Neurovasc Technologies Inc., of Laguna Hills, Calif., has entered a strategic partnership with the Wego Group that includes $34 million in funding to support the company’s product portfolio development and global clinical trial program. Specifically, the funding first will go toward studies of the company’s stent-retriever, designed to treat patients suffering an acute ischemic stroke, in markets such as Japan, the EU, U.S. and China.
“This is an exciting time to be partnering with a company dedicated to improving stroke and neurovascular therapies,” said XueFeng Wu, CFO from the Weihai, China-based Wego Group, which focuses on the R&D, production and sale of single-use medical devices. “Neurovasc and Wego have partnered to execute a comprehensive development strategy including the commencement of several pivotal clinical trials around the world in 2020. This series of efforts we feel will bring huge social and commercial value.”
Of note, Neurovasc is hoping to bring a full neurovascular platform to market. It is aiming to help clinicians more efficiently and effectively treat neurovascular disease. According to the Centers for Disease Control and Prevention, roughly 795,000 people in the U.S. have a stroke each year.
The company currently has CE mark for the Versi mechanical thrombectomy system, which is used for clot removal from the blood vessels of the brain during an acute ischemic stroke. The company has two studies listed at Clinicaltrials.gov, one of which is a Japanese approving study (NCT04129203). A second study evaluated the system for acute ischemic stroke (NCT03366818). Researchers from the second study concluded that the system was safe and effective, publishing their findings in the Journal of NeuroInterventional Surgery.
Vitor Mendes-Pereira of the University of Toronto’s Toronto Western Hospital said he had worked with the company for several years and expressed enthusiasm about the approach it uses through the design process. “This gives me full confidence in the strength of Neurovasc’s foundation and I am looking forward to their future projects,” said Mendes-Pereira.
For his part, Neurovasc CEO Jim Ma noted that his company’s growth will move faster in the wake of this partnership. “We remain focused on delivering innovative technology that enables reproducible results, thereby helping physicians provide better outcomes for their patients,” he added.
In May 2018, the company reported that it had closed a $6.3 million series B preferred stock financing. The funding, which attracted multiple investors, was led by Shangbay Capital.
In June 2019, Acumen Research and Consulting released research saying the global blood clot retrieval devices market value should hit $2.29 billion by 2025 and grow at CAGR of about 17.5% from 2018 to 2025.
A host of other companies are in the clot retrieval space, including Boston Scientific Corp., Argon Medical Devices, Medtronic plc, Penumbra Inc., Angiodynamics, Johnson and Johnson and Bayer Healthcare.
The companies are seeing strength in addition to competition. This was seen this week when Penumbra reported quarterly results Feb. 25, with its neuro business seeing decent sequential growth. “Our ability to estimate the stroke thrombectomy market has become more challenging given recent market unevenness and competitive entries,” CEO Adam Elsesser said. “Our latest 2019 estimate is that approximately 43,000 to 45,000 patients were treated with mechanical thrombectomy in the United States. Our sense is that the market will continue to grow by a similar absolute number of patients in 2020.”
William Blair’s Margaret Kaczor said her organization estimated that fourth-quarter stroke sales had grown 14% year-over-year, coming in below its 18% estimate, “but largely in line with expectations for midteens stroke market growth as Penumbra continues to benefit from a growing mechanical thrombectomy … market and its market leading position in aspiration.” At the same time, there is an expectation for decreasing stent retriever sales “given increased efficacy of its latest generation catheters that are reducing the need for bailout stents.”
For his part, Wells Fargo’s Larry Biegelsen noted that in Japan, reimbursement for stroke procedures was cut by 40% last November. “The change stemmed from separators no longer being used in stroke cases, thus removing reimbursement for the separator and effectively lowering overall procedure payment. PEN’s recent discussions with its Japanese distributor also led to some changes in inventory and timing of purchases.”
While there is a host of options for stroke, Tom Merrill, associate professor of mechanical engineering at Rowan University and CEO and co-founder of Mullica Hill, N.J.-based Focalcool LLC, is developing Khione, which relies on therapeutic hypothermia to prevent ischemia reperfusion injury. His company reported in January 2022 that it had scored a nearly $2 million grant from the National Institute of Neurological Disorders and Stroke, part of the NIH.
The goal of the company is to use precooling before bringing in this series of catheters and then maintaining the low temperature after catheterization to minimize the damage from reperfusion injuries.