General Introduction

At Alfa Remask, we firmly believe that scientific breakthroughs are not beneficial if they are unable to be put into practice! Therefore, we have developed a business plan to distribute our unique product to the public. Here at Alfa, we are driven towards building a company that operates out of the United Kingdom, delivering its masks overseas.

We have decided to first sell masks in India as it is a relatively wealthy BRIC economy, as well as having the most TB cases globally. Thus, we feel it is really important to start work there as soon as we can. To produce our masks, we will be partnering with Triviton as they are the largest medical device manufacturer in India and also offer turnkey manufacturing. We will then sell these masks to NGOs as well as both private and public hospitals. In the future we have plans to expand the region of operations beyond India, as well as using parts of our current design to develop tests for other respiratory diseases.

India has become our initial sales location, due to its relatively wealthy BRIC economy in addition to their globally-high TB cases.

Below we go into greater detail about the product. We discuss; our consumer research (both with hospitals and members of the public), intellectual property and the patent we have written, how the company will be legally formed and structured, how we raised investment, and a business plan.

Survey Breakdown

In order to help us better understand the TB testing marketplace, as well as the possible public perception of our product, we created 2 surveys. The first survey was sent to medical professionals specialising in TB, and was designed to inform us what features were most desirable, as well as what drawbacks were most notable with current tests. The second survey was much shorter, and contained only multiple choice questions relating generally to preferred price, preferred mucus sampling method and expected wait times.

Survey 1

The two medical facilities that we spoke to were the WHO as well as St Bart’s Trust (an NHS trust controlling 5 large hospitals). In response to what their preferred tests are, The WHO stated that it recommended USING Mantoux or IGRA tests, whereas the NHS said that it prefers Xpert Cepheid and MaldiTof.. The NHS’s cheapest test was Cepheid at £50, which was also fastest, giving results in 24 hrs. The WHO said that the cheapest test it knew of was the Mtb antigen skin based tests, costing £4.30, and giving results in a few hours. ALFA REMASK is superior to both of these tests in both speed and cost, as well as ease of use.

Giving a sputum sample requires the patient to abstain from drinking and eating for 2 hrs, and then violently cough up enough mucus to fill a teaspoon. Unsurprisingly, the Who said that it has had patients in the past, specifically in LEDCs with poor health services, who have refused to give samples. The WHO went on to state that it has had similar responses to the mantoux test, where a patient is injected with tuberculin, and waits 2 days to see if a rash forms.

When asked if they would consider ordering our tests, the WHO said that it only evaluates medical devices, but St Bart's stated that it would if it , “had robust data to show it was at least non inferior with other tests like Cepheid “.

A major part of our product is to have replaceable lateral flow strips, so the hospital can have a stockpile of empty masks, and when they need to test for a specific disease, they can put the appropriate test strip in it. The WHO said that it would be a very good idea so long as, “there is no risk of cross contamination and price is low”.

The NHS told us that its most serious problem with current tests were the “Cost and the need to have a lab”, and the WHO echoed this by stating, “There is a need for a true point of care device and a reliable non-sputum based test”. This clearly states that both the largest medical institution in the UK, and the largest medical institution in the world want a device like ALFA REMASK!

When discussing the WHOs “END TB strategy”, they said that “testing is central but the weakest link”. This makes it look highly likely that the global demand for cheap TB tests is going to skyrocket.

In conclusion, both the NHS and the WHO were intrigued and excited by the idea, as well as expressing their support for it. The NHS is looking for a “point of care device”, and the WHO is likely to advise governments to greatly increase the purchasing of cheap tests.

Survey 2

In the second survey we got well over 400 responses. The first question told respondents how to give a sputum sample and then asked how they felt about it. 39% said they felt “ uncomfortable”, and 14.3% going on to say they felt “very uncomfortable”. This means that over half of the people were unhappy giving samples. We then asked them a similar question relating to the Mantoux tests. This received an even worse response with 34.2% saying it would be “uncomfortable”, and 25.6% saying it would be “v. uncomfortable”. However, when asked about doing our tests.(requiring the patient to wear a mask for a few minutes), 51% said that they would feel “very comfortable”. This clearly shows that our mask would be easier to use and much more agreeable.

