EPISURF
Episurf beviljas nytt patent i Kina avseende borrguide tillhörande Episealer (Finwire)
2021-06-09 11:09
Medicinteknikbolaget Episurf Medical har beviljats ett nytt patent i Kina avseende en borrguide som tillhör implantatet Episealer Femoral Twin. Det framgår av ett pressmeddelande.
Patentet uppges ge starkare IP-skydd för individanpassade borrguider. De anses utgöra en viktig del av Episealer-teknologin.
Tim Hansson
tim.hansson@finwire.se
Nyhetsbyrån Finwire
Episurf Medical (Nasdaq: EPIS B) today announces that the first Episealer surgery (Episealer Knee) in Portugal has been scheduled. The Episealer Knee and Episealer Talus implants were recently registered and approved for sale and distribution in Portugal.
We are adding yet another country in which the Episealer implants are used, and I am pleased that our global regulatory strategy results in additional surgeries in more and more countries, says Pål Ryfors, CEO Episurf Medical.
Episurf Medical (Nasdaq: EPIS B) today announces that the company has appointed Medcom Tech as distributor for Episurf Medicals implant technology, comprising Episealer Knee and Episealer Talus, in Spain and Portugal. Medcom Tech is a development and distribution company focusing on orthopaedic surgery, traumatology, neurosurgery and anesthesia. The company has approximately 140 employees and is headquartered in Spain.
Medcom Tech, which is a well-established company in Spain and Portugal. We look forward to offering our implant technology through the skilled sales force of Medcom Tech, says Pål Ryfors, CEO Episurf Medical.
Medcom Tech is very pleased with this agreement, Episurf perfectly matches with our strategy of bringing high technological companies to Spain and Portugal and help them to grow in our markets. Medcom Tech sells high innovative products in more than 500 hospitals in Spain and Portugal, says Juan Sagales, CEO Medcom Tech.
Episurf Medical (Nasdaq: EPIS B) today announces the initiation of an investigator-initiated European multicentre study with 5 years follow-up of 50 Episealer Knee patients. The study is a continuation of the European multicentre study, from which 2 years follow-up results were published in September 2020 (Holz, J. et al, Patient-specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years, KSSTA online 2020).
The interim study from 2020 concluded that the results indicate that there is a definitive place for the Episealer device in the management of a focal chondral or osteochondral defect affecting the distal femur. The study sponsor, investigator Associate Professor Tim Spalding, University Hospitals Coventry and Warwickshire NHS Trust, UK, will now perform the 5 years follow-up together with surgeons from 8 additional clinics in 6 European countries. Preliminary results from the follow-up are expected during the fourth quarter of 2021, while full results are expected in early 2022.
This study can be performed thanks to the study groups engagement and persistent follow-up of their patients, and we appreciate the initiative taken by Mr Tim Spalding. There has previously been a focus on 2 years data for the Episealer patients. We are happy to now be in a position to get results from a large group of patients that have had their implants for 5 years. Recent publications with strong 2 years results have been very useful in Episurfs dialog with healthcare providers, customers, and authorities in our markets. We are confident that the 5 years results will provide even stronger evidence in support of the Episealer, showing that the technology is reliable over time says Pål Ryfors, CEO Episurf Medical.
Endelig grønt i dag 
Hvis den fortsetter å ta sommerferie frem til august og det kommer noen gode nyheter igjen da så kan det fort bli eksplosivt, har konsolidert i fire måneder nå allerede, og akkurat nå ligger den og filler det lille gappet som var igjen
Veldig spennande selskap som bygger stein på stein. Har nok lidd litt under lite elektiv kirurgi under Covid, men kan fort bli ein av vinnarane utover hausten når ting normaliserer seg.
Det hadde vært interessant å se hvordan markedet reagerte hvis det var et oppspart behov som tok fart når ting åpner opp igjen.
Med mindre me får ein fundamental korreksjon på børsen utover hausten er eg rimeleg trygg på at me skal snuse på 4-talet før jula ringer inn. Selskapet sprer teknologien til stadig fleire land og har solide patenter på alt av utstyr. Når dei i tillegg har så gode resultater fra pasientene så er det bare eit tidsspørsmål før selskapet begynner å tjene gode pengar.
