Hall & Wilcox has advised medical device startup Margin-Clear Pty Limited in its most recent capital raising from existing shareholders, sophisticated investors and professional investors of $1.25 million (over-subscribed in response to an initial target of $450,000).
Margin-Clear was founded in 2018 by three subspecialist cancer surgeons from different leading tertiary institutions around Australia to develop, commercialise and manufacture the Margin-Clear device, which is an absorbable patch implanted by the operating surgeon to reduce the risk to the patient of residual cancer cells potentially left behind at the 'margin' during cancer surgery.
The company is raising funds to progress product development and collect safety data to complete a United States Food and Drug Administration (FDA) regulatory submission. The product development path and subsequent US market entry assumes regulatory approval by the FDA. In addition, a Key Opinion Leader (KOL) engagement program will be established with leading US surgical and radiation oncologists ahead of the market introduction of Margin-Clear.
Health & Community Leader, Partner Alison Choy Flannigan led the Hall & Wilcox team, assisted by Lawyer Rebecca Kazzi, Foreign Qualified Lawyer Candice Gibson and Paralegal Lauren Krejci.
Hall & Wilcox advised on all aspects of the transaction, including advising on fundraising requirements under the Corporations Act, corporate legal advice preparing the client for due diligence prior to the capital raising, TGA regulatory, the Information Memorandum, amending the Constitution and Shareholders Agreement to increase attractiveness for investors, and assisting with company secretarial including applications for shares, members registers, minutes, notices to ASIC etc.
Margin-Clear also used the Hall & Wilcox FIRB app to check whether investors required FIRB approval. The app has been designed to help foreign investors, investees and advisors determine whether Foreign Investment Review Board approval is required before a proposed transaction or acquisition is implemented. The app is updated as the FIRB rules and requirements change.
‘It is great to assist health, pharmaceutical and medical device startups to capital raise to enable them to bring their products to market and improve outcomes for patients,’ Alison said.
‘We have recently advised a number of clients in the sector which have been over-subscribed. It is great to see investment in the sector and our clients thrive. What is pleasing in this transaction is that Margin-Clear was not only able to attract capital for its future activities but also attract investors and partners with industry expertise and track-record in the life sciences commercialisation.’
Margin-Clear CEO and Managing Director David Burnett is a liver and pancreas cancer surgeon at John Hunter Hospital, NSW. On the capital raising, David said: ‘I was particularly encouraged by the success of the capital raising, with overwhelming support even in the midst of the COVID pandemic. The additional capital, as well as the strengthening register, will enable the ongoing development of this innovative novel brachytherapy device with major industry partners.
‘The product has the potential to provide surgeons with a new solution to one of the key issues in cancer surgery – the risk of leaving microscopic cancer cells behind. It’s evident from the strong support of patients, surgeons, funders and investors that there is a clear addressable market for this product.’
Hall & Wilcox’s Health & Community team advises the health, aged care, retirement living, life sciences (pharmaceuticals, medical devices and health and medical research), disability, education and community service sectors.
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