Dextera Surgical Receives Expanded Indication in Solid Organ Surgery for MicroCutter 5/80 ™

-- Including Liver, Pancreas, Kidney and Spleen Surgical Procedures –

 

REDWOOD CITY, Calif. --  Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and commercializing the MicroCutter 5/80™ stapler, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to use its MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads in conjunction with open solid organ parenchymal dissection techniques including organs such as the liver, kidney, pancreas and spleen.

 

“The small size and large degree of articulation provided by the MicroCutter 5/80 is especially beneficial in maneuvering within the confined spaces around solid internal organs,” said Brendan C. Visser, M.D., associate professor of surgery at Stanford University Medical Center. “In addition, with the small footprint of the MicroCutter’s jaws, I’m able to successfully operate with less dissection.”

The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix. With the current clearance, the MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins four to five millimeters in diameter and arteries three to seven millimeters in diameter.

 

“This clearance expands our reach in the United States into a new clinical area for which we have already demonstrated success in Europe,” said Julian Nikolchev, president and CEO of Dextera Surgical Inc. “This expanded indication represents an additional 44,000 procedures in the United States annually, and we look forward to bringing the MicroCutter 5/80 to surgeons for these applications.”

 

About Dextera Surgical

 

Dextera Surgical designs and manufactures proprietary stapling devices for minimally invasive surgical procedures. In the U.S., surgical staplers are routinely used in more than one million minimally invasive laparoscopic, video-assisted or robotic-assisted surgical procedures annually.

 

Dextera Surgical also markets the only automated anastomosis devices for coronary artery bypass graft (CABG) surgery on the market today: the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System. These products, sold by Dextera Surgical under the Cardica brand name, have demonstrated long-term reliable clinical performance for more than a decade.

 

Forward-Looking Statements

 

The statements in this press release regarding the beneficial use of the MicroCutter 5/80 in open solid organ surgery, the expanded indication representing an additional 44,000 procedures in the United States and bringing the MicroCutter 5/80 to surgeons for this extended use are "forward-looking statements." There are a number of important factors that could cause results to differ materially from those indicated by these forward-looking statements, including the risks detailed from time to time in Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, under the caption “Risk Factors.” Dextera Surgical expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.

 

 

View source version on businesswire.com: http://www.businesswire.com/news/home/20170831005206/en/

 

Contacts:

 

Dextera Surgical Inc.

Bob Newell, 650-331-7133

Vice President, Finance and Chief Financial Officer

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