IVTY Invuity, Inc. (delisted)

Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today announced the results of two studies that were published at the Scientific Sessions of the Heart Rhythm Society in Boston last week.  The studies were co-authored by teams from Northwestern University and University of Pennsylvania and focused on the potential risk of damage to the insulation of pacing leads related to the use of electrocautery devices with insulated blades.

The first study provides updated guidance for clinicians when applying electrocautery to tissue near pacing leads. The study used Invuity’s PhotonBlade to demonstrate that leads coated with polyurethane and copolymers are more susceptible to damage compared to silicone coated leads. Also, less lead insulation damage is observed when the blade is in a flat orientation (parallel to the lead) compared to a blade in an active-edge orientation (perpendicular to the lead). Finally, less damage is observed using CUT settings compared to COAG settings.

The second study compared PhotonBlade to a competitive insulated electrocautery device. The study demonstrated that with either device, higher settings increase the risk of lead insulation damage and confirmed the finding from the first study that less lead insulation damage is observed when using CUT mode versus COAG mode.  The study also demonstrated that the use of PhotonBlade resulted in less damage to leads when compared to the use of the competitive device. Overall, 40% of leads tested with PhotonBlade showed damage compared to 75% of leads tested with the competitive device. At an equivalent commonly used setting, 13% of leads tested with PhotonBlade showed damage compared to 39% of leads tested with the competitive device.

Robert D. Schaller, MD, cardiac electrophysiologist at the Hospital of the University of Pennsylvania and Assistant Professor of Penn Medicine, and co-author of the 2nd study, commented, “I was pleasantly surprised and excited by the results of the study. This data gives us a better understanding about electrocautery devices, their optimal use, and their utility during device procedures. I believe this study should shape the discussion surrounding these tools in device change-outs or any procedures where a lead is present.”

Steven Kutalek, MD, Professor of Medicine, and Director of Drexel University’s cardiac electrophysiology fellowship program, who was not involved in this research, said, “These studies were well designed and bring compelling new data regarding our use of electrocautery. PhotonBlade gives me great visualization and allows me to use any generator. With its focused energy and the low power settings possible from my existing generators, I have great confidence around all types of leads. I would not rely on any other energy tool for my complex device or lead revision procedures.”

“PhotonBlade exemplifies our focus on introducing disruptive technologies to the market that impact patient outcomes,” said Scott Flora, Invuity’s Interim Chief Executive Officer. “PhotonBlade brings a unique combination of improved visualization and low thermal spread to electrophysiologists performing change-outs and revisions. This research further demonstrates the value of PhotonBlade by highlighting the potential to reduce the risk of lead damage during these critical procedures.”

PhotonBlade integrates Invuity’s proprietary Intelligent Photonics® technology into a high-value advanced energy device used for cutting and coagulation of soft tissue during surgical procedures. PhotonBlade represents a first-of-its kind device, providing directed, thermally cool illumination at the point of surgical treatment while delivering precise energy with low thermal spread and eliminating the need for a proprietary generator.

The full abstracts presented at HRS 2018 can be found online at:B-PO02-073 at https://www.heartrhythmjournal.com/article/S1547-5271(18)30246-7/pdfB-PO06-037 at https://www.heartrhythmjournal.com/article/S1547-5271(18)30250-9/pdf

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 patented Intelligent Photonics® technology delivers enhanced visualization, which facilitates surgical precision, efficiency and safety.  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.

CONTACT:

Company Contact:Jim MackanessChief Financial OfficerInvuity, Inc.415-655-2129

Investors:Mark KlausnerWestwicke Partners443-213-0501irdept@invuity.com