Nanosynex

Michelle Heymann is a Brazilian-Israeli entrepreneur the co-founder & VP Marketing of Nanosynex, a company developing a disruptive solution to diagnose antimicrobial resistance (AMR) in record time. She established Nanosynex in 2017, after completing the Technion  MBA program, where she met her co-founder, Diane. The young business executives realized the potential of the technology of Prof. Levenberg (Technion) and created Nanosynex to take it from lab to market. Being two entrepreneurs from different origins, they made sure to leverage their cultural differences to bring creative thinking to their company.

Previously, Michelle was covering Healthcare & Science news in the leading Brazilian newspaper, Folha de S. Paulo. Michelle also cowrote the book “Quarta Capa: o livro sobre os livros”, about the reading habits in Sao Paulo, Brazil and Buenos Aires, Argentina. She holds a B.Sc. in Communication & Journalism from Mackenzie Presbyterian University (Brazil) and a MBA from the Technion.

Antimicrobial Resistance (AMR) is one of today’s biggest global threats, according to the WHO, causing 700,000 deaths yearly. 

AMR is the consequence of widespread inappropriate use of antibiotic. Doctors use their expertise to prescribe the most appropriate antibiotic to their patients, because the diagnostic test results takes days to be released.

However, the antibiotic is inappropriate in 50% of the cases. The misuse of antibiotics increase the AMR problem. 

Nanosynex solution is a diagnostic test that checks bacterial resistance to antibiotics in record time. Composed of disposable microfluidic cards, a benchtop reader and an analysis software, the phenotypic test allows doctors to determine the appropriate antibiotic treatment for their patients and provide same-day-results (<5h).

By prescribing a targeted antibiotic earlier, Nanosynex elevates the humanity by generating positive impact to people's health, by saving lives, reducing the spread of resistant bacteria, reducing morbidity and mortality rates and cutting healthcare costs. 

Antimicrobial Resistance (AMR) has been declared as one of today’s biggest global threats by the World Health Organization. Every year, 700,000 people die due to AMR worldwide. By 2050, this figure will be 15 times bigger, ending in 10M deaths yearly.

AMR is the consequence of widespread inappropriate use of antibiotic. Doctors use their expertise, intuition and professional judgement to do an ‘educated guess’ whether an infection is present and what is likely to be causing it, and thus defining the most appropriate treatment.

Diagnostic tools are used as a second and complementary step by physicians to confirm/change that initial prescription. This is because current Antimicrobial Susceptibility Testing (AST) solutions are lab-based, have remained basically unchanged in several decades and take too long to provide results.

As consequence, 50% of patients are receiving wrong administration of an antibiotic. The overuse and misuse of antibiotics, due to the lack of efficient solutions to detect bacterial resistance at an early stage, allows the emergence of “superbugs”, increasing the major global threat of Antimicrobial Resistance. 

Nanosynex is developing a personalized diagnostic test that checks bacterial resistance and susceptibility to antibiotics in record time. Composed of three items (disposable microfluidic cards, a benchtop reader and an analysis software) the phenotypic test allows doctors to determine the appropriate antibiotic treatment for their patients and provide same-day-results, therefore saving lives, reducing the spread of resistant bacteria and cutting healthcare costs.

The benchtop reader consists of a fluorescent imaging system, coupled with an incubation unit and a motorized stage. A disposable card is composed of several droplet-based microfluidic arrays connected to a shared inlet; each array will examine one treatment, a treatment being defined as one concentration of one antibiotic. The software will monitor, aggregate and translate bacterial growth data into in order to make determinations (Susceptible/Intermediate/Resistant) and provide the minimum inhibitory concentration for each antibiotic.

Nanosynex brings two main innovations to the Antimicrobial Susceptibility Testing: the sensitive fluorescent readout and the unique microfluidic structure, which automatically disperses the sample into hundreds of smaller volumes, allowing us to start testing from lower bacterial volumes. 

The patented solution is based on a revolutionary scientific development from the Dean of the Technion Biomedical Engineering Faculty, Professor Shulamit Levenberg. 

