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News in Brief - July 2008
Brief items of the latest industry news...

Appointments - July 2008
Stay up to date with the latest changes in personnel...

Surgicraft Choose Harvard As Exclusive Distributor - July 2008
Surgicraft Ltd have chosen Harvard Healthcare Ltd as the exclusive distributor for...

Orthopaedic Marketing Specialists - July 2008
A new marketing company has been set up by Jason Wilson, specialising in...

LDR Begin ROI-A™ Marketing - July 2008
LDR is marketing its ROI-A™ partial vertebral body replacement device...

Apatech Succeed In Commercial Fundraising - July 2008
ApaTech has announced the successful completion of a $45m fundraising, which are to...

DSM Receive €50m Funding Boost - July 2008
DSM Biomedical will receive funding from the Biomedical Materials Program...

Invibio Presents New PEEK Research Data - July 2008
Invibio® Biomaterial Solutions posted original research data at the 8th World...

Kuros Recruit First Patient For Tibial Shaft Fracture Study - July 2008
Kuros Biosurgery AG has recruited the first patient into a Phase IIb clinical trial with...

Company News In Brief
Acrobot has signed an exclusive distribution agreement with Corin Group for key markets, including the UK, Germany and Australia.

Corin will have exclusive distribution rights in these markets for the Acrobot Navigation system for hip resurfacing procedures. It will purchase systems from Acrobot and market them through its own in-country sales infrastructure.

The agreement will enable more customers to access the Navigation system, which is now usable in a wider range of procedures including uni-condylar knee and total hip replacements.

The distribution arrangement is Acrobot’s first commercial route-to-market agreement and covers the important procedural area of hip resurfacing in several key markets for that procedure.

Graeme Brookes, CEO of Acrobot, said: “Our excellent relationship with Corin, a leader in the hip resurfacing field, has played a fundamentally important part in enabling us to bring our systems to market. The relationship with Corin was instrumental in the initial development of the Acrobot Navigation system, and this coupled with the strength and reach of Corin’s sales infrastructure provides excellent opportunities for both parties.”

“The Acrobot system enables surgeons to plan and perform Cormet hip resurfacing surgery with a level of precision that was not possible before” said Peter Huntley, CEO of Corin Group PLC.

“This system gives us a competitive advantage in the hip resurfacing field in some of our major markets, and we are looking forward to working closely with Acrobot to promote this innovative technology”.

Sectra will deliver an overall IT infrastructure for information exchange and cooperation among hospitals to the Swedish county council Region Skåne. The infrastructure supports automatic sharing and distribution of radiology information to all departments involved in the radiology workflow. Costs decline and production increases when all information is available to all, regardless of location and regardless of where the patient visited last time. Region Skåne encompasses 10 hospitals together performing more than 900,000 radiology examinations annually.

“With the Sectra system, we have the possibility of information exchange and cooperation within and outside the region,” said Eva Hansson, strategist in the management group in Region Skåne.

“It is important for us at Sectra to assist our customers with the challenges they face, today and in the future. The trust placed in us by Region Skåne through this order is confirmation that we can deliver future-proof products and meet the high demands our customers place on us,” said Marie Ekström, President, Sectra Scandinavia.

Invibio® Biomaterial Solutions has unveiled its newly redesigned website, www.invibio.com.

The enhanced website is streamlined, providing easy access to material properties and comparisons, medical application information, processing and application guidelines, abstracts and papers, case studies, and more.

The new website also features a comprehensive resource library providing access to the latest, most in-depth knowledge specific to breakthrough medical applications as well as insight to regulatory, research, and development initiatives.

Invibio president Michael Callahan, said: “The extensive expansion and redesign of our website reflects our continued commitment to giving Invibio customers the materials, expertise, support, and knowledge they need to develop new applications and grow market share in a fast-paced and competitive industry.”

informa Healthcare has published Encyclopedia of Biomaterials and Biomedical Engineering, Second Edition.

