We are developing a new re-generation surgical stitch which are stronger, safer and more comfortable for patients. It offers three improvement over traditional surgical stitch: higher tensile strength, better biodegradability, and built-in anti-inflammatory properties.

Conventional stitch often fall short, they may be too weak, linger in the body too long, or cause inflammation. Our solution finds the balance, providing reliable support while being gentle on tissue and requiring no removal, which reduces the risk of infection and speeds up recovery (Chen at al., 2023).

By merging high-performance biomaterials with real-world usability, we’re making surgery recovery smarter, faster, and more human-centered.

Based on actual market research and clinical demand analysis, we have decided to focus the application direction of this innovative product on the field of cesarean section surgical suturing, providing a dedicated solution for postpartum recovery.

The number of caesarean sections is gradually increasing around the world, but many of the sutures used for postoperative repair still have serious shortcomings that affect patient recovery. Four major issues stand out:

One major concern is the limited biocompatibility of traditional sutures. Non-absorbable materials, which are still widely used, tend to provoke long-term foreign body reactions. This can lead to ongoing inflammation and slower wound healing—something particularly problematic for new mothers who need to recover quickly.

Another issue is the lack of effective anti-inflammatory and antibacterial properties. Although absorbable sutures are now common, most don't actively prevent infection. This raises the risk of postoperative complications and can delay the healing process.

Strength and durability are also important, but many current sutures don’t hold up well under stress. In high-tension areas like the abdominal wall, especially after a caesarean, the wound is at risk of reopening if the sutures aren’t strong enough during the early healing phase.

Lastly, comfort and cosmetic outcomes matter too. Standard sutures can cause noticeable scarring and ongoing discomfort around the wound, which can slow down recovery and reduce patient satisfaction.

To solve these problems, we’ve developed a new type of surgical suture made from a dissolvable material that combines strong tensile support with anti-inflammatory features. These sutures not only help wounds heal faster and more cleanly but also avoid the hassle of needing removal. Designed specifically for caesarean section patients, this new approach aims to make recovery smoother, more comfortable, and more satisfying overall.

To better understand the real market demand for surgical sutures, our team conducted a series of interviews with both patients and medical professionals. These conversations helped us identify specific unmet needs from the user perspective and guided our decision to focus on cesarean section (C-section) applications as the most urgent and impactful scenario.

1. Patient Interviews

We first reached out to several patients from different age and health backgrounds to explore their personal experiences with wound healing.

In the upper left image, we spoke with a teenage girl recovering from a minor surgery. She expressed strong concern about healing speed, as she hoped to resume school activities as soon as possible.

In the upper right image, we interviewed a C-section patient who had recently undergone surgery. She emphasized the importance of tensile strength, anti-inflammatory performance, and scar prevention, since abdominal wounds are constantly stretched during recovery. Her needs highlighted how C-section patients require sutures that are not only strong and durable but also promote gentle, aesthetic healing.

In the lower left image, we communicated with a diabetic patient who faced challenges related to inflammation control and ulcer prevention. For her, a suture that could resist infection and accelerate tissue repair would greatly reduce postoperative risks.

Finally, in the lower right image, we spoke with an elderly patient who stressed the difficulty of slow healing and the discomfort caused by traditional sutures.

Overall, through these conversations, we found that while all patients value comfort and healing safety, C-section patients represent the group with the most urgent and multidimensional needs — requiring strength, flexibility, anti-inflammatory protection, and aesthetic recovery all at once.

2. Insights from Medical Experts

During these interviews, several patients pointed out an important insight:

Although they are the end users of surgical sutures, their actual product choice is determined by doctors. Recognizing this, we extended our research to hospitals and clinical professionals.

Our team visited two of the top medical institutions in China — Peking Union Medical College Hospital (协和医院) and Peking University Hospital of Stomatology (北大口腔医院) — to conduct on-site interviews with surgeons and procurement personnel.

Doctors confirmed that the primary selection criteria for sutures include biocompatibility, infection resistance, tensile performance, and cost-effectiveness. They also emphasized that hospitals seek innovative materials that are both clinically validated and economically sustainable.

This feedback aligns with the market analysis: traditional sutures struggle to balance patient comfort and hospital cost control. Therefore, our project aims to bridge this gap — offering a bioactive suture that combines clinical efficacy, economic feasibility, and scalable production potential.

3. Summary: Gap and Opportunity

Through combined patient and professional insights, we identified a clear gap in the current market:

Traditional sutures cannot simultaneously meet the healing comfort patients expect and the cost-performance standards required by hospitals.

Our product, ReGenStitch, is designed precisely to fill this gap — delivering higher tensile strength, controlled biodegradation, and anti-inflammatory properties that benefit both patient outcomes and hospital adoption.

By grounding our design in real-world interviews, we ensure that ReGenStitch not only solves a scientific problem but also responds to a genuine clinical and emotional need in women’s health.

Our team's latest research and development of surgical sutures adopts innovative synthetic biological technology to organically integrate the three functional modules, significantly improve the wound closure effect, and effectively solve many shortcomings of traditional sutures.

Structural support system: bacterial cellulose skeleton

We use the genetically modified E. coli Nissle 1917 as the production platform, which enables it to synthesize bacterial cellulose by introducing specific genes. This nanofiber network formed by glucose molecules through special bonding not only has excellent mechanical properties, but also shows good biocompatibility. Compared with traditional materials, it can better adapt to the needs of surgery and avoid problems such as excessive material or inconsistent degradation (Shi et al., 2014).

Antibacterial repair system: chitosan complex

Starting from shrimp shells and other wastes, through microbial fermentation and enzymatic treatment, we obtained a chitosan complex with dual effects. Among them, high molecular weight chitosan can form a protective barrier on the surface of the wound, quickly stop bleeding and inhibit bacterial growth; while low molecular weight chito oligosaccharide can penetrate deep into the tissue, not only enhancing the antibacterial effect, but also stimulating cell growth and vascular formation, greatly accelerating the healing speed (Mourya & Inamdar, 2008).

Inflammation Control System: Natural Active Ingredients

We use genetic engineering technology to efficiently synthesize curcumin in E. coli. This natural active ingredient can accurately regulate the inflammatory reaction, reduce postoperative redness and swelling, inhibit scar formation, and create a more favorable micro-environment for wound repair (Kotha & Luhria, 2019).

These three systems cooperate with each other to form a complete solution: the cellulose skeleton provides stable structural support, the chitosan complex is responsible for antibacterial and hemostasis, and curcumin finely regulates the inflammatory reaction. This synergy makes our sutures show significant advantages in clinical applications.

