Dextera Surgical Implements Temporary Shipping Hold on MicroCutter 5/80™
July 06 2017 - 4:05PM
Business Wire
-- Reports Preliminary Financial Results for
Fourth Quarter and Fiscal Year 2017 –
-- Company to Host Conference Call Today,
July 6, 2017 at 4:30 p.m. EDT --
Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and
commercializing the Dextera MicroCutter 5/80™ Stapler, today
announced that it placed a temporary shipping hold on the
MicroCutter 5/80 Stapler and reload cartridges in response to six
reports that surgeons were unable to clamp the MicroCutter 5/80
Stapler after inserting a MicroCutter 30 Reload into the stapler
prior or during a surgical procedure. No adverse events or
complications have been associated with these reports.
Dextera Surgical has conducted an engineering analysis of the
affected lots of staplers and reloads. The company has identified
two root causes – one in the stapler and one in the reload
cartridge - which prematurely engage the lock-out safety feature
within the stapler. The lock-out feature, which results in an
inability to clamp the stapler and prevents firing, is a built-in
safety feature in the MicroCutter 5/80 Stapler. One root cause is
related to a ratchet mechanism in the handle. Dextera Surgical has
already implemented changes to the MicroCutter 5/80 Stapler design
and new lots of the stapler have been manufactured. Analysis of the
blue and white reload cartridges revealed that, intermittently, the
reload is not sitting flush within the stapler jaws which then
engages the lock-out safety feature prematurely. Dextera Surgical
is implementing a solution for the reload cartridges.
To assess the risk to patients, Dextera Surgical conducted
extensive in vitro testing of the MicroCutter stapler and reload
cartridges. The company also reviewed all prior reported complaints
and associated adverse events for the last 12 months for the
MicroCutter stapler and blue and white reload cartridges, related
to the current configuration of the MicroCutter. A majority of the
reports indicate the inability to clamp was identified prior to use
in the surgical procedure and Dextera Surgical’s internal testing
indicates no increased risk of tissue damage even if the problem is
not identified before use in a surgical procedure. Prior to using
the MicroCutter 5/80 Stapler, as provided in Dextera Surgical’s
instructions for use, users are instructed to clamp and unclamp the
stapler to confirm proper loading and to inspect the reload.
After evaluation and analysis of the events and testing of the
noted manufacturing lots, Dextera Surgical estimates that
approximately 60% of staplers have been used successfully with no
incident. Since the remaining staplers do not pose a safety
concern, they will remain in circulation.
“We are first and foremost committed to patient safety, and
quickly implemented a voluntary temporary shipping hold to fully
investigate the issue,” said Julian Nikolchev, president and CEO of
Dextera Surgical. “While we are disappointed to encounter this
issue, we remain steadfast in pursuing our mission to develop this
innovative technology to bring smaller and more flexible surgical
staplers to the marketplace. Importantly, because the MicroCutter
5/80 Stapler is the only surgical stapler with a five-millimeter
diameter and 80 degrees of articulation, we believe that close
monitoring of the performance and rapid incremental improvements to
both the stapler and reloads is necessary so that we are able to
provide this pivotal tool for surgeons who are trying to meet the
increasing need for less invasive surgical procedures.”
Preliminary Results of Operations for Fourth Quarter and Full
Year Fiscal 2017
Dextera Surgical expects to report total product sales including
both the cardiac products and the MicroCutter of $940,000 to
$960,000 for the fourth quarter of fiscal 2017. Dextera Surgical
expects to report approximately $350,000 as well as a $75,000 back
order for the MicroCutter 5/80 compared to prior guidance of
$600,000 to $700,000 for the fourth quarter of fiscal 2017. For
fiscal 2017, Dextera expects to report total product sales of $2.9
million to $3.0 million, including MicroCutter product sales of
$1.1 million to $1.2 million. Previously, Dextera expected
MicroCutter sales for fiscal 2017 to be $1.4 million to $1.5
million. The expected decrease in product sales of the MicroCutter
5/80 for the fourth quarter of fiscal 2017 is due in part to a
backorder for blue reload cartridges in the first part of the
quarter (as announced on the May 4, 2017 quarterly call) as well as
the current temporary shipping hold on staplers and reloads.
Dextera will record an expense of approximately $150,000 related to
the finished goods in stock but not shipped in the fourth quarter
of fiscal 2017.
Conference Call Details
To access the live conference call today at 4:30 p.m. Eastern
Time via phone, please dial 844-419-1785 from the United States and
Canada or 216-562-0472. The conference ID is 51626212. Please dial
in approximately 10 minutes prior to the start of the call. A
telephone replay will be available beginning approximately four
hours after the call through July 13, 2017, and may be accessed by
dialing 855-859-2056 from the United States and Canada or
404-537-3406 internationally. The replay passcode is 51626212.
To access the live and subsequently archived webcast of the
conference call, please visit the Investor Relations section of the
company’s website at ir.dexterasurgical.com. Please connect to the
website at least 15 minutes prior to the presentation to allow for
any necessary software downloads.
The webcast is also being distributed through the Thomson
StreetEvents Network. Institutional investors can access the call
via Thomson StreetEvents at www.streetevents.com, a
password-protected event management site.
MicroCutter Indication Information
The MicroCutter 5/80 Stapler and MicroCutter 30 Reloads are
manufactured and cleared for use in the United States 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. The MicroCutter 5/80 Stapler may be used with both
MicroCutter 30 White Reloads in vascular/thin tissue and
MicroCutter 30 Blue Reloads for standard tissue.
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 extent of the
root causes of the clamping issue of MicroCutter 5/80 and the
reload cartridges, and the preliminary results of operations 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170706006103/en/
Dextera Surgical Inc.Bob Newell, 650-331-7133Vice President,
Finance and Chief Financial
Officerinvestors@dexterasurgical.com