Personalized Orthopaedics
™
The Eagle-i3D
THA 3D Navigation System
Virtual Planning Meets Clinical Results
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Pre-op Planning Software
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3D PSI Alignment Guides
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Post-op Assessment, Planned vs. Achieved
Not FDA cleared for commercial use
THA 3D NAVIGATION SYSTEM
Not FDA cleared for commercial use
3 Steps to Improved THA Outcomes:
Software Planning App (SaaS)
Precise 3D Pre-Op Planning Features
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Acetabulum: Anteversion/Inclination
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Femoral: Leg Length/Offset
User-Friendly MD Controls
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Mini-viewers: Implant Rotation & Translation
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Visual Controls: Hide/Show Opacity
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Distance Heat Map: Medial Wall Thickness
3D PSI Intra-op Alignment Guides
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Patient Specific Instrumentation (PSI)
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3D Printed
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AI-based Modeling
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Precise Templating
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Open Platform Surgical Approaches (posterior; anterior; lateral)
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Pre-Selected Implants
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Less Instrumentation
Post-Op Assessment & Archive
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Electronic Medical Records
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Analysis Reports & Patient Tracking
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Liability Mitigation
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Patient Education
TECHNOLOGY
Eagle-i3D™ is total hip arthroplasty (THA) alignment system that uses 3D imaging to print Patient-Specific Instrumentation (PSI). Eagle-i3D™ is designed to enhance the surgeon's own skills to improve accuracy, reduce surgical times, achieve a 95% success rate and minimize surgical revisions.
Real Time Metrics
Medial Wall Threat
Alignment Axes
Leg Length, Abduction, Anteversion, Implant-Bone Contact Area
Red, Yellow Green Heat Map
With/without Femur
UNMET CLINICAL NEED
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Hip implants are misaligned 50% of the time during THA surgery
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Estimated $1.3B annual cost for revision hip surgeries
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Approximately 1 out of 5 (20%) of THA surgeries are revised annually
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Surgeons & hospitals are NOT paid for revisions occurring within first 90 days
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Patients requiring revision experience complications including pain and discomfort
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Estimated Medicare & Medicaid penalties of $134M/year
THE EAGLE-i3D PSI SOLUTION
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Designed to improve placement accuracy by 90%
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Designed to reduce surgical times by up to 35%
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May increase surgeon compensation
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May minimize hospital penalties, fines & litigation
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Designed to minimize revisions, saving hospitals $1500/case
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Designed to reduce O.R. time & equipment, saving hospitals up to $525/case
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May reduce post-op recovery time
Our patented use of multiple 3D printed devices in a single procedure to remove bone, confirm bone removal, assist in placing implant and confirm correct implant placement allows for a truly customized surgical procedure.
“the Eagle-i3D instruments can achieve better cup position than any published study of conventional techniques ”
– Alister Hart, et. al.
Professor Alister Hart & LIRC
The Eagle-i3D Hip Replacement System has been validated by renowned academic hip replacement surgeon, Professor Alister Hart, founder and co-director of the London Implant Retrieval Centre (LIRC) – the world's largest failed implant retrieval center Bone and Joint Proceedings Feb/2017 . Alister Hart has collected failed hip replacements from 500 surgeons in 29 countries to determine how and why they fail.
SURGEONS
FOUR KEY SURGICAL STEPS:
1
Remove
Bone
Confirm bone removal
2
Guide implant placement
3
Confirm implant
placement
4
Implant misalignment occurs 50% of time during Total Hip Arthroplasty (THA). The Eagle-i3D™ Hip Replacement System is designed to guide surgeons to a significantly improved success rate in THA.
Eagle-i3D™ Precision
Compared to conventional THA procedures, the Eagle-i3D™
Patient-Specific Instrumentation (PSI) positions the hip replacement precisely along three dimensions – not two, including depth of reaming and optimal angle positioning.
The Eagle-i3D™ Hip Replacement System adheres to the current, well-known THA procedure, and may save up to 35% in surgery time compared to both traditional and robotic procedures.
