Sydney-based biotech Tetratherix (ASX: TTX) has advanced plans to take its universal bone regeneration technology to the global market after finalising an exclusive distribution agreement with Nasdaq-listed Henry Schein, Inc.
The company, which listed on the ASX in June last year following a $25 million IPO, says the deal paves the way for the first Tetratherix product launch in the US and other major markets.
Henry Schein, the world’s largest provider of health care solutions to office-based dental and medical practitioners, will initially launch Tegenix to the market which is Tetratherix’s initial product for dental surgery.
Tetratherix is a developer of novel clinical products based on its patented biomaterial polymer platform technology that is used for bone regeneration, tissue spacing and tissue healing.
The company’s key product, the Tetramatrix platform, comprises a unique group of biomaterials developed by CTO and founder Dr Ali Fathi at the University of Sydney.
The Tetramatrix platform is a liquid-injected, water-based gel that solidifies into a scaffold at body temperature to act as a framework for tissue regeneration.
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 distribution agreement with Henry Schein, which is subject to minimum purchases, will give the market access to Tegenix through the US group’s global sales and distribution network.
Henry Schein, a Fortune 500 company, has operations or affiliates in 33 countries and territories.
“Finalisation of these terms validates Tetratherix’s initial commercial rollout and confirms a scalable route to market for Tegenix with a global leader in this space,” says Will Knox, the CEO of Tetratherix.
“Consistent with the communicated strategy in our IPO prospectus, we anticipate the first commercial shipment to HS to occur in FY27 following FDA 510(k) clearance of Tegenix.”
Today’s announcement by Tetratherix was accompanied by a start to construction of the company’s new advanced manufacturing facility at Alexandria in Sydney.
The facility will support expanded production of Tetratherix’s synthetic polymer platform products to meet expected global demand.
Tetratherix says the facility, which is expected to be operation this year, has been designed with scalability in mind, supporting both near-term dental applications and future expansion into other clinical indications.
Meanwhile, another newly listed Australian med-tech, Epiminder, has also announced a breakthrough in the US with the first implant of its Minder System in North America.
Epiminder, a medical device company developing breakthrough epilepsy monitoring technology, says the Perelman School of Medicine at the University of Pennsylvania has enrolled and implanted the first study patient as part of the Diagnosing Epilepsy To Effect Change (DETECT) study.
The Melbourne-based Epiminder says four other US sites have enrolled for the study and are actively recruiting patients, including the Mayo Clinic Rochester, Mayo Clinic Jacksonville and Mayo Clinic Phoenix, and Beth Israel Deaconess Medical Center.
“This first US implant of our Minder device marks a watershed moment for Epiminder and the global epilepsy community,” says Rohan Hoare, CEO of Epiminder.
“We are excited to take the next step in translating years of rigorous scientific development and clinical validation into real-world impact for patients who have exhausted traditional monitoring options.
“This study is just the beginning of what we believe will be a fundamental transformation in how the world diagnoses and manages epilepsy.”
Epiminder, which is backed by hearing technology giant Cochlear (ASX: COH), listed on the ASX in November after raising $125 million in an IPO.
Shares in Epiminder were trading 1.5c higher at 93.5c at 11.39am (AEDT), well below their $1.50 issue price.
Tetratherix shares, which were issued at $2.88 each, were trading 10c higher at $3.50.
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