Wednesday, September 14, 2022
Ark Surgical Ltd., an Israeli medical device company, announced today that it has received US Food and Drug Administration (FDA) clearance for its patented LapBox tissue containment removal system for manual morcellation. Designed to enable the safe and simple removal of tissue, the LapBox empowers gynecologists to use manual morcellation for minimally invasive laparoscopic procedures as an alternative to higher-risk open surgery.
Uniquely designed as a double-walled container, the LapBox creates a secure, enclosed environment to prevent the risk of dispersion of cancerous cells during morcellation. It also employs an easy-to-use delivery technology providing gynecologists with improved control and maneuverability to optimize laparoscopic surgery.
"We are delighted to meet this major regulatory milestone," said Stav Tori, CEO of Ark Surgical. "Following our recent successful first-in-human study, our strategic plan is being implemented. We remain committed to bringing a much-needed safe tissue containment solution for the millions of women requiring myomectomies and hysterectomies."
"Today, the majority of hysterectomies are still being performed by open surgery with a large abdominal incision," said Dr. Edward Evantash, Chief Medical Officer of Ark Surgical. "The advanced LapBox containment system paves the way for many more women to now benefit from a minimally invasive approach, which is proven to reduce pain, shorten recovery times and decrease complications."
Ark Surgical is initiating a Round B investment and will be presenting the LapBox at the American Association of Gynecologic Laparoscopists (AAGL) 2022 Global Congress in Aurora, CO - Dec 1-4, 2022.