Eagle-i3D™ Total Hip Arthroplasty
Our Hip Replacement System is designed to improve hip implant placement accuracy by 90%. It assists in the positioning of the acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative CT or MRI imaging scans.
The Eagle-i3D Hip Replacement System first captures individual patient measurements through pre-operative planning and modeling of the orthopedic procedure using a segmented CT scan. Delivery of devices may be provided in as little as 5 days after CT scan images are obtained. Other companies may require as many as 4 weeks to provide devices. Ultimately 3D tools will be printed onsite in hospitals as more 3D printers become more prevalent.
FOUR KEY SURGICAL STEPS
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Bone removal with patient specific device
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Precise confirmation of bone removal
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Accurately guided implant placement
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Confirmation of correct implant placement
Virtual Planning Meets Clinical Results
The Eagle-i3D™ Hip Replacement System is used to place acetabular components in THA procedures in patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis and non-union of femoral fractures.
The Eagle-i3D™ Hip Replacement System is designed to be used in anterior, anterolateral, lateral, posteriorlateral and posterior approaches.
Applies to all three surgical approaches. App accepts virtually all total hip implants.
Poor Outcome (failure)
Eagle-i3D PSI Outcome
As depicted above, Eagle-i3D instruments assist with placement at a desirable inclination angle 40 +/- 10 degrees and anteversion angle of 15 +/- 10 degrees and to a proper depth of planned placement.
HOSPITALS
An estimated 1 our of 5 (20%) of all hip replacements require revision surgery at great expense and patient discomfort. Importantly, surgeons and hospitals are not reimbursed for surgical revisions done within 90 days. The Eagle-i3D™ Hip Replacement System is designed to improve surgeon accuracy by up to 90% relative to conventional techniques – while reducing surgical time.
1,2
Reducing Costs
In addition to the cost of hip revision surgeries, federal penalties are levied on hospitals, averaging $164,000/year/hospital. Approximately 80% of orthopedic surgeons will face litigation for revisions over the course of their career. There is an estimated savings of $1500 per case by limiting revision surgeries, and $525 per case savings in reduced OR time and equipment costs using the Eagle-i 3D™ Hip Replacement System.
The Eagle-i 3D™ Hip Replacement System is designed to achieve improved outcomes, in less time and at lower cost. This allows the average orthopaedic surgeon performing hip replacement to realize improved procedural success and increased income .
Eagle-i3D™ Advantages vs. Robotics
The Eagle-i 3D™ Hip Replacement System demonstrates comparable outcomes to robotic surgery, with 35% faster surgical time at a fraction of the cost – with a one-time price of $2,000 per procedure.
Key Efficiencies
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3D PSI is designed to improve implant accuracy by 90%
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May increase consistency odds for Facility and Surgeon compensation success
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May minimize hospital penalties, fines & litigation
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Designed to minimize revisions, saving hospitals $1500/case
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May reduce O.R. time & equipment by $525/case
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Reduce surgical time by up to 35%
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May reduce post-op recovery time
System Components
The Eagle-i3D™ Hip Replacement System consists of:
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Preoperative plan documentation based on patient's CT scans or MRI imaging
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Six custom-made patient-specific jigs
This allows for precise, directed removal of bone from the acetabulum during THA surgery and accurate placement of the acetabular prosthetic implant at a desired anteversion and abduction angle during hip replacement surgery.
All components are provided non sterile.
All jigs are single-use only.
Jig 1
Jig 2
Jig 3
Jig 3a
Jig 4
CAUTION: Investigational Device. Limited by United states law to investigational use.
3D-CT PSI Implant Guides
PATIENTS
If you or a family member has been diagnosed with a condition requiring hip replacement surgery, ask your orthopedic surgeon about the Eagle-i3D™ Hip Replacement AlignmentSystem.
Did you know that even experienced orthopedic surgeons misalign implants up to 50% of the time during Total Hip Arthroplasty (THA)?
