Encircle Compression Therapy Newa & Media

NZ Merino Product wins International Medical Design Award in United States

11/4/11

Christchurch based The Merino Company and Mt Maunganui based product development company, Locus Research, have scored a major international win with a Medical Design Excellence Award (MDEA) announced in the United States for their innovative range of merino wool compression garments designed and developed in New Zealand.

The Medical Design Excellence awards, announced on Friday night (April 8) recognise the achievements of medical product manufacturers, engineers, designers and clinicians who are responsible for groundbreaking innovations that "change the face of healthcare".

The compression garments, 'Encircle Compression Therapy', were developed for The Merino Company (TMC) by a crack Kiwi team led by Locus Research, partnered with the AgResearch Textiles Group and the Medical Research Institute of New Zealand. The project was co funded and supported by the Ministry of Science and Innovation (MSI).

Professor Richard Beasley, director of the MRINZ, who is an internationally recognised respiratory physician led the research team which tested the garments.

The Encircle products use textiles made by Levana in Levin (the company is part of TMC).

More than 40 per cent of people over 45 suffer from circulatory problems, ranging from venous stasis, hypertension, varicose veins, deep vein thrombosis (DVT) to ulcers and chronic venous disease (CVD). CVD is one of the fastest growing chronic diseases and in the United States accounts for 4.6 million lost working days every year.

Until now, methods used to treat CVD include compression bandaging and compression hosiery. Such bandages are difficult to apply (patients usually need to see a healthcare professional), they are seldom reused, they can be hot and uncomfortable and they are invariably made of synthetic materials which are not compatible with the skin environment. In fact, synthetic bandages often contribute to infection of skin tissue.

Encircle garments are composed of an innovative proprietary material made up of two fibres. The first is merino, which is composed of keratin, also found in the outer layer of the human skin and the second, Thermacool, is an elastane polyester which can channel out moisture from the skin. Merino and Thermacool were weft-knitted into a new structure whereby the merino is placed on the inside for next-to-skin comfort. The result is a comfortable garment that creates a micro environment around the skin to assist and regulate the skin or wound environment. Unlike other existing therapies, Encircle garments are convenient for wearers – the knee high garments can be pulled on, and zipped up, rather like a snug sock. The garments can be purchased in three pressure grades from light to firm.

The product has impressive medical research and clinical claims to back up its effectiveness. The MRINZ random controlled trial, conducted by Professor Beasley and his team, was undertaken in 20 healthy adults who wore the stocking on one leg for 120 minutes, while the other leg was used as the control. Doppler Ultrasound was used to study and measure the change Encircle has on blood movement within the body (known as Hemodynamics) and measurements were taken of leg circumference to assess the influence the stocking has on leg swelling, oedema and lymphatic drainage. The Ministry of Health approved study, showed increased lower limb venous blood flow during prolonged seat immobility (meaning the Encircle garments are ideal for long distance flying), increased Peak Systolic Velocity (PSV) by 24%, increased total blood flow by 14%, and reduced swelling and oedema. The study has already been published in the international medical journal 'Advances in Therapy'.

TMC and Locus Research are also in line for a further award as they are finalists in the respected DuPont Australia and New Zealand Innovations Awards to be announced in Australia in mid May. The DuPont Awards recognise technical innovation in four key categories.

Andy Wynne, CEO of The Merino Company, said that the company was honoured to receive international recognition for Encircle.

"The MDEA Award recognises the quality of the design and research work as well as the commercial potential of this unique product. We are developing a whole business around Encircle and see significant potential in taking merino to a new level."

Joseph Stuart, Senior Investment Manager at MSI, said the Government invested in the Encircle programme because it recognised the potential for increased innovation through stronger collaborations between business and research organisations.

"The Merino's Company's success positions the company and New Zealand with a world-leading platform for ongoing textile development, adding significant value from the farm to market."

Production of Encircle is already underway, with significant order already produced for the Australian pharmacy market, through pharmacy distributors, Symbion Pharmacy Services, and TMC is also working with medical distributors in New Zealand, Scandinavia and the United Kingdom.

Encircle Compression Therapy was born out of the Transform Initiative created by Locus Research for Textiles New Zealand in 2007, when the industry was investigating ways to increase the level of textile related innovation coming out of New Zealand The Transform programme also led to the Bio harness (Zephyr Technology), which was used to monitor the state of health of the trapped Chilean miners last year.

Bythe Rees-Jones, lead designer for the Encircle project for Locus Research, said merino derived products were already being used in a variety of medical products, such as keratin protein and lanolin, but the team believed merino could offer significant therapeutic advantages for sufferers of CVD conditions when merely used as a fibre, as it has unique moisture absorbent, antibacterial, antimicrobial and odour-inhibiting properties.

