FDA approves first 3D-printed bioabsorbable nerve repair device

Published 26/06/2025, 13:34
FDA approves first 3D-printed bioabsorbable nerve repair device

ROCK HILL, S.C. - 3D Systems (NYSE:DDD), currently trading at $1.39 with a market capitalization of $188 million, announced Thursday that its bioprinting technology has enabled FDA approval for a first-of-its-kind bioabsorbable device for peripheral nerve repair. According to InvestingPro data, the company maintains a healthy current ratio of 2.79, indicating strong short-term liquidity despite recent market challenges.

The device, called COAPTIUM CONNECT with TISSIUM Light, was developed through a partnership between 3D Systems and French MedTech company TISSIUM. The U.S. Food and Drug Administration granted De Novo marketing authorization for the sutureless solution earlier this week.

The medical device utilizes TISSIUM’s proprietary biomorphic programmable polymers combined with 3D Systems’ bioprinting technology to create high-resolution, elastomeric biodegradable implants for nerve damage repair.

"This is a significant advancement in patient care," said Scott Turner, vice president of advanced systems at 3D Systems. "It has been tremendously rewarding to work alongside the talented team at TISSIUM to design a complete 3D bioprinted solution that offers the potential for patients to recover from peripheral nerve damage."

This achievement builds on 3D Systems’ work in bioprinting, which includes an ongoing joint development program with United Therapeutics Corporation aimed at creating bioprinted human lungs for transplantation. While the company’s revenue reached $431.76 million in the last twelve months, InvestingPro analysis reveals over 16 key insights about the company’s financial health and market position.

The global 3D bioprinting market was valued at $1.3 billion in 2024 and is expected to reach $2.4 billion by 2029, according to data cited in the press release statement.

3D Systems has previously worked with surgeons to plan more than 150,000 patient-specific cases and manufacture over two million implants and instruments for FDA-cleared and CE-marked devices from its facilities in Colorado and Belgium.

The company’s bioprinting technology focuses on fabricating living tissues to develop new therapeutics and improve patient outcomes. Trading near its 52-week low, InvestingPro’s Fair Value analysis suggests the stock may be undervalued, presenting potential opportunities for investors interested in the bioprinting sector. For comprehensive analysis, including detailed financial metrics and expert insights, explore the Pro Research Report available on InvestingPro, covering this and 1,400+ other US stocks.

In other recent news, 3D Systems has reported a challenging first quarter for 2025, with earnings per share of -$0.28, significantly missing the forecasted -$0.14. Revenue also fell short of expectations, coming in at $94.5 million against an anticipated $100.34 million. The company has withdrawn its full-year guidance for 2025 due to economic uncertainties, although it remains focused on cost reduction initiatives aimed at saving $70 million by mid-2026. In a strategic move to manage its debt, 3D Systems has retired approximately $88 million of debt and issued $92 million in new convertible notes due 2030, with Cantor Fitzgerald & Co. acting as the financial advisor. Additionally, Craig-Hallum analyst Greg Palm has downgraded the stock’s price target to $2.00, citing weaker-than-expected results and a lack of visibility into the company’s future performance. Despite these challenges, 3D Systems plans to focus on returning to profitability by implementing an additional $20 million in cost reductions. The company also recently completed the sale of its Geomagic asset portfolio, bolstering its cash reserves to $250 million.

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