On August 13, Concept Medical was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for below-the-knee (BTK) use of its MagicTouch drug-coated balloon catheter (DCB) for the treatment of peripheral artery disease (PAD).

In the US, there are currently three FDA drug-coated balloons approved for treating above-the-knee PAD: Medtronic’s IN.PACT Admiral, Becton Dickinson’s Lutonix, and Philips’ Stellarex. Despite the heightened caution surrounding paclitaxel-coated devices, there is still a large unmet need for BTK DCB interventions for high-risk patients who may require the benefits of drug-coated devices, such as limiting the blockage or re-growth of plaques post-intervention, thereby limiting the need for re-intervention.

Recognising that this is a market with great potential and no current competition, companies are racing to enter and monopolise the US BTK DCB market. Earlier in the week, the FDA denied Becton Dickinson’s premarket approval (PMA) for BTK use of Lutonix. Breakthrough therapy designation can expedite market access through priority review, and allow companies to work closely with the FDA to receive additional review resources. If Concept Medical is the first company to receive approval for BTK DCB use, it would not only monopolise the large, untapped market, but could potentially steal market share from Medtronic, Philips, and Becton Dickinson in the DCB space.

Additionally, with a new type of balloon on the market for patients with BTK PAD, Concept Medical could take a portion of the patient pool that is currently only treated with regular balloons, taking market share from major manufacturers in that space as well.

Concept Medical is positioned to potentially disrupt this market and become a threat to larger manufacturers who have an established presence in the peripheral space. However, as it is a smaller company in a market dominated by major manufacturers with large device portfolios, Concept Medical will also be a target for acquisition.

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