Invuity Provides Update on PhotonBlade Commercialization
June 13 2017 - 8:00AM
Invuity, Inc. (NASDAQ:IVTY), a medical technology company focused
on minimal access surgery, today provided an update on plans for
PhotonBlade commercialization. As previously announced, the Company
began a limited market release of PhotonBlade in March, 2017.
During this phase, the Company gathered feedback on product
performance which has informed upcoming product enhancements for
PhotonBlade. In addition, a small number of customer
observations were recently received, which related to possible
unintended energy discharge with the potential to cause tissue
damage to patients. To mitigate the potential for patient
injury, the Company has elected to initiate a voluntary recall and
remove the small number of remaining units from the field.
The Company expects to begin shipping product again in the third
quarter of 2017, after planned product enhancements have been
made.
“During this limited market release, we received extremely
positive market feedback on PhotonBlade. However, due to a small
number of reports of unintended energy release from the device we
have proactively elected to take these steps”, said President and
CEO Phillip Sawyer. “This is consistent with our corporate
values centering on quality and safety and we are rapidly
implementing product improvements in preparation for a full market
release.”
About Invuity®
Invuity, Inc. is a leading medical technology company focused on
developing and marketing advanced surgical devices to improve the
ability of physicians to perform minimal access surgery through
smaller and hidden incisions. The company's proprietary Intelligent
Photonics™ technology delivers enhanced visualization which
facilitates surgical precision, efficiency and safety. In addition,
the company utilizes comprehensive strategic marketing programs to
create stronger institutional partnerships. Clinical applications
include women’s health, encompassing breast cancer and breast
reconstruction surgery, gynecology and thyroid surgery. Additional
applications include procedures for electrophysiology, spine,
orthopedic, cardiothoracic, and general surgery. Invuity is
headquartered in San Francisco, CA. For more information, visit
www.invuity.com.
Forward-Looking Statements
This announcement contains forward-looking statements that
involve risks and uncertainties, including statements regarding
financial projections for 2017, expectations for the launch of
PhotonBlade, future product introductions and our commercial
strategies. Actual results could differ materially from those
projected in the forward-looking statements as a result of certain
risk factors, including, but not limited to: fluctuations in demand
or failure to gain market acceptance for the Company's devices; the
Company's ability to demonstrate to and gain approval from
hospitals to use the Company's devices; the highly competitive
business environment for surgical medical devices; the Company's
ability to sell its devices at prices that support its current
business strategies; difficulty forecasting future financial
performance; protection of the Company's intellectual property; and
compliance with necessary regulatory clearances or approvals. The
Company undertakes no obligation to update the forward-looking
information in this release. More information about potential
factors that could affect the Company's business and financial
results is included in its filings with the Securities and Exchange
Commission, including, without limitation, under the captions:
"Management's Discussion and Analysis of Financial Condition and
Results of Operations," and "Risk Factors," which are on file with
the Securities and Exchange Commission.
CONTACT:
Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129
Investors:
Mark Klausner
Westwicke Partners
443-213-0501
irdept@invuity.com
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