Nanosynex is revolutionizing the antimicrobial prescription practice by allowing physicians to get same-day results, which supplants the empirical practice limitations. Thus, Nanosynex ensures saving at least one day of hospitalization per patient and bringing accurate and fast treatment to the patients, while reducing the spread of resistant bacteria and significantly decreasing the large economic burden associated with it.

Nanosynex diagnostic test can help any person, in particular young women and old men, since UTI, the second most common infection  have a higher prevalence on them and women during pregnancy, abortion and childbirth, since the increasing antibiotic resistance can raise their risk of infections.

The financial implications of AMR proliferation are devastating for the society: it is estimated that AMR costs the EU economy and healthcare system €1.5B per year, while causing cumulative losses in OECD countries of +€2.9T. Research shows that a continued rise in resistance by 2050 would lead to 10 million deaths every year and a reduction of 2%-3,5% in Gross Domestic Product. This can be supported by the current global economic crisis generated by the COVID-19, which led to one of the worst stock market crashes in contemporary history, showing the sharpest drop since Black Monday (1987).

Nanosynex choose to fight one of the main threats to humanity according to the World Health Organization. There are ten fronts defined by the WHO to fight Antimicrobial Resistance (AMR), one being boosting new rapid and reliable diagnostic and another being public awareness.

Nanosynex work is focused on the development of a faster diagnostic test kit, which can help avoiding future pandemics, and, as part of the efforts to explain this market need to the public, Nanosynex generates public awareness.

Therefore, Nanosynex is driving actions and generating awareness about one of the most difficult problems of our world.

Michelle Heymann and Diane Abensur (both featured at Forbes 30 under 30 Israel), Nanosynex co-founders, met around a common passion for healthcare and innovation during their MBA at the Technion Institute of Technology (Israel). The young business executive were scouting for innovative technology transfer opportunities when they found out about the technology of Prof. Levenberg, women Dean of the Technion Biomedical Engineering Faculty. 

The founders’ vision was to find a solution to address a major healthcare problem: to provide faster diagnostic to treat patients' infection early and  fight the AMR while preventing future pandemics.

Once they realized that prof. Levenberg technology was a perfect match to their vision, the entrepreneurs decided to create Nanosynex to take it from the lab to the market. At that time they already had a strategic partner, Biosynex, who committed to help them getting into the European market.

Driven by the belief that only a great team could make Nanosynex successful, they hired top-notch engineers and microbiologists. Being women entrepreneurs from different origins, they made sure to respect gender and national diversity. Today they are eight people from four countries, leveraging their cultural differences to bring creative thinking and to gather a worldwide advisory network.

Since childhood I am passionate about healthcare. All my family’s work is around healthcare (each one works on a different healthcare profession) and I wanted to work on something different, but yet, in the healthcare area. I used to cover Healthcare & Science news and understood that without the advance on science we won’t improve our healthcare systems.

The Antimicrobial Resistance is indeed one of the biggest global problems in the health system. Bacteria proliferates fast and antibiotics takes time to be developed. When I was 2 years old I had a severe infection that completely scared my parents (and my father is a physician). My grandma died from a sepsis caused by bacterial infection.

However these personal stories are not what makes me passionate about my project: I am passionate about bringing science into a healthcare cause that now might not be a major cause of death as used to be before the antibiotic era, but that can become as dangerous as in the past and that we need to be prepared to. I am passionate about the idea of preventing and anticipating what could be a major health crisis, a pandemic, and supporting it with all my means.

Although I don’t have a tech background, it takes someone fascinated and dedicated to its project to deliver it in a great way.

I am both fascinated and dedicated to my project and I can understand the problem  that we are trying to solve from several perspectives: internally (from a family dedicated to healthcare), externally (as a media person, covering the news), actively involved (as a manager of Nanosynex). I have crucial skills that make me good to lead this project such as: ability to work under pressure and to meet deadlines or to deliver in short time frame; ability to speak different languages and to communicate with different people about several subjects, team work ability, among others.

