TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
Paris, France, Cambridge, USA, June 24, 2025 – TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair.
This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.'
Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1.
In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1.
TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months.
The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber.
Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.'
***
About TISSIUM
TISSIUM is a clinical and commercial stage MedTech company based in Paris, France, Cambridge, USA, and with a manufacturing site in Roncq, France. The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, programmable, elastomeric polymers designed to address critical unmet needs in atraumatic tissue repair and tissue reconstruction.
TISSIUM's diversified pipeline includes seven products across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants. Each solution is designed to optimize tissue repair through controlled and consistent procedures with specialized delivery and activation devices to maximize the performance and usability of its products.
Founded in 2013, TISSIUM is built on breakthrough research and intellectual property originating from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital).
For more information, please visit www.TISSIUM.com and follow us on LinkedIn: TISSIUM.
***
Contacts
Investor relationsRomain Attard – Chief Financial Officer
[email protected]
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNN
an hour ago
- CNN
HHS carries out mass firings across health agencies after Supreme Court decision
Thousands of employees across US federal health agencies received an email Monday afternoon telling them they were out of a job as of the close of business. The firings were originally communicated April 1 for most of the included employees, but they'd been delayed as a legal battle played out. That culminated in a US Supreme Court decision July 8 that, the US Department of Health and Human Services said in the email, means the agency 'is now permitted to move forward with a portion of its [reduction in force].' HHS eliminated 10,000 employees across agencies including the US Food and Drug Administration, the US Centers for Disease Control and Prevention and the US National Institutes of Health in a reorganization announced March 27; some have since gotten their jobs back, but the number losing employment Monday is in the thousands, a spokesperson for the agency confirmed. Some of those 10,000, though, are protected at least temporarily under a different court case, NY v. Kennedy, and are not being separated immediately, the spokesperson said. That includes employees at six units of the CDC — the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the National Center for Environmental Health; the Division of Reproductive Health; the National Institute for Occupational Safety and Health; the Office on Smoking and Health; and the National Center for Birth Defects and Development Disabilities — the Center for Tobacco Products at the FDA; the Office of Head Start; and the Division of Data and Technical Analysis under the Assistant Secretary for Planning and Evaluation. 'All employees previously notified on April 1 have been separated, except for those' to whom the temporary restraining order in NY v. Kennedy applies, the HHS spokesperson said. In that case, a US District Court judge in Rhode Island earlier this month granted a preliminary injunction request from a coalition of 19 states and the District of Columbia to halt the reorganization plan announced March 27. Last week, in a separate case, the Supreme Court allowed federal agencies to proceed with their reduction-in-force, or RIF, plans, putting on hold a lower court order that had temporarily blocked President Donald Trump from taking those steps without approval from Congress. But the justices noted that 'we express no view on the legality of any Agency RIF and Reorganization Plan,' leaving open the possibility that it could rule against a specific agency's layoff plan in the future if the reductions appeared to make it impossible for the department to carry out its obligation under the law. Filed by a coalition of more than a dozen unions, nonprofits and local governments, that case stemmed from an executive order Trump signed in mid-February that kicked off the process of significantly reducing the size of federal agencies. 'HHS previously announced our plans to transform this department to Make America Healthy Again and we intend to do just that,' HHS spokesman Andrew Nixon said in an email to CNN after the Supreme Court's ruling last week. Meanwhile, the District Court of the Lower District of California is continuing to consider whether the federal agencies can continue to withhold the RIF plans from the court's view. The Trump administration is arguing that the court has 'no basis' to review the legality of the plans. Earlier Monday, the Supreme Court said Trump could proceed with his plan to carry out mass layoffs at the Department of Education, and within two hours, the department sent notices to employees indicating that it's immediately resuming its plans. The employees were told they would be let go on August 1, while HHS's terminations were nearly immediate. 'You are hereby notified that you are officially separated from HHS at the close of business on July 14, 2025,' read Monday's notice to dismissed HHS employees, according to copies obtained by CNN. 'Thank you for your service to the American people.' CNN's John Fritze, Devan Cole and Sunlen Serfaty contributed to this report.
