What: Anticipating a FDA decision that could have allowed it to begin marketing its SurgiBot robotic surgery system in the United States, investors propelled shares in TransEnterix, (NYSEMKT:TRXC) 51.2% higher last month, according to data from S&P Global Market Intelligence.
So what: TransEnterix is eagerly awaiting a FDA decision on SurgiBot and it had previously indicated that it expected a decision on approval from regulators before the end of March.
However, last week management reported via a filing with the SEC that it was pushing back its timeline for a FDA ruling until April.
Despite the setback, TransEnterix' shares have continued to gain ground this month, probably due to hope that a temporary delay won't significantly derail management's plans to launch SurgiBot and challenge market share leader Intuitive Surgical's (NASDAQ:ISRG).
Intuitive Surgical markets the da Vinci surgical system globally and last year, sales of systems and the consumables used in them totaled $2.3 billion.
Now what: Assuming no further delays from the FDA, investors should get insight into SurgiBot's market potential within a quarter or two. TransEnterix has hired former sales leaders from Intuitive Surgical to spearhead its launch and the SurgiBot could have intriguing advantages over the da Vinci that allows it to establish a foothold.
Notably, the SurgiBot is a mobile system that can be moved from operating room to operating room. It also features haptic feedback, which surgeons may prefer, and an articulating camera. Importantly, management is pricing SurgiBot at roughly a third of the cost of the average da Vinci system.
Although there's no guarantee that the FDA will approve SurgiBot or that hospitals will line up to buy it, the market for robotic surgery is growing rapidly and it's ripe for disruption. Investors, however, might want to temper some of their enthusiasm because the company is a bit cash strapped and therefore, it will rely heavily on a successful SurgiBot roll-out.