Updated
Working prototype
Note
5 units soldNote
As alluded, TransEnterix announced that the FDA approved the expanded indications for Senhance on May 29, 2018. The mentioned regulatory catalyst is the 510(k) clearance for Senhance to be used in the laparoscopic inguinal hernia and cholecystectomy (gallbladder removal) procedures. In the US, there are correspondingly 760.0K and 1.2M inguinal hernia repairs and gallbladder removals performed each year. It’s interesting to note that the approval will double the potential annual procedures to approximately 3M, thereby leading to more Senhance sales). Delighted by the said development, the President and CEO (Todd Pope) stated:This indication expansion immediately doubles the addressable market for Senhance in the US and validates our regulatory strategy to successfully add to our indications for use. These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.
Of note, we stated in the prior research that there are significant challenges in selling a medical device (especially one with a 7-figure price tag). It’s unlikely for a hospital administrator to purchase a new device that costs them millions of dollars. Hence, strong competitive moats are needed to close the sales. We noted in the prior research:
First, the sales professionals have to be quite knowledgeable, convincing, and experienced. Second, the new device has to be cost-efficient. Third (and most important), the new product has to fit within the existing operating structure: a hospital is unlikely to invest in more instruments (or those incompatible pieces) which incur additional costs. Interestingly, Senhance is overcoming all stated barriers. As follows, the said robot employs an “open architecture,” which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. For instance, Senhance is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments. It’s highly likely that this moat was what enabled TransEnterix to disrupt the market shares of the reigning champion, da Vinci.
As presented, TransEnterix has no problem in selling Senhance. The initial approval for minimally invasive laparoscopic procedures (colorectal and gynecologic) is now expanded to cover inguinal hernia and gallbladder surgeries: they are some of the most common abdominal operations. It is evident that Senhance is gaining traction to service a larger market. Taken altogether, it is most likely revenues will ramp up drastically in the next few quarters. Commenting on the quality and applicability of Senhance, the Chief of Surgery at St. Marien Hospital in Siegen, Germany (Dr. rank Willeke) shared:
We have utilized Senhance broadly across a wide range of general surgery, upper GI surgery, and colorectal procedures at our institution. We believe this procedural expansion for the US will allow surgeons there to incorporate the Senhance, as we have, as a highly-efficient, enabling and very promising technology that can impact the vast majority of surgeries commonly performed by general surgeons and their sub-specialties.
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Disclaimer
The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.