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SALT LAKE CITY - SINTX Technologies, Inc. (NASDAQ:SINT) has executed a private label agreement to supply OsseoSculpt, a biologic designed to complement its FDA-cleared SINAPTIC Foot & Ankle Osteotomy Wedge System, according to a company press release.
The company reported its first commercial revenue from OsseoSculpt in the third quarter of 2025 following successful evaluations by multiple design surgeons. The biologic features a nanocrystalline HCA surface with biomimetic pore architecture that provides an osteoconductive scaffold to support bone healing. This revenue development comes as SINTX struggles with profitability, posting a negative EBITDA of $6.89 million in the last twelve months and a concerning revenue decline of over 40% year-over-year.
"Pairing our SINAPTIC wedges with a custom-built biologic closes a critical gap at the point of care," said Lisa Marie Del Re, Chief Commercial Officer at SINTX.
The company plans a limited release through select design and early-adopter sites, with broader U.S. rollout scheduled through the first quarter of 2026. SINTX indicated that offering both products together simplifies procedures for surgeons and facilities.
SINTX Technologies specializes in advanced ceramic applications of silicon nitride for medical and other high-value applications. The company’s silicon nitride products have been used in human implants since 2008.
The SINAPTIC wedge system is designed for foot and ankle osteotomy procedures, offering precision fit and compatibility with biologic augmentation to support bone healing.
In other recent news, SINTX Technologies, Inc. has received FDA 510(k) clearance for its SINAPTIC Foot & Ankle Osteotomy Wedge System, marking its entry into the U.S. reconstructive foot and ankle surgery market. The silicon nitride-based implant system is scheduled for commercial launch in the first quarter of 2026 and will be manufactured in the United States. Additionally, SINTX announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for its antipathogenic fabric technology, further securing its innovative developments in silicon nitride compositions. This patent follows the recently issued U.S. Patent No. 12,433,356, which covers the composition of silicon nitride for antipathogenic fibrous materials. In financial developments, SINTX has raised approximately $3.8 million through the immediate exercise of certain outstanding warrants. This transaction involved the purchase of 1,099,431 shares of common stock at $3.32 per share, with new unregistered warrants issued for additional shares. These recent advancements highlight SINTX’s continued focus on expanding its technology and financial base.
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