Embracing the duty of innovators, we tackle clinical pain points with a cross-disciplinary approach. The ReGenStitch project began with a core value—alleviating patient suffering—and used Integrated Human Practices (IHP) as its continuous guide, fundamentally redesigning the function of surgical sutures. Our sustained interactions with surgeons, postpartum recovery experts, biomaterials engineers, and end-users ensured the seamless integration of technological innovation and social responsibility.

Identifying Pain Points, Defining the Mission

To truly understand the hidden pain behind the joy of new life, we first listened to the real experiences of C-section patients, confirming that suture removal pain, infection risk, and scarring were urgent clinical problems. A comprehensive survey validated the core need for a suture that balanced high mechanical strength with superior biocompatibility. Affirmation from Biomaterials Experts solidified our initial direction of using Bacterial Cellulose (BC) as the novel scaffold.

Iterative Design, Responding to Challenges

The Chief Surgeon of Peking University Hospital highlighted the high clinical risk of infectious complications, prompting us to integrate the Chitooligosaccharide (COS) module to establish a natural antibacterial shield. Feedback from Postpartum Recovery Experts shifted our focus from mere closure to healing quality, leading to the final inclusion of Curcumin for its anti-inflammatory and anti-scarring properties. Furthermore, to address the environmental pollution from traditional COS extraction (which contradicted our green goal), we built a microbial enzymatic system, fulfilling the project's commitment to SDG 12.

Integrating Functionality, Ensuring Translation

We successfully integrated the three functional modules—BC support, COS antibacterial, and Curcumin anti-inflammatory—and verified their mechanical properties and clinical operability in pigskin suturing experiments. Through communication with medical investors, incubators, and biomaterials companies, we clearly defined the high-value commercial route, targeting C-section sutures as the entry point, and gained strong industry endorsement.

Starting with Human-Centric Care, Succeeding Through Innovative Practice

We actively identify problems, genuinely listen to needs, and precisely respond to feedback. This process transformed ReGenStitch from an idea into an active tissue repair platform that integrates support, antibacterial, and anti-inflammatory functions, leveraging the power of synthetic biology to bring higher quality recovery experiences to patients worldwide.

The power-interest matrix

We utilized the Mendelow’s Matrix to analyze our stakeholders, classifying them based on their Power and Interest concerning the project's outcome. This ensured our resources were focused on key decision-makers (such as clinicians and investors).

We believe analyzing stakeholders is the cornerstone of achieving responsible innovation and Integrated Human Practices (IHP) . This analysis was crucial for ReGenStitch, ensuring our synthetic biology breakthrough precisely addresses real-world clinical needs.

High Power, High Interest: This core group, including Chief Surgeons and Postpartum Recovery Experts, directly defined the project's core functions (antibacterial COS and anti-inflammatory Curcumin) through their clinical insights (e.g., concerns about infectious complications and chronic pain). Medical Investors (e.g., Qinglan Capital) and Biomaterials Companies (e.g., MeiKeLe) also fall here, providing vital guidance on funding, technical validation, and market positioning for the high-value C-section segment.

High Power, Low Interest: This quadrant includes National Regulatory Bodies (NMPA/CFDA) and the Biosafety Committee. While their direct involvement is low until the clinical phase, they hold absolute approval power. Our IHP work proactively addressed their requirements, such as ensuring the eco-friendly process for COS extraction.

Low Power, High Interest: This group is the source of inspiration and the ultimate beneficiary. It includes C-section Patients and their Families, whose suffering from stitch removal pain and scarring formed the empathy starting point. Nurses and Hospital Pharmacies are also here, guiding our design for product usability and storage stability.

Low Power, Low Interest: This group provides background support for sustainability and innovation. This includes Kombucha Manufacturers (inspiring the BC scaffold) and Shell Waste Processors (providing raw materials for green COS extraction) and the general public/high school education community, with whom we fulfilled our duty for science popularization.

