ENTREPRENEURSHIP

Introduction

Our Goal is to Address a Growing Need in Diabetes Care: Hypoallergenic Bio-Based Glue for Skin-Friendly Patches.

The global prevalence of diabetes, including both Type 1 (T1D) and Type 2 (T2D), is rising at an alarming rate. More than 537 million adults are affected by diabetes[1], and over 700 million people are expected to be living with the condition by 2045 [1].

Increase in the global diabetes prevalence over the years. Adapted from Statista (2024, May). Diabetes Care Devices - Global | Statista Market Forecast.
Fig. 1. Increase in the global diabetes prevalence over the years. Adapted from Statista (2024, May). Diabetes Care Devices - Global | Statista Market Forecast.

The technology has become an essential tool in day-to-day management. In 2023, more than 9 million people were using Continuous Glucose Monitors (CGMs) to track glucose levels [2], and approximately 1.15 million were using insulin pumps, with Type 1 diabetes patients making up 95% of insulin pump users [3].

However, while these devices have transformed diabetes management, they are not without complications. Skin reactions are a significant issue, affecting a substantial number of patients. Research shows that about 28% of CGM users and 29% of insulin pump users experience skin irritation, ranging from mild redness and itching to more severe reactions such as pain, blisters, and skin peeling [4]

Severe reactions include:

  • Lipoatrophy: The thinning or loss of fat tissue under the skin.
  • Lipohypertrophy: The thickening or abnormal buildup of fat under the skin.
  • Scarring: The formation of fibrous tissue resulting from injury, which replaces normal skin after a wound heals.
  • Local erythema: Skin redness in a specific area, often due to irritation or increased blood flow.
  • Subcutaneous infection occurs beneath the skin, affecting the tissue layers just under the surface.
  • Exacerbation of pre-existing inflammatory skin conditions: The worsening or flare-up of a pre-existing skin condition, such as eczema or psoriasis.
  • Irritant or allergic contact dermatitis (ACD): Skin inflammation caused by direct contact with an irritant or an allergic substance, resulting in itching, redness, and sometimes blistering[5][6].

Many reactions can occur within the first 24 hours of use or develop after months of wearing the devices. In some cases, these issues become so severe that patients are forced to stop using the devices altogether - about 38% of CGM users and 47% of insulin pump users report skin reactions after more than six months of use [4].

Children with diabetes face an even more significant burden. Studies have shown that 60% of children and young adults using CGMs or insulin pumps report skin complications, such as redness, rashes, and itching, with 22% having to discontinue their use due to these skin issues [5][7]. The emotional toll on children and their families can be immense, adding stress to an already challenging condition.

These statistics represent a critical need for better materials in diabetes care devices - effective, safe, and comfortable for long-term skin contact. Traditional adhesives often worsen the problem, causing allergic reactions that limit the usability of life-saving technology.

Our Commercial Potential

Our project aims to solve the growing issue of complications caused by medical adhesives by developing a bio-based, hypoallergenic glue called “holdfast,” specifically designed for diabetes patches and other medical devices. By minimizing skin irritation and ensuring painless removal, our solution will improve the quality of life for millions of diabetes patients, reducing the emotional and physical burden of device-related skin complications.

Estimated global revenue growth of the diabetes care devices market. Adapted from Statista Market Forecast (2024, May). $ - USD.
Fig. 2. Estimated global revenue growth of the diabetes care devices market. Adapted from Statista Market Forecast (2024, May). $ - USD.

We carefully analyzed the market to ensure we could penetrate it with our bio-based glue. The global diabetes care devices market (TAM) is projected to reach 41.6 billion USD by 2027 [8] (Fig. 2., Fig. 3.), with glucose monitoring systems (CGMs) and insulin pumps comprising a significant portion of this market [9]. Estimating that adhesives contribute around 10-15% to the overall device cost, our product's serviceable available market (SAM) could be approximately 4.2 billion USD to 6.2 billion USD (Fig. 3.). To estimate our serviceable obtainable market (SOM), we calculated 2% of the maximum SAM, yielding approximately 180 million USD (fig. 3.), given competition from industry giants like 3M, Dow, and H.B. Fuller.

Visual representation of a total addressable market (TAM), serviceable available market (SOM), and serviceable obtainable market (SOM) for diabetes care devices. $ - USD. Estimated based on Statista Market Forecast (2024, May).
Fig. 3. Visual representation of a total addressable market (TAM), serviceable available market (SAM), and serviceable obtainable market (SOM) for diabetes care devices. $ - USD. Estimated based on Statista Market Forecast (2024, May).

