“Lack of standardisation are hampering growth of Med-tech sector”
Leo Mavely, Founder & CEO, Axio Biosolutions
Established in 2008 in a start-up incubator in Ahmedabad, Axio Biosolutions Pvt Ltd today is a global name that uses innovative medical technology to create breakthrough products and improve people’s lives. The company stepped into the healthcare market with one single mission: To SAVE, IMPROVE and TOUCH LIVES of civilian and military victims from uncontrolled haemorrhage.The products are based on an empathetic understanding of real problems in the medical space with solutions that have wide applications. It all started when founder and now CEO of Axio, LeoMavely , while in college, had a life changing experience when he helped a road accident victim bleeding profusely from his injuries. It was then that he recognised the need to develop a product that can help accident victims from traumatic bleeding and save lives.
Nearly a decade later, Axio has today become a unique technology-led-healthcare company from India that is revolutionising the ‘advanced wound care market’ across the globe. With parent company, Advamedica Inc, based at Massachusetts, United States, Axio has been funded by marquee investors such as Ratan Tata Accel Partners, and IDG Ventures.
Axio developed an innovative solution that could reduce the mortality rate due to traumatic bleeding and save precious lives. The company’s products are currently being used by Military, Hospitals, Ambulance services, Industries, Relief aid and are part of the standard field kit of defence forces in many countries. Its patented product, Axiostat, is US FDA and CE approved and has successfully completed a
120 patient clinical study conducted by the MIMS Hospital in its ambulatory services. With Axio, India is leading the way into the affordable, innovative and effective healthcare market. In an interaction with BioSpectrum, LeoMavely, CEO of Axio shares his views about the trends and challenges before the Haemostat market in India. Edited excerpts;
Axio completed 10 years. What were the issues you faced then and what are issues you face now?
When I started Axio Biosolutions right after my college in 2008, globally markets were reeling under recession. There weren’t many funding avenues nor was there clarity on regulation. Due to this, it took us many years to bring our product to market.
However, in past 5 years, there has been a lot of interest in med-tech and life sciences. We were able to raise multiple rounds of funding and get regulatory approval in Europe and USA. Now, most challenges are related to scaling up and expansion. The Axio team has grown to almost 100 people and making sure all stay connected to one vision is challenging.
What is the current strength of your R&D team? What is the current focus of your R&D?
We have a strong R&D team consisting of 12 members with inter-disciplinary skill sets. The team has people from various backgrounds including pharma, chemical engineering, biomaterials expertise, industrial designers, and product specialists among others. The R&D team is led by Dr Kiran Sonaje who has over 12 years of experience in biomaterials and polymeric drug delivery systems. At the core, we are a specialised biomaterials company and our R&D is focused on developing products for Wound management, Drug delivery, and also solutions for consumer health care.
How many products has Axio developed in these years and how much investment have gone into developing the products?
Currently we have a range of hemostatic products targeting various conditions in interventional cardiology, interventional radiology, hemo-dialysis, emergency trauma, military trauma and dental. These are first of its kind products in India and are approved by USFDA & European CE mark. Apart from products in market, we have also developed wound care products for surgical sites, donor graft sites, diabetic foot etc. These are currently under limited pilot evaluation and will soon be made
available in the market. Our R&D investments are usually 8-10 per cent of total fund raise.
How many patents are granted to your firm till now? How many are pipeline?
We have close to 10 patents in various stages of grant and evaluation. We have another 5 patents in pipeline.
What are the USPs of your products in the market?
We are the first company to bring out a chitosan haemostatic product with 100% active ingredient. Our product, Axiostat, is ready to use and can be cut to suit different wound sizes. It is easy to apply and take off, and more importantly can be used by a non- medical first responder. Axiostat is unique in its design as a bio-adhesive wound dressing. The moment it is applied to an open wound, it reacts with the negatively charged blood and clots the blood to stop bleeding, within seconds. Removing Axiostat from the wound is also extremely simple. All one has to do is apply saline or water. Axiostat absorbs the water to become a gel like substance that can be easily peeled off.
By entering into partnerships with government and private players for supplying haemostat products and having operation in USA, is your firm now focusing on market expansion? Besides India which are the markets you will be looking to focus in the days to come?
Axio currently has a presence in over 12 countries. However, our primary focus is India. We expect Axiostat to change the paradigm of primary acute care in the wound space. We are working with all major corporate hospitals, government hospitals and almost all elite armed forces in the country. We are also very active in MENA, South-east Asia and parts of Europe.
There are over 50 companies in this space both local and MNCs. How do you see competition in the market?
The Haemostat market is over $2.5 billion, globally. However, there are only 4-5 companies worldwide who have succeeded in commercialising a haemostat capable of controlling arterial bleeding. Axio Biosolutions is one of them. Currently in India, there are no direct competitors to our product, Axiostat. There are few who make similar claims but don’t have any clinical evidence or regulatory approvals. That said, we prefer to have competition in this segment as we believe it would create more awareness about such an acute problem of people succumbing to injuries due to uncontrollable bleeding.
What are challenges before the sector in India?
Med-tech is the fastest growing industry in India. There are many start-ups trying to bring in very novel devices and, I think, we will definitely see more of it in the coming years. However, lack of proper regulation, uncertainty in policies and lack of standardisation are hampering the growth of this sector.
What are the latest trends in the global haemostat market and India in particular?
The haemostat market usually gets a novel product once in 10 years. Currently chitosan and such polysaccharide based products are popular. There has been more awareness in the market over last few years. In the US, the White House has launched a STOP THE BLEED campaign to help victims of gun violence get immediate help. As bleeding out from gunshot wounds has been the major killer in mass shootings in the US, they launched this initiative to train the public and prepare them to face such situations, if ever needed. We did a similar campaign in March 2018 in many cities in India. As part our initiative, we partnered with major hospitals across India, and provided extensive training to doctors, nurses and paramedic staff in using Axiostat. Our aim is not only to train hospital and paramedic staff on how to stop uncontrollable bleeding, but also the public because accidents can happen anywhere, at any time. We will be doing more campaigns like this to create awareness and save maximum lives.
What is the revenue target you have in mind to touch by 2023 from the current the sales?
We expect to hit Rs 250-300 crore run rate by 2023.