Possible——Market Measurement

With economic development, cesarean sections have become increasingly common among pregnant women, and expectations for the procedure continue to rise. From the initial use of non-absorbable sutures like nylon to today’s predominantly absorbable surgical sutures, the high-end market for cesarean sutures has gradually emerged. The immense market potential has attracted major companies to invest in R&D and enter this space.

The current global market for cesarean sutures is $1.87 billion, with China's market valued at $630 million – making it the world’s largest single market. The premium suture segment is dominated by international players:

Johnson & Johnson: 41% market share

Medtronic: 23% market share

BD (Becton Dickinson): 15% market share

Domestic Chinese brands hold only 25% market share, indicating significant growth potential. Our market penetration targets are:

Years 1-2: Achieve 0.3% market share

Years 3-4: Reach 1.2% market share

Year 5: Attain 3.5% market share

Scalable——Industrialization and Scale-up

Our team has successfully developed a minimum viable product (MVP) of our bioactive surgical suture and conducted practical suturing tests. The results demonstrated excellent performance — our suture showed comparable tensile strength, elasticity, and thickness uniformity to those of commercially available surgical sutures. In all key parameters, it performed on par with or even better than current market products.

We strongly encourage you to watch our product testing video to see the real-world performance and potential of ReGenStitch.

Our product has successfully demonstrated preliminary production in the laboratory, and we also possess the capability for industrialization and scale-up. This strength is mainly reflected in two aspects: cost control and standardization.

1、Wide and low-cost raw material sources The synthesis of cellulose depends on glucose and other common raw materials, with a mature and stable supply chain. Chitosan can be obtained from discarded shrimp and crab shells, making it a low-cost and renewable resource. Curcumin is efficiently synthesized through fermentation engineering, thereby avoiding the yield bottlenecks and batch-to-batch fluctuations of traditional plant extraction.

2、Choice of Escherichia coli Nissle 1917 as the production chassis This strain has been widely used in probiotic and bioproduct development and has a strong foundation of safety and industrialization. Through genetic engineering modifications, the chassis can stably synthesize cellulose and curcumin, which are then combined with chitosan derived from chitin.

3、Standardized, modular production Our three functional modules can be produced through modular fermentation and integrated downstream processing, enabling standardized mass production. The product takes the form of biodegradable surgical sutures, directly targeting the surgical consumables market.

Inventive——Technology

Our project’s innovation lies in its comprehensive and systematic design:

we have organically integrated three functional modules—cellulose scaffold, chitosan composite, and curcumin anti-inflammatory system—into a single degradable suture, forming a synergistic whole:

• Cellulose scaffold: Provides stable and long-lasting structural support, effectively solving the problems of easy breakage and uneven degradation in conventional sutures.
• Chitosan composite: Delivers dual hemostatic and antibacterial effects, acting at multiple levels from the wound surface to deep tissue, accelerating healing while reducing infection risk.
• Curcumin module: Efficiently synthesizes natural active compounds via synthetic biology, enabling precise regulation of inflammatory responses, reducing postoperative swelling and scar formation, and creating a more favorable healing environment.

This multi-module integrated design directly addresses unmet clinical needs:

most degradable sutures on the market remain generic and lack optimization for specific surgical scenarios. In contrast, our solution is specially enhanced for cesarean section procedures, emphasizing faster recovery, reduced complications, and improved postpartum experience—fully embodying an innovation driven by real patient needs.

At the same time, for hospitals and procurement departments, the product not only improves patient satisfaction and clinical outcomes but also offers advantages in cost control and standardized supply, making it an innovative solution that delivers value for both patients and healthcare institutions.

Legalization and Patent application

In our product development plan, we recognize that legal compliance and patent application are crucial steps toward industrialization. However, due to our limited professional background in this area, we sought continuous guidance from lawyer Yang Yong of DeHeng Law Offices, one of the top law firms in China.

Mr. Yang, who specializes in intellectual property and biotechnology-related patents, has provided us with invaluable advice on how to structure our patent strategy and ensure legal compliance throughout our R&D process. We are deeply grateful for his professional support and insights, which have helped our team build a solid foundation for the future protection and commercialization of ReGenStitch.

In order to avoid possible legal disputes, we have made the following laws and regulations that need to be followed, as well as disclaimers.

Follow the law:

Comply with YY 1116-2020 "Absorbable Surgical Sutures" (Standards of the National Drug Administration)

Classification management: Surgical sutures belong to Class II or Class III medical devices (according to the degree of risk).

Registration/Filing:

• Imported and domestic stitches need to apply for registration or filing with the State Drug Administration (NMPA).

• You need to submit product standards, clinical trial data (some cases can be exempted), biocompatibility reports and other materials

Production license: Manufacturing enterprises need to obtain the Medical Device Production License.

Business license: Business enterprises need to obtain the Medical Device Business License (Class II filing, Class III license).

Conclusion

1、Stitching is a medical device and needs to meet the requirements of registration, production and operation supervision.

2、Patients have the right to know the suture information and can claim for quality problems.

3、In the event of a dispute, medical records and product qualifications are the key evidence.

Patent Landscape for Surgical Suture Project

Project leverages synthetic biology to design multifunctional surgical sutures integrating bacterial cellulose (BC),

chitosan/chitooligosaccharides (CS/COS), and curcumin. To protect innovation and build commercial barriers,

we propose a patent strategy in three categories: Product, Process, and Application.

Patent Categories

• Product Patents

Composite Surgical Suture: A novel suture integrating BC, CS/COS, and curcumin with multifunctional properties.

Optimized Ratios and Functional Parameters: Specific formulations ensuring mechanical strength, biodegradability, and anti-inflammatory effects

• Process Patents

BC Synthesis: Using E. coli Nissle 1917 engineered with bcsA/bcsB genes to produce high-purity bacterial cellulose.

CS/COS Production: Shrimp shell waste biotransformation via Bacillus subtilis and Acetobacter, combined with E. coli BL21 surface-displayed CHI-1 enzyme for continuous fermentation.

Curcumin Biosynthesis: 4CL1, DCS, and CURS1 gene cascade expressed in engineered E. coli for efficient curcumin synthesis.

Composite Material Fabrication: Mixing BC, CS/COS, and curcumin under defined conditions (acid dissolution, stirring, plasticizer addition, drying).

• Application Patents

Infection Control and Hemostasis: Sutures that prevent infection while enabling rapid hemostasis.

Anti-inflammatory and Accelerated Healing: Combination of curcumin and COS to regulate inflammation and promote tissue regeneration.