In a small percentage of cases, misalignment may require revision surgery. That's why we developed the Eagle-i3D™
Hip Replacement System to assist your orthopedic surgeon in obtaining a much higher (~ 90%) success rate in THA at reduced cost and discomfort to you.
When the orthopedic surgeon uses the Eagle-i 3D™ Hip Replacement System, patients may have less complications that typically occur as a result of implant misalignment during THA. This may include:
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Leg length discrepancy, which can result in nerve impairment, gait abnormalities and lower back pain.
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Joint instability can result in higher dislocation rates, implant wear and potential revision surgery.
POTENTIAL COMPLICATIONS
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Leg length inequality
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Hip instability/dislocation / Implant loosening
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Premature implant wear
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Hospital re-admission / Revision hip surgery
RESOURCES
American Academy of Orthopedic Surgeons (AAOS)
National Institures of Health (NIH)
Centers for Disease Control (CDC)
REFERENCES
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Bozic KJ, Kurtz SM, Lau E, Ong K, Vail TP, Berry DJ. The epidemiology of revision total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009;91:128–133.
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Orthopedic Network News Volume 22, Number 3, July 2011; Reference to Millenium Research Group Data.
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Bosco, JA 3rd., Karkenny, AJ., Hutzler, LH., et al. Cost burden of 30-day readmissions following Medicare total hip and knee arthroplasty. The Journal of Arthroplasty. 2014; 29(5): 903-5.
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Schwarzkopf R., Schnaser E., Nozaki T., Kaneko Y., Gillman MJ. Novel, Patient-Specific Instruments for Acetabular Preparation and Cup Placement. Surg Technol Int. 2016 Oct 26;XXIX:309-313.
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http://www.stephenmurphy.org/cv/Steppacher%20Mechanical%20Cup%20Navigation.pdf
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Eagle-i3D data on File.
CAUTION: Investigational Device. Limited by United states law to investigational use.
OUR TEAM
EXECUTIVES
Jeff Chandler
Chief Executive Officer
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35+ Yrs. in Orthopedic Medical Devices
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Early-stage Formation/Commercialization
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Zimmer; SNN; Linvatec/ConMed; Startups
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Aquarius Medical: Founder (venture-backed)
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Capital; Disposables; Implants; OrthoBiologics
Michael Gillman, MD
Founder, CMO
CEO 2012-17. Dr. Gillman is a leading orthopedic surgeon in Southern California, a pioneer in out-patient patient-specific joint replacement, and #1 Mission Hospital joint replacement performer: lowest readmission, shortest length of stay, low-est discharge to SNF, lowest cost. Mike received a Masters in Biological Sciences from Stanford, MD from Case Western, Alpha Omega Alpha, & residency training from Harvard & Tufts faculty.
James Ham
Executive
Mr. Hamm is a successful entrepreneur in the ophthalmic and orthopedic markets. Prior to BullsEye, Jim served for six years as CEO at SynergEyes. Before SynergEyes, Jim was President & CEO at Kineticos, successfully positioning the orthopedic company for sale to Integra Lifesciences. Before that, Jim was Director of Sales and Marketing at Allergen.
SCIENTIFIC ADVISORY BOARD
Ran Schwarzkopf, MD
Leading East Coast hip and knee surgeon, NYU Langone. Dorr Award winning paper 2015. Ran completed his Medical Degree and a Master in Biomechanical Engineering in 2006. He received orthopaedic surgery training at the NYU Langone Hospital for Joint Diseases, and further
specialized in hip and knee surgery at the
Brigham and Women’s Hospital, affiliated with Harvard Medical School.
Derek Amanatullah, MD
Assistant Professor of Orthopedic Surgery,
Stanford University Medical Center. Dr. Amanatullah specializes in hip and knee replacements for individuals with osteoarthritis, rheumatoid arthritis, infectious arthritis and avascular necrosis. He also performs revision surgeries of knee and hip implants with
problems.
Ed Domanski
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Industry manufacturing expert
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Launched 3D PSI TKA into US (Zimmer; SNN)