The 2009 Spine Technology Awards were presented in eight categories: Biomaterials, Device Technologies for Cervical Care, Lumbar Care, Motion Preservation of the Spine, Minimally Invasive Care, Diagnostics and Imaging, Pain Management, and Regenerative Technologies.  Surgeon judges evaluated entries for originality, clinical relevance, and the likelihood that the technology will improve current standards of care. Presented by Orthopedics This Week and RRY Publications, the Spine Technology Awards are intended to recognize innovative spine surgery products and the engineering teams and inventors who create them.

A gel made from synthetic and natural sources could encourage growth of the neural stem cells when injected into a patient’s brain, according to research from Clemson University. Ning Zhang presented the gel at the Military Research Forum in Kansas City on September 2, 2009. Zhang says the gel has demonstrated an ability to reconstruct vascular networks at brain injury sites, such as those caused by trauma during combat.

The hydrogel is injected into the lesion site to direct the response of neural stem cells in the brain to regenerate normal brain tissue at the lesion site. Zhang predicts the procedure may be ready for human testing in about three years. The research is supported by a $220,000 grant from the U.S. Department of Defense.

Four weeks after hydrogel treament on a lesion in a rat’s brain, a well-structured vasculature network was rebuilt. In this mosaic image, green is neurofilament staining for neurites and red is staining for blood vessels. Image by Clemson University

The newest members of the Biomedical Scientific Advisory Board include Samuel Stupp, James Kirkpatrick and Wouter Dhert, all leaders in the field of biomedical materials science. They join existing members Tony Mikos, Ivo Buschmann, and Patrick Cahalan.

Samuel Stupp is a Board of Trustees Professor of Materials Science, Chemistry, and Medicine at Northwestern University (Chicago, USA), where he also serves as the Director for the Institute for BioNanotechnology in Medicine. He received this year an honorary doctorate from Eindhoven University for his pioneering work in complex molecular systems and their biomedical applications, and is the recipient of numerous awards and honors, including the Materials Research Society Medal Award and the American Chemical Society Award in Polymer Chemistry.

James Kirkpatrick is an expert in pathology and in vitro methods for biomaterial research and has authored nearly 350 articles in peer-reviewed journals on the topic. He has taught at universities across the globe and is currently Professor of Pathology and Chairman of the Institute of Pathology at Johannes Gutenberg University (Mainz, Germany). Dr. Kirkpatrick also serves as an external reviewer for several research councils and programs throughout Europe, as well as scientific journals, and was President of the European Society for Biomaterials from 2002-2007.

Wouter Dhert joins Drs. Stupp and Kirkpatrick, and brings almost 20 years of experience in translational orthopaedic research on biomaterials and tissue regeneration to DSM’s Biomedical Scientific Advisory Board. He is Professor of Translational Musculoskeletal Research, Director of Orthopaedic Research at the University Medical Center Utrecht, and part-time professor in Tissue Repair at the Faculty of Veterinary Medicine at Utrecht University (The Netherlands).

Apic concludes that without adequate funding for appropriately trained and staffed infection prevention departments, progress in eliminating healthcare-associated infections could stall. APIC plans to use the survey results to drive awareness of the need for resources for infection prevention programs.

According to the company, OsteoCrete exhibits compressive strength and expandability yielding a binding quality that surpasses calcium-based orthobiologics. The magnesium-based material is resorbable as it is replaced with bone during healing and it is injecatble and osteoconductive.

Tom Lally, President of BSI said in a release that the “magnesium-based technology along with other ingredients provides significant compressive strength and possesses Ph-neutral qualities that make it ideal as a delivery system for possible future applications.”

The OsteoCrete Bone Void Filler device uses a similar material composite noted in the patent that the FDA cleared for long-bone and pelvis applications.

The presentation addresses the challenges of restoring sight, which are immense, and the advances in this area which go hand in hand with advances in technology. As is the case with most electrical prostheses, these advances cross many scientific disciplines, from biophysics to electrical engineering. Of equal importance is the surgical aspect of being able to successfully implant such devices.

Dr. Hendriks will discuss two approaches being employed; the subretinal implant, and the epiretinal implant.  It is noteworthy that close to 300 patents have been filed and granted on this topic. Over the past 12 months, 26 patents were filed or granted naming various assignees, such as the Doheny Eye Institute, Neurosystec Corporation, IMI Intelligent Medical Implants AG, Retina Implant GMBH, Second Sight Medical Products Inc., W.C.Heraeus GMBH & Co., and NewCyte, Inc., to name a few.