Special Populations: It is mainly designed for pregnant women and can also be used in any surgery that requires surgical sutures

Waste Valorization: Transforming shrimp shell waste into valuable biomedical components, promoting green manufacturing

Patent application list

ID	Category	Patent Type	Patent Content	Description
P1	Product Patent	Invention Patent	Composite surgical suture (BC + CS/COS + Curcumin)	Multifunctional integration, distinct from traditional single-material sutures
P2	Product Patent	Invention / Utility Model	Optimized ratios & parameters (strength / degradation / anti-inflammatory dosage)	Ensures stable performance for different surgical needs
P3	Process Patent	Invention Patent	Bacterial cellulose synthesis (EcN + bcsA/bcsB)	Genetic engineering for high-purity BC production
P4	Process Patent	Invention Patent	CS/COS production (shrimp shell biotransformation + CHI-1 enzymatic hydrolysis)	Waste valorization + continuous fermentation
P5	Process Patent	Invention Patent	Curcumin biosynthesis pathway (4CL1 + DCS + CURS1 gene cascade)	Microbial factory replacing plant extraction
P6	Process Patent	Invention / Utility Model	Composite material fabrication (dissolution, stirring, plasticizer, drying)	Strong industrial feasibility
P7	Application Patent	Invention Patent	Post-surgical infection control & hemostasis	High clinical value
P8	Application Patent	Invention Patent	Anti-inflammatory & accelerated wound healing	Targets inflammation control and tissue regeneration
P9	Application Patent	Invention Patent	Special populations (diabetes / elderly)	Precision medicine application
P10	Application Patent	Invention Patent	Waste valorization (shrimp shells → biomedical material)	Green & sustainable manufacturing value

Note: These are planned application numbers (P1–P10). Once officially filed, they can be replaced with real CN (China) or PCT (international) patent numbers.

Competed company

Medical Device Industry Consultation — Weigao Corporation

To gain a deeper understanding of our competitive landscape, we consulted Manager Sha Junfeng from Weigao Corporation, one of China’s leading medical device companies. During our discussion, he pointed out that due to the unique nature of our project, our potential competitors are highly established players with long-term market experience and strong clinical validation. Therefore, our competitive strategy should not simply replicate traditional product competition models.

Mr. Sha emphasized that in the medical device field, many key data and market strategies are internal and not publicly disclosed, which makes understanding real competition more complex. With his guidance, we gained a clearer view of the major competitors, their market positions, and the hidden dynamics of industry competition. He also advised us to focus on differentiation through innovation, clinical value, and sustainability, rather than price or marketing alone.

His insights have helped us refine our business positioning and build a more strategic and realistic path toward entering the medical device market.

We have three major competitors: Johnson & Johnson's Ethicon, Medtronic's Covidien, and Becton Dickinson. All three of these companies are highly authoritative in t he medical industry. Below are brief introductions, product comparisons, and market share analyses for these three companies.

Johnson & Johnson's Ethicon

Aesculap, a subsidiary of Johnson & Johnson Medical, is the global leader in surgical sutures with a history spanning over 60 years. Renowned for its innovation and high-quality products, Aesculap offers a range of sutures including absorbable and non-absorbable varieties, antibacterial sutures, and specialized sutures for minimally invasive surgeries.

Representative products:

• Vicryl®: An absorbable suture suitable for general soft tissue suturing.
• Prolene®: A non-absorbable polypropylene suture used in cardiovascular and plastic surgeries.
• Monocryl®: A single filament absorbable suture designed to reduce tissue reaction.

Pricing:

The price of a single suture ranges from approximately $10 to $50, with significant variations depending on the model and region.

Market share:

It holds approximately 35% to 40% of the global market share and has consistently been ranked first for an extended period.

Medtronic's Covidien

Medtronic bolstered its presence in the suture market through the acquisition of Covidien. The company's products are known for their cost-effectiveness and broad application, especially in the field of disposable suture devices.

Representative Products:

• Polysorb™: An absorbable suture with a coating that reduces tissue friction.o
• Sofsilk™: A silk-based non-absorbable suture used in ophthalmology and skin suturing.
• Caprosyn™: A rapidly absorbable suture that is absorbed in approximately 56 days.

Pricing:

Single sutures cost around $5 to $30, with some products priced lower than those of Johnson & Johnson.

Market Share:

Approximately 25% to 30%, with a high market penetration rate.

Becton Dickinson (BD)

BD is a global medical technology leader. Its surgical sutures are recognized for their precision and suitability for specific applications, such as orthopedics and dentistry. In recent years, BD has expanded its product line through acquisitions, including C.R. Bard.

Representative Products:

• Maxon™: A high-tension absorbable suture ideal for fascia suturing.
• Surgipro™: A non-absorbable polypropylene suture with strong tensile strength.
• Luxa™: An antibacterial-coated suture that reduces the risk of infection.

Pricing:

Single threads are priced from approximately $15 to $60, with some products being higher in cost.

Market Share:

Approximately 15% to 20%, with rapid growth.

Compared to the three aforementioned companies, our product excels in nearly every aspect of surgical suture performance, boasting lower costs and greater cost-effectiveness. Thus, our advantages are clear, and we believe an increasing number of patients will opt for our product.

Swot analysis

We used a SWOT framework to summarize the overall situation our product will face during commercialization:

• Strengths: High material strength, low cost, sustainability, and environmental friendliness.
• Weaknesses: Limited clinical data, restricted initial production capacity, and physicians’ reliance on existing device usage habits.
• Opportunities: Growing market demand for safer and more durable sutures, supportive policies, and gaps in the high-end surgical consumables market.
• Threats: Strict regulatory barriers, competition from industry giants, and high clinical trial costs.

Through this SWOT analysis, we plan to leverage our advantages in technology, cost, and sustainability, and seize opportunities such as the rapid growth of the cesarean and high-end surgical consumables markets as well as policy support, to accelerate product implementation. At the same time, we will proactively invest in clinical validation, capacity expansion, and market education to mitigate weaknesses and address regulatory and competitive threats, thereby laying a solid foundation for commercialization.

Cost Calculation

Cost Analysis — Consultation with Dr. Peng Changhong, CFO of SDIC CMC Capital

Cost estimation in the biomedical field is a complex process that requires a deep understanding of both finance and biotechnology. At the beginning of our project, we attempted to conduct cost modeling independently, even trying to use AI-based analytical tools, but the results were unsatisfactory. We soon realized that biomedical product cost analysis involves numerous interlinked variables — from laboratory inputs and clinical validation to large-scale manufacturing — and cannot be accurately assessed without professional expertise.

Fortunately, we had the privilege of consulting Dr. Peng Changhong, the Chief Financial Officer of SDIC CMC Capital, a professional private equity investment management company jointly founded by SDIC (State Development & Investment Corporation Group) and China Merchants Group, both leading state-owned enterprises. Dr. Peng holds a Ph.D. in Synthetic Biology, uniquely combining expertise in financial management and biotechnology, which allowed him to provide insights that bridged both disciplines.