When we asked the respondents how long they wanted to wait for results, we received a surprising answer. Only 35.6% would prefer to have it on the same day. A plurality, 40.6% would be willing to wait for 1-3 days. This is in contrast with the NHS and WHO’s guidance in which they state that they want rapid tests.

The final 2 questions related to pricing. We asked the respondents to guess what the average price of a TB test in the UK was. They were then told that it is £195 and had to say how it compared to their estimate. Over 70% said that it was higher than predicted, and this echos when the NHS said that they were looking for a cheaper test. We then asked what they thought a test should cost. The plurality of respondents, 32.9%, said that they would pay between £20-£60, 26.2% said they would pay between £10 and £20. In fact, the fifth highest category was the £1-£2 mark. This suggests that our target price is a little low, however, this survey was taken from UK citizens, who tend to have more disposable income than Indians.

In conclusion, the response to survey 2 was mostly expected, however it appears that members of the public could still be satisfied by a slower, more expensive test. The full data from the second survey is presented below.

Legally setting up a company

Company structure

The company will be based in the United Kingdom, and so can be either “limited by shares” or “limited by guarantee”. Limited by shares is when a company has shares and investors. It makes profit and is managed by directors. It can give money back to investors as part of a share buyback or as dividends.This is the structure used by serious commercial enterprises. A “limited by guarantee'' company is usually an NGO or a charity. It is controlled by guarantors and is run by directors. The company is responsible for its own debts, and the guarantors are only personally liable for the sum of money for which they guarantee. There are no statutory mechanisms for converting between the two structures. Both structures have inherent advantages and disadvantages as outlined here:

Limited by Shares	Limited by Guarantee
Easy to get investment, as investors can buy equity, and get paid dividends.	Difficult to get investment over the amount guaranteed, as if the company goes into liquidation, that is the most the debtors can legally claim.
Easy to find highly qualified employees when starting up, as equity can be offered to them.	Difficult to find good employees early on as the company can offer them little money. Thus, the pool of qualified employees is reduced to only those who strongly care about the NGO’s aims.
Easy to create new products, as investment is relatively simple to obtain. However,shareholders may move to block production of new products, as they would rather be given dividends rather than reinvesting profit in the company.	Relatively easy to create new products, as all profits must be reinvested in the company. However, due to the charitable nature of the structure, profit margins may be smaller, so there is less internal money to invest. External investment is also hard to gain.
Subject to corporation tax (circa 20%)	No corporation tax.
Possibly attracts better leadership, as a higher salary can be offered, and the director can invest their own money, further incentivising them.	Leadership would need to be emotionally attached to the cause, as apart from a small salary there are no other incentives to perform well.
Operates efficiently and quickly as it can afford to employ and replace creative, hard-working and skilled workers.	Less efficient as it can not afford the best quality of workers, and the good workers that it does have may not work as hard, as they know that they are tricky to replace.

In order to complete our mission of ridding the world of respiratory infection through testing, we will set up a limited by shares company, as it will be far easier to initially grow the company quickly, which will get more testing done as well as more reliably ensure the success of our mission. It will also make the future production of non-TB tests easy. It is the more efficient of the two structures and is better for delivering a cutting-edge product.

Name

The company name will be: alFA REMASK Ltd. As of 8/8/22 this is currently an available name in the UK. This name was chosen because it is the name of the iGEM team and “Ltd” is a requirement by law for a “limited by shares” company.

Director

It is a legal requirement for a Ltd company to have one or more directors. They must;

Follow the rules established by the “memorandum of association”- a legal document signed by all initial shareholders agreeing to form the company, as well as the rules established by the “articles of association”- a document listing the company’s by-laws.
Keep company records, such as accounting records as well as records of the company generally.
File accounts with Companies house, as well as the company tax return with HMRC.
Declare to shareholders whether they may benefit from a company transaction.
Pay corporation tax.

The director may hire other people to carry out these tasks, however the director remains legally responsible for ensuring that they are completed.

alFA REMASK Ltd. will have at least 2 directors at all time, one of whom is or has been a medical professional. This is to ensure that all of our products are functional and to reassure our investors that this is not another “Theranos” type situation.

