Industry News

Press Release of May 12, 2008

Data Presented at AAOS Shows Important Benefits of Pioneering Ceramic-on-Metal Hip Replacements

Laboratory and clinical data has recently been published showing the advantages of ceramic-on-metal ‘CoM’ bearings1. This articles showed significant reductions in wear compared with metal-on-metal ‘MoM’ in laboratory studies and early clinical data showed reductions in whole blood metal ions. There were several articles and presentation at the recent AAOS and ORS meetings, 3-9 March 2008 in San Francisco. These further demonstrated the benefits of this novel bearing surface combination2. It has provided further explanation as to how the ceramic-on metal bearing work by identify the corrosion element of metal-on-metal wear and how this is minimized with ceramic –on-metal³.
This additional data also demonstrated that it is imperative to use tested and approved materials⁴.

“We are excited by this promising data supporting COM products, which produce lower wear as the ceramic head acts as an insulator and inhibits the corrosive wear. This also means lower levels of metal ions are produced which is good news for both surgeons and patients,” said John Fisher, PhD, Director of the Institute of Medical & Biological Engineering.

Study Findings

Studies were conducted by the Institute of Medical and Biological Engineering, at the University of Leeds, UK. The clinical study was conducted in collaboration with the University of Witwatersrand, South Africa. Highlights from the poster presentations are outlined below.^1,3,4

• “In vitro wear of ceramic-on-metal hip replacements,” authored by Sophie Williams et al, tested the following Hip Replacements (36 mm) in vitro: Biolox Delta, Wrought CoCr. Bearing combinations tested compared MOM, COC (ceramic head and liner) and COM. The study found:
• Wear, ion release and friction of COM bearings is less than MOM and comparable to COC (Figure 1)
• Differential hardness also avoid stripe wear of ceramic heads
• Reduced ion release addresses concerns associated with MOM
• Metal-on-Ceramic is not an appropriate bearing surface combination

By using metal liners in this bearing combination the risk of liner fracture has been completely eliminated.
“Clinical assessment of ceramic-on-metal hip replacements,” authored by Anton Schepers Dick van der Jagt et al, is a randomised prospective clinical trial comparing metal ion levels to those in total hip replacements comprising bearings in comparing metal ion levels in patients with different bearing combinations (COP (Ceramic-on Polyethylene), COC, MOM).^1,2

• Early results from the ongoing study, which includes 120 patients to date, show:
  • There have been no unexpected adverse events with the COM bearings thus far
  • There is a trend towards reduced ion level in vivo with COM compared with MOM (Figure 2)

“This data demonstrates the advent of an exciting new era in joint replacement, as COM will allow greater design flexibility to suit individual patients’ needs. This improved flexibility and reduced wear means joint replacements last longer so many patients could avoid the need for further surgery.” Prof. Fisher said.

Loosening of total hip replacements caused by polyethylene wear has prompted renewed interest in so-called ‘alternate bearings’ metal-on-metal and ceramic-on-ceramic. However ceramic-on-metal bearings have advantages over both these combinations:

• Reduced wear and hence metal ion levels compared with metal-on-metal
• Larger heads in smaller cups compared with ceramic-on-ceramic
• Eliminates possibility of both fracture and chipping of ceramic liners
• Elimination of damage to femoral heads known as stripe wear

About DePuy

DePuy, a Johnson & Johnson company, is committed to helping surgeons and patients achieve excellence in orthopaedic care. COM joints are available within the existing DePuy portfolio and forms part of the Pinnacle^TM system.

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Press Release of March 18, 2008

European Orthopaedic companies Mathys Ltd Bettlach and Lima-Lto S.p.A. sign Strategic Alliance

The two Orthopaedic companies, the Swiss Mathys Ltd and the Italian Lima-Lto SpA concluded a close strategic cooperation this week in Villanova, Italy.

Renowned clinics and surgeons have long placed their trust in the competence of both lead-ing European Orthopaedic companies. Mathys Ltd situated in Bettlach and Lima-Lto S.p.A located in the north Italian town of Villanova are each independent family businesses. Both companies have been involved in the area of joint replacement for the past decades. This will not change in the future. “The independence of both companies will not be relinquished through the cooperation” say Gabriele Lualdi, President of Lima and Dr. Arne Faisst, COO and Chairman of the Executive Board of Mathys Ltd.

