From regenerating damaged muscles to rewriting the cell manufacturing playbook, Switzerland’s next wave of biotech innovators is turning regenerative medicine into a precision science. Once considered futuristic, technologies like autologous tissue grafts, gene-edited therapies, and cell-state reprogramming are now gaining real-world traction with Swiss startups at the forefront.
These five companies are not just riding the regenerative wave; they’re actively reshaping it, backed by major investments, clinical milestones, and even billion-dollar pharma partnerships. Together, they reflect a shift toward platform-based innovation, scalable solutions, and a deep commitment to restoring function, not just treating symptoms.
NewBiologix: Rewriting the Cell Therapy Manufacturing Playbook
In an industry plagued by high costs and variability, Lausanne-based NewBiologix is taking aim at one of regenerative medicine’s biggest bottlenecks: manufacturing. Its proprietary cell line engineering platform could transform how gene therapies are produced — and who can access them.
The biotech, established in 2022 by serial biotech entrepreneur Igor Fisch, has developed a platform for the advanced engineering of cell lines used in the production CGTs. Specifically, NewBiologix is developing stable, reproducible production for Adeno-associated virus (AAV) vectors, which it hopes will contribute to more extensive use and development of CGTs.
“By addressing the inefficiencies inherent in current manufacturing techniques, we aim to lower production costs and enhance consistency,” says Fisch. “In doing so, we hope not only to improve access to existing therapies but also to enable the expansion of gene therapies into broader indications, encouraging greater engagement from the pharmaceutical industry.”
Thanks to the USD 50 million injection of cash secured during its 2022 funding round, NewBiologix was able to advance its commercial ambitions and is now licensing its proprietary cell line optimised for the production of AAV particles to contract development and manufacturing organisations (CDMOs).
The firm has also created a subsidiary in the US, set its sights on Europe, and going forward plans to provide its clients with a more comprehensive manufacturing solution, “offering a full platform that integrates our technologies directly into clients’ production processes, empowering them to generate their own therapies efficiently and consistently,” Fisch asserts.
Limula: The Push for Fully Automated, Scalable CGT
While NewBiologix targets upstream consistency, Limula is revolutionising what happens on the manufacturing floor. Also based in Lausanne, this startup is building a system where cell therapies are made inside a single, closed device — no pipettes, no clean rooms, no human hands.
Last year, Limula landed an over EUR 6 million seed round of funding to develop its modular solution for on-demand and at-scale manufacturing of cell therapies in a single device. This novel technology “combines the functionality of a bioreactor, where cells are incubated and grown, with a centrifuge, which concentrates and separates cells,” explains CEO Luc Henry. “We are the only platform that integrates both into a single system where the cells remain in the same container throughout.”
The firm’s LimOne solution is the first implementation of this technology and earlier this year, Limula completed a fully functional LimOne system. “For the past three months we have been gathering data and the results are very exciting. They confirm that our system performs extremely well across the full manufacturing sequence—actually better than existing equipment for single unit operations,” the CEO affirms.
Limula is in the process of building a clinical-grade version of the single-use consumables that come into contact with the cells and by next year hopes to deliver a product that meets the standards required for clinical trials. Moreover, the biotech firm is fundraising to produce a fully GMP-compliant version, enabling customers to secure regulatory approval for therapies manufactured using Limula’s system.
CUTISS: Scaling Up Personalised Tissue Engineering
Moving beyond the lab bench, CUTISS is proving that regenerative medicine can be both personalised and industrialised. With skin as its proving ground, the company is combining automation and biotech to deliver functional, life-changing tissue for burn victims — and potentially much more. Schlieren-based CUTISS develops personalised skin grafts through advanced tissue engineering and has brought its lead product to Phase III trials and raised EUR 90 million. To achieve these milestones, CUTISS has adopted a novel modus operandi within the realm of what co-founder & CEO Daniela Marino deems “tech-bio,” working at the intersection of engineering and biology.