Shareholders

The shareholders are those who own equity in the company. As such they control it, the director only manages it. Shares may be of different kinds, such as voting or non-voting and shareholders have the power to remove a director if they see fit. The equity of a company is normally structured such that the founders have together 100%, and then sell off equity for investment. Some shareholders may be considered a person with significant control (PSC). A person is a PSC if they:

Own over 25% of the shares
Control over 25% of voting rights.
Have the power to appoint or remove a majority of the directors.

PSCs must be reported to the company house.

In conclusion, our project will become ALFA REMASK LTD., a limited by shares company. A director will be initially chosen from a member of our team, and all members will have equal equity.

Initial equity offering to employees

alFA REMASK Ltd. will initially have few employees as in the first few months. This is because the mask’s designs will be being modified by Triviton to be more suitable for mass production. It is expected that it will take about 4 months and 8-10 design cycles to get the prototype to a design that we deem acceptable. As such, we will not need lots of inhouse engineers. alFA REMASK is a company that makes masks, except it outsources the manufacture and design.

Initial employees can be offered equity to incentivise them to work. It also allows the company to pay the employee a slightly lower salary, if only at the beginning. The company can either offer an initial share of equity or an EMI.

An Enterprise Management Incentive (EMI) is a tax efficient way to reward, incentivise and retain employees by using the promise of equity. It is an option which specifies; the proportion of total shares, the time at which it matures, the price, and any performance or other conditions which must be satisfied for the option to be exercised. However, there are a few requirements and limitations.

Requirement	Limitation
Employment time	At least: 25 hrs a week, or 75% of the individual’s total employment time
Owns limited amount of equity when awarded EMI	The employee is only eligible if they own less than 30% of the total equity at issuance.
The employee’s EMI is small	The maximum value of shares under an EMI is £250,000
The company issues a small number of EMIs	The total values of all the shares under EMIs is less than £3 million.
Exercise period	The exercise time must be under 10 years
Maximum number of full time employees	249
Maximum value of company’s gross assets	£30 million

There is a capital gains deduction on the exercise price, but then there is a capital gains tax at the exit price. The CGT applies to only 10% of the difference between the exit price, and the market value price of those shares at issuance.

alFA REMASK will award EMIs of 1-2% to its initial employees. They will only be exercisable if the employee still works there, as well as other conditions which are still to be decided.

How we won investment

In order to gain the necessary funds to complete our research, we employed a number of methods. We contacted angel investors as well as large biotechnological companies and other institutions with a notable philanthropic history. We had to pitch our idea, as well as answer questions about what the money was going to be used for, and about our principal values.

The angel investor is an alumnus of the City of London School, and we knew them to have been very generous to previous iGEM teams, specifically to the 2021 Ribotox team. We first contacted them around September 2021, where we outlined the fundamental aims of the 2022 team. Namely these were as follows: winning the hardware, education, and entrepreneurship awards; achieving a gold prize overall; increasing the diversity of the team and developing the idea enough that it could be further researched at an undergraduate level. We explained that we were going to achieve greater diversity by fully including the pupils at the City of London School for Girls. At this time, we were yet to form a team and yet to decide what idea to pursue.

In late October 2021 the team had been chosen, and we set about finding our idea. We first split into different groups, and researched multiple ideas. These were: treating Coeliac’s disease by using a probiotic gut bacterium to break down the gluten; creating a mesh “tea bag” that contained genetically modified bacteria capable of destroying toxins in spiked drinks; using CRISPR spCAS9 to modify Enterococcus, removing it’s antibiotic resistance; and a mask that could diagnose TB infections. By March 2022, every group had created an investment proposal, detailing the biology of the idea, the originality of the idea, and the probability of success. Internally, it was decided that the angel investor would be shown only one of the ideas, and alFA REMASK was chosen.

In April during a pitch style presentation, we explained fully how much money was necessary to finish the project, and what it would be used for. After doing so we had to answer supplemental questions relating to the fields of our team values, motivations and originality. After doing this we were awarded the funding. The investor requested that the specific amount be kept confidential, however we are able to say that this was 50% of our total funding.

