Futura Medical PLC Futura receives positive QMS Audit Opinion (5600V)
10 August 2020 - 4:00PM
UK Regulatory
TIDMFUM
RNS Number : 5600V
Futura Medical PLC
10 August 2020
10th August 2020
Futura receives positive Quality Management Systems Audit
Opinion for MED3000 under EU Medical Device Regulation
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a
pharmaceutical company developing a portfolio of innovative
products based on its proprietary, transdermal DermaSys(R) drug
delivery technology and currently focused on sexual health and
pain, is pleased to announce that it has received a positive audit
opinion for its Quality Management Systems (QMS) from the relevant
EU Notified Body in the European approval process for MED3000.
In February 2020 Futura commenced formal proceedings for MED3000
to be approved as a medical device and a clinically proven
treatment for Erectile Dysfunction (ED) in Europe by an EU Notified
Body(1) . In order to obtain pre-marketing clearance within the EU
under the new Medical Device Regulations (MDR), two requirements
have to be met: Submission of Technical Documentation (TD) which
includes sufficient efficacy, safety and quality data; and
demonstration that the Company can operate to a high standard of
quality through a Quality Management System (QMS). In receiving a
positive audit opinion, the Company is pleased to announce that our
QMS meets the required standard for the new Medical Device
Regulations.
The Company submitted the TD on MED3000 for review to the
Notified Body as announced on 14th July 2020. With this positive
QMS audit opinion it paves the way for the Notified Body to
complete its review of the technical documentation. Futura
continues to target a 2021 European approval date.
James Barder, Chief Executive of Futura Medical commented: "We
are pleased to have fulfilled the key filing requirements for
MED3000 for European approval as a clinically proven treatment for
ED. In parallel with the regulatory processes and executing upon
our strategic plans, Futura has now appointed specialised corporate
advisers with international experience to facilitate commercial
discussions with potential licensing and marketing partners."
He added, "We continue to see potential for MED3000 as an ED
treatment in OTC markets as well as for prescription use. If
successful, EU approval will allow MED3000 to be marketed
throughout the EU including the UK without the need of a doctor's
prescription subject to any national marketing restrictions.
MED3000's differentiation on speed of onset, high tolerability and
safety combined with efficacy will provide a new, highly accessible
option for many patients suffering from the debilitating effects of
the condition."
Note
(1)Notified Bodies are organisations designated by EU countries
to oversee the approval of medical devices
within the EU and the UK.
-ENDS-
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
www.Futuramedical.com
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Supriya Mathur
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 922 0891
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) technology. Each DermaSys(R)
formulation is separately patented and specifically tailored for
the selected indication and application, as well as being optimised
for clinical efficacy, safety, administration and patient
convenience. The products are developed for the prescription and
consumer healthcare markets as appropriate. Current therapeutic
areas are sexual health, including erectile dysfunction, and pain
relief. Development and commercialisation strategies are designed
to maximise product differentiation and value creation whilst
minimising risk.
MED3000 is Futura's topical gel formulation that is a
breakthrough treatment for erectile dysfunction (ED) through a
unique evaporative mode of action. Futura has conducted a Phase 3
study using MED3000 in ED, referred to as "FM57". This was a 1,000
patient, dose-ranging, multi-centre, randomised, double blind,
placebo-controlled, home use, parallel group study delivering
highly statistically significant results compared to pre-treatment
baseline, consistently meeting all co-primary endpoints of IIEF,
SEP2 and SEP3 (internationally accepted clinical trial endpoints in
ED) with over 60% of patients experiencing a clinically meaningful
improvement in their ED. MED3000 also begins to work immediately in
some patients, with 60% of patients seeing onset of their erection
within 10 minutes of application.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
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END
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