Imagine an adhesive production process that's faster, more affordable, and environmentally sustainable.

Our team has unlocked this future by transforming standard industrial E. coli bacteria into efficient adhesive factories. By transferring the adhesive synthesis machinery into these bacteria, we've achieved growth that's 10 times faster, cheaper, and far more controllable than traditional methods.

Representation of Synhesion shares rising after we create a successful start-up.
Fig. 4. Representation of Synhesion shares rising after we create a successful start-up.

This breakthrough enables us to produce a high-performance, eco-friendly "super glue" that no longer depends on non-renewable, oil-based materials. Instead, we've replaced them with low-cost, sustainable glucose. The result? A scalable process that slashes costs and environmental impact.

But we didn’t stop there. To maximize production efficiency, we engineered a new strain of E. coli, removing competing pathways to free up resources exclusively for adhesive synthesis. This strategic innovation paves the way for the mass production of reliable, eco-conscious adhesives, setting a new standard for the industry.

We’re not just manufacturing adhesives—we’re shaping the future of sustainable materials.

As of the time of this work, no patented technology exists for the production of holdfast adhesive in E. coli, which is precisely what we are offering, leaving an opportunity in the IP landscape. Additionally, current diabetes care devices rely on chemical adhesives like cyanoacrylates[15], which often lead to adverse skin reactions, highlighting a significant need for alternative solutions. This together shows our immense commercialization potential.

Our Product Description

Bio-Based Hypoallergenic Glue Composition

Key ingredients of the polysaccharide that makes up the adhesive are:

  • Glucose;
  • Mannosamine uronic acid;
  • N-Acetylglucosamine;
  • Glucosamine.

Features

  • Hypoallergenic;
  • Eco-Friendly;
  • Stronger than super-glue.

Important Considerations

Impact on Diabetes Care Devices:

  • Question: How can a glucose-containing polysaccharide be used in diabetes devices without affecting measurements?
    • Answer: The polysaccharide does not readily break down into monosaccharides in C. crescentus natural environment, minimizing the likelihood of interference. We will validate this through glucose measurements via artificial membranes.

Detachment of Sensors:

  • Question: If the adhesive is strong, how will users detach sensors?
    • Answer: The best current method for detachment is ethanol, which dissolves the adhesive. We are also exploring enzyme-based sprays (glucosidase) for future detachment solutions.

