EndoTheia has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its technology that radically improves minimally invasive flexible endoscopic surgery. Click here to read more.

EndoTheia feature on the cover of MedTech Outlook's December Endoscopy Edition as one of the “Top 10 Endoscopy Solutions Providers of 2022”. Visit the online article by clicking here or download a .pdf of the printed article by clicking here.

EndoTheia submits a full patent application for a future expansion product to the USPTO.

The provisional application protecting EndoTheia's foundational nested tube technology is converted into a full patent application and is submitted to the USPTO. EndoTheia also submits two provisional applications for future expansion products.

EndoTheia has registered with the USPTO secure brand protections through trademark applications for items such as the company name, company logo, and specific select brand names for their initial devices to reach the market.

EndoTheia has been awarded $300,000 in SBIR matching funding from the state of TN to support its commercialization efforts. This funding will be used to continue support for previously established in-state manufacturing partnerships and to support a First-in-Human clinical trial to evaluate the safety and efficacy of EndoTheia’s endoscopic technology. Click Here for more info. 

EndoTheia expands its corporate headquarters, located in Nashville TN, by extending their engineering workspace. This increased workspace will enable additional engineering effort to advance their technology to the market.

EndoTheia has reached a design freeze for their first product. This is a major milestone and means that the device is ready for production manufacturing to support the planned V&V testing to support FDA 510(k) submission.

EndoTheia received approval to conduct a small-scale first-in-human (FIH) study to assess the safety of our endoscopic technology in support of our upcoming regulatory submission. Subject recruitment will commence in Q1 of 2023.

EndoTheia receives FDA signs off on their submitted pre-submission outlining their planned regulatory pathway and selected predicate device to support a 510(k) application. Further, alignment is reached on all proposed V&V activities to support the future 510(k) market application.

EndoTheia significantly expands its overall team to drive the development process forward to both support key development milestones and to accelerate the overall timeline to market for their initial product rollout. Additional effort has been added within the areas of quality control, mechanical engineering, R&D engineering, product development and manufacturing. EndoTheia welcomes Laura Davis, Tyler Efird, Chris Schlichter, and Jake Childs to the team!

EndoTheia received funding from the National Institutes of Health to conduct experiments to explore the utility of their technology in a robotic endoscopic submucosal dissection (ESD) application. The final experiments were a success, demonstrating clear benefits of the technology and the vast potential within the robotic space.

The provisional application protecting EndoTheia's first product is converted into a full patent application and is submitted to the USPTO.

EndoTheia is awarded $300,000 in SBIR match funding from the state of TN to forge in-state manufacturing partnerships, finance laboratory testing efforts for upcoming regulatory submissions, and secure vital intellectual property. 

EndoTheia engages with the FDA through a pre-submission regarding the required testing to support a future 510(k) market application for their initial product. EndoTheia and the agency reach alignment on the required testing related to human factors and select V&V activities for their first product.  

EndoTheia is awarded a $1.4m SBIR Direct-To-Phase II Grant from the National Institute of Biomedical Imaging and Bioinformatics (NIBIB) to explore the use of EndoTheia technology in the minimally-invasive treatment of renal calculi. 

EndoTheia is awarded a $1.4m SBIR Direct-To-Phase II Grant from the National Institute of Deafness and Communication Disorders (NIDCD) to explore the use of EndoTheia technology in the nonsurgical surveillance and diagnosis of middle ear disease. 

After incubating within Vanderbilt University since 2018, EndoTheia begins formal operations and moves into its first engineering offices and engineering laboratory, located in the bustling Midtown district of downtown Nashville, to begin developing next-generation endoscopic devices.

EndoTheia negotiates and exclusive license with the Vanderbilt University Center for Technology Transfer and Commercialization (CTTC) to commercialize the underlying micromachined concentric tube technology.

EndoTheia is awarded a $1.2m SBIR Direct-To-Phase II Grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to further study the use of EndoTheia's technology in the treatment of biliary disease. 

EndoTheia is awarded a $225k STTR Phase I Grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to investigate the use of EndoTheia's technology in the endoscopic treatment of early-stage colorectal tumors.

EndoTheia, Inc. is formally incorporated to commercialize an innovative flexible medical device technology originally developed at Vanderbilt University.