“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Vesalio CEO Steve Rybka
Dr. Arthur “Jay” Ulm, MD, is a neurovascular neurosurgeon and the inventing founder of Vesalio. He is currently driving the innovation of new and improved stent retrievers for first pass brain clot removal with the help from his team at Vesalio, now including CEO, Steve Rybka.
Vesalio’s NeVa thrombectomy platform is intended for retrieving clots in the cerebral vasculature to minimize the damage caused by stroke. With the recent wave of new technology in the mechanical thrombectomy field during the past decade, the standard of care and treatment has changed dynamically.
“Previously, IV medications would be given to stroke patients in the hopes they would dissolve or break down the clot,” Rybka explains. “The standard of care is evolving to interventional procedures including mechanical thrombectomy that provide quicker and more predictable therapeutic treatment. Dr. Ulm and the physician design team knew from their experience with previous generation technologies that there was a need for a new device specifically designed to capture the clot, regardless of clot type, in the device thus reducing the number of passes needed to effectively recanalize the blocked vessel.”
“The market leading stent retrievers are actually technologies that were designed for other applications,” Rybka points out. “Treating physicians realized these stent-type devices that were used for aneurysm procedures, actually did a pretty good job in engaging a clot in a vessel to remove it.”
In 2015, there were five independent clinical studies completed showing that the use of these intervention devices for clot removal resulted in better patient outcomes. While the technologies used in these studies are now widely used for stroke treatment, there are still limitations. Current technologies are not effective in removing organized or firm thrombus, can add to the potential creation of clot fragments that migrate to downstream vessels and often require multiple attempts to remove the clot.
Vesalio has partnered with T3 Labs through multiple GLP and Non-GLP preclinical studies, since 2016 to develop their family of devices in an effort reduce the amount of “passes” or attempts required to remove a variety of clot types while reducing fragmentation that can result in clots migrating to more difficult or impossible to reach areas of the brain.
“With NeVa, we’ve been able to create a means where the device itself can interact with the clot and improve the ability to actually get the clot inside the basket, or nitinol tube. This includes even the most difficult calcified clots,” Rybka says.
As a direct result of GLP preclinical studies performed at T3 Labs, Vesalio received a CE mark in October 2017. They are currently planning a second CE submission for an extension of their NeVa product line, offering more sizes, lengths and diameters.
Finding a partner that understands the process
When selecting a preclinical partner, Vesalio wanted a lab that understands the complete development process, from the unmet clinical need and requirements (including regulatory and quality) to the extensive amount of documentation required.
“We wanted a partner that could help us in developing proper GLP protocols to make sure that we’re doing the research ethically and meeting the safety and quality requirements of the product for future clearance,” says Rybka. “Another important factor was the execution at the lab itself; understanding the prior training and documentation needed for what we’re trying to accomplish.
“All of those aspects involve proper process and qualified personnel. T3 checked every box with a glowing gold star. It’s a complex relationship that’s very different from our other outsourced partners that we work with. Choosing a capable and knowledgeable lab partner is absolutely crucial to your medical device company’s success.”
Value of an experienced team
Vesalio introduces NeVa, a revascularization device, featuring unique technology to significantly improve first pass success with all types of clots and to restore blood flow in the brain for patients experiencing acute ischemic stroke (AIS) due to a large vessel occlusion (LVO) Our first attempt at improving interventional stroke practice is NeVa™, a multifunctional stent retriever designed to capture and remove all clot types, including the hard, organized ones that resist more traditional devices. With this unique design and with the NeVa™ Drop Zone Retrieval Technique™ that we have been developing with our leading users, we believe we have a real shot at improving first pass success in emergency stroke intervention.
“We have done 7-10 labs with T3,” Rybka states. “Every T3 Labs scientist exhibits exemplary levels of professionalism when it comes to interacting with the physicians and associated team members we bring in to conduct our preclinical tests.”
Vesalio started working with T3 Labs as a preclinical partner in 2016 for data collection and proof of concept, in addition to some early onsite prototyping.
“T3 Labs has been a true partner throughout this entire process. We understand and are appreciative of the value they bring to development, quality and regulatory processes.”
What to look for in a preclinical partner
“The key [to selecting a preclinical partner] is ensuring they have strong regulatory and clinical acumen,” he advises. “If you don’t understand the full level of testing and documentation required at the preclinical level, let alone the full regulatory burden, it can be overwhelming for young companies like ours. The more educated feedback and input a preclinical CRO can give you to help you meet and accomplish your goals, the better off you are.”
If you are a physician innovator, researcher, or medical device company of any size, and want to bring your new product to life as efficiently as possible, T3 Labs and GCMI can help from concept through preclinical to commercialization. Contact us today. For more information on Vesalio, visit https://www.vesalio.com/.