8/16/12

Chronic Low back Pain: Wonder product that promotes bone fusions in spine surgeries

Frost & Sullivan Market Insight

Published: 18 Nov 2003

Chronic Low back Pain: Wonder product that promotes bone fusions in spine surgeries
Date Published: 18 Nov 2003

By Balaji Ramamurti, Industry Analyst (Medical Devices) It has been estimated that 60%-80% of the Americans will experience an episode of disabling low back pain at least once in their lifetime. Also 10%-20% of the population suffer from low back pain every year, of whom 90% recover within 6 weeks. There are many causes for this low back pain, including, herniated discs, trauma, osteoporosis, tumors and other mechanical factors. The condition costs the economy about $60 billion due to lost work, medical costs and rehabilitation. Acute or short term back pain does not last for more than few weeks. Usually, the cause of this pain is more mechanical in nature, such as, sports or domestic chores. The acute back pain if left untreated can lead to more serious condition. Chronic back pain lasts for more than 3 months and the causative factor is more difficult to detect. Non-operative therapeutic options for patients suffering from back and neck pain include rest, heat, analgesics and physiotherapy. If these treatments fail, then the surgical treatments include relieving the pressure (decompression) on the spinal cord or nerve root with or without "welding" or causing "fusion" between two adjacent "back bones" (vertebral bodies). Fusion surgery of the spine involves permanently immobilizing two vertebral bodies with respect to each other, by immobilizing them with implants and promoting bone growth between them. Instrumented fusion restores the spine anatomy, stabilizes the spine, and preserves disk space from collapsing. Spine surgery involving fusions is becoming more frequent in the US and around the world. Spine fusion achieved through bone growth involves the same physiologic process of fracture healing between broken bones. During fracture healing in the body, a cocktail of several proteins called "growth factors" are released at the fracture site. Bone morphogenetic protein (BMP) is a family of growth factors that is a part of this cocktail. The effect of these growth factors is to transform the stem cells in the bone marrow and the surrounding tissues into bone precursor cells. There are more than 10 members of the BMP family. Two groups of researchers working at the Creative Biomolecules (now Curis Inc.) and the Genetics Institute (now Wyeth) deduced the gene sequence of the various BMPs, which facilitated the mass production of human BMPs. As of October, 2003, there are two BMP products approved by the US Food and Drug Administration (FDA) and commercially available in the US market. The product from Medtronic, Memphis, TN is sold under the commercial name "Infuse". It consists of a collagen sponge soaked in a specific protein called BMP-2 (Fig.1). It is indicated for use in low-back fusion surgeries. The results of the clinical study indicated that the fusion rate of the patients with the Infuse was equivalent to those of the patients who received bone graft from their own body (autograft) harvested from the pelvic bone. Also the patients who received the Infuse had shorter operating time, lower blood loss, and did not experience hip pain since they avoided harvest of autograft from the pelvis. The second product is from Stryker Biotech, Hopkinton, MA is "OP-1", which is the commercial name for BMP-7, another member of the BMP family. The FDA has not yet approved OP-1 for spine procedures. Currently, OP-1 is being used for long bone fractures only. Another major spine company DePuy Acromed (a Johnson & Johnson company) located in Raynham, MA is planning to market MP52 (BMP-14) acquired from Biopharm, Germany for spine and trauma use. Such BMP products are a boon for spine fusion surgeries where the incidences of fusion failure is as
www.frost.com.libproxy.mit.edu/prod/servlet/market-insight-print.pag?docid=8190004 1/2

8/16/12

Chronic Low back Pain: Wonder product that promotes bone fusions in spine surgeries

high as 30%-50%. But it comes with a price. For example, a single dose of Infuse costs about $4000 dollars, and two doses are required to fuse a single spine level. The high price is due to a combination of high manufacturing costs, royalties and premium attached to new technology. The Medicare reimburses only 50% of the cost and the insurance companies have differing policies about reimbursement. The surgeons are also wary of widely using the product due to the cost. Although the BMP product "Infuse" is indicated for lower back using a specific surgical technique, in future it can be expected to expand the indications of BMP products for other parts of the spine and for other surgical approaches, too. Eliminating the price factor, we can expect to see the BMPs playing a major role in spine fusion procedures in the future. Surgeons say that even with the advent of "nonfusion" technologies, such as, artificial discs, spine fusion procedures are here to stay. Frost & Sullivan will be soon publishing a report on BMPs titled "Bone Morphogenic Proteins in Spine Fusion Market (US and Asia)". The report number is A640.
BA CK TO TOP RETURN

www.frost.com.libproxy.mit.edu/prod/servlet/market-insight-print.pag?docid=8190004

2/2