Invuity® Reports Positive Clinical And Economic Outcomes Data From Mastectomy Study

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.

SOURCE Invuity, Inc.

Related Links

http://www.invuity.com