1 gps with surgeon’s checklist ™ software. low cost, technologically advanced outcome for the...

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GPS with Surgeon’s Checklist™ software

Low cost, technologically advanced outcome for the orthopedic surgeon

• Radlink intra-operative radiographic information offers best quality image, lowest cost, ease of use, quick results and superior patient outcomes.

• Improves productivity and quality of THA, TKA and other implant procedures.

• Enables correct placement of implants in virtually all situations. Hospital avoids ACA penalties for readmission and complications.

• Checklist developed through close working relationships with leading Posterior Approach (Brad Penenberg) and Anterior Approach (Joel Matta) surgeons .

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GPS & Surgeon’s Checklist™* software *Patent

Allowed

Radlink GPS

POSTERIOR APPROACH

• Images appear in four seconds.• Surgeon's Checklist™ ensures proper implant fit. • Supervision allows us to be online with any Radlink unit.• PACS provides access to pre-op images .• Template software can be imbedded in pre or intra-op image.• Wireless. Works with any X-ray generator in market.• Quantitative data for surgeon to defend his practice in litigation• Image viewing area is 2-4x that of C-Arm (regular/mini)

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Posterior Approach THA

• Patient position: automatically draws reference lines to reconcile position• Calculates pelvic inlet diameter (Tilt) ratio to compare pre-op and intra-op

tilt• Automatically prompts patient rotation correction suggestions• Limb length measurement: automatic with either teardrop or trans-ischial

line• Offset measurement• Cup abduction angle measurement• Cup anteversion angle measurement• Precise magnification calculation

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Anterior Approach THA• Connects to any C-Arm.• Surgeon's Checklist™ ensures proper implant fit.• Radiographic ellipse overlay for inclination and anteversion angles.• LLD and offset can be measured/verified by digital overlay of pre-op and

intra-op limbs, on full AP pelvis taken on 12” C-Arm, or by stitching operative and contra-lateral images together.

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Anterior Approach THA• Ilioischial line to tear drop angle allows for accurate inclination.• Software auto-detects bony landmarks.• Eliminates cost and time of printing and shortens surgery times.• No need to break scrub – use sterile instrument and touch screen.

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Acetabular Cup Positioning

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Pick & choose auto-detected bony landmarks

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Anterior Approach:Overlay operative side over non-operative side

for LLD/Offset Verification

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Total Knee Arthroplasty (TKA)

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Incidence of Cup Malpositioning with Conventional THA

Callanan M., Jarrett B., Bragdon C., Zurakowski D., Rubash H., Frieberg A., Malchau H., Risk Factors for Cup Malpositioning, Clin Orthop Relat Res (2011) 469:319-329

•Retrospective study at Massachusetts General Hospital•Evaluated Post-op AP pelvis and cross-table lateral radiographs on 1750 patients who underwent primary THA or revision (1709 hips were primary THA)•Defined acceptable abduction range as 30◦ - 45◦ and acceptable anteversion range as 5◦ to 25◦

Results•63% of cups were within the abduction range•79% of cups were within the anteversion range•Only 50% of cups were in the range for both abduction and anteversion range

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Radlink GPS – Clinical DocumentationIntraoperative digital radiography: An opportunity to assure1

Penenberg et al.

Methodology

Consecutive prospective evaluation of 139 primary THAs using digital radiography1

AP radiography with patient in the lateral decubitus position taken after acetabular component placement and femoral trial insertion

Implant position and sizing were adjusted according to the radiograph

Final intraoperative film was compared to a postoperative standard radiograph in supine position at 2 weeks postoperatively to verify the accuracy of intraoperative digital imaging.

1Penenberg B, Woehnl, A., Intraoperative digital radiography: An opportunity to assure, Seminars in Arthroplasty 25 (2014) 130-134.

Radlink GPS – Clinical DocumentationIntraoperative digital radiography: An opportunity to assure1

Penenberg et al.

Results

In 98% of cases, intraoperative measurements were within 5◦ of postoperative onesIn 90% of cases, intraoperative measurements were within 3◦ of postoperative onesThe mean intraoperative cup abduction angle was 40 ◦ (range 23◦-52◦) and the mean postoperative cup abduction angle was 41◦ (range 25◦-55◦)Cup orientation was adjusted in 10% of casesFemoral component was upsized in 55% of casesIntraoperatively measured limb length discrepancy and offset were within 3mm of the post-operative measurement in all cases


Radlink Economic Value PropositionReduces time/cost required for intraoperative imaging in posterior approach cases

• GPS offers 4 second x-ray vs. 12 minutes to process film

• Time savings result in reduced cost per case of approximately $8,000

• Total time for intraoperative x-ray and measurements is less than 2 minutes per case (does not require extra time like navigation)

Eliminates the need to print out C-arm images during anterior approach cases

• Estimated cost to print C-arm images @ 12 cases/week = $11,000/year

*Assumes 4 intra-operative x-rays are taken per case and assumes OR time is valued at $100-$200 per minute

Radlink GPS Economic Value Proposition

Potential to reduce incidence of dislocation and associated costs of closed reductions and revision surgery •Ability to verify proper cup position with GPS may reduce incidence of dislocation

