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The veil is beginning to elevate on medical robotics startup Mendaera Inc. because it exits stealth mode and heads towards regulatory submission with a design freeze on its first system and verification and validation imminent.
Two former Auris Health leaders co-founded the San Mateo, Calif.-based firm. Mendaera additionally has monetary help from Dr. Fred Moll, the Auris and Intuitive Surgical co-founder who is called “the father of robotic surgery.”
“Among the innovators in the field, Mendaera’s efforts to make robotics commonplace earlier in the healthcare continuum are unique and can potentially change the future of care delivery,” acknowledged Moll in a launch.
But Mendaera isn’t a surgical robotics developer. Instead, it stated it’s engaged on expertise that mixes robotics, synthetic intelligence, and real-time imaging in a compact system “no bigger than your fist” for procedures together with percutaneous devices.
Mendaera co-founder and CEO Josh DeFonzo. | Source: Mendaera
Josh DeFonzo, co-founder and CEO of Mendaera, provided new particulars about his startup’s expertise and targets in an unique interview, as he introduced the acquisition of working room telepresence expertise that Avail Medsystems developed.
Avail, which shut down final yr, was based by former Intuitive Surgical and Shockwave Medical chief Daniel Hawkins, who’s now CEO at MRI automation software program startup Vista.ai.
“We’re a very different form factor of robot that focuses on what I’ll describe as gateway procedures,” DeFonzo stated. “It’s a different category of robots that we don’t believe the market has seen before [as] we’re designing and developing it.”
Those procedures embrace vascular entry for supply of gadgets or therapeutic brokers; entry to organs for surgical or diagnostics functions; and ache administration procedures resembling regional anesthesia, neuraxial blocks, and power ache administration. DeFonzo declined to enter a lot element about particular procedures as a result of the product continues to be within the growth stage.
“The procedures that we are going after are those procedures that involve essentially a needle or a needle-like device and real-time imaging, and as such, there are specific procedures that we think the technology will perform very well at,” he stated. “However, the technology is also designed to be able to address any suite of procedures that use those two common denominators: real-time imaging and a percutaneous instrument.”
“And the reason that’s an important point to make is that oftentimes, when you are a specialist who performs these procedures, you don’t perform just one,” added DeFonzo. “You perform a number of procedures: central venous catheters [CVCs], peripherally inserted central catheter [PICC] lines, regional anesthetic blocks that are in the interscalene area or axial blocks. The technology is really designed to enable specialists — of whom there are many — the ability to perform these procedures more consistently with a dramatically lower learning curve.”
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Mendaera marks progress so far
Preclinical testing has proven the expertise has improved accuracy and effectivity as compared with freehand strategies, whatever the particular person’s ability stage, asserted DeFonzo. User analysis spanned round 1,000 totally different healthcare suppliers starting from emergency drugs and interventional radiology to licensed medical medical doctors, nurse practitioners, and doctor’s assistants.
“It seems to be very stable across user types,” he stated. “So whether somebody is a novice, of intermediate skill level, or advanced, the robot is a great leveler in terms of being able to provide consistent outcomes.”
“Whereas when you look at the same techniques performed freehand, the data generally tracks with what you would expect: lesser skilled people are less accurate; more experienced people are more accurate,” DeFonzo famous. “But even in that most skilled category, we do find that the robot makes a fairly remarkable improvement on accuracy and timeliness of intervention.”
Last yr, the startup expanded right into a manufacturing facility to accommodate development and quantity manufacturing for the product’s launch and stated its system can be powered by handheld ultrasound developer Butterfly Network’s Ultrasound-on-Chip expertise.
Butterfly Network received FDA clearance in 2017 for the Butterfly iQ for iPhone. | Source: Butterfly Network
Mendaera’s goal is to ultimately deploy these programs “to the absolute edge of healthcare,” beginning with hospitals, ambulatory surgical facilities and different procedural settings, stated DeFonzo. The firm will then push to various care websites and first care clinics as proof builds to help the expertise.
“The entire mission for the company is to ensure essentially that high-quality intervention is afforded to every patient at every care center at every encounter,” he stated. “We want to be able to push that as far to the edge of healthcare as possible, and that’s certainly something we aim to do over time, but it’s not our starting point explicitly.”
“As a practical starting point, however, we do see ourselves working in the operating room, in the interventional radiology suite, and likely in cath labs to facilitate these gateway procedures, the access that is afforded adjacent to a larger intervention,” DeFonzo acknowledged.
Mendaera stated it expects to submit its system to the U.S. Food and Drug Administration for evaluation by means of the 510(ok) pathway by the top of 2024 with the aim of providing the product clinically in 2025.
“What we really want to do with this technology is make sure that we’re leveraging not just technological trends, but really important forces in the space — robotics, imaging and AI — to dramatically improve access to care,” stated DeFonzo. “Whether you’re talking about something as basic as a vascular access procedure or something as complex as transplant surgery or neurosurgery, we need to leverage technology to improve patient experience.”
“We need to leverage technology to help hospitals become more financially sustainable, ultimately improving the healthcare system as we do it,” he stated. “So our vision was to utilize technology to provide solutions that aggregate across many millions, if not tens and hundreds of millions, of procedures to make a ubiquitous technology that really helps benefit our healthcare system.”
Mendaera’s analysis and growth group will work with staff from Avail on the best way to finest add the telepresence expertise to the combination.
“We see a lot of power in what the Avail team has built,” DeFonzo stated. “Bringing that alongside robotic technology, our imaging partnerships and AI, we think that we’ve got a really good opportunity to digitize to a further extent not only expertise in the form of the robot, but [also] clinical judgment, like how do you ensure that the right clinician and his or her input is present ahead of technologies like artificial intelligence that hopefully augment all users in an even more scalable way.”
Editor’s be aware: This article was syndicated from The Robot Report sibling web site Medical Design & Outsourcing.