Collagen Solutions PLC Study Update Patient Assessments Completed (3626R)
21 September 2017 - 4:01PM
UK Regulatory
TIDMCOS
RNS Number : 3626R
Collagen Solutions PLC
21 September 2017
Collagen Solutions Plc
(the "Company" or the "Group")
ChondroMimetic(R) Study Update
Patient Assessments Completed, Analysis Ongoing
Collagen Solutions plc (AIM: COS), the developer and
manufacturer of medical grade collagen components for use in
regenerative medicine, medical devices and in-vitro diagnostics,
announces that the final patient has been assessed in the
eight-year extension clinical study of 15 patients who received a
ChondroMimetic(R) implant as an osteochondral scaffold for the
repair of cartilage defects in the knee.
Study Highlights:
-- Clinical trial enrolled 17 patients in 2009-2010; six-month
results demonstrated safety and improved clinical outcomes
-- Original six-month MRI data analysed retrospectively in 2017
using quantitative MRI techniques indicated early improved
structural defect repair
-- 15 patients enrolled between June and September 2017 for
prospective eight-year extension study
-- Full clinical and quantitative MRI data analysis ongoing
The 15 patients were part of the original six-month safety and
early clinical outcomes study of 17 patients in 2009-2010, which
showed filling of the original defect and early signs of
integration with healthy cartilage. The current extension phase of
the study with these same patients uses enhanced MRI imaging
techniques to permit longitudinal assessment of durability of
cartilage repair and the integration of the ChondroMimetic implant,
as well as clinical outcomes.
A retrospective analysis of the original MRI images was recently
performed using T2 mapping, an imaging technique that is used to
quantify the differences between native and implanted cartilage
tissue. The analysis indicated that the ChondroMimetic scaffold was
virtually indistinguishable from surrounding cartilage at six
months following surgery. This technique and other MRI analyses
will be replicated for the long-term study to assess the
sustainability and completeness of bone and cartilage defect
filling, as well as cartilage quality.
The "Last Patient Out" milestone has now been completed and the
data is being compiled and audited, in line with the Company's
previously announced timelines. Following the completion of the
Clinical Study Report, Collagen Solutions will submit it as part of
a package to the regulatory authorities for approval and the
re-establishment of the CE mark targeting commercialisation outside
the US in mid-2018.
The Company has made a presentation available regarding this
study update on its website at:
http://ir.collagensolutions.com/content/investors/presentations.asp
Jamal Rushdy, CEO of Collagen Solutions said: "We are pleased
with the progress of the long-term ChondroMimetic study and are
enthusiastic about the potential for this product to enable
surgeons to treat patients affected by early arthritis and
cartilage defects with a simple, proven, and cost-effective
treatment. To our knowledge, ChondroMimetic will be the only
arthroscopically applied cartilage scaffold backed by long-term
evidence, significantly differentiating it from competing
therapies. This study extension is a fundamental step forward in
our programme for developing ChondroMimetic as a product which has
the potential to address 450,000 annual cartilage procedures and
provide access to a potential US $500M-$1B market opportunity."
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. The Company's products are
used in a wide variety of applications including orthopaedics,
cardiovascular, dental, plastic surgery, wound healing, neurology
and urology.
Enquiries:
Collagen Solutions Plc Contact via Walbrook
Jamal Rushdy, Chief Executive
Officer
Gill Black, Chief Financial
Officer
Cenkos Securities plc (Nominated Tel: 0207 397 8900
Adviser and Broker)
Stephen Keys
Steve Cox
Walbrook PR Tel: 020 7933 8780 or collagen@walbrookpr.com
Mike Wort Mob: 07900 608 002
Anna Dunphy Mob: 07876 741 001
This information is provided by RNS
The company news service from the London Stock Exchange
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