SI BONE : NASS virtual Conference Surgeon Panel Presentation

North American Spine Society

Analyst Surgeon Panel

7:00 - 8:00AM PT

October 8, 2020

Safe Harbor Statement

This presentation contains "forward-looking statements," which are statements related to future events, expectations, results, activities, events or developments that SI-BONE expects, believes or anticipates will or may occur in the future. Forward-looking often contain words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. Such statements are based on SI-BONE's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, especially the information contained in the section captioned "Risk Factors". With respect to the forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.

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Surgeon Introductions

~200 iFuse Cases Performed

Peter Whang, MD	William Tobler, MD
Yale School of Medicine
Mayfield Clinic

Bharat Desai, MD	Robert Eastlack, MD
Panorama
Scripps Health

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Executives Attending

P r o v e n t r a c k r e c o r d s

Jeffrey Dunn	Laura Francis
Chairman, President, CEO & Founder	Chief Financial Officer & Chief Operating Officer
7 time CEO

Tony Recupero	Mike Pisetsky
Chief Commercial Officer	General Counsel & Chief Compliance Officer

W. Carlton Reckling, MD	Nikolas Kerr
Chief Medical Officer
Private practice for 20 years	VP, Global Product Management & Business Development

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NASS - Analyst Surgeon Panel

Peter Whang, MD, FACS

• Medical Education: Duke University, 1999
• Residency: Orthopaedic Surgery, University of California, Los Angeles
• Fellowship: The Rothman Institute at Thomas Jefferson University, Philadelphia, PA
• Board Certifications: AB of Orthopaedic Surgery, Orthopaedic Surgery, 2009, recertified 2020

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Dr. Whang's Background

• Associate Professor, Yale Department of Orthopaedics and Rehabilitation
• Specializes in treating diseases of the cervical, thoracic, and lumbar regions of the spine
• Topic: Prevalence, Education and Treatment of SI Dysfunction

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Prevalence of SI Joint Pain
15-30%	32-43%
Component of chronic LBP	Symptomatic Post-Lumbar Fusion

	30.0%
			27.0%
22.6%
		18.5%
				14.5%
Bernard	Schwarzer	Maigne	Irwin	Sembrano
1987	1995	1996	2007	2009

DePalma - Pain Med 2011

32% Katz 2003

35% Maigne 2005

43% DePalma 2011

40% Liliang 2011

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Burden of Disease: Utility Values

High

Quality of Life

Low

SI joint Pain

Hip osteoarthritis Lumbar stenosis Degenerative spondy Knee osteoarthritis Lumbar spondylosis

Cher - Med Devices Evid Res 2014

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SI Joint Diagnostic Challenges

• SI joint symptoms are similar to those of other lumbar spine and hip conditions
• Imaging studies often inconclusive
• Referral pain patterns from the three

structures overlap

(Lumbar Spine - SI - Hip)

Lumbar Spine - SI - Hip

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Diagnostic Algorithm

Presentation & History

Physical Exam (Lumbar, SI Joint, Hip)

Positive Fortin Finger

Positive Provocative Tests

Positive Intra-articular

SI joint Diagnostic Block(s)

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SI Joint Treatment Continuum

Treatment Intensity

Medications				Radiofrequency
External
(NSAIDS,	Ablation
Support
opiates, etc.)
	(SI Joint Belt)

Therapeutic

SI Joint

PhysicalInjections

Therapy (anesthetic & steroids)

Non-Surgical Management

MIS	Open
SI Joint	SI Joint
Fusion	Fusion

Surgery

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iFuse Implant System®

Unique Patented Design

• Triangular shape (minimizes rotation)
• Interference press fit (immediate fixation)
• Porous titanium surface
  (allows for bony ongrowth/ingrowth for long-term fusion)*

Specifications

3X stronger than screw

(iFuse vs. 8.0mm cannulated screw, Mauldin 2009, SI-BONE)

6X greater rotational resistance than screw

(Test Report. SI-BONE300610-TS Revision A, vs. Rialto)

Clinical Evidence

• ONLY SI joint fusion product with multiple prospective safety and effectiveness publications including 2 RCTs
• More than 80+ peer-reviewed publications (www.si-bone.
  * MacBarb - Int J Spine Surg 2017 (Part 2)

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iFuse - 3D™

Proven triangular shape

1st 3D-printed implant for the SI joint

Demonstrates Substantial

Bone Ingrowth, Ongrowth, and Through Growth1

o Porous surface mimics cancellous bone

• Self-harvestingtechnology
• Ability to apply graft material

1. MacBarb G, et al. Int J Spine Surg. 2017:11;116-28.

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iFuse Procedure Overview

Incision	Pin	Soft Tissue	Measure
(~3 cm)		Protector

Drill	Broach	Insert Implant		Repeat
(optional with			(2 more times)
sharp-tip broach)

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iFuse Implant System® Publications

…...……………………… 10	RCT (INSITE, iMIA)
…………….…………... 9	Prospective, Multicenter
………….……….…. 7	Comparative
………………. 19	Retrospective Case Series
……..………. 8	Systematic Review, Meta-analysis
…………. 7	Cost-effectiveness, Productivity, etc.
…….10	Stability, Implant Placement, etc.
13	Complications, Survivorship, etc.

