The South African at the cutting edge of x-ray vision

TALI FEINBERG

The duo is made up of South African Stuart Wolf and Israeli Nissan Elimelech of Augmedics.

“The xvision is the first augmented reality device approved for surgery. The system provides the surgeon with all the information required, including an x-ray-like view of the patient. Using the xvision, the surgeon is able to navigate instrumentation used in surgery precisely,” says Wolf, who attended King David Victory Park, and went on to study a BSc Electrical Engineering at the University of the Witwatersrand. He made aliyah in 1989, and started graduate studies at the Israel Institute of Technology (Technion) where he graduated with an MSc in Electrical Engineering specialising in signal and image processing.

“With the xvision, we are able to able to navigate the screws into exactly the correct anatomical position with a high level of accuracy without the need for opening the patient,” he says. “The surgeon is able to see a three-dimensional view of the spine through the skin, and plan and then guide the screws to their correct position. All of this is performed while the surgeon is looking directly at the patient, not at x-ray views on a remote monitor. This paves the way for an increased adoption of minimally invasive spine surgery.” The surgeon wears the device as a headset, which is custom fit to each user.

Augmedics was founded by Elimelech, the current chief executive. “I joined him mid-2015. It was his idea, but he originates from the business and marketing side and he needed someone to work with on the technological aspects. We joined forces and began building the company, raising funds and developing the technology. I had worked in different start-ups in the past, but at Augmedics, we pushed the envelope and drove forward quickly,” says Wolf.

“In one and a half years, we had grown from two to five people, running on seed funding and then we raised a further $8.5 million (R123.2 million) in a round of funding led by the AO Foundation [a non-profit organisation dedicated to improving the care of people with musculoskeletal injuries]. We then grew quickly to about 25 employees and then to our current size of about 40 people both in Israel and in the United States.”

Wolf says that, “Initiating and running a start-up is obviously very intense and most of your time and thoughts are devoted to advancing the company. The initial goal of the company was to develop smart-glasses that provided x-ray-like vision to the surgeon. This would enable performing minimally invasive surgery in unforeseen ways. As development progressed, we realised that we needed to shift slightly and add further capabilities to the system. This is typical of a start-up, where the goalposts are not as fixed. You need to be agile and be prepared to make quick changes. You also need to be prepared to take risks. Often before development is mature, it needs to be demonstrated and used.”

His ultimate vision – no pun intended – is to continue to grow Augmedics into a world leader for surgical augmented reality applications, and to turn the start-up into a successful large company which “improves the health of as many people as possible and provides employment for as many people as possible”.

The xvision system recently received US Food and Drug Administration (FDA) approval. This is a big achievement, as all medical products for sale in the US must have FDA approval.

“The process of FDA approval requires proving to the FDA that the device is able to perform what it claims, and that it can do so without harming the patient, Wolf says. “This requires the company to perform extensive device testing including laboratory testing and cadaver testing. The process usually takes between six to 12 months. There are different routes to FDA approval. The route most companies prefer to go is through the 510(k) process, where you can prove that your device is equivalent to another device on the market. This reduces the amount of testing required.

“As we are the first augmented-reality device to be approved for surgery, the FDA was unsure that we met the criteria for 510(k) approval, and we first needed to overcome this hurdle. This included meeting with the FDA and demonstrating the device to it, which is an unusual step. After successfully moving through this stage, the FDA still had many new questions that we needed to answer and prove. The process in our case took nine months, and we were required to prove safety in two different cadaver trials, open surgery and percutaneous [minimally invasive] spine surgery.”

The next step is to begin sales in the US. “We have a sales and marketing branch headquartered in Chicago with area sales managers spread over the US. As the sales progress, we are also ramping up production, which is another challenge. Following the successful launch of the xvision-spine, we will branch into other medical applications where there is a great need for minimally invasive and guided procedures.”

Wolf says they will focus on launching in Europe next, and thereafter to other markets. South Africa might be one of them.

His advice to young entrepreneurs and start-ups is to “work hard and don’t be afraid to fail. Also know that if you have a good idea that you can show there is a market need for, then you will be able to raise money and you will be able to succeed. Developing technology and then looking for the market for it is usually the wrong path for a start-up.”

He says that although Israel has been branded as the “start-up nation”, the number of people in Israel working in start-ups is relatively small. “It may be large in relation to other countries, but still most of Israeli industry is traditional. Having said that, I would still say that we have a thriving community of scientists, programmers, and engineers in the start-up industry, and we are successful at developing start-up companies. I would prefer to see many more of our great start-ups developing into large companies and not being taken over by multinationals.”