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FOCUS ON QUALITY AND REGULATION PUTS ALIMETRY INTO THE FAST LANE

Alimetry is an exemplar of how focusing on diversity, innovation, quality control and regulatory requirements can help get a new medtech device to market within two years.


Led by surgeon Greg O’Grady, the Alimetry team is now working through the FDA approval process for their next-generation technology for diagnosing gastric disorders.


Alimetryᵀᴹ is deep tech – something novel that offers significant advances over current technology. This non-invasive device helps diagnose gastric dysfunction. It senses the underlying motility of the stomach to detect the contributing causes of common symptoms such as abdominal pain, indigestion, nausea and vomiting.


At present the diagnostic process for gastric symptoms is really inadequate. Patients often come out of a prolonged process with no clear answers, while clinicians end up having to do trial-and-error therapy. Alimetry’s goal is to explain symptoms in a way that can directly inform personalised therapy. If successful, this will transform the diagnostic pathway for millions of patients worldwide suffering from diseases such as chronic indigestion and chronic nausea and vomiting.


The Gastric Alimetry system is made up of a reusable recording device manufactured at the Auckland Bioengineering Institute, and a stretchable and disposable sensor array designed here but made in the US. The patient consumes a standardised meal and logs their symptoms on an app. Test data is sent to the cloud for analysis and the clinician receives a detailed and actionable report.


At just two years old, Alimetry is already well ahead of usual start-up timelines. Chief Operating Officer Hanie Yee cites the team’s diversity as one of the key components to that success.


“Armen Gharibans is an unconventional engineer with a lot of clinical research experience. Yaara has joined us from Israel with a very strong start-up background to manage the regulatory side. Greg is a general and lower gastrointestinal (GI) surgeon and a bioengineering PhD with a track record in start-ups, and my background is commercialisation in MedTech, most recently at Fisher & Paykel Healthcare. The rest of the team have equally diverse backgrounds that fosters a creative environment for all of us to work within” says Chief Operating Officer Hanie Yee.


“The idea began with research conducted at the Auckland Bioengineering Institute over a decade ago. We’ve known about electrical activity in the stomach for 100 years, but the team at the ABI took what they knew about bioelectricity from cardiac work and applied it to the stomach,” says co-founder Gharibans.


O’Grady says he was seeing too many patients go through laborious, invasive and expensive rounds of repeat diagnostic testing, only to end up with inconclusive results and confusion. “This experience helped to inspire a decade of scientific work led out of the ABI to map in unprecedented detail the electrical activity in the human gut, which was funded by the New Zealand Health Research Council.


Over in San Diego, Gharibans was looking at the same problem. He relocated to New Zealand in 2018 to join the team at the University of Auckland – a “dream come true”.


Yarmut came on board to manage the regulatory side. “Alimetry’s engineers are interested in quality and they wanted to get the best possible device to market. Focusing on quality and regulatory requirements early in the process would help speed that up.”


Yee says a lot of start-ups try to fit regulatory and quality retrospectively once the product is ready. “We started with regulatory and quality simultaneously with product design. Greg and Yaara share the same vision and have created the framework which enables the team to achieve milestones in a short space of time. It’s the do it once, do it right approach.”


The focus on quality has paid off with Alimetry achieving the ISO 13485 international quality management system accreditation as well as CE mark within two years of the company being established.


Alimetry is now seeking FDA approval whilst clinical trials are being completed globally. “This will get us into the all-powerful US market, hopefully within 12 months. Our quality management will comply with FDA rules and we can then leverage that.”


Alimetry has regulatory clearance in New Zealand and the EU with trials underway in Australia, New Zealand, Canada and the EU. The team hope to start commercial research sites in New Zealand this year.


In the meantime, the high-energy team is waiting to see if their work earns them a 2021 NZ Hi-Tech Award, which recognises outstanding innovation, contribution and success in New Zealand’s hi-tech sector. The awards will be announced at the end of May.