Nuoyi Mai'er (Suzhou) Medical Technology Files IPO Following Approval of China's First Regenerative Medicine Dental Membrane

Dec 01, 2023 18:22 CST Updated 18:23

Neo Modulus

Developer of Human Tissue Repair and Organ Regeneration Products

Instrument Family

Pioneer in Medical Device Media Reports

Share Professional Medical Device Knowledge

Source: Medtech Dive 医潜

On November 30, the official website of the National Medical Products Administration showed that the innovative product "Gelatin-Polycaprolactone Layered Gingival Repair Membrane" by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. has been recently approved for marketing.

This product broke through foreign technical barriers and was approved to enter the special review process for innovative medical devices in October 2022.The first high-end medical device product in China used for treating gum recession and periodontal tissue expansion.

According to the company, this is also since the implementation of the Special Approval Procedure for Innovative Medical Devices in 2014,The first oral implant innovative medical device approved in China.

Capture the first in China

Gingival recession leads to tooth sensitivity, mobility, and even tooth loss, while sufficient gingiva is crucial for maintaining the health and stability of natural teeth or dental implants. Clinically, "autogenous keratinized gingiva transplantation" has shown good results in increasing the width of keratinized gingiva and is considered the gold standard for periodontal soft tissue augmentation. However, free gingival grafts require harvesting tissue from the patient’s own mouth, which involves high surgical difficulty and causes secondary harm to the patient.

Gingival repair membrane can achieve the same repair effect as the gold standard "autologous free gingival graft".And better aesthetic results; avoiding the harvesting of the patient's own tissue, greatly reducing the surgical difficulty and harm to the patient, allowing more patients to benefit from the treatment, improving oral health levels, and having significant clinical value.

After 6 months of treatment, the gingival repair membrane can achieve the same repair effect as autografts and better aesthetic results.

The newly approved Neo Modulus® Gelatin-Polycaprolactone Layered Gingival Repair Membrane is a white, film-like structure with a fibrous layer. It is a three-layer composite membrane made from gelatin and polycaprolactone using electrospinning technology. The top and bottom layers are composed of gelatin, while the middle layer is made of polycaprolactone, and it does not have a distinct front or back side.Among them, the gelatin fiber layer contacts the wound to assist in widening the keratinized gingiva; the polycaprolactone fiber layer enhances the mechanical strength of the composite membrane, facilitating handling and removal without direct contact with human tissue.

This unique nanofiber structure design balances regeneration and mechanical effects, enabling rapid epithelialization of gingival tissue and ultimately achieving excellent gingival regeneration and repair. It overcomes the technical difficulties of autonomous soft tissue augmentation in periodontal applications while delivering superior aesthetic results. This bandage-like membrane can self-degrade after gingival repair.

The product is suitable for widening the keratinized gingiva in the oral cavity and deepening the vestibular groove. The appropriate model can be selected based on the expected repair area size of the application site. The product's market launch will provide new options for patient treatment.

Sino-German Cooperation

Focus on Tissue and Organ Repair and Regeneration

Neo Modulus was founded in March 2017 as an innovative enterprise that researches and produces regenerative implant medical devices for "achieving human tissue repair and organ regeneration."

Since its establishment six years ago, Neo Modulus has been committed to the domestic creation and international leadership of its products and technology.In-depth cooperation with scientific research institutions such as the University of Freiburg, Germany, mastered the design and development of front-end raw materials and key process preparation technology, realized the localization of high-end core equipment, formed independent intellectual property rights, and broke the foreign technical barriers.

Through the introduction of domestic and international technologies and independent innovation in high-end equipment, Neo Modulus' product line covers key technical routes in the field of tissue engineering such as electrospinning, 3D printing, and chemical synthesis. It encompasses a wide range of product forms including membranes, bone materials, gels, and agents, extending to multiple clinical departments such as dentistry, ophthalmology, otorhinolaryngology, surgery, reproductive medicine, and sports medicine. Neo Modulus is one of the comprehensive solution providers in China with a complete range of offerings and advanced technology in the fields of regenerative medicine and tissue engineering.

Neo Modulus SubsidiaryThe three R&D and production bases in Suzhou, Weifang, and Taicang, together with the Beijing Medical Center and the overseas laboratory in Freiburg, Germany, form a "3+1+1" R&D and innovation structure.。Since its establishment, "Gelatin-Polycaprolactone Layered Gingival Repair Membrane"“Nasal Cavity Packing Sponge”High-end medical device products have been successively approved.Enter the special review process for innovative medical devices.

Currently, Neo Modulus is developingArticular Cartilage Regeneration Products, dedicated to promoting the regeneration of true hyaline cartilage and its subchondral bone.Without the need to use cells, growth factors, or other drugs;A New Generation of Biodegradable Vascular Graft Products,Designed for patients with chronic kidney disease undergoing dialysis, focusing on the durability and sustainability of artificial vascular grafts.

Raised hundreds of millions of yuan

350 Million Layout in 3D Bioprinting

In August 2021, Neo Modulus announced the completion of its RMB 150 million Series A+ financing.Led by CDH VGC (CDH Innovation and Growth Fund), with all existing shareholders including HD Investment, SND Ventures, Eling Capital, Junmao Capital, and Baofu Investment following up.Since its establishment in March 2017, Neo Modulus has cumulatively raised 400 million RMB.

In March 2023, Neo Modulus announced the completion of a multi-hundred million yuan Series B financing round.Led by SND Finance, with participation from Junmao Capital, CDH Investments, Huiding Investment, Yiling Capital, and Boya Junzi Lan.

On October 30, 2023, Neo Modulus's 3D bioprinting regenerative implantable medical device project officially commenced production.

Neo Modulus 3D Bioprinting Regenerative Implantable Medical Device ProjectTotal investment of 350 million yuan,Construction began in May 2021, with the project being carried out in two phases and a total construction area of approximately 40,000 square meters. Currently, Phase I has completed an investment of 150 million yuan, with six standalone buildings completed, including the production center, biological safety evaluation center, and the comprehensive building. The facility integrates an advanced transformation system for high-end medical device products, incorporating R&D design, physical and chemical testing, cell culture, and bio-assessment. It is equipped with state-of-the-art biomimetic manufacturing equipment such as an electrospinning system, 3D printing system, freeze-drying system, and automated filling system. The main products include more than ten high-end implantable medical device products such as gradient-layered biological membranes, nasal cavity filling sponges, medical adhesives, and bone-filling materials.

Within five years after the project reaches its production capacity, it is expected to achieve a revenue breakthrough of 1 billion yuan.Phase II of the project is currently in planning, and in the future, a large platform for the industrialization of high-end medical devices will be built.

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According to the results of the "Fourth China Oral Health Epidemiology Survey Report",The periodontal health rate of adults in China is only 9.1%.We also look forward toAfter the launch of Neo Modulus® Gelatin-Polycaprolactone Layered Gingival Repair Membrane, it will benefit the general public.

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