Market Opportunity.
ArThec offers a scalable, curative Advanced Therapy Medicinal Product (ATMP) platform positioned to capture significant value by preventing high-cost joint replacement surgeries.
The Growing Market Imperative.
Osteoarthritis (OA) is characterized by the progressive and irreversible loss of joint cartilage, ultimately leading to functional impairment and, in advanced stages, permanent disability. It is a major and escalating global health burden: OA affects hundreds of millions of patients worldwide, and a substantial share of them progress to severe disability. Importantly, the total number of patients with degenerative disease continues to rise, while the average age at which patients undergo their first surgical intervention continues to fall.
The Addressable Market and Value.
The scale of end-stage joint failure underscores the urgent need for effective, disease-modifying therapies. The global endoprosthesis market was valued at USD 19.32 billion in 2019 and is projected to reach USD 29.79 billion by 2027, reflecting strong and sustained demand for reconstructive surgery.
Pearl addresses this critical medical need earlier in the disease course by targeting early to moderate OA, which represents majority of OA patients. Based on current epidemiology, the theoretical total addressable market (TAM) for this patient segment is estimated at 177 million individuals globally in 2024.
Curative Value Proposition for Payers.
Pearl is being developed as a tissue-restorative therapy with the potential to modify the course of osteoarthritis by replacing damaged cartilage with organised, functional cartilage tissue that integrates with the surrounding joint structures. By targeting cartilage loss and joint deterioration at an earlier stage of disease progression, Pearl aims to support preservation of the native joint and, in appropriately selected patients, to prevent progression to end-stage disease requiring joint replacement. In current clinical practice, joint replacement represents a common consequence of osteoarthritis progression, particularly in patients with advanced structural damage. While endoprosthetic procedures can provide symptomatic relief, they are associated with high lifetime costs, especially in younger and more active patient populations, where revision surgeries may be required over time. These repeat interventions contribute to a substantial long-term economic and societal burden.By focusing on joint preservation and structural tissue restoration, Pearl has the potential to reduce the need for late-stage surgical interventions and associated revision procedures. As such, it represents a promising and potentially cost-effective option for healthcare payers, subject to confirmation of long-term clinical and health-economic outcomes.
Scalability and Business Model.
The manufacturing process is structured to achieve scalability. While ATMP production inherently involves complex, resource-intensive workflows, ArThec’s process is designed to scale efficiently relative to industry standards. The procedure is well-defined for qualified professionals and can be performed in GMP-certified facilities equipped specifically for cell-culture operations, ensuring compliance with regulatory and technical requirements.
ArThec’s business model is deliberately flexible and positioned for strong value generation, leveraging multiple revenue channels including license fees, royalties, technology transfer partnerships, and the sale of specialized medical devices.
Meet ArThec Team.
Marek Putko, MBA
CEO
A leader with over thirty years of experience in sales and marketing management, with hands-on expertise in project development and the implementation of sales strategies. He possesses extensive market knowledge gained through work with leading international corporations as well as domestic medical and pharmaceutical companies.
Dr Sławomir Jaros, EMBA
Co–Founder, CSO, CQO
Biotechnology and biopharmaceutical leader with over two decades of experience integrating science, innovation, and executive management. He has led cross-functional areas including R&D, GMP manufacturing, QC/QA, regulatory and clinical activities, supporting programs from early development through late-stage and commercial operations.
Grzegorz Sobieraj, MD
Co–Founder, Supervisory Board Member, Principal Investigator
Specialist in orthopedics and traumatology of the musculoskeletal system. He holds clinical leadership roles, including heading the orthopedic ward at Ortho Sport Clinic and serving as Medical Director at the St. John of God (Bonifraters) hospital in Łódź, with additional management experience in an orthopedic department in Brzeziny. He is affiliated with major professional societies (e.g., ESSKA, ICRS, Polish Arthroscopic Society, Polish Orthopedic Society).
Intellectual Property & Technological Barriers to Entry.