The Functional Stakeholder Pyramid

The Power-Interest model alone is insufficient to reflect the completeness of IHP. Therefore, we further categorized all stakeholders into four Functional Pillars to illustrate the flow of feedback from empathy (Patients) to technical iteration (Experts) and finally to responsible translation (Regulation). This Dual Model design perfectly illustrates how we deeply Integrated social needs into every design and validation step.

I. Core Users and Clinical Guidance

• C-section Patients and their Families: The ultimate end-users and empathy starting point, providing real needs concerning pain, stitch removal, and scarring.
• Chief Surgeons/Clinicians: Validate product feasibility regarding surgical operability, infection prevention, and clinical application.
• Postpartum Recovery Experts: Guide the necessity of anti-inflammatory and anti-scarring design, ensuring a focus on healing quality.
• Nurses and Hospital Pharmacies: Focus on product ease-of-use, stability, and routine management.

II. Technology, Industry, and Commercialization

• Biomaterials Companies: Provide material expertise, confirm BC scaffold feasibility, and participate in clinical trial collaboration.
• Medical Investors/Capital: Evaluate commercial value and market potential, and provide funding and business guidance.
• Industry Incubators/Accelerators: Offer resource connection, industrial promotion, and scalability advice.
• Synthetic Biology/Metabolic Engineering Experts: Guide gene pathway simplification, yield optimization (BC, Curcumin), and green extraction process (COS).

III. Regulation, Safety, and Sustainability

• National Regulatory Bodies (NMPA/CFDA): Hold final approval power for product market entry, requiring high standards for compliance and long-term safety.
• Biosafety Committees/Ethicists: Assess the potential risks of engineered strains and ensure research adheres to ethical standards.
• Shell Waste Processors/Kombucha Manufacturers: Provide raw materials for green COS extraction and inspiration for the BC scaffold, relevant to SDG 12 (Responsible Consumption and Production).

IV. Public and Education

• General Public and High School Education Community: Participate in surveys to confirm pain point universality and serve as the audience for our science popularization and promotion of responsible innovation.

By systematically managing the expectations and feedback of these stakeholders, we not only solved technical challenges but, more importantly, ensured that ReGenStitch could safely and effectively transition from the lab to the market, genuinely alleviating patient suffering and fulfilling its social value.

Emotional Origin: The Hidden Pain Behind the Joy

Our story began with a simple visit that fundamentally changed the project's direction. While celebrating the successful C-section of a team member's sister and the arrival of a new life, we witnessed the real suffering hidden behind the joy: persistent pain and itching at the suture site, along with anxiety over infection and permanent scarring. Her painful expressions during dressing changes and stitch removal resonated deeply, raising a profound question: Must recovery from modern surgery be so difficult and painful? This human-centric concern became the most primal emotional driver for the ReGenStitch project.

Clinical Dilemma: The Limitation of Passive Sutures

Driven by this empathy, we examined the multi-billion dollar global suture market, only to find functional upgrades had almost stalled. Sutures still played a passive "bystander" role, unable to actively safeguard healing.

• Pain Point 1 (Compliance): Non-absorbable sutures, despite high strength, require painful secondary removal, increasing patient time and cost.
• Pain Point 2 (Healing Quality): Absorbable sutures, while avoiding removal, can have degradation products that cause local acidification and inflammation, hindering tissue healing and potentially becoming a breeding ground for bacteria.
• The Core Question Emerged: How can a suture actively intervene, integrating high-strength closure, antibacterial defense, and anti-inflammatory regulation to truly realize that "the endpoint of suturing is not closure, but recovery"?

Interdisciplinary Inspiration: The Revelation from Kombucha

The solution appeared unexpectedly. On another visit to the sister, she offered us Kombucha. We observed the tough SCOBY bio-film floating in the tea. The main component—Bacterial Cellulose (BC) —possesses high strength and excellent biocompatibility, precisely the ideal "mechanical scaffold" that traditional synthetic polymers struggle to achieve! This cross-disciplinary inspiration formed our starting point: ReGenStitch. We decided to use synthetic biology to engineer the BC scaffold and incorporate natural Chitooligosaccharide (COS) (antibacterial) and Curcumin (anti-inflammatory) to actively manage the entire healing cycle.

