Axio Biosolutions, which produces a cheap haemostat, is the first Indian company to receive US FDA clearance for a wound dressing.
When a landmine reportedly left an Indian Army soldier bleeding during the 2016 surgical strikes while still within the other side’s shooting range, his fellow personnel immediately tended to his injuries with a haemostat known to seal wounds within three minutes.
The soldier was then carried to safety by his team.
his tidbit of information may seem insignificant, but in the heat of a conflict situation, or even a road accident, it can mean the difference between life and death.
Developed by Bengaluru-based startup Axio Biosolutions, the haemostat, Axiostat, is helping soldiers of the Indian Army, as well as those around the world, tend to their injured peers and address a major cause of preventable death: Blood loss as a result of trauma.
While it’s the not first haemostat in the world, it is the first wound-dressing product from India to receive the US Food & Drug Administration’s nod for US sales, and by far the cheapest in the world.
In India, Axiostat costs between Rs 29 (for dental use) and Rs 2,250 (for military use), while imported haemostats tend to cost between Rs 12,000 and Rs 20,000 for the two categories, respectively.
It is already being exported to 15 countries in West Asia and Europe, with US sales likely to begin towards the end of this year, founder and CEO Leo Mavely told ThePrint.
Back home, the biggest customers of Axiostat include the Indian Army, the CRPF, the National Security Guard, and the Indian Navy. The Border Security Force (BSF) was its first customer, signing on in 2014, and continues to use the product to this day.
Axio Biosolutions was the first company in India to provide emergency haemostats for use in first-aid kits, with the advanced stop-bleeding kit or ASK+ employed in case of automobile accidents.
A scary experience
Mavely, a bio-engineer who graduated from the Maharshi Dayanand University in Rohtak, Haryana, founded Axio Biosolutions in 2008, put on this path by a scary episode he had as a student.
While in college, Mavely told ThePrint, he was a volunteer for efforts to help road accident victims reach hospitals on time. One day, barely a kilometre away from a Apollo Hospital, an accident left a man bleeding profusely.
“I felt helpless, there was nothing I could do to control the bleeding or stabilise him immediately,” said Mavely.
“All I could do was wrap the wound with a jacket to restrict the blood flow but soon even the jacket was saturated with his blood,” he added.
Luckily, the victim did eventually make it to hospital on time, but the helplessness he felt at the time continued to haunt Mavely, and he decided to explore biomaterials for a possible solution to prevent blood loss through open wounds during the golden hour: The one-hour period after an accident where a victim’s chances of survival are believed to be the highest.
“I researched products capable of controlling arterial bleeding and found none in India,” he told ThePrint. “It struck me that we still didn’t have a solution for such a primal issue — bleeding that could kill someone,” he said.
“Mortality rate can be reduced by 60 per cent if profuse bleeding can be stopped instantly,” he added.
While looking for incubators where he could work with biopolymers, he chanced upon NirmaLabs in Ahmedabad. At NirmaLabs, Mavely started ‘Project-1006’ with an attempt to develop an affordable and efficient haemostat for developing markets. This project eventually became Axio Biosolutions.
After successful pre-clinical studies and trials, Axiostat was ready to be commercialised. By 2013, it had been cleared for sales in India and Europe. Approval from the US Food & Drug Administration approval followed in 2018.
How does it work?
Blood loss is among the leading causes of preventable death in road accidents.
There are two ways to stem blood loss in the immediate aftermath of an injury, until the patient can be taken to a medical facility. One is a tourniquet, a tightly-wound bandage tied above an injury that restricts the flow of blood to the site of the wound. It is usually used on arms and legs.
A haemostat, meanwhile, prevents blood loss by actually blocking the exit for blood on the wound.
Haemostatic agents are typically a loose powder sealed into a bandage. They are then applied directly on the wound with pressure, with some haemostats requiring the powder to be pushed deep into the wound.
Blocking the flow of blood works on the principle of simulating the clotting process. This is done by allowing fibres to group together and overlay in a matrix or mesh-like structure, providing enough structural strength to stop the forceful gush of blood.
Traditional agents achieve this by increasing the production of fibrin, a protein that’s formed when blood clots. But Axiostat works by producing a new kind of polymer, called the chitosan.
Chitosan is formulated by extracting a naturally occurring fibrous substance called chitin, which is produced by crustaceans like crabs and lobsters, and is the primary component of their exoskeleton shells. Its function in these animals is comparable to keratin’s in humans.
Chitin can be extracted from crabs, shellfish, lobsters, shrimps, fish scales, and even the cell walls of fungi. Axio Biolsolutions extracts it from the thin shellfish shells after they have been discarded by the fishing and meat industry.
The chitin is then converted to chitosan by a process called deacetylation. This is achieved by treating it with sodium hydroxide and adjusting the pH value of the product.
Chitosan also carries the additional benefit of needing no additives. Traditional haemostats do, and the additive could often end up reacting with the fibrin.
“The moment the positively charged Axiostat is applied to an open wound, it reacts with the negatively charged blood and becomes a very sticky substance,” Mavely said.
“It instantly becomes very sticky and clots the blood. Axiostat is effective within 2 to 3 minutes,” he added.
Axiostat requires no pressure while or after application. Once applied, the dressing can be removed — within 48 hours — by wetting it, following which it converts into a gel. This can simply be peeled away without moving the clot underneath it.
Axiostat can also be cut according to the required size.
‘Meeting unmet needs’
Axio’s vision on their website states that they intend to develop “affordable, high-impact medical products that can solve unmet healthcare needs of emerging markets”.
Talking to ThePrint, Mavely repeated this objective.
“Our focus is to build the first global wound-care brand from India,” he added.
“We don’t want to limit ourselves to hospitals and battlefields and going forward we will be introducing solutions for every user,” Mavely said.
“We envisage a future where contemporary knowledge of biomaterials, medicine and engineering will be integrated into designing novel solutions to address the huge unmet demand in wound care,” he added.
To this end, Axio also sells another haemostatic dressing called MaxioCel.
It can be applied topically to minor wounds such as ulcers, sports injuries, and post-surgical wounds, and is said to aid in pain reduction and scar improvement. The dressing can also be peeled away.
Article Credit: The Print