In-Vivo Studies

Pre-Clinical Testing

In-vivo studies are supported by personnel experienced in minimally invasive and surgical procedures to test a range of clinical indications in a variety of large and small species. We work with sponsors on appropriate model selection, addressing model limitations, and ensuring the biological response is similar to that of humans. Our primary goal with in-vivo work is to accelerate the translation of our clients’ technologies into clinical use by generating robust, relevant pre-clinical data that supports safety, efficacy, and regulatory readiness.

Pre-Clinical Study Types

• Proof of Concept (POC)
  • Hands-on experience with devices and therapeutics for iterative learning in a rapid and acute setting.
• Feasibility
  • Determine potential challenges or expected results in chronic or acute characterization of procedural methods, models, or device performance.
• Good Laboratory Practice (GLP)
  • An acute or chronic study that adheres to formal quality standards (21 CFR Part 58) and supports safety and performance for regulatory submissions.

Study Services

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

Test System Expertise

• Therapeutic areas:
  • Cardiovascular, Gastrointestinal, Oncology, Hepatic, Renal, Neuroscience, Pulmonary, Metabolic and Diabetic Disease

• In-vivo models:
  • Swine, Sheep, Canine, Rabbit, Chinchilla, Guinea Pig, Rodent

Imaging Modalities

• In-vivo imaging modalities:
  • Fluoroscopy
  • Ultrasound
  • Endoscopy
  • CT
  • o 0.55T, 1.2T 1.5T, 3T, 7T MRI (and others)
• Ex-vivo imaging modalities:
  • High-Resolution Radiography
  • Micro CT
  • Bioluminescence and Fluorescence
  • Microscopy

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.