The 4-volume edition bolsters an already strong emphasis on subjects integral to tissue engineering including bioreactors, scaffolding materials and fabrication, tissue mechanics, cellular interaction, and the development of major tissues and organs.

A Who’s Who of over 450 internationally recognized experts communicate the latest research findings in two hundred and ninety eight balanced entries arranged for readers’ ease-of-use.

Since the 2004 publication of its first edition, Encyclopedia of Biomaterials and Biomedical Engineering has served as a complete compendium of cutting-edge information for scientists, engineers, physicians, and clinicians looking to stay abreast of new research findings in the fields.

Arthro Kinetics has provided an update to its spinal development program.

Following an extensive program of biomechanical testing Arthro Kinetics’ lead nucleus replacement product has successfully attained all of its in-vitro and safety goals and will now enter pre-clinical studies in the second half of 2008. If successful, the Company expects to initiate a first in man study for this implant in early 2009.

This internal program also provided the foundation for the discovery of a novel, proprietary annulus closure device. Arthro Kinetics has filed patent applications for this innovative device, which though highly complementary to the nucleus replacement product, is of itself a significant new opportunity for Arthro Kinetics. The Company expects this device to enter human studies in 2009.

Surgicraft Choose Harvard As Exclusive Distributor

Surgicraft Ltd have chosen Harvard Healthcare Ltd as the exclusive distributor for the Surgilig™ product in England, Scotland and Wales.

Surgilig™ is a synthetic ligament used in acromio-clavicular reconstruction to replace the ligament and recreate the anatomy. Designed by Professor Angus Wallace at Nottingham, it is made of double braided polyester with a weave design that acts as a scaffold encouraging tissue in-growth.

Surgilig™ now has over 10 years proven clinical experience in the UK and has more recently entered the international market.

Harvard Healthcare is a newly established company specialising in the distribution of niche products. Harvard Healthcare’s Managing Director, Vaughan Rimmer, said: “having always been associated with gold standard products, we’re all very excited about this new addition to our range. The history of Surgilig™ is excellent. Our commitment is to maintain that standard and develop the system to the next generation of ACJ reconstruction.”
Orthopaedic Marketing Specialists

A new marketing company has been set up by Jason Wilson (FormerDePuy, Johnson and Johnson Marketing Manager), specialising in healthcare marketing with a emphasis on Orthopaedics.

getmoretime provides a portfolio of marketing tools to companies, hospitals and surgeons, including, Viral Marketing, Digital Technology and Traditional Marketing, along with Promotional material.

“Right now there is a surge of interest from patients who want to know which treatments are available to them driven by our ‘information society’, increased expectations, patient demographics, new prostheses and surgical techniques.”

“For the manufacturers we can help them present their products using the latest digital marketing techniques; for the hospital we provide a range of educational tools and promotional materials; and for the surgeon we can help them to establish and grow their private practice through a business approach; and all of these elements ultimately help the patient allowing them access to considered information they require.”
LDR Begin ROI-A™ Marketing

LDR is marketing its ROI-A™ partial vertebral body replacement device following 510(k) clearance from the FDA. The ROI-A™ system incorporates the verteBridge™ anchoring technology.

The ROI-A™ is a stand-alone implant system with zero profile, self-locking anchoring plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved anchoring plates inserted along the sagittal plane, requiring no additional exposure to the vertebral bodies.

Christophe Lavigne, CEO of LDR, said, “The entry of the ROI-A™ implant into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies. This is really an exciting innovation and we will soon be introducing other products that incorporate our verteBRIDGE™ anchoring technology.”

Since launching the ROI-A™ more than 75 procedures have been performed with extremely positive feedback from the surgeons.
Apatech Succeed In Commercial Fundraising

ApaTech has announced the successful completion of a $45m fundraising, which are to be invested in additional commercial resources, further clinical and new product development and a significant expansion of manufacturing capacity.