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Prospective Clinical Studies

RCTs

Deformity - RCT

INSITE	iMIA	SIFI	LOIS	SALLY
NCT01681004	NCT01741025	NCT01640353	NCT02270203	NCT03122899
Investigation of Sacroiliac	iFuse Implant System®	Sacroiliac Joint Fusion with	Long-TermFollow-up in	Study of Bone Growth in
Fusion Treatment	Minimally Invasive	iFuse Implant System	INSITE/SIFI	the Sacroiliac Joint After
	Arthrodesis			Minimally Invasive Surgery
				with Titanium Implants
Multicenter,	Multicenter,	Multicenter, Prospective,	Extended follow-up for	SI joint fusion with the
Prospective, RCT (USA)	Prospective, RCT (EU)	Single-arm	INSITE & SIFI	iFuse-3D implant
2-yearfollow-up	2-yearfollow-up	2-yearfollow-up	5-yearfollow-up	5-yearfollow-up
148 patients enrolled	103 patients enrolled	172 iFuse patients	Safety & Effectiveness	(outcomes & CT scans)
(102 iFuse, 46 NSM)	(52 iFuse, 51 CM)	26 sites	103 iFuse patients from	51 Patients
19 sites	9 sites, 4 countries		select SIFI & INSITE	11 sites
			sites (12)
Publications	Publications	Publications	Publications	Publications
6mo	6mo	6mo interim	3yr	6mo interim
1yr	1yr	1yr	4yr
2yr	2yr	2yr	5yr	(follow-up continues)

SILVIA

NCT04062630

SIJ Stabilization in

Long Fusion to the Pelvis: Prospective Cohort Analysis

Multicenter, Prospective, RCT (USA) 2-yearfollow-up

• Standard multilevel fusion with fixation to pelvis using S2AI screws
• Same + use of iFuse-3D in the "bedrock" trajectory

Site enrollment

in progress

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Consistent Prospective Study Results (INSITE, iMIA, SIFI)

Graphs using data from:

iMIA 24mo data as of August 17, 2017 (publication in progress)

Polly - Int J Spine Surg 2016 (INSITE 2yr) Duhon - Int J Spine Surg 2016 (SIFI 2yr)

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Mean 54-point improvement

Mean 26-point improvement

	Clinically Meaningful Improvement			Clinically Meaningful Improvement
VAS	20 points		ODI	15 points
Source: Childs - Spine 2005;30:1331.	Source: Copay - Spine J 2008

Whang - Med Devices Evid Res 2019 (LOIS 5yr)

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February 2020

Only SI Joint Fusion Device

Cleared by the FDA with

multiple RCTs and prospective

clinical publications

iFuse Implant System Clinical Evidence

Consistent Positive Clinical Outcomes

• Rapid pain relief (~50-point improvement)
• Improvement in back function (~30-point ODI improvement)
• High patient satisfaction (>90%)
• Superior outcomes compared to non-surgical management
• Durable outcomes (out to 5 years)
• Low revision rate (< 5%)
• Better outcomes vs. open fusion
• Solid biomechanical analysis
• Cost-effective

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Bharat Desai, MD

• Medical Education: Temple University School of Medicine
• Residency: Geisinger Medical Center
• Rotating Internship / Residency: Geisinger Medical Center, Orthopedic Surgery
• Orthopedic Trauma Fellowship: Harborview Medical Center/UW School of Medicine

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Dr. Desai's Background

• Clinical Practice: Orthopedic Trauma & Foot/Ankle Panoramaorthopedic & Spine Center, Golden CO
• Orthopedic Pelvis/ Acetabular Surgeon:
• Chief Medical Officer (CMO) OrthoColorado Hospital
• Topic: Sacroiliac Joint Fusion in Trauma and the Role of Telehealth

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Non-Traumatic Fractures Are Often Occult

• Few are identified with plain X-ray
• CT and MRI are more sensitive
• 70% of patients with pubic rami fx also have sacral fx

1. Lyders EM et al. Amer J Neurorad 2010;31(2): 201-210.
2. Sahota O, et al. FFN Meeting. 2019; Abstract 249.

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CTs are 75% Sensitive

Axial CT scans of the pelvis in 2 different patients demonstrate bilateral non-traumatic sacral fractures (white arrows) with mottled sclerosis/lucency and cortical breaks.

