SI-BONE clears Onyx as SI-BONE stock sits 17.41% below its high

Published on 10/05/2026 at 07:48 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Q2 revenue rose 15.17 percent to USD 56.01 million. SI-BONE stock costs EUR 16.10 on October 5, 2026 after EUR 16.05.

SIBN, US8257041090, Illustration mit AI erstellt.

SI-BONE (ISIN US8257041090) received FDA 510(k) clearance for its iFuse Granite Onyx System on September 28, 2026, while SI-BONE stock stood 17.41 percent below its Nasdaq 52-week high of USD 21.89 at a primary-exchange price of USD 18.08 on October 2, 2026. The clearance covers the companys first compromised-bone product intended for use outside the pelvis, according to GlobeNewswire.

Onyx expands the device platform

Onyx is designed for spinal fusion constructs where screw loosening can occur at the upper and lower instrumented vertebrae. The company said loosening affects as many as 27 percent of fusion constructs, giving the new system a defined clinical problem to address.

The product is SI-BONEs third platform with FDA Breakthrough Device designation. Its bone-density-specific surface and anatomy-specific thread form are intended to support rapid osseointegration and reduce micromotion, although the clearance itself does not establish commercial sales or clinical outcomes.

Revenue growth meets operating progress

SI-BONE reported USD 56.01 million of revenue in the second quarter of 2026, compared with USD 48.63 million in the prior-year quarter, a 15.17 percent increase. The company also reported a GAAP net loss of USD 4.09 million, narrower than the USD 6.15 million loss in the prior-year quarter, according to Markets Insider.

That report also put quarterly revenue at USD 56.01 million against a USD 55.34 million consensus estimate, while diluted earnings per share came in at a loss of USD 0.09 versus a consensus loss of USD 0.15. For the latest twelve months, gross margin was 79.53 percent and operating cash flow was USD 2.48 million.

Reimbursement adds a second catalyst

Management said three new diagnosis-related groups for Granite procedures took effect on October 1, 2026, with reimbursement expected to rise by USD 20,000 to more than USD 50,000 per procedure. The update was discussed at the Morgan Stanley healthcare conference on September 14, 2026, according to Investing.com.

The combination matters because Onyx extends the existing platform into a larger spinal-fusion opportunity, while the reimbursement changes support the Granite franchise. The company is expected to report its next quarterly results on November 9, 2026, after the market close.

SI-BONE stock before the next report

SI-BONE stock was trading at EUR 16.10 at Lang & Schwarz on October 5, 2026 at 7:47 a.m. CEST, up 0.31 percent versus the prior close of EUR 16.05 on October 2, 2026. The company had a market capitalization of USD 801.8 million as of October 2, 2026, and its Nasdaq 52-week range was USD 11.48 to USD 21.89.