Siste oppdatering fra selskapet kan ein sjå her:
De har jo noen konkurrenter innenfor samme metode, men det er først og fremst konkurrenter som har alternative behandlingsformer som f.eks. stamcellebehandling jeg tror blir den største utfordreren.
Omfattende forskning viser at stamceller har evne til å danne ny brusk, øke kvaliteten på skadet brusk og dempe betennelse / slitasjegikt i ledd. For pasienten er dette alltid fantastiske nyheter.
Stamceller er spennande teknologi, men når det kommer til Artrose så trur eg det er plass til mange aktører.
Ser i denne artikkelen fra Aftenposten at dei ikkje er like optimistisk som Stamcellehuset når det kommer til varigheten av behandlinga.
Utdrag:
Vi kjenner i dag ikke til noen behandling som kan stoppe eller reversere sykdomsprosessen. Ferske studier viser at injeksjon av en type stamceller som kan isoleres fra beinmarg eller fettvev inn i knær med artrose, fører til redusert smerte og bedret leddfunksjon de neste 1–2 årene. Men det er ingen tegn til at denne behandlingen fører til reparasjon av bruskskaden. Dette er veldig kostbar behandling.
Andre former for injeksjonsbehandling, som kortisonlignende medisiner, hyaluronsyre og noen typer blodceller tilbys også. Også disse kan dempe smerter og bedre funksjon, men er ikke påvist å kunne påvirke selve sykdomsprosessen.
Eg trur at Episurf vil finne sin plass i marknaden.
Rart at stamcellebehandlingen hjelper hvis den ikke reparerer?
Jeg også, jeg syntes bare det var på sin plass å nevne risk-faktorer 
Eg setter pris på alle innlegg som belyser risiko rundt investeringane mine så det var ikkje meint som noko kritikk. Eg er på ingen måte noko ekspert på stamcellebehandling, men stamceller veit jo i utgongspunktet ikkje kva dei skal bli når dei “veks opp” om eg hugsar rett. Dei må få info gjennom vekstfaktorar og liknande for å utvikle seg til den typen celler ein ønsker, i dette tilfelle brusk. Så det er jo ikkje sikkert ein har heilt kontroll på denne prosessen. Har meir tru på at dei eventuelt kan dyrke ny brusk utanfor kroppen og sette denne inn i etterkant. Då vil dei kunne ha kontroll på prosessen på ein annan måte.
At ein ser ei betring ei stund etter behandling kan jo eksempelvis skyldes placebo/undersøkelseseffekt eller anna? Den er jo velldokumentert.
Ellers så burde ein vel ha sett ein meir varig effekt skulle ein tru. Det kjem vel også litt an på grunnen til at ein har artrose i utgongspunktet. Om det er ein autoimmun variant så vil vel også nydanna brusk etter kvart bli angrepet kanskje? Men her er eg på veldig tynn is. Det er lenge sidan eg hadde immunologi på bioingeniørstudiet så detaljane her er ikkje heilt på G.
Eg har i alle fall trua på at Episurf kjem til å ta ein del av denne store marknaden, men eg har tatt feil før så ein får sjølv gjera seg opp ei meining.
Med Mcap på 700 MSEK, så har de god plass til å gå 10x hvis de tar en god bit av det globale knemarkedet på rundt 100 millarder SEK.
Ref: Knee Replacement Market Size, Share, Growth | Global Report [2020]
Episurf Medical (NASDAQ: EPIS B) today announces that the development of the companys 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 launch in the US of the Episealer Patellofemoral System during 2022.
Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us, comments Pål Ryfors, CEO Episurf Medical.
Episurf Medical (NASDAQ: EPIS B) today announces that a case report with 5-years follow-up data of the very first Episealer Talus patient has been accepted for publication in the peer-reviewed scientific journal Foot & Ankle Surgery: Techniques, Reports & Cases (Holz J., Ryd L., Kaiser R., Hollander K., van Dijk N., Schneider S., Treatment of an Osteochondral Lesions of the Talus with a novel Patient-specific Metallic Implant: A Case Report with 5-year Follow-up and Review of the Literature., Foot & Ankle Surgery: Techniques, Reports & Cases, 2021). The publication will appear in volume 1, issue 3, Autumn 2021. Foot & Ankle Surgery: Technique, Reports & Cases is an official publication of the American College of Foot and Ankle Surgeons and publishes the latest advances in cutting-edge surgical techniques for correction of foot and ankle disorders.
