- Cleveland, Ohio-based medical device maker Checkpoint Surgical received breakthrough device designation from FDA for its brief electrostimulation therapy system intended for use in patients being treated for nerve injury, the company said Wednesday.
- The technology, called the Checkpoint BEST system, is designed to improve outcomes after surgical intervention by providing electrical stimulation of peripheral nerves to bolster nerve regeneration.
- Checkpoint Surgical said it is actively enrolling patients in a clinical study of the technology at Washington University in St. Louis and is interested in adding more study sites, building on a recent study in animals.
Checkpoint Surgical is a portfolio company of NDI Medical, a venture capital and commercialization firm focused on neurodevice technologies. Checkpoint already has 510(k) clearance for a nerve muscle stimulator and locator product, a single-use, handheld device the company said can be used during surgical procedures that require tissue dissection or nerve exploration and repair. It also markets a version designed specifically for head and neck procedures.
A June 2018 investor report written by Checkpoint CEO Len Cosentino said the company had approximately 300 U.S. hospital customers and reported roughly $4.4 million in 2017 revenues, about 80% of which came from the original nerve stimulator and locator. Cosentino said the company aims to achieve profitability and positive operating cash flow in the fourth quarter of 2019.
The report teased the company's expansion beyond intraoperative nerve protection and repair into post-surgical nerve repair, a new area it said was at least a $1 billion market opportunity.
"Our long-term objectives are to grow revenue from our existing products in the intraoperative nerve protection and repair business to $15 million over the next four years, to further grow the business through new applications, such as in the application for amputees, and to commercially launch the therapeutic nerve regeneration business," Cosentino wrote in the report.
The breakthrough device designation is the latest step for the nerve regeneration business. Cosentino said Wednesday the designation will allow the company to deliver the technology to the patients "much sooner."
The FDA program aims to increase interaction between developers of treatments or diagnostics for life-threatening or irreversibly debilitating diseases or conditions, and improve timeliness of review. Designated devices that later receive marketing authorization may also benefit from a newly finalized CMS reimbursement model allowing products to receive payment even without initially demonstrating a substantial clinical improvement standard.
Amy Moore, a plastic and reconstructive surgeon at Washington University in St. Louis who specializes in peripheral nerve injury, said in Checkpoint Surgical's announcement the breakthrough-winning technology "represents a paradigm shift in the treatment algorithm of nerve injuries, if proven successful in our clinical trial."
"As clinicians we will be able to proactively deliver a therapeutic intervention which augments the current care and counters the inefficient initiation of nerve regrowth,” she said.
Other designated devices announced this month include a wireless cardiac pacing system for treatment of heart failure, a liquid biopsy for liver cancer, and a device that uses pulsating sonic waves to fracture heavily calcified plaque in coronary arteries.