Hysterectomy – A Very Common Surgery

Hysterectomy is the most common gynecological surgery after the C-section, and according to US statistics, one of three women undergoes the procedure. Many women undergo the procedure prior to menopause due to pelvic pain, painful menstruation, bleeding, myomas and other factors related to a sensitive uterus.

When the uterus is removed in a minimally invasive laparoscopic procedure, it is first morcellated (cut into smaller pieces) and then removed through a small incision in the abdomen. One of the most common complications resulting from this surgery is that residual tissue from the uterus remains in the abdominal cavity, and since one in 350 women undergoing a hysterectomy has undiagnosed uterine cancer, the survival of postoperative cancerous tissue in the abdomen means there is a very high risk of it spreading throughout the body.

The phenomenon is so risky that in 2014, the FDA issued a warning regarding morcellating the uterus during laparoscopic hysterectomies, and calling on companies to develop products that will prevent the spread of uterine tissue during morcellation thereby enabling continued use of the minimally invasive laparoscopic approach, which is well-preferred over open surgery which requires longer hospitalization, longer recovery time and leaves a big scar, while presenting risk of infection, complications and even death.

Envelopes and Contains the Uterus for Its Quick and Safe Removal

Ark Surgical developed LapBox, a groundbreaking innovative product for removing the uterus through laparoscopy – without the risk of any cancerous tissue spreading in the abdomen, thus helping millions of women overcome the serious implications of open surgery.

LapBox is a device for single use, which is inserted into the abdomen through a small incision, and once inside, it deploys a flexible sealed container that envelopes the uterus, allowing the surgeon to morcellate and remove the uterus quickly and safely. The sealed container enveloping the uterus is inflated inside the abdominal cavity, its double lining prevents the dispersion of morcellated tissue into the abdominal cavity. At the end of the procedure, the surgeon deflates the container and easily pulls the entire container out of the abdominal cavity, knowing with confidence that no cancer cells were dispersed in the body.

LapBox provides an enclosed and hermetically sealed environment for safely and effectively performing the laparoscopic surgery (resection and cutting the uterus). The device eliminates the greatest concern about performing the procedure.

The Alternative: Open Surgery

As noted above, a hysterectomy is one of the most common procedures among women around the world. In the US alone, approximately 600,000 hysterectomies are performed annually and in tiny Israel, approximately 5,000 are performed annually.

There are currently three options available for surgeons who perform hysterectomies: open surgery, laparoscopic or vaginal surgery (relatively rare). Until 2014, laparoscopic surgery was the Gold Standard, but following the FDA’s warning, the rate of laparoscopic surgery dropped significantly, given the danger of spreading cancer.

The main alternative to laparoscopic surgery is open surgery, where a large abdominal incision is made to enable removal of the organ. The problem with open surgery is the increase in complications and infections, in addition to longer hospitalization periods, greater pain levels, and a long recovery impacting  quality of life. Open surgery is also associated with higher death rates as well as with higher costs to the hospital and insurer  in comparison to laparoscopic surgery.

The FDA is actively calling for solutions to help bring back the option of laparoscopic surgeries, which are more beneficial to the patient’s well-being and safety , including allowing the quick and safe return to daily routine.

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Effective and Easy to Use Solution

Israeli gynecologist, Dr. Abraham Yaari, graduate of the Hadassah Medical School in Jerusalem and who has been working in the US for the past 25 years, was looking for an easy-to-use highly safe solution which will provide a response to the problem arising from uterine morcellation and the FDA’s warning.

As a gynecologist, Yaari was well-aware of the other two devices available on the market, but given that surgeons like him avoided using them because of their awkward use which extends the surgery time and their long learning curve, Yaari developed the LapBox prototype and success followed shortly behind.

LapBox was presented at a major conference in the US to senior executives of leading medical device companies who tried the device in a simulator and were able to successfully and quickly operate the device on their first attempt, without any prior knowledge or experience with it. In addition, the device was introduced to leading US and European surgeon gynecologists who were enthusiastic about the invention’s control, ease of use and high safety profile.

Gynecologists consider the device to be extremely safe as a result of the double-lining which increases the efficacy and safety of the procedure while simultaneously reducing the likelihood of medical malpractice claims that they may face.

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LapBox – the Advantages

• Responds to the FDA’s specific requirements.
• Dramatically improves the patient’s experience – smaller scar, less pain, fewer infectious complications (which can even cause death), shorter hospitalization time with faster return to daily routine.
• Saves hospital costs, surgery time, hospitalization time and resources.
• The only double-lined device that prevents in the tissue spread in the abdominal cavity.
• Shortens surgery time when compared with the competitors and the surgical alternatives.
• Easy to use with a short learning curve.
• Increased safety reduces the likelihood of medical malpractice claims.
• Allows morcellation with a power or manual morcellator.

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Market and Potential

LapBox addresses a pressing need in women’s health, thus responding to a rapidly growing segment with a target market of 50% of the world’s population. The target global potential market is projected at 1.5 M procedures and $750 M annually. It is expected that LapBox will, in all probability, receive FDAclearance, and and will be widely and rapidly adopted by surgeons worldwide.

Ark Surgical is also planning on further development of devices based on the same technology, to provide simple and safe removal of additional internal organs. Expanding into other surgical domains , after the device is cleared for market, will enable the company’s growth and expansion.

Milestones

In early 2020, the company began a first in human clinical study which is expected to be completed by the end of the year. The study followed successful trials in animals. So far, two gynecological surgeries were performed successfully using LapBox at one of the Assuta Medical Centers. The Company expects the device to receive FDA clearance during the second half of 2021, upon which a pilot will be initiated for using the device at a limited number of select US hospitals  by leading gynecologists who have already expressed interest in using it. Important to note that obtaining FDA clearance does not require the company to conduct a clinical study. This is expected to expedite the filing and clearance process. According to the company’s business plan, sales of LapBox will expand to hospitals beyond the US starting in 2022.