However my abilities is not what gives me a unique position to deliver the project. Both my partner and I dedicated major efforts in building a strong multidisciplinary (covering all our needs in terms of Microbiology, Business and several Engineering disciplines, such as Mechanical Engineering and Biomedical Engineering) and internationally (more than 5 nationalities) team, since we understands that’s the key to success.

The delivery of this project not only relies on me, but it relies on our amazing and dedicated team composed of eight people, with years of experience bringing medical devices from the lab to the market and in our synergy and teamwork. This is what gives us a unique position to deliver our project.

The first hire that we did, was a wrong hire, although he was a great speaker and had amazing technical resume. He had dozens of years of experience as an engineer in big corporates and was a nice person to deal with. However, he wasn’t ready for the pace of a startup and for the expectations and pressure that come with it.

At first sight, we didn’t notice that this could be a problem, since both of us (the founders) previously worked at big corporates and were great to work under pressure, but after a month we realized he wasn’t delivering well.

The sentence “you hire slow and you fire fast” is applicable here. We were low in resources and couldn't afford paying someone who would delay our R&D process. We worked out with him on a deal so he would quit the company in good terms. Before finalizing the deal with him, we hired our current VP R&D, paying attention to the mistakes initially made in recruiting to avoid repeating them. We allowed a smooth transfer of knowledge before the shift in personal officially happened, which contributed to keep moving forward the startup R&D.

I used to lead the Brazilian branch of a female young group that helped Israeli day care centers. Our goal was to raise funds to help sponsoring the costs of the children that were part of these day care centers. The main activity we used to plan was the creation of food baskets and a massive event to sell these among the community.

I also led the educational and public relations of Bnei Akiva, a youth movement, in São Paulo, Brazil. I was responsible for defining, creating and spreading the content among the volunteer trainers. Also, I was responsible for the interaction with similar entities and for thinking and preparing activities for the interaction between these entities. I had to speak to different people, bring up ideas, convince them and led them into my plans, while at the same time hearing and being open to their ideas.

Nanosynex has a clear edge over its competitors as it can provide same-day results while keeping up with the high accuracy of phenotypic automated solutions (categorical agreement of 95%), by using a combination of patented proprietary microfluidic technology and a disruptive method of tracking bacterial growth by fluorescence, presenting the following advantages:

• a highly convenient assay method to estimate the number of viable cells in multi-well plates;

• a much more sensitive than turbidity-based readouts (used by the state-of-art);

• low bacterial cell requirements (<1 µL per test treatment) which reduce the need for sample preparation steps that depend on lengthy culturing; 

• a unique sample dispersion technique which enable automatic microfluidic handling to hundreds/thousands of nanoliter reaction chambers in a compact, robust, and inexpensive format (allows to capture more bacterial heterogeneity and increase accuracy and assay speed);

• loading and operation simplicity which obviates the need of extensive training and reduces manpower and unit complexity, cost, and reliability;

• microfluidic features which enable a reduction of reagents consumption by over 300-fold and reduction of size footprint of machinery.

Thus, by providing an accurate (95% of categorical agreement to the gold standard) same-day result, Nanosynex diagnostic test will not only spare at least a night in the hospital for inpatients cases (~$1800), but it will also help the patient recovering faster and help reducing the spread of resistant bacteria, therefore, limiting the extension of potential pandemics like COVID-19.

Outcome / Humanitary value: fight the resistant bacteria / prevent resitant bacterial epidemics

Outputs: 

- Who is affected? Everybody, in particular people in risk: people with weak immunology system, old people, pregnant women and infant.

- What is produced? A rapid diagnostic test that checks bacterial resistance to antibiotics and allows doctors to prescribe targeted antibiotic treatments to their patient in the same day as the sample is collected.