Business Model

Synhesion business model canvas
Fig. 5. Synhesion business model canvas.
  1. Customer Segments:
    • B2B: Medical device manufacturers seeking better adhesive solutions with potential applications beyond diabetes care devices to all patches.
    • Diabetes Care Companies: Companies that produce insulin pumps, continuous glucose monitors (CGMs), and patch-style insulin delivery systems.
    • Wearable Health Tech Firms: Companies that develop wearable devices, such as electrocardiogram monitors, heart rate monitors, patch sensors, etc., require adhesive materials for skin contact.
  2. Value Proposition:
    • A hypoallergenic, bio-based adhesive for medical patches that reduces skin irritation for diabetes patients and is stronger than commercially available adhesives, ensuring it stays for longer periods of time than current options but is painlessly removed from the body.
    • An environmentally friendly and sustainable alternative to traditional adhesives.
    • Improved diabetes patient comfort, leading to higher compliance with continuous glucose monitoring (CGM) and insulin pump use.
  3. Channels:
    • Selling our technology to biomanufacturing companies that provide the supplies needed for glue production.
    • Direct sales to medical device manufacturers once our technology is refined.
    • Direct sales to patch manufacturers.
    • Partnerships with diabetes care providers for promotion.
  4. Customer Relationships:
    • Direct B2B sales.
    • We will establish long-term partnerships with healthcare providers with an established customer base. Our research and public data indicate that Dexcom, Medtronic, and Abbott are the key players worldwide, making them our primary targets.
    • Continuous feedback loops from patients and caregivers will be collected with our healthcare supply partners.
    • Support channels for troubleshooting and advice via healthcare supply providers' websites.
    • Branding through social media and diabetes associations.
  5. Revenue Streams:
    • Licensing of our bio-based adhesive production technology.
    • Direct sales of adhesive to medical manufacturers.
    • Sales to companies that develop medical wearable devices.
  6. Key Resources:
    • A facility with biomanufacturing equipment, bioreactors, and a local laboratory where we can conduct our experiments.
    • To minimize capital expenditure (CapEx), we will outsource large-scale production to companies like Genomatica and Culture Biosciences.
    • Specialists with technological expertise in biomaterials, a research team, and scientific collaborators.
    • A legal department for patenting, rights protection, etc.
    • Financial resources (investments from VC and angel investors) for research, development, and commercialization.
    • IT department for incorporating AI into our scale-up process optimization and modeling.
    • The commercialization team will look for commercialization opportunities/partners.
  7. Key Activities:
    • Our main activity will be researching and developing our bio-based adhesive with varying properties for diabetes care device patches.
    • We will also test our product and ensure it complies with regulatory approval processes.
    • Then, we will validate the market and product scaling.
    • Once scaled up, the next step is selling and distributing.
  8. Stakeholders & Partners. Our key stakeholders include regulatory bodies that oversee and license biomedical products, biomanufacturing companies utilizing bioreactors and bacteria, and medical device manufacturers:
    • Healthcare-associated institutions, such as the Kaunas Regional Biomedical Research Ethics Committee, will assist in conducting biomedical research to ensure our adhesive is safe and suitable for use.
    • Regulatory bodies are essential for obtaining the necessary licenses for medical device use, including compliance with government institutions and biomedical trials. 
    • Venture Capital (VC) funds like cultivateMD and Horizon 2020 that specialize in investments in medical devices.
    • Biomanufacturing companies
      • Bioenergy LT will collaborate with us until our technology is ready for direct sales, leveraging their 10+ years of expertise in bioreactors and scale-up processes. 
      • Our next target company is Industrial Biotech, which focuses on biobased production, sustainable processes, bioprocess development, environmental solutions, cross-industry collaboration, research, and regulatory compliance.
      • The third pick is Culture Biosciences. This US-based startup accelerates bioprocess development by offering customers access to shared bioreactors, allowing them to run experiments without expensive equipment.
    • Medical supplies/devices manufacturers, such as Dexcom, Medtronic, and Abbott, will be targeted as our partners in the medical field. Once our technology is developed, we will sell our glue for diabetes care devices and directed patches.
  9. Cost Structure:
    • Research and product development costs.
    • Operational expenses.
    • Manufacturing and material procurement (for companies producing and scaling up the glue).
    • Regulatory approval and testing costs.
    • Sales, marketing, and distribution expenses.
    • Salaries for employees.
    • Facilities cost.

Direct Competitors: Companies producing adhesive solutions for medical devices like CGMs and insulin pumps.

Indirect Competitors: Manufacturers of diabetes management devices that bundle their adhesive solutions.

Table 1. Comparative table of Synhesion direct competitors
Comparative table of Synhesion direct competitors

Table 1 outlines the giants producing adhesives applicable for medical devices. They operate in both the US and Europe, providing solutions to significant diabetes care device manufacturers like Roche Diabetes Care, Dexcom, and Abbott. According to our research, the key manufacturers in the diabetes care device market are active in both regions. After establishing contact and presenting our proposition, we would collaboratively evaluate which market (EU or US) would be the most suitable for both us and our partners (diabetes care device manufacturers).

Competitive advantages of Synhesion:

  • Practical: Our adhesive reduces skin irritation and enhances device adherence.
  • Collaborations: We have great potential for strong partnerships with biomanufacturers and medical device companies.
  • Stakeholders: Our stakeholder base in industry, healthcare, and sustainability is broad.
  • Sustainable: Our approach aligns with EU-supported sustainable development goals [10]
  • Entrepreneurial Environment: Lithuania's favorable regulatory and innovation climate benefits us. The Lithuanian government prioritizes biotechnology as a key industry, providing significant support through incentives for research and development (R&D) and streamlined regulatory processes. This commitment is evident in the national biotechnology strategy aimed at doubling the sector's GDP contribution by 2030 to 5% of total GDP) [11].

A SWOT (strengths, weaknesses, opportunities and threats) analysis allowed us to identify internal factors impacting our project, assess our competitive position, and inform our strategic planning.

SWOT analysis of Synhesion project.
Fig. 6. SWOT analysis of Synhesion project.

STEEPLE was our tool for analyzing the external environment, which enabled us to comprehend trends and envision new opportunities.

