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2016-10-18

EPISURF MEDICAL AB: Recent peer reviewed clinical study publication reveals high failure rates for biological knee cartilage treatments and thus highlights the

Episurf Medical AB
Company Announcement

Recent peer reviewed clinical study publication reveals high failure rates for
biological knee cartilage treatments and thus highlights the need for
alternative treatment options

The clinical paper A Randomized Multicenter Trial Comparing Autologous
Chondrocyte Implantation
with Microfracture: Long-Term Follow-up at 14 to 15 Years, by Gunnar Knutsen,
MD, PhD, Jon Olav Drogset, MD, PhD, Lars Engebretsen, MD, PhD, Torbjørn
Grøntvedt, MD, PhD, Tom C. Ludvigsen, MD, Sverre Løken, MD, PhD, Eirik Solheim,
MD, PhD, Torbjørn Strand, MD, and Oddmund Johansen, MD, PhD has been published
in the Journal of Bone and Joint Surgery (J Bone Joint Surg Am,
2016;98:1332-9). Patients with cartilage injuries of the femoral condyles of
the knee joint have been followed over a period of up to 15 years after
biological treatment.

This information was published, 2016-10-18 14:10 CEST (GLOBE NEWSWIRE) --

The management of painful lesions of the articular cartilage and underlying
bone in the knee remains problematic. One option is to undergo a biologic
treatment referred to as autologous chondrocyte implantation (ACI), which
involves harvesting cartilage cells during a first surgery, having these cells
grown in a laboratory for a number of weeks and then having them implanted to
the damaged cartilage zone during a second surgery. These patients have to
undertake prolonged rehabilitation to allow the cells to start generating new
hyaline cartilage.

Microfracturing is another biologic treatment for articular lesions of the knee
joint, involving a surgeon to stimulate bone marrow to fill the damaged area
and allowing the body to generate fibrocartilage, a less durable version of
cartilage compared to the natural articular hyaline cartilage.

"In this recent publication Knutsen et al. report on their very well executed
randomized clinical trial on autologous chondrocyte implantation vs.
microfracturing with long-term follow-up. They show a 43% failure rate for ACI
vs. 33% for microfracturing at 15 years. 57% of the remaining patients in the
ACI group and 48% of those patients in the microfracture group showed
radiographic signs of early osteoarthritis, even though there were improvements
in clinical scores (Lysholm score and VAS). We do not yet know the long-term
results of the Episealer knee implant but there have been no revisions after 4
years. It is a consensus opinion in the field that secondary biologic
procedures should not be an option. Therefore, these long term results put
surgery for chondral lesions into perspective; failures are common and salvage
procedures after such failures are in great want. The Episealer implant may be
an optimal salvage option after failed biology", says Episurf’s Senior Medical
Advisor Prof. Leif Ryd.

“With debilitating cartilage injuries continuing to cause patients problems
with their day-to-day life, the Knutsen study supports that current biological
treatment options can offer less than ideal results. Episurf can offer hope to
these biologically failed patients” concludes Prof. Ryd.

For more information, please contact:

Rosemary Cunningham Thomas, CEO, Episurf Medical

Tel: +46 (0) 70-7655892

Tel: +44 (0) 7803-753603

Email: rosemary@episurf.com

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a
more active, healthier life through the availability of minimally invasive and
personalized treatment alternatives. Episurf Medical’s Episealer® personalized
implants and Epiguide® surgical drill guides are developed for treating
localized cartilage injury in joints. Episurf Medical’s ?iFidelity® system
enables implants to be cost-efficiently tailored to each individual’s unique
injury for the optimal fit and minimal intervention. Episurf Medical’s head
office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq
Stockholm. For more information, go to the company’s website: www.episurf.com.

This information is information that Episurf Medical AB is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above.

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