FDA approval for a medtech company’s first product is often a precursor to a takeover, but it can also presage a float. Israeli-US company ReWalk Robotics has filed for a $57.5m Nasdaq IPO a fortnight after obtaining US de novo approval of its powered exoskeleton for spinal cord injury patients’ personal use.
Speaking to EP Vantage on Monday regarding the FDA approval, and before the company filed for its IPO, ReWalk’s chief executive Larry Jasinski said: “Right now, with our approval and some recent success in reimbursement we think we have the space to build a standalone company for a while.”
However, Mr Jasinski also acknowledged that an acquisition of a company with such new technology might be risky for a larger company. Perhaps ReWalk had to take the IPO route – traditionally regarded as the second-best outcome for medtech VCs – because it was unable to find a buyer.
In its SEC filing, the company said that its 2013 revenue was $1.6m, a 65% increase from 2012, though net losses widened to $12.2m from $6.7m a year before.
At least five companies are developing robotic exo-suits of this nature, though the technology varies considerably, as does the cost. Most are aimed at paraplegic patients who have suffered spinal cord injuries. Patients with this form of paralysis have been shown to suffer fewer infections and other complications such as muscle wastage if they stand for an hour each day. Most patients use a standing frame to achieve this, but exoskeleton developers believe that their devices are a better proposition.
At prices of up to $150,000 – though ReWalk’s is at the cheaper end at just $69,500 – they had better be. ReWalk has had some success getting its system reimbursed in Europe, where it has been sold since 2012, and will have to achieve the same on a widespread scale in the US.
ReWalk’s new approval covers a model intended for everyday use by patients; it already sells a slightly different device to rehabilitation facilities.
The company’s backers include Israel HealthCare Ventures, Pontifax and Japanese robotics company Yaskawa Electric, which Mr Jasinski says is the largest manufacturer of robots in the world. “They are a strategic investor in our company, and they also have distribution of products in Asia. They’re a very significant partner for us as they’re building a fairly large organisation over there,” he says.
The company has not said how many shares it will offer or given pricing details, but there is an awful lot of buzz around these technologies and there is a good chance that the offering will appeal to shareholders; the technology is pleasingly reminiscent of science fiction.
ReWalk plans to put its IPO funds towards sales and marketing efforts as well as developing the device for new indications, perhaps by developing new models. There was also a suggestion that it might acquire or invest in other technologies in the future. The company seems as intent on an independent future as the patients it seeks to treat.