Provexis Regulatory News (PXS)

29 June 2016 Provexis plc

Product launch - Fruitflow® + Omega-3 dietary supplement

Provexis plc ("Provexis" or the "Company"), the business that develops, licenses and sells the proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient, is pleased to confirm the launch of its new Fruitflow® + Omega-3 dietary supplement product, which is exclusively available through the Company's new e-commerce website www.fruitflowplus.com

Fruitflow® is a patented, scientifically-proven tomato extract which inhibits platelet aggregation, a known cause of heart attack, stroke and venous thrombosis. It is a natural product classified as a food which is easy to digest.

In May 2009 Fruitflow® was the first technology to be substantiated by the European Food Safety Authority ('EFSA') under the new Article 13(5) for proprietary and emerging science. In December 2009 the European Commission authorised the health claim 'Helps maintain normal platelet aggregation, which contributes to healthy blood flow'.

In 8 human trials, consumption of Fruitflow® has been proven to maintain healthy platelet aggregation and improve blood flow. In the largest single study for Fruitflow®, positive effects were observed in 97% of individuals tested. This compares favourably with single-drug therapies such as aspirin which can be ineffective in up to 30% of individuals; further, there are no recorded side effects from Fruitflow®.

On 31 May 2016 the Company announced in a trading update that more than 50 regional consumer healthcare brands containing Fruitflow® have now been launched by direct customers of DSM, with a number of further regional brands having been launched through DSM's distributor channels.

Provexis seeks to harness the power of natural ingredients and combine them with proven science to develop safe, clinically proven cardioprotective solutions, hence the decision with this new product to combine Fruitflow® with Omega-3 for even greater cardioprotective effect.

Fruitflow®+ Omega-3 is a two-in-one supplement in an easy to take capsule, supporting healthy blood flow and normal heart function. The added ingredient of Omega-3 has a separate, positive European Commission approved health claim: 'Omega-3 Fish Oil EPA and DHA contribute to the normal function of the heart'.

Each Fruitflow®+ Omega-3 capsule contains 150mg of Fruitflow®, and 250mg of the purest Omega-3 to help boost DHA/EPA levels. Taken daily, Omega-3 works by altering the balance of fats that circulate in the blood, which are used for incorporation into blood cells. A healthy balance of Omega-3/6 fats in blood cells is reported to slow down formation of fatty plaques in the arteries, helping to maintain normal heart function.

Fruitflow®+ Omega-3 offers the first 100% natural, safe, scientifically proven solution for healthy blood flow and cardiovascular health. It can be used in primary prevention for healthy adults who understand the dangers of CVD and who want to take control of their diet and lifestyle to maintain cardiovascular health. 

Initially the benefits of each Fruitflow®+ Omega-3 capsule will last 12-18 hours, but with continued daily use the capsules will provide 24 hour protection.

Fruitflow®+ Omega-3 marketing initiatives

The Company has been working on the marketing, public relations, sales and fulfilment aspects of its new e-commerce channel with the judicious use of expert outsourced partners and with continuing support from DSM, and it has sought to minimise setup costs.

The Company is planning to conduct a Key Opinion Leaders roundtable for Fruitflow® in September 2016, with considerable support from DSM, which is expected to be a good opportunity to promote Fruitflow® more widely across key digital and other mainstream media channels.

The Company has setup a Facebook page for Fruitflow®+ Omega-3 - www.facebook.com/FruitflowPlus - and this will be updated on a regular basis.

Fruitflow®+ Omega-3 will be promoted across DSM's key digital communities and channels, to include boosted posts on DSM's Facebook channels targeting health conscious consumers.

A digital marketing strategy has been agreed for the product, seeking to drive and optimise online leads and sales and this will be implemented in the coming weeks.

The Company is keen to increase the brand awareness and potential sales of its Fruitflow®+ Omega-3 capsules, along with the brand awareness of Fruitflow® more widely, and further sales channel opportunities are under review.

The Company and DSM are keen to secure greater medical advocacy for Fruitflow®, particularly with reference to the US Food and Drug Administration's guidance in May 2014 concerning the use of low dose aspirin which remains a strong opportunity. Fruitflow® has been promoted at some major cardiovascular health events, including the European Society of Cardiology's annual congress in London which was attended by more than 30,000 healthcare professionals.