In a first phase both contracting parties have agreed to exchange two joint replacement sys-tems, to be sold under private labels. Paolo Pirazzoli, General Manager of Lima explains that through this cooperation the ability to bid successfully against the large American competi-tors will be massively improved. Dr. Arne Faisst is also extremely satisfied adding that the alliance entails additional future advantages: “The collaboration includes many opportunities for important synergies. We shall pursue projects to increase efficiency, for example in the procurement of raw materials”.

Through this close collaboration it will be possible for clients of both companies to have ac-cess to a joint replacement portfolio from European companies. “Our customers profit from the long-standing experience and know-how of the two leading Orthopaedic manufacturers”. “In this ways we can promote the European philosophy thus reanimating and strengthening the established tradition of European Orthopaedics”, adds Dr. Arne Faisst.

Background Lima-Lto

The Italian company was founded in 1945 and can be proud of over 60 years of experience in medical technology. The company started developing implants for hip and knee in the 70’s. The Lualdi family still runs its business in four different areas: Orthopaedics, Aero-space, Mechanics and Motors and its products are commercialized world-wide.

The company has ten subsidiaries and three manufacturing sites in Italy, the headquarters are located in northern Italy : Villanova di San Daniele.

Background Mathys Ltd Bettlach

The Swiss Orthopaedic company was founded in 1946 and looks back on a 50 years of experience in the field of medical techniques. Mathys has concentrated exclusively on the development, production and distribution of joint replacement since 1 November 2003. The products are manufactured predominantly in Switzer-land but also in Germany. The current company activities lie in the area of implants for hips, knees and shoulders as well as in synthetic bone replacement material. The company has 9 subsidiaries in Germany, France, Belgium, England, The Neth-erlands, Holland, Austria, Australia, New Zealand and Switzerland is owned by the families Mathys and Marzo. Major shareholder Hugo Mathys acts as the Chairman of the Board of Directors and CEO; Dr. Arne Faisst is COO and Chairman of the Executive Board.

For further information please contact:
Regula Haag
Head Corporate and Market Communication

The New President of the BOA gives Christmas Lecture

Mr Stephen R Cannon, MA, MCh(Orth), FRCS, the newly-installed President of the British Orthopaedic Association gave the second Furlong Christmas Lecture in The Director’s Suite of The Science Museum on 11th December.

The Furlong Research Charitable Foundation was delighted to welcome Mr Stephen Cannon as its speaker this year. The subject of his lecture was The Fixation of Tumour Prostheses to Bone.

As Director of the Bone & Soft Tissue Tumour Unit at The Royal National Orthopaedic Hospital, Stephen Cannon’s research interests are the fixation of endoprostheses to bone, the attachment of soft tissue to metal, and the surgery of malignant diseases of the pelvis. He is one of the world’s leading experts in this highly specialised area and his talk was both fascinating and uplifting as he described the huge progress that has been made in the treatment of such tumours. It was particularly heart-warming to hear how the longevity and quality of life of these, often very young, patients, has been greatly enhanced.

In keeping with the festive nature of the Christmas Lecture, the sixty invited guests were greeted with mulled wine and canapés on arrival. Following the lecture much lively discussion took place over a festive buffet meal.

The Furlong Christmas Lecture has become an enjoyable and important fixture in the calendar.

Cricket Legend opens a world leader in Sheffield

From Left to Right
Keith Jackson - Technical Director JRI; Lady Mayoress of Sheffield; Darren Gough - Captain Yorkshire County Cricket Club; Counc. Arthur Dunworth - Lord Mayor of Sheffield; Brian Jones - MD JRI; Dr Houben - Director, Furlong Research Charitable Foundation; Mrs Houben - Director, Furlong Research Charitable Foundation.

International cricket star Darren Gough officially unveiled the orthopaedic implant and instrument manufacture specialists, JRI’s new £6 million manufacturing facility in Sheffield on 14 September 2007.

The event saw around 230 attendees, including the Lord Mayor of Sheffield - Councillor Arthur Dunworth, the Master Cutler - Alan Reid, NHS Trust Heads and surgeons and nurses, taken on a tour of the cutting-edge facility.

Guests learnt about JRI’s creation of ‘The Furlong HAC Total Hip Replacement’ – the world’s most successful cementless total hip replacement.  This included life changing stories; including one from Fred Lewis, aged 74, who following a Furlong hip replacement, was able to return to engineering work and won a charity walk.

Mr Ruddlesdin, Orthopaedic Surgeon at Barnsley NHS Foundation Trust, addressed attendees about his experience fitting patients with the Furlong hip for the past 21 years; restoring life in thousands of people. Frank Smallpiece, who has worked at JRI as a highly-skilled polisher for 28 years, also spoke about his role; including his pride at receiving a thank you letter from a South African patient who had a Furlong hip.