Activities:

- R&D: development of the diagnostic test kit; pilots / experiments in-house and ex-house; feedbacks and iterations

- G&A: company mantaince and financial activity (including fundraising and grants applications) to allow the R&D work

- Marketing: awarness of the development made (including interviews with the media) and establish partnerships to bring the product to the market

- Sales: bring the product to the market 

Short-term outcomes:

- Diagnostic 

- Doctors will base their treatment decision on diagnostic test results.

- Patient will be treated faster

- Shorter hospitalization / Faster bed turnover

 Long-term outcomes:

- Correct use of antobiotics, avoiding the current abuse and misuse that lead to antimicrobial resistance

- Control of the antimicrobial resistance crisis

- Ability to quickly test and isolate multidrug resistant patients that transmit the infection and eventually lead to epidemics

- Improvement of mortality and morbidity rates

Currently Nanosynex is in its R&D phase - not yet commercializing - so the company serves mostly to its employees, 8 people, and four advisors, a total of 12 people.

Next year the company is expected to hire at least 4 additional employees and one advisor, reaching a total of 16 people.

In 5 years from now, Nanosynex will be operating in the market and selling more than 1 million diagnostic tests. The company is expected to grow to 30 employees and keep around 6 advisors on board. The total amountof people directly being affected by Nanosynex will be 36, however the company's product will be affecting millions of life in a meaningfull way, since it will be contributing to their health. So we can acess a number of 1.5 million people being positively affected by Nanosynex in 5 years.

Nanosynex goal for the next year is to fully evolve its prototype into a market-ready product to be launch in the market and to start developing its second generation product.

In the next five years, Nanosynex expect to be selling millions of diagnostic tests and to be introducing to the market its second generation product, which is disruptive complementary product for direct testing of urine samples, to be used prior to Nanosynex first product in the workflow, to bypass bacteria culturing. This process saves an additional diagnostic day and increases the value of Nanosynex system by enabling AST results in the same day as the urine sample is collected from the patients, as opposed to at least 3 days time-to-results using conventional methods. 

From a geographical perspective, Nanosynex will start selling in Europe, in its the priority countries (France, Germany, Spain, the UK, Switzerland and Israel), and  progressively expand across Europe. Nansoynex already secured bi-national strategic alliances with key EU actors in the field of rapid diagnostics for the distribution of its product: Biosynex (FR) and Vitro (ES). As part of the five-years plan, Nanosynex will start exploring expanding internationally to the US and to the BRICS.

In parallel to the R&D and commercial expansion, Nanosynex pretends to use its marketing channels and its connection to the media to raise awareness to the issue and help to elevate the humanity by explaining how to prevent and deal with infections and, therefore, improving the global “good health and well-being”.

We can identify the following barriers along the product development process with a horizon of one year (goal: finalize prototype) to five years (goal: sales in the EU and expansion from the EU to the US and BRICS markets):

Financial (applicable up to 5 year from now): inability to secure equity funding due to external changes affecting the fundraising landscape (eg. economic crisis)

Technical (applicable mostly in the next year): product development delayed because of unsuccessful partnership with one of our subcontractors, or development mismatch between the different disciplines (biological assay; microfluidics; hardware engineering and data analysis) involved in the Nanosynex product

Regulatory (applicable up to 5 year from now): inability to secure regulatory clearance due to lack of compliance to the regulatory process or strengthened regulations in place in the different target areas (EU and then US and BRICS)

Market (applicable mostly from 3 to 5 years from now): new competitors with a better product and strong market penetration capabilities as barriers to entry 

Cultural (applicable mostly from 3 to 5 years from now): lack of understanding of a culture and understanding of how to adapt the product to fit their needs 

Financial: we have developed a robust fundraising strategy relying on a combination of non-dilutive and equity funding and we plan to continue along that line by monitoring relevant grants and competitions bids, as well as cash flows strict monitoring to mitigate the risk of potential private funding barriers

Technical: we have one project manager per subcontractor, in charge of ensuring smooth interactions and timely work deliverables. If a subcontractor becomes a development barrier, we have a backup plan (the second-best option chosen during due diligence). In terms of internal product development, we hold weekly R&D team meetings to align the multidisciplinary work.

