EndoTheia Case Study

The company was founded in 2018 in Nashville, Tennessee as a spin-off from Vanderbilt University. Its first years were spent as an incubator, and its operations officially began in 2020. During this period, the company initiated its partnership with Alleima through Endosmart, (which was later acquired by Alleima), an expert in the shape memory alloy nitinol. Traditional instruments used to remove kidney stones often have limitations due to the lack of control over the ends. To address this gap in the market, EndoTheia created FlexStone™, where the basket used to remove the kidney stone can be controlled independently. This groundbreaking solution allows surgeons to directly control its movements, making it easier to navigate around anatomical structures and reach stones in hard-to-reach areas of the kidney. It is an innovation that results in a less invasive procedure for the patient.

Complementary partnerships

To start, EndoTheia attempted to design the nitinol cage independently, but the company soon realized the value of partnership.

“We are experts in maneuverability, but not in how to process and form nitinol. With this partnership, we could shorten our path to the market,” says Joshua Gafford, Chief Technology Officer at EndoTheia. The decision to entrust Alleima as a supplier
was based on its expertise in nitinol combined with its customer-oriented approach.

“We were impressed by their quality and performance. It was exactly what we were looking for, and the basket worked immediately.” When changes were necessary, Alleima provided assistance with customized solutions to meet EndoTheia’s specific needs.

FlexStone™ flexible kidney stone retrieval device

Broad nitinol portfolio for various applications

Apart from maneuverability, the size of the cage is another critical factor. EndoTheia
required a maximum diameter of 0.7 mm. The basket needs to be both incredibly small and very flexible in order to create the strength needed for precise control.

“Alleima’s nitinol basket had the exact properties we were looking for.” The partnership with Alleima will make it possible for EndoTheia to accelerate its market
launch and fully realize its value proposition. With technological advances in the medical industry moving further toward miniaturization, EndoTheia believes it is well positioned for the future. Having a partner like Alleima with expertise in nitinol will help the company realize the full value of its technology.

“Each of us can focus on what we do best. For us, that is the maneuverability aspect.” A key milestone for EndoTheia will be presenting the outcome of the initial clinical study of FlexStone™ in early 2025. The commercial launch date is planned for the following quarter. The company’s long-term ambitions go beyond treatment for kidney stones, with its sights set on becoming a leading innovator in other selected medical fields. Joshua Gafford foresees the partnership with Alleima developing into active research in other areas where the company’s supplementary strengths have the potential to facilitate joint innovations and new groundbreaking applications.