RESEARCH TRIANGLE PARK  — As technology continues to alter the global market, a Research Triangle Park-based medical devices company believes it will pioneer a shift in the future of health care: robotic surgery.

Various regulatory approvals and a recent quarterly report showing 2,863 percent growth in revenue over the year have evidenced the potential behind Transenterix Inc.’s vision. In mid-November, Transenterix announced that it had been named to Deloitte’s 2018 Technology Fast 500 list.

Time magazine selected Todd Pope, the company’s CEO and president, as a member of its inaugural 50 Most Influential People in Health Care list this year.

Todd Pope

Transenterix’s profitability plan rests firmly on increasing the footprint of its Senhance Surgical System, a device that would look natural in a scene from “Star Wars” or “Alien.”

“We call the product Senhance because it enhances the surgeon’s senses,” said Pope. “It doesn’t replace them. It allows them to be steady. It allows them to be more precise. It allows them to reach areas they couldn’t reach prior. It allows them to see in areas with better vision than they’ve ever been able to see.”

In 2015, Transenterix acquired the system that would become Senhance from SOFAR SpA, a medical devices company based in Trezzano Rosa, Italy. The cash and stock deal, valued at $99.8 million, comprised SOFAR’s surgical robotics division.

“We believe we’ve created a disruptive surgical robotics company,” Pope told analysts in a conference call after the acquisition.

TransEnterix

Senhance allows surgeons to perform an entire operation while seated at a console across the room from a patient’s bed. The surgery itself is done by a multi-port robotic system – controlled remotely by the surgeon – with multiple arms that utilize instruments and a camera.

Benefits that robotics provide to surgeons, Pope said, include the ability to see in 3D throughout the operation and avoid fatigue from standing up for long periods of time.

The system performs minimally invasive operations, a surgical technique of making small incisions to reduce things such as surgery recovery time and pain for patients when compared to more traditional open surgery approaches. Senhance concentrates only on soft tissue operations in the abdominal cavity down to the pelvis, like gynecological and colorectal surgeries.

Todd Pope, CEO of Transenterix
While previous devices proved unreliable as primary sources of revenue for Transenterix, which was founded in 2006, Senhance began showing viability as a central platform for the company over the last couple years.

In fiscal 2016, the company sold one Senhance system for $1.5 million. The following year, Senhance sales rose to four systems, bringing in $7.1 million.

Through the first three quarters of the current fiscal year, Transenterix had already brought in revenue of $16.6 million, a 133.8 percent improvement on sales for the entirety of last year. The company sold 10 Senhance systems in those quarters. One of the sales went to the Magee-Women’s Hospital of the University of Pittsburgh Medical Center, a $19 billion revenue health care provider.

In a November conference call, Pope said two more orders had already been made during the current quarter. The company provided fourth quarter guidance of four or five total Senhance sales, expected to boost Transenterix’s full-year revenue to between $23 million and $24.4 million.

Transenterix missed earnings by a whopping 566.7 percent in the final quarter of 2017, reporting a 40 cent loss per share when analysts had estimated only a 6 cent loss per share. But the company has beat estimates in two of the three fiscal quarters this year as it sells Senhance in various international markets.

With cash and short-term investments of $81.4 million expected to support Transenterix’s business through 2020, the market is still far from a guarantee.

RBC Capital analyst Glenn Novarro said during a non-deal roadshow with Transenterix in May that around 60 percent of surgical procedures on a global basis are still done using an open approach instead of a minimally invasive one. While robotic surgery has gained popularity, Pope said, it still represents less than 5 percent of all surgeries.

Questions surrounding the efficacy of these approaches have also been raised. A study published in The New England Journal of Medicine in October tested 2,500 women with stage 1 cervical cancer. Half of them received minimally invasive surgery, and among that group, 79 percent received robotic surgery.

The study stated that the women who received minimally invasive surgery were 65 percent more likely to die over the following four years than those who underwent open surgery. The results prompted the University of Texas MD Anderson Cancer Center to stop offering minimally invasive surgery specifically for early stage cervical cancer.

Other studies have shown minimally invasive techniques to be effective for numerous other treatments. With that, the NEJM study tested women who received treatment between 2010 and 2013, years before Transenterix began its work on Senhance. That study did, however, include treatment using Intuitive Surgical Inc.’s da Vinci device.

Before Senhance, the da Vinci was the only robotic system approved for soft tissue surgeries. A 2018 study by the Clinic for General, Visceral and Vascular Surgery in Germany stated that Senhance reduced costs significantly in high caseloads when compared to the da Vinci. The study concluded that testing and researching differences between robotic-assisted surgical systems had become feasible.

Pope said Transenterix has a great safety record.

Since late-2017, approvals from the U.S. Food and Drug Administration and CE markings in the European Union have expanded the type of treatments Senhance can be used for to over 6 million in those two regions.

Senhance is also an open platform, meaning that technology created outside of Transenterix’s operations can be brought in and implemented into the system. Pope used the example of Senhance’s compatibility with camera technology made by Stryker Corp.

One way that Stryker’s technology will benefit Senhance, Pope said, is that it will eventually be able to create “no fly zones” to prevent unintended tissue damage during surgery. These “no fly zones” will automatically stop the system whenever a surgeon gets too close to puncturing specific areas.

Analysts are bullish on Transenterix’s future. A consensus price target of $5 among five analysts would represent a 60.7 growth in price per share compared to Transenterix’s price of $3.11 at Friday’s close.

However, Pope tries not to focus on the stock price day-to-day, opting instead to look toward the company’s long-term mission.

“Our constituents in our market are patients, hospitals, and then the medical staff, surgeons and nurses,” Pope said. “As long as we’re bringing value to each one of those folks, and trying to make our quarterly number each three months, those are the things that really drive value.”

This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism