Freezing Gallstone Disease in its Tracks.
A minimally invasive gallbladder cryoablation solution capable of defunctionalizing the gallbladder in place – eliminating the need for surgical removal.
At Ictero Medical, we are focused on advancing the standard of care for gallbladder disease through the development of innovative, minimally invasive cryoablation technology. Our mission is to provide a potential treatment option for high-risk patients who may not be ideal candidates for surgery. By integrating catheter-based delivery with proprietary cryoablation methods, we are working to develop a minimally invasive approach that may offer an alternative to traditional surgical procedures.
The CholeSafe™ System is designed to utilize medical-grade cryogen spray to freeze the gallbladder from the inside out. This approach is intended to allow high -surface-area coverage while maintaining low intraluminal pressures and aiming to minimize impact on surrounding tissues. The system is being developed with the goal of enabling percutaneous access through a single entry site, potentially allowing for treatment under mild sedation and analgesia. If successfully developed and approved, the CholeSafe System could represent a less invasive option for select patients with gallbladder disease.
Gallstone Disease – Among the Most Prevalent Gastrointestinal Disorders Worldwide
Gallstones form when super concentrated bile crystalizes within the gallbladder, leading to pain and infection.
A Single Surgical Option in a Complex Disease Landscape.
Gallbladder surgery is standard-of-care to treat gallstone disease.
However, surgery can lead to increased risk in certain patient populations:
- Unfavorable anatomy
- Critically ill patients
- Chronic comorbid conditions
The System Impact of Complex Gallbladder Cases.
Patients
- Adverse Events
- Prolonged Recovery
Hospitals
- Cost of Complications
- Delayed Treatment
Clinicians
- Technically Difficult
- Limited Options
Current Non-Surgical Options Offer Relief—Not Lasting Results.
The CholeSafe System™
The CholeSafe System is a minimally invasive gallbladder cryoablation system capable of defunctionalizing the gallbladder, without the need to remove it.
Cryoablation Spray Catheter & Controller
Introducer Catheter
- 18 Fr ID x 15 cm working length
- Deployable malecot to maintain lumen access
- 0.035” guidewire compatible dilator
- Tuohy valve working port
Cryoablation Spray Catheter
- 9 Fr OD x 65 cm working length
- Deployable nitinol cage w/ rotating spray nozzle
- Real-time temperature feedback
- Ultra-low pressure management system
The CholeSafe Technical Advantage
Treats the source of the disease
Engineered to deliver controlled, high–surface area ablation that targets mucosal tissue and enables gradual gallbladder volume reduction.
Versatile deployment options
Guidewire-compatible system streamlines therapy and is designed for use with minimal fluoroscopic imaging or direct visualization.
Rapid treatment approach
Offers quick duration freeze cycles with the potential for treatment under mild sedation and minimal pain management.
Pre-Clinical Testing.
Rigorous pre-clinical testing demonstrates significant 90-day gallbladder volume reduction
- Average gallbladder reduction (96%) 90 days post-ablation in swine animal model (n=11)
- Histologic analysis confirms contraction of gallbladder lumen and fibrosis of gallbladder wall
- Minimal damage to surrounding hepatocytes supports localized ablation zone
Axial view of T1 weighted imaging 20 min contrast delay (90 days post-ablation)
Coronal view of T2 weighted imaging (green) vs. approx. baseline (red)
Pre-Ablation: 5.09 x 2.81 x 2.38 cm = ~17.82 mL
Post-Ablation: 0.48 x 0.45 x 0.75 cm = ~0.08 mL
~99% volume reduction
Histologic section of gallbladder fundus showing fibrotic capsule adhered to preserved liver bed
Clinical Testing.
Phase I First-in-Human (FIH) testing observed acute safety and demonstrated technical feasibility
- Ablate and resect study design (n=8)
- Average 1 min freeze/4 min thaw cycles
- Total treatment time ~45-60 min
- Gross & histologic indicators of intended gallbladder ablation
- No adverse events reported 30-90 days post-treatment
Fluoroscopic image of insufflated human gallbladder lumen (red arrow) with cryogen nozzle/cage (white arrow)
Gallbladder Prior Treatment
Gallbladder 1 hr Post-Cryoablation
US Market Opportunity.
*ASP $9,000; market size represent best estimates based upon literature
CholeSafe System™ Competitive Advantage.
Current Traction & Milestones.
This device is not available for sale within the United States.
Be Part of Our Vision!
Join us on our mission to transform gallstone treatment. At Ictero Medical, we are pioneering minimally invasive solutions to improve patient outcomes and expand access to safer care. Connect with us to explore how we can revolutionize gallbladder treatment together. Our team is eager to share our vision and discuss opportunities to make a lasting impact in healthcare.
Disclaimer
Ictero Medical is a development-stage company advancing a medical device for a novel medical procedure. Our business is subject to significant risks and uncertainties, including, but not limited to, the outcomes of pre-clinical and clinical studies, the safety and efficacy of our product and procedures, regulatory approvals, and compliance requirements.
This presentation is provided for informational purposes only and does not constitute an offer to sell, or a solicitation of an offer to buy, any securities of the company. It contains forward-looking statements based on current expectations, assumptions, estimates, and projections about our business and industry. These forward-looking statements are subject to a number of risks and uncertainties—many of which are beyond our control—that could cause actual results, performance, or achievements to differ materially from those anticipated.
Readers are cautioned not to place undue reliance on these forward-looking statements. Ictero Medical undertakes no obligation to update or revise these statements to reflect future events or circumstances.