Creo Medical Group PLC US FDA clearance for MicroBlate(TM) Flex device (8285K)
07 January 2021 - 6:00PM
UK Regulatory
TIDMCREO
RNS Number : 8285K
Creo Medical Group PLC
07 January 2021
Creo Medical Group plc
("Creo" or the "Company")
US FDA clearance for MicroBlate (TM) Flex devic e
Creo Medical Group plc (AIM: CREO), the medical device company
focused on the emerging field of surgical endoscopy, announces that
it has received 510(k) clearance from the US Food & Drug
Administration ('FDA') for its tissue ablation device MicroBlate
(TM) Flex .
MicroBlate(TM) Flex is the fourth device within Creo's portfolio
of flexible endoscopy devices for the gastrointestinal ('GI')
market to receive FDA regulatory clearance, alongside CE marking
already received across the range in 2020. The first Creo product
to receive FDA clearance, Speedboat(TM) Inject , is being used by
clinicians in the UK, EU, US, South Africa and APAC.
Creo's suite of devices have been designed to be used with the
CROMA Advanced Energy Platform, powered by Kamaptive(TM)
full-spectrum adaptive technology, a seamless, intuitive
integration of multi-modal energy sources, optimised to adapt to
the tissue effect required for different procedures such as
resection, dissection, coagulation and ablation.
About MicroBlate(TM) Flex
Creo's MicroBlate(TM) tissue ablation technology utilises Creo's
very high frequency microwave energy allowing physicians to
precisely ablate diseased tissue in multiple organ types and many
different clinical access methods. MicroBlate(TM) Flex is an
additional soft tissue ablation device within the range, designed
to ablate nodules and tumours in several soft tissue types,
including the lung. MicroBlate(TM) Flex has potential to treat a
number of other conditions, where a small diameter flexible device
enables access into otherwise inaccessible regions of the body.
MicroBlate (TM) Flex could be particularly useful to treat a range
of ENT indications, including nasopharyngeal cancer and nasal
polyps.
Creo's additional ablation product, MicroBlate(TM) Fine also
received 510(k) clearance from the FDA in November 2020 and the
first in-man clinical use of MicroBlate(TM) Fine was announced in
December 2020. FDA clearance paves the way for the roll-out of
these devices into the US market and with the full range of
products CE marked during 2020 Creo also has access to the EU and
UK markets enabling commercialisation of the GI suite.
Full details of Creo's product range can be found here:
http://www.rns-pdf.londonstockexchange.com/rns/8918P_1-2020-6-14.pdf
Craig Gulliford, Chief Executive Officer of Creo, commented:
"We are delighted to receive FDA clearance for the
MicroBlate(TM) Flex device and we remain focussed on completing our
programme of regulatory clearances for the full suite of advanced
energy surgery products for the flexible endoscopy market. We
expect to see further first clinical use of our products in various
markets and we look forward to utilising our enhanced global sales
and marketing capability to drive commercialisation of our
range."
Enquires:
Creo Medical Group plc investors.creomedical.com
Richard Rees (CFO) +44 (0)1291 606 005
Cenkos Securities plc +44 (0)20 7397 8900
Stephen Keys / Camilla Hume (NOMAD)
Michael Johnson / Russell Kerr (Sales)
Walbrook PR Ltd Tel: +44 (0)20 7933 8780 or creo@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: +44 (0)7980 541 893 / +44 (0)7515
909 238
About Creo Medical
Creo Medical, founded in 2003, is a medical device company
focused on the development and commercialisation of minimally
invasive surgical devices, by bringing advanced energy to
endoscopy. The Company's mission is to improve patient outcomes by
applying microwave and RF energy to surgical endoscopy. Creo has
developed the CROMA Advanced Energy Platform powered by
Kamaptive(TM) full-spectrum adaptive technology to optimise
surgical capability and patient outcomes. Kamaptive(TM) is a
seamless, intuitive integration of multi-modal energy sources,
optimised to dynamically adapt to patient tissue during procedures
such as resection, dissection, coagulation and ablation of tissue .
Kamaptive(TM) technology provides clinicians with increased
flexibility, precision and controlled surgical solutions.
The Company's strategy is to bring its CROMA Advanced Energy
Platform powered by Kamaptive(TM) technology to market, enabling a
wide range of medical devices which the Company has designed,
initially for the emerging field of GI therapeutic endoscopy, an
area with high unmet needs. The CROMA Advanced Energy Platform will
be developed further for bronchoscopy and laparoscopy procedures.
The Company believes its technology can impact the landscape of
surgery and endoscopy by providing a safer, less-invasive and more
cost-efficient option of treatment.
For more information about Creo Medical please see our website,
investors.creomedical.com
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