Overview
COVID-19 has significantly and adversely affected preclinical research and clinical trials across the universe of life science companies as a result of the suspension of elective procedures in the U.S. and globally, as well as the challenges posed by travel bans, the furlough of or requirement that clinical study personnel work remotely, restrictions on access to hospitals and laboratories for clinical research professionals, as well as social distancing precautions. Nevertheless, Minneapolis-based VentureMed and its preclinical research partner, Boston-area-based CBSET, were able to overcome these obstacles with laser focus and a mutual determination to continue the momentum and progress on an important research project for VentureMed.
VentureMed develops and markets innovative endovascular devices that address unmet needs in the treatment of peripheral arterial disease (PAD) and stenoses of AV fistulas & grafts. VentureMed created the FLEX Vessel Prep System that optimizes treatment of complex lesions by safely creating long, linear micro-incisions to deliver acute lumen gain and vessel compliance for more effective PAD revascularization with other therapies like drug coated balloons.
“VentureMed was on a roll. The first generation of our FLEX device had demonstrated very promising clinical performance following FDA clearance. As we prepared to introduce an improved second-generation device, it was important for us to clearly demonstrate our device’s mechanism of action and the potential for FLEX to optimize the delivery of drugs from drug coated balloons (DCB) to atherosclerosed peripheral arteries,” explained Jenny Zeroni, Vice President, R&D and Operations for VentureMed.
Background
Vessel preparation in PAD has been hypothesized to improve drug uptake from DCB therapies. VentureMed enlisted CBSET to help prove this theory using the company’s FLEX Vessel Prep System.
VentureMed is keen to differentiate the effectiveness of its FLEX system in the crowded PAD market and anticipated that data demonstrating that FLEX not only enhanced safety and ease-of-use of DCB procedures, but also improved drug uptake in the vessel, would be valuable to both patients and clinicians.
Although headquartered in Minneapolis, MN, also known as Medical Alley, VentureMed believed the depth and breadth of CBSET’s experience and expertise in DCB analysis made them the ideal preclinical research organization partner to assess and validate VentureMed’s hypothesis. To keep this project on track, VentureMed contacted CBSET to see if they could execute a study via livestreaming, as VentureMed personnel and their physician advisors were unable to travel because of COVID-19.
CBSET was a great fit and exceptional business partner for this project as their mission is to advance biomedical research through innovative, high-quality services. CBSET combines top-tier research with operational expertise. Since its inception, CBSET has focused on developing technical and scientific acumen through collaborative projects in the medical device, pharmaceutical and academic communities. CBSET operates out of a 40,000 square foot, GLP-compliant, AAALAC-accredited facility in the Boston area, which includes animal vivaria, procedure rooms, catheterization / imaging labs, surgical and necropsy suites, histopathology, SEM, and a range of other technologies.
CBSET’s Director of Innovation and Research, Rami Tzafriri, PhD, cites four reasons why CBSET is a leader in preclinical research:
- Credibility: “We are recognized as unbiased experts, bringing independent credibility to sponsors’ regulatory filings.”
- Culture: “Our culture is science, rather than commerce, as we value new models and creative collaborations.”
- Mission: ”As a 501(c)(3), non-profit corporation, CBSET’s motivation is to enable sponsors’ success.”
- Integrated resource: “Our multidisciplinary team includes board-certified veterinary, quality, biological and quantitative sciences expertise, as well as board-certified pathologists – all in one facility.”
Results
The elegant simplicity of the FLEX Vessel Prep technology is particularly well-suited to these challenging times, as it lends itself well to remote training. Consequently, VentureMed was able to leverage not only the experience and expertise of the CBSET staff and the sophistication of the CBSET laboratory and technology, but also CBSET’s willingness to be trained on use of the FLEX Vessel Prep System and work “live” via internet meetings to conduct the study. Thus, a combination of livestreaming internet meetings used for product training, along with a simple, easy-to-learn FLEX device, all contributed to the successful and timely completion of a complex pharmacokinetic drug uptake study, the results of which will be communicated in Q4 of this year.
“Human clinical studies provide limited insights into the mechanisms of action and no ability to measure local drug delivery. Previously, using a human cadaver model, we demonstrated that the FLEX Vessel Prep System delivers an array of micro-incisions in calcific human arteries and designed an animal model of the disease to the ability of FLEX to successfully enhance local drug delivery,” says CBSET’s Dr. Tzafriri.
“The results of this study provide the first compelling evidence I have seen of a vessel preparation device that enhances drug (paclitaxel) uptake after DCB treatments, and moreover, with minimal vessel trauma,” concludes Dr. Tzafriri.
Conclusion
COVID-19 has severely disrupted research and development and clinical research programs across the medical device industry. The medical device field requires hands-on, face-to-face interaction, which was severely disrupted during the ongoing pandemic challenges. ”VentureMed and CBSET both were prepared to adapt and function in this new and challenging environment by continuing development in a more virtual way, modifying operations and building relationships in new ways,” says Jenny Zeroni. “At the peak of the uncertainty and shut-downs across the industry, we were able to collaborate with CBSET to execute, complete and deliver data from a key study. The structure at CBSET, together with the talent and flexibility of the CBSET team, allowed the VentureMed and CBSET teams to design and execute a complex study virtually, and deliver successful results,” Zeroni concludes.
