Moon Surgical, Backed by Johnson & Johnson and NVIDIA, Advances U.S. Launch of Maestro Soft-Tissue Robotic System

Dec 07, 2023 18:40 CST Updated 18:40

Johnson & Johnson

Medical Device R&D and Manufacturer

Backed by JJDC, the venture capital arm of Johnson & Johnson, and Nvidia, the leader in AI chips, and advised by Frederic, co-founder of Intuitive, Moll Moon Surgical is nearing its mission. According to CEO Anne Osdoit, the company, which has offices in Paris and California, received the CE mark for the commercial version of its Maestro robot in September and expects FDA approval in the coming months.

MedTech Dive recently interviewed Osdoit, a biomedical engineer and partner at venture capital firm Sofinnova Partners, where she discussed preparing for robotic product launches in the U.S. and opportunities in soft tissue surgery.

1. How is your robot different from Intuitive's da Vinci that is currently on the market?

Annie Ostdoigt: Surgical robots have always been what Intuitive Surgical is working on - especially the Da Vinci robot, which is the real protagonist in this field - they have designed many robotic arms to hold these instruments, and then basically bring the surgeon behind the console in a room outside the sterile area. Through this console, the surgeon is able to manipulate the different instruments held by these robotic arms.

What Moon Surgical does is different, essentially keeping the surgeon at the center of the operating room, next to the patient. We preserve the surgeon's two arms because surgeons are trained to be highly skilled with two functional arms.

We have added an extra set of arms at the bedside for the surgeon, holding two instruments for him and manipulating them in an intelligent and autonomous manner, which means we have a system that better integrates into the right way of doing things.

We haven't changed the way we train surgeons, nor the instruments being used. In terms of footprint, our system is much smaller and can be used in virtually any operating room. This allows us to better serve patients. It's more convenient for surgeons. They can control everything—not remotely—but maintain their workflow and efficiency while benefiting from the robotic features they appreciate.

2. How do surgeons use robotic arms?

Either directly controlled by the surgeon or manipulated autonomously, the surgeon will grab the instrument held by the robot, manually move it to a certain location, and then let go. So, this is one method; the second way is that they can be autonomously operated. With artificial intelligence, you can instruct them to follow what the surgeon has done within a range, so what is seen on the screen is always relevant and focused on the surgeon's own instruments. Likewise, our second arm usually exposes the tissue the surgeon is interested in. The second hand can manage this exposure in a smart way.

3. When do you expect to launch the Maestro robot in the United States?

We did obtain FDA clearance and CE certification for the initial version of this system, but it was not a commercial version. For our second-generation system, we have obtained CE certification, and we are looking forward to receiving FDA clearance in the coming months. This is a new system, one that allows us to scale. Beyond that, the plan is for a limited market release in the U.S. next year, ahead of a larger commercial launch in 2025.

Moon Surgical plans to launch its commercial version of the Maestro surgical robot in the U.S. on a limited basis next year, with a broader release scheduled for 2025.

4. How is your system programmed?

We are not directly competing with da Vinci. Da Vinci is an incredible product that provides support for surgeons under very complex conditions, where surgeries require fine suturing in extremely confined spaces — prostate surgery being a primary example. It’s also an excellent system where the size of the room isn’t an issue, and neither is the number of people required to support the procedure.

What we see is that the vast majority of laparoscopic surgeries today are not performed with the da Vinci robot, and in the future, there will not be a da Vinci robot in every operating room.

There are about 30,000 operating rooms in the U.S. that perform laparoscopic procedures, but only 4,800 of them have da Vinci systems. So we developed a system to essentially bring some robotic capabilities to the rest of the market: 94% of patients have soft tissue surgery without a robot.

These patients will undergo surgeries in a mobile environment, typically less complex procedures: gallbladder removal, hernia repair, appendectomy, weight-loss surgery, reflux surgery — non-cancer cases that do not require these large and complex platforms. We believe that we can significantly enhance existing practices without the expense, effort, and cost associated with larger platforms.

5. Will suppliers consider your system to have a cost advantage?

Of course, cost is an important limiting factor for adopting robots. But apart from cost, there is also the business model. When you enter ambulatory surgery centers or outpatient departments of hospitals, the barriers to entry for these facilities and suppliers are huge, manifested in the large-scale purchase of complex equipment.

Therefore, we have developed a subscription-based model that is based on volume tiers, essentially divided into three different levels, and you will pay a monthly fee according to the tier you are in. This is an all-inclusive fee covering the system, disposable supplies, and services. It allows them to access the technology very easily and replenish their disposable supplies as they use it.

Many hospitals are operating at a loss, and many hospitals are short of staff. We are helping providers build a system that can help surgeons improve efficiency.

6. Why are we seeing so many companies, large and small, competing to develop new surgical robots?

I want to say, if people have been following the huge success of Intuitive Surgical, you know they created the market. I mean, surgeons love the robot, they love the control and confidence it offers, which is very appealing to patients.

Therefore, it is considered an opportunity to become a fast follower or a less fast follower. Many companies are already chasing this market and trying to develop different variants of the da Vinci robot.Another part of the market is orthopedics.，Orthopedics has deeply penetrated and adopted the outpatient setting.，Today, manyASCOwned by orthopedic surgeons who recognize the benefits of using robotics to place hip or knee implants, particularly spinal implants.

The adoption of these robots has already given rise to a large number of second-generation or third-generation companies attempting to enter the market.

About Moon Surgical

Moon Surgical is a medical device company that develops surgical robots for laparoscopic assistance. In 2019, Moon Surgical was founded by Professor Brice Gayet in Paris, France. From the outset, the company quickly leveraged its expertise in the field of medical surgical robotics, collaborating with more than 30 top surgeons from Europe and the United States to conduct research, development, and validation across multiple clinical indications.

On June 7, 2022, Moon Surgical raised $31.3 million in Series A funding. GT Healthcare Capital & Partners led this round of financing. Industry investors Johnson & Johnson Innovation (JJDC, Cathay Health), Sofinnova Partners, and medical technology leaders Yann Fleureau, Siddarth Satish, Sacha Loiseau, and Richard Leparmentier also participated. Cathay Global Healthcare Fund also joined the venture.

On December 6, 2022, the Maestro surgical robot received FDA 510(k) clearance. In May this year, Moon Surgical's Maestro raised $55.4 million. This round of financing was co-led by Sofinnova Partners and NVentures, NVIDIA's venture capital arm, with other investors including Dr. Fred Moll, the "father of surgical robotics," Dr. Josh Makower, as well as existing investors GT Healthcare Capital and Johnson & Johnson Development Corporation (Johnson & Johnson Ventures). The funds will be used to support the ongoing development and commercialization of the company’s surgical system, the Maestro System.

On September 19, 2023, Moon Surgical's latest version of the Maestro surgical robotic system received CE approval in Europe. The initial version of Maestro obtained CE approval earlier in April this year, marking another significant milestone in a series of positive updates from Moon Surgical.

The updated Maestro system features enhanced scalability and a more refined design aesthetic. Compared to the previous version, it now offers automatic setup with bedside guidance and configurations tailored specifically for surgeons. Additionally, the new version includes cloud connectivity, further integrating the operating room and overall ecosystem experience. It also supports surgeon-guided automatic range control, further optimizing surgical visualization.

Source: Medical Device Innovation Network Translation, ReferenceMass Device

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