Tenon Medical, Inc. (“Tenon”), a medical device company formed in 2012, has developed a proprietary U.S. Food and Drug Administration (“FDA”) cleared surgical implant system, which is designed to optimize sacroiliac joint (“SI-Joint”) fixation / fusion surgery and corresponding outcomes. Tenon is preparing a national launch of this system to address the greatly underserved market opportunity that exists in this space.

 We estimate that over 30 million American adults have chronic lower back pain. Published clinical studies have shown that 15% to 30% of all chronic lower back pain is associated with the SI-Joint. For patients whose chronic lower back pain stems from the SI-Joint, our early clinical experience indicates the system to be introduced by Tenon could be beneficial for patients who are properly diagnosed and screened for surgery by trained healthcare providers.

Based on market research and internal estimates, Tenon believes the potential market for surgical intervention of the SI-Joint to be 279,000 procedures annually in the US alone, for a potential annual market of more than $2.2 billion. These estimates are driven by coding data for SI-Joint injections to treat pain and informed assumptions relative to surgical intervention candidacy.

In 2019, approximately 475,000 patients in the United States were estimated to have received an aesthetic injection to temporarily alleviate pain emanating from the SI-Joint and/or to diagnose SI-Joint pain. Additionally, several non-surgical technologies have been introduced in the past 10 years to address patients who do not respond to injection therapy, including systemic oral medications and opioids.

To date, the penetration of a surgical solution for this market has been relatively low (5-7%). We believe this is due to complex surgical approaches and suboptimal implant design of existing options. The penetration of this market with an optimized surgical solution is Tenon’s focus.

We believe the SI-Joint is the last major joint to be successfully addressed by the orthopedic implant industry. Studies have shown that disability resulting from disease of the SI-Joint is comparable to the disability associated with several other serious orthopedic conditions, such as knee and hip arthritis and degenerative disc disease, each of which has surgical solutions where an implant is used, and a multibillion-dollar market exists.

(Note: Tenon Medical, Inc. downsized its small-cap IPO at pricing on April 26, 2022, to price 3.2 million shares, down from 4.0 million shares in the prospectus, at $5.00 – the mid-point of its $4.50-to-$5.50 price range – to raise $16 million. The slimmer pricing terms meant a 20 percent cut in the deal’s estimated proceeds of $20 million in the prospectus. The pricing reflects a 2-for-1 reverse stock split that was effective on April 6, 2022, according to Tenon Medical’s pricing announcement.)