CEO Simon Cartmell said: “These funds allow us to continue the successful development of ApaTech into a world leading orthobiologics company. We see significant potential in Actifuse and the portfolio of new technologies we are developing and I am delighted we have been able to secure investment from, and involvement of, two world class financial institutions who clearly share our vision of the future.”

As a result of the investment from 3i plc and HealthCor, the Board of Directors will change significantly. Peter Chambré becomes Non-Executive Chairman, with Dr Nigel Pitchford and Michael Mashaal, MD joining the Board as investor directors on behalf of 3i plc and HealthCor respectively.

Following on from the investment, ApaTech has signed an 11.5 year lease on two buildings at Centennial Park, Elstree, for a total of 32,000 square feet of office, manufacturing and development activities. Adjacent to the Company’s current location the new buildings provide a four fold increase in manufacturing capacity, equivalent to sales of $100-125m and office accommodation for an additional 45 UK-based staff.

Planning permission has been received for the $13m development and preparatory work to fit out the new facility has been initiated. Office occupancy is planned for January 2009, with manufacturing for sale intended from August 2009.

Simon Cartmell said “The Elstree site is an excellent location for ApaTech and we are all looking forward to moving into the new facility which will be a world class manufacturing and corporate headquarters, reflecting the Company’s values and ambitions”.

Apatech have also announced a number of appointments, (see below)
DSM Receive €50m Funding Boost

DSM Biomedical will receive funding from the Biomedical Materials Program (BMM), a Dutch public-private partnership in biomedical materials.

In total, BMM allocated over €50m to seven R&D projects, four of which were initiated by DSM Biomedical. The funding will help DSM to expand its R&D portfolio and accelerate the development time of new biomedical materials, contributing to the realisation of DSM’s ambition to become a leading player in the biomedical market.

DSM received funding for its participation in NANTICO and IDiDAS. The NANTICO project focuses on the development of medical coating technologies for the prevention of implant-associated infections. The target for the IDiDAS project is the treatment of intervertebral disc degeneration - the major cause of chronic low back pain - via drug delivery and smart polymer implants.

The approval of these two projects by BMM yields an expansion of the DSM Biomedical R&D department in Limburg, the Netherlands, with at least eight new scientists for which the recruiting process will start immediately. Actual start of the projects is anticipated in begin later this year.

Steve Hartig, President DSM Biomedical, said: “Open innovation is an important area for DSM Biomedical. By joining forces with industrial and academic partners, we will be able to significantly speed up the development of better biomedical materials for caregivers. The funding we received today shows the recognition for the quality of the projects we are working on.”
Invibio Presents New PEEK Research Data

Invibio® Biomaterial Solutions posted original research data at the 8th World Biomaterials Congress in Amsterdam, The Netherlands.

Invibio presented two posters exploring preliminary evaluations of new forms of PEEK-OPTIMA (porous and fiber) that may enhance tissue interaction and integration, which were conducted in collaboration with the School of Chemical, Biological, and Materials Engineering, University of Oklahoma.

Invibio also hosted two Congress forums, ‘Biomaterial Surface Interactions and the Versatility of PEEK’ and ‘The Tribology of PEEK Polymer: Promising Results for Bearing Applications.’ Presenters at the forums included Prof. Geoff Richards (AO Research Institute), Dr. Susan Scholes, Ph.D (Durham University) and Dr. Steven M. Kurtz (Drexel University).

Every four years, WBC addresses clinical and medical development and application trends and issues across the global materials science, bioengineering, biotechnology and tissue engineering continuum; this year, 2,300+ scientists, medical professionals and manufacturers from the medical device and pharmaceutical industries attended.

Topics included: wear performance of PEEK-OPTIMA materials in screening tests and in spinal and knee arthroplasty; laser welding of PEEK-OPTIMA for medical devices; polymer solutions for radiology treatment improvements; tensile fracture behaviour in the presence of a Notch Riser; PEEK vs. titanium potential for bone formation of human primary osteoblasts; surface modification of PEEK using oxygen plasma treatment to aid cell growth response; and effects of hydroxyapatite coatings on PEEK and carbon fiber-reinforced PEEK properties.