Rees-Jones praises the other researchers in the Encircle team such as Dr Stewart Collie, from the AgResearch Textiles Group for "his amazing knowledge of textile science".

"Encircle's success has come from a great team, and the fact we did user centred design. The team essentially became the patient and that is how we created the product."

Rees-Jones says the MDEA award is "massive" as it was won in the general hospitals devices and therapeutic products category against a stack of other major international medical products companies and players. He says the use of the MDEA badge on Encircle products will provide immense credibility for international marketing and already the team is fielding enquiries from as far afield as Norway and Denmark.

Professor Beasley says he was impressed by the commitment of Locus Research and The Merino Company to undertake "rigorous testing of its product" prior to launching it on the market.

"This commitment has been acknowledged in the Medical Design Excellence Award and provides an excellent model for other New Zealand companies who develop healthcare products.

The Press

New Zealand Merino wins medical award

19/4/11

Encircle a Finalist in Dupont ANZ awards

11/3/11

Encircle has been announced as a finalist in the Biennial Dupont ANZ Innovation Awards in the medical and healthcare category.

This is a great achievement for the Encircle team with the Dupont awards recognising innovation, research and development in both New Zealand and Australia. Winner will be announced in May.

The recognition is a further confirmation of the great team and the achievements made in the care and treatment of chronic venous disorders. Dupont Awards Finalists Announced.

Proven: Encircle increases venous bloodflow by 24%

15/2/11

The Encircle team are happy to announce the publication of the clinical trials manuscript which proves the efficacy of the Encircle Compression Therapy. This provides a detailed overview of the performance from a clinical perspective and appropriately is being published in the 'Advances in Therapy' journal. We would like to thank Richard and Thom and the MRINZ team for their efforts and interest.

The Medical Research Institute of New Zealand's study is entitled 'Merino Wool Graduated Compression Stocking Increases Lower Limb Venous Blood Flow: a Randomized Controlled Trial'.

The Abstract Reads:
Graduated compression stockings represent a nonpharmacological approach to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) due to prolonged immobility through reducing lower limb venous stasis. A novel merino wool, double-layer, below-knee graduated compression stocking has been developed to reduce the risk of air travel-related DVT and PE.

Methods:
Twenty healthy adult participants were randomized to wear the novel graduated compression stocking on either the left or right leg. Doppler ultrasound measurements of popliteal venous blood flow were made on both legs over a 120-minute period. The primary outcome was peak systolic velocity in the popliteal vein at 120 minutes. Secondary outcomes included mean flow velocity, total volume flow, vein cross-sectional area, and change in ankle and calf measurements.

Results:
The popliteal vein peak systolic velocity was 0.35 cm/s (95% confidence intervals [CI], 0.22 to 0.49, P<0.001) higher with stocking use at 120 minutes, a difference of 24%. Mean flow velocity and total volume flow were also significantly higher with stocking use. Ankle and calf circumference were decreased with stocking use, with an overall difference of -6.3 mm (95% CI, -11.3 to -1.2, P=0.021) and -7.9 mm (95% CI, -13.3 to -2.4, P=0.011), respectively.

Conclusion:
The novel merino wool double-layer, below-knee graduated compression stocking increases lower limb venous blood flow during prolonged seated immobility. Its use is likely to reduce the risk of DVT and PE in situations of prolonged seated immobility, such as long-distance air travel. The reduction in lower limb swelling associated with their use suggests that the stockings are likely to have utility in the treatment of chronic venous insufficiency and lymphedema.

Stage Two Clinical Study — The effects of Encircle Compression on venous Haemodynamics

16/8/10

Professor Richard Beasley and the Medical Research Institute of New Zealand (MRINZ) have put together a really great clinical study to assess the efficacy of the Encircle Compression Therapy. We have now completed three of the five groups of study participants. In this ethics approved study we are looking at qualifying three key aspects :

The physiological effects of Encircle Class 1 compression on participant haemodynamics via Doppler ultrasound (measurements of Peak Systolic Velocity, Mean Flow Velocity, Total Volume Velocity and Vein Diameter);
The sizing range and specifications to determine the effectiveness of a standardized S, M, & L sizing system (as opposed to custom tailor-made sizes which we have already proven to deliver great physiological benefit);
Individual consumer preference towards the products.
Encircle has received some very positive feedback relating to the product's comfort, application, and design aspects. And at a first glance it looks like several participants have shown a positive physiological effect. The true physiological health benefits will be charted once all of the data has been pooled and analysed later this month. At this stage it appears that the results are heading positively in the right direction.