After Darren Gough, famous for his success on the England cricket team and winning the BBC’s Strictly Come Dancing series three, officially opened the new facility; guests and staff had the opportunity to meet him and network with others.

Brian Jones, Managing Director of JRI, said: “We’re delighted key representatives from Sheffield and the healthcare industry gathered with our staff to mark this milestone for JRI. At the new facility we plan to increase production by further improving efficiency and growing as a team; with seven new employees already adding to the current 78 members of staff.”

Mr Ruddlesdin said: “JRI are an excellent company, and I will use their orthopaedic implants and instruments until the day I retire. For 25 years I have never had a problem with a JRI hip. As a Yorkshire person it is important that I’m using an implant that is made with local materials and manufactured by the local people.”

For images relating to this press release contact Jason Brannan on: T: 0114 222 6312 E: j.p.brannan@medilink.co.uk

Useful Links

www.jri-ltd.co.uk

Located at:

Contact: Keith Jackson, Technical Director, JRI Ltd.
T: 0114 257 3200,
F: 0114 257 3204,
E: jri@jri-ltd.co.uk

Investing in Orthopaedics

Joint Replacement Instrumentation Ltd (JRI) was founded in 1969 by Mr Ronald Furlong, FRCS and commenced manufacturing in Sheffield in 1977.

Following his death in 2002 and that of his widow Eileen in 2003, their estate, including 100% ownership of JRI, was bequeathed to The Furlong Research Foundation, a registered charity which they founded in 1989 with the express purpose of supporting education and research in the field of Orthopaedics.

The continued growth and commercial success of JRI enables it to Gift Aid a significant portion of its profits to the Foundation which in turn supports educational and research projects among the orthopaedic community.

JRI's manufacturing facility in Sheffield is staffed by men and women from the heart of the highly skilled British Steel industry, and is also equipped with the most modern computerised CNC machinery and measuring technology. This ensures the high quality of implants and instruments on which hospitals and surgeons alike have come to depend.

The JRI instrument and prosthetic loan system is increasingly popular and assists our new customers to become familiar with any surgical procedure at low cost. Thirty percent of the total company business is export with worldwide distribution.

Mathys Ltd Bettlach develops new bio ceramic

Media Release, July 6th, 2007

Mathys Ltd with its headquarter in Bettlach, Switzerland, is the only developer, manufacturer and distributor of artificial joint replacements worldwide with its own ceramic production plant. Over the past years, they have been researching and working on a new bio-ceramic.

The family run company has been actively involved in the development of bio-ceramics since the 1970s. Therefore, Mathys possesses 35 years of experience in this field – which speaks for competence and tradition. Some of the current employees have worked on the development of bio-ceramics ever since the company was founded. Their knowledge is one of a number of imperative prerequisites in such a sensitive area as the manufacturing of ceramic implants.

Product portfolio grew over time. During the first two decades the manufacture of ceramics had an exclusive focus on hip ball heads. The product range has been extended over the last ten years to accommodate the global trend towards ceramic-ceramic pairings.

Because ceramic is hard and virtually wear-free it offers many advantages, especially for ceramic-ceramic pairings. Discussions on polyethylene wear or the effect of metal ions in conjunction with metal-metal pairings are irrelevant for ceramic products. To avoid impingement, Mathys has launched large ceramic pairings with 32 and 36mm heads.

The safety of ball heads made by Mathys from so-called Bionit, an aluminium oxide ceramic, has doubled over the past few years thanks to continuous quality improvements. Today, the demand for thin, wear-proof ceramic implants with larger heads is on the increase. Mathys has spent the last three years developing a new ceramic to satisfy these demands. ceramysTM is as hard as the well-known product Bionit – but it is up to three times more break-proof and equally as resistant to wear.

Advantages of ceramysTM ceramysTM is a so-called dispersion ceramic. It is a composite of two well-known and established ceramics: aluminium oxide and zirconium oxide. The difference between the two newcomers to the range lies in the mix ratio. Over the entire pallet, Mathys can now provide ceramic implants made out of two materials

The Mathys ceramysTM line up consists at the moment of ceramic heads and inlays for the modular pressfit cup system: seleXysTM. The new material allows manufacturing inlays with a smaller wall thickness. This offers to use larger heads for smaller hip cups, what will increase the range of motion and reduce the risk of damage on the ceramics due to impingements or subluxation. Further, the new ceramysTM offers also a solution for the rare case of a ceramic breaking: Three revision heads in sizes 36, 32 and 28 mm can be combined with four different titan sleeves (S – XL). An ideal answer not only for ceramic breakings, but for luxation problems or difference in length of legs as well.

