The decision, announced Monday, involved Cirtec withdrawing the FDA premarket approval for the Nuvectra Algovita spinal cord stimulation system and converting that information into a master file housed at the FDA. This allows Cirtec to give its customers access to the Algovita information so they can use it to develop new technologies. For example, if a startup that has a development agreement with Cirtec wants to run a preclinical or clinical trial based on the Algovita technology, that startup can cite the past studies in the master file in its submission for an FDA investigational device exemption application, Cirtec CEO Brian Highley told Medical Design & Outsourcing.
Cirtec bought Algovita to add it to its Simplifi neuromodulation R&D platform than to commercialize Algovita directly. As a contract manufacturer, Cirtec is not in a position to do postmarket surveillance, Highley said. It also sells components of the system.
“Very basically, we can take the device and sell off-the-shelf components under this master file and get them in the hands of one of our customers quickly,” Highley said. “It’s also customizable, so if you need a smaller device or different configurations, we can easily modify the system for them.”
Several customers who are interested in the technology can now reference the FDA master file with Cirtec’s permission.
Plano, Texas-based Nuvectra filed for Chapter 11 bankruptcy protection in November 2019 and Cirtec bought the Algovita intellectual property and certain assets from Nuvectra in May 2020. Cirtec was not among Nuvectra’s creditors, Highley noted. Two contract manufacturers with unsecured claims were Minnetronix Medical and Greatbatch Medical, now a part of Integer Holdings (NYSE:ITGR). Minnetronix was owed nearly $2.8 million, and Greatbatch’s unsecured claim was nearly $2.2 million.
Nuvectra began as the QiG Group, a part of Greatbatch Medical before its spinout was approved in February 2016. But its Algovita device was up against stiff competition in the SCS space, which is dominated by much larger companies — Abbott, Boston Scientific, Medtronic and Nevro.
“There’s a lot of innovation going on in neuromodulation, but in order for a startup or somebody in academia to get something to market quickly, they’d have to go to Medtronic, Boston or Abbott,” Highley said. “These guys don’t like to deal with some of the small startups. We were looking for a way of supporting the neuromodulation community and providing an option to get a product in a customer’s hand quickly.”
Cirtec’s PMA-to-master-file conversion, which it undertook on the FDA’s advice, is not common, but contract manufacturers have done it before, according to longtime medtech consultant Mark Bonifacio.
“That’s a great strategy for the CM, and you’ve really got what you wanted if they get the 510(k) approval or the PMA,” Bonifacio said in an interview with MDO. “It’s not uber-common but it’s definitely not weird or it’s not out of the jurisdiction of the FDA to say this. … I think it’s a good suggestion for Brian and the folks at Cirtec to go down that route.”
Cirtec’s move has also drawn praise from others.
“Translating neuromodulation research concepts in academia just became much easier,” said University of Minnesota Medical School professor Greg Molnar in a news release. “Having access to Cirtec’s Simplifi clinical neurostimulation system and master file can be leveraged to support physician-sponsored IDE studies that would otherwise not be possible.”
“Leveraging Cirtec’s Simplifi neuromodulation platform has enabled Comphya to significantly reduce our cost and time to market by leveraging the existing validation reports and other objective evidence rather than creating our own,” added Cirtec customer Rodrigo Fraga, CEO of Comphya.