Accelerating U.S. Regulatory Readiness for Respiratory Assist System with Veranex 

Situation

A leading respiratory medical device company, developer of an innovative respiratory assist system, needed a preclinical research partner that could match their pace and budget as they transitioned from European success to U.S. FDA approval. Their early academic research environment proved too slow and rigid, prompting the search for a more agile and collaborative CRO.

Successes

• Veranex recommended transitioning from sheep to calf models, improving study manageability and physiological relevance.
• The collaboration enabled the client to refine protocols efficiently, particularly around anticoagulation—one of the most challenging aspects of device performance.
• Veranex's flexibility and scientific curiosity allowed the company to test new assays and techniques, fostering innovation and confidence ahead of GLP trials.
• The fourth study with Veranex served as a successful GLP dry run, setting the stage for regulatory submission.
• The client valued the long-term partnership and consistency developed with Veranex, prioritizing it over cost-based alternatives.

Services by Veranex

• GLP and non-GLP preclinical study execution
• Animal model consultation and optimization
• Protocol development and refinement
• Anticoagulation strategy testing
• Laboratory support for novel assay development
• Regulatory pathway alignment and GLP readiness

Veranex Sets Gold Standard in Preclinical Testing: Revolutionizing Drug Delivery for Atrial Fibrillation

Situation

Atrial fibrillation (AF) affects an estimated 10 million Americans, yet current treatments are either invasive or carry toxic side effects. A leading cardiac therapeutics company, led by a Chief Scientific Officer and Assistant Professor of Cardiology at a major university, is developing a minimally invasive hydrogel-based drug delivery system to treat AF more effectively. To bring this innovation to life, the company partnered with Veranex for preclinical testing and development.

Successes

• The company's catheter-based system delivers therapeutics directly to the pericardial space, reducing off-target toxicity and eliminating the need for open-heart surgery.
• Veranex provided a cath lab environment, fluoroscopy, and large animal expertise that enabled the client to test and refine its prototype efficiently.
• The Veranex team offered hands-on mentorship and scientific collaboration, helping the company navigate unfamiliar regulatory and technical processes.
• The partnership helped the client generate critical data and user feedback, positioning the company for FDA Pre-IND discussions and future clearance.
• The company leveraged a comprehensive medtech ecosystem—including leading universities, research institutes, and industry organizations—alongside Veranex to accelerate development of a Class III device.

Services by Veranex

• Preclinical testing in cath lab and large animal models
• Prototype evaluation and procedural simulation
• Scientific mentorship and regulatory guidance
• Support for FDA documentation and study planning
• Collaboration with academic and clinical stakeholders

Biological Pacemakers: Revolutionary Gene Therapy Innovation Supported by Veranex

Situation

A leading pediatric cardiology researcher at a major university and children's hospital is developing a groundbreaking gene therapy to regenerate the heart's natural pacemaker cells—offering a potential alternative to implantable pacemakers, especially for pediatric patients. These children often face multiple high-risk surgeries due to the limitations of current pacemaker technology.

Successes

• The research team developed a gene therapy that converts heart muscle cells into pacemaker cells using a single gene delivered via mRNA.
• Preclinical studies at Veranex demonstrated that the therapy could restore and regulate heart rhythm in large animal models without implanted devices.
• Continuous ECG monitoring over 30 days showed near-normal heart rates and adaptive pacing, with no safety concerns identified by cardiologist review.
• The data generated at Veranex supported four major grants.
• Veranex's cardiac cath lab capabilities and electrophysiology expertise were instrumental in executing complex large-animal studies and meeting tight grant deadlines.

Services by Veranex

• Large-animal preclinical study design and execution
• Cardiac catheterization and electrophysiology testing
• 24/7 ECG data collection and analysis
• Grant support and documentation
• Translational research infrastructure and scientific collaboration