Non-Clinical In-Vivo Studies

Pre-clinical studies are supported by operators experienced in minimally invasive and surgical procedures to test a range of clinical indications in a variety of small and large species. We work with sponsors on disease/injury model selection, ensuring the biological response is similar to humans. We are also able to address the inherent limitations of the model, the physiological and anatomical constraints, and the inherent variability of the model.

Non-Clinical Study Types

• Proof of Concept (POC)
  • Hands-on experience with prototypes for basic learning in a rapid and acute setting.
• Feasibility Study
  • Determine potential challenges or expected results in chronic or acute characterization of procedural methods, models, or device performance.
• Formal Good Laboratory Practice (GLP)
  • Support safety and performance for regulatory submissions and/or satisfy design control requirements in chronic or acute evaluations.

Non-Clinical Study Services

• Protocol and Report Development
• Model Development and Refinement
• Interventional and Surgical Procedures
• Pharmacokinetics
• Histology
• Necropsy and Histopathology
• Submission and Post-Market Support

Product and Test System Experience

• Experience with devices and body systems:
  • Intravascular, Urology, Surgery, Gastroenterology, Otolaryngology, Reproductive Health, Regenerative Medicine
• Pre-clinical in-vivo models:
  • Swine, Sheep, Canine, Guinea Pig, Chinchilla, Rabbit, Rodent

Imaging Modalities

• In vivo imaging modalities:
  • Fluoroscopy and Angiography Suites
  • Ultrasound (TC, Doppler, ICE, IVUS)
  • Endoscopy (rigid, flexible, US)
  • CT
  • 55T, 1.5T, 3.0T, 7T MRI
• Ex vivo imaging modalities:
  • High-Resolution Radiography
  • Micro CT
  • Bioluminescence and Fluorescence

Publications and Presentations

• Giday S, Van Alstine W, Van Vleet J, Ducharme R, Brandner E, Florea M, Johnston K, Negron-Garcia J, Ringenberger K. Safety analysis of a hemostatic powder in a porcine model of acute severe gastric bleeding. Dig Dis Sci. 2013 Dec;58(12):3422-
• Rodenberg EJ, Patel DS, Shirley B, Young BW, Taylor AF, Steidinger HR, Fisher SJ, Patel AN. Catheter-based retrograde coronary sinus infusion is a practical delivery technique for introducing biological molecules into the cardiac system. Catheter Cardiovasc Interv. 2019 Nov 1;94(5):669-676.
• Dake MD, Van Alstine WG, Zhou Q, Ragheb AO. Polymer-free paclitaxel-coated Zilver PTX Stents–evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011 May;22(5):603-10.