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Healthcare Enterprise - Fertiligent medical device receives FDA approval
07-04-2010
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:
- 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.”
--ENDS--
Notes 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.
Enquiries
Bishopsgate Communications
Robyn Samuelson/Gemma O'Hara/Siobhra Murphy
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