Team:GreatBay United/Entrepreneurship

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  1. Background
  2. Description
  3. Design
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• Wetlab
  1. Proof of Concepts
  2. Engineering
  3. Result
  4. Measurements
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• Drylab
  1. Hardware
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  3. Proposed Implementation
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• Team
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• Business Plan
• Background Introduction and Market Pain Point
• Operation Strategy
• Analysis of Competing Commodities
• Core Team
• Current Progress
• Hardware design
• Experiments

Business Plan

Our project is designed to construct a complete system for bacterial endotoxin detection, which will provide patients and medical agencies with a convenient and efficient method to detect various types of endotoxins, thus advancing the efficiency of diagnosis and treatment.

Background Introduction and Market Pain Point

Our project is designed to construct a complete system for bacterial endotoxin detection, which will provide patients and medical agencies with a convenient and efficient method to detect various types of endotoxins, thus advancing the efficiency of diagnosis and treatment.

n 1965, Dr. Bang, a zoologist at Johns Hopkins University, successfully acquired the plasma-less solute of Limulus blood cells, which was called the Limulus amebocyte lysate(LAL). Since then, LAL was widely utilized in the detection field, for instance, detecting bacterial endotoxins in the human body and drugs. In the United States, every drug authorized by the Food and Drugs Administration must pass the LAL testing.
LAL is extracted from Limulus blood, thus an increase in the demand for LAL will inevitably lead to a rise in Limulus blood requisition. Therefore, blood is extremely important in modern biological industries and its value is irreplaceable at present. If Limulus extinct, it will have disastrous impacts on relevant industries. However, because of overfishing and pollution, Limulus already granted protection in the provinces Guangdong, Guangxi, and Fujian and the central government released a series of policies, enforcing companies to reduce the production of LAL. Therefore, the market urgently needs a new testing reagent to fill in the production gap caused by the decline in natural LAL production.

Our Products and Services

We plan to utilize synthetic biology and scientific methods to synthesize LAL and achieve the function of bacterial endotoxin detection. Our product includes three major systems, detection system, cascading system, and condensation system. According to our design, the ultimate product can detect the presence of bacterial endotoxins from the tested samples and also identifies the type of bacteria present in the sample, therefore benefits medical treatment processes and reduce mortality of bacterial infections, Finally, we hope to use this detection technique to develop different types of products and establish a database to facilitate the retrieval of bacterial endotoxins.

Market Analysis

Based on the statistics from 120 companies in the field of medical treatment and equipment production, EvaluateMedTech estimated that the global medical technology(including medical equipment and diagnosis reagents) sales reached 440 billion dollars and the growth rate was 4.4%. The IVD industry itself occupied 12.4% of the total market share with an annual sale of 54.5 billion dollars.
There are 300 to 400 firms that develop in-vitro diagnosis reagents, including 200 massive companies. However, only 20 companies have an annual profit above 100 million RMB. Other companies are relatively small-scaled, and their products had limited variety. Marketresearchreports.biz estimated that the Chines in vitro diagnosis market will expand by 10% and the total scale will reach more than 10 billion dollars.
Imported equipment and reagents occupied more than 50% of the share of the Chinese IVD market. Since the request from hospitals and medical agencies gradually rises to 90% of total demand, China’s in-vitro diagnosis industry will benefit from the increase in patients and the rise in average testing cost. It is estimated that the annual rate will remain at a high level of 16-18%. Based on the government policy of relieving the citizen’s financial pressure on medical treatment, the production of medical reagents is expected to increase. Moreover, China has 20% of the world’s population while the market share of medical detection is less than 15%, and hundreds and thousands of hospitals, blood donation stations, medical laboratories, and physical examination agencies provide a potentially huge IVD reagent market.

