SI-BONE, INC. SI-BONE Corporate Overview
May 2024
Safe Harbor Statement
This presentation contains "forward-looking statements," which are statements related to events, results, activities 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. Risks to SI-BONE's results include the company's ability to introduce and commercialize new products and indications, its ability to maintain favorable reimbursement for procedures using its products, changes in payor requirements for authorization of procedures involving SI-BONE's products,the impact of any future economic weakness on the ability and desire of patients to undergo elective procedures including those using SI-BONE's devices, its ability to manage risks to its supply chain, and future capital requirements driven by new surgical systems requiring instrument tray investment. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these and other risks and uncertainties, many of which are described in the company's most recent filings on Form 10-K and Form 10-Q, and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov), especially under the caption "Risk Factors". SI-BONE does not undertake any obligation to update forward-looking statements and expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
This presentation includes certain non-GAAP measures, including Adjusted EBITDA. For a reconciliation of such non-GAAP measures to GAAP accounting metrics, please refer to the final page of this presentation or SI-BONE's most recent earnings release.
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Market Leader in the Sacropelvic Space
Innovation | Evidence | Education | Commercialization |
4 Differentiated Product Families | 4 Randomized Controlled Trials 1,2,3 | 3,700+ WW Physicians 5,6 | 85 Territory Managers |
79 WW Patents | 130+ Peer-reviewed Publications 4 | 100,000+ Procedures Performed 7 | 250 CSS and Agents |
>$3B Opportunity
Breakthrough Products
Differentiated Health Economics
Scalable Infrastructure
Note: As of March 31, 2024. | |||
1. | Polly DW, et al. Int J Spine Surg. 2016 Aug 23;10:28. [INSITE 2yr] | 5. | Trained and performed at least one procedure since inception of the company. |
2. | Dengler J, et al. J Bone Joint Surg Am. 2019;101(5):400-11. [iMIA 2yr] | 6. | Physicians encompasses surgeons and interventionalist. |
3. | SAFFRON and SILVIA are ongoing RCTs. | 7. Since inception. |
4. www.si-bone.com/results
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Large Addressable Markets with Attractive Fundamentals
Pelvic Trauma 5 | 60,000 |
~470,000
Target U.S. Annual | Sacropelvic Fixation | 130,000 | |
Adult Deformity 3 | + Degenerative Spine 4 | ||
Procedures 1 | |||
> $3 Billion
Total U.S. Addressable
Market 1 | SI Joint Dysfunction 2 | 280,000 |
$0.3 Billion
$1.0 Billion
$2.4 Billion
- Management estimate for existing and potential products in 2024. Total addressable market defined as target case volume x Current ASP.
-
Sources: Jensen M, et al. Magnetic Resonance Imaging of the Lumbar Spine in People Without Back Pain. N Engl J Med. 1994;331:69-116.; Bernard
1987, Schwarzer 1995, Maigne 1996, Irwin 2007,Sembrano 2009.; INSITE RCT data: 5 years in pain and 31% of patients screened were eligible for surgery.; 4. 1.2M therapeutic injections per year with average patient in 5 years of pain = ~280K cases - 30K target procedures; 70K Deformity Procedures (Source: U.S.2020 Wallstreet Report) less Pediatric Procedures (Source:www.hopkinsmedicine.org)
- 100K target procedures: 400K Lumbar Fusion Procedures (Source: 2020 Wallstreet Report); 25% procedures are L4-S1 and L5-S1
(Source: Orthopedic Network News, October 2020) - US Fragility FX TAM: 136K Incidence x 40% surgical candidates = 54K; High Energy FX TAM: 6K Pelvic Trauma Surgeries = 6K Source: Management estimates based on internal research; Melton, et al. (1981). Epidemiologic features of pelvic fractures. Clin Orthop Relat Res; Rommens, et al. (2017). Fragility fractures of the pelvis. JBJS; Demetriades, et al. (2002). Pelvic fractures with abdominal injuries. J Am Coll Surg.