In addition to this we also spoke with the Friends of CLSG, and were hoping that they would match the first investor, mirroring the split of girls to boys in our team. As such we had an online meeting with the friends on the 14th of June. Again, we presented alFA REMASK’s investment proposal. They were impressed, however they asked many questions specifically relating to how many girls this money would help, and what it was actually to be used for. We agreed to take a series of assemblies at CLSG, where we would explain our project to girls in year 9 and above, as well as outlining genetic engineering more generally. By the 15th of June they had agreed on a sum of money, and by the 22nd we were awarded £4,000. On September 21st, they later kindly donated £3,500 more, after additional questioning.

As well as angel investors we also spoke with the liveries and guilds of the City Of London, as they have famous philanthropic pasts. Unfortunately, however, these endeavours were unsuccessful as many of the liveries already supported the City Of London Schools by offering bursaries, and as such felt that they were unable to donate any further financial assistance.

In summary, we had 2 sources of funding; the alumnus of CLS, and the Friends of CLSG. As previously stated we are unable to release the amount donated by the alumnus, but we are able to say that 50% of the funding was the £7,500 from the Friends of CLSG.

Link to Investment Proposal for iOS

Patents and Intellectual property

There are a multitude of different types of intellectual property; patents, trademarks, copyright and trade secrets. ALFAREMASK LTD. will need to apply for a trademark to protect the name, however, a more important matter is that of the patent. A patent is a piece of legislation which protects an individual’s or company’s designs from plagiarism, within a specified geographical region, for a specified amount of time. It gives the owner the ability to sue others for patent infringement, as well as granting them the ability to sell the whole patent or licences to individuals operating in that specified region and timeframe. Our company will be manufacturing, distributing and vending its tests in India, and so the patent will fall into the jurisdiction of the Indian Patent Office.

For a patent to be accepted by the IPO, it must fulfil a set criteria. These points are as follows;

The subject matter must be patentable. A patent protects designs for a new process or part that can add value to its field of use. This excludes items such as musical compositions or names from being patented as they are covered by other types of intellectual property.
The idea is novel. This excludes ideas that have already been patented from being patented by others.
The idea is inventive. The designs must be original and creative. The patent will be rejected if the idea is obvious.
The idea has utility. The idea must be capable of furthering the progress of humanity by either enabling a new capability or by decreasing the labour required for performing a task.
The idea does not conflict with section 3 or 4 of the Patents Act 1970. Section 3(i) states, “The following are not inventions within the meaning of this Act,...any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.”

In order to be able to protect our work we must not conflict with point (5), however our business will be based around producing TB tests, a product which is clearly a medical diagnosis device! In practice, however, Section 3(i) is interpreted as referring only to novel medical methods, and so devices are covered.

At the IPO, an expedited patent can cost around £500, and takes 2-4 months to be approved. The approval process involves an examiner investigating whether it fulfils all 5 criteria, as well as citing the patents of any other devices referenced in our patent. (The only other device mentioned in our patent is the rivet, which will be very easy to cite). The examiner will also look through the records of other patent offices to see is something similar has been patented there.

We decided to patent the fastener that attaches the lateral flow test strips to the mask. Our fastener allows for the test strips to be swapped by the user, and so if successfully prosecuted it would prevent competitors both from mounting lateral flow tests strips to masks, and from developing competing modular tests designs. A successful prosecution at the IPO would also ease the prosecution at other patent offices as there would be a precedent. Having a patent would make ALFA REMASK LTD look much more attractive to investors as it would already have a value- the patent. Writing the patent ourselves also takes the financial burden off the company as patent attorneys normally cost around £4,000. The patent is shown in the PDF below.

Link to Patent for iOS

Business Plan

In order to describe our ideas more fully, we have created a business plan. It details; our market research using PEST and SWOT analysis, market segmentation, the regulations and certifications we need to obey, our rigorous financial modelling of economies of scale, thorough financial projections for the first 4 years as well as a long-term timeline.

Link to Business plan for iOS

Outro

As you can see we have put a lot of thought into our business ideas, and we firmly believe that this idea is profitable and has the capacity to revolutionise TB detection. It grants governments and health workers better information on the current infection situation, enabling them to save more lives. Thank you for reading!

Footnote

References can be found within the business plan.