure during the period 2015-2017 and assess the joint mobility of the treated knee and compare with healthy, non-treated knees as well as benchmark against knees that have undergone total knee arthroplasty (total knee replacement).

“We are honoured that Charité, which was one of the first users of the Episealer®, has taken this initiative to follow up and compare the clinical outcome of the Episealer® procedure. This is the first comparative Episealer® study and we look forward to seeing the outcome. After 6 years’ clinical use, we have received very positive feedback from surgeons as well as from many patients. We expect results during 2019 that will confirm that the Episealer® can help restoring the knee function of patients where the treatment alternatives previously have been very limited” says Prof. Leif Ryd, Senior Medical Advisor, Episurf Medical.

“Our clinical program is comprehensive and we are now adding a comparative study. This study is highly interesting, much due to the fact that the results are expected shortly” says Pål Ryfors, CEO Episurf Medical.

4 Likes
#907

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2 Likes
#908

31/01-2019 11:00:00: (EPIS-B.ST) Change in number of shares and votes in Episurf Medical

#909

08/02-2019 08:30:00: (EPIS-B.ST) Year-end report 1 October - 31 December 2018

#910

Når er break even her?

#911

Positivt i tyskland:

The development is driven by the German market
where the growth in the fourth quarter 2018
amounts to about 187% compared to the fourth quarter
of 2017.

Kliniske resultater i 2019

The Episealer® technology is now involved in several
clinical trials. In 2019, we expect results from the large
European multicenter study that is ongoing, involving 100
patients and 11 surgeons in 7 European countries.

» It was recently announced that an investigator-initiated
clinical study was started at the Julius Wolff Institute at
the Charité University Hospital in Berlin. The study will
follow up patients who have undergone an Episealer®
procedure during 2015-2017. This study is particularly
interesting for two reasons: first, because this is the
first comparative study of the Episealer®, and, second,
because we expect to see results already in 2019.

Stor USA studie godkjent av FDA

While the clinical activities in Europe have increased, the
largest anticipated clinical study is the one planned for the
US. At the end of 2018, the US FDA (Food and Drug Administration)
approved our application to initiate a clinical
trial in the US for the Episealer® knee implant. This was a
significant milestone for us, the culmination of a three-year
effort. The results from the study will later form the basis
for our PMA application for market approval in the US. The
so-called IDE (Investigational Device Exemption) study is
designed as a prospective, multicentre, randomized and
controlled trial. The study will be conducted both at US and
European clinical centres. It is aimed to show non-inferiority
in clinical status improvement at 24 months as
compared to microfracture, the surgical standard of care
technology. Further, the study aims to show superiority in
return to weight-bearing compared to microfracture. 180
total subjects will be randomized at a 2:1 ratio to either the
Episealer® group or the control group.

Stadig større populasjon, og ikke minst nå vil vi etterhvert se flere og flere over den viktige 5års grensen.

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Tilgang til kapital er den viktigste utfordringen som selskapet hele tiden må jobbe med, virker som styret er trygge på at de ikke trenger å kjøre en dumpingsemisjon som vi har sett tidligere, men at det blir løst med “kredittfasilitet” og/eller rettede emisjoner.

The Board of Directors is continuously reviewing the
company’s financial need and financial position, as well as
the optimal capital structure for the company. Should there
be additional capital needs, the Board is of the opinion
that the company is in a good position to secure future
financing either within the existing credit facility or by way
of a directed common share issue.

3 Likes
#912

Dette er en YA-lignende løsning?

#913

Håper de snart kan ta i bruk lånefinansiering istedet for utvanning, da blir det mer spennende å være småaksjonær med en gang.

1 Like
#914

Jeg tenker at en partner for USA satsningen er ganske viktig å få på plass, kan de kjøre hele dette løpet selv? Dersom en partner i alle fall er med å dra lasset vil det kunne medføre en kraftig oppjustering av mcap som vil gjøre det lettere å hente penger uten den massive utvanningen vi har sett så langt. Lav mcap og stadig nye aksjer som trykkes er jo ikke en ideell kombinasjon for eksisterende aksjonærer om man ikke hele tiden spytter inn nye midler selv.

#915

Et eller flere partnerskap der USA er viktigst hadde vært gull. Meget dyrt med slike studier. PHO klarte faktisk å finansiere USA-satsinga selv, men de brukte MYE penger på det i mange år og gjør det fortsatt. Også gjelder det å finne dedikerte partnere, noe Ipsen for PHO ikke var. PHO hadde også en annen partneravtale for et produkt som ble skrinlagt der man i ettertid har sett at partneravtalen kom nok fordi man ville legge ned forskninga for å beskytte et annet produkt.

3 Likes
#916

Jeg tenker jo at Episurf er en soleklar oppkjøpskandidat og

1 Like
#917
#918

12/02-2019 08:30:00: (EPIS-B.ST) New Australian patent approval for Episurf Medical

#919

12/02-2019 11:15:00: (EPIS-B.ST) Kliniska resultat för Episealer® presenteras vid tysk klinisk kongress

1 Like
#920

14/02-2019 07:33:29: (EPIS-B.ST) Redeye: Episurf Medical - Ljusglimtar i Q4’18 ger hopp

#921

20/02-2019 08:45:00: (EPIS-B.ST) Episurf Medical reaches milestone of 500 implants

1 Like
#922

Hm… 406 implantater ved utgang 2018, melding om 500 ila kommende uker. Har snøballen endelig begynt å rulle?

1 Like
#923

Vi er uke 8 nå, skal vi se 500 innen utgang av uke 11?

94*52/11 = 444 i år :sweat_smile:

2 Likes
#924

27/02-2019 13:30:00: (EPIS-B.ST) Another Canadian patent approval for Episurf Medical

#925

28/02-2019 11:00:00: (EPIS-B.ST) Change in number of shares and votes in Episurf Medical