Insight Medical Systems gained 510(k) clearance from the FDA for its flagship product, ARVIS® (Augmented Reality Visualization and Information System). This is the first wearable surgical navigation system to be cleared for both hip and knee arthroplasty. ARVIS combines tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty.  Unlike other augmented reality (AR) platforms, ARVIS is the first system with proprietary hardware designed to assist arthroplasty surgeons in enhancing component positioning precision to improve joint arthroplasty outcomes.

“Developing our own hardware allowed us to make a system that’s optimized for arthroplasty surgeons and to avoid the compromises that come with adapting off the shelf augmented reality glasses,” said Jonathan Nielsen, VP of R&D at Insight.

“This is an important milestone for Insight.  We are excited to move forward with commercializing ARVIS with our partner DJO and to bring the benefits of augmented reality to hip and knee surgeons without the typical cost and complexity,” said Nick van der Walt, CEO of Insight.

In March of 2021, DJO® announced a strategic investment in Insight Medical Systems to support DJO’s commitment to the growing computer-assisted surgery market.  ARVIS® complements DJO’s ASC 360™ solutions and adds to their full range of implant solutions, surgical tools, and digital care solutions that uniquely span the continuum of care, well positioning DJO as a leader in the rapidly expanding ASC setting.    

Austin, TX, March 30, 2021 – DJO, a subsidiary of Colfax Corporation (NYSE:CFX), is a leading global provider of medical technologies to get and keep people moving, today announced a strategic investment in Insight Medical Systems (“Insight”), a technology company dedicated to wearable surgical navigation in orthopaedics. Insight’s flagship product, ARVIS® (Augmented Reality Visualization and Information System), will combine tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty. Unlike other augmented reality (AR) platforms, ARVIS is the first system with proprietary hardware designed to assist arthroplasty surgeons in enhancing component positioning precision to improve joint arthroplasty outcomes.

The Computer Assisted Surgery (CAS) Technology market is growing at a compound annual growth rate (CAGR) of 32%1. Similarly, the shift in the site of care from hospitals to Ambulatory Surgery Centers (ASCs) is expanding rapidly. If half of routine total joint cases were done in the ASC, UnitedHealth Group quantified this shift as having the potential to help 500,000 patients avoid overnight hospital stays and save $3B annually2. As surgeons look to incorporate technology into their surgical workflows whether at the hospital or ASC, the discussion often focuses on balancing the clinical benefit of a technology with the added time and cost associated with it. The high acquisition cost of current CAS systems can include a capital-intensive investment as well as per-case disposables and service contracts. These costs, along with the large footprint of technologies like robotics, are particularly restricting for ASCs.

“DJO® has been partnering with the orthopaedic surgeon community to understand their technology needs across all anatomies and in all settings in which they operate,” said Louis Vogt, President and General Manager of DJO Surgical®. “The Insight team has developed an impressive 3D AR technology that tracks the surgeon’s viewpoint and delivers navigation and patient-specific information right at the surgical site in a highly efficient and seamless workflow. ARVIS complements DJO’s ASC 360™ solutions and adds to our full range of implant technologies, surgical tools and digital care solutions that uniquely span the continuum of care.”

“We’re thrilled to partner with a leading MedTech company that has an impressive growth trajectory,” said Nick van der Walt, CEO of Insight. “DJO and Insight have a shared vision of improving clinical outcomes with technology in a streamlined, cost-effective way. We will build on the current capabilities of ARVIS in knee and hip arthroplasty and expand to other indications in orthopaedics.”

For ease of use, the ARVIS system will be compatible with existing surgical helmets, and a single tray of trackable instruments eliminates the need for disposables. Insight will leverage DJO’s sales channel to launch ARVIS in the second half of this year. The EMPOWR™ Partial, Primary and Complex Primary Knee and Hip implant systems will be compatible. The EMPOWR portfolio is the culmination of research, clinical legacy and material technologies that have resulted in hip and knee products that help restore healthy kinematics and provide surgical efficiencies optimized for today’s health care environment. Driven by premium, intelligently designed single-tray instrumentation, these implant systems have up to a 50% reduction in storage and sterilization costs compared to similar products on the market3.
For more information about DJO’s EMPOWR brand and ASC 360 offering, visit djoglobal.com/empowr and djoglobal.com/asc360.

About DJO®
DJO, a subsidiary of Colfax Corporation (NYSE: CFX), is a leading developer and distributor of high-quality medical devices that provide proven solutions for musculoskeletal health, joint reconstruction, vascular health, and pain management. The Company’s extensive range of products and integrated technologies address the orthopedic continuum of care from performance and mobility to surgical intervention and post-operative rehabilitation; enabling people around the world to regain or maintain their natural motion. For additional information about DJO, please visit www.DJOGlobal.com.