CNN
an hour ago
- CNN
HHS carries out mass firings across health agencies after Supreme Court decision
Thousands of employees across US federal health agencies received an email Monday afternoon telling them they were out of a job as of the close of business. The firings were originally communicated April 1 for most of the included employees, but they'd been delayed as a legal battle played out. That culminated in a US Supreme Court decision July 8 that, the US Department of Health and Human Services said in the email, means the agency 'is now permitted to move forward with a portion of its [reduction in force].' HHS eliminated 10,000 employees across agencies including the US Food and Drug Administration, the US Centers for Disease Control and Prevention and the US National Institutes of Health in a reorganization announced March 27; some have since gotten their jobs back, but the number losing employment Monday is in the thousands, a spokesperson for the agency confirmed. Some of those 10,000, though, are protected at least temporarily under a different court case, NY v. Kennedy, and are not being separated immediately, the spokesperson said. That includes employees at six units of the CDC — the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the National Center for Environmental Health; the Division of Reproductive Health; the National Institute for Occupational Safety and Health; the Office on Smoking and Health; and the National Center for Birth Defects and Development Disabilities — the Center for Tobacco Products at the FDA; the Office of Head Start; and the Division of Data and Technical Analysis under the Assistant Secretary for Planning and Evaluation. 'All employees previously notified on April 1 have been separated, except for those' to whom the temporary restraining order in NY v. Kennedy applies, the HHS spokesperson said. In that case, a US District Court judge in Rhode Island earlier this month granted a preliminary injunction request from a coalition of 19 states and the District of Columbia to halt the reorganization plan announced March 27. Last week, in a separate case, the Supreme Court allowed federal agencies to proceed with their reduction-in-force, or RIF, plans, putting on hold a lower court order that had temporarily blocked President Donald Trump from taking those steps without approval from Congress. But the justices noted that 'we express no view on the legality of any Agency RIF and Reorganization Plan,' leaving open the possibility that it could rule against a specific agency's layoff plan in the future if the reductions appeared to make it impossible for the department to carry out its obligation under the law. Filed by a coalition of more than a dozen unions, nonprofits and local governments, that case stemmed from an executive order Trump signed in mid-February that kicked off the process of significantly reducing the size of federal agencies. 'HHS previously announced our plans to transform this department to Make America Healthy Again and we intend to do just that,' HHS spokesman Andrew Nixon said in an email to CNN after the Supreme Court's ruling last week. Meanwhile, the District Court of the Lower District of California is continuing to consider whether the federal agencies can continue to withhold the RIF plans from the court's view. The Trump administration is arguing that the court has 'no basis' to review the legality of the plans. Earlier Monday, the Supreme Court said Trump could proceed with his plan to carry out mass layoffs at the Department of Education, and within two hours, the department sent notices to employees indicating that it's immediately resuming its plans. The employees were told they would be let go on August 1, while HHS's terminations were nearly immediate. 'You are hereby notified that you are officially separated from HHS at the close of business on July 14, 2025,' read Monday's notice to dismissed HHS employees, according to copies obtained by CNN. 'Thank you for your service to the American people.' CNN's John Fritze, Devan Cole and Sunlen Serfaty contributed to this report.
Yahoo
2 hours ago
- Yahoo
Philip Morris International (PM): A Bull Case Theory
We came across a bullish thesis on Philip Morris International on WorldlyInvest's Substack. As of 2ⁿᵈ July, Philip Morris International's share was trading at $175.91. PM's trailing and forward P/E were 27.70 and 24.43 respectively according to Yahoo Finance. Diego Cervo/ Russo views Philip Morris International (PM) as one of the most remarkable examples in the author's portfolio of a company with the capacity to reinvest and transform itself. Over the past 14 years, PM has invested aggressively into developing Reduced Risk Products (RRPs) like IQOS, VEEV ONE, and ZYN. IQOS, its flagship heat-not-burn product, is now a major success in Japan and expanding in Western Europe. The regulatory backdrop is improving, with ZYN recently gaining FDA recognition as reduced-risk. PM's deep investments are creating network effects in its RRPs ecosystem, where scale, retail presence, and consumer loyalty drive competitive advantage. Russo sees PM as having built a durable path to grow nicotine market share in safer formats — aligning both with societal trends and future revenue/profit growth. PM's capacity to suffer — making $14B+ in RRP investments ahead of peers — positions it as the clear leader in the industry's future. The company's investments in innovation and renovation of their product lineup, underwritten cumulative smoke-free product investments of $14 billion, growing sharply from a smaller base of $2.4 billion in 2015, make it an attractive investment. Previously, we covered a on Philip Morris International by Librarian Capital in June 2025, which highlighted the company's potential as a backdoor play on the AI energy boom through its nuclear energy infrastructure assets. The stock has depreciated by 1.90% since then. This previous thesis emphasized PM's critical energy infrastructure and potential to profit from the AI energy spike, but it didn't play out as AI focus shifted. WorldlyInvest's current thesis shares a similar view on PM's growth potential, but emphasizes its successful transformation through investments in Reduced Risk Products like IQOS and ZYN, positioning it for future revenue growth. PM isn't on our list of the 30 Most Popular Stocks Among Hedge Funds. While we acknowledge the risk and potential of PM as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