Regulatory: the team and our regulatory consultant follow changes in the regulatory landscape through trainings to identify potential future barriers and update the product validation methods to fit to them.

Market: we gather competitive intelligence data on competitors to make sure our competitive advantage is still valid and rely on our strong strategic partner for distribution to secure a market share and overcome potential barriers to entry  

Cultural: we have a multicultural team (5 different nationalities) and we organize strategic and team building seminars to communicate the corporate culture and define best practices to make the most of our cultural differences by turning them into an asset and understanding the needs of the different countries we will target.

Nanosynex already build an initial database with 25 relevant customers and 15 of them demonstrated strong interest to develop a partnership. Three of them are already Nanosynex partners: Rambam hospital, Shaare Zedek hospital and Henri Mordor University hospital.

Currently the team member exchange materials and have calls to discuss customers needs and ways to proceed in the development with the clinical microbiologists leading the labs in these 3 hospitals. The company also have period Scientifc Advisory Board meetings to aling everybody's ideas and introduce relevant companies reports.

In terms of distribution, Nanosynex have a distribution agreement with Biosynex, a leader in the French rapid diagnostic market, with a worldwide presence in 70 countries, including more than 20 European countries, among them, the top ten most dynamic European countries in the Life Sciences sector, as well as a LOI with Vitro SA, a Spanish group specialized in the development, manufacture and distribution of equipment, software and reagents for in-vitro diagnosis (IVD).

Nanosynex is planning to set up several other partnership like those to support on the product development and help bringing this solution to the global market.

Nanosynex business model structure is B2B2B, where Nanosynex entrust distributors (such as strategic partner Biosynex, in France) as their intermediary to sell to the clinical microbiology labs, Nanosynex final customer, which will then perform the test on their patients.

The distributors will commercialize the product, following the usual pattern of IVD industry companies offering a solution in two parts (hardware/software and disposables): distributors will lease the machines to the labs (with an option to buy at the end of the leasing period) and agree on a minimal number of disposable cards to buy per year. Labs willing to buy the machine directly will have a preferential price for disposable cards. The company is getting a 50% margin on top of the COGS and the distributors are getting a 40-50% margin on top of Nanosynex price.

Currently, since Nanosynex activities are focused in R&D, without any revenue, the company uses a combination of grants, prizes, loans and equity investment to support its activities. The company plans to start selling in 2023, which will contribute for the company's financial sustainability. 

Until Break Even Point, when the annual revenues will cover for our annual expenses, we expect to have two additional investment rounds: round A and round B. Round A will happen during 2020 and round be is expected to happen on 2023.

Nanosynex raised about $2M in a Pre-Seed and Seed rounds.

Pre-seed round (2017): $250K in equity + $60K in non-dilutive funding (grants & prizes)

Seed round (2018-2019): $1M in equity + 550 in non-dilutive funding (grants & prizes)

Nanosynex recently (2020) received the approval to receive two other grants from the Israel Innovation Authority and from the EIC/H2020, adding to the total another $3.6M.

Considering these grants, Nanosynex raised a total of $5.5M.

Nanosynex is looking to raise a round of $8M during 2020. Some offers were already received (we will disclose only on need basis).

We currently have a burnrate of $120/month. We expect this burnrate to increase up to $170/month until the end of 2020 depending on cash available. About 75% of the expenses are R&D related, 15% are G&A and 10% are Marketing.

We believe that great people are everywhere and we want to help as much as we can. The elevator prize will help us to grow Nanosynex internationally and to spread around the globe our message and our willingness to make the world a healthier place.

The Elevator Prize will give us additional tool, means and channels to fight the resistant bacteria, to be ready and prevent pandemics. And we all know how a pandemic can be devastating.

The Elevator Prize can help us help the world - and we count on that.

We need partnership for funding our company since we are currently raising $8M.

We also want to strengthen and diversify our board, so we will be glad to find a neutral board member to join us.

Last but not least, we are planning our regulatory path now, and any support available in this area will help us mitigating risks in the future.