About Insight Medical Systems
Insight Medical Systems is a medical device company with a focus on orthopedic surgical procedures. It is leveraging augmented reality technology to provide a highly cost effective and easy-to-use alternative to surgical navigation systems and robots. Insight is currently expanding their R&D and Marketing teams to accelerate product development and prepare for commercialization. Prospective candidates should email resumes to info@insightmedsys.com. For additional information about Insight, please visit www.insightmedsys.com.

ARVIS is pending clearance by the FDA.

ARVIS is a registered trademark of Insight Medical Systems.

References

  1. SmartTrak Computer Assisted Surgery Revenue projections: https://www.smarttrak.com/
  2. https://www.unitedhealthgroup.com/newsroom/research-reports/posts/2020-12-10-research-ambulatory-surgery-centers-490916.html
  3. Based on calculation of no. of trays compared to DePuy Pinnacle and Zimmer Biomet G7. https://www.ajog.org/article/S0002-9378(16)30358-1/pdf for cost of sterilization https://www.corailpinnacle.net/sites/default/files/2018-10/DSEMJRC05181044%20PINNACLE%20Surgical%20Technique.pdf
    https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/hip/2336.2-GLBL-en_G7%20Surgical%20Technique.pdf

    Based on calculation of no. of trays compared to Oxford Uni Knee.
    https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/oxford-partial-knee-microplasty-instrumentation-surgical-technique.pdf

DJO Contact:
Ashley Brown
ashley.brown@djoglobal.com


Insight Contact:
Nick van der Walt
nvanderwalt@insightmedsys.com

PRESS RELEASE
February 19, 2019

 

LAGUNA HILLS, CA – Insight Medical Systems, Inc. conducted its first cadaveric evaluation of
ARVIS™, its Augmented Reality Visualization and Information System. At this pioneering event, each
surgeon was able to successfully achieve three landmark goals by navigating a distal femoral and
tibial resection in a knee procedure, navigating an acetabular cup position in a hip procedure
according to their preferred approach, and measuring leg length and joint offset.

To create this immersive augmented-reality visualization and navigated execution system, ARVIS™
combines tracking cameras with both a 3D display and handsfree interface in a standalone surgical
headset. The system, which includes a single tray of trackable instruments, provides the surgeon
with key data without the need for imaging or external equipment, as is seen in the traditional
medical technologies of computer navigation and robotics. ARVIS™ is worn and controlled by the
surgeon, tracks from the surgeon’s viewpoint, and delivers information to the surgeon right at the
point of care.

After the lab, Michael Alexiades, M.D. stated, “The cadaver lab for both hip and knee replacement
has shown me ARVIS™ is intuitive and natural to use, and highlights that the potential of this
technology is not for the far future, but is ready to implement now.”

“The lab was a great success and we are pleased to have reached this important milestone,” said
Nick van der Walt, Insight’s founder and CEO. “It was exciting to see ARVIS™ working in a surgical
environment for the first time. We’re looking forward to completing the development of the
product and obtaining FDA clearance.”

Insight Medical Systems will be exhibiting at this year’s AAOS Annual Meeting in Las Vegas, March
13-15 at booth #6534.

Please visit www.insightmedsys.com for more information regarding Insight Medical Systems.

 

About Insight Medical Systems
Insight Medical Systems is a medical device company with a focus on orthopedic surgical
procedures including spinal fusion, joint replacement and ACL reconstruction. It is leveraging augmented
reality technology to provide a highly cost effective and easy-to-use alternative to surgical navigation
systems and robots. The addressable market in the USA for computer assisted surgery in orthopedics is
estimated to reach $1 Billion by 2021.

The device referenced in this statement is not cleared by the FDA for distribution in the USA.

Media Contacts:
Jonathan Nielsen
VP of R&D
jnielsen@insightmedsys.com
949-468-7775

 

 

PRESS RELEASE
July 9, 2018

Onkos Surgical® and Insight Medical Systems team up to explore applications of augmented reality in musculoskeletal oncology.

 

LAGUNA HILLS, CA – Insight Medical Systems (Laguna Hills, CA) has teamed up with Onkos Surgical, Inc. (Parsippany, NJ) to explore opportunities to apply Insight Medical’s ARVIS™ (Augmented Reality Visualization and Information System) in musculoskeletal oncology. The companies are working on a pilot project to assess the technology for use in tumor surgery.

ARVIS™, currently under development, has tracking and visualization capabilities which allow precise and efficient execution of surgical plans. The headset has the ability to project virtual models of the patient’s anatomy into the surgeon’s field of view during the surgical procedure so that anatomical structures beneath the surface are visible. Similarly, virtual models of the implants or instruments are projected so that the surgeon can see their relationship to the hidden anatomical structures. Key measurements, such as the orientation and position of instruments and implants relative to the patient’s anatomy, are displayed. This may enable less invasive surgery, improve outcomes and reduce patient risk.