In the case report, the authors report on a 33-year old male patient who experienced persistent pain and reduced range of motion following an ankle sprain, and the patient underwent medial talar dome ankle surgery in May 2016 (Hamburg, Germany). The patient was treated with an Episealer Talus implant, and he was the first patient worldwide to receive this implant. The patient was consequently followed up at 3, 6, 12, 24, 36, 48 and 60 months using the standard subjective outcome measures VAS pain score, Foot and Ankle Outcome Score (FAOS), and sports subscale of the Foot and Ankle Ability Measure (FAAM). The article reports that there was immediate pain relief, and a fast rehabilitation was achieved. Six weeks postoperatively, the patient returned to work. There have not been any limitations in activities of daily living or work-related activities until today and the patient was able to return to his athletic level and started playing soccer again. The authors conclude that the first implantation of this novel patient-specific metal implant for the treatment of focal osteochondral lesions of talus has been highly successful up to five years after implantation.
Although this is a single patient case report, this article shows that a bespoke metal implant can articulate against joint cartilage over 5 years time with excellent results. It works in the ankle and we have previously shown it works in the knee, says Prof. Leif Ryd, Senior Medical Advisor to Episurf Medical.
The Episealer Talus implant used in this surgical procedure was performed on a custom-made basis, implying a regulatory exemption to produce an implant before market approval.
Tenk at det har gått fem år allerede!
Nesten litt oppsiktsvekkende👍🏻
DNB
The Q2 report was essentially in line with our expectations. Episurf plans to file for a 510(k) clearance in the US in Q4 for the Patellofemoral implant system. There have been some delays in the EPIC knee trial and we have pushed the completion and subsequent launch back c1 year (launch in the US in 2025). We have lifted our fair value for the shares to SEK2.7-8.2 (previously SEK2.5-8).
Q2 report essentially in line with our expectations. The company reported revenues of SEK2.1m (our estimate: cSEK2m). Product sales were cSEK2m (our estimate: cSEK1.9m). Sales were up by c233% YOY but Q2 last year was hurt by the pandemic outbreak. Overall costs were essentially in line with our estimates and at quarter-end, the company had cSEK121m in cash on the balance sheet.
New markets added to the sales organisation. During H1, the company added several new distributor markets to its sales organisation. Among others, the company struck agreements in Australia, New Zealand, Portugal, and Spain. In addition, it recently announced a distribution agreement in the UK to complement its own sales reps. It also hired a sales rep in the Benelux region.
EPIC Knee trial delayed. We believe the EPIC knee trial (the US PMA trial for the Episealer Implant System) is delayed. The combination of the pandemic and too-strict inclusion criteria for the trial appear to have made it hard to recruit patients. However, protocol amendments should be in place during the autumn and all paperwork (ethics committees, etc) should be completed so new patients could be operated on according to the amended protocol in Q4 this year. We estimate that this has led to a c1 year delay from our original forecast to get the implant system approved and launched in the US.
Might reach the US market in 2022. Despite the delay in EPIC knee, we believe the Patellofemoral implant product could reach the market in the US next year, as this product needs only a 510(k) clearance and the company plans to submit the application in Q4 this year (normally a 90-day process). We believe the company will hire a few staff in a US subsidiary but work mainly with one or more of the independent distributor networks available in the US.
New fair value of SEK2.7-8.2/share. We believe the company is moving in the right direction, with growth in its clinical documentation set to continue into 2022. The new patella implant product could add revenues earlier than previously forecast and allow entry into the US market sooner than with the Episealer implant system. We believe its financial position is stable, and its cash should take it into 2023.
Click here to view full report (https://www.dnb.no/seg-fundamental/fundamentalweb/GetReports.aspx?file=CMPSP_178712.pdf&Sid=1-7XT0MIJ)
Best regards
Patrik Ling | DNB Markets | Equity Research | Senior Analyst Healthcare
