According to WHO, about 5.8 million people die each year and more than 50 million people suffer as a result of injuries, greater than the number of deaths due to HIV, tuberculosis, and malaria combined. We have developed a compound to stop post-traumatic bleeding in 40 seconds, so the injured person can reach definitive care without losing a fatal amount of blood.
This September will mark the 3rd anniversary of Miraqules. To date, we’ve raised $170K grant money and $40K equity funding. Highlights: 1. Product development, completed. 2. Preclinical trials completed. 3. Applied for USFDA 510(K) clearance. 4. Received LOIs from Israeli and Indian Defense and 3 hospitals in India. 5. Received 10+ organic distributor enquiries from the US, UAE, Africa & India. 6. Agreement in place with a contract manufacturer for commercial production.
Up-coming milestones: 1. $50K revenue by June’21. 2. Initiating pilot with Israeli and Indian Army by Aug’21.
A report of Industry ARC shows that the Global hemostatic agents market is $8B and growing at a CAGR of 7.1%. North America held the largest market share followed by Europe. In the Asia Pacific, India, China and Japan are the leading countries with large patient pool. This market can be segmented by type, by treatment and by end-user. The market by types is thrombin, gelatin, collagen, oxidized regenerated, fibrin sealants and combination hemostats. The hemostatic agents market is also segmented by the treatment which includes cardiovascular, general surgery, digestive and neuro-surgery. The end-users of hemostatic agents are hospitals, ambulatory services, surgery centres and nursing homes. This market has the potential to grow much bigger than it is expected. Our personal interview with doctors from more than 25 hospitals shows that a medium-size trauma hospital in India receives around 2000 bleeding cases per month combining all departments. Army expenditures make it more lucrative. The Indian Army imports around $100M worth of wound care products each year.
Problem or Opportunity
According to WHO bleeding kills around 5.8 million people annually, more than the combined death due to HIV, Tuberculosis and Malaria combined. According to the Committee of Tactical Combat Casualty Care, US army, almost 80% of soldiers die within 30 minutes after the injury due to massive blood loss. In the case of civilians, almost half of the accident victims die before reaching the point of treatment because of the same reason. Considering it as a pressing issue, The American College of Surgeons have started a campaign named “Stop the Bleed” with an aim to train 200 million people to save lives if people nearby are severely bleeding.
Solution (product or service)
We have developed a compound, StopBleed®, that can stop post-traumatic bleeding in 40 seconds that is 5 times quicker than existing solutions. The powder form makes it flexible to use in any severity, size, and shape of the wound. It also has healing properties. For minor injuries one simply needs to pour it on the wound and it: 1. Stops the bleeding; 2. Prevents infections; and 3. heals the wounds. For major injuries, it will act as a pre-hospital treatment allowing the injured person to reach the nearest point of care without losing a fatal amount of blood. StopBleed® also works with people having blood clotting disorders.
A handful of companies are working in pre-hospital bleeding management, such as QuickClot, Axiostat, Celox, HemCon—our direct competitors. However, these products are far behind in terms of technology, as these are made up of a single biomaterial whereas StopBleed is a chemical combination of biomaterials. Additionally, StopBleed is the first product in the world that has a structural resemblance with naturally occurring fibrin strands. And that's why the competitors take more than 200 seconds compared to 40 seconds of StopBleed to clot blood. On the other hand, the market leaders of the wound care domain (Ethicon, Pfizer, Baxter International and C. R. Bard) have limited themselves to the operation theatres only. It seems like they are not interested in introducing any product for pre-hospital bleeding management. Thus, we don't see them as our direct competitors at the moment. But if they start venturing into the pre-hospital bleeding management domain—they will be our biggest fear.
Advantages or differentiators
StopBleed is the first product in the world that has a structural and functional resemblance to natural fibrins. We have applied for a patent (PCT) on the production process and the European Patent Office has already acknowledged its novelty. The key differentiators of StopBleed are: 1. StopBleed clots blood 5X faster (40 seconds VS 200+ Seconds of the competitors); 2. Can heal wounds (Competitors don’t); 3. Works with people having blood clotting disorder (Competitors don’t); 4. Anyone can use it—neither prior knowledge of application nor dosage information required; 5. Large surface area can be covered in a single-use (Competitors are limited by their size); 6. Multiple time usages (Offering in a flip-top bottle VS sachet for one-time use); 7. It costs 50% less ($10 VS $20-30/packet of the competitors). One of the beauties of StopBleed is that it can’t be reverse-engineered and we have invented the production process. That is why, even knowing the primary components of StopBleed, it cannot be replicated or reproduced. StopBleed is a new compound that we have invented in our lab by using known polymers. Whereas, our direct competitors are made with single biomaterials. Celox, ChitoFlex, Axiostat, HemCon – all these products are nothing but just Chitosan in various forms –QuikClot is just Kaolin—Surgispon is just Gelatin—So in terms of defend-ability StopBleed is in a better position than others.
