BioMonde secures requisite product and marketing licences to expand use of its larval therapy products in two significant wound care markets - USA and Europe.
The US Food & Drug Administration (FDA) have approved both
formats of Larval Therapy product (Free Range and BioBag) as
medical devices. Under these 510(k) licences, Larval Therapy
products are indicated for the debridement of non-healing necrotic
skin and soft tissue wounds including pressure ulcers, venous
stasis ulcers, neuropathic foot ulcers, and non-healing traumatic
or post-surgical wounds.
In Germany, the Federal Institute for Drugs
and Medical Devices (Bundesinstitut für Arzneimittel und
Medizinprodukte – BfArM), have approved Larval Therapy products as
a medicine and full Marketing Authorisation has been granted on 11
Feb 2014. This now enables further licencing across Europe under
the Mutual Recognition process.
The significance of attaining these licences
is that in the US, BioMonde is now able to offer it’s Larval
Therapy products to US based clinicians and patients. The US wound
care market is the largest in the world and is estimated to be a
$6bn revenue market. In Germany, for the first time BioMonde is now
able to market its Larval Therapy products and make clear claims
supported by the appropriate clinical evidence. The BfArM marketing
authorisation will now open up the wider European wound care market
estimated to be a €5bn revenue market.
Gareth Kempson, BioMonde CEO commented “With
the support of our investors (Finance Wales and Sir Roger Jones),
the management team continues to hit key milestones defined within
a agreed strategy set out in 2012. Clearing the critical regulatory
hurdles in Europe and the US provides the platform to deliver the
growth aspirations this ambitious wound care business has. Across
key operations in UK and Germany, in the current trading year to
Mar 2014, BioMonde is on track to deliver 200% growth in EBITDA and
more than 20% growth in year-on-year revenue. It’s been a fantastic
effort by Team BioMonde and I’m very proud of the hard work,
commitment and effort demonstrated by all of our staff.”
BioMonde is in the final stages of closing a
£3.5m funding round. This investment will support BioMonde’s
expansion in to the US and other European territories. BioMonde is
currently planning the set up of a purpose built production
facility in the the US and is on track to deliver product in the US
market in Q3 2014.