Surgical robotics is dominated by various versions of the da Vinci system from Intuitive Surgical, a competent but expensive tool that’s become a standard in modern advanced hospitals. It took Intuitive about 30 years to achieve this status, but there are systems from J&J, Medtronic, CMR Surgical, and others that are chipping away at the company’s dominance. All of these systems operate under the “master-slave” concept, which involves a surgeon sitting behind a console, away from the patient, who manipulates the mechanical arms of the robot via some kind of joystick-like device.
Thanks to kind support from Biomed Israel, the leading international Life Science and HealthTech conference in Israel (see more below), we met with Ronen Castro, the CEO of Human Xtensions at the company’s offices in Netanya, Israel.
Ronen told us about Dr. Amir Szold, a leading laparoscopic surgeon in Israel, who suggested making a laparoscopic hand-held device that has the articulation features of the existing robots, but keeps the surgeon with the patient. He felt that most of the technology in existing robotic systems does not deliver real benefits, instead complicating matters and creating costs. He imagined distilling out the beneficial concepts of surgical robots into a small, easy to use device that laparoscopic surgeons can adopt quickly.
Human Xtensions, founded as a result of this idea, thanks to its multi-disciplinary team of engineers, created the unique HandX system. It has the same degrees of freedom as the larger robots, but in a hand-held device that can be quickly adopted by laparoscopic surgeons, and which doesn’t require the surgical staff to radically change how to prep for and perform existing procedures.
We had a chance to try out manipulating a couple laparoscopic tools using the HandX. The device looks futuristic and at first the controls seem awkward and unfamiliar. But once it’s placed into your hand, the controls don’t need much explaining and become second nature almost immediately. For example, the movements of the jaws of the grasper mimic how your fingertips push onto the tabs of the controller, following along as you squeeze and release. Pan and tilt of the wrist does the same at the articulated distal tip.
Tools that can be snapped in and out of the controller can have up to 8 degrees of freedom, of which four are motorized and four are manual. And they are small tools, all being a diameter of 5 mm compared to da Vinci’s smallest being 8 mm, making them a bit less invasive and leaving a smaller skin mark. As other laparoscopic systems, Human Xtensions’ technology can be used in a wide variety of abdominal surgical procedures, such as GI, hernia, collorectal, thoracic, etc.
This new way of controlling laparoscopic tools the company describes as “endo-robotic surgery”. Its leadership sees it as being able to disrupt the existing market, thanks to significant cost reductions, all while offering surgeons capabilities previously only available from very expensive robotic systems. Moreover, there’s potential for this technology to motivate more surgeons to adopt the minimally invasive approach, as about 50% of surgical procedures in the U.S. are still done in an open fashion.
Currently, the awkwardness of conventional laparoscopic tools keeps many physicians from using them in a variety of cases. Surgeons end up manipulating laparoscopic devices to the limits of their own hands, and this causes quite a bit of physical and mental stress during procedures. The HandX, which mechanizes and motorizes four degrees of freedom compared to conventional devices, should make laparoscopy much more accessible to more physicians and make it applicable to a greater variety of procedures. Interestingly, the device has the option to reverse the tilting of articulated tips of its devices for those that feel that to be more natural.
Check out a short video from Human Xtensions introducing the HandX system:
Human Xtensions is somewhat unique for an Israeli medtech firm, as it is independent, is publicly traded, with a portfolio of patents, has a product on the market, but which has not been acquired by one of the large players in the industry. Because of its tiny domestic market, Israeli firms typically end up joining large conglomerates. Human Xtensions chose to proceed with direct sales of its technology in the U.S. by recently opening an office in New Jersey, but in other countries it is working with local distributors.
While the first products from Human Xtensions are are already being made available to surgeons, the company claims that it has an ongoing R&D pipeline that should result in additional “endo-robotic surgical” devices. Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. The HandX device, not being in the same regulatory category, does not have such limitations and is the only robotic assisted surgical device on the market that does not need specific indications. So it can immediately be used for general surgery, bariatric surgery, colorectal, urology, gynecology, etc. Moreover, the required training to get proficient with the device is only a few hours, unlike two weeks or more for the da Vinci.
The CEO of the company describes the experience of using its products as “still being a surgeon, by the patient bedside, but with the same functions inside the body as the da Vinci.” An attractive proposition in a world in which technology has contributed significantly to the distancing of physicians from their patients, usually leading to negative side effects.
In order to be most attractive to different sizes of clinics, Human Xtensions makes its products available for outright purchase, but also as a subscription model in which the clinic pays on a per-procedure basis, an option that minimizes capital investments. This would benefit smaller facilities that don’t perform a lot of procedures, and the option comes with on-site assistance, training, and the like.
A number of clinical studies have been performed with the HandX, and physicians have given positive reviews of the system, indicating that there’s potential for substantial adoption of this product.
Here’s an excellent video of the HandX used in clinical practice:
Product page: Human Xtensions HandX…
Biomed Israel, is the leading international Life Science and HealthTech conference in Israel. This year it is scheduled for May 16-18, 2023 in Tel Aviv, and topics range from medical robotics, to bio-convergence, to the impact of AI on biopharma. Over 6,000 industry leaders, scientists, engineers, physicians, and investors will be attending for the 21st consecutive year of this conference. It is the largest event in Israel that brings together Israeli healthcare professionals and industry experts with international colleagues to work for three consecutive days on business opportunities, develop partnerships, and to seek new collaborations. Hundreds of Israeli life science firms will be showing off their products and technologies to attendees from all over the world. More info can be found at the Biomed Israel website. The conference is co-chaired by Ruti Alon, Founder and CEO of Medstrada, Ora Dar, PhD, Senior Expert, Medical Sciences and Health Innovation, and Nissim Darvish, MD, PhD, Managing Partner, Eliraz Ventures.