Target U.S. Annual
Procedures
Total U.S. Annual
Addressable Market
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Three Large Unmet Clinical Needs In Sacropelvic Conditions
SI Joint Dysfunction | Pelvic Trauma | Sacropelvic Fixation | ||
15-30% Chronic LBP is SI Joint 1 | 27% Mortality from Bedrest, Downward Spiral 3 | 24% Rate of Failure ASD Surgery 5 | ||
High Burden of Disease 2 | 14-41% Rate of Screw Loosening/Backout 4 | 28% SI Joint Issues Post Spinal Fusion 6 |
1. | Bernard - Clin Orthop Relat Res 1987; Schwarzer - Spine 1995; Maigne - Spine 1996; | 3. | Morris - Postgrad Med J 2000. |
Irwin - Am J Phys Med Rehabil 2007; Sembrano - Spine 2009. | 4. | Wong - J Ortho Surg (Hong Kong) 2019; Kim - Arch Orthop Trauma Surg 2016; Eckardt - Injury 2017; Reuther - Rofo 2014. | |
2. | Cher - Med Devices (Auckl) 2014. | 5. | Eastlack - Spine 2022. |
6. | Manzetti - Clin Spine Surg 2022. |
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Comprehensive Sacropelvic Solutions Portfolio
iFuse INTRA | iFuse TORQ® | iFuse / iFuse 3D | iFuse Bedrock Granite® | |||||
Intra-articular | Cutting-Edge Pelvic Fixation | Market Leader in | Breakthrough Fixation, | |||||
Stabilization & Fusion | & Fusion; and Fragility Fractures | SI Joint Fusion | Fusion, Foundation | |||||
Small surgical profile | TORQLock reduces toggle | 6x > rotational resistance vs. screws2* | Higher pull-out strength vs. Solera5* | |||||
Long length increases joint contact | EZDrive® decreases surgical steps | 2 RCTs, 125+ Peer-reviewed studies3 | Rapid osseointegration | |||||
Intra-articular placement improves stabilization1* | IntelliHarvest® self-harvests bone | Promotes osseointegration4* | Largest neck on the market |
SI Joint Dysfunction
Pelvic Trauma | |||
1. | SI-BONE Technical Study 301310-TS. | Sacropelvic Fixation | |
2. | SI-BONE Technical Study 300610-TS. | ||
3. | Polly - IJSS 2016; Dengler - JBJS Am 2019; www.si-bone.com/results | ||
4. | MacBarb - IJSS 2019 (Part 2). | ||
5. | SI-BONE Technical Study 301098-TS. |
* Biomechanical and animal studies not necessarily indicative of human clinical outcomes.
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Patent Protected Differentiated Platform
- 79 issued patents: U.S. (60), OUS (19)
- 56 pending patents: U.S. (35), OUS (21)
INSTRUMENT | 3-D TECHNOLOGY | ||||||||
▪ | iFuse implant patent until Dec 2025 | ||||||||
▪ | Triangular broach instrument patent until Feb 2034 | ||||||||
▪ | iFuse 3D implant patents until Sept 2035 | Triangular broach instrument and | Rectilinear profile, longitudinal | ||||||
the methods of using the | struts, and struts connecting the | ||||||||
instrument | longitudinal struts | ||||||||
iFuse Bedrock Granite | iFuse TORQ | ||||||||
▪ | iFuse Bedrock Granite® implant patent until Feb 2039 | ||||||||
▪ | iFuse TORQ® implant patent until Nov 2040 | Inner shank with external distal | Helical threads, porous network of | ||||||
threads and an outer sleeve with | struts disposed between the | ||||||||
threads, surface growth features, | threads, and the porous height is | ||||||||
and fenestrations | less than the major thread diameter | ||||||||
Note: As of March 31, 2024
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Portfolio Overview
Sacroiliac Joint Dysfunction Treatments
Non-surgical Management
Medications | External | Radiofrequency |
(NSAIDS, | Support | Ablation |
opiates, etc.) | (SI Joint | |
Belt) | ||
Physical | Therapeutic | |
Therapy | SI Joint | |
Injections | ||
(anesthetic & | ||
steroids) |
Procedures
Bone Allograft | MIS |
SI Joint | SI Joint Fusion |
Stabilization | |
& Fusion |
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REPRESENTATIVE
COMPETITOR
Proprietary, Differentiated iFuse Technology®
Rotation | | 6x resistance |
(vs. 12mm Rialto screw)1 | ||
Strength | | 3x strength |
(vs. stand 8.0mm cannulated screw)2 | ||
Safety | | Low complication rate3,4 |
Revision | | 3.5% (4-year)5 |
Clinical Evidence | | 2 RCTs6 |
Surface | | Porous |
- Proven triangular design and procedure
- Porous, 3D-printed titanium implant
- Bony on-growth,in-growth,
and through-growth7
TPS-COATED iFUSE
CANCELLOUS BONE
3D-PRINTED iFuse 3D
3 MONTH SHEEP STUDY 7
1. | SI-BONE Technical Study 300610-TS. Torsional Rigidity of the iFuse Implant Compared with a SI Joint Screw in a Sawbones Model. | 4. | Whang P, et al. Int J Spine Surg. 2023 Oct 5:8543. |
2. | SI-BONEReport. Strength of materials of the SI-BONE iFuse Implant vs. 8.0 mm Cannulated Screw. Mauldin RG. December 2009. | 5. | Cher DJ, et al. Med Devices (Auckl). 2015;8:485-92. |
3. | SI-BONE Corporate Records. Complaing Handling & Post-market Surveillance. December 2022. | 6. www.si-bone.com/results | |
7. | MacBarb RF, et al. Int J Spine Surg. 2017;11:16 (Part 2). |
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SI-BONE Inc. published this content on 06 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 May 2024 20:44:00 UTC.
