TransEnterix Inc (NYSEAMERICAN: TRXC) is having an overwhelmingly strong start to the trading session this morning after the company announced that it has filed a 510(k) submission with the FDA. Of course, the news excited investors who are sending the stock up. Today, we’ll talk about:
- The FDA submission;
- what we’re seeing from TRXC as a result; and
- what we’ll be watching for with regard to the stock ahead.
TRXC Announces Regulatory Update
As mentioned above, TransEnterix is having an overwhelmingly strong start to the trading session this morning after the company announced a regulatory update. In a press release issued early this morning, the company said that it has filed a 510(k) submission with the FDA surrounding its Senhance Ultrasonic Instrument System.
TRXC said that advanced energy devices, including ultrasonic devices, are some of the most versatile and critical tools for surgeons in minimally invasive surgery. By delivering controlled energy these devices effectively ligate and divide tissue, minimizing thermal injury to surrounding structures. In a statement, Todd M. Pope, CEO at TRXC, had the following to offer:
Advanced energy devices are an important tool within laparoscopic surgery because of their applicability within a wide range of procedures… Once approved, we believe the addition of the Senhance Ultrasonic will be a useful tool for surgeons and help drive broader penetration of Senhance and help advance digital laparoscopy in the U.S.
The above statement was followed up by Dr. Guy Orangio, FACS, FASCRS, Chief of the Section of Colorectal Surgery at LSU Health NEw Orleans and Past President of the American Society of Colon and Rectal Surgeons. Here’s what he had to offer:
Advanced energy devices, such as the one now developed for Senhance, represent the most common tools that surgeons utilize when performing challenging tissue dissections… Adding such capability to a digital laparoscopic platform will further enable wide clinical use.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of TRXC, the news proved to be overwhelmingly positive. With 501(k) submission, the company has taken a big step toward the approval and commercialization of Senhance. So, it comes as no surprise that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:54), TRXC is trading at $5.86 per share after a gain of $0.18 per share or 3.17% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TRXC. In particular, we’re interested in following the story surrounding the company’s 501(k) submission and its Senhance system. Noneheless, we’ll continue to follow the story closely and bring the nws to you as it breaks!
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