SAN FRANCISCO, Sept. 14, 2015 /PRNewswire/ -- Invuity, Inc.
(NASDAQ:IVTY), an advanced medical technology company, today
announced the results of a company-sponsored retrospective analysis
performed by leading surgeons and validated by an outside
healthcare consulting firm. The study demonstrated clear clinical
and economic benefits for the use of the company's Eikon™
illuminated retractor system with integrated Intelligent Photonics™
during Nipple Sparing Mastectomies (NSM), an advanced surgical
approach to breast cancer surgery.
The chart review study is the first in a series of planned
analyses designed to determine if enhanced intracavity illumination
and visualization can help improve patient outcomes while also
reducing anesthesia and operating room times and overall procedural
cost. A previously conducted breast surgeon thought leader survey
indicated that the Eikon™ illuminated retractor system with
Invuity's integrated Intelligent Photonics™ reduced surgical
challenges and potential complications of NSM.[1] To further
validate and quantify the results from the prior survey, a
participating breast center and hospital conducted a chart review
to determine if reductions in anesthesia time or complications
could be achieved upon transitioning to the Eikon™ system.
The retrospective chart review assessed NSMs followed by breast
reconstructions performed by breast surgical oncologist
Beth DuPree, MD, FACS, Holy Redeemer
Health System (Meadowbrook, PA)
and by plastic surgeon William
Scarlett, DO, FACS, FACOS, FAACS, Bucks County Aesthetic
Center (Bensalem, PA) prior to and
after adopting the Eikon™ system.
The results suggest the introduction of the Eikon™ system
improved surgical efficiency and safety, and reduced complications
for patients, as well as contributing to better economic outcomes
for the hospital:
- Anesthesia time was reduced by an average of 31 minutes (10
percent) in bilateral NSM cases.[2]
- Overall complication rates decreased, including a statistically
significant 70 percent reduction of epidermolysis (blistering or
pealing of the skin or nipple-partial thickness).[3]
- Overall potential cost savings associated with using the Eikon™
system were estimated to be between $580 and
$2,000.[4]
"We are pleased with these positive results, which show there
are tangible and significant benefits to both patients and
hospitals from the use of our Intelligent Photonics technology
during advanced surgical procedures," said Invuity CEO Philip Sawyer.
Each year, approximately 232,000 women are diagnosed with breast
cancer that requires surgery[5], but many are unaware of surgical
procedures that can safely and effectively treat their cancer while
still maintaining the shape and contour of the breast, including
sparing the nipple, areola and surrounding breast tissue. With
advanced surgical approaches such as NSMs, the cancerous tissue is
removed through a single incision made in an inconspicuous or
discrete area on or near the breast, resulting in less visible
scarring. Patients who undergo this approach are at no higher risk
of recurrence than patients who undergo any other surgical
technique.[6]
"Nipple Sparing Mastectomies have become a desirable option for
the oncologic treatment of breast cancer with excellent clinical
and aesthetic outcomes shown in appropriate patients," said
Beth DuPree, MD, FACS. "Based on the
positive outcomes of this analysis, we plan to conduct continued
research to further confirm the benefit of advanced access and
visualization technologies in enabling this innovative approach to
breast cancer surgery."
"We look forward to continuing our research. Whenever possible,
before surgery, patients should partner with their care team to
learn about the breast reconstruction options available to them,"
said William Scarlett, DO, FACS,
FACOS, FAACS. "Having advanced access and visualization tools from
the beginning not only helps reduce surgical time and
complications, but enables us to give patients aesthetic results
that can help boost their psychological and emotional
recovery."
For the white paper on the study results, please click here:
www.invuity.com/technology/evidence/.
About Invuity®
Invuity, Inc. is a medical
technology company focused on developing and marketing advanced
photonics devices to improve the ability of surgeons to illuminate
and visualize the surgical cavity during open minimally invasive
and minimal access surgery. The company's patented Intelligent
Photonics™ technology enables enhanced surgical precision,
efficiency and safety by providing superior visualization. Clinical
applications include breast and thyroid oncology, plastic
reconstructive, spine, orthopedic, cardiothoracic and general
surgery among others. 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 market opportunities and potential
results from future new initiatives. 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.
[1] LIT 11195 --NIPPLE SPARING MASTECTOMY AND THE ADVENT OF AN
ENABLING SURGICAL ILLUMINATION AND VISUALIZATION SYSTEM Clinical
Experience Survey of Thought Leaders in Breast Surgery, Rache
Simmons, MD, et al.
[2] LIT 12023 RETROSPECTIVE CHART REVIEW OF NIPPLE SPARING
MASTECTOMIES WITH AND WITHOUT AN ENABLING INTRACAVITY ILLUMINATION
AND VISUALIZATION SYSTEM, Beth Baughman DuPree MD, FACS, et
al.
[3] Ibid
[4] LIT 11922 Healthcare Consulting Firm: NSM Economic Findings,
July 2015
[5] U.S. Breast Cancer Statistics. Accessed on August 31, 2015.
http://www.breastcancer.org/symptoms/understand_bc/statistics.
[6] Study Finds Nipple-Sparing Mastectomy Does Not Increase Risk
of Breast Cancer Recurrence. Accessed on January 28, 2015 from
http://www.plasticsurgery.org/news/past-press-releases/2011-archives/study-finds-nipple-sparing-mastectomy-does-not-increase-risk-of-breast-cancer-recurrence.html.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/invuity-reports-positive-clinical-and-economic-outcomes-data-from-mastectomy-study-300142067.html
SOURCE Invuity, Inc.