In India and around the world, thousands of accident related deaths occur due to preventable blood loss. This high level of unnecessary deaths prompted Leo Mavely and Ashish Pandya, co-founders of Axio Biosolutions, to seek a solution. Their challenge was to develop a product that would be effective in stopping bleeding in cases of traumatic injury. In 2007, after being recognized for his undergraduate research in bioengineering, Leo Mavely found himself at the NirmaLabs Incubator in Ahmedabad. It was here that Leo and Ashish had the opportunity to begin researching and developing the solution they had in mind.
Today, Axio Biosolutions produces the first haemostatic emergency dressing in India. The Axiostat is now used by trauma and casualty care centres in hospitals, by emergency service providers such as ambulances, and by defense personnel such as the Indian military. It is, according to Leo, the most affordable external haemostat in the world.
For their life-saving innovation, Axio Biosolutions recently won the CNBC-Samsung Innovation Quotient 2012 for the top social innovations with technology intervention in India. They were also finalists for the Piramal Prize 2010, and were selected one of the top 75 startups in India by DARE magazine. Still, says Leo, “the biggest achievement we consider is seeing our product Axiostat saving numerous lives of innocent victims on roads.”
We recently had a chance to connect with Leo Mavely, co-founder, Chairman, and Managing Director of Axio Biosolutions, to hear the company’s story and to learn more about the Axiostat solution they have developed. Excerpts.
SocialStory: How did you begin your journey in health care and how did it lead to Axio Biosolutions?
LM: It all started during the final year of my undergraduate Bioengineering studies in Delhi. As part of a 5 member team, we were developing a few microfluidic devices using biopolymers under the guidance of our mentor, Dr. Asthana. We won an award for the devices at a technofest in IIT-R and on a quest to commercialize these, I ended up at one of the earliest tech incubators in the country, NirmaLabs Ahmedabad. Even though I was in the final year, they were kind enough to pick me for a grooming and incubation program. While screening pain-points for developing markets at NirmaLabs, we found a few verticals in healthcare which are mostly neglected.
Pre-hospital trauma care was one such neglected domain where there are hardly any products to stabilize a victim in an accident. Axio was born as a platform to address these unmet wound care needs. Early on we identified traumatic bleeding as one of the leading causes of death on roads and battlefields. In a country where more than 1,50,000 people die from road accidents every year, this seemed like a huge public health problem. Even though we are in the 21st century, the products we use to control bleeding (for example, cotton gauze) are from the Trojan era. There was enough scope to facilitate a technology driven innovation in this sector and that is exactly what we pursued.
As luck would have it, I was fortunate enough to find my co-founder, Ashish Pandya who had a similar passion and vision to make the world a safer place to live in. We both started this journey together and after 4 years into it, we think it was worth the pursuit.
SS: Can you tell us about the process you embarked upon with the clinical trials to figure out the best combination of materials, and more about the biomaterials that you use to manage wounds.
LM: We started working on this issue on a clean slate. Started looking at all solutions cheap, expensive, safe, risky, available and/or inaccessible around the globe to figure out their current status of development. This background research gave us lot of insights into the market and research situation. Most of the top class hemostats used are in a surgery room and are incapable of being used on external traumatic bleeding. All of them work on the principle of absorbing blood and after a while they get saturated. Many others work on activating the clotting cascade and are prohibitively expensive. In developing markets there is not even a single product available that is intended to control profuse bleeding. However, bleeding continues to kill many unsuspecting victims who would have otherwise lived if they had an aid in hand.
With this background, we focused our efforts on controlling bleeding through adhesion instead of absorption. This led us to certain interesting biomaterials found in fish and which were used by the US army during Afghan, Iraq wars. Taking a cue from this, we started developing a dressing that was robust, affordable and easy to use by a layman. Early prototypes were ready within 6 months and we got our proof-of-concept established by the end of first year. The incubation at NirmaLabs finished at this stage and we established Axio Biosolutions Pvt Ltd in Ahmedabad (Axio in greek means ‘Creating value’).
Due to a lack of standardization for efficacy, safety, and consistency, we started the pre-clinical evaluation of these materials according to USFDA guidelines. This work got published in an international journal and helped us in fetching the necessary regulatory requirements in India. Axiostat – Emergency Haemostatic Dressing, which was the outcome of this work, has been proven to control profuse traumatic bleeding within 2-3 minutes of application. It has already been used in various indications such as scalp lacerations, limb punctures, deep wound bleeding and has shown positive results. We did a pilot launch in 2012 and started clinical post market studies in few hospitals. Currently Axiostat is being used in major hospitals in Gujarat, Delhi and also on the field operations of paramilitary regiments in their survival kit.
SS: You provide advanced wound management and create value by delivering affordable health solutions for unmet healthcare needs. How have you ensured you are able to deliver AXIOSTAT at an affordable price point?
LM: From day one, our focus has been to make Axiostat accessible to a larger mass at an affordable price. To make this a reality we started utilizing indigenous resources and a patented process for the manufacture of large scale biomaterials in a comparatively short duration. Currently Axiostat is the most affordable external haemostat available across the world. We are confident that the current price will come down considerably once the volumes go up. Axiostat is a single use application that can stop major bleeding quickly and hence apart from cost benefits, it also saves a lot of time and manpower in a resource constrained scenario.
SS: How many deaths in India are caused by traumatic bleeding and an inability to stop the bleeding at the accident site?
LM: On an average more than 1.5 lacs people die annually due to road accidents in India. 30% of these fatalities are only due to uncontrolled bleeding. That is 17 deaths per hour, out of which 5 deaths are preventable if they were given an aid to control bleeding quickly. More than 8 million victims reach emergency centres in India with observable profuse bleeding. With a slight time delay, any one of these can turn into a fatality if bleeding is not controlled immediately. With the advent of organized emergency service providers, the accessibility of trauma care is being solved and we see this as a huge opportunity to use these channels for delivery of high-tech products at accident spots. On a military scenario where life of every soldier is a critical priority on the battlefield, bleeding to death is a huge problem. Having identified this, a few paramilitary regiments in India who have active field operations are now carrying an Axiostat pack with them on every mission.
SS: What’s next for Axio Biosolutions? Do you want to focus on different channels within advanced wound management or move to other verticals within health care?
LM: We have only completed half of our journey in this pursuit. Having developed and commercialized Axiostat, our next aim is to make this accessible on every first aid kit in the country. Hence we are in the process of scaling up our operations and are also including more indications where Axiostat can be of great use. Along with controlling bleeding, we also have a few other solutions of advanced wound care in our pipeline. These are for infection control and wound healing using biomaterials. Axio will broadly be working on making wound management affordable and efficient.
SS: Have you completed the process of getting regulatory clearance for manufacturing and marketing? If so, have you made any strategic distribution partnerships for Axiostat?
LM: Yes. Axiostat is India’s first Emergency Haemostatic Dressing that has been approved for manufacturing and marketing. We currently target 3 major market segments. These are Trauma & Casualty care in hospitals, Emergency service providers such as ambulances and defence personnel such as military, and paramilitary and CRPF. These are niche markets which are highly sensitive to price and quality of products being accepted. We already have authorized dealers for marketing and distribution in key territories and are also in talks with large players for a strategic tie-up to make Axiostat accessible to a larger mass. We are also in the last stages of getting CE approval for European market.