Our ReGenStitch project was not a one-time endeavor but progressed through multiple rigorous DBTL cycles guided by Integrated Human Practices (IHP) , ensuring technical innovation precisely solves clinical pain points.

Design

Proposing solutions or action plans. A purposeful strategic decision based on problems identified in the previous L phase or through IHP feedback.

Build

Executing the designed solution. The practical construction of gene circuits, engineered strains, hardware, or software in the lab.

Test

Assessing if the built outcome meets the design goal. Collecting quantitative data through experiments, measurements, or expert validation.

Learn

Analyzing test results and IHP feedback, discovering new problems, bottlenecks, or opportunities to guide the next D phase.

Survey & Biomaterials Expert Consultation

Design

Based on empathy for postpartum pain, we designed (decided) to develop a high-strength, pain-free novel suture, and designed a survey to validate the universality of the pain point.

Learn

Survey data showed 65% strongly resisted removal, demanding high strength and biocompatibility. Inspiration from Kombucha's BC was recognized as the ideal "mechanical scaffold".

Build

Biomaterials Experts affirmed that traditional polymers fail to balance high mechanical strength and biocompatibility, validating the scientific rationale for choosing the BC scaffold.

Test

In this initial cycle, the expert consultation served as the "Test" to validate the design direction before lab "Build" work began.

Consultation with a Physician from Peking Union Medical College Hospital

Design & Learn

Learning from literature revealed long BC synthesis pathways hinder industrial production. Consulting a Synthetic Biology Expert, we designed a simplified strategy: introducing only the core synthesis genes, BcsA and BcsB, into E. coli to boost productivity.

Build

We successfully built the BcsAB co-expression engineered strain.

Test

Testing the strain showed cellulose production increased by 55% compared to the wild-type, validating the effective engineering of the BC scaffold.

Consultation with Dr. Yuan Xiaopei from Peking University People's Hospital

Design

Based on the Chief Surgeon's clinical feedback—that "infectious complications are the main cause of prolonged suffering"—we designed (decided) to integrate a highly effective, natural, and safe antibacterial shield (Chitosan/COS) into the suture.

Learn

Biomaterials Experts guided us to COS as the ideal agent (broad-spectrum, low molecular weight, high efficacy). We also learned that the raw material (shrimp/crab shell waste) aligns with SDG 12.

Build

We built the functional blueprint for ReGenStitch: BC scaffold + COS antibacterial defense.

Test

Experts warned that traditional COS extraction uses harsh chemicals, generating high industrial pollution, which challenged our project's "green" premise and defined the next sustainable development bottleneck.

Bioengineering Expert Consultation

Design

To resolve the high pollution bottleneck identified in the previous cycle, we designed to build a microbial enzymatic system to achieve eco-friendly Chitin extraction.

Learn

We consulted Bioexperts and learned that the synergistic action of Bacillus subtilis and Acetobacter could achieve environmentally friendly deproteinization and demineralization via microbial fermentation.

Build

We built the microbial enzymatic co-culture system using the two selected bacteria.

Test

Testing the system showed that the Chitin yield increased significantly to ∼14.5%, successfully proving the feasibility of our green extraction strategy in terms of sustainability and efficiency.

Biomanufacturing Expert Consultation

Design & Learn

Learning (Efficiency Failure):Biomanufacturing Experts warned that traditional enzyme extraction for COS was too costly and unstable. Our initial attempt using crude enzyme extracts failed due to poor stability and fast decay.

Design Decision: Consulting a Molecular Biology Expert, we designed a novel approach: introducing the INP (Ice Nucleation Protein) gene to anchor the enzyme onto the cell surface for stable whole-cell catalysis.

Build

We successfully built the INP-CHI surface-display engineered strain (BL21-INP-CHI).