Operation Strategy

Based on the statistics from 120 companies in the field of medical treatment and equipment production, EvaluateMedTech estimated that the global medical technology(including medical equipment and diagnosis reagents) sales reached 440 billion dollars and the growth rate was 4.4%. The IVD industry itself occupied 12.4% of the total market share with an annual sale of 54.5 billion dollars.
There are 300 to 400 firms that develop in-vitro diagnosis reagents, including 200 massive companies. However, only 20 companies have an annual profit above 100 million RMB. Other companies are relatively small-scaled, and their products had limited variety. Marketresearchreports.biz estimated that the Chines in vitro diagnosis market will expand by 10% and the total scale will reach more than 10 billion dollars.
Imported equipment and reagents occupied more than 50% of the share of the Chinese IVD market. Since the request from hospitals and medical agencies gradually rises to 90% of total demand, China’s in-vitro diagnosis industry will benefit from the increase in patients and the rise in average testing cost. It is estimated that the annual rate will remain at a high level of 16-18%. Based on the government policy of relieving the citizen’s financial pressure on medical treatment, the production of medical reagents is expected to increase. Moreover, China has 20% of the world’s population while the market share of medical detection is less than 15%, and hundreds and thousands of hospitals, blood donation stations, medical laboratories, and physical examination agencies provide a potentially huge IVD reagent market.

Analysis of Competing Commodities

The advantages of natural limulus reagent are:
The technology of extracting limulus reagent from live limulus is mature, making operations convenient and provides results in a short period of time, making it suitable for mass bacteria detection.
The disadvantages of natural limulus reagent are:
The method of directly extracting blood from horseshoe crab's body leads to a higher mortality rate of horseshoe crabs, which is not conducive to maintaining the ecological environment. Moreover, the raw material, which are horseshoe crabs, have now been listed as a protected animal, which means that the raw material of endotoxin detection reagent is strictly controlled. In addition to being able to react with endotoxin, horseshoe crab reagent will also react with (1-3) -β-D-glucan, resulting in false positive results and non-specific interference. The quality standards of horseshoe crab reagent products (sensitivity, accuracy, specificity, stability, self-reaction time, etc.) are not perfect, and there is no unified industry standard at this stage.

The advantages of recombinant factor C technology are:
recombinant factor C is a chemically synthesized reagent. Compared with traditional limulus reagent, recombinant factor C has more stable traits and relatively better uniformity. The current reagent price is currently equivalent to limulus reagent, but with the continuous promotion of this technology, the cost will decrease in the future.
The disadvantages of recombinant factor C technology are:
According to the analysis of common problems in the "Study on the Applicability of the Method for Detecting Bacterial Endotoxin by Recombinant C factor Method" published by China Pharmaceutical in 2019, it can be seen that the recombinant C factor method is prone to problems in operation, resulting in the inability to detect the results. The technology has no cascade amplification system and cannot amplify the signal to be tested. The recombinant C factor method takes a long time to detect. The recombinant C factor reagent depends on a specific temperature for preservation and needs to be operated in the laboratory. It is limited by the use site and cannot be used in daily life.

Advantages of our product:
1. This product is synthesized by biotechnology, does not need to capture raw materials by killing horseshoe crabs, meets the requirements of national policies and helps to protect horseshoe crabs, an endangered species.
2. The raw materials for preparing this product are mainly Bacillus subtilis and Escherichia coli. Both of these two bacteria are very common, easy to be cultured on a large scale and low in cost.
3. Natural horseshoe crab reagent needs to be treated with chemical reagents (such as chloroform, calcium, magnesium ions, etc.), which has pollution risk, but this product does not need this process.
4. This product has a cascade amplification system, which can provide clearer detection results.
5. This product adopts the coagulation principle of natural limulus reagent. Medical personnel who have had experience in limulus reagent detection in the past can learn to use it in a short time.
6. This product does not need other auxiliary equipment and is easy to operate.
7. The waste liquid treatment method of this product is the same as that of other medical testing reagents, which is convenient for control.

Overall, our product is advantageous because it is synthesized by biotechnology, greatly decreasing the number of limulus captured and killed, which also provides people with a quick and convenient way to detect bacterial infections at home, as well as ensuring people's safety and decreasing pollution risks since natural horseshoe crab reagent needs to be treated with chemical reagents, such as chloroform, clacium, magnesium ions, etc. Our product is also expected to be widespread because the raw material required for preparing the device is common bacteria, and is easy to be cultured on a large scale and low in cost.

Core Team

Central Executive Officer: Mia Zhang
Head of Technology and Development: Vebe Wang, George Zhang
Head of Hardware Development: Jolee Zhou, Bill Wang
Manager of Finance and Database: Amber Wang
Head of Marketing, Social Connections, Sales and Services: Alicia Liu, Vincent Cheng
Propaganda Minister: Lyndon Yang

Current Progress

Our team had established the proof of concept, successfully modified PSA protease, constructed B. subtilis-E. coli shuttle vector, yeast surface display, protein purification, hardware design, and mathematical modeling. We have developed a prototype of our product.

