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EndoTheia News

EndoTheia Reaches Design Freeze

September 5th, 2023

EndoTheia reaches design freeze for its next-generation steerable device for ureteroscopic procedures. The company will now work with contract manufacturing partners to move forward with production-equivalent builds in support of our upcoming commercial rollout.

EndoTheia Receives IRB Approval for First-In-Human

September 5th, 2023

EndoTheia receives approval to conduct a first-in-human (FIH) study to assess the safety of our novel steerable technology in the ureteroscopic treatment of kidney stones. Subject recruitment will commence in Q1 of 2024.

EndoTheia Strengthens IP Portfolio

August 25th, 2023

EndoTheia further strengthens its intellectual property portfolio through the conversion of two provisional patent applications into full non-provisional patent applications.

EndoTheia Announces Successful Clinical Trial Results

July 18th, 2023

EndoTheia announces the successful results of a clinical trial run at Vanderbilt University assessing a new medical device for the treatment of biliary disease. All primary and secondary endpoints were successfully met during the trial and no adverse events were noted. Results to be used in support of a FDA 510(k) submission scheduled for later this year. Click here to view the press release.

EndoTheia Wins Innovation Award

June 21st, 2023

EndoTheia receives the ‘Innovation Award’ after being invited to present its technology at TechConnect’s World 2023 International Conference held in Washington, DC.

EndoTheia Strengthens IP Portfolio

June 16th, 2023

EndoTheia receives a claims allowance notice on its foundational patent for steerable sheath technology.

EndoTheia Receives Breakthrough Device Designation

January 10th, 2023

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 Featured on Cover of MedTech Outlook

December 21st, 2022

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 Expands IP Portfolio

December 16th, 2022

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

EndoTheia Expands IP Portfolio

November 1st, 2022

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 Files with the US Patent and Trademark Office to Secure Brand Protection

October 2nd, 2022

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.

LaunchTN Continues Its Support for EndoTheia by Providing Additional Capital

September 30th, 2022

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 it Engineering Footprint

September 21st, 2022

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 Reaches 'Design Freeze' For Its Initial Product

September 7th, 2022

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 Receives Approval for First-In-Human

August 5th, 2022

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 Submits Q-Sub to the FDA

June 6th, 2022

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 Engineering Team

January 15th, 2022

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 Completes Robotically-Facilitated ESD Experiments

November 17th, 2021

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.

EndoTheia Expands IP Portfolio

October 5th, 2021

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

EndoTheia Receives Match Funding from LaunchTN

September 30, 2021

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

September 24th, 2021

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 Receives Direct-To-Phase II SBIR Grant

August  31, 2021

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 Receives Direct-To-Phase II SBIR Grant

August 13, 2021

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. 

EndoTheia Begins Formal Operations at New HQ

September 28, 2020

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 Secures Exclusive License to Commercialize Underlying Technology

August 31st, 2020

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 Receives Direct-To-Phase II SBIR Grant

June 16, 2020

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 Receives Phase I STTR Grant for ESD

August 1st, 2019

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 is Formally Incorporated

August 15th, 2018

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

At A Glance

June 2023

TechConnect World Innovation Conference and Expo - Joshua Gafford, EndoTheia's Chief Technology Officer, presents EndoTheia's technology at the 2023 TechConnect World Innovation Conference, held at the Gaylord National Harbor in Washington DC.

June 2023

Hamlyn Symposium - Robert Webster, EndoTheia's President, presents EndoTheia's technology at the 2023 Hamlyn Symposium, held at Imperial College.

May 2023

Emerging Tech Venture Summit - Joshua Gafford, EndoTheia's Chief Technology Officer, presents EndoTheia's technology at the 2023 Emerging Tech Venture Summit, held at the San Jose Convention Center in San Jose, CA.

August 2022

Hamlyn Symposium - Robert Webster, EndoTheia President, presents EndoTheia's technology at the 2022 Hamlyn Symposium, held at Imperial College

May 2022

ICRA - Robert Webster, EndoTheia President, presents EndoTheia's technology at 2022 ICRA workshop entitled `Frontiers of Endoluminal Intervention: Clinical and Technical Challenges.' 

May 2022

IGT Workshop - Laura Davis, Sr. R&D Engineer, presents EndoTheia technology at the 2022 IGT Workshop.

April 2022

AUA - Naren Nimmagadda presents early results of EndoTheia's technology at the 2022 meeting of the Annual Urological Association.

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