Under his guidance, we were able to construct a realistic and scientifically grounded cost framework for our bioactive suture. He helped us identify key cost-driving components, rationalize our material sourcing (including bioprocess optimization), and forecast the financial viability of future industrial-scale production. His involvement transformed what initially seemed like an insurmountable challenge into a structured, data-driven cost model — forming a solid financial foundation for ReGenStitch’s future commercialization.

We have made different prices below to achieve the sales volume required for break-even

3-5 Year Financial Report Forecast Chart

In this section, we will calculate the total cost (variable cost + fixed cost), including production site expenses, raw material costs, production equipment purchases, laboratory R&D expenses, patent application fees, regulatory approval fees, labor, utilities, and transportation. We will also determine the pricing of our surgical sutures and conduct a break-even analysis.

Cost component summary:

Fixed cost:

Rent: ¥3.5575M (annual)

Lab equipment: ¥2.5M – ¥0.5M subsidy = ¥2.0M (one-time)

Labor: ¥510k/month × 12 (R&D staff) + ¥2.526M (factory workers) = ¥8.646M (annual)

Utilities and miscellaneous: ¥92,400 (annual)

Variable Cost:

Raw materials: The cost of preparing bacterial cellulose, chitosan/chitooligosaccharides, and curcumin, such as E. coli Nissle 1917, shrimp shell waste, deproteinized substrates, etc.

Bacterial Cellulose Preparation Cost:

Preparation method:

Chassis strain: E. coli Nissle 1917 (EcN)

Key genes: bcsA + bcsB (introduced into EcN)

Cost estimation:

Item	Cost (¥/g)	Description
Glucose	0.2	Conventional carbon source in medium
Yeast extract	0.5	Promotes bacterial growth
Fermentation energy	0.3	Equipment operation (stirring, heating)
Purification	0.4	Washing, drying, sterilization
Total	1.4 ¥/g	Before scale-up optimization

Chitosan/Chitooligosaccharide Preparation Cost:

Preparation method:

Raw material: Shrimp shells (waste)

Deproteinization: Bacillus subtilis fermentation (3 days)

Demineralization: Acetobacter fermentation (5 days)

Enzymatic hydrolysis (COS): E. coli BL21 (surface display CHI-1 enzyme)

Cost estimation:

Item	Cost (¥/g)	Description
Shrimp pretreatment	0.1	Washing, crushing
Deproteinization	0.3	Bacillus subtilis culture
Demineralization	0.2	Organic acid dissolution by Acetobacter
Enzymatic hydrolysis	0.5	Enzyme expression by engineered E. coli
Purification	0.4	Filtration, drying
Total	1.5 ¥/g	Chitosan + COS mixture

Curcumin Preparation Cost:

Production details:

Item	Cost (¥/g)	Description
Ferulic acid	1.0	Synthetic precursor, activated by 4CL1
Engineered bacteria culture	0.8	E. coli (with DCS/CURS1 genes), fermentation + IPTG induction
Purification	0.6	Chromatography, desalting, drying
Total	2.4 ¥/g	Microbial biosynthesis pathway

Manufacturing Cost per Unit:

Process	Cost/unit (¥)	Description
Dissolution & stirring	0.10	8h stirring at room temperature
Mixing & plasticizing	0.05	Glycerol addition + 1h mixing
TPS dispersion	0.08	8h stirring with varying concentrations
Drying & molding	0.15	Drying with equipment
Sterilization	0.20	EO gas or irradiation
Packaging	0.30	Medical-grade vacuum packaging
Subtotal	0.88 ¥/unit

Total Raw Material Cost per Unit:

Raw Material	Usage per unit	Price (¥/g or ml)	Cost/unit (¥)	Source
Bacterial cellulose (BC)	0.5 g	1.4 ¥/g	0.70	Produced by EcN
Chitosan (CS)	0.3 g	1.5 ¥/g	0.45	Extracted from shrimp shells
Curcumin	0.05 g	2.4 ¥/g	0.12	Microbial synthesis
Acetic acid (1% sol.)	1 ml	0.02 ¥/ml	0.02	Solvent
Glycerol (plasticizer)	0.16 g	0.05 ¥/g	0.008	20% of dry CS+BC
Thermoplastic starch (TPS)	0.04 g	0.1 ¥/g	0.004	4% CBT experiment
Total	-	-	1.30 ¥/unit	-

Fixed Cost

Site Rental Cost

Our R&D headquarters is located in Tianjin. The city provides strong support for biopharmaceutical development, such as accelerated regulatory approval and subsidies in synthetic biology.

Chosen site: Binhai New Area (TEDA Biotech Innovation Park).

TEDA Biotech Innovation Park G1 Building: 3444㎡ lab, annual rent approx. ¥3.5575 million (including tax, ¥86/㎡/month).

Airport Economic Zone R&D Building: 750㎡ min rental, ¥1/㎡/day (~¥30/㎡/month), includes cleanroom and dormitory facilities.

Basic Renovation (500㎡ as example)

Item	Unit Price (¥/㎡)	Total Cost (¥)	Notes
Lab partition	300–500	150k–250k	Panels/glass
Epoxy flooring	150–200	75k–100k	Anti-corrosion, anti-static
Ventilation	400–600	200k–300k	Biosafety cabinets, HVAC
Cleanroom setup	800–1200	400k–600k	Class 10,000 standard
Utilities upgrade	200–300	100k–150k	Dual circuits, pure water
Office renovation	500–800	250k–400k	Office + meeting rooms
Subtotal	-	1.18–1.8M	Basic renovation

Equipment

Equipment	Unit Price (¥)	Quantity	Total Cost (¥)	Notes
Biosafety cabinet (Class II)	50–80k	2	100k–160k	Microbial handling
Laminar hood	20–30k	3	60k–90k	Sterile ops
Fermenter (50L)	150–200k	2	300k–400k	BC production
Freeze dryer	250–350k	1	250k–350k	Material dehydration
Subtotal	-	-	710k–1.0M	Core equipment

Other Fees

Item	Cost (¥)	Notes
Fire approval	30k–50k	Drawing review
Environmental review	20k–40k	Wastewater treatment
Lab furniture	100k–150k	Corrosion-resistant benches
Subtotal	150k–240k	-

Total Renovation + Equipment Cost

Category	Cost Range (¥)
Renovation	1.18–1.8M
Equipment	710k–1.0M
Other Fees	150k–240k
Total	2.04–3.04M (mid-value ¥2.5M)

Government Subsidy

Binhai New Area provides 30% renovation subsidy (up to ¥1M). Mid-value estimated subsidy: ¥500k.

Personnel Cost

R&D staff salaries (Tianjin market level):

PhD researchers: ¥20k–40k/month (13-month pay).

Master’s researchers: ¥10k–16k/month (120k–160k/year).

Technicians (Bachelor): ¥4k–6k/month.

