Progress with product development programmes from December
2011
Since December 2011, when the Company raised GBP25m through the
issue of new Ordinary Shares, Tissue Regenix has made significant
progress with the product development programmes anticipated at
that time:
Porcine Meniscus - pre-clinical trial completed and approval
received from the Medicines and Healthcare Products Regulatory
Agency ("MHRA") in order to commence the first UK clinical trial of
Tissue Regenix's meniscal device to aid knee repair. Following
final tests and preparations it is anticipated that this clinical
trial will start by the first quarter of 2015.
-- The trial approval marks a critical stage towards gaining EU
clearance (via a CE Mark) which will enable full commercialisation
of the dCELL(R) meniscus and allow it to be used by clinics and
doctors to help UK and European patients.
-- Tissue Regenix's dCELL(R) meniscus will be used to repair
damage from 'tears' in the meniscus knee cartilage as a result of
acute injury or degeneration.
-- Meniscal injuries affect around 1.5 million people per year
in Europe and US, and the dCELL(R) meniscus potentially addresses
this substantial unmet clinical need.
Porcine Ligament - pre-clinical trial is now completed with the
final report imminent and the start of clinical trials targeted by
the end of 2015.
-- Successful completion of the clinical trial will allow Tissue
Regenix to move towards gaining EU clearance, enabling full
commercialisation of dCELL(R) ligament and allowing it to be used
by clinics and doctors in the UK and Europe.
-- Tissue Regenix's dCELL(R) ligament will be used to repair
anterior cruciate ligament ("ACL") ruptures.
-- ACL ruptures are the second most common injury of the knee requiring surgical intervention. Approximately 900,000 procedures are performed annually, growing at 7% CAGR (2012-2020).
Porcine Dermis - pre-clinical trial completed and pre-market
submission to the Food and Drug Administration ("FDA") to
demonstrate the device is at least as safe and effective to a
legally marketed device (a "510k submission") is expected to take
place in 2015. Approval of the 510k submission will allow the
product to be commercialised in the US.
Porcine General Surgical Patch - pre-clinical trial completed
and 510k submission anticipated in the first quarter of 2015.
Approval of the 510k will allow the product to be commercialised in
the US under the name Surgipure(R).
Human Heart Valves - continued positive data from the 1000+
dCELL(R) Human Heart Valves implanted in Brazil has been presented
by Tissue Regenix's partner, Professor da Costa at several major
cardiology conferences. This data continues to demonstrate the
superiority of decellularised valves over conventional
cryopreserved ones and discussions are underway with selected
tissue banks in the EU and Asia/Pacific about making these
available to clinicians.
Recent developments with human tissue-derived products
Since setting out its product development programmes in 2011,
Tissue Regenix has made significant progress with a number of
additional opportunities for human tissue-derived products. The
Company has found that human tissue-derived products have lower
development costs and are quicker to bring to market, primarily in
the US, than the porcine equivalents as they are classed as
transplant tissues. Unlike the porcine-derived products, they do
not require pre-clinical or clinical trials to gain approval to
sell. Depending on the type of tissue, a restriction with the human
tissue-derived products, can be availability of supply as the
material is derived from deceased donors. However, the Company has
focused on the development of its human tissue-derived products due
to the speed and cost advantages of bringing them to market as well
as the benefits it brings in de-risking the subsequent commercial
launch of the porcine equivalents.
In November 2012, Tissue Regenix established a subsidiary
company in the US, 'Tissue Regenix Wound Care Inc.', as part of its
commercialisation strategy for its dCELL(R) technology platform.
DermaPure(R), Tissue Regenix's decellularised human dermis product
for chronic wounds was launched in the US in June 2014. A trial in
the UK has shown that patients who have had chronic wounds for an
average of 4 1/2 years and who were treated with a single
application of DermaPure(R) have seen an average 87% reduction in
the size of all wounds, while 60% of patients were completely
healed, with virtually no recurrences. The commercial launch of the
DermaPure(R) dermis allograft allows Tissue Regenix to target a
market worth $1.4 billion a year for wound healing devices and
equipment.