A real life ‘Micro-environment’ for healing

24/5/10

The Encircle team has just completed a very interesting electron microscopic examination of Encircles patented bi-component fabrics.
Encircles material technologies are based on leveraging the unique attributes that naturally occur in merino fibre. When ‘encircled’ in this novel way, these attributes create an effective micro-environment to buffer the micro climate of the wearer to help manage and regulate the skin and epidermis for healing. Using merino fibre next to the skin, Encircle has put a real life fibre at the core of its material technologies and by doing this Encircle has created an amazing fabric surface topography.

Ethics Approval and the ‘go’ for stage two clinical trials

1/5/10

Thanks to the help from the team at the Medical Research Institute of New Zealand (MRINZ), Encircle has received ethics approval to carry out comprehensive clinical trials on the Encircle Compression Therapy system (stage two trials). These trials will measure the physiological effect Encircle graduated compression has on lower limb venous haemo-dynamics. The team is excited by the prospect of clinically measuring and proving the efficacy of the products. Early Doppler ultrasound studies have shown very promising results so this study is being conducted on a much larger scale. Participants are now being recruited by the MRINZ for the study, which is set to take place in August/September. These studies will provide robust research and evidence for clinical compliance with Medsafe and the Therapeutic Goods Administration (TGA) in Australia; helping EMD obtain pre market approval.

Levin super sock praised

06/11/09

Encircle was featured in this week's Horowhenua Mail, as reported by Faye Lougher:

A brand new health product and a training intiative drew praise for Levana Textiles during a visit by Deputy Prime Minister Bill English to Levin on Tuesday. Mr English praised the company for creating jobs and training their own workers rather than waiting for skilled workers to arrive on their doorstep.

Levana recently began a knitting school where nine Levin locals were taken off the benefit and trained up as knitting mechanics and machine operators at the factory. "It's a smart business and it's good to see Levana taking responsibility for training new staff and giving them specialised skills. They are turning people who would otherwise be on the dole into trained workers. "They are not waiting for someone to supply them with skilled workers, they are creating them themselves. We need a lot more of it," said Mr English.

Levana had also developed a range of medical compression garments, named Encircle, aimed at the elderly community and had the potential to revolutionise the medical world. Levana chief executive Andy Wynne said at present the elderly community suffering from skin issues and venous insufficiencies such as oedema, venous eczema, ulceration, and thrombosis had to see a specialist to be fitted with either a tightly applied bandage or compression socks. Levana's newly developed medical compression garment overcame the problems of patients having to present themselves at a hospital or doctor's surgery to have the bandage changed and the difficulty in changing a medical compression sock themselves. The garment was made from a double-sided technical textile engineered to provide allow blood to flow back into the limb. This made it much easier for the elderly patients to use. The pack came with one outer garment and three pairs of washable inner socks.

The compression garment had been named as one 20 to go through to round two in The New Zealand Focus on Health Challenge run by New Zealand Trade and Enterprise. The own of the winning design would get the opportunity to commercialise the product in the United States. Entries in the challenge covered the full range of health-related products and services including health IT, medical devices, natural products, services such as training and support, skin care, food supplements, and pharmaceuticals. The challenge provided entrants with the opportunity to learn how to fast-track their idea, product or service to the United States; up-skill their business knowledge and get quality training, support and advice from prestigious sources; connect with international health and business professionals and mentors to enhance their chance of success faster. They would also share a prize pool valued in excess of $750,000. Levana had spent two years testing the product and patenting the technology.

Doppler Testing Complete

26/09/09

The EMD design team completes the successful testing of efficacy via Doppler ultrasound in Wellington.

The test measures the increase in blood flow with the different types and grades of compression.

The results indicated the Encircle treatment delivering an increase in blood flow. This is necessary for the delivery of effective compression.

This test precedes the full clinical trial which will occur early in 2010.

Focus on Health - Round 2

21/09/09

Encircle Medical Devices is selected out of 104 entries to be a semi-finalist in the NZ Focus on Health initiative. Design Director Blythe Rees-Jones will be presenting to Judges on the 7th of October via Cisco Webex to the US.

The New Zealand Focus on Health Challenge is a business development competition to help fast track commercialization of the New Zealand health market. It gives participants the chance to be connected to a network of influential health and business professionals in the Unites States and New Zealand, including investors, partners and buyers. The Challenge is designed to stimulate new product development, innovation, commercialization and collaboration within New Zealand’s healthcare industry.

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