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Dutch start-up Preceyes is raising its maiden round of equity financing that will enable its robotic surgical system - the first of its kind to be CE marked for ocular surgery - to be market-ready and launched for broad commercialisation.
Eindhoven University of Technology spin-out Preceyes CE marked its robotic surgical system for performing vitreoretinal surgery earlier this month. The current version of the system is for research use and will be rolled out to select key opinion leaders, from whom the company will gather feedback for developing a commercial, "industrialised" version of the system.
CEO Gerrit Naus told FirstWord MedTech that the firm has been supporting itself financially mainly through grants, subsidies and loans, since it was founded in 2015. Having used these funds to take its technology from proof-of-concept through to CE marking of the current research platform, it is now in the midst of discussions with potential investors to raise more capital to get to commercialisation stage.
The market opportunities
The first market that Preceyes is targeting and its key focus for now is vitreoretinal diseases. According to the company’s estimates, over 6.5 million people worldwide are treated each year for retinal disorders and this number is increasing in tandem with the ageing population. Among these patients, 20% involve precision microsurgical procedures that require highly skilled surgeons. The use of a robotic system like Preceyes to assist in the particularly demanding tasks can "help surgeons reach that level of performance" required more frequently and consistently, the company believes.
The second market that Preceyes will be targeting, further down the line, is for drug delivery applications, specifically subretinal administration of therapeutic agents, gene and cell therapy that require high precision, targeted delivery. Naus said that the market for cell and gene therapy itself is still emerging, but the opportunity here is significant. "The delivery of these therapies cannot be done well manually because of the high precision and stability that is required to deliver the injection. Our system could support surgeons in injecting the drug at a very precise location, for a prolonged period of time. The stability of the system guarantees that you don't have any tremor or create a hole that is bigger than it needs to be."
The lowdown on Preceyes
The Preceyes system comprises a single, robotic manipulator arm, which holds and positions a surgical instrument inside the eye. With one hand, the surgeon uses a joystick that is adjoined to the robotic arm to maneuver the instrument, and perform multiple injections, peeling and tissue manipulation tasks. With the other hand, the surgeon could hold another instrument and perform the procedure manually.
The system is designed to filter tremors, allow semi-automation of certain steps and has a motion-profiling feature which means the instrument’s movement could be limited to what is preset, avoiding potentially dangerous actions that could result in surgical complications.
The Precyes Surgical System (Source: Precyes)
According to Naus, the learning curve for Preceyes is "very short". He highlighted that at the Euretina meeting last year, the company had invited eye surgeons to a session to try out the technology. They were given five minutes of explanation, five minutes of training, and then they were given a surgical task to perform - first manually, then with the help of the Preceyes robotic system. "The results that we saw was that overall, surgeons were able to perform the task more efficiently with the robot, compared to just manually - and that’s just from five minutes of training," he told FirstWord MedTech.
He acknowledged that the time it took to perform the task with the robot varied from surgeon to surgeon, but in terms of outcomes, there were less complications and less damage to the retina when the robot was used.
The company has already done a first-in-man clinical study with Oxford University to assess the safety and efficacy of Preceyes against manual surgery, specifically comparing how robot-assisted surgery performs in the removal of retinal membranes (either epiretinal membrane or inner limiting membrane). The results of the 12-patient study, published last year in Nature Biomedical Engineering, showed that robot-assisted surgery was typically slower than manual surgery for all participants, but the authors argued that "safety took precedence over speed." In the robot cases, there were fewer inadvertent retinal touches that resulted in fewer microhemorrhages, compared to the controls, but this did not reach statistical difference. That said, the authors indicated that the absence of any obvious difference supported the robotic system's safety profile.
The company is now expanding this clinical work with the Rotterdam Eye Hospital. The firm announced in May that it has initiated a randomised prospective, open-label surgical intervention study to compare robotic assistance to standard manual surgery in performing an epiretinal membrane peel, considered to be a very technically challenging procedure that is performed only by highly trained specialist eye surgeons.
Naus said he expects the first data readout from the 15-patient study with Rotterdam Eye Hospital to be ready at the end of this year.
What's to come, where's the competition
In terms of competition, the closest rival is Medical Microinstruments (MMI) from Italy. The company last year raised €20 million in series A to advance its robotic surgical system that incorporates wristed microinstruments, similar to those used by systems like Intuitive Surgical’s da Vinci. In fact, one of MMI’s backers is a former executive of Intuitive, and the Italian company also has a couple of other industry veterans and long-time healthcare investors as backers.
However, little has been heard about the progress MMI is making, which still leaves Preceyes ahead of the race.
Naus estimates that it would take the company about 18 months from now to complete industrialisation work on its technology and get an updated CE mark, which means it would be around 2021 that the new surgical system would make its commercial debut.
This second, commercial version of the robotic system will include proprietary surgical instruments with embedded sensors that can measure the distances between the instrument and the retina, enabling even more precision during the procedure.
Furthermore, Preceyes will be looking at the manufacturability of the technology, so that the device can be produced at scale and sold "at the right price point to help wider market adoption," said Naus.
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