STEEPLE represents social, technological, economic, environmental, political, legal, and ethical factors. This framework encouraged us to evaluate the potential impact of each element on society and how products and services will integrate into future scenarios.

STEEPLE of Synhesion - social, technological, economic, environmental, political, legal, and ethical analysis.
Fig. 7. STEEPLE of Synhesion - social, technological, economic, environmental, political, legal, and ethical analysis.
  1. Social Factors:
    • Increasing Diabetes Prevalence: With diabetes on the rise globally, there is a growing need for reliable diabetes care devices. Hypoallergenic, long-lasting adhesives will be essential for users who need continuous monitoring or insulin infusions (insulin pumps, continuous glucose monitors).
    • Patient Preferences: There is a trend towards personalized, user-friendly healthcare devices, and the discomfort caused by skin reactions or frequent replacement of patches or devices is a significant pain point. A hypoallergenic solution can enhance the quality of life for many patients and bring forth the importance of individual care. 
    • Aging Population: Countries like Japan, Germany, the US, Europe, including Lithuania, have aging populations, increasing demand for non-invasive, reliable medical devices that can be used without frequent replacements or skin irritation.
  2. Technological Factors:
    • Innovation in Biomanufacturing: Synhesion aligns with the growing trend of biomanufacturing and synthetic biology innovations. Producing bacterial glue offers a sustainable alternative to synthetic adhesives (cyanoacrylates and others), which are less environmentally friendly and are notorious for causing skin reactions.
    • Compatibility with Diabetes Devices: Technological integration with diabetes care devices (insulin pumps, CGMs, etc.) is key. The glue must meet technical requirements for durability, flexibility, and ease of manufacturing.
    • Regulatory Approvals: Any new medical-grade adhesive technology needs to comply with strict regulatory standards. Developing a bacterial glue that meets these technological and safety standards is essential for adoption by manufacturers.
  3. Economic Factors:
    • Growing Diabetes Market: The diabetes care device market has a high growth rate (CAGR 6.3%-16%)[16][17], driven by increasing incidence rates and the demand for advanced care devices.
    • Cost Efficiency: Biomanufacturing processes, if scaled correctly, could potentially reduce production costs.
    • Healthcare Budgets: Economic conditions in different regions (e.g., healthcare spending in developing vs. developed countries) may affect adoption rates. Our product may appeal to both premium and cost-sensitive markets depending on the pricing structure.
  4. Environmental Factors:
    • Sustainability: One of our key selling points is the sustainability of bacterial glue as an alternative to synthetic adhesives. In an era where manufacturers and consumers are more environmentally conscious, promoting the biodegradable and eco-friendly nature of this product will resonate strongly.
    • Waste Reduction: The longer adhesion properties of our adhesive will reduce medical waste by minimizing the frequency of adhesive changes. This will certainly attract the device manufacturers looking to improve their environmental footprint.
  5. Political Factors:
    • Healthcare Regulations and Policies: Different countries have different medical device regulatory bodies (e.g., the FDA in the US, EMA in Europe, PMDA in Japan). 
    • Healthcare Accessibility: Government healthcare policies may influence how diabetes care devices, including those incorporating our adhesive, are covered by public and private healthcare systems. For example, in countries with universal healthcare, government policies may favor cost-effective, long-lasting solutions.
  6. Legal Factors:
    • Intellectual Property (IP): Protecting the IP around our bacterial glue production technology is crucial. We understand that ensuring we own the IP, have patents and legal protections is very important.
    • Product Liability: As with all medical devices, there are potential risks related to product liability. We must demonstrate our product is safe, hypoallergenic and easily peeled off to avoid legal disputes related to skin reactions or other issues.
    • Global Trade Regulations: Import/export regulations and trade policies can affect our ability to scale internationally.
  7. Ethical Factors:
    • Patient Safety: Given the use of our product in medical devices for patients with diabetes, which is a vulnerable group, ensuring the highest patient safety standards is an ethical imperative.
    • Access to Innovations: There’s a moral obligation to ensure that innovations like our bacterial glue are accessible globally, particularly in underdeveloped countries with a high prevalence of diabetes but fewer healthcare resources.
    • Sustainability Ethics: Using eco-friendly manufacturing processes aligns with growing ethical demands for sustainability in healthcare products.

