Preterm birth refers to the birth of an infant before 37 weeks of gestation. The major issue with preterm birth is that there can be multiple causes resulting in several diseases or medical complications. Hence, it is more challenging and complicated to develop the clinical tools that can assist in risk assessment and contribute to the effective reduction in the preterm birth rates.
In 2015, Dr Nir Arbel and XiangQian (XQ) Lin started work in this direction and founded CARMENTIX, a start-up company based in Singapore and backed by Esco Ventures, the life sciences investment arm of Esco Group dedicated to nurturing promising early-stage startups with novel innovations and technologies in the life sciences arena that will improve human well-being and quality of life. In an interview with Biotechin.Asia, Dr Nir Arbel, CEO of Carmentix, described his journey and motivation behind his startup.
What motivated you to work in this direction?
Though there are many therapeutic areas of interest, women’s health is under-served in some aspects. Most prefer to work on the most common and high visibility healthcare issues such as cancer, creating and exacerbating the void in true unmet needs that are under-served. We decided from the very beginning to focus on women’s health and quickly narrowed down to preterm birth as one of the biggest unmet needs in the field. Our decision was validated by our methodical approach – its incidence rate, the presence of a clinical and/or therapeutic solution, cost-vs-benefit to both payers and providers, competitive benchmark against both current and in-development comparables, and regulatory risks.
Once we were convinced that this is the direction, we strategized the development plan, paying attention to reducing scientific risk. Additionally, we set clear milestones and decision checkpoints, aligning the budget to these factors in the process.
What is your technology? What is the current stage of development?
Carmentix is developing a diagnostic kit that would allow for the accurate preterm birth risk assessment of pregnant women. We have developed a panel of novel proprietary biomarkers utilizing a proprietary data mining software (metadata and bioinformatics analytical methods) that will allow for the early prediction of preterm birth as early as 16 to 20 weeks of gestation. It is an immunoassay that requires cervical vaginal fluid samples. In parallel, we have also initiated prospective clinical studies to allow for the fine-tuning of the biomarker algorithms and validation of developed kits.
We have completed an initial clinical study confirming our proprietary biomarkers with incredible accuracy, achieving an extremely high Positive Predictive Value (PPV) of 100% in the initial study. This means that a woman who has been indicated for preterm birth would stand a high chance of presenting it, barring any interventions. Thus, by using our proposed diagnostic kit, clinicians will be able to intervene or introduce prophylactic measures at the early stage of pregnancy and significantly reduce the preterm birth rates, mitigating both medical and social burdens in the process.
The company is looking to expand the sample biobank to 10,000-15,000 samples in the next 3 years in parallel with the development of our prototype next year. We also envision a diagnostic test to be launched in the US and EU in 2020, followed by Asia in 2021. Although we are cognizant that the PPV would not be as high with an increase in sample size, our results have grabbed the attention of key opinion leaders with whom we are in discussions for collaborations, providing us a clear indication that we are on the right track, and that what we dreamed possible is only a few years from coming true.
What is your business model and your target market?
Our goal is to reduce preterm birth rates reliably in the markets that we plan to enter. To do so, our diagnostic tests would be designed for use by clinicians within specialist facilities and/or reference laboratories. This would maximize patient access for pregnant women that present themselves for a routine check-up in the late first to early second trimester. Additionally, this would also help us build our sample library, allowing us to improve on the correct tagging of high-risk women correctly so that they could benefit from prophylactic treatment and/or timely medical intervention.
The financial burden of preterm birth is immense. In the US, first-year preterm babies are estimated to incur 10 times more in medical cost compared to normal term babies. Thus, to mitigate this significant medical costs as well as potential social resources required to sustain preterm babies into adult lives, early prediction is the key factor to reducing preterm births. We estimate the global market for such a prognostic kit to be USD 4 to 6 Billion.
Currently, there are no products in the market that can predict preterm birth risk before symptoms occur. Our key differentiating factor is our operational process in which we thoroughly think, plan and execute the best solution for both patient and provider. This has allowed us to be very efficient in development time and expenditure leading to where we are today.
When asked about the experiences of the start up journey and words of advice to fellow entrepreneurs, Dr Arbel said,”The story of Carmentix, like all start-up journeys, has been challenging but exciting. We faced several technical obstacles from a very early stage and we continue to experience interesting developments. However, since we did have the privilege to prepare a solid development plan with contingencies, we were able to accomplish all our milestones in the timeframe we originally planned for. I cannot emphasize enough how important it is to think through our entire development pathway before taking the first step. It is clear that not all is known at the early stages of research. However, if you think about who is going to buy your product or who is going to pay for it, reflections of those thoughts can assist you in the early stages.”
As preterm birth is a global issue, Carmentix’s goal is to achieve a cost-effective solution that would be robust, accurate and able to accommodate the majority of clinical settings worldwide.
More about the co-founders:
XiangQian Lin (Chairman)
He is a young Singaporean entrepreneur with experience in the life sciences tools/medtech industry, global work experience and contacts, proven business management, and early-stage investment track record. He started to work at the age of 13 and founded first business at 17 (re-engineered family business into a life sciences tools company and grew enterprise value from single digits to approximately 100M+, in 14 years, a 25%+ CAGR) Successfully developed and commercialized over a dozen product lines in the life sciences tools and medtech space.
Dr Nir Arbel (CEO)
Dr. Arbel has extensive experience in multiple startup companies developing therapeutics and diagnostics. Until recently Dr. Arbel was Head of R&D for Acumen research laboratories involved in a clinically relevant diagnostic tool for Sepsis. Dr. Arbel previously served as a project manager at VIDAC-Pharma, a startup company developing novel small molecules for the treatment of cancer-based on a unique mode of action. Throughout his work, Dr. Arbel led the R&D of the pre-clinical phase of development of API for the treatment of non-melanoma skin cancer. He obtained his PhD degree from Ben-Gurion University in Israel.
Please visit the company website for more details.