GLP Preclinical Excellence: We Set the Standard in Medical Device Studies

Advancing a First-of-Its-Kind Heart Failure Sensor with Veranex Preclinical Expertise

Situation

A leading medical device company developed the first implantable wireless sensor to monitor pulmonary artery pressure in heart failure patients. With over 1.4 million NYHA Class III heart failure patients in the U.S., the need for innovation was urgent. To meet stringent FDA Class III regulatory requirements, the company needed a preclinical partner with deep expertise and real-world clinical simulation capabilities.

Successes

• Veranex helped refine the sensor's design from an anchored right ventricular septum placement to a passively anchored pulmonary artery configuration, improving safety and ease of use.
• The team conducted GLP studies at Veranex to support their IDE submission, enabling first-in-human clinical trials.
• The collaboration resulted in a highly mature product at the time of clinical trial launch, reducing risk and accelerating regulatory approval.
• Following FDA approval in 2014, the device was acquired for $435 million.

Services by Veranex

• Implant design and delivery optimization
• Real-world cath lab simulation and testing
• Regulatory strategy and IDE support
• Procedural training development
• Long-term collaboration on next-gen device innovation

Turning a Preclinical Setback into Regulatory Success with Veranex

Situation

A medical device company's single-use radiofrequency applicator for intraoperative coagulation and ablation was on the path to FDA 510(k) clearance when early GLP preclinical studies raised red flags. A request for additional information from the FDA triggered company-wide concern, prompting a search for a preclinical partner capable of executing a flawless study under the highest compliance standards.

Successes

• Veranex executed a high-stakes GLP study that resulted in a 510(k) submission with zero follow-up questions and regulatory clearance in just 1.5 months.
• When anatomical model issues arose mid-study, Veranex swiftly enrolled replacements, avoiding delays and maintaining compliance.
• The team coordinated access to multiple surgical oncologists and board-certified veterinarians, ensuring FDA expectations for clinical exposure were met.
• Veranex's logistical precision, staff qualifications, and commitment to the project enabled the company to meet aggressive timelines and endpoints.
  
  

Services by Veranex

• GLP preclinical study design and execution
• Rapid model replacement and scheduling coordination
• Access to surgical specialists and veterinary staff
• Full-service preclinical logistics and compliance management

A Preclinical Partnership Driving Stroke Innovation

Situation

A neurovascular device company, led by a neurovascular neurosurgeon and experienced CEO, set out to improve outcomes in acute ischemic stroke by developing a new generation of stent retrievers. Their thrombectomy platform was designed to overcome limitations of legacy devices by capturing all clot types, including firm and organized thrombus, more effectively and with fewer passes.

Successes

• Since 2016, the company has partnered with Veranex on 7–10 GLP and non-GLP preclinical studies to develop and refine their thrombectomy platform.
• The studies directly supported the company's CE mark approval in 2017 and laid the groundwork for an expanded product line.
• Veranex provided rapid model replacement, expert coordination with surgical specialists, and full regulatory protocol support.
• The device demonstrated improved first-pass success and reduced clot fragmentation, even with calcified clots.
• The company credits Veranex's professionalism, regulatory acumen, and collaborative approach as critical to their development and commercialization success.

Services by Veranex

• GLP and non-GLP preclinical study execution
• Access to surgical specialists and board-certified veterinarians
• Onsite prototyping and early data collection
• Strategic guidance for CE mark and product line expansion