Cleveland-based MediView XR Inc, a medical device company, has secured $4.5 million in seed funding. The investors included Inside View Investment LLC, Plug and Play Ventures and Northwest Ohio Tech Fund.
Coming out of the Lerner Research Institute at the Cleveland Clinic is a breakthrough surgical technology that gives surgeons 3D X-ray-like vision and helps them remove cancer tumors in a way that is similar to controlling a video game. The company that formed around that technology, MediView XR, Inc., announced the closing of its $4.5 million Seed round and that it has moved into its second round of in-human evaluation surgeries. Surgeons and patients will see another gain by using MediView Real-Time, Fused Holographic Visualization, or RTFHV, system in the form of dramatically reduced radiation exposure, because MediView’s extended reality “XR” medical imaging system no longer requires surgeons to use as much X-Ray while operating. The system leverages the capabilities of Microsoft’s HoloLens to look directly into a patient and see tumors in 3D through the patient’s skin, even allowing the surgeon to walk around and view the tumor, organs and other anatomy from any angle. The system lets that surgeon perform the procedure without taking their hands off the patient or the tool that they are manipulating to cut, or ablate, the tumor away.
The Seed funds from Inside View Investments, LLC, Plug and Play Ventures, and Northwest Ohio Tech Fund will be used to further develop the system and get it through FDA approval which the company expects to see happen in 2021. MediView has already used this system on five liver tumor patients in the first set of trials and has started a new nine-patient human trial in August 2019.
Dr. Charles Martin III, an Interventional Radiologist at the Cleveland Clinic, who was the first in the world to use the system was motivated to do so by seeing first-hand the limitations of traditional medical imaging technology and all the radiation exposure associated with those procedures. He says that using a Microsoft HoloLens with its “XR” holographic visualizations has the potential to make his job much easier because he can now see the tumor in three dimensions during surgery while the more traditional fluoroscopy technique only had 2D displays:
“Augmented Reality is the first opportunity we have had to bring true three-dimensionality to medicine. To see inside a patient in real-time through their skin is truly transformative. It is a unique time to be involved with the technology.”
MediView CEO and Co-Founder John Black agrees, “During my 15-year career working in medical devices, I have never seen a technology that universally evokes positive emotion from the first experience.” Black started out in construction engineering and today he applies that learning to building devices that improve healthcare.
Mina Fahim and Greg Miller will be joining MediView as CTO and CIO, respectively, in October. Fahim states that “a substantial portion of complications in surgeries could be avoided with better visualization technology.” Fahim is formerly of Medtronic and St. Jude Medical and has been a research development engineer by trade. Miller co-founded two startups, most recently CentraComm, where he had oversight of day-to-day operations and has worked in vision and manufacturing automation, says: “MediView’s use of futuristic technology will save many lives.”
The Real-Time, Fused Holographic Visualization system which puts a Microsoft HoloLens onto the face of the lead surgeon, is like a missile-guidance system. It lets the surgeon plan out a digital path to the patient’s tumor, which improves patient experience and understanding of what will be done during their procedure. During surgery, like in a comic book or Star Trek, a surgeon who puts on the HoloLens can look directly at their patient and see all of the patient’s internal anatomy under skin. You can see their organs, blood vessels, bones and other structures. You can see the cancerous lesions within the organs. You can peel back layers of anatomy or make different anatomy appear or disappear. As you move around the patient their internal anatomy remains in its correct anatomical location. When you pick up your surgical instrument you see a light saber-like light-ray emitting from the end of the tool. As you bring the instrument toward the patient you can see that light-ray extending into the patient and how it will intersect each piece of the anatomy. As you reach your targeted location the system alerts you that you are at proper placement.
All of this is done without radiation emitting from an X-Ray machine which is currently used to do the same procedure. Instead the system “fuses” sensor readings from Ultrasound devices with CT or MRI scans, along with positioning data from the tool that the surgeon is using to cut away tumors and presents them the most advanced 3D holographic display used in surgery rooms today. Karl West, Director of Medical Devices at Cleveland Clinic and Director of the Lerner Research Institute, where MediView’s device was developed, explains how important it is that surgeons be able to see tumors and surrounding tissue and blood vessels this way:
“As minimally invasive surgery becomes the norm for treating many types of diseases, I realized the greatest shortcoming was visualization of the targeted region. It didn’t make sense that with all the other improvements in medicine that we were still using 2D imaging.”
At the Cleveland Clinic, four critical pieces of technology were refined and synchronized in 3D to bring X-ray vision and guidance to surgery rooms:
○ Active anatomic CT/MRI Registration. This core technology gives the surgeon 3D X-ray-like vision into their patient. Using a patient’s own CT or MRI, the surgeon can see beneath the skin to the patient’s organs, blood vessels, bones and other unique structures. The surgeon can identify critical anatomy and risk structures to achieve an optimal guidance and definitive location of the cancerous tumor.
○ Preoperative Plan with Intraoperative Display. Other AR companies let you review 3D images to plan your surgery. MediView takes this a leap further by letting the physician actually plan their trajectory with the light-ray tool targeting the tumor during the procedure.
○ Intraoperative Tool Tracking. MediView’s system tracks the surgeon’s tools throughout the procedure. When a surgeon picks up an instrument and brings it into the operative workspace, the tool is transformed into a holographic image allowing the tools to be visualized prior to entering and while inside the patient. This allows the surgeon to continuously see if that tool is in the right place and whether they need to advance or adjust trajectory based on real-time navigation. If the tool is properly aligned with the planned path, proper placement is confirmed by changing the color of the display from red to green. Similar to a self-driving car that follows a map, this system will turn back to red to warn a surgeon that they are off their planned path.
○ Real-Time Holographic Ultrasound Overlay. The final piece of MediView’s system is a first-of-its-kind holographic ultrasound technology. This technology produces a separate 3D hologram using ultrasound. This hologram is created during the procedure as the surgeon scans over the patient with the ultrasound probe. This provides real-time confirmation that all imaging, anatomy and tools are properly aligned.
Why is this a breakthrough? Because for the first time these holographic images are “tracked” to moving soft tissues with what is called “active registration.” Other systems can only track bones since they are rigid structures and easier to track and visualize. The MediView system tracks these images and the guidance system to not just the tumor itself, but other soft tissues that are moving as the patient breathes or moves. It is this active registration of the hologram with mobile soft tissue anatomy that is the initial key differentiator for MediView. The synchronized interplay of the hologram with the guidance technologies differentiates MediView from others developing in this emerging technology space. To provide comprehensive and accurate guidance, the surgeon is able to see all of the MediView’s data and system capabilities synchronized together in real-time 3D as they move around the patient in the surgical suite. Using hand gestures and voice commands, the surgeon has complete autonomous control of all data and imaging being presented to them to enhance clinical decision making. The operator can reposition, rotate, scale and select components of the holograms to simplify their job and improve clinical workflow.
In the future, Black sees numerous other uses and applications where this technology can transform care. MediView will be using the funding to develop this transformative technology further to help surgeons with spine, neurosurgery, breast, ENT, orthopedic, and even more general surgeries as well. Black is convinced that “this holographic technology will transform a wide variety of procedures and help countless surgeons deliver better care to their patients.”