Morrisville surgical device maker TransEnterix plans to focus on getting its ALF-X robot approved in the United States, but the company has not given up on its goal of winning regulatory approval for its SurgiBot robot.
TransEnterix executives provided the update in a Friday conference call with Wall Street analysts when discussing the company’s second-quarter earnings. TransEnterix is seeking to break into a global surgical robotics market that has been dominated by a single product, the da Vinci model, for the past 15 years.
TransEnterix CEO Todd Pope told analysts that his company represents the first serious competition in the surgical robotics field, having recently sold its first ALF-X robot in Italy. TransEnterix is courting numerous hospitals in Europe, Asia and the Middle East to buy the machine, which costs between $1.5 million and $2 million.
“There’s a company out there that’s not had competition since the beginning of their organization, and they’re reacting as you would expect,” Pope said. “It’s a big market, it’s a growing market, and us being the first company in the world in this space to have another approved robot, it’s got their full attention.”
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TransEnterix has met three times with Food and Drug Administration officials to discuss the FDA’s April decision not to approve the SurgiBot product in this country. Company executives believe that SurgiBot has the potential of meeting FDA safety standards, but the company has now shifted its focus to submitting an application for the ALF-X.
The ALF-X is already approved for use in Europe and the first one was recently purchased by an Italian hospital.
“I’ve had numerous hospital executives and surgeons tell me they are thrilled to finally have a choice in robotics that delivers meaningful clinical benefits with responsible economics,” Pope said.
“I personally spent most of the past month in the field in Europe, meeting key pipeline accounts, observing surgery and talking to surgeons and hospital administrators,” Pope said. “I came away from my time in the European market even more confident than ever about the value proposition of the ALF-X, and in our ability to be successful in the market.”
TransEnterix reported a net loss of $80.1 million in the second quarter, compared to a net loss of $9.3 million a year ago. However, $61.8 million of the second quarter net loss was an accounting adjustment of “goodwill impairment.” The company said it had to write down non-cash losses to intangible assets largely stemming from the FDA’s decision not to approve SurgiBot.
TransEnterix shares traded at $1.47 in mid-morning trading, down from a high of $5.69 in April.
The 100-plus employee company has about 75 workers in Morrisville.