In order to aid the sales of DermaPure(R) the Company appointed
distributors around the country in addition to seven sales
representatives employed directly by Tissue Regenix. Through this
network, sales representatives will actively promote Tissue
Regenix's dCELL(R) human dermis in Acute Care hospitals, Veteran
Affairs hospitals and institutions, as well as in Long Term Acute
Care hospitals.
Additionally, Tissue Regenix has been assigned a permanent level
II Healthcare Common Procedure Coding System (HCPCS) product
reimbursement Q-code for DermaPure(R) by the Centers for Medicare
& Medicaid Services ("CMS"), the US Federal Government funded
health programmes. The new, unique Q-code assignment for Tissue
Regenix is reflected in the Hospital Outpatient Prospective Payment
System Final Rule for the calendar year 2015, released by CMS on 31
October 2014. The new reimbursement code took effect from 1
January, 2015. The Q-code will enable wound care clinics,
ambulatory surgical centres and hospital outpatient facilities
located outside the Acute Care hospitals to apply for reimbursement
under Medicare for patients who are treated using DermaPure(R). The
decision will allow greater access to DermaPure(R) for clinicians
and provide an advanced treatment for wound care patients with
chronic and acute wounds.
Given the success to date, a core part of Tissue Regenix's near
term strategy is to accelerate commercialisation in the US. In
addition to DermaPure(R) used for the treatment of chronic wounds,
the Company has identified opportunities for human-derived meniscus
and ligament products, which it intends to bring to market in the
US, along with those of its porcine-derived products, which are
eligible for regulatory approval via the 510k submission approach.
The Company will also continue to progress the porcine products
towards CE Mark with the intention of allowing commercialisation
across the UK and Europe. Underpinning the commercial launches, the
Company will continue to build its dCELL(R) evidence base including
evidence of the benefits of dCELL(R) both in terms of health
economics and mechanism of action.
Current core application areas
The Company has identified wound care and orthopaedics as the
two core application areas for its current product development and
commercialisation plans. Orthopaedics remains a significant and
growing market among medical devices. Total global sales are
estimated at $45 billion, within which the Company has identified a
market with global revenue of $4.6 billion where its products are
relevant. Global regenerative, soft tissue and cartilage repair is
expected to grow at 6.6% CAGR through 2019. Patients continue to
demand alternatives to joint replacement as they seek to extend
their physically active lives. There is a significant need
therefore for soft tissue grafts/replacements within the sports
medicine arena. The Company also considers wound care to be an
attractive market for its products, with the incidence of wounds
growing in the US due to diabetes and obesity, along with lifestyle
changes. Within this sector, skin substitutes, currently comprises
only 5% of a total wound market considered to be worth $7 billion
and is regarded as a growth area.
Current trading and outlook
As reported in the Company's interim results announced on 29
October 2014, the launch of DermaPure(R) during the first six
months of 2014 was an important milestone in the Company's progress
from its roots as a purely development-focused company to becoming
a business with commercially available products. The diversity and
strength of the dCELL(R) platform coupled with the Company's strong
commercial focus provides a solid base to grow the business and the
Company continues to aim towards the full commercial roll-out of
its dCELL(R) technology across a range of target markets, including
multiple applications where the Company sees opportunity for
DermaPure(R). Since reporting interim results on 29 October 2014,
the Company has continued to perform in line with the Board's
expectations, seeing encouraging momentum since the launch of
DermaPure(R) in the US, with initial revenues now being recognised
as anticipated.
Near term objectives for 2015 include line extensions in the
dental and orthopaedic markets in order to expand the commercial
opportunity for DermaPure(R), which will pave the way for launch in
other orthopaedic applications. In addition, the Company aims to
launch SurgiPure(R) in the US, the porcine general surgical patch,
complete the clinical results from the EU trial of the porcine
meniscus product and complete the relocation of the UK
manufacturing facility.
Important Notice
This announcement has been issued by, and is the sole
responsibility of, the Company. This announcement is for
information only and does not constitute an offer or invitation to
underwrite, subscribe for or otherwise acquire or dispose of any
securities or investment advice in any jurisdiction in which such
an offer or solicitation is unlawful, including without limitation,
the United States, Australia, Canada, the Republic of South Africa
or Japan.
No prospectus or admission document will be made available in
connection with the matters contained in this announcement.
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