ROCK HILL, S.C. - 3D Systems (NYSE:DDD) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its TOTAL ANKLE Patient-Matched Guides. These guides are designed to be used with Smith+Nephew's SALTO TALARIS and CADENCE Total Ankle Systems, aiming to improve the precision and efficiency of total ankle replacement surgeries.
The newly cleared products, developed in collaboration with Smith+Nephew, offer surgeons a patient-specific 3D-printed instrument set that facilitates tailored surgical planning and implant positioning. This technology is expected to reduce the number of procedural steps, operating room time, and intraoperative x-ray radiation exposure compared to traditional non-patient-specific instruments.
Ben Johnson, 3D Systems' vice president, highlighted the company's 25-year history in supporting patient-matched cases, which now exceed 175,000. He emphasized the role of their VSP surgical planning workflows, Selective Laser Sintering technology, and DuraForm ProX PA materials as key differentiators in the market.
Mark McMahan, Smith+Nephew's vice president of marketing for global orthopedics, expressed enthusiasm for the partnership with 3D Systems, pointing to the potential for enhanced surgical precision and patient outcomes.
3D Systems, a pioneer in personalized medicine, has produced over 2 million medical device implants and supports over 100 FDA-cleared and CE-marked devices. The company's VSP surgical planning solutions combine medical image processing, surgical planning, and 3D printing.
The collaboration with Smith+Nephew is part of 3D Systems' strategy to expand its orthopedic offerings. The orthopedic devices market is growing rapidly, with a compound annual growth rate of 11.2%, and is projected to reach $5.3 billion by 2032.
Both 3D Systems and Smith+Nephew will be presenting the TOTAL ANKLE Patient-Matched Guides at the American Orthopaedic Foot & Ankle Society Annual Meeting 2024, taking place from September 11-14 in Vancouver, British Columbia, Canada.
This development is based on a press release statement from 3D Systems.
In other recent news, 3D Systems Corporation is making strides in its business operations despite a decline in consolidated revenue for the first half of 2024 due to weaker hardware sales. The company has successfully secured a nearly $250 million contract in the dental sector and has plans for the expansion of new dental technologies. Earnings projections for full-year revenues are estimated between $450 million and $460 million, driven by anticipated sales growth in the latter half of 2024.
Furthermore, 3D Systems has amended its 2015 Incentive Plan, introducing 4 million new shares available for awards and extending the plan to 2034. The company also regained compliance with New York Stock Exchange listing standards.
In addition to these developments, financial analysts have adjusted their outlooks for the company. Lake Street Capital Markets, Loop Capital, and Cantor Fitzgerald have all lowered their price targets for the company, while maintaining their respective Buy, Hold, and Overweight ratings.
Lastly, Baker Hughes, a global energy technology company, has successfully implemented Oqton Manufacturing OS, a software solution for additive manufacturing, leading to significant advancements in efficiency and cost reduction. This software is a product of Oqton, a subsidiary of 3D Systems.
InvestingPro Insights
In light of 3D Systems' (NYSE:DDD) recent FDA clearance for its TOTAL ANKLE Patient-Matched Guides, a closer look at the company's financial health and stock performance through InvestingPro data reveals a mixed picture. With a market capitalization of $261.8 million, 3D Systems operates with a moderate level of debt and has liquid assets that exceed its short-term obligations. These factors could provide some financial stability as the company continues to innovate in the medical device sector.
Yet, challenges are evident with the company's stock price having experienced significant volatility and a downward trend over the past year, as indicated by a one-year price total return of -61.11%. The stock is also currently trading at a price that is only 28.61% of its 52-week high, which could suggest a potential discount for investors willing to bet on the company's recovery and future growth in the expanding orthopedic devices market.
InvestingPro Tips highlight that analysts are not optimistic about the company's profitability in the near term, and there is a consensus on the downward revision of earnings for the upcoming period. Moreover, the stock's RSI suggests it is in oversold territory, which might interest traders looking for potential buying opportunities. For investors seeking a more comprehensive analysis, InvestingPro provides additional tips that could shed further light on the investment potential of 3D Systems.
It's worth noting that there are 15 InvestingPro Tips available for 3D Systems, offering a deeper dive into the company's performance metrics and stock behavior. These insights could be particularly valuable for investors considering a position in 3D Systems as it embarks on expanding its orthopedic offerings and leveraging its FDA-cleared technologies.
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