Our stakeholder, Klaudijus Melys introduced us to the Ansoff matrix. This tool helped us explore growth opportunities and risks associated with each of them through four main strategies:

  1. Market Penetration
  2. Product Development
  3. Market Development
  4. Diversification
Ansoff matrix for Synhesion, the strategy was applied to identify the go-to-market strategy.
Fig. 8. Ansoff matrix for Synhesion, the strategy was applied to identify the go-to-market strategy.

1. Market Penetration (Existing Products, Existing Markets):

We are introducing a new product to an existing market (the diabetes care device industry), we aim to penetrate this market by offering a safer, eco-friendly alternative to toxic adhesives.

We will focus on gaining market share by convincing manufacturers to switch to our adhesive, emphasizing its hypoallergenic and biodegradable benefits over existing options.

2. Market Development (Existing Products, New Markets):

After gaining traction in the diabetes care device sector, we can further consider expanding our adhesive into other medical devices or even wound care markets that also require hypoallergenic, non-toxic adhesives.

This strategy allows to leverage the same product in related medical fields, targeting new customer segments.

Why are other strategies less suitable?

3. Product Development (New Products, Existing Markets): While product development could be an option later, our focus now is on introducing our glue into the market, not creating multiple new products.

4. Diversification (New Products, New Markets): Since our project is new and we have a specialized product, diversification would be too risky at this stage. Our initial objective is building credibility within the niche before exploring unrelated markets or products.

Applications

The primary use of our adhesive will be for direct application to diabetes care device patches. After successfully entering the market, we will consider expanding to a secondary application, which involves applying the adhesive to other medical patches. Tertiary applications include 1) adhesives for surgical wound closures, 2) adhesives for prosthetics, and 3) adhesives for securing medical devices such as bandages, electrodes, and cosmetic patches.

Minimum Viable Product (MVP)

The Minimum Viable Product (MVP) for our bio-based hypoallergenic adhesive is designed to meet the core needs of our target market while showcasing the potential of our technology. Below is a comprehensive breakdown of the MVP components, product features, and considerations.

MVP Components

  • Requirement: The adhesive must effectively bond to human skin, particularly sensitive skin, without causing irritation or allergic reactions.
  • MVP Feature: Testing will demonstrate that the adhesive can maintain adhesion for several hours to a few days, depending on patch usage, and withstand typical movements without peeling.
  • Requirement: The adhesive should not contain common allergens found in existing medical adhesives.
  • MVP Feature: We will provide proof of non-allergenicity through skin sensitivity assays (e.g., ELISA testing using blood serum from individuals who have experienced reactions to medical patches).
  • Requirement: The adhesive should be derived from bio-based sources and be biodegradable, aligning with sustainability goals.
  • MVP Feature: The glue is produced by bacteria (Caulobacter crescentus) using sugars as a media, resulting in a naturally occurring adhesive known as holdfast glue.
  • Requirement: The adhesive should allow for easy and painless removal without damaging the skin or leaving residues.
  • MVP Feature: User tests will confirm that the glue can be removed cleanly after use, with additional measures (like sprays containing enzymes that break down the polysaccharides) considered if detachment proves challenging.
  • Requirement: The adhesive must work effectively with diabetes monitoring or insulin delivery patches.
  • MVP Feature: Testing will demonstrate that the adhesive bonds to typical diabetes patch materials (e.g., medical-grade polyester) without compromising functionality.
  • Prototype: An adhesive that adheres to sensitive skin without causing reactions.
  • Sticking Duration: Demonstration of effective adhesion duration (e.g., for glucose monitoring device patches).
  • Hypoallergenic Claims: Initial lab results from ELISA testing using blood serum from individuals with known skin reactions and tests on artificial membranes to understand whether the polysaccharide diffuses or not.

Intellectual Property

Patented

During our iGEM journey, we sought expert advice to turn our project into a viable startup. With guidance from Dr. Eglė Radzevičienė, a patent attorney experienced in intellectual property, explored patentability and began navigating the patenting process (more about that in Integrated Human Practices). To address the financial challenges, we consulted Violeta Sutkienė from METIDA (more about that in Integrated Human Practices), who introduced us to reimbursement options, potentially recovering a part of the patent fee. With their support, we are preparing to enter the Baltic Sandbox Ventures pre-accelerator program for financial assistance, bringing us closer to securing our intellectual property and launching our startup.

