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Management's Discussion and Analysis of Financial Condition and Results of Operations 67 Item 7A.
Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans, of which we estimate 1.1 million are annual surgical candidates.
To further support the needs of surgeons and bunion patients, we offer the Adductoplasty Midfoot Correction System, designed for reproducible surgical correction of the midfoot, two systems for minimally invasive osteotomy procedures, namely the Nanoplasty 3D Minimally Invasive Bunion Correction System and the Percuplasty Percutaneous 3D Bunion Correction System, and the SpeedMTP System for great toe fusions.
We continue to expand our footprint in the marketplace by extending our SpeedPlate Rapid Compression Implant platform to new applications, as well as providing surgeons with advanced digital solutions with our IntelliGuide patient specific, pre-op planning and cut guide technology .
We also provide a direct-to-patient outreach program that educates patients on the benefits and risks of our Lapiplasty System and other products with a "Find a Doctor" tool on our website that allows potential patients to search for surgeons trained on our procedures and products in their local markets.
Bunions generally increase in prevalence and severity over time.
Bunions are in reality complex 3D deformities caused by deviation and rotation of the metatarsal bone in three anatomic dimensions as shown below.
Certain published long-term clinical studies have demonstrated highly variable recurrence rates ranging from 3.6% to 78% following 2D Osteotomy surgery and 38% following Lapidus Fusion surgery.
We believe surgeons have become increasingly aware of the need for 3D bunion correction based on the frequency of lectures and medical journal publications on this topic in recent years.
Our single-use, sterile-packed implant kits feature low-profile titanium fixation designed to stabilize the TMT joint and to allow early weight-bearing in a walking boot during the critical healing period.
REMOVED
Management's Discussion and Analysis of Financial Condition and Results of Operations 66 Item 7A.
To further support the needs of bunion patients, we have introduced our Adductoplasty Midfoot Correction System, designed for reproducible surgical correction of the midfoot.
We continue to expand our footprint in the foot and ankle market with the introduction of our SpeedPlate Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty and Adductoplasty Procedures, as well as other common bone fusion procedures of the foot.
In 2024, we initiated limited market releases of a number of new products, including two systems for minimally invasive osteotomy surgeries: (1) the Nanoplasty 3D Minimally Invasive Bunion Correction System and (2) the Percuplasty Percutaneous 3D Bunion Correction System.
Additionally, we have developed a differentiated direct-to-patient outreach program that educates patients on the benefits and risks of our Lapiplasty System and other products.
We also offer a "Find a Doctor" tool on our website that allows potential patients to search for surgeons trained on our procedures and products in their local markets.
We have experienced considerable growth since receiving 510(k) clearance for the Lapiplasty System in March 2015.
Our revenue increased from $39.4 million in 2019 to $209.4 million in 2024, representing a compound annual growth rate of 40%.
Bunions affect approximately 67 million Americans and generally increase in prevalence and severity over time.
(2) Approximate number of surgical bunion procedures performed in the United States per year according to iData Research, Inc.