Hardware design

Our hardware consists of two cubic receptacles binding together. Every plane is stuck together with waterproof glue to protect the electric circuits. The small, pink container is the water bath with a temperature sensor that detects the water temperature. The bottom of the water bath is a heater that heats the water and maintains water at optimum temperature. The lid has four holes in which four test tubes are placed. The four test tubes form the experiment group, repetition group, positive contrast group, and negative contrast group to reach the highest accuracy available. The external container mainly stores the processing unit and the monitor which shows the current water temperature to the user. This design helps the user to control the water temperature, therefore, increases testing efficiency. 

Experiments

Based on how LAL works to achieve the visualisation of the detection results of endotoxin, we sperated our aritificial LAL into threee parts: The detection system to activate the following system when endotoxin is present, the casecade system to magnify the signal and the agglutination system to achive cell-level agglutination.

Merchandize Model

Our target customers can be divided into three different groups, the public, hospitals, and bacteria detection agencies. Therefore, our group’s core work is to develop different types of artificial LAL kits to satisfy the different needs of the users. The profit model aims to combine hardware cost with the added value of our endotoxin detection technology, and to release our products in pharmacies, hospitals, and bacteria examination agencies. The team’s major long-term cooperators include hardware manufacturing factories, bacteria cultivation plants, and biotechnology companies. Those aforementioned companies and factories are responsible for the production of raw materials and assembling, while our company controls the core technology and is responsible for the development, renovation, propaganda, data management, sales, and other services; therefore, forming a complete artificial LAL industry chain. In this chain, capital flows from the customers to our company so that we can make a profit, and we pay the cost of manufacturing our products to the upstream companies. Our group will continue renovating our technology and increasing its competitive strength to make a profit in the long run.

Stockholder’s Rights Structure

Since our company is still in the stage of fundamental development, the stockholder’s rights structure will change significantly as the company develops. Therefore, we divide the whole process of company growth into the following three stages, and the rights will change in response to actual situations. ​

1. Establishment Stage: In this stage, our company cooperates with Blupha Lab to start the experiments and product design. To maintain the members’ activeness, the Central Executive Officer will retain 45% of the share, Bluepha Lab will own 45% and the rest belongs to other members of the company. Our company exercises the common stock system.

2. Development Stage: In this phase, our company will cooperate with 2-4 investors. The Central Executive Officer still owns 45% of the share and has the right to transfer part of the share, but the transferred share cannot be more than 15% of the share controlled by the Central Executive Officer. The investors occupy 47% of the total share and the proportion for each investor is directly proportional to the amount of capital they invested. The rest 8% belongs to other members of the company. In this stage, all stocks are common stocks.

3. Perfection Stage: In this stage, our company is eager to attract more investment. In this stage, the Central Executive Officer holds 20% of the share and is allowed to control a certain amount of senior share(no more than 10% of the share owned by the officer). Internal members occupy 5% of the share and the rest 75% belongs to the investors. The amount of stocks held by each investor is directly proportional to their investment in our company.

Funding Plans

From a realistic perspective, our company organized Series Pre-A, A, and B funding, subsequent fundings will be arranged according to the company’s management. ​

Pre-A Funding: Our company has already developed a prototype product. Therefore, we aim to pass the state’s authorization and spend 2-3 months to release a small number of products onto the market. We plan to receive feedback from the customers and establish the fundamental sales and after-sales services system. In this funding series, we hope to raise 5 million RMB support and we will organize the activity in January 2022.

Series-A Funding: Through the pre-A funding series and accomplishing our tasks, our company will establish popularity among the customers and gain useful feedback and market source data. Thus, our goal for this stage is to find long-term cooperators and set up an efficient supply chain. Meanwhile renovating our technology, products, and propaganda system. We plan to attract 32.5 million RMB during series-A funding.

Series-B Funding: After series-A funding and the company’s development, we aim to release different types of products to satisfy the users’ demand from hospitals and bacteria examination agencies, therefore expanding our business field. Moreover, we will initiate the construction of the bacteria endotoxin database with mega data and start to explore the field of e-commerce, expanding our sales model from physical stores to online marketing. Since our company structure will increase rapidly, and we require more funds to achieve our goals, our company plan to raise 250 million RMB during series-B funding.