MIT-Technological Innovation Gains FDA Approval for Bladder Cancer Treatment
Cambridge, MA — A groundbreaking medical system developed from technology originating in the Massachusetts Institute of Technology (MIT) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of a particularly aggressive form of bladder cancer. This milestone represents the culmination of over a decade of research and development, led by Professor Michael Cima and his team at MIT’s Koch Institute for Integrative Cancer Research.
The concept took shape more than ten years ago in Professor Cima’s laboratory, with support from key funding sources including the National Institutes of Health and MIT’s Deshpande Center for Technological Innovation. The project soon evolved from academic research into a commercial startup, TARIS Biomedical LLC, co-founded by Cima alongside renowned Koch Institute Professor Robert Langer. In 2019, the company was acquired by pharmaceutical giant Johnson & Johnson, paving the way for further development and regulatory approval.
Engineering a New Paradigm for Bladder Cancer Drug Delivery
At the heart of the approved therapy is an innovative device designed for the localized delivery of drugs directly into the bladder—a novel approach that addresses significant challenges in treating high-risk, non-muscle-invasive bladder cancer. The MIT research team reframed the medical challenge as an engineering problem. Their development process involved close consultation with urologists and a detailed analysis of the shortcomings of previous treatment methods.
“We aimed to create a system that seamlessly fits into urologists’ existing procedures, so intuitive that clinicians would know how to use it without needing to read an instruction manual,” explained Professor Cima, a David H. Koch Professor of Engineering and professor of materials science and engineering.
This design philosophy led to a device capable of being inserted through standard catheters used in urology. Utilizing a special “shape memory” alloy, the device could be straightened for insertion and would then revert to a folded shape inside the bladder. This configuration prevents the device from being expelled during urination and allows for sustained drug release over approximately two weeks. Removal is facilitated via a cystoscope—a thin, flexible instrument already commonly used by urologists.
Clinical Success and Patient Impact
To date, the device has been deployed in thousands of patients. In clinical trials involving individuals with high-risk bladder cancer unresponsive to conventional therapies, the treatment demonstrated remarkable efficacy: 82.4 percent of patients showed no detectable cancer following treatment with the system. Furthermore, over half of these patients remained cancer-free nine months post-therapy.
These outstanding outcomes bring significant hope for patients suffering from this difficult-to-treat form of bladder cancer. “Seeing these results is incredibly gratifying,” said Cima. “Yet, it’s important to recognize that this achievement involved a vast network of contributors—likely numbering over a thousand—including the MIT inventors, clinical collaborators, company scientists, and patients who participated in trials.”
From Whiteboard Scribbles to Life-Changing Innovation
The genesis of the technology traces back to informal brainstorming sessions in Cima’s lab, where ideas were meticulously documented on a whiteboard that remained a permanent reference throughout the project. Early efforts focused on understanding the limitations of existing therapies for bladder diseases such as interstitial cystitis—a painful condition treated via frequent drug infusions.
Through detailed collaboration with urologists and review of prior clinical failures, the research team defined critical design criteria that would inform the final product. Support from MIT’s Deshpande Center enabled graduate student Heejin Lee, who integrated this research into his PhD thesis, to design and optimize the drug delivery device.
Notably, the technology’s path exemplifies the strength of the MIT innovation ecosystem, which fosters interdisciplinary collaboration and provides resources to pursue bold, unconventional ideas. The project also benefited from the entrepreneurial experience of co-founder Robert Langer, whose expertise in biomedical engineering helped guide the technology toward commercial viability.
Looking Ahead
With FDA approval secured, the innovative bladder cancer treatment is poised to offer new hope for patients with limited options. Beyond cancer therapy, Professor Cima envisions the platform being adapted for other medical conditions requiring localized drug delivery.
“This is just the beginning,” he said. “Our goal is to continue pushing the boundaries of what’s possible by combining engineering principles with medical insights to improve patient outcomes.”
The development stands as a shining example of how fundamental research at MIT can translate into life-saving medical technologies with real-world impact.
For media inquiries, contact:
Abby Abazorius
Email: abbya@mit.edu
Phone: 617-253-2709
Image Credit: Peter Vanderwarker / MIT
The device technology was developed at MIT’s Koch Institute for Integrative Cancer Research.
