# Collagen Solutions Engineering towards CE Mark

- Link: https://www.directorstalkinterviews.com/collagen-solutions-engineering-towards-ce-mark/412736348
- Published: 2017-09-21T15:32:41+01:00
- Author: Giles Arbor

**⌊Hardman & Co Report Report Downloads⌉⌊Hardman & Co Report Report Downloads⌉Collagen
Solutions Plc** (LON:COS) is a biomaterials company developing and manufacturing
medical grade collagen components for use in medical devices, research, and regenerative
medicine. A number of investment initiatives have been introduced recently to accelerate
the rate of growth, including global commercial infrastructure and development of
a pipeline of finished medical devices, the first of which will be ChondroMimetic
for repair of small cartilage lesions. In June 2017, COS embarked upon an 8-year(
average) follow-up study of patients originally implanted with the device in 2009-
10. The last patient has now been reassessed.

**Strategy:** Management has embarked on an investment strategy through a series
of initiatives to increase the growth opportunities. This strategy is moving COS
from a reliable quality collagen supplier to one that also has proprietary products
that will move it into profitability, and cash generative, at a faster pace.

**ChondroMimetic:** Best described as a clever bi-layered and easy to use sponge
that allows the regeneration of cartilage and bone. The product has good provenance
having received CE Mark in 2008 and implanted into ca.200 patients. However, for
reasons prior to COS’s ownership the CE Mark lapsed.

**Patient re-evaluation:** As part of the process of re-applying for CE Mark, COS
has undertaken an extension study to reassess 15/17 patients from the original trial
in 2009-10. This will provide unprecedented 8-year follow-up data about the quality
of the cartilage repair and support CE Mark and marketing material.

**Next steps:** The last patient has now been rescanned. All the data has to be 
compiled, audited and analysed for completion of a Clinical Study Report. This will
form part of the package for submission to the regulators for CE Mark around the
end of 2017. It will also assist in commercial partner negotiations.

**Investment summary:** ChondroMimetic fulfils Collagen Solutions plc’s stated strategy
to move further up the value chain. The 8-year data will significantly differentiate
it from competing therapies, and with the last patient now assessed the enrolment
phase has been de-risked. In order to maximise returns, COS will need to sign a 
strong commercial partner in readiness for launch around the middle of 2018, and
capable of undertaking the trials needed to launch the product in the US.

 

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