Estimated monthly personnel costs:

Item	Monthly Cost (¥)	Notes
Rent (500㎡)	60k–100k	Lab + office
PhD researchers	200k–400k	2–4 people
Master’s researchers	100k–160k	6–8 people
Total/month	360k–660k (mid-value ¥510k)	excl. equipment/raw materials

Factory staff salaries (5 million units/year, semi-automated):

Department	Staff Count	Monthly Salary (¥/person)	Annual Cost (¥)
Raw material prep	8–10	5,500	660,000
Spinning/weaving	4	6,000	288,000
QA & sterilization	6–8	6,500	546,000
Packaging/storage	5–7	5,000	360,000
Equipment maint.	2–3	8,000	240,000
Admin/management	3–4	9,000	432,000
Total	36–47	-	2,526,000

Automation optimization: By purchasing mid-range multifunctional spinning equipment (¥1.5M–2.5M), labor can be reduced by 8 workers (saving ¥576k/year), capacity can double, and ROI is achieved in ~3.5 years.

Variable cost:

Raw materials: ¥1.30/unit

Processing: ¥0.88/unit

Total variable cost per unit: ¥2.18

Total variable cost per year：2.18*777k=¥1.7M(Calculated based on Break-even Point

sales volume)

Total cost (annual):

Total cost = ¥12.2958M+¥1.7M=¥13.9958M

Break-even Analysis

Parameter	Value	Description
Fixed cost (annual)	¥12.29 million	Includes plant depreciation, management salaries, equipment maintenance
Variable cost (per unit)	¥2.18	Raw materials ¥1.30 + production & packaging ¥0.88
Average price (per unit)	¥18 (Year 1 pilot price)	To be gradually increased to ¥25–35 in subsequent years

Break-even Analysis

To evaluate financial feasibility, we calculate the break-even point based on fixed and variable costs.

The formula is:

With an estimated fixed cost of ¥12.2958M per year, a variable cost of ¥2.18 per unit, and an average sales price of ¥18 per unit in the pilot phase, the break-even sales volume is:

Using actual numbers: Break-even Units = 12,295,800 ÷ (18 - 2.18) ≈ 777,000 units/year

At this sales level, the corresponding revenue is approximately:

777,000×18≈¥14.0M

Therefore, the company needs to sell about 777,000 surgical sutures annually to cover all costs and achieve profitability.

Beyond this point, the gross margin per unit will be approximately ¥15.82 (¥18 – ¥2.18), ensuring strong profit leverage as sales scale up

We have made different prices below to achieve the sales volume required for break-even 3-5 Year Financial Report Forecast Chart

Timeline

Development Timeline Planning — Consultation with Mr. Wang Yi (Director, Zhiyu Medical Technology Co., Ltd.) and Mr. Lian Leyao (Director, NewPeak Technology Co., Ltd.)

To develop a clear and realistic roadmap for our product’s growth, we consulted Mr. Wang Yi, Director of Beijing Zhiyu Medical Technology Co., Ltd., and Mr. Lian Leyao, Director of Beijing NewPeak Technology Co., Ltd. Both experts possess extensive experience across the fields of medical innovation and emerging technologies, having evolved from hands-on R&D professionals to strategic-level company leaders.

As board members, they provided us with macro-level strategic insights that go far beyond day-to-day operations. During our discussions, they helped us define a structured development timeline for ReGenStitch: identifying what milestones should be achieved in the first and second years (prototype optimization and pre-clinical validation), how to progress in the third and fourth years (regulatory approval and pilot production), and how to reach large-scale adoption and commercialization in the fifth year and beyond.

Their guidance enabled us to transform our abstract goals into a feasible, phased timeline aligned with the realities of the medical device industry — balancing innovation speed, compliance requirements, and market readiness. Their strategic advice provided the long-term direction necessary for ReGenStitch’s sustainable growth and market success.

Finger：Director of Beijing Zhiyu Medical Technology Co., Ltd.: Wang Yi & Director of Beijing Xinjian Technology Co., Ltd.: Liao Le Yao

Market Entry Strategy

Our market entry strategy is designed to balance clinical validation, brand recognition, and financial sustainability. Given the high barriers to entry in the surgical suture industry, we will adopt a stepwise penetration approach, starting with niche high-value segments and gradually expanding to the mass market.

Phase I (Years 1–2): Pilot Launch in High-Value Niches

Target Segments: Private maternity hospitals, premium obstetrics clinics, and cosmetic surgery centers.

Rationale: These institutions prioritize patient satisfaction (scar reduction, comfort, safety) and are less price-sensitive compared to public hospitals

Actions:

Provide 50,000–100,000 units free or at discounted prices for pilot use in C-sections and cosmetic surgeries

Collect clinical data (infection reduction, scar improvement, healing speed) to validate product performance.

Collaborate with key opinion leaders (KOLs) in obstetrics and plastic surgery to build early adoption and endorsements.

Launch “Scar-Free Mother” campaign on social platforms (Xiaohongshu, WeChat, mother–infant communities) to build patient awareness.

Phase II (Years 3–4): Expansion into Tier-1 Public Hospitals

Target Segments: Leading Tier-1 and Tier-2 public hospitals in urban centers.

Rationale: These hospitals perform a large volume of C-sections and general surgeries, representing significant scale.

Actions:

Apply for NMPA Class II/III registration and initiate the process of entering the National Reimbursement Drug List (NRDL) for partial insurance coverage.

Conduct multi-center clinical trials with top 3A hospitals to strengthen credibility.

Deploy medical education programs:

Online: 3D animation training modules for doctors (¥200,000 budget).

Offline: Product demonstration workshops in the Top 20 obstetrics hospitals (¥500,000 annual budget).

Establish distribution partnerships with medical device suppliers to accelerate adoption.

Phase III (Year 5 onwards): Mass Adoption & Scale-Up

Target Segments: Nationwide public hospitals, insurance-backed procurement, and international expansion.

Rationale: With validated data and regulatory approval, we can directly compete with incumbents (J&J, Medtronic, BD).

Actions:

Secure inclusion in provincial volume-based procurement (VBP) schemes to drive cost competitiveness.

Scale up GMP production (≥2,000㎡ facility) to meet demand of 5–6 million units annually.

Explore international PCT patent protection and FDA/CE certification for overseas expansion.

Form strategic partnerships with industry leaders (e.g., Mindray, Weigao) for co-distribution or acquisition opportunities.

Key Differentiators in Market Entry

1、Value-driven positioning: Start with scar-free, infection-resistant sutures for women’s health and aesthetics.

2、Evidence-based adoption: Collect robust clinical evidence before pursuing scale.

3、Doctor & patient education: Build trust via professional training and social media campaigns。

4、Scalable pricing strategy: Introductory low pricing for pilots (¥18/unit) → gradual increase as adoption grows (¥25–30/unit).