The presentation will review patenting trends over the past few years and explore recent patent publications by a select few companies on the subject of retinal implants to convey some of the latest research efforts and interesting advances in this area.

Some key points to be covered in the presentation include:
1. Different approaches to retinal implants
2. A review of patenting trends around these technologies
3. A review of patent publications by a select few companies in this  area
4. An overview of how this activity impacts the research efforts and advances in this area

Web event:

Biomaterial Trends: HACs
Date:    Wednesday, May 27
Time:    2:00 p.m. EDT
1:00 p.m. CDT
11:00 a.m. PDT
Duration:    50 minutes
Who should attend:    Product development teams and reimbursement specialists for medical devices.

Ted Mannen, member of Epstein, Becker & Green

Ted Mannen is based in Washington, D.C., where he specializes in reimbursement and health policy as a member of the law firm of Epstein Becker & Green, P.C., and as a managing director of that firm’s consulting affiliate, EBG Advisors, Inc. He is also managing director of ContentHealth LLC, for which he edits the health policy web site, HealthHombre (healthhombre.com). Mannen has advised a large number of device and diagnostics companies on introduction of new health care technologies into reimbursed markets.

Daniel McLain, PhD, CNS, DABFE, cofounder and president of Walker Downey & Associates Inc.

Daniel McLain is cofounder and president of Walker Downey & Associates Inc., an evidence-based product safety and development consulting firm located in the heart of the third coast scientific and biotechnology community—Madison, WI. He received his PhD in nutritional toxicology and preventive medicine from Cornell University (Ithaca, NY). McLain has more than 25 years of experience in toxicology, drug and device development, vaccine development, statistics, and risk assessment. He has specific expertise in medical device material biocompatibility, immunotoxicology, and developmental and reproductive toxicity (DART). He is the the current convener of ISO 10993—Biological Evaluation of Medical Devices—Part 11: Systemic Toxicity Evaluation. He has contributed to and has meaningful personal experience with IND, BLA, 510(k), GTAC, and CTD preparation. He is experienced with the design, conduct, analysis, and reporting of preclinical safety and pharmacokinetic studies for drugs, devices, biologics, and combination products, as well as with the international regulatory submissions associated with them. McLain is a Diplomate and Fellow of the American College of Forensic Examiners (DABFE, Toxicology) and the American College of Nutrition (FACN), and is a board-certified nutrition specialist (CNS). Additionally, he is an active and contributing member of the Society of Toxicology (25-years), the Regulatory Affairs Professional Society (16-years), ISO/AAMI (13-years), and the American Society for Quality (13-years).

Christopher D. Roberts PhD MBA, Head of Clinical Support, International, Smith and Nephew Wound Management

Christopher D. Roberts PhD MBA is head of clinical support, international for Smith and Nephew Wound Management. He is a trained medical microbiologist and served as VP of Global Clinical Research at Smith and Nephew Wound Management for more than 20 years. He has taken on a specialist role to support the international sales teams, ensuring clinical and scientific evidence is understood and aligned appropriately. He has a keen interest in the role of topical antibacterials for management of infected or at-risk wounds, the use of topical wound coverings in burn wound management, and tissue engineering. Roberts has presented at many global wound-healing events and has published a number of articles in peer-reviewed journals. He was presented with a lifetime achievement award at the World Union of Wound Healing Societies Toronto in June 2008.

RPI graduates, founded Ecovative Design LLC, which will begin volume manufacturing of its organic insulation and packaging materials.

The association added a new extension to the Cardiovascular Module, which includes information for all FDA classifications of catheters and other related interventional devices.

Characterization, numerical information and links to specific devices have also been completed for 16 materials in the Orthopaedic Module, with bioresponse information added for Polylactic Acid/Hydroxyapatite (HAPLA). In addition, 80 new producers have been added with links to specific devices.

Comprehensive reviews of the literature concerning biocompatibility of candidate materials and coatings are peer-reviewed by 75 industry experts. The database continues to expand into materials for neurological and dental applications, as well as additional content for cardiovascular and orthopaedic applications.

The translucent substance enables the claw tips of certain crabs as the pincers pick and hold prey. It also is present on the walking legs of some crabs. The biomaterial can bend six times further before breaking than the rest of the crab’s body materials.

The material is also present in small insects, because small parts are more at risk for fracture that large ones. And because the material is used in small organisms, the researchers hope it could be used in the engineering of microsized machines and tools.