dijous, 21 de gener del 2016

Intuitive Surgical: Q4, FY2015 earnings trounce street; New FDA 510(k)

Intuitive SurgicalIntuitive Surgical (NSDQ:ISRG) released a bevy of good news today, posting Q4 and fiscal year 2014 earnings that trounced street estimates and announcing FDA 510(k) clearance for the Integrated Table Motion for the da Vinci Xi surgical system.

Intuitive Surgical reported profits of $190 million, or $4.99 per share, on sales of $676.5 million for the 3 months ended December 31. That amounts to significant 29.4% bottom-line gain on sales growth of 11.9% compared with the same period in 2014.

Adjusted to exclude 1-time items, earnings per share were $5.89; Wall Street analysts were looking for an adjusted EPS of $5.04. Revenue also beat analyst estimates by over $20 million.

For the full fiscal year 2015, Intuitive Surgical reported profits of $588.8 million, or $15.54 per share, on sales of $2.4 billion for the 12 months ended December 31. That amounts to a massive 40.6% bottom-line gain on sales growth of 11.9% compared with the numbers the company recorded in 2014.

After adjusting to exclude 1-time items, earnings per share were $19.28, topping analysts expectations of $18.40 by nearly a dollar. Revenue also beat analyst expectations by a more narrow $24 million.

“Our strong results reflect expanded use of our products in general surgery and international markets. While robotic-assisted surgery has been growing for years, we believe we are in the early stages relative to our long-term opportunity,” CEO Dr. Gary Guthart said in a press release.

The company also announced the joint 510(k) clearance for it and Hill-Rom Holdings (NYSE:HRC) Trumpf Medical division’s Integrated Table Motion for its da Vinci Xi surgical system, which combines the robotic system and Trumpf’s TruSystem 7000dv advanced operating table.

“Integrated Table Motion is another significant advancement in our effort to deliver a first-rate product and service ecosystem to help surgeons navigate complex procedures. This product allows surgeons to maximize reach and access throughout the surgical process, enabling more efficient interaction with tissue and target anatomy,” Intuitive Surgical chief medical officer Myriam Curet said in a press release.

The newly cleared Integrated table motion allows the operator to make a “comprehensive range of table adjustments” during surgical procedures, the company said. The table can be repositioned in real time while the robotic arms on the da Vinci system are docked, allowing the surgical system access to more regions of patients.

“Our collaboration demonstrates the true power of partnership. When innovative, focused companies like Intuitive Surgical and Trumpf Medical come together to bring highly advanced medical technologies together in a true spirit of cooperation, good things can happen for patients and their caregivers. We are proud of this new, enabling capability in minimally invasive surgery,” Hill-Rom Surgical Solutions prez Dirk Ehlers said in prepared remarks.

In addition to basic repositioning, the new system allows for the table to be repositioned so gravity can expose anatomy during multi-quadrant da Vinci procedures, allow for enhanced access to target anatomy at preferred angles, and repositioning for anesthesiologists patient care.

“Managing any complex surgical procedure requires intricate coordination and orchestration. Adding Integrated Table Motion to our surgical system will be a tremendous leap forward in helping our team streamline and simplify our workflow during surgery. I am proud that our hospital will be one of the first to implement the Integrated Table Motion system and look forward to the response from our physicians,”  Jill Hauswirth of New York’s Crouse Hospital said in a prepared statement.

The system will be available in the U.S. over the next several months, the company said.

The post Intuitive Surgical: Q4, FY2015 earnings trounce street; New FDA 510(k) appeared first on MassDevice.



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