Leo Mavely, Founder and CEO, Axio Biosolutions, India’s leading MedTech company, tells Jisha Krishnan why patients living with diabetes need better wound care solutions. As do victims of road accidents, military personnel as well as millions suffering from chronic wounds.

According to the International Diabetes Federation (IDF), there are 84 million adults living with diabetes in South-East Asia, making it the epicentre of the epidemic. By 2045, the number is estimated to increase to 156 million. A complex disease, diabetes is often considered to be synonymous with blood sugar management through medication, exercise and diet. However, there’s another crucial aspect that is often ignored. Caring for diabetes-related chronic wounds, like diabetic foot ulcers.

“Diabetes impairs one’s wound-healing capabilities. And when someone suffering from diabetes has a wound that does not heal, it can soon become life-threatening,” says Leo Mavely, Founder and CEO, Axio Biosolutions, a pioneering MedTech company from India that is disrupting the wound care management industry. The startup, founded in 2008, offers a range of innovative products spanning pre-hospital, intra-operative and post-operative clinical needs.

In 2018, Axio became the first Indian company offering a wound care solution to get a clearance from the United States Food and Drug Administration (USFDA). Axiostat, an innovative haemostatic dressing that stops bleeding instantly, also has clearances from the European Union. Earlier this year, the company launched MaxioCel, a next-generation, Chitosan-based advanced wound care dressing that provides comfort and faster healing to patients suffering from chronic wounds.

Edited excerpts from an interaction with Leo Mavely, Founder and CEO, Axio Biosolutions, on the emerging MedTech segment, the challenges, the opportunities and more:

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How big is the global wound care management industry?

Currently, the global wound care market is pegged at USD 19.8 billion and studies say that it has the potential to grow to USD 24.8 Billion by 2024. This growth spurs from the rising incidents of road accidents, trauma victims, and the increasing prevalence of chronic diseases such as diabetes that impair one’s wound-healing capabilities. The increasing prevalence of diabetes cases calls for specialised wound care to help avoid complications, such as infections and amputations, thereby improving the quality of life of patients.

What are the major challenges in wound care?

While affordability of wound care products has always been a major challenge, absence of proper regulation, uncertainty in policies and lack of standardisation are the other issues that demand attention. A more structured framework can encourage more entrepreneurs to get into the field and come up with innovative products that can benefit people. A standardised framework can also ensure that all medical devices or products adhere to a certain quality standard.

What inspired you to get into this segment?

While I was in college studying biotechnology, I encountered a road accident that changed my life. Although I managed to get the victim to a nearby hospital, we just couldn’t stop the bleeding on time. That feeling of helplessness stayed with me and I wondered why we didn’t have a solution for such a primal issue – bleeding that could kill someone. Studies show that mortality rate can be reduced by 60 per cent if bleeding can be stopped instantly. In an emergency, the first 60 minutes are considered the “golden hour”, within which it is critical for the victim to access basic medical care. However, in most cases, by the time s/he reaches the hospital, it is too late.

While I was still in college, I started researching products that are capable of controlling arterial bleeding and found that there were none in India. I worked with biopolymers for my college project and with that background, I founded Axio Biosolutions in a startup incubator called NirmaLabs in Ahmedabad. That’s where I developed Axiostat, an affordable and efficient trauma haemostat made of 100 per cent chitosan (a natural biomaterial, derived from shellfish, modified for medical application) that stops profuse bleeding within two-three minutes of its application.

What was the process of developing your flagship product like?

At NirmaLabs, I started Project-1006 to develop an affordable and efficient trauma haemostat for developing markets. This metamorphosed into Axio. For further pre-clinical studies, Axiostat was contracted to Good Manufacturing Practice (GMP) certified facilities in Ahmedabad. We had successful pre-clinical trials in 2009. However, as this was a new product, we needed more approvals to gain credibility. In 2011, Axiostat was approved by the Food and Drugs Control Administration (FDCA) to be sold in India. Post that, we got our big break when we got the ISO 13485 and CE (European Clearance) certificates in 2013. Soon, we started supplying our product to the Indian Army. Last year, we received the US FDA approval, which was a huge milestone for the company.

