A new long-term clinical study sponsored by Medtronic aims to expand the use of the company’s flagship orthobiologic product, INFUSE Bone Graft, into two new spinal indications: posterolateral fusion (PLF) and transforaminal lumbar interbody fusion (TLIF). The proposed global ten-year study, called B.O.N.E. (BMP Outcomes and New Evidence in PLF and TLIF Procedures), will begin with two pilot dosing studies, one each for PLF and TLIF patients. If successful, the pilot studies are expected to be followed by larger pivotal studies for each indication.

The road to this new clinical study has been long and bumpy for Medtronic. INFUSE, a recombinant human bone morphogenetic protein-2 (rhBMP-2) product, was approved by the FDA in 2002 for use in anterior lumbar interbody fusion (ALIF) procedures. Despite initial acclaim and widespread adoption in the US, much of it off-label, potential risks involved with the use of INFUSE have threated the product’s continued adoption and growth.

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INFUSE first came under fire in June 2011 when Spine Journal revealed that Medtronic paid millions in consulting fees to medical authors in exchange for underreporting complications and emphasising benefits in INFUSE’s previously published clinical trials. Following this revelation, Medtronic commissioned Yale University in August 2011 to conduct an independent review of data related to the safety and effectiveness of INFUSE. In June 2013, the Yale University Open Data Access (YODA) Project’s two independent groups suggested that the Medtronic-associated studies misrepresented efficacy and underreported complications for both on-label and off-label indications, and selected analyses and results that favored rhBMP-2—the key element to INFUSE—compared with iliac crest bone graft for lumbar spinal fusion.

In April 2016, the company again faced backlash after an article was published in the Minneapolis Star Tribune criticizing Medtronic’s handling of data collected during a retrospective chart review of INFUSE between 2006—2008. Additionally, shipments of INFUSE were on hold in Europe, where the product is called InductOs, after the European Medicines Agency (EMA) called for the product’s marketing authorisation to be suspended in late 2015. The shipping was expected to resume in mid-FY2018.

This onslaught of negative press contributed to declining revenues for INFUSE, causing a challenge for Medtronic. The lengthy and costly process to obtain regulatory and reimbursement approval for a novel device can be crippling for device companies, even large players such as Medtronic. After such a consuming process, many companies can’t afford to abandon a product that doesn’t perform as expected.

In order to move forward, Medtronic has made it a priority to focus on expanding the clinical indications for INFUSE in the US. Through updated research and improved data displaying the BMP product’s safety and efficacy in a greater number of spinal procedures, Medtronic hopes to improve physician usage of the product and restore INFUSE’s place as a leader in the biologics market. In late 2015, positive data led to FDA approval for three additional spinal surgery indications for the INFUSE bone graft. Additionally, favorable data from Medtronic demonstrating successful spinal fusion with no cancer risk were published. Through the newly announced B.O.N.E. study, Medtronic is again pushing to expand the number of indications for INFUSE for less off-label product use and improved physician confidence.

However, despite this recent turnaround and moderate market growth for Medtronic’s INFUSE, GlobalData expects the use of lower-priced products such as demineralised bone matrices (DBM) and synthetic bone graft substitutes, which emerged as the negative press for INFUSE swirled, to grow through the forecast period while the market for BMP products remains stagnant. Improved physician and public perception of INFUSE will recuperate Medtronic’s image in the biologics space, but GlobalData believes the product will likely not attain the market dominance it once held.