Financing plan

Resources

As a new medical device company, even with technological advantages, we still face the challenge of an insufficient resource network. The most significant shortcomings lie in the clinical and regulatory fields: lacking deep connections with key opinion leaders (KOLs) makes it difficult for us to promptly obtain valuable clinical feedback, product endorsements, and early application support. At the same time, we lack experienced regulatory experts who are familiar with the complex approval pathways of the FDA and NMPA, as well as communication channels within regulatory authorities, which leads to a registration process that is both slow and uncertain. In terms of market promotion, we have not yet established a mature network of distribution partners. As a new company, it is often difficult to quickly adapt to hospital bidding and procurement processes, making it challenging to build a sales network, which in turn hinders product commercialization to some extent.

On the supply chain side, we also face difficulties in finding specialized suppliers for medical-grade biomaterials and precision components. Such suppliers are often reluctant to handle small-batch, high-quality orders, which limits our bargaining power and increases supply risks. The absence of this type of resource network often becomes a critical bottleneck in the survival and growth of startups.

Nevertheless, we also possess valuable resources that provide a foundation for product development and growth:

• Core technological resources: We have already completed preliminary validation at the laboratory stage and possess potential for industrial-scale expansion.
• Team resources: Our members have extensive research and practical experience in molecular biology, materials science, and engineering, coupled with strong motivation for sustained scientific engagement.
• Collaborative resources: We have established strong relationships with university laboratories, research institutes, and certain investment organizations, from which we have received support in technical guidance, funding, and early market insights.
• Facilities and equipment: The team already has access to essential laboratory infrastructure, including fermentation, purification, and testing platforms, providing robust support for continued R&D.

Risk analysis and method

Risk Analysis — Consultation with Beijing Food and Drug Safety Center

Our team is developing an innovative bioactive surgical suture specifically designed for postpartum and C-section wound recovery, focusing on three major features: aesthetic outcome, anti-inflammatory function, and biodegradability. While the market potential is significant, we are fully aware that our project also faces complex regulatory and market-related risks.

Figure. At the Beijing Food and Drug Safety Center — our teammate in the middle is holding the bacterial cellulose suture model, which may appear slightly unclear due to the distance.

To gain professional insight into the medical device approval and risk management process, we visited the Beijing Food and Drug Safety Center. We brought a prototype version of our surgical suture for discussion — it is important to note that this sample was not the synthetic biology–produced version from our laboratory, but rather a model made from commercially available bacterial cellulose for safety and compliance purposes. Although this version differs in origin, its functional characteristics (mechanical strength, flexibility, and surface structure) remain consistent with our intended design.

During the consultation, experts from the Safety Center provided us with detailed feedback and regulatory guidance. They emphasized that as a Class II/III medical device, a suture product must undergo rigorous biocompatibility testing, stability verification, and multi-stage clinical validation prior to approval. They also reminded us that data transparency and traceable production processes will be critical for obtaining certification from the National Medical Products Administration (NMPA).

From this meeting, we gained a deeper understanding of the regulatory timeline and compliance framework, including how to prepare documentation, what testing institutions are qualified, and how to plan for a realistic 1–3 year approval cycle.

This consultation allowed us to transform potential risks into a structured, manageable plan, ensuring that our project progresses under scientific, legal, and safety-compliant standards.

From the perspective of operations and capital, the project requires a substantial initial investment, including the construction of a GMP-compliant factory, clinical trials, and hospital-related promotion expenses, with an estimated need for at least 20 million RMB in capital reserves. Based on this, our team plans to prioritize a light-asset model, such as ODM subcontracting, to reduce early-stage risks. At the same time, we aim to first validate the product’s effectiveness through small-scale clinical trials, then establish cooperation with key hospitals to gradually open up the market. Only after the product’s performance, regulatory compliance, and business model are fully validated can the project’s sustainability and competitiveness be ensured.

Exit strategy

We have four exit strategies. The first is strategic mergers and acquisitions. We will seek large healthcare groups or competitors like Broussonetia papyrifera to acquire our company. Alternatively, we could divest parts of our business by spinning off high-value business units for separate sales to quickly recoup capital.

Another option is selling our patents and intellectual property. We could license core patents to peers to collect royalties while retaining ownership. Alternatively, we could package and sell our IP, transferring patents, trademarks, and trade secrets in one transaction to technology acquirers—an approach particularly suitable for companies like ours that possess high-barrier technologies but lack commercialization capabilities.

A further choice involves collaborating with other companies through business trusteeship. We could sign agreements with competitors for them to take over product sales and customer service, while our company receives revenue shares or one-time fees, gradually exiting the market.

If none of these three methods resolve our issues, we may proceed with bankruptcy liquidation. Courts would appoint receivers to conduct comprehensive asset auctions and settle debts according to legal procedures. However, this would only occur if the aforementioned three approaches prove unfeasible.

Further explanation

Our exit strategy is designed to provide clear paths for investors and stakeholders to realize returns while ensuring sustainable development of the company. We will pursue three potential exit options, depending on the company’s growth trajectory and market conditions.

1、Acquisition by Major Medical Device Companies

We will actively position the company as an attractive acquisition target for global and domestic leaders in surgical sutures and biomaterials. Potential acquirers include Johnson & Johnson (Ethicon), Medtronic, Becton Dickinson (BD), as well as leading Chinese companies such as Weigao Group and Mindray. These companies already dominate the suture market but seek innovative materials with multifunctional properties (anti-infection, anti-inflammatory, scar reduction). Our unique IP portfolio and clinical validation will make us a strategic fit.

Target timeline: Year 5 onwards, once large-scale clinical data and regulatory approvals are secured.

Expected deal size: ¥500M–1B valuation, based on comparable M&A deals in biomaterials.

2、IPO on the STAR Market or HKEX

As the company scales to nationwide adoption, we may pursue an independent public listing on the Shanghai STAR Market or Hong Kong Stock Exchange (HKEX). Both markets are friendly to biotech companies with innovative technologies and strong IP portfolios.

Prerequisites: Proven revenue track record (≥¥200M annual revenue), GMP-certified production capacity, and global patent protection (PCT, FDA, CE approvals).

Target timeline: Year 6–8, after achieving positive net income and stable market share.

3、Strategic Partnerships and Partial Exit

We will also consider forming strategic joint ventures with domestic or international medical device firms. In this case, investors can partially exit by selling shares to the strategic partner, while the company continues to operate independently with stronger distribution channels

Example: Co-distribution agreement with Mindray or Weigao for domestic hospitals, combined with licensing deals for overseas markets.

This strategy provides flexibility and early liquidity options for investors before a full exit.

