TIDMCOS
RNS Number : 4560F
Collagen Solutions PLC
21 February 2018
21 February 2018
Collagen Solutions Plc
(the "Company")
Positive Eight-Year Results of ChondroMimetic(R) Cartilage
Repair Clinical Study
Study confirms sustained long-term repair of knee cartilage and
improved clinical symptoms
Collagen Solutions Plc (AIM: COS), the developer and
manufacturer of medical grade collagen and tissue components for
use in regenerative medicine, including orthopaedic, dental, wound
care, and cardiovascular applications, announces successful results
from an eight-year extension clinical study of 15 patients who
received ChondroMimetic(R) implants as an osteochondral scaffold
for the repair of cartilage defects in the knee. These positive
results have now allowed Collagen Solutions to submit an initial
submission for CE Mark.
Data highlights
-- Quantitative 3D MRI analysis in the long-term study concluded
that cartilage regeneration in the treated defects had reached a
level and structural quality nearly identical to native
cartilage.
-- Improvement in patient clinical symptoms, including pain,
function and activity level after treatment sustained over the
eight-year period.
-- The 'Knee Injury and Osteoarthritis Outcome Score' (KOOS), a
well-known and validated patient reported outcome measure, showed
outcomes following the ChondroMimetic(R) procedure were equal to or
better than KOOS scores reported in the literature for
substantially more expensive two-stage cartilage repair
technologies.
Backed by these results ChondroMimetic(R) is positioned as the
only minimally invasive, cost-effective, single-stage treatment
that fits within surgeons' current surgical techniques for smaller
cartilage defects with eight-year clinical effectiveness and repair
quality data.
The market
There are over 1 million surgical procedures in the U.S. and
Europe performed each year to treat cartilage defects of the
knee(1) , yet current treatments have not demonstrated sustainable
efficacy beyond five years post-treatment and/or have limited
adoption due to cost and complexity. The current indication target
for ChondroMimetic(R) is positioned to address at least 30%-40% of
these surgeries once adopted world -wide.
Clinical results
The results of the ChondroMimetic(R) eight-year follow-up study
demonstrated favorable improvement for clinical outcomes of pain,
function and activity level. Specifically, patient reported scores
from the "Modified Cincinnati Rating System" improved from 64.4
pre-operatively to 80.9, which was a highly statistically
significant change (p=0.0065) and represented an 8-year overall
grading of 'excellent'. Further the study reported KOOS scores for
5 subscales that were equal to or better than KOOS values reported
in the literature for more expensive two-stage cartilage repair
technologies (Saris AJSM 2008 and Saris AJSM 2014
respectively).
Advanced quantitative, 3D MRI analysis examined the tissue
within the ChondroMimetic(R)-treated defects and found improved
cartilage volume and tissue quality that was sustained through the
8-year follow-up. The extent of total defect filling was reported
as an average of 95.1%, and repair tissue mean T2 relaxation time
(a relative measure of tissue structure) was 52.5 ms, compared to
52.3 ms for the surrounding native cartilage in the same knees.
These results demonstrate near complete filling of defects and
regeneration of high-quality cartilage nearly indistinguishable
from native cartilage.
Commenting on these clinical study results, Dr. László Hangody,
orthopedic surgeon and the Principal Investigator for the study
said: "Based on our first-hand clinical experience with
ChondroMimetic(R) and these new results confirming the
sustainability of both cartilage regeneration and the improvement
in patient outcomes, it is my firm belief that this scaffold has an
important place in the treatment of focal chondral lesions as an
alternative to microfracture." Dr. Alan Getgood, orthopedic surgeon
involved with ChondroMimetic's(R) early development, also
commented: "The long term quantitative MRI data of cartilage repair
volume and tissue quality in patients who were treated with
ChondroMimetic(R) are extremely attractive. This is consistent with
the previously performed animal studies which showed a 25%
improvement in cartilage repair over controls."
The Company has made a presentation available regarding this
study with further details on its website:
http://ir.collagensolutions.com/content/investors/presentations.asp
Partnering opportunities
In December 2017, Collagen Solutions announced that it signed a
license and distribution agreement with a South Korean industrial
partner. The Company is in active discussions with potential
multi-national partners and distributors, in anticipation of a
European launch following CE Mark approval.
European regulatory clearance next steps
Collagen Solutions has started the submission process to
re-establish the CE Mark for ChondroMimetic(R). Following
finalisation of the clinical study report, supplemental data will
be submitted to complete the submission and support CE Mark
approval, targeted for the second half of 2018.
Commenting on these positive results, Jamal Rushdy, CEO said:
"This compelling data is a significant achievement in the
decades-long effort by clinicians and scientists to develop a
cost-effective and clinically effective treatment for these types
of cartilage defects. We have illustrated the commercial
opportunities with the announcement of an agreement with our South
Korean partner in December last year. We look forward to announcing
further key milestones including the granting of the CE Mark over
the next few months. We are excited by ChondroMimetic's(R) progress
and believe that Collagen Solutions is now in a period of solid
progression which will provide future sustainable revenue
generation."
Investor evening on 26 February 2018
As recently announced, on Monday 26 February Jamal Rushdy, CEO,
will give an update to investors on ChondroMimetic(R) and in
particular the significance of the most recent clinical data
compared to current competitive procedures. Jamal will also
summarise the key milestones expected this year for both
ChondroMimetric(R) and the Company's core business activities. This
event will also allow investors to meet Collagen Solutions' new
CFO, Hilary Spence. The presentation will be filmed and the video
will be available on the Company's website shortly afterwards at:
http://ir.collagensolutions.com/content/investors/presentations.asp.
For more information on the event please contact
lisa.baderoon@collagensolutions.com or collagen@walbrookpr.com.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014
Collagen Solutions Plc Tel: +44 (0) 141 648 9100
Jamal Rushdy, Chief Executive Officer
Hilary Spence, Chief Financial Officer
Lisa Baderoon, Head of Investor Relations Tel: +44 (0) 7721 413 496 or lisa.baderoon@collagensolutions.com
Cenkos Securities plc (NOMAD and Broker) Tel: +44 (0) 207 397 8900
Stephen Keys
Steve Cox
Walbrook PR Tel: +44 (0) 20 7933 8780 or collagen@walbrookpr.com
Anna Dunphy Mob: +44 (0) 7876 741 001
Helen Cresswell
About Collagen Solutions:
Collagen Solutions Plc is a global supplier, developer, and
manufacturer of medical grade collagen, tissues, and related
medical devices and components for use in regenerative medicine,
medical devices and in-vitro diagnostics and research. The Company
is also expanding its range of biomaterials-based finished medical
devices based on its internal and acquired intellectual property
for commercialisation with partners via licensing and distribution
arrangements, including ChondroMimetic(R). The Company's products
are used in a wide variety of applications including orthopaedics,
cardiovascular, dental, plastic surgery, wound healing, neurology
and urology.
For more information go to: www.collagensolutions.com
1 DRG Sports Medicine Devices US and Europe 2015
This information is provided by RNS
The company news service from the London Stock Exchange
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