•Improper cup position is leading cause of dislocation

•In one study summarizing costs of hip dislocation following primary THA at Mayo Clinic, hospital saw total of 99 dislocations over 5-year period.1

•Dislocation resulted in $2,433 additional cost per closed reduction and $13,717 additional cost per revision surgery ¹

•Total institutional cost over 5-year period was $718,713 ($143,743/year)*

1Sanchez-Sotelo J, Haidukewych J, Boberg C, Hospital Cost of Dislocation After Primary Total Hip Arthroplasty. Journal of Bone and Joint Surgery (88) February 2006

*Costs included operating room and implants, hospital and nursing, orthopedic surgeon, pharmacy, physical therapy, laboratory medicine, anesthesia, radiology, central supply, internal medicine consults, and pathology

Radlink GPS Economic Value Proposition

May reduce re-admission penalties•With GPS, x-ray normally taken in recovery room is now taken before closing up

•Medicare charges $265,000 for each excess readmission after knee or hip replacement surgery that is above the U.S. average

Potential to reduce litigation•Use of GPS to compare limb length of operative and non-operative side may reduce incidence of leg length discrepancy

•Limb length discrepancy is leading reason for malpractice suits in orthopedics

Competitive Overview

Radlink GPS is the most technologically advanced computer assisted surgery system at the lowest cost and lowest radiation levels

Category: Radlink

GPSMAKO

Rio RobotStryker

CASDigital X-ray Systems

(Carestream, GE, Fuji…)Film X-ray

Cost: $95,000 $1,000,000+ + CT system

$250,000 $150,000+$3 per X-ray in consumables

Intra-op X-Ray Quality: Superior No intra-op images No intra-op images Superior Acceptable

Time for Image: 4 seconds No intra-op images No intra-op images 6-8 Seconds 10 minutes

Surgeon Checklist (or Guidance):

✔ ✔ ✔

Radiation vs. chest X-ray

0.7x0.07 mSv

15x (CT pre-op)1.5 mSv

None (infrared)0 mSv

0.7x0.07 mSv

1x0.1 mSv

Wireless: ✔ ✔ ✔ optional ✔

PACS/Office Connectivity:

✔ optional optional optional NO

Functions with any implants

✔ ✔ ✔

Functions with any X-ray systems

✔ ✔

No Reference pins required

✔ ✔ ✔

Radlink GPS vs. Robotics• Approximately 1/10 the price• No Pre-operative CT Scan Required (often not reimbursed, cost

absorbed by hospital)• Minimal incremental time (< 2 minutes) added to workflow• No per-case disposables cost (estimate: $1,200 for certain

robotics systems)• GPS has less than 1/15 the radiation exposure of robotics system• Small footprint and portable• Significant annual warranty cost for robotics system

(approximately $100,000)

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Radlink GPS vs. MAKO: Accuracy of Intra-operative Measurements

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As a %of Total

Radlink1 7 out of 139 5%

MAKO2 5 12% of total 7 16% of total 12 out of 48 25%

Inclination Outliersbetween 5-10%

Anteversion Outliersbetween 5-10%

Total Outliersbetween 5-10%


2Vaibhav K, Dorr L, Banks S, Zhang Z, Wan Z, Precision of Robotic Guided Instrumentation for Acetabular Component Positioning, Journal of Arthroplasty 30 (2015) 392-397

Comparison of Intra-operative vs. Post-operative angle measurement

With Radlink GPS, only 5% of post-operative measurements were more than 5% different from the intra-operative measurement

Radlink Hub

• Radlink Hub software is designed to connect large communities of PACS users

• Remote Diagnosis Consultation made extremely easy with integrated workflow

• Successful across slow internet links found in developing countries

Value-added to Radiology

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Cedars-SinaiDiagnostic Center

(HUB)

MedicalClinic

CommunityHospital

Orthopedic SurgeryCenter

ChiropracticTherapy Clinic

CardiologyClinic

Connected 55 Cedar Sinai Facilities to Cedars Sinai Radiology center offering capability of secondary opinion by a specialist

Radlink Hub at Cedars Sinai

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Created software architecture allowing images from GE, Fuji, Siemens, Radlink equipment to be broadcast across hospital network and internet

Luan People Hospital

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FastMed Urgent Care Centers

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And other non-Radlink Clinics

United Health Care Network

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And other non-Radlink Clinics

Radlink can assist hospitals in closing Remote Diagnosis contracts with hospitals in China.

Current contracts between Chinese hubs and US hospitals:• Dalian Central streams images to Cedars Sinai. • Luan Peoples Hospital streams images to UCLA.• Nanchong Central Hospital streams images to Cedars Sinai.• Dalian University contract currently being offered.• Numerous additional contracts will be awarded this year for up to $120,000/year. • Radlink hardware and software controls the information flow in China and the US.

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Tibet

Harbin

Qui Qui Har

Inner Mongolia

Dalian Central Hostpital Cedar Sinai, USA

$120,000/year

Radlink Remote Diagnosis

Radlink Hub

Software

Rural clinics 52 other sites

International Remote Diagnosis Opportunity

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• USA FDA

• China CFDA

• European Conformity (Conformité Européenne)

• UL Certified

Worldwide Regulatory Approvals

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1 gps with surgeon’s checklist ™ software. low cost, technologically advanced outcome for the...

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