Ceramics open up new alternatives for procedures that could previously only be implemented with metallic materials. On the bottom line, the mentioned advantages of ceramysTM and other ceramics implants are very beneficial, especially to the patient.

General Information about Mathys AG Bettlach

Since November 1, 2003, Mathys has concentrated exclusively on the area of joint replacement, and produces hip, knee and shoulder implants as well as biomaterials, both in Bettlach and in Germany. Mathys has developed, produced and distributed products for joint replacement since 1963, although the company has only marketed implants under its own trademark since 1996/97. The company, with its nine subsidiaries in Germany, France, Belgium, England, the Netherlands, Austria, Australia, New Zealand and Switzerland, is owned by the Mathys and Marzo families. Hugo Mathys serves as the President of the Board of Directors as well as being the CEO; Dr. Arne Faisst is the COO.

For enquiries, please contact:

Mathys Ltd Bettlach Patents Revolutionary Bone Replacement Material

Media Release, May 8th, 2007

The orthopaedics company Mathys, in Bettlach, has developed and patented the world's first fully synthetic, kneadable bone replacement material. The advantage of this product, referred to as a putty, is that it can be moulded into any desired form and can be strengthened with osteoinductive substances and antibiotics. In addition, it is easy to handle, which results in shorter operation times.

The revolutionary breakthrough in this highly advanced product (putty) is that the human body recognises the material as the body's own bone. As the implant degrades, new bone is simultaneously formed. The putty material is a kneadable and malleable compound that has the appearance of a granulate and is complemented with a polymeric powder. "As soon as the powder comes into contact with liquid, it swells to a viscous gel that holds the granulate together. The advantage of this process is that the material can be moulded into any desired form, with none of the granules being lost," states Dr. Arne Faisst, the COO of the Mathys Group. An additional advantage is the possibility of blending in osteoinductive substances and antibiotics. Such substances can remain affixed to the particles for far longer in a putty, which allows them to be released over a longer period of time.

Both the Product and the Manufacturing Method are Patented
This idea for this product originated from an internal Mathys invention, which was further developed to the final product through close collaboration with Bettlach's Dr.h.c. Robert Mathys Foundation and Medipol SA, Lausanne. The critical factor here was the evaluation of the manufacturing method, which the Mathys company and its employees, with their many years of experience, helped bring to fruition. Since then, Mathys has successfully patented on both the product itself and the manufacturing method. The product is expected to gain clinical approval in the summer of 2007.

Mathys Focuses on Fully Synthetic Materials
Mathys, the Swiss orthopaedics company, has been producing synthetic bone replacement materials for over 25 years. While other suppliers use raw materials derived from humans or animals, Mathys has focused on creating fully synthetic products through an elaborate manufacturing process. "The risk of disease transmission when processing bone from human cadavers or animals is too high for us. Similarly, there is a potential ethical conflict regarding the use of cadaver bones. It is for these reasons that we use only a wholly synthetic material, which is better and permits faster regrowth of the body's own bone," adds Dr. Faisst. The quantities of bone replacement material being put to use is increasing, especially in the areas of orthopaedics (joint replacement), traumatology (treatment of bone fractures), for the spinal column, and in the field of dentistry.

Over 25 Years of Experience ? More Than 100,000 Implants
As early as 1982, Mathys developed Ceros®, a granulate used in dental applications, in collaboration with the Dr. h.c. Robert Mathys Foundation. The in vivo testing involved more than 50 studies in various hospitals. Since the year 2000, the same material has been used for indications in the area of osteosynthesis. For orthopaedic applications, is being marketed under the trade name of cycIOS™. All products are still being produced by Mathys.

General Information about Mathys AG Bettlach

Since November 1, 2003, Mathys has concentrated exclusively on the area of joint replacement, and produces hip, knee and shoulder implants as well as biomaterials, both in Bettlach and in Germany. Mathys has developed, produced and distributed products for joint replacement since 1963, although the company has only marketed implants under its own trademark since 1996/97. The company, with its nine subsidiaries in Germany, France, Belgium, England, the Netherlands, Austria, Australia, New Zealand and Switzerland, is owned by the Mathys and Marzo families. Robert Mathys Jr. serves as the President of the Board of Directors, Hugo Mathys that of CEO and Dr. Arne Faisst is the COO.

For enquiries, please contact:
Regula Haag