Risk Management in Exit

To ensure successful exit opportunities, we will:

Build a robust IP portfolio (covering product, process, and application patents, both domestic and PCT)

Secure multi-center clinical validation to enhance acquisition/IPO attractiveness.

Develop scalable GMP facilities that meet both domestic and international regulatory standards.

Skills

We define “skills” as reusable, integrated competencies that enable us to reliably advance our bio-based composite sutures for cesarean section from the laboratory stage to clinical application and the market.

The Squirrel-Beijing team is composed of a group of multidisciplinary students from Beijing, with backgrounds spanning science, engineering, social sciences, and the humanities. This diversity not only fosters rich intellectual exchange but also ensures efficient cross-disciplinary collaboration. Within a strong academic research atmosphere, we have accumulated solid experimental and research experience, equipping the team with the ability to continuously iterate ideas and move from concept to experimental validation.

We also collaborate with laboratories, leveraging well-equipped synthetic biology platforms to ensure that our ideas can be tested and optimized under real working conditions. Meanwhile, through the Human Practices process, we have conducted multiple rounds of interviews and exchanges, gaining systematic experience in entrepreneurial implementation and key details of experimental protocols. This has not only accelerated experimental progress but also laid the foundation for the pace of future commercialization.

Capabilities

“Capability” = Output efficiency that is reusable, scalable, and measurable under given resource conditions

We define capability as output efficiency that is reusable, scalable, and measurable within the constraints of available resources.

At present, our product has completed preliminary validation in the laboratory and has demonstrated strong potential in cost control and standardization:

Low-cost and widely available raw materials

• Cellulose synthesis relies on conventional glucose feedstock, supported by a mature and stable supply chain.
• Chitosan can be extracted from waste materials such as shrimp and crab shells, making it a low-cost and renewable resource.
• Curcumin is efficiently synthesized through fermentation engineering, avoiding the yield bottlenecks and batch-to-batch instability of traditional plant extraction.

Mature production chassis

• We selected Escherichia coli Nissle 1917 as the chassis strain, which has been widely applied in probiotics and bioproduct development, with a strong foundation of safety and industrialization.
• Through genetic engineering, we achieved stable synthesis of cellulose and curcumin, which can be combined with chitosan to form a complete functional system.

Standardizable process system

• The three functional modules can be scaled up via modular fermentation and integrated downstream processing, enabling standardized mass manufacturing.
• The final product, a biodegradable suture, directly targets the surgical consumables market and demonstrates strong market adaptability.

Stakeholders

Squirrel-Beijing plans for the sustainable development of our cesarean-focused surgical suture. To achieve this, we emphasize long-term, two-way relationships with key stakeholders: How do we keep collaboration continuous? What do we expect from them—and what do they need from us? Guided by our power-vs-demand map and the stakeholder pyramid, we group partners into four clusters to keep engagement focused and practical.

This structure lets Squirrel-Beijing maintain stable, accountable relationships—aligning clinical value (patients & doctors), institutional decisions (procurement, regulators, insurers), industrial capacity (biotech partners), and social license (public)—so our solution can progress credibly from pilot to scale.

For more details, please refer to Human Practice.

Customer Communication and Clinical Feedback

To better understand the clinical demand and market potential for our bioactive surgical suture, we actively reached out to both potential patients and medical professionals across different regions and hospital levels in China.

As shown in the top-left image, we first communicated directly with end users — potential consumers who expressed strong interest in our product’s aesthetic, anti-inflammatory, and biodegradable properties. However, through these conversations, we quickly realized that final purchasing decisions in the medical device sector are not made by patients themselves, but by hospitals and doctors. This finding guided us to expand our interviews to multiple hospitals and clinical specialists.

To ensure wide coverage, we conducted consultations with hospitals of different regions and tiers:

• In northern China, we visited Beijing; in the south, we spoke with professionals in Changsha (Hunan Province) and Ganzhou (Jiangxi Province).
• In terms of institutional hierarchy, our interviewees included top-tier national hospitals such as Peking University People’s Hospital and Xiangya Hospital of Central South University, as well as district-level hospitals like Wangcheng People’s Hospital in Changsha, and even community-level medical centers such as Beiwaitan Street Community Health Service Center.
• We also extended our scope to a veterinary surgery expert, acknowledging that pet surgery has become an emerging application area for high-quality sutures.

Across these institutions, we engaged with specialists from general surgery, orthopedics, trauma centers, and community healthcare, forming a comprehensive and multi-layered perspective.

The six doctors who provided feedback include:

1. Yuan Xiaopei (袁晓培) — Chief Physician, Peking University People’s Hospital
2. Zhang Bin (张斌) — Physician, Beiwaitan Street Community Health Service Center
3. Liu Yang (刘杨) — General Surgeon, Xiangya Third Hospital, Central South University
4. Gong Yuxing (龚宇星) — Exotic Animal Surgery Specialist, Veterinary Surgical Clinic
5. Yang Xiaojiang (杨晓江) — Orthopedic Doctor, Wangcheng People’s Hospital, Changsha
6. Zhou Xiaozhong (周晓忠) — Director, Trauma Center, First Affiliated Hospital of Gannan Medical University (Jiangxi)

All six experts strongly expressed enthusiasm and confidence in our product concept. They agreed that if ReGenStitch successfully passes clinical testing and regulatory approval, they would be among the first to trial and adopt it in their medical practice.

They highlighted that features such as improved tensile strength, anti-inflammatory performance, and biodegradability directly address long-standing pain points in post-surgical care — especially for C-section patients, where both functionality and cosmetic recovery are critical.

Importantly, our communication with these experts was not a one-time exchange, but a continuous collaboration throughout our research and commercialization process. Their professional insights have not only strengthened the clinical relevance of our project but also provided valuable strategic guidance for future market adoption.

Investor Engagement

Interestingly, at our current stage, we had not yet actively sought out investors, as we believed our product was still in the early development phase. However, quite unexpectedly, during our presentation at the CCiC (China iGEM Community Conference), our project attracted the spontaneous attention of several investors from the biomedical and synthetic biology industries.

As shown in the figure, 3 investors approached us immediately after our presentation, expressing strong interest in our project’s progress and future commercialization potential. They inquired in detail about our technical roadmap, production feasibility, and the possibilities of early-stage investment. What surprised them most was that our entire team consists of high school students — they were deeply impressed by our technical depth, presentation professionalism, and the level of maturity our project had already achieved.

Representatives from Meikole, a company specializing in biomedical materials, discussed potential collaboration opportunities for pilot testing in clinical scenarios and joint material development. Meanwhile, the Synthetic Biology Network, an industry-leading innovation platform and incubator, recognized our project as an outstanding example of applied synthetic biology, expressing willingness to support us with resource connections and public outreach. Additionally, Qinglan Capital, a venture fund focusing on women’s health and minimally invasive surgery, noted the strong long-term potential of our innovation and indicated interest in providing early-stage funding and strategic guidance.

