Nimble Science Receives Health Canada Class II License for Novel SIMBA™ Capsule to Directly Sample the Small Intestine
- sabina8108
- Sep 3
- 3 min read
CALGARY, AB — September 3, 2025 — Nimble Science, a precision medicine company with a cutting-edge data platform, announced today that it has received a Medical Device Licence from Health Canada for its SIMBA™ Capsule. This ingestible device is the first to collect targeted and preserved fluid samples from the small intestine for physiological assessment. The approval designates the SIMBA Capsule as a Class II medical device, marking a significant milestone for the company and its partners.
Revolutionizing Access to the Small Intestine
The SIMBA Capsule is the size of a vitamin pill and travels autonomously through the gastrointestinal system. It uses pH to both open and self-seal within the targeted region of the ileum-jejunum, collecting a fluid sample from this critically active zone. This region is responsible for nutrient absorption, digestion, and immune function, and imbalances in the gut microbiome are increasingly linked to a wide range of conditions.
Historically, the ileum and jejunum have been difficult to access through traditional endoscopy, earning them the nickname "the body's black box." The SIMBA Capsule provides an unprecedented opportunity to study this small bowel microenvironment for both clinical and research applications.
Over the past two years, the device has been used as an investigational tool in clinical studies worldwide. Nimble Science and its partners are leveraging the SIMBA Capsule to study the small intestine in over 14 conditions, including in asymptomatic or "healthy" individuals. This dataset is critical for advancing research and clinical applications and will help researchers better understand gut health and evaluate new therapies.
"The device has been designed and extensively tested for accuracy in collecting a high-quality sample from the small bowel," says Dr. Joseph Wang, inventor, co-founder, and CTO of Nimble Science. "It includes the ability to preserve the sample and then self-seal prior to entry to the colon to prevent contamination. It has demonstrated utility in a broad number of use cases."
Regulatory Approval and Future Impact
Health Canada's approval of the SIMBA Capsule as a Class II medical device confirms its safety and effectiveness. This license, combined with Nimble Science’s ISO 13485:2016 MDSAP certification, demonstrates our commitment to quality and will form the foundation for global expansion.
"This Health Canada approval is a tremendous validation of our team's dedication and the potential of our technology," said Sabina Bruehlmann PhD, co-founder and CEO of Nimble Science. "The SIMBA Capsule is pioneering a new era of gastrointestinal (GI) intelligence. By moving beyond the limitations of traditional, invasive procedures like endoscopy, this technology provides researchers and clinicians with a safe and scalable way to unlock the powerful role of the small intestine in health. With its SIMBA Capsule Nimble is building a first-in-class dataset, which, when combined with the revolutionary potential of AI, will catalyze this new frontier.”
About Nimble Science
Nimble Science is a precision medicine company that provides a multi-omic data platform to advance healthcare innovation. Its SIMBA™ Capsule enables unparalleled access to the microenvironment of the small intestine. Nimble's mission is to empower researchers and clinicians with transformative tools to unlock new possibilities in diagnostics and therapeutics. The SIMBA GI Data Platform is available for partnered or independent use to advance research applications.
The company is supported by leading life science investors, including Fusion Fund, Seventure Partners, Ki Tua Fund, and Corundum Systems Biology.
Media Contact:
Nimble Science
1.866.493.4633
Sabina Bruehlmann, CEO
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