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advances in spinal technologies: an asian perspective

1 July 2008

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advances in spinal technologies: an asian perspective Arpita Halgeri The spinal implant market in Asia has been growing at a rate of 20% every year on average and promises greater growth in the coming years. Main drivers of growth are increased awareness of spinal disorder treatments, an increased GDP leading to higher government and patient spending power, increased usage of motor vehicles and machinery leading to rising number of trauma surgeries and lastly, an increase in obesity leading to back problems and injuries among the middle to high social class. On the research front, many western companies are collaborating with Asian academic institutions, especially in Japan, Korea and Singapore to design products catering specifically to the Asian patients’ and surgeons’ needs. Innovative products from the west are being tested and accepted in Asia as more and more hospitals look for a competitive edge over the others. A few local implant manufacturers are starting to manufacture higher end, sophisticated implants but 95% of the advanced technologies in Asia are provided for by the large multinational companies like Stryker, J&J and Medtronic. However, there are many challenges that face companies trying to introduce new technologies into Asia. This paper will first cover high-growth spinal technologies that are taking off here and then discuss some of the challenges that will face companies in this space. Innovation Over the last few years, there have been significant improvements in spinal products and technologies. The need for less invasive surgeries, better patient outcomes and need to maintain mobility and curvature of the spine after surgery are driving companies to come up with novel procedures and products. The technologies leading the scene in Asia are minimally invasive procedures, non-fusion motion preservation devices, bone growth factors and biologics. MIS Minimally invasive surgery (MIS) has revolutionized many surgical procedures, including spinal surgery. A traditional open surgery involves a 6 to 10 inch incision that gives surgeons a good view of the area surrounding the joint. It however also results in severed muscles, blood vessels and nerves in that area. MIS involves making only a small incision, around 3 to 4 inches wide. Since the area the surgeons operate in is much lesser, sophisticated tools and electronics are needed to ensure that the quality of the surgery is not compromised. A MIS procedure requires an endoscope, a thin, telescope-like instrument, which is inserted through a small opening or incision. At the end of the endoscope is a small camera the size of a dime, which provides surgeons

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with a close-up view of the internal systems via television screens. Small surgical instruments are inserted through other incisions. The aim is for better placement and for surgical accuracy and precision. In Asia, MIS has caught on especially in countries like Japan, Singapore and Korea. In Japan, hospitals are embracing technologies that lead to faster turn around time in view of the aging population crisis. Patients that are post-MIS recover 3 times faster than patients that have undergone normal surgery allowing hospitals to cater to the masses without compromising on quality. In Singapore, all hospitals are using MIS procedures for spinal surgery. Apart from high-cost of living and increased spending power of patients, Singapore also gets a flurry of wealthy patients from Indonesia, Malaysia and other parts of Asia in search of first-class healthcare. In countries like India and China, select private hospitals that make up around 5% of all hospitals incorporate MIS in their surgical procedures. Going forward, more and more hospitals will incorporate the minimally invasive approach. With the innovation of better optics and video equipment, retractor and instrumentation systems, image-guided systems, and new biological agents, most of the traditional "open" spine procedures will be slowly replaced by MIS procedures over the next 5 years driven by faster discharge time and reduced pain for the patient. Non-Fusion Technologies Recently there has been an explosion of new motion preservation techniques and devices available for spine surgery in Asia. (e.g., Next -generation prosthetic discs have been introduced by Scient’X, Axiomed, and Aesculap. Many companies, such as Paradigm Spine, Impliant, Neuro France Implants, Abbott, St. Francis Medical Technologie, have brought out dynamic stabilization devices) They pose a better alternative to spinal fusion. Local companies like A-spine in Taiwan are also developing Non-Fusion products catering to the Asian patients. Patients from Asia have smaller body frames and hence require smaller implants. Dynamic stabilization devices treat pain caused by both degenerative disc and facet disease by supporting and limiting the motion around the painful segment. These devices are best suited for younger patients as they maintain flexion and extension. It is not a good suggestion for patients who are older, have osteoporotic bones, or whose bones have fused on their own with aging and do not have flexible backs. The treatment has high success in treating back pain, mostly discogenic (pain due to disc degeneration) back pain. Another positive aspect is that if these devices fail to support a diseased and degenerated lumbar spine, the patient and physician continue to have the surgical option of a lumbar fusion. Disc and nucleus replacement techniques differ from dynamic stabilization in that they replace a component of the motion segment.

Biologics A type of material that is increasingly being used in this region during spine surgery is bone grafts (autologous bone and/or allograft) or bone graft complements such as demineralized bone matrix. Advances in molecular biology have made available

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genetically engineered BMPs that can be placed inside a collagen (protein) sponge (Medtronic with Infuse bone graft) or other ceramic type implants and used instead of bone in areas of desired fusion. Other materials such as ceramic and carbon fiber have been used as carriers of bone graft or vertebral body replacements. Due to the potential morbidity of using a patient's own bone and the limited supply of cadaveric bone, attention has been directed toward developing newer materials such as plastics and polymers (polylactic acid) to serve as spacers and conduits for bone graft material. There is always the challenge that the materials to be implanted in the human body should be safe without causing allergic reactions or damaging other parts of the spine. Moreover, there are varying views between patients and surgeons about the X-ray visibility of the metallic parts in the body. While patients are hesitant about seeing the metallic parts in their body on an X-ray or other imaging tests, the surgeons feel it would be ideal if the implants were made of a material that could easily be seen, which would make it easier to monitor the effectiveness of the artificial disc over time. The market for biomaterials and spinal implants will always have a proportional growth in Asia as one can observe a competitive landscape with products that are more biodurable and made up of biocompatible materials.

Restraints Companies introducing new technologies to countries like China, Japan, Australia and Taiwan will need to account 1-2 years for clinical trials and regulatory approval of Spinal implants that would mostly fall into Class 3 products. In China however, pre-existing companies can introduce new products without undergoing clinical trials. Reimbursement is another concern in Asia, with many countries like China, Australia and Japan having strict pricing policies for various medical products. Products intended for similar use, irrespective of the innovation in them, are fixed at a particular rate by certain governments. New products that do not have already existing counter parts need to prove efficiency or efficacy over the already existing products to command a higher price. This is proving to be the biggest challenge thus far in Asia as governments are compelled to cut reimbursement rates drastically owing to the rise in healthcare compensation and deficits. This also limits the use of certain innovative technologies being brought into those countries where such policies are applicable. Lastly, a large percentage of the patient population is apprehensive about the new technologies being used on it. In Asia, many patients' decisions are influenced by information provided by their peers. This type of information highlights the risks, while downplaying the significant benefits of technology.

These recent developments raise the following questions:

� Will China and India be the next growth frontier for the adoption of innovative spinal technologies?

� Will Asia produce its own innovative spinal implant products? Which country will lead this push?

� What is the best method to raise awareness and increase adoption of innovative surgical technologies in Asia?

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Arpita Halgeri is an analyst at Clearstate. You may contact the author via email at: thinking@clearstate.com

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