We aim to price our product competitively, which is around MRP $35-$40/ bottle. The current production cost is ~$5/bottle and our price to the distributor will be $20/bottle. During our process development, we have seen that the production cost can go down to $2/bottle. Considering the interest from the distributors, hospitals and army agencies, we’ve calculated a revenue of $1.5M by Dec’22. We are targeting to reach an ARR of $100M by 2025.
We will make money on every bottle we sell. StopBleed will be introduced in the market with an entry-level price of ~$20/bottle (gross margin will be $15/bottle). We are currently focusing on our B2B & B2G customer segment. When there is a lack of distribution and marketing power—in this field the “word of mouth” works really quickly and effectively which happens with the B2G segment. Network Outreach in the government and army agencies: Received an LOI from the Indian army. They have planned to incorporate us in their IDEX and MAKE 2 program. We will also leverage their global presence and clientele to reach other army agencies. As a part of the "Make in India" movement, the Indian government has planned to incorporate us at their Government e-Marketplace portal. We received an LOI from the Israeli Defense Force for piloting and future procurement. The Director of the Japan External Trade Organization (India branch), reached out to us for StopBleed. For the B2B segment, we are going to use the existing distributor network. As discussed earlier, there is a well-established distribution system for the wound care market and the distributors have themselves contacted us enquiring about the product and asked for samples. Also, there are Healthcare Conference & Events: In healthcare events, we get users organically. In a science conclave of Global Bio-Asia, we had received 50+ queries in a single day. The fun fact is, we were not allowed to sell our product otherwise could have made some money. At the same time, we are also talking with a couple of firms who will act as strategic sales partners and will work on a profit-sharing model. Alongside, we have our influencers –the Doctors. Mubeen himself went to 5 Doctors out of which 3 have given LOIs and 2 have given a verbal commitment.
Money will be spent on
We will close our seed round of $1M in the next 8 months ($500 before FDA approval & the rest $500 after FDA approval). The current investment opportunity of $500K is at a $7M cap. So far we have received a soft commitment of $200K. Almost 70% of the fund will be utilised for commercial production. 10% will be used towards regulatory activities for country wise registration of the product. 5% will be used for marketing and increasing the customer reach. And the rest 15% will be spent on management and company building.
The principal risks to our business: 1. Regulatory pathway- StopBleed is an unclassified medical device according to the US FDA and that requires us to undergo 510K approvals. It may cause a delay in market entry. 2. Financial Risk- There is always a limited funding opportunity for product related startups in the healthcare sector especially in India. However, we have been fortunate to have the handholding of BIRAC and have received INR 1.5 Crores as non-dilutive funding to date from various National and International organisations. But now we are fast running out of cash as we are coming close to the market. Currently, we are fundraising to finance our activities. 3. Human Resource Risk- Early employees in a startup always play a crucial role in the long term sustainability of the startup. As founders, we are always obsessed with the problem and trying to find a solution for the masses. To keep a low burn rate we are working without any salary for the last year. We are looking for people who will share the same passion that we possess and work towards making Miraqules a Miracle.
Incubation/Acceleration programs accomplishment
1. We have a lab and office space at KIIT Technology Business Incubator, India. 2. Part of MassChallenge Israel 2019 Accelerator program—Miraqules was the Platinum Winner (2nd position).
Won the competition and other awards
1. One of the TOP 20 Global start-ups to win Y Combinator sprint grant 2020. 2. Considered as one of the TOP 100 global start-ups by Slingshot, Singapore Government. 3. Honoured to get invited to be a speaker at IISF,2020 organised by NSTEDB, DST, India 4. Winner of Birla Global Innovation Challenge2020 5. Won the MassChallenge Platinum Winner Title’2019 6. Won the Dare to Dream contest organized by Defense Research and Development Organisation, India 7. Represented the state of Odisha at the Global BioAsia Conclave 2019 8. Represented the state of Odisha at the Global BioIndia Conclave 2019 9. Counted at world’s top 500 deep tech startups by Hello Tomorrow 2018 10. Counted as top finalists for RebelBio program, Imperial College London, White City Incubator, UK 2018
Two PCT applications filed. PCT/IN2019/050965 PCT/IN2020/050364