Futura Medical Regulatory News (FUM)

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® 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 Body1. 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

¹Notified 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® technology. Each DermaSys® 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