Creo Medical Group PLC US FDA clearance for MicroBlate(TM) Fine device (8519D)
November 02 2020 - 2:00AM
UK Regulatory
TIDMCREO
RNS Number : 8519D
Creo Medical Group PLC
02 November 2020
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Creo Medical Group plc
("Creo" or the "Company")
US FDA clearance for MicroBlate (TM) Fine 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) Fine .
This is the third device to gain FDA regulatory clearance within
Creo's portfolio of flexible endoscopy devices for the
gastrointestinal ('GI') market alongside SlypSeal(TM) Flex and
Speedboat(TM) Inject. The range is 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 of tissue.
About MicroBlate(TM) Fine
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) Fine, believed to
be the smallest diameter MW ablation needle antenna in the world,
has the same dimensions as a standard biopsy needle which, when
used with typical ultrasound navigation tools, enables improved
access to and the ablation of a wide range of organs (such as
pancreas, liver, kidney, lung and muscle) during open,
laparoscopic, percutaneous and endoscopic procedures .
Creo's Speedboat(TM) Inject , already CE marked and with FDA
clearance, is being used by clinicians in the UK, EU, US, Africa
and APAC. On the back of this progress, the balance of Creo's GI
suite of products were also CE marked during 2020 providing access
to the EU and UK markets enabling commercialisation of the GI
suite. MicroBlate(TM) Fine is the first of the ablation platform
with US clearance and paves the way for the roll-out of more
devices into the US market. 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 our
MicroBlate(TM) Fine device and w e continue to work hard, despite
the impact of the COVID-19 pandemic, to continue our program of
regulatory clearances for our expanding suite of advanced energy
surgery products for the flexible endoscopy market.
"With regulatory clearance in the UK and Europe and US
clearances coming through, we are gearing up for first clinical use
of these products in various markets. This rapid progression of
device clearances, along with the recent dramatic expansion of
Creo's Global commercial sales capability, puts Creo in great shape
to drive global commercialisation.
"Despite the COVID-19 pandemic, during 2020 Creo has added a
significant direct sales presence in both the USA and key EU
markets as well as adding to global distribution channels. This,
combined with an increased range of products including through the
recent acquisition of Albyn Medical, gives Creo a full service
offering in the GI sector. "
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 / Cameron MacRitchie
(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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