Invibio president Michael Callahan, said: “Clearly, PEEK polymers are enabling innovation and advancement in numerous new areas that, hopefully, will lead to improved patient care and clinical outcomes; this strong and steady trend shows no signs of abating and new and promising applications are emerging every day.

The field of spine implant design is just one example; PEEK-OPTIMA is now broadly accepted as a high-performing and versatile alternative to metallic, ceramic and other biomaterials across the spinal fusion community and is used in the development of novel motion preservation and dynamic stabilization applications,” said Callahan.

“Additionally...PEEK-OPTIMA has gained acceptance in a wide range of non-spine markets including arthroscopy, dental, pharmaceutical, cardiovascular and orthopaedics.”
Kuros Recruit First Patient For Tibial Shaft Fracture Study

Kuros Biosurgery AG has recruited the first patient into a Phase IIb clinical trial with KUR 113, investigating the treatment of acute, open tibial shaft fractures, associated with a high incidence of complications.

This investigational combination product, KUR-113, consists of a modified variant of parathyroid hormone (PTH) incorporated into a fibrin sealant. When mixed together, the bioactive and the sealant generate a fibrin composite that forms to the shape of the bone defect. KUR-113 is applied to the site of the fracture following surgical fixation with intramedullary nailing or plating.

The study will compare the proportion of patients healed six months after treatment with various doses of KUR-113 as an adjunct to surgical management versus surgical management alone.

Didier Cowling, CEO of Kuros, said: “We are pleased with the continuing progress we are making with our bone regeneration programmes. KUR-113 is designed to stimulate in-situ bone formation with the aim of increasing the speed of successful repair and reducing the rate of secondary interventions. We believe KUR-113 has the potential to be used as an adjunct treatment in many long bone fractures.”
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Stay up to date with the latest changes in personnel

Inion has announced the promotion of David Follows to the role of Chief Operating Officer.

David joined Inion in June 2007 as Chief Commercial Officer from Ethicon Endo-Surgery UK, where he was Managing Director. He has more than 28 years of commercial experience in the medical devices industry, predominantly with subsidiaries of Johnson & Johnson.

In his new role, David will be responsible for manufacturing, supply chain, logistics, research & development and quality control, as well as sales outside the U.S.

Chris Lee, CEO said: “David’s promotion is very well deserved. He has made an excellent contribution to the restructuring and refocusing of the organisation in the areas under his control and continues to be a highly valued member of the team.”

ApaTech has announced several senior management appointments and organizational changes.

Lynn Lester joins ApaTech as VP Human Resources reporting to CEO Simon Cartmell. Lynn joins from Cambridge Antibody Technology plc.

Dr Tom Buckland is promoted to the position of VP Research and Development, an extension of his current research responsibilities.

Dr Jim Cassidy relinquishes his clinical development responsibilities to focus on the regulatory aspects of new product development as VP Regulatory and Scientific Affairs.

Rick Thomas joins as Area Director N Europe, responsible for sales activities in UK, Eire, Benelux and Scandinavia. Rick joins from Medtronic Inc where he was UK Sales Manager for Kyphon.

Finsbury is pleased to announce the appointment of two business consultants; Phil Davies and Brendan McGrath will bring a wealth of orthopaedic experience to Finsbury.

Phil Davies will be working with the company as a Business Consultant. Phil has been extremely successful in the orthopaedic industry, most recently undertaking the position of Managing Director at Plus Orthopaedics. Phil will bring a plethora of strategic advice to Finsbury.

Using his vast knowledge and experience of the global orthopaedic market, Brendan McGrath will offer strategic advice in support of the company’s position in developing technology concerning Finsbury’s new hip products.

Andy Foley, Sales Director, has said: “I am delighted to welcome Phil and Brendan on board at this time when the company is rapidly expanding and reaching its vision as a significant player in Global orthopaedics.”
Appointments Sponsored by
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