Baltic Sandbox Ventures is confident in Synhesion team’s ability to excel in the iGEM competition by demonstrating technical and scientific excellence, which will be crucial for advancing with them. As part of their long-term interest, they encourage the development of a viable intellectual property (IP) strategy, including patents or trade secrets, to secure our competitive position in the synthetic biology market. Baltic Sandbox Ventures fund is eager to explore investment opportunities in high-potential startups such as Synhesion and has sent us a letter of intent (LOI) highlighting that successful completion of the incubation program and achievement of key milestones, could lead to investment discussions, potentially in exchange for equity.

We have filed a patent application for our newly developed proteins.

Company Projection

In the past 10 months, we successfully established adhesive production in E. coli. Over the next 6 months, we plan to optimize gene expression for enhanced protein synthesis, which we hope will resolve the current issue of our glue forming as rings in the flask. Once we achieve efficient shedding of our adhesive into the media, we will focus on selecting a purification strategy.

Current literature suggests that holdfast adhesive can be purified using organic solvents, such as phenol [11]; however, this approach does not alignwith our commitment to sustainability. Instead, we are exploring the following eco-friendly purification methods:

  1. Ultrafiltration: This technique utilizes membranes to separate molecules by size, effectively concentrating and purifying polysaccharides like holdfast without harsh chemicals.
  2. Ion Exchange Chromatography: This method separates components based on charge, providing an environmentally friendly purification option.
  3. Size Exclusion Chromatography: This technique separates molecules by size and effectively purifies polysaccharides without harmful solvents.
Timeline of iGEM project Synhesion.
Fig. 9. Timeline of iGEM project Synhesion.

We have established a strong connection with BotaBio, a biomanufacturing company equipped to perform various chromatography techniques on polysaccharides, and we will collaborate with them on our purification methods.

Once we optimize holdfast production and select the most suitable purification strategy, we will scale up. Our partnership with BioEnergy LT will facilitate a smooth scale-up process. This company specializes in microbiological products for crop productivity and has over 11 years of experience optimizing fermentation processes and scaling from lab-scale to 200 L bioreactors. Dr. Audrius Gegeckas, the COO of BioEnergy LT, has assured us of his support and access to necessary equipment for scale-up. With their expertise, we are confident in our success.

Dr. A. Gegeckas, COO of Bioenergy LT estimates that our scale-up will take approximately 2-3 years.

Concurrently with the scale-up, we will evaluate the following properties of our adhesive to ensure its suitability for medical patches.

A snippet of Synhesion timeline.
Fig. 10. A snippet of Synhesion timeline.

By approximately 2028, we aim to reach Technology Readiness Level (TRL) 8 (see Fig. 10). At that point, we will begin testing our adhesive in relevant environments, specifically as a medical patch adhesive, while continuously gathering user feedback for further improvements.

How will we test our product?

Adhesion Strength Tests:

  • Peel Strength: Measure adhesion to skin or patch materials under various conditions (ASTM D903 [12]);
  • Tensile Strength: Assess maximum stress during stretching (ASTM F2258 [13]);
  • Shear Strength: Evaluate resistance to sliding forces (ASTM D1002 [14]);
  • Cohesion Tests: Determine internal strength of the adhesive;
  • Moisture Resistance: Test performance in humid conditions;
  • Temperature Stability: Assess performance under varying temperatures simulating body conditions.
  • Composition Analysis: Identify chemical makeup to ensure biocompatibility and safety for medical use;
  • pH Sensitivity: Evaluate how pH changes affect adhesion properties and stability;
  • Toxicity Testing: Conduct cytotoxicity tests to ensure no harm to cells or tissues (ISO 10993-5).
  • Collaborate with Kaunas Biomedical Research Committee to conduct tests according to ISO 10993 standards, evaluating interactions with biological tissues.
  • Shelf Life Studies: Assess how long the adhesive maintains its properties under storage conditions.
  • Regulatory Compliance: Ensure all testing meets relevant regulatory guidelines for medical adhesives.

Hypoallergenicity establishment


Our team did a thorough analysis of the Synhesion glue potential hypoallergenicity. The review can be found below:

Customer Acquisition

The most important part of our commercialization is actually talking to our potential customers, e.g. companies that are working on the production of the patches and diabetes care devices themselves. Our primary targets are outlined in Fig. 11.

Synhesion stakeholder mapping.
Fig. 11. Synhesion stakeholder mapping.

We estimate that the testing period will take about six months, allowing us to reach TRL 9 by 2029. At that point, we aim to sell our product directly to manufacturers of diabetes care devices and medical patches.

