Halifax medical device maker ABK Biomedical has closed a US$30 million, or about C$40.9 million Series C funding round, marking one of the largest capital raises in Atlantic Canada so far this year.

The round was co-led by two new investors: Austin, Texas-based medtech venture capital fund Santé Ventures and “a significant, undisclosed MedTech strategic investor.” Existing shareholders F-Prime Capital of Cambridge, Massachusetts and Eight Roads, which has offices on five continents, also re-upped their stakes.

ABK Biomedical plans to spend the money on clinical research, as well as seeking an Investigational Device Exemption, or IDE from the United States Food and Drug Administration for its Eye90 microspheres product. The exemption would allow the company to conduct human clinical studies of its technology. 

“We have made tremendous progress at ABK over the past three years,” said CEO Mike Mangano in a statement. “We have strengthened our manufacturing and supply chain by building two GMP facilities that produce our microspheres, delivery devices, and process our irradiated microspheres into our final Eye90 microspheres unit doses.

“We have recruited an expert cross-functional team, transferred product from R&D to manufacturing, and implemented rigorous clinical and regulatory competencies.”

In pharmaceuticals, the initials “GMP” usually refer to “good manufacturing practices” — Health Canada standards for the industry.

The Eye90 microspheres are millions of tiny, highly radioactive, x-ray-visible glass beads that deliver cancer-treating radiation to a liver tumour once injected into the patient’s bloodstream in a process called radioembolization. The microspheres can be seen on CT scans, allowing doctors to assess how effectively their injections are targeting a tumour.

ABK also makes a second, similar medical device called Easi-Vue embolic microspheres, which block the blood vessels surrounding a tumour, but do not emit radiation.

The Easi-Vue spheres received a 510(k) approval from the FDA earlier this fall, which means they can now be sold in the U.S. because the agency has determined them to be “substantially similar” to other products already on the market.

In its statement, ABK said it also plans to direct a smaller portion of the $40.9 million towards further assessing and developing the Easi-Vue technology.

The Eye90 spheres, though, are unlike exusting products and will have to work their way through the full, often costly regulatory process. The IDE would allow ABK to conduct what it describes as a “pivotal trial,” which usually refers to Phase III clinical trails, the final research-related step in the process of seeking FDA approval.

Founded in 2012 by Dalhousie University researchers Dr. Bob Abraham, Daniel Boyd and Sharon Kehoe, ABK said prior to the Series C round it had raised more than C$50 million over its lifetime, suggesting a new total in the neighbourhood of C$90 million.

The company’s latest close is for the same amount of money as a raise it conducted in 2019.

The deal comes as Atlantic Canadian innovation-driven companies have announced several eight-figure raises this year. They includie a US$50 million stock market raise from Dartmouth’s Meta Material; a C$39.5 million VC round by Mara Renewables, also based in Dartmouth; and a $26 million VC raise by Halifax’s Milk Moovement.

The raise also helps offset an anemic third quarter for Nova Scotian venture capital rounds, which saw just $11 million of deals close, compared to $36 million in the second quarter, according to data from the Canadian Venture Capital and Private Equity Association.