Test

Testing showed that the BL21−INP−CHI whole-cell catalyst's hydrolysis efficiency was significantly superior to the traditional crude enzyme extract, validating the successful solution to the cost and stability bottleneck.

Postpartum Recovery Physician Consultation

Design

Consulting a Postpartum Recovery Expert revealed that chronic pain and hypertrophic scarring from inflammation were major patient concerns. Based on this, we designed (decided) to integrate anti-inflammatory and anti-scarring functions.

Learn

Consulting a Clinical Pharmacology Expert, we learned that due to long-term implantation risks, Curcumin was the safest choice (natural, gentle, proven anti-inflammatory). We also learned its synthesis pathway required optimization for high, byproduct-free yields.

Build

Guided by a Metabolic Engineering Expert, we built the Curcumin synthesis system in E. coli by co-expressing the DCS and CURS1 genes.

Test

Testing showed that the DCS-CURS strain successfully synthesized Curcumin, reaching yields of 13−14 μM, over 26 times the baseline level, validating the highly efficient activation of the synthesis pathway.

Our ReGenStitch is not only scientifically rigorous but also possesses a clear and responsible path to industrialization.

Market Positioning and Key Validation

Consultation with Investors and the CFO of SDIC Investment

Through discussions with the CFO of SDIC Investment and the Director of Beijing Zhiyu Medical Technology, we accurately targeted C-section sutures as our high-value entry point—a massive global market demanding high recovery quality.

Technical Feasibility Validation: The comprehensive DBTL cycles validated the functionality of the three integrated systems (BC support, COS antibacterial, Curcumin anti-inflammatory) and established an efficient, eco-friendly process for converting waste into high-value COS.

Clinical Performance Validation:Pigskin suturing experiments, conducted under the guidance of professional surgeons, confirmed ReGenStitch's excellent tensile strength and clinical operability, balancing high mechanical performance with biocompatibility.

Industry Support, Regulatory Foresight, and Commercial Roadmap

Consultation and Presentation of Pigskin Suturing Experiments at the Beijing Haidian District Center for Food and Drug Safety Monitoring

We proactively sought industry guidance to ensure a risk-controlled path to commercialization. Crucially, we consulted experts at the Beijing Haidian District Center for Food and Drug Safety Monitoring. This communication allowed us to preemptively understand the strict CFDA/NMPA requirements for novel implant materials (e.g., in vitro toxicology, in vivo degradation, and clinical trial standards). This regulatory foresight significantly mitigates future regulatory risk and ensures our Mid-Term Goal (initiating clinical trials) is designed based on official compliance standards.

Our commercialization path is clear and risk-controlled:

Short-Term (2 Years): Complete MVP development, animal testing, and safety validation.

Mid-Term (3-5 Years): Initiate clinical trials and pursue CFDA approval.

Long-Term (5+ Years): Secure the C-section suture market before expanding the platform to other high-value fields like orthopedics and cardiovascular surgery.

The impact of ReGenStitch extends beyond clinical and market success; we actively demonstrate social responsibility and scientific outreach.

Education and Public Engagement: We conducted outreach to bridge the public's knowledge gap on synthetic biology, introducing BC and enzymatic conversion principles to high school students, fostering interest in life sciences, and raising public awareness about responsible innovation in postoperative care.

Sustainable Development Goals (SDG): Our project aligns deeply with the UN SDGs. By alleviating patient suffering and enhancing healing quality, we directly contribute to SDG 3 (Good Health and Well-being). Furthermore, by utilizing our microbial enzymatic system to convert shrimp/crab shell waste into high-value COS, we greenified the production process and strongly supported SDG 12 (Responsible Consumption and Production).

Through these practices, ReGenStitch achieves a comprehensive unity of scientific innovation, commercial value, and social responsibility.

We, Squirrel-Beijing, leverage the power of synthetic biology to bring higher quality healing and recovery to patients worldwide. ReGenStitch unifies commercial value and social responsibility by alleviating patient suffering and enhancing postoperative quality of life, thereby redefining the endpoint of sutures—from closure to recovery.