Wright Medical Group scored US premarket approval for the initial version of its biologic bone filler Augment three years ago, but it has only now scored the real prize: approval of the injectable form.
This ought to put a rocket under the Memphis, Tennessee group’s bone filler sales. But analysts have been oddly reluctant to make pronouncements about the new product’s likely value, and though Wright’s shares jumped 5% yesterday it is unclear how much this will change the company or the competitive landscape.
Augment is a biological bone graft used to fill bone defects in ankle or hindfoot fusion procedures. Such grafts are viewed as an improvement on the alternative, autografts, since they eliminate the need for a separate operation to harvest bone for grafting. This means less pain and inconvenience for patients, and lower costs to payers thanks to shorter hospital stays.
The product incorporates recombinant human platelet derived growth factor and a blend of collagen and β-tri-calcium phosphate, biologicals that encourage the regrowth of the patient’s own bone.
The original form of the graft, approved in 2018, came in two parts – a cup containing the β-tri-calcium phosphate granules and a vial containing the growth factor solution – that had to be mixed by the surgeon at least 10 minutes before its introduction to the graft site. Augment Injectable is pre-mixed, and should be much easier for surgeons to use; Wright says it is the first clinically proven injectable protein therapeutic to be approved for ankle or hindfoot fusions.
Second approval, second place
Naturally the new form will cannibalise sales of the old, which are forecast to reach around $43m globally this year, according to EvaluateMedtech’s consensus of sellside estimates. But it could also push Wright’s total sales skywards; writing in February analysts from BMO Capital Markets said FDA approval of Augment Injectable should revitalise sales growth in Wright’s biologicals segment.
Few have been willing to make any sales forecasts for Augment Injectable itself. Guggenheim analysts, for example, have said that the product could be “a needle-mover” for Wright’s biologicals franchise, but added that the lack of visibility into its approval prospects made assigning a value to it challenging.
Of the companies developing and selling bone fillers Wright is forecast to be the fastest growing, at a rate of 13% a year out to 2024.
Even so, it cannot hope to take on Medtronic, which has annual bone filler sales of more than half a billion dollars. Wright says the market for Augment Injectable is $300m each year, but forecasts are less than a third of this. Perhaps the new approval will prompt analysts to revise their estimates – but Wright has little chance of toppling the leader.
|The bone filler market|
|Forecast global sales ($m)|
|Augment||Wright Medical Group||43||58||74||91||+13%|