“Onkos Surgical is investing heavily in capabilities and technology to bring innovation to musculoskeletal oncology surgeons. Augmented reality technology has the potential of simplifying the complex and providing surgeons with input and feedback that may improve the precision of surgical planning and interoperative workflow. This technology fits well with our portfolio of Precision Oncology solutions,” said Patrick Treacy, CEO and co-founder of Onkos.

“The convergence of 3D imaging, modeling and printing with advanced simulation technology will be transformative for oncology surgeons,” said Shervin Oskouei, MD, Assistant Professor of Orthopedic Surgery at Emory University School of Medicine in Atlanta, Georgia. “Oncology surgeons are working on complex pathologies that require precise surgical intervention. Augmented reality may present an interesting approach to navigating these complex reconstructions.”

“We’re excited to partner with Onkos, who is a leader in the field of orthopedic oncology,” said Jonathan Nielsen, Vice President of R&D, Insight Medical Systems. “There is a great opportunity to improve precision and visualization in these complex procedures, and Onkos is an ideal partner to jointly develop a system that complements their expertise in surgical planning and implant design.”

 

About Insight Medical Systems
Based in Laguna Hills, CA, Insight Medical Systems is a medical device company with a focus on orthopedic surgical procedures including spinal fusion, joint replacement and ACL
reconstruction. It is leveraging augmented reality technology to provide a highly cost effective and easy-to-use alternative to surgical navigation systems and robots. The addressable market in the USA for computer assisted surgery in orthopedics is estimated to exceed $1 Billion by 2022. For more information, visit www.insightmedsys.com

About Onkos Surgical
Based in Parsippany, NJ., Onkos Surgical is a privately held surgical oncology company founded in 2015. Onkos Surgical believes surgical oncology deserves attention, focus and innovation. Through dedication and strategic partnerships, Onkos Surgical will advance surgical oncology solutions and advocate for and support the surgeons and caregivers that dedicate their lives to the surgical treatment of cancer. For more information, visit www.onkossurgical.com

Media contacts:

Sean P. Curry
Senior Vice President, Commercial Operations
scurry@onkossurgical.com
(973) 264-5400

Nicholas R. van der Walt
CEO
nvanderwalt@insightmedsys.com
(858) 225-9882

LAGUNA HILLS, CA – Insight Medical Systems is a game-changing startup that offers augmented reality navigation for orthopedic surgical procedures such as spinal fusion, joint replacement, and ACL reconstruction. Despite the proven benefits of surgical robots and navigation systems, these large systems have not been widely adopted in orthopedics due to their high cost, steep learning curve, and poor usability. Insight is leveraging maturing augmented reality technology to provide a highly cost-effective and easy-to-use alternative that the surgeon can wear. The addressable market in the USA for computer assisted surgery in orthopedics is estimated to reach $1 Billion by 2021.

The ARVIS™ system being developed has tracking and visualization capabilities which allow precise and efficient execution of surgical plans. The headset projects virtual models of the patient’s anatomy into the surgeon’s field of view during the surgical procedure so that hidden structures beneath the surface are visible. Similarly, virtual models of the implants or instruments are projected so that the surgeon can see their relationship to the hidden anatomical structures. Key measurements, such as the orientation and position of instruments and implants relative to the patient’s anatomy, are displayed. This can enable less invasive surgery, improve outcomes and reduce patient risk.

With consistent enthusiastic and positive feedback from surgeons, ARVIS™ shows great promise for quick adoption after its scheduled release in early 2019. David Mayman, M.D. stated, “This is a huge leap forward in computer navigation… navigation unplugged! Finally, there are no issues with line of sight and no big computers in the room.”

“Insight is creating a new standard of care in surgical navigation”, said founder and CEO, Nick van der Walt. “We’re taking the accuracy of a large console navigation system, but condensing that into something the surgeon can wear. In doing that we hit three prime benefits: provide the accuracy, have something that’s cost-effective, and something that’s efficient.”

Insight Medical Systems will be exhibiting at this year’s AAOS meeting in New Orleans, March 7-9, at booth #7013. Contact info@insightmedsys.com to schedule a hands-on demo to see what Insight’s technology is capable of.

Please visit www.insightmedsys.com for more information regarding Insight Medical Systems.

 

About Insight Medical Systems: Insight Medical Systems is a medical device company with a focus on orthopedic surgical procedures including spinal fusion, joint replacement and ACL reconstruction. It is leveraging augmented reality technology to provide a highly cost effective and easy-to-use alternative to surgical navigation systems and robots. The addressable market in the USA for computer assisted surgery in orthopedics is estimated to reach $1 Billion by 2021.