Evaluation and Preclinical Validation of FibroFix a Mechanically Advanced Tissue Regenerative, Meniscal Cartilage Repair Device

The meniscus has a poor blood supply and as a result ~90% of injuries do not heal. In the
majority of these cases, surgery is required to remove the damaged tissue which if left
untreated causes significant discomfort and impairs mobility (1). The surgical procedure, a
partial meniscectomy, alleviates the symptoms but destabilises the knee joint, resulting in
uneven load distribution and an increased likelihood of developing OA and the eventual
requirement for TKR (2,3,4,5). Although old age brings an increased risk of meniscal tears,
the injury is most commonly observed in patients aged 11-44 for whom TKR is not a viable
option (6). The result is long term disability for these patients.
The meniscus plays a very demanding role in the knee joint, carrying up to 80% of the load
placed on the knee. When running and jumping, meniscal load will frequently exceed 8 times
body weight. The combination of poor blood supply and demanding mechanical role mean
there are few available therapies that can deliver either meniscal regeneration or functional
replacement. We believe FibroFix is the only device capable of offering both (see appendix A
and B).
Developed through awards in 2009 and 2010 of £1.6m from the Wellcome Trust and £269k
from The TSB Regenerative Medicine programme, FibroFix is an advanced prototype
implantable medical device. Short term pilot study large animal data on the device is positive,
demonstrating stable fixation, biocompatibility, mechanical performance and initial
chondroprotection. Simultaneously, significant advances have been made developing the
GMP production processes required for ISO13485 accreditation and successful implantations
in human cadavers to develop the surgical technique have been conducted in partnership with
corporate multinational, ArthrexGmbh. An award in April 2011 of £732k from the NIHR i4i
Programme to an Orthox led consortium provides funds to further develop the FibroFix
device and manufacturing process and evaluate the outputs in vitro, and through a pilot human
clinical study.
However, restrictions on the i4i programme preclude preclinical in vivo work being funded.
Therefore, the project described in this application will deliver the pivotal proof of concept
long term in vivo efficacy study required to complement the work on the i4i programme,
ensuring expeditious translation of FibroFix into the clinic.
Devices developed on the i4i project will be trialled in a 6 month sheep meniscal repair study.
This will be conducted to GLP standard, required for regulatory submissions, and
subcontracted to Northwick Park Institute for Medical Research (NPIMR) under the
supervision of Dr Paul Sibbons, with whom Orthox have a longstanding existing
collaboration. The results are expected to be completed within 12 months of the project start
and included in the design history file for the submissions to gain approval for initiation of the
pilot human clinical study in Q4 2012.