Financial Analysis

Potential pre-seed investments are expected from Baltic Sandbox Ventures, after proving that the technology is patentable. We have received a letter of intent from the Center for Physical Sciences and Technology, and we anticipate investments from them as well.

We plan to 1) get a pre-seed for the research and development scale. Then, 2) a seed investment for a bit larger scale-up, pay service fee for BioEnergy LT or other similar companies. After that, 3) send samples to our potential customer(s), and gather feedback from them. Finally, 4) improve the product based on the feedback (loop continues).

Our financial cost structure will become clearer once we finalize an effective purification procedure, allowing us to calculate yield based on media volume. Most of our costs will be associated with human resources. The average salary in Lithuania is €2,161 per month (brutto), and we estimate needing at least:

  1. Three people for R&D,
  2. Two individuals for outreach and investor relations,
  3. Two laboratory personnel for routine testing,
  4. One accountant (can be outsourced),
  5. One person for sales/account management,
  6. Two people for business development/marketing.

Thus, our monthly salary expenses will be at least €23 771. The costs of reagents and equipment will depend on the potential funding that we will receive from the VC.

Letters of Intent

We obtained letters of intent that confirm interest from our potential partners in further developing our product.

LOI from Baltic Sandbox Ventures
Fig. 12. LOI from Center for Physical Sciences and Technology
Fig. 13. LOI from Baltic Sandbox Ventures

Exit Strategy

Our plan for eventual exit is via sale to a larger company, potentially through a share sale or technology licensing deal.

Entrepreneurship Event Cycle

Early on in our project, our team identified a key problem in the higher education system - an insufficient integration of entrepreneurshipin the life sciences field [18]. This motivated us to introduce a cycle of initiatives called "Encode your enterprise.” This cycle aimed to explore the fundamentals of entrepreneurship and its links to life sciences through interactive workshops, informative lectures, and mutual learning events."

A photograph from the Encode Your Enterprise event cycle.
Fig. 14. A photograph from the Encode Your Enterprise event cycle.

During the course of these events, we have not only improved our audiences' understanding of the importance of combining these disciplines together but have also filled our own knowledge gaps by actively participating in the organized discussions and workshops, raising questions about the relevance of our project and its sustainable nature. 

We have created a strong relationship with Baltic Sandbox Ventures, which helped us establish a strong foothold in the ever-growing life science startup culture in Lithuania. This has also opened a roadmap for our project in terms of communication opportunities as we joined their platform as well as created a mutual fundamental base of lecturers and experts who could share their knowledge with our enthusiastic community of learners. 

The events of "Encode your enterprise":

  • Fire-side chat with Baltic Sandbox Ventures technologies analyst Eglė Jašinskaitė and venture partner Dominykas Milašius - exploring what is a start-up;
  • Discussion moderated by doctorate student Klaudijus Melys with participants - start-up "SeqVision" co-creator Jonas Juozapavičius, Business Development Manager of "Biomatter" synthetic biology company - Ieva Lingytė, "Brachydose" CEO and co-creator Neringa Šeperienė and "Psylink" co-founder - Laura Martinkute Korsakova. During the course of the discussion, we were presented with the inspiring storylines of young entrepreneurs and pursued open dialogue with the audience, which primarily consisted of Vilnius university Life Sciences Center first-year students;
  • Workshop intended for the improvement of project writing skills with Goda Jankauskaitė - a project manager at "Civitta";
  • Workshop in market research and the art of pitching by Eglė Jašinskaitė.

By pursuing this 4-initiative cycle, we identified our own knowledge gaps, incentivized open dialogue with the leading representatives of the life science startups, and actualized the necessity to communicate the importance of entrepreneurship and its responsible application potentials for commercialization.

Conclusion

The rising global prevalence of diabetes, particularly the widespread use of Continuous Glucose Monitors (CGMs) and insulin pumps, has highlighted the issue of skin complications caused by traditional medical adhesives. These complications, ranging from mild irritation to severe reactions, often lead patients to discontinue use, with children being particularly affected. To address this, a bio-based hypoallergenic adhesive called "holdfast" was developed, which minimizes skin irritation while being sustainable and cost-effective. The project leveraged a novel bacterial production method to offer an eco-friendly, scalable adhesive solution, holding significant market potential in the diabetes care sector.