What prompted you to address the needs of patients suffering from chronic wounds?

Today, there is a colossal increase in diseases like diabetes that impair the wound-healing process, leading to chronic wounds. India is becoming a world diabetic capital with millions of patients needing advanced wound care products every year. However, there are no products in wound care management that provide substantial relief from the high levels of discomfort and pain endured by patients. We really wanted to come up with a product that not only helps stop bleeding but also reduces pain and enhances faster healing. Hence, we developed our second product line, MaxioCel, a next-generation wound care dressing made of chitosan that provides comfort and faster healing to patients suffering from chronic wounds, such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, cavity wounds, skin abrasions, donor sites and post-operative surgical wounds, to name some. MaxioCel helps address a huge gap in the market with its combined haemostatic, pain management and scar improvement properties.

Which sector comprises your biggest clientele?

Our biggest customers, currently, are the Indian Army and Paramilitary Forces. They use Axiostat for bullet and blast injuries. The Border Security Force (BSF) was our first client in 2014 and they continue to be our key customer. We work with nearly 200 battalions across the country. Almost all frontline defence forces actively involved in the day-to-day conflict operations use Axiostat.

What are Axio’s future plans?

Right now, we are present in over 12 countries, where our products are used by defence forces, government healthcare facilities as well as private hospitals. Having received the USFDA approval last year, we are all set to start active operations in the US. We also plan to get into the B2C segment where our products can be bought over the counter.

Our world-class Scientific Advisory Board, comprising Dr Shiladitya Sengupta, Assistant Professor of Medicine at Harvard Medical School and Dr S V Mahadevan, Professor of Emergency Medicine at Stanford University, among other experts, will continue to help us bring the latest scientific and technological innovation into the wound care and surgical market. We believe in keeping with the government’s vision to ‘Make in India’. It is important that our product innovation is not just limited to one particular market, but serves the global community. We want to build the first global wound care brand from India and that is something our team is super thrilled about.

Do you see more Asian companies venturing into the Medtech space?

Medtech is the fastest growing industry in India. There are many startups trying to bring in novel medical solutions and, I think, we will definitely see more of it in the coming years. Contrary to popular perception, funding doesn’t have to be a stumbling block. I strongly feel that if you have an innovative product with a good plan of scaling it sustainably, investors will be interested in your business.

However, there are industry challenges, such as the lack of awareness and proper regulation as well as standardisation, which need to be addressed. In India, most MedTech companies have to look at regulations and standards defined by other countries, like the USFDA and the European CE, to develop their product. It’s about time that we develop our own standards. When it comes to healthcare, quality must be given utmost importance. After all, human lives are at stake here!

Is technology the solution to Asia’s healthcare woes?

Technology has transformed the way healthcare is delivered, not just in Asia but world over. New technologies and innovations provide opportunities for more personalised treatment and early and accurate diagnosis. Technology can help the industry meet the growing demand for a quality and efficient healthcare delivery system. Some technologies that are already disrupting the space are Artificial Intelligence (AI), Machine Learning (ML) and Big Data, used for enhancing the operational efficiency, diagnostic capabilities and treatment protocols at the organisational and clinical level. While technological advancement in healthcare is inevitable, I also believe that the government can play the role of a catalyst to create a conducive environment by providing proper infrastructure for growth and increasing consumer demand.

Will startups pave the way for a healthier world?

Earlier, health-tech startups were mainly associated with providing diagnostic, enterprise and medicine delivery solutions, among others. However, today, we have startups offering a wide range of core healthcare solutions – whether it is in mental health, early diagnosis and intervention, bleeding control, pain management for chronic wounds, or any area for that matter. So, yes, startups are definitely paving the way for a healthier world by creating an ecosystem that facilitates a better and faster healthcare environment.