SINGAPORE (Feb 21): At the SLINGSHOT 2019 start-up competition that took place during the Singapore FinTech Festival late last year, Breathonix was declared as one of two sector winners for the HealthTech, BioTech and MedTech category. The company beat more than 2,000 other participating start-ups worldwide to bag one of the 12 $50,000 Startup SG grants.
“We are very lucky to be [a] winner,” Du Fang, co-founder and chief operating officer of Breathonix, tells The Edge Singapore in a recent interview. “We didn’t expect [to win].”
Incorporated less than a year ago, Breathonix is attempting to develop a better way to diagnose lung cancer compared to the current methods. In particular, it is building a software that can identify biomarkers from a patient’s exhaled breath that correlate with the lung disease.
These biomarkers are volatile organic compounds (VOCs) produced by cells during the metabolism process. They can be found, for example, in a person’s exhaled breath, which contains about 1,000 VOCs, according to Du. In the case of a lung cancer patient, the VOCs produced are different from that of a healthy person. “These can be seen like a fingerprint. Different diseases will give different fingerprints,” he says.
Hence, by analysing a patient’s exhaled breath for certain biomarkers that correlate with lung cancer, Breathonix is able to detect the disease earlier and without any pain. This is conducted using a breath sample collecting device, which is then fed into a mass spectrometer to identify the types of VOCs.
Currently, a computerised tomography scan is only effective at identifying late-stage lung cancer, which by then significantly reduces a patient’s chances of survival. On the other hand, a tissue biopsy is painful as it involves the extraction of cells from the lungs. “That’s why most patients will miss out on treating lung cancer early,” he says.
Breathonix is trying to deal with an expensive problem. Citing costs published by the UK’s National Health Service, the cost of lung cancer to the UK is ₤9,071 ($16,442) per patient per year, and the total cost of this disease to the country’s economy is around ₤2.4 billion.
To be sure, Breathonix is not the only startup to develop this method of diagnosis. Some of its rivals, including UK-based Owlstone Medical and North America-based nGageIT Digital Health, are also using VOC biomarkers from breath to diagnose for diseases.
However, Du says, Breathonix’s online sampling method of identifying the biomarkers is superior compared to its rivals’ offline sampling method. In particular, the company obtains a patient’s breath using its proprietary breath sampling device, which is then plugged into a mass spectrometer to run real-time analysis. This minimises any chance of the breath sample getting contaminated or degraded.
In contrast, the other method obtains and stores a patient’s breath using a swap tube, which is then transported to a centralised laboratory for analysis. This introduces a higher chance of the breath sample getting contaminated or degraded, says Du.
Clinical trials, regulatory hurdles
Thus far, Breathonix has conducted 80 clinical trials on lung cancer patients from the National University Hospital. The company’s diagnostic software managed to hit an accuracy level of 80%, Du notes.
However, he adds, the company requires more clinical trials in order for the software to make better sense of the data. This will be conducted in China sometime this year, given that the country has more lung cancer patients compared to Singapore. “As we increase the sample size, the accuracy level should go up,” he says.
Following that, the company will apply for regulatory approval for its diagnostic software and breath sampling device, says Du. This includes the China Food and Drug Administration (CFDA), the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA). He adds that the company will also seek approval from Singapore’s Health Sciences Authority (HSA), though that will come much later.
Du says the priority is to obtain approval from CFDA first, followed by FDA and EMA. This is because Breathonix plans to sell its diagnostic software and breath sampling device in China first, followed by the US and EU. “We focus on the bigger markets first,” he says. “Small countries are more tricky to get approval. They have to be done one by one.”
While acknowledging that the Singapore market is small, gaining approval from HSA will help to ease the process of obtaining approval from similar regulatory authorities in Southeast Asia. This is because HSA is widely recognised in the region, says Du.
Overall, the clinical trials and approvals could take about three to four years to complete, Du says. Thereafter, Breathonix plans to sell its diagnostic software on a subscription basis together with the breath sampling device. The products will be sold to hospitals and healthcare centres.
Now, because of the typical time required to clear the regulatory hurdles, Breathonix’s path to commercialisation, much less profitability, will almost certainly take some years. Yet, there are some investors willing to take a bet on the company already. According to Du, he recently secured an investment of RMB5 million ($995,909) from a Chinese VC firm, which he declines to name.
Besides this VC firm, there are other backers as well. They include the National University of Singapore, via the NUS Graduate Research Innovation Programme (NUS GRIP). NUS GRIP is a start-up incubator that enables PhD and research staff at NUS to start their own deep tech companies whilst completing their studies or working full time. It has provided the company with seed funding. In addition, Breathonix has received a non-diluting grant from Enterprise Singapore, the government agency whose job is to help local companies grow.
From research to entrepreneurship
Breathonix was the brainchild of Jia Zhunan, who is the company’s other co-founder and CEO, and Du’s wife. Both she and her husband were originally from China. They are now permanent residents of Singapore. They came here 10 years ago on a scholarship from the Ministry of Education.
Jia conceived the idea to start a MedTech business while she was still a PhD student at NUS, conducting research on VOCs linked to lung cancer. Jia notes that her professor had encouraged her to venture into the start-up scene. So when she graduated with a PhD in hand, she did not hesitate to join the first batch of NUS GRIP in April last year.
Meanwhile, Du was also a PhD graduate from NUS, and he completed his postgraduate studies in integrated science and engineering. After graduating, he worked in the corporate sector for a couple of years, before joining his wife at NUS GRIP. “I’m always keen to be an entrepreneur,” he says.
While it is still early days, Jia says Breathonix’s long-term plan is to eventually make breath testing convenient and portable. That would mean shrinking the mass spectrometer and combining it together with the breath sampling device into a single handheld device. This would allow people to diagnose themselves from home or anywhere else, without having to step into a hospital.
Du also envisions the device as being able to diagnose other diseases, for instance diabetes. “You can smell fruitiness from the breath of diabetes patients. This is due to the presence of certain VOCs,” he says.