Key References

  1. Magliano, D. J., & Boyko, E. J., IDF Diabetes Atlas 10th edition scientific committee. (2021). IDF Diabetes Atlas (10th ed.). International Diabetes Federation. Chapter 3, Global picture. Available from: https://www.ncbi.nlm.nih.gov/books/NBK581940/.
  2. Garg, S. K. (2023). Past, present, and future of continuous glucose monitors. Diabetes Technology & Therapeutics, 25(S3), S-4. doi: https://doi.org/10.1089/dia.2023.0041.
  3. Top reasons driving the demand for insulin pumps [2021]. (n.d.). Available from: https://www.fortunebusinessinsights.com/blog/insulin-pump-a-savior-among-diabetics-globally-10553.
  4. Diedisheim, M., Pecquet, C., Julla, J., Carlier, A., Potier, L., Hartemann, A., Jacqueminet, S., Vidal-Trecan, T., Gautier, J., Laforgue, D. D., Fagherazzi, G., Roussel, R., Larger, E., Sola-Gazagnes, A., & Riveline, J. (2023). Prevalence and description of the skin reactions associated with adhesives in diabetes technology devices in an adult population: Results of the CUTADIAB study. Diabetes Technology & Therapeutics, 25(4), 279–286. doi: https://doi.org/10.1089/dia.2022.0513.
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  6. Asarani, N. A. M., Reynolds, A. N., Boucher, S. E., de Bock, M., & Wheeler, B. J. (2020). Cutaneous complications with continuous or flash glucose monitoring use: Systematic review of trials and observational studies. Journal of Diabetes Science and Technology, 14(2), 328-337. doi: https://doi.org/10.1177/1932296819870849.
  7. Passanisi, S., Galletta, F., Bombaci, B., Cherubini, V., Tiberi, V., Minuto, N., Bassi, M., Iafusco, D., Piscopo, A., Mozzillo, E., Di Candia, F., Rabbone, I., Pozzi, E., Franceschi, R., Cauvin, V., Maffeis, C., Piona, C. A., & Salzano, G. (2024). Device-related skin reactions increase emotional burden in youths with type 1 diabetes and their parents. Journal of Diabetes Science and Technology. doi: https://doi.org/10.1177/19322968241253285.
  8. Statista. (n.d.). Diabetes care devices - Global | Statista Market Forecast. Available from: https://www.statista.com/outlook/hmo/medical-technology/medical-devices/diabetes-care-devices/worldwide#revenue.
  9. Heinemann, L., & Kamann, S. (2016). Adhesives used for diabetes medical devices: A neglected risk with serious consequences? Journal of Diabetes Science and Technology, 10(6), 1211–1215. doi: https://doi.org/10.1177/1932296816662949.
  10. United Nations. (n.d.). The 17 goals | Sustainable Development. Available from: https://sdgs.un.org/goals.
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  12. Standard test method for peel or stripping strength of adhesive bonds. (n.d.-b).www.astm.org/d0903-98r17.html.
  13. Standard test method for strength properties of tissue adhesives in tension. (n.d.-b).www.astm.org/f2258-05r15.html.
  14. Standard test method for apparent shear strength of Single-Lap-Joint adhesively bonded metal specimens by tension loading (Metal-to-Metal). (n.d.-b).www.astm.org/d1002-10r19.html.
  15. Heinemann, L., & Kamann, S. (2016b). Adhesives used for diabetes medical devices. Journal of Diabetes Science and Technology, 10(6), 1211–1215. doi: https://doi.org/10.1177/1932296816662949.
  16. Diabetes care devices market. (2022, July 12). https://www.futuremarketinsights.com/reports/diabetes-care-devices-market. www.futuremarketinsights.com.
  17. Diabetes Devices Market Size, Share & Trends Analysis Report by type (Blood glucose monitoring devices, insulin delivery devices), by distribution channel (Hospital pharmacies, retail pharmacies), by end-use, by region, and segment Forecasts, 2024 - 2030. (n.d.). https://www.grandviewresearch.com/industry-analysis/diabetes-devices-market.
  18. Blankesteijn, Marlous, Houtkamp, & Jorick. (2022). Digital Tools and Experiential Learning in Science-Based Entrepreneurship Education. https://research.vu.nl/ws/portalfiles/portal/218423598/Digital_Tools_and_Experiential_Learning_in_Science_Based_Entrepreneurship_Education.pdf.

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