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MedCAD’s AccuStride® Receives 510(k) Clearance
MedCAD - Custom Surgical Solutions

MedCAD’s AccuStride® Receives 510(k) Clearance for New Entry into Foot and Ankle Marketplace

DALLAS, TX MAR. 26, 2025 (PR Newswire) — Dallas-based MedCAD has announced the 510(k) clearance of its AccuStride® Foot and Ankle System, making these patient-specific precision devices available to surgeons. The unique design of these devices, coupled with the company’s proprietary software, will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure. The patent-pending AccuStride® System marks the company’s first offerings for lower extremities; MedCAD is also a leading manufacturer of patient-specific, custom-designed cranial and maxillofacial reconstruction implants, including virtual planning and surgical devices.

“MedCAD’s newly announced, patient-matched solution is unlike anything else available for surgeons who routinely perform complex or revision cases in the treatment of the entire foot,” said Nancy Hairston, CEO and president of MedCAD. “We have experienced a surge in inquiries and interest from leading foot and ankle orthopedic specialists who are eager to use our ‘whole foot’ solutions for multiple pathologies, and we expect these custom 3-D printed devices to reduce the frequency and duration of surgeries, and to deliver high quality, durable outcomes.”

The AccuStride® System is designed to improve proximal phalanx and metatarsal arthroplasty outcomes, and to provide custom solutions for Lapidus revisions and cavus foot corrections. Its components are constructed of UV-curable acrylate polymers or titanium alloy materials and can be delivered in as few as five days after receipt of medical imaging and surgeon design approval. The system is intended for use in patients 12 years and older.

“The goal of MedCAD’s portfolio of patient-matched product solutions is to provide surgeons with customizable options that are as anatomically unique as their patients,” said Hairston. “MedCAD has been building a strong reputation for putting cutting-edge planning technology into the hands of surgeons so that they can deliver life-changing outcomes for the people they heal. With AccuStride, we recognized that when one part of a foot is experiencing problems, significant issues can show up in other areas as well, and with our advanced, wholistic approach, the outcomes are unmatched, and the possibilities are virtually endless.”

Forward Looking Statement

Certain information set forth in this presentation contains “forward-looking information”, including “future-oriented financial information” and “financial outlook”, under applicable securities laws (collectively referred to herein as forward-looking statements). Except for statements of historical fact, the information contained herein constitutes forward-looking statements and includes, but is not limited to, the (i) projected financial performance of the Company; (ii) completion of, and the use of proceeds from, the sale of the shares being offered hereunder; (iii) the expected development of the Company’s business, projects, and joint ventures; (iv) execution of the Company’s vision and growth strategy, including with respect to future M&A activity and global growth; (v) sources and availability of third-party financing for the Company’s projects; (vi) completion of the Company’s projects that are currently underway, in development or otherwise under consideration; (vi) renewal of the Company’s current customer, supplier and other material agreements; and (vii) future liquidity, working capital, and capital requirements. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment.

These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

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