Lyders EM et al. Amer J Neurorad 2010;31(2): 201-210.

1

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MRI vs. CT

CT vs MR Imaging

• MRI was substantially better than CT in detecting non-traumatic fractures

• In addition, two or more non-traumatic fractures were frequently present

Cabarrus MC, et al. American Journal of Roentgenology. 2008;191: 995-1001.	1

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Nonsurgical VS Surgical

Nonsurgical management:

Surgical management:

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Non-surgicaltreatment: High Mortality (up to 27%)

148 patients (126 women) were studied:

• 83% (n=123) of patients suffered a pelvic fracture in low energy trauma
• Mean (SD) length of hospital stay was 21.3 (17.6) days
• Inpatient mortality was 7.6% and at one year was 27%
• There was a marked adverse effect on the mobility of survivors with all patients using at least a walking stick at discharge and 51.1% (n=70) needing assistance for mobility
• Rates of institutionalization rose from 20.9% (n=31) at admission to 35.8% (49/137) of survivors at discharge

Morris R, et al. Postgrad Med J. 2000;76 (900):646.

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Post-op: Day 5

Case courtesy of Bharat Desai, MD, Panorama, Golden, CO
*Results may vary	1

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William Tobler, MD

• Undergraduate: University of Notre Dame, 1974; University of Innsbruck, Austria, 1971-1972
• Medical Education: University of Cincinnati College of Medicine, 1978
• Internships: Internal Medicine, 1978-1979, and General Surgery, 1979-1980, Good Samaritan Hospital, Cincinnati
• Residency: Neurosurgery, UC Medical Center & Mayfield Clinic, 1980-1985

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Dr. Tobler's Background

• Clinical Practice
• Sacro Pelvic, Trauma or Adult Deformity Experience
• Topic: The shift in spino-pelvic procedures to the ASC setting and why are sacroiliac fusions with iFuse a good fit.

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Robert Eastlack, MD

• Medical Education: Baylor College of Medicine, MD, 1999
• Residencies: University of California, San Diego, Orthopaedic Surgery, 2005
• Fellowships: Mayo Clinic, Orthopaedic Surgery, Spine, 2006
• Board Certifications: American Board of Orthopaedic Surgery, Orthopaedic Surgery, 2008

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Dr. Eastlack's Background

• MIS degenerative and open/MIS deformity practice
• ISSG member and SRS Adult Spinal Deformity Committee Chairman
• Division Head, Spine Surgery at Scripps Clinic
• Topic: Biomechanical and clinical evidence for long constructs including the ISSG study and SILVIA

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Retrospective, 60 patients (37 IS; 23 S2AI)

6 reop for IS vs. 1 reop for S2AI (OR 8.1)

• 5 reop in IS
• Reoperation higher for iliac bolts

Failure rate at 2 years 26.5%

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Evaluated 35 patients with S2AI screw fixation, PLIF/TLIF at L5-S1

CT analysis with > 2yr f/u

Concluded

• 50% loosening by 2yrs
• Loosening correlated with lower fusion at L5-S1

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Clinical Challenges with Iliac & S2AI Screws

Review

Long Construct	ILIAC	S2 ALAR-ILIAC
Complications	SCREWS (IS)	SCREWS (S2AI)
2015 - 2019, 8 studies with 729 Patients
RE-OPERATION	21.1%	19.0%
2015 - 2019, 5 studies with 575 Patients
PAINFUL PROMINENCE	5.8%	1.7%
2013 - 2019, 6 studies with 610 Patients
SCREW LOOSENING	6.6%	10.2%

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Iliac Screws vs. S2AI Screws

