TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round

TransEnterix (NYSE:TRXC) said today that it filed an application with the FDA seeking 510(k) clearance for its Senhance robot-assisted surgery platform and priced a $24.9 million funding round.

The application is a huge step forward for the company, CEO Todd Pope told MassDevice.com today in a telephone interview.

“The most important milestone that we’ve hit now is that we have filed our FDA 510(k) submission with the FDA, and we wanted to make sure we have enough cash to get all the way through submission, acceptance and a launch here in the U.S.,” Pope told us.

Pope said he’s hopeful the company’s application will be approved within 6 months, although he offered that the timeframe relies on some back-and-forth with the FDA and could be shorter or longer.

“It’s great that we’ve filed with the FDA, and it’s great that we now have cash to fund our operations well beyond the response back from the FDA and our launch here in the U.S.,” he said.

The system has also seen some significant upgrades in the past few months, Pope added, as the company made the system compatible with both Stryker (NYSE:SYK) and Novadaq vision systems.

“We are now compatible with 2 of the leading vision systems on the market today – Stryker and the Novadaq systems. Both of those are now compatible with our Senhance robot, and that’s a big move forward for the industry. Instead of a closed system, it’s more open architecture to allow hospitals and surgeons to use those vision systems in conjunction with the Senhance,” he explained.

Pope said the entry was exciting for the company – and for the American medical device industry, which hasn’t seen another robotic system cleared for the Senhance’s applications in almost 20 years.

“There hasn’t been another robot in the U.S. market since the late 1990s for the applications, so the market is very excited. In medtech you won’t find another category that hasn’t had a 2nd entrance in 18 years, so that’s exciting. We feel close now and I think that’ll be a great thing for the market,” he said.

TransEnterix plans to offer units consisting of 1 share of common stock, 1 Series A warrant to purchase another share of common stock and 1 Series B warrant to purchase 0.75 shares of common stock at $1 apiece.

Series A warrants in the round will be exercisable at any time after issuance and usable up to 1 year, with the caveat that the units will expire within 10 days if the company receives FDA 510(k) clearance. Series B warrants in the round will be exercisable from the date of issuance through 5 years, the company said.

“The Series A will allow us, within those 10 days of FDA approval, to raise upwards of another $24.9 million,” Pope told us, adding that he plans to reveal more developments during the company’s earnings report release, scheduled for May 10.

Stifel is acting as the sole book-running manager for the offering, which is slated to close on or about May 3, according to a press release.

TRNX shares were off -37.2% to 68.5¢ each today in mid-afternoon trading.