Beyond financial support, all three parties encouraged us to continue advancing the project beyond the competition, emphasizing that what we had already achieved as high school students was truly exceptional. They expressed genuine willingness to sponsor and support our continued research and development after the iGEM competition, helping transform ReGenStitch from a competition project into a commercially viable biotechnology venture.

Enterprise Visits and Further Investment Interest

Encouraged by the strong responses we received at the CCiC conference, we continued to stay in contact with the investors who had previously expressed interest in our project. In addition, we took the initiative to visit a biotechnology innovation park in Haidian District, Beijing, where we personally met with four biotechnology companies — Biofront, DP Technology, Zhishidao Laboratories, and SicaGene.

During our visits, we presented our project progress and demonstrated some of our experimental outcomes. The company representatives spoke highly of our creativity and the practicality of our research results, particularly expressing amazement at the performance of our porcine skin suture experiment, which visually demonstrated the strength, flexibility, and healing potential of our bioactive suture.

All four companies showed strong interest in our future development, commending the level of innovation our team had achieved at the high school level. They also expressed willingness to explore further cooperation or investment opportunities, encouraging us to continue advancing our work beyond the iGEM competition stage and toward real-world clinical application.

Figure. Team members visiting four biotechnology companies — Biofront, DP Technology, Zhishidao Laboratories, and SicaGene — in Beijing’s Haidian District to present project results and discuss potential investment collaboration.

We focus on a three-module composite suture—bacterial cellulose (BC) scaffold + chitosan/chitooligosaccharide (CS/COS) for antibacterial and hemostatic function + curcumin for anti-inflammatory regulation—using synthetic biology to achieve safer, more eco-friendly, and more efficient postoperative recovery.

Environmentally Friendly

• Medical-grade chitosan/COS is prepared from shrimp shell waste, reducing solid waste and by-products that pollute marine environments.

Structural Stability and Healing Efficiency

• BC provides high tensile and knot strength, avoiding the problems of “excess rigidity/imbalanced degradation” seen in traditional sutures.
• Offers stable support for early healing, with expected benefits including shorter hospital stays and nursing time, as well as reduced need for suture removal and follow-up visits.

Clinical Accessibility and System Value

• Lower infection rates, fewer dressing changes, and reduced hospitalization days can generate cost savings for healthcare systems and improve bed turnover efficiency.

Safety Risks and Negative Spillovers

• A very small number of patients may be allergic to shellfish-derived materials; pre-operative inquiry and clear warnings are required.
• Quality fluctuations of bio-based raw materials and production lines may affect consistency; mitigated through GMP/QMS compliance, supplier qualification, and stability testing with retained samples.
• Postoperative residues and packaging must be disposed of as medical waste to prevent secondary contamination.

We plan to establish a clinical follow-up and real-world evidence system, refine adverse event reporting and recall protocols, and continuously conduct health-economic evaluations to support reimbursement and market access. A phased pilot rollout will ensure that safety, efficacy, and affordability are aligned throughout the scale-up process.

1. Identification of Customers and Unmet Needs

We identified C-section patients, particularly postpartum mothers, as our primary customer group. Through interviews with six doctors across top-tier hospitals, regional hospitals, and community health centers, we confirmed unmet clinical needs in scar-free healing, infection prevention, and suture degradation. These insights directly shaped our product design.

2. Feasibility, Scalability, and Innovation

We successfully produced a minimum viable product (MVP) — a triple-composite bioactive suture combining bacterial cellulose, chitosan/chitooligosaccharide, and curcumin. Mechanical and physical tests showed our prototype performs on par with commercial sutures, validating its feasibility and scalability for future clinical application.

3. Product Development Plan and Milestones

Guided by medical experts and industry professionals, we developed a three-stage roadmap:

• Year 1–2: Optimization and clinical-grade prototype preparation
• Year 3–4: Preclinical and regulatory testing

Year 5: Market entry and scale-up manufacturing

• These milestones were refined through consultation with directors from Beijing Zhiyu Medical Technology Co., Ltd. and Beijing Xinjian Technology Co., Ltd.

4. Skills, Capabilities, and Stakeholders

Our interdisciplinary team includes students with backgrounds in biology, engineering, business, and social sciences. We received mentorship from lawyers (DeHeng Law Firm) on patent and compliance, finance experts (China Investment & CITIC Private Equity) on cost modeling, and medical specialists on product functionality. These collaborations make our business case both credible and robust.

5. Long-Term Impacts and Sustainability

We considered both positive and potential negative impacts. Our suture uses shrimp shell waste to produce chitosan, promoting circular bioeconomy and environmental sustainability. Potential risks such as shellfish allergy and bio-based material variability are addressed through GMP/QMS compliance and clear labeling. Our approach integrates social responsibility, environmental awareness, and economic feasibility — ensuring sustainable innovation.

【1】MSN. (n.d.). 2023 China Health Statistics Yearbook. MSN. [in Chinese]

【2】NetEase. (n.d.). 23-province alliance centralized procurement: Surgical sutures officially included in the procurement program. NetEase Subscription. [in Chinese]

【3】Device House. (n.d.). Tariff war and centralized procurement as dual drivers: Domestic sutures break through challenges. [in Chinese]

【4】Tencent News. (n.d.). The life-and-death battle of centralized procurement for surgical sutures. [in Chinese]

【5】Shanghai Observer. (n.d.). NMPA releases ten measures to support the innovative development of high-end medical devices. [in Chinese]

【6】General Office of the State Council. (2019, December 3). Opinions on promoting the normalization and institutionalization of centralized drug procurement with target quantity. http://www.gov.cn/zhengce/zhengceku/2019-12/03/content_5457915.htm [in Chinese]

【7】Chen, L., Wang, Y., & Zhang, K. (2023). Advances in absorbable suture materials and their clinical applications. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 111(5), 1120–1130. https://doi.org/10.1002/jbm.b.35369

【8】Kotha, R. R., & Luthria, D. L. (2019). Curcumin: Biological, pharmaceutical, nutraceutical, and analytical aspects. Molecules, 24(16), 2930. https://doi.org/10.3390/molecules24162930

【9】Mourya, V. K., & Inamdar, N. N. (2008). Chitosan-modifications and applications: Opportunities galore. Reactive and Functional Polymers, 68(6), 1013–1051. https://doi.org/10.1016/j.reactfunctpolym.2008.03.002

【10】Shi, Z., Zhang, Y., Phillips, G. O., & Yang, G. (2014). Utilization of bacterial cellulose in food. Food Hydrocolloids, 35, 539–545. https://doi.org/10.1016/j.foodhyd.2013.07.012