Author	Date	Follow-up	Construct	#	Construct Failure	Infection	Screw Prominence	Halo / Loosening	SI Joint Pain /	Pseudarthrosis
Patients	Pathology
Mazur	2015		2 to 41		Iliac Screw	37	1	1	3	N/A	N/A	7
	mo	S2AI	23	0	1	2	N/A	N/A	2
Guler	2015		6 to 24		Iliac Screw	25	3	N/A	1	2	N/A	N/A
	mo	S2AI	20	7	N/A	0	0	N/A	N/A
Ilyas	2015		Avg 29		Iliac Screw	43	3	15	13	8	N/A	N/A
	mo	S2AI	22	1	1	2	0	N/A	N/A
Ishida	2016		Min 12		Iliac Screw	32	0	4	8	9	3	N/A
	mo	S2AI	68	0	1	2	7	6	N/A
Elder	2017		Min 12		Iliac Screw	25	5	11	3	3	3	2
	mo	S2AI	68	6	1	0	2	6	4
					Iliac	162	12/162	31/137	28/162	22/125	6/57	9/62
	Total			Screw	(7.4%)	(22.6%)	(17.3%)	(17.6%)	(10.5%)	(14.5%)
			S2AI	201	14/201	4/181	6/201	9/178	12/136	6/91
							(7.0%)	(2.2%)	(3.0%)	(5.1%)	(8.8%)	(6.6%)

Mazur et al. JNS Spine 2015;23:67-76

Guler et al. Eur Spine J 2015;24:1085-1091

Ilyas et al. J Spinal Dis Tech 2015;28:E199-E205

Ishida et al. Global Spine J 2017;7:672-680

Elder37 et al. Spine 2017;42:E142-E149

Rates of Loosening, Failure, and Revision of Iliac Fixation in Adult Deformity Surgery

Eastlack RK, Sorceneau A, Mundis GM, Daniels A, Smith JS, Line B, Passias P, Nunley P, Okonkwo DO, Than K, Uribe J, Mummaneni P, Chou D, Kebaish K, Shaffrey C, Bess S, ISSG

ISSG PON-database Inclusion

• ASD (coronal Cobb≥20°, SVA≥5cm, pelvic tilt ≥25° and/or thoracic kyphosis >60°)
• ≥ 18 years old
• 2yr f/u
• >5 level fusion with pelvic fixation

Multicenter with 410 patients with available at radiographs

Endpoints

• Loosening = lucency around the screw on radiographs
• Failure = breakage
• Rod fracture below L4
• Revision surgery

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Results

Overall Rates (iliac and S2AI combined)

Loosening		13.41%
Fracture screw		2.37%
S1 screw loosening		2.92%
Lower rod fracture (below L4)		14.08%
Revision (any)		22.77%
HRQL improvements WORSE with pelvic fixation failures:
PCS 7.69/10.46	p=0.028
SRS 0.83/1.03	p=0.019
ODI 12.91/19.77	p=0.0016

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Conclusion

Substantial rate (29.4%) of pelvic fixation failure following

ASD correction with IS/S2AI screws

Poorer outcomes as a result

Compared to IS, S2AI screws had:

• Higher rate of loosening
• Lower rate of rod fracture

Implications:

• Sacropelvic fixation with long constructs have high failure rates
• Probable differential failure mechanism between iliac and S2AI fixation
• Less optimal/durable clinical improvements with failures

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Pelvic Fixation and the SI joint in Deformity Surgery

Does continued motion at the SI joints cyclically stress the lumbopelvic fixation to failure?

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Effect of Long-Construct Fusion on the SI Joint: Biomechanical Study, J Uribe, et al., 2019

How does additional sacroiliac joint stabilization affect:

• L5-S1Range of Motion
• Sacroiliac Joint Range of Motion
• L5 Screw Stress
• S1 Screw Stress
• S2AI Screw Stress

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Methods

Cadaveric Model

• 7 specimens (5F/2M, 44-66yrs); L1 - Pelvis

Loading

• 7.5 N-m Moments
• • Flexion/Extension
  • Lateral Bending
  • Axial Rotation

Treatment Groups

• Intact
• L2 - S1 pedicle screws + ALIF
• L2 - S2AI + ALIF
• L2 - S2AI + ALIF + SAI (iFuse-3D)

Metrics

• Range of Motion: L5-S1 and SI Joint
• Screw Moments: S1 and S2AI

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BEDROCK: Reduction in SIJ Range of Motion

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S2AI Screw Bending Moment

Bedrock/SI joint stabilization reduced S2AI screw bending moments in all loading directions.

45

Conclusions

• Bedrock stabilizes the SI joint
• Bedrock protects the S2AI screw
• May facilitate SI joint fusion

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Thank you for joining us today

Disclosure

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The iFuse Implant System is also indicated for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. Risk information available upon request.

One or more of the individuals named herein may be past or present SI-BONE employees, consultants, investors, clinical trial investigators, or grant recipients. Research described herein may have been supported in whole or in part by SI-BONE.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc.

iFuse-3D, iFuse Bone, iFuse Decorticator, iFuse Implant, iFuse Navigation, iFuse Bedrock and iFuse Neuromonitoring

are trademarks of SI-BONE, Inc.

© 2019 SI-BONE, Inc. All rights reserved.

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