Adapting Preclinical Protocols in Real Time: Product Development Firm Supports Novel Cardiovascular Therapy
Situation
A cardiovascular pharmacology expert at a prominent academic institution developed a novel therapy aimed at reducing reperfusion injury after myocardial infarction. This therapy specifically targets the four primary sources of reactive oxygen species (ROS). Having secured early-stage grant funding, the expert sought a preclinical partner capable of simulating realistic clinical conditions and refining protocols for optimal translational relevance.
Successes
- The product development firm advised a crucial protocol modification, shifting from intravenous to intra-arterial administration, to more accurately reflect clinical delivery methods.
- During an active study, the firm's team made a critical real-time decision to delay test agent administration after numerous defibrillation shocks. This mirrored real-world clinical judgment and maintained the integrity of the study.
- The initial test compound demonstrated a 70% reduction in infarct size and a notable improvement in cardiac function when compared to control groups.
- This collaboration significantly accelerated the therapy's readiness for subsequent grant phases and positioned it for long-term survival studies and eventual clinical translation.
Services by Veranex
- Preclinical protocol development and refinement
- In vivo myocardial infarction model execution
- egulatory-aligned study design and randomization
- Support for grant progression
From Concept to Commercialization: Innovator's Journey to Transform Spinal Access with Product Development Firm Support
Situation
What started as a university capstone project to mitigate complications arising from epidural misplacement has evolved into Innovator, a medical technology startup dedicated to real-time spinal needle guidance. With assistance from their university's entrepreneurial program and a product development firm, the team successfully navigated the intricate path from initial concept to market readiness.
Successes
- Innovator strategically shifted from an initially compatible prototype to a universally compatible system, a decision driven by valuable clinician feedback and market demands.
- A substantial grant secured funding for development and preclinical testing, which included four cadaver studies conducted at the product development firm. These studies demonstrated significant improvements in procedural metrics.
- The team has achieved a functional prototype and is now preparing for regulatory submission, with manufacturing transfer and verification testing on the horizon.
- Innovator acknowledges the product development firm's responsiveness and expertise as vital in enabling first-time entrepreneurs to maintain focus on commercial and clinical success.
Services by Veranex
- Preclinical feasibility and cadaver study execution
- Study protocol design and technical guidance
- Real-world operating room simulation
- Mentorship and commercialization support
- Regulatory strategy alignment and readiness
Testing and Prototyping
Testing and Prototyping
Ensure your innovative design performs flawlessly and meets critical standards. Our comprehensive testing services are backed by dedicated facilities and advanced equipment, allowing us to assess any product type with various levels of rigor.
Quality Services
Quality Services
Build quality into your medical device from the ground up. Our integrated quality services are essential for navigating complex requirements and ensuring your product is developed to the highest standards for a safe and effective device.
Regulatory Services
Regulatory Services
Navigate the complex regulatory landscape with confidence. Our regulatory experts are integrated into your product development process, providing the strategic guidance needed to anticipate requirements and streamline your path to approval.
Human Factors
Human Factors
Design intuitive and safe devices that truly meet user needs. Our human factors expertise is critical in product development for ensuring your device is designed around the user, minimizing risk and enhancing the overall experience for patients and practitioners.
