Ictero Medical partnered with Biotex to create the world's first groundbreaking solution to treat high-risk gallbladder conditions without the need for a cholecystectomy from the critical product development phase to First-In-Human study.
Through cryoablation, a proven interventional radiology procedure less invasive than traditional surgeries, the innovative hand-held Cholesafe device aims to defunctionalize the gallbladder inside the patients body by freezing it and stopping its ability to cause further complications.
The controller is operated via a touchscreen user interface and provides realtime therapeudic parameters.
The screen guides the user through the intended workflow, beginning with connecting the ablation catheter and inserting a cryo cartridge into the system.
The three-part catheter system consists of a cryoablation catheter, an introducer, and an aspiration catheter.
The introducer sheath adopts existing drainage tube workflows and provides secure retention through a mechanical basket on the distal tip to ensure the device remains in place throughout the procedure.
The cryoablation catheter has a rotational nitinol nozzle that sprays the liquid cryogen inside the gallbladder, rapidly and uniformly freezing the tissue.
Once interluminal temperatures reach the predetermined threshold (down to negative 40 degrees Celsius), the tissue has achieved ablation damage and will result in tissue scarring that effectively defunctionalizes the gallbladder, mitigating further gallbladder disease.
Ictero Medical came to Biotex with a prototype, aiming to achieve early feasibility and first-in-human (FIH) clinical studies. However, taking a prototype and deciding which features to include as the minimal viable product for the study proved difficult. Navigating approvals in other countries was also challenging as each country has unique requirements, approval timelines, and a constantly changing regulatory landscape.
To achieve a successful collaboration, our engineers worked closely with Ictero Medical to ensure our goals and expectations were aligned, providing transparency and prompt communications as we faced the challenges head-on.
The CholeSafe device has required all Biotex departments to work together to get to the first-in-human milestone study. At Biotex, it is easy for us to collaborate across departments due to our company structure and overall goal for success with every project. I am excited to continue working on CholeSafe through the life of the project to ensure patients receive access to this device.
Project Manager, Biotex
Biotex specializes in developing, launching, and manufacturing medical and bio-technologies. We partner with entrepreneurs, start-ups, and established companies to bring concepts to life with our full spectrum of medical device development and manufacturing.
In close collaboration with Ictero Medical, Biotex facilitated two design iterations of the CholeSafe device - alpha and beta - to prepare for clinical studies. The iterations included involvement from all areas of Biotex’s product development departments.
For the CholeSafe project, Biotex implemented a 7-step process customized to address the client's specific needs, from Product Initiation to Study Monitoring and Close-Out, including the following phases under our core services.
To meet the specific demands of a project, Biotex adheres to a non-linear process. Instead of a one-size-fits-all model, we adopt a customized approach to strategically address our client's needs and their device's unique requirements.
Industrial Design, Mechanical Engineering, Software Development, Electrical Engineering, and Design Controls were pivotal in developing the CholeSafe prototype, guiding the product development process from conceptualization to the FIH study. With our iterative approach to product design, our comprehensive team ensured CholeSafe's design would result in a superior device focused on functionality, safety, aesthetics, and ease of use.
The CholeSafe design process began with our industrial designers creating the preliminary sketches and integrating the client's initial core design concepts. These sketches inspired collaborative discussions from Ictero Medical and Biotex, which paved the way for further product design enhancements.
After the sketches had been finalized, our industrial designers created low-fidelity mockups, offering a visual representation of the device so we could better evaluate its design, functionality, and usability.
The concepts and components behind our Industrial Design team's designs supported future animal studies and preliminary prototype builds.
Our Mechanical Engineering Team transformed the approved mockups into functional CAD (Computer Aided Design) models, incorporating accurate specifications and dimensions for Ictero Medical's review and approval.
The prototype iteration involved four main components that incorporated the chosen industrial design and mechanical design requirements, allowing our team to develop a custom sterile packaging tray to house disposable components as one kit.
Early CAD models for the cryoablation catheter.
Custom sterile packaging tray for the disposable components.
Our software developers created state diagrams for the CholeSafe device's firmware. During the process, our team also created the firmware on three separate PCBs (Printed Circuit Boards), along with the development of two CPLDs (Complex Programmable Logic Devices).
Finally, the team created a standalone PC software for data graphing, export, and settings control.
The standalone PC software was built to be highly configurable during initial device tests.
The CholeSafe User Interface was developed to guide surgeons through the procedure.
Biotex electrical engineers developed and manufactured two custom complex PCBs for the CholeSafe system, which complied with the required considerations for isolation of a patient-contacting lead to pass electrical safety testing and ensure safety for human use.
Our team also created custom cable assemblies for easy connection during manufacturing and sourced off-the-shelf PCBs where applicable to ensure efficient software/firmware development and device control.
Biotex created custom PCBs in-house for quick turnaround during development.
Biotex developed and executed the test plans and provided the final reports.
The documents integrated into our custom electronic QMS (Quality Management System) included Biocompatibility Testing, Preliminary Electrical Safety Testing, Preliminary Electromagnetic Compatibility Testing, and Bench Performance Testing (including preliminary software system testing) based on the clinical risk assessment.
Criterion, our in-house ISO/IEC 17025 and FDA ASCA (Basic Safety and Essential Performance) accredited testing services, was pivotal in performing the electrical safety and electromagnetic compatibility testing for the CholeSafe system, completing all tests in record time.
By providing the protocols and reports with maximum efficiency, the Criterion team helped Ictero Medical meet the safety and compliance requirements for the CholeSafe device necessary for the FIH study.
As an ISO 13485-certified medical device company, Biotex offers the services of our Manufacturing team, which has developed the necessary documentation and processes to perform the small-scale manufacturing of the CholeSafe device.
Our team created assembly procedures, labels, travelers, and the required device build traceability needed for human use of devices. Disposable assemblies and tray sealing were also performed in our Class 7 cleanroom.
The Biotex Clinical Research Team provided support from the onset of the CholeSafe project, choosing the country for the FIH clinical study and developing the required clinical documentation for the startup and trial approval. Our clinicians have extensive expertise in diverse facets of clinical trials, such as proficiency in GDPR and HIPAA compliance, allowing them to provide resources with experience in the host country to support site visits.
For the CholeSafe project, our clinical team continues to perform monitoring and will continue to conduct the study close out.
Biotex is committed to providing a unique one-stop-shop experience for small startups like Ictero Medical, aiming to achieve specific milestones in every stage of our partnerships.
Currently, Ictero Medical has successfully started its FIH clinical study for the CholeSafe system, and clinical investigations are ongoing. In the meantime, Biotex remains a collaborator on the project and will continue to provide support through further clinical studies, FDA submissions, and transfer to production.
Ictero’s success depends on the quality and speed of our clinical trials. That’s why we partnered with Biotex, with the experience and expertise to match our goals and challenges. Whether it’s setting up our first-in-human trial, working with clinical sites around the world, or navigating the regulatory requirements, they offer comprehensive and reliable services that help us accelerate our feasibility studies and increase our value.
CEO & Co-Founder, Ictero Medical
This device is not available for sale within the United States.
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