Marketing initiatives have also included DSM's product video for Fruitflow® which is primarily targeted at potential business customers for Fruitflow® in the consumer healthcare sector. The video has been a good opportunity to promote Fruitflow® more widely and it has been viewed by a wide variety of current and prospective customers for Fruitflow®. Further bespoke versions of the video have been released, and a new promotional video has also been shown to prospective customers in the US market. The product video is available to view via the Company's websites www.provexis.com and www.fruitflowplus.com

The Company remains in the process of submitting some of the underlying scientific studies for Fruitflow® for publication in appropriate scientific journals, to include the Company's Aspirin Comparison Human Trial for Fruitflow® and a separate 'Fruitflow® review' paper. The Fruitflow® review paper includes a scientific summary of the entire Fruitflow® project from its inception. The publication of these two studies is expected to be a significant opportunity to promote Fruitflow® further, with further study publications envisaged in due course.

Fruitflow® and Blood Pressure - Collaboration with University of Oslo

In November 2014 the Company signed a two stage collaboration agreement with the University of Oslo to undertake further research into the relationship between Fruitflow® and blood pressure regulation. Recent work undertaken by the University has shown that Fruitflow® has a potential new bioactivity, leading to blood pressure lowering effects which would be of relevance to a large number of consumers and patients with a wide range of cardiovascular conditions.

The first stage of the collaboration work, completed in 2015, was focussed on developing the science and the key results from this stage were very encouraging, with strong evidence from the laboratory based work that a standard 150mg dose of Fruitflow® in powder format has the potential to give a clinically relevant reduction in systolic blood pressure.

The Company and the University are now in the process of conducting the second stage of the collaboration work which is seeing the parties undertake a small clinical trial in Oslo by way of a proof of principle study. Study designs were submitted for ethics approval before finalisation, with a potential dosage for the study of 150mg Fruitflow® in powder format twice per day. The Company and the University expect to be able to complete the clinical trial in the next few months and the results of the proof of principle study will be announced as soon as possible thereafter.

Dawson Buck, Chairman of Provexis, commented:

"We are delighted to announce the launch of our Fruitflow®+ Omega-3 dietary supplement product, a natural, safe, scientifically proven solution for healthy blood flow and cardiovascular health.

Fruitflow® and Omega-3 have separate, positive EFSA health claims and the product packaging and related marketing programme reflect these strongly.

The Company and DSM are committed to a number of ongoing marketing initiatives for Fruitflow® and the Company's new Fruitflow®+ Omega-3 capsules, seeking to give Fruitflow® and this innovative new dietary supplement product further global exposure.

The new Fruitflow®+ Omega-3 dietary supplement product is expected to provide the Company with an additional income and profit stream, and help to increase the brand awareness of Fruitflow® more widely.

The product launch today is a very positive development for the business, seeking to generate value for shareholders, and we remain positive about the outlook for the product and the business."

-ends-

For further information please contact:

Provexis plc Tel: 07490 391888

Dawson Buck, Chairman enquiries@provexis.com

Ian Ford, Finance Director

Cenkos Securities plc Tel: 020 7397 8900

Bobbie Hilliam

Notes for editors

About Provexis plc

AIM-listed Provexis is focused on the development and licensing of its proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient.

In May 2009, the Company's Fruitflow® technology was the first to be substantiated by the European Food Safety Authority ("EFSA") under the new Article 13(5) for proprietary and emerging science. In December 2009 the European Commission authorised the health claim "Helps maintain normal platelet aggregation, which contributes to healthy blood flow", which was the first wording to be authorised under Article 13(5).

In June 2010 it was announced that the Company had entered into a long-term Alliance Agreement with DSM Nutritional Products to commercialise Fruitflow®, and in June 2015 the Company confirmed it had agreed significantly enhanced financial terms for its Alliance Agreement with DSM for Fruitflow®.

The Company's Alliance partner DSM Nutritional Products has developed the market actively for the Company's novel, patented Fruitflow® heart-health ingredient in all global markets, with over 50 regional consumer healthcare brands now having been launched by direct customers of DSM, and with a number of further regional brands having been launched through DSM's distributor channels.

An increasing number of further commercial projects have been initiated by DSM with prospective customers, including some prospective customers which are part of global businesses, with good prospects for these projects to be launched as consumer products. Interest in the technology exists in all major global markets.

On 29 June 2016 the Company launched a high quality dietary supplement product containing Fruitflow® and Omega-3 which is being sold initially from a separate, dedicated website www.fruitflowplus.com on a mail order basis.

The Company is engaged in a two stage collaboration agreement with the University of Oslo ('the University') to undertake further research into the relationship between Fruitflow® and blood pressure regulation. The Company is very pleased with the encouraging results from the first stage of the collaboration with strong evidence that a standard dose of Fruitflow® has the potential to give a clinically relevant reduction in systolic blood pressure. The Company and the University are now in the process of conducting a small clinical trial by way of a proof of principle study.

Provexis was founded in 1999 and is headquartered in Reading, Berkshire.

Provexis shares are traded on the AIM market of the London Stock Exchange under the ticker symbol PXS.

For further information, please visit www.provexis.com