Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year.

While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery. “There is no other device … that is using both the technology of augmented reality on a headset and has the full capabilities of surgical navigation, of tracking the surgical instrument very precisely to locate and guide the surgeon throughout the surgery,” Nissan Elimelech, Augmedics’ founder and CEO, told BioWorld MedTech. He added that initial shipments of headsets and systems to hospitals will begin in the first quarter of 2020.

The FDA cleared the XVS system, with XVS software, “as an aid for precisely locating anatomical structures in either open or percutaneous spinal procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy.” The predicate for the 510(k) submission was Medtronic plc’s Stealthstation S8 surgical navigation system

The system is comprised of a transparent near-eye-display headset, as well as the capabilities found in a traditional surgical navigation system. It plots the real-time positioning of surgical tools and superimposes a virtual trajectory over the patient’s CT imaging data. Using the headset, the navigation data is then projected in 3D onto the surgeon’s retina, enabling him or her to see both the patient’s anatomy and navigation guidance without looking away to a remote screen.

Agnostic to other instruments

Xvision Spine system. Credit: Augmedics Ltd.

In addition to the headset, the system includes a set of universal adapters, allowing it to be used with any instrument the physician chooses and a single-use marker set similar to those used with conventional surgical navigations systems.

The FDA based its decision on a percutaneous laboratory study with XVS at Rush University Medical Center (RUMC). Investigators positioned 93 screws in the thoracic and sacro-lumbar areas of five cadavers using the system and compared the trajectory with the actual screw tip positions. The overall clinical accuracy, assessed by two independent neuroradiologists, was 98.9%, based on the Heary and Gertzbein scales, which measure thoracic and lumbar accuracy, respectively.

“The ability that Augmedics’ xvision provides to visualize the patient’s spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing,” said Frank Phillips, professor of orthopedic surgery at RUMC and one of the investigators in the study. “The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field – as well as the ability to ‘see the spine’ through the skin in minimally invasive procedures – differentiates the Xvision from conventional spinal navigation platforms.”

Economical

Elimelech also underscored the XVS’s cost-effectiveness. “Because of the small footprint of only a headset, we can actually take down the cost to sell the device for a nominal fee,” he said.

Augmedics has not yet set a price for the XVS system, but Elimelech said it will be a fraction of what conventional surgical navigation systems cost – somewhere in the $20,000 to $50,000 range, vs. $300,000 to $500,000.

“Augmedics’ mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow,” Elimelech said. “Xvision is our first product of many to follow that will revolutionize surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow and help them do their jobs as effectively and safely as possible.”

Future indications

With FDA clearance for the spine indication in hand, Augmedics is starting to explore other applications for its XVS system. Among the potential future indications are cranial/brain surgery, joint reconstruction, trauma surgery and ear, nose and throat procedures. “Basically, any procedure that requires high precision, the xvision can be a great platform to help surgeons navigate their implants and instruments,” Elimelech said.

Meanwhile, the company is pursuing marketing authorization for the XVS system in the EU and hopes to earn CE mark approval in the coming year.

Founded in Yokneam, Israel, in 2014, privately held Augmedics is currently conducting a series B financing to support its commercialization efforts in the U.S. The company hopes to raise $20 million to $30 million by the time the financing closes in mid-2020, with plans to increase its commercial team “exponentially,” Elimelech said. To date, Augmedics has raised a total of about $20 million, including seed rounds, an $8.3 million series A in 2017 and $10 million from bridge financing this year – part of the ongoing series B.

Earlier this year, Augmedics made the strategic decision to flip from an Israeli to a U.S.-based company. It now has a full-time staff of 13, including a president, vice president of sales, marketing manager and eight area sales managers.