Transenterix Inc (NYSEAMERICAN: TRXC) is climbing in the market this morning after announcing that it has filed an FDA 510(k) submission. Of course, if the submission is approved, it will lead to an opportunity to expand revenue, leading to excitement among investors and sending the stock on a run for the top. 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 Heads For The Top On FDA Submission
As mentioned above, TransEnterix is having an incredibly strong start to the trading session this morning after the company announced that it has filed a new FDA 410(k) submission. In a press release issued early this morning, the company announced that it has filed the submission for additional Senhance System instruments, including 3 millimeter diameter instruments. If approved, TRXC says that these instruments would allow the Senhance system to be used for microlaparoscopic surgeries, allowing surgeions to make tiny incisions that are deemed virtually scarless for patients.
Currently, the Senhance system is cleared in the United States for laparoscopic colorectal, genecologic, inguinal hernia and cholecystectomy surgery. In a statement, Todd M. Pope, CEO at TRXC, had the following to offer:
TransEnterix is the first company to seek FDA clearance for robotically-driven 3 millimeter instruments for abdominal surgery in the U.S… We believe Senhance robotic assistance can enable surgeons to expand their use of virtually scarless surgery in more patients, and expands the value that robotics can bring over traditional manual approaches.
The above statement was followed up by Dr. Steven D. McCarus, MD, FACOG, Chief of Gynecologic Surgery at Florida Hosptial Celebration Health. Here’s what he had to offer:
Microlaparoscopy is the current frontier in the process of reducing invasiveness, pain, scarring and opioid use post-surgery… With Senhance, robotic microlaparoscopic surgery is a reality, bringing precision, control and sensitive force feedback to the use of these tiny surgical instruments. Surgeons have not had the ability to use such small instruments with a robotic surgical platform before, and this offers patients an attractive, virtually scarless approach to many surgeries.
What We’re Seeing From The Stock
One of the first things that we learn when we start to dabble in the market is that the news causes moves. In the case of Transenterix, the news released by the company proved to be overwhelmingly positive. After all, if approved, this submission could unlock a solid stream of revenue. So, it’s no surprise to see that investors are excited and sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (10:08), TRXC is trading at $3.62 per share after a gain of $0.23 per share or 6.94% 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 Senhance system and excited to see the results of the new 510(k) submission. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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