Fertiligent medical device receives FDA approval
07 April 2010 - 4:00PM
UK Regulatory
TIDMHCEG
RNS Number : 7916J
Healthcare Enterprise Group PLC
07 April 2010
07 April 2010
Healthcare Enterprise Group PLC
(AIM: HCEG)
("Healthcare Enterprise" or the "Group")
Fertiligent medical device receives FDA approval
Healthcare Enterprise, an international healthcare group, is pleased to announce
that Reproductive Sciences Limited ("RSL" or "the Company"), in which it holds a
27% interest, has reported that its Fertiligent artificial insemination device
has received formal approval from the US Food and Drugs Administration ("FDA")
for its sale in the United States.
Highlights:
· FDA approval received
· European CE approval for the final model received in March 2010
· Manufacturing & assembly agreement signed with Catheter Research, Inc of
Indianapolis, Indiana, USA
· Discussions underway to appoint US and international distributors with
the aim of commencing sales later in 2010
RSL holds the worldwide sales and marketing rights to Fertiligent's products,
including the "Evie" device. HCEG has contributed management oversight to RSL,
with direct private investment from funders including Nigel Wray.
RSL has focussed on Fertiligent's "Evie" product, a high quality, low cost
intrauterine sperm pump to help assist infertile couples conceive. From initial
trials conducted in Germany and Israel, Fertiligent offers infertile couples an
enhanced intrauterine insemination success rate and the chance of avoiding
invasive and costly artificial reproductive techniques such as in vitro
fertilisation.
The Company, RSL, owns 45% of the issued capital in the Israeli Fertiligent
Limited company, with options to increase that holding to 78% of the fully
diluted capital. RSL also owns the exclusive, worldwide sales & marketing rights
to the Israeli Fertiligent company's products.
Lyndon Gaborit, Executive Deputy Chairman of Healthcare Enterprise, commented:
"We are delighted that this critical milestone has been achieved for the
Fertiligent 'Evie' medical device. FDA approval, and the recently received CE
approval for the final production version, significantly reduces risk and paves
the way for a roll out of this exciting product around the world. Women's
reproductive health is a significant and increasing market and this new product,
which provides couples with a low cost alternative to existing reproduction
methods such as IVF, should, we believe, find good market acceptance with
associated returns to RSL's investors, including HCEG."
For further information, please contact:
+-----------------------------------+-------------------------+-----+
| Healthcare Enterprise Group PLC | | |
| Lyndon Gaborit | Tel: +44 (0)20 7680 | |
| | 3649 | |
+-----------------------------------+-------------------------+-----+
| Daniel Stewart & Company plc | Tel + 44 (0)20 7776 6550 |
| Andrew Edwards/Emma Earl | |
| | |
+-----------------------------------+-------------------------------+
| Bishopsgate Communications | | |
| Robyn Samuelson / Giang Nguyen | Tel: +44 (0)20 7562 | |
| | 3355 | |
| | | |
+-----------------------------------+-------------------------+-----+
Note to Editors
Healthcare Enterprise
Healthcare Enterprise Group PLC (HCEG) is a healthcare investment group which
invests in synergistic products and services within the healthcare industry. It
currently has two main investments:
· Ebiox Limited - Patented decontamination and disinfectant products that
are safe and alcohol free but substantially more effective than conventional
methods at destroying embedded microorganisms. The Ebiox range includes hand
hygiene products, surface disinfectants and products to clean and decontaminate
surgical instruments. HCEG owns 20% of Ebiox Limited.
· Reproductive Sciences Limited - Innovative slow release pump for
intrauterine insemination, proven to significantly enhance pregnancy success
rates. HCEG owns 27% of the Company.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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