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A homegrown biotechnology story that has been 15 years in the making, built on its co-founder Dr Ali Fathi's ambition to create regenerative medicine that supports the body's own healing processes, is entering a new phase as Tetratherix aims for a $25 million ASX listing at the end of this month.
Already backed by Radar Ventures' Atlanta Daniel and Rod Drury, the founder of Xero (ASX: XRO), the company has completed multiple trials of its patented Tetramatrix and is targeting the markets of bone regeneration, tissue spacing and tissue healing.
Tetratherix chair Emma Cleary says the current total addressable market for these applications alone is US$6.8 billion ($10.4 billion). The company's expected market capitalisation, at an initial public offering (IPO) price of $2.88, is $145 million.
Its products all come in ready-to-use syringes filled with water-based solutions derived from Fathi's research at the University of Sydney.
Harnessing intelligent chemistry, the Tetramatrix flowable solution transitions into a solid, adhesive hydrogel matrix at human body temperature, which Tetratherix claims is not recognised by the body as a foreign object.
The injectable fluid with minimally invasive delivery is modular in nature, possesses similar properties to natural tissue and gradually bioresorbs in the body once it has served its purpose.
Tetratherix also highlights the Tetramatrix's advantage of medical device classification for regulatory approval processes, enabling a fast track to approval compared with drugs or therapeutic candidates.
The Sydney-based biotech expects to roll out its first two bone regeneration products in 2026 in the United States through a partnership model it believes "deliberately mitigates" the challenges of costly in-market direct sales and distribution in medtech by co-developing and licensing products.
"Our progress has already been substantial and well established," Cleary explains in the prospectus.
"We have clinically validated our first product in bone regeneration and are now moving through regulatory approvals and toward commercialisation in oral surgery.
"At the same time, we are working with some of the world’s leading organisations to unlock new applications in radiation oncology, ophthalmology and tissue repair."
Tetratherix will use $10.2 million from the IPO proceeds to move to a larger manufacturing site in the Sydney suburb of Alexandria, where since 2017 it has operated a state-of-the-art 200sqm facility with ISO:13485 certification. Manufacturing will continue at its current site until the new facility is finalised, with a planned 2027 opening date.
Having spent $1.9 million on research and development (R&D) in the past financial year, the IPO proceeds allow for $11.3 million in further R&D towards different applications, with the largest portion of the funds assigned for tissue healing.
In the prospectus, founder, executive director and chief technical officer (CTO) Ali Fathi says that 15 years ago he found himself asking why, in the age of advanced biology and material science, was regenerative medicine still so inaccessible and impractical at the point of care.
"This question ignited the work that would become my PhD at the University of Sydney, where I had the privilege to study and work within a rare environment that refused to acknowledge any arbitrary boundaries between engineering and medicine," he says.
"That foundation taught me to think independently, outside the traditional dogmas of biology and chemistry."
In 2011, he achieved a breakthrough by creating a new class of polymers that could be "almost invisible to the human body", predominantly composed of water, injectable, able to form a physical matrix to bridge tissues and heal injuries, and then be reabsorbed once its purpose is fulfilled.
"Four functional monomers, each with a specific role, each part of a larger system, combined to create what we now recognise as a genuine breakthrough," he says.
"In my hands, complex chemistry became simple and modular like 'medical building blocks', providing a toolset for solving problems medicine had no current answer for."
Towards the end of his PhD, he met Terence Abrams, who would become co-founder and chief operating officer (COO) of Tetratherix when it was formally established in 2015.
"His operational brilliance in chemical engineering and his uncompromising belief in this mission made our partnership invaluable," he says.
"We built Tetratherix from the ground up, brick by brick. We were directors, engineers, scientists, regulatory officers and bookkeepers. We took an empty warehouse and turned it into a state-of-the-art cleanroom, compiling our first quality system line by line to manage the facility.
"Within 18 months of incorporation, we had scaled manufacturing and launched our first human clinical study. The relationships we built during those early, formative years, including the enduring support of our first principal investigator, Dr. Dax Calder and our seed investors, still define Tetratherix today."
In 2018, the pair then met Will Knox, who came on as CEO in 2021 as the company worked towards commercial-scale production, following a $5.7 million Series A in March 2020. Prior to that, the company had raised $4 million, and in August last year, it issued $2.57 million worth of SAFE notes.
"Will immediately grasped what others missed: the power of a lean, unconventional operating model combined with transformational science," Fathi says.
"Will helped us see that what we have built is not merely a set of products but a technological platform which we call Tetramatrix."
Knox says the IPO represents a major milestone that is many years of hard work in the making for the team, and especially the founders.
"This IPO will provide us with essential growth capital to advance our innovative, scalable platform technology, which has already been met with outstanding interest in sizeable markets demonstrating an unmet need," Knox says.
"We believe Tetratherix has the potential to become a global medical technology leader, and we now look forward to executing on our growth strategy, delivering value to our loyal shareholders and providing innovative new solutions to patients."
Barrenjoey and Morgans are joint lead managers (JLMs) and underwriters to the offer for Tethratherix, which will be traded under the ticker TTX.
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