EndoTheia
Augmenting The Capabilities Of Flexible Endoscopes

Endoscopic kidney stone removal can take a very long time, especially when stones are in difficult-to-reach locations. In many cases, stone fragments are even left behind where they can re-grow, thereby defeating the purpose of the intervention, and subjecting the patient to additional pain and future interventions.

What makes capturing kidney stones so challenging is that current stone retrieval baskets can only extend straight out from the endoscope. The only way to maneuver them is to bend the tip of the endoscope. However, current endoscopes can only bend controllably in certain directions and often require full articulation just to reach the relevant location in the kidney, leaving no directional capabilities to aim the stone basket and capture the difficult to reach stone.

EndoTheia, a developer of next-gen medical devices for flexible endoscopy, addresses this challenge with its adjunct tools that are compatible with standard, commercially-available ureteroscopes. The company’s FlexStone retrieval system replicates all of the functions of a normal kidney stone basket while also providing physicians with the additional ability to steer the basket around corners to access these stones in challenging locations. By pairing proprietary steerable sheath technology with Nitinol basketing technology, EndoTheia enables physicians to aim and steer kidney stone baskets independently of the motion of the ureteroscope.

Augmenting the Dexterity of Flexible Endoscopes

The therapeutic capabilities of flexible endoscopes are hindered by the direct coupling between endoscope motion, the visual field of view, and the motions of any interventional tools that pass through them. Imagine trying to sketch a picture by holding the pencil in your mouth and staring only straight forward. That is basically what performing an endoscopic procedure is like today. EndoTheia’s specialized adjunct tools solve this by interfacing with flexible endoscopic platforms to augment their distal dexterity and therapeutic capability.

“Our tools essentially act as steerable conduits that convert existing passive endoscopic tools into dexterous tools,” says Joshua Gafford, Chief Technology Officer, EndoTheia. “These tools can be manipulated by the physician independently of the endoscope’s configuration.”

Simply put, EndoTheia is putting the pencil back in the artist’s hand by providing the surgeons with the ability to independently aim the interventional tools delivered through the endoscope. Even better, their device does not restrict the field of view or the motion of the endoscope. The technology enables physicians to reach in all directions and around corners.

For procedures that utilize dual-channel endoscopes, EndoTheia’s technology provides bimanual capabilities, where each tool can be manipulated independently. This gives the physician two miniature “arms” at the tip of the endoscope, and is groundbreaking for procedures where complex movements are required. For instance, when cancerous tissue must be excised from the inner lining of the gastrointestinal tract via endoscopic submucosal dissection, one arm can be used to pull the diseased tissue away from the lumen wall (a maneuver called countertraction). The other arm can guide an electrosurgical cutting tool to precisely excise it from the surrounding healthy tissue.

This countertraction maneuver is impossible with standard endoscopes in use clinically today. However, EndoTheia’s technology makes the complex simultaneous countertraction and excision maneuver easy to accomplish, without re-engineering the endoscope. Making these interventions easier has the potential to bring the benefits of endoscopic submucosal dissection to many more patients.

Novel Technology

EndoTheia’s foundational technology, originally invented at Vanderbilt and the University of Tennessee, enables the creation of extremely thin-walled, steerable devices. Because these devices are so thin, they can pass through standard endoscopes, and still carry current interventional tools within themselves. This provides unprecedented dexterity to endoscope-delivered tools, opening the door to new therapeutic applications of endoscopy. The company uses super-elastic materials, proprietary micromanufacturing techniques, and elastic interactions between two concentrically-nested tubes to create their devices.

We truly believe that the only way to make a great medical device is through combined effort, with engineers and clinicians working hand-in-hand toward the greater good

This proprietary steerable sheath technology enables EndoTheia to create highly dexterous endoscopic devices without any pull wires or discrete linkages which is what enables EndoTheia’s devices to be so small, and have such thin walls. The steerable basket of the FlexStone retrieval system has an outer diameter of 0.7mm and a wall thickness of just 150 microns, providing an open inner lumen small enough for a kidney stone basket to pass through, or even a laser fiber. Achieving these specifications in typical, tendon-actuated systems would be a significant challenge both from a manufacturing and assembly standpoint.

EndoTheia’s disruptive platform technology can be used across a vast array of clinical specialties, including urology, gastroenterology, neurology and otology.

Essential Surgeon-Engineer Partnerships

EndoTheia’s established relationship with Vanderbilt University Medical Center provides the company with access to an extensive network of highly skilled clinicians across all specialties. This relationship also offers EndoTheia’s engineers with the opportunity to observe first-hand how physicians provide care to patients. This type of observational feedback is critical to generating experiential knowledge of endoscopy workflows.

Indeed, EndoTheia was born from a long-term partnership between surgeons and engineers. Based on this DNA, EndoTheia involves physicians continually, at process. All of EndoTheia’s devices undergo multiple rounds of early-formative testing, followed by larger-scale rigorous evaluations to ensure that clinical feedback directly informs device design requirements.

Because of this, EndoTheia’s devices respect all the nuances of endoscopic workflows, which differ based on the specific use case of the device. This heavy focus on workflow integration enables EndoTheia to develop devices that provide the best application-specific results for physicians. This critical clinician feedback has enabled the company to optimize the feel of their devices, since having excellent ergonomics is essential to promoting market adoption.

“We believe that the only way to make a great medical device is through combined effort, with engineers and clinicians working hand-in-hand toward the greater good,” says Gafford.

Making its Mark

EndoTheia is focused on bringing multiple products to market. Answering the FDA’s call to action for new duodenoscopes due to significant infection issues with existing scopes, the company will first launch a disposable sheath and endcap combination. This product will enable the treatment of biliary tract disorders using standard forward-viewing endoscopes, which can be effectively sterilized. The goal is to replace the infection-prone reusable duodenoscopes currently in clinical use. By pairing a steerable sheath with a disposable, tip-mounted endcap with a side-viewing mirror, the system can replicate the specialized functions of duodenoscopes.

The company plans to pursue a 510(k)-market application for its first device in Q1 of 2023 and then submit a follow on the application in late 2023 for the full system. It has already submitted two pre-submission requests to the FDA to de-risk this regulatory strategy and has received agency feedback confirming alignment on its device classification, proposed predicate device, indications for use, and planned verification and validation testing requirements.

The second offering is the FlexStone retrieval system, which is intended for the ureteroscopic removal of kidney stones. The pilot rollout of this device is anticipated in late 2023. The company also has plans to expand the use of the technology to enable the independent steering of laser fibers for ureteroscopic laser lithotripsy.

EndoTheia’s minimally invasive device to diagnose middle ear disease has also been granted priority status by the FDA, and labeled a “breakthrough device” by the agency. It is only the seventh device in Ear Nose and Throat (ENT) procedures to ever receive this designation. This will streamline the regulatory process, enabling the company to rapidly bring its innovative solution to doctors and patients. The company anticipates a pilot rollout of this device in late 2024.

EndoTheia is currently conducting a small-scale first-in-human study to demonstrate the safety and efficacy of its devices in human patients. It is planning to release the results of the study by Q3 of next year.

Beyond the initial product offerings, EndoTheia continuously vets additional clinical applications in otology, neurology, and cardiology while simultaneously continuing to innovate and build a strong IP portfolio. There is also great potential for surgical robotic applications of this technology, and the EndoTheia team is currently collaborating with Vanderbilt University, University of Tennessee, and University of North Carolina at Chapel Hill to develop a robotic system that leverages EndoTheias steerable sheath technology.