“Our approach is autologous – we extract stem cells from the patient’s skin and bioengineer skin tissue in the lab,” says Marino. “This tissue is then regrafted to regenerate for patients. It is regenerative medicine in its purest form. Moving beyond healing and scarring, toward true restoration of structure and function in an accessible way.”
Focused for now on skin, CUTISS may in future look to apply its platform to other tissues such as corneas, gums or muscle. “Skin is among the most demanding tissues to manufacture. Once we have mastered that, smaller-scale applications become significantly more feasible,” Marino maintains.
CUTISS opened a Series C round in 2024 following its strong Phase II efficacy and safety results, securing over EUR 26 million despite investor concerns about scale-up capacity, something the firm handled through a partnership with the laboratory instruments specialist Tecan. “We recently announced a partnership with Tecan, exactly to enable industrial scaling of the automation of skin production,” Marino affirms.
The next big milestones for CUTISS will be the second tranche of Series C funding it is in the process of raising and the initial data readouts for its Phase III lead candidate, centred on burns, at the end of the year.
MUVON: Repairing Muscle at Its Core
Where CUTISS tackles skin, MUVON goes deeper — into the muscle tissue itself. This Zurich-based biotech is restoring strength to patients with urinary incontinence by regenerating muscle from their own precursor cells, aiming to offer long-term relief where current treatments fall short.
“As we age, we lose about 1 percent of muscle mass per year, beginning in middle age. This loss is due to a decline in the quality and quantity of specific cell populations that are vital for muscle regeneration. Our approach focuses on replenishing this pool of muscle precursor cells, which act as a natural booster, allowing weakened or damaged muscle fibres to regenerate and restore function. By combining these cells with biomaterials, we can help muscles regain strength and functionality,” explains CEO and co-founder Deana Mohr-Haralampieva.
MUVON chose to focus on Female Stress Urinary Incontinence (SUI) “because it represents a significant unmet need in women’s health, affecting millions of women globally, particularly after childbirth” says Mohr-Haralampieva. “Our goal is to regenerate the damaged muscle itself, offering a solution that not only provides long-term relief but also addresses the root cause of the condition.”
Having completed a phase 1/2 clinical trial with promising results, the firm is now conducting a phase II clinical trial and looking to raise EUR 65 million to support further trials and its commercialisation efforts.
HAYA Therapeutics: Unlocking the Dark Genome
Finally, while others rebuild the body’s structure, HAYA is focused on its genetic software. With a landmark partnership with Eli Lilly, HAYA’s work decoding the regulatory genome marks a leap in how cell states are understood, manipulated, and repaired — not just in fibrosis, but potentially in obesity and beyond.
HAYA’s lead candidate, HTX-001, targeting myocardial fibrosis, is currently undergoing GLP-compliant toxicology studies, with first-in-human trials expected to begin early next year. Meanwhile the biotech entered a multi-year USD 1 billion agreement with the US Big Pharma to apply its platform to support Lilly’s preclinical drug discovery efforts.
HAYA’s platform is designed to decode the regulatory genome – a gene involved in controlling the expression of one or more other genes – at both single-cell and bulk resolution. “This multimodal approach integrates functional genomics with a proprietary computational framework, enabling target discovery, validation, and therapeutic design across multiple disease contexts,” asserts Samir Ounzain, HAYA’s CEO and scientific co-founder.
For Ounzain, the partnership with Lilly has proven the potential of HAYA’s platform well beyond its in-house fibrosis-centred efforts. “The focus of the collaboration is obesity, a clear demonstration that our platform is capable of extending well beyond our proprietary fibrosis programmes and into new indications where cell-state reprogramming can offer a differentiated path forward.” This, in the CEO’s view, makes the deal more than a turning point for the company. “It is a landmark collaboration, not just for HAYA, but for the field more broadly, as it represents one of the first major deals to explore the therapeutic potential of the regulatory genome.”
