Myomar Molecular, which is developing tests for monitoring muscle health, has won Health Canada approval, clearing the way for it to begin selling its product to customers through healthcare providers, such as physiotherapy clinics.
Chief Executive Rafaela Andrade said in an interview Wednesday the nod from regulators comes in the form of a Medical Devices Establishment License — a certification not of a specific product, but rather of Halifax-based Myomar as a company.
The process, which took a few months from the time Myomar submitted its application to receiving approval, makes it possible for Andrade’s team to begin commercializing their test, building on still-ongoing beta testing the business has been conducting with individuals via its website.
“We are excited to put the product in front of our first customers, which will be … any health professional that’s interested in assessing muscle health using our tests now will be able to partner with us,” said Andrade, who holds a PhD in molecular biology.
The first version of the test must be administered by Myomar, which involves the company arranging for the collection and transport of samples to its laboratory. So next year, Andrade plans to add an at-home kit to the product lineup.
In the meantime, Myomar recently finished moving into a new, larger space in The Labs, a wet laboratory facility owned by Invest Nova Scotia in preparation for producing and administering tests at a larger scale. The company also recently on-boarded a new software engineer and a head of operations, bringing its total headcount to seven.
An additional benefit of the Health Canada license, Andrade added, is that the quality control processes her team adopted will ease the path to additional regulatory approvals, since the requirements are often similar, even across jurisdictions.
“All the quality management systems that we are putting in place will be useful for further medical device licenses from Health Canada, and also the United States,” she said.
In March, Myomar closed a $1.1 million funding round, and the company is preparing for another raise later this year. The deal, which included a mix of equity and non-dilutive funding, was led by a Nova Scotia angel investor, with the Atlantic Canadian and Ontario divisions of the Women’s Equity Lab angel network also participating.