ArThec is an innovative Advanced Therapy Medicinal Product (ATMP) platform, built on a layered IP strategy protecting the core methodology, proprietary devices, and manufacturing processes, securing long-term market exclusivity.
Foundational Technology and Differentiation.
ArThec is fundamentally a technology company operating in regenerative medicine, with its product engineered as a tissue-engineered ATMP. The core innovation lies not only in preserving the intrinsic biological and biomechanical properties of cartilage throughout the manufacturing process, but also in applying advanced biotechnological, GMP-grade tissue-engineering methods that enable the production of large-surface cartilage fragments. These tissue constructs are sufficiently extensive to fill cartilage defects substantially larger than those treatable using traditional surgical techniques, thereby expanding the therapeutic window for patients with more advanced focal damage.
ArThec’s proprietary process yields fully formed, high-quality hyaline cartilage with complete histological, biochemical, and mechanical characteristics of native tissue. This ensures long-term stability, physiological function, and seamless biological integration.
A further differentiating element is the use of proprietary medical devices that enable safe, patient-friendly harvesting of donor cartilage while eliminating tissue loss during manufacturing entirely, maximizing consistency and production efficiency.
This integrated technological platform stands in sharp contrast to competing biological approaches—such as cell suspensions, scaffolds, and scaffold-cell constructs—where cells frequently lose their phenotype, typically generating mechanically inferior fibrocartilage rather than durable, stable hyaline cartilage.
Robust, Layered Patent Protection.
ArThec is an IP-driven company, and its long-term competitive advantage is anchored in a comprehensive and strategically structured intellectual property portfolio. The company already holds granted patent protection for its core technology, forming a solid foundation for future expansion of the IP estate.
Building on this foundation, ArThec is developing multiple patent families that safeguard its ATMP technologies, advanced tissue-engineering methodologies, and proprietary medical devices integral to the platform. This layered approach—combining existing protection with ongoing expansion—ensures durable exclusivity and establishes strong barriers to entry.
Corporate & Financial Milestones.
A clear path to market is established through confirmed regulatory status in major markets and defined clinical milestones, backed by a planned financing round.
Regulatory Approach.
The Pearl product has secured crucial regulatory validation: it is officially classified as a tissue-engineered Advanced Therapy Medicinal Product (ATMP) by the EMA/CAT (confirmed May 2021). Arthec holds SME status, enabling early eligibility for the EMA’s PRIME scheme to accelerate development and the later transition to the full PRIME program for enhanced regulatory support. Clinical trials will be conducted with EMA guidance to ensure compliance and robustness. Upon successful clinical outcomes, Arthec plans to submit a centralized Marketing Authorization Application (MAA) to the EMA. The centralized procedure grants approval valid across the EU, facilitating broad patient access. This pathway highlights Arthec’s commitment to bringing PEARL safely and swiftly to European patients.
Clinical Development Timeline.
The clinical strategy utilizes existing Hospital Exemption (HE) data as a ancillary data intended to support the arguments and evidence regarding the therapy’s safety and efficacy potential during the discussing of the detailed scope and design of Pearl’s further clinical development.
Financial Strategy.
The current focus is the founding, concentrated on therapeutic medical experiments using the PEARL Hospital Exemption product.
Team and Governance.
ArThec is managed by a multidisciplinary team combining deep scientific expertise in biotechnology and orthopedics with proven track records in the capital markets, drug/therapy development, patients treatment and GxP regulatory compliance.
Executive Management and Expertise.
The management team combines scientific rigor and business acumen:
Marek Putko (Chairman of the Board): Over 30 years of experience in sales, marketing, and management within the pharmaceutical and medical industry.
Dr Sławomir Jaros (CSO, CQO, Member of the Board): PhD in biotechnology, Executive MBA, and an expert in innovative technologies and therapies development.
Grzegorz Sobieraj, MD: Orthopedics and traumatology specialist, recognized as a pioneer in innovative joint surgery procedures
