Neo Modulus' Innovative Gelatin-PCL Stratified Gingival Repair Membrane Gains Approval as Company Files for IPO

Dec 03, 2023 00:02 CST Updated 00:02

Neo Modulus

Developer of Human Tissue Repair and Organ Regeneration Products

Source: Siyu MedTech; Editor: Zhang Yuqing

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On November 30, 2023, the National Medical Products Administration updatedNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.(hereinafter referred to as Neo Modulus)Neo Modulus' "Gelatin-Polycaprolactone Layered Gingival Repair Membrane" product has been approved, with the registration certificate number as "China Medical Device Registration No. 20233171776”。

NMPA Update Original Text as Follows:

“Recently, the National Medical Products Administration (NMPA) has reviewed and approved the innovative product registration application for "Gelatin-Polycaprolactone Layered Gingival Repair Membrane" submitted by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.

The product is a white film with a fibrous layer structure, made of a three-layer composite membrane composed of gelatin and polycaprolactone using electrospinning technology. The top and bottom layers are made of gelatin, while the middle layer is made of polycaprolactone, and there is no distinction between the front and back sides. Among them, the gelatin fiber layer comes into contact with the wound to assist in widening the keratinized gingiva; the polycaprolactone fiber layer adds mechanical strength to the composite membrane, facilitating handling and removal without direct contact with human tissue.

This 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 applicable site. The product's market launch will provide new options for patient treatment.

The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.”

# Market Overview

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 grafting" 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.

The gingival repair membrane can achieve the same repair effect as the gold standard "autologous free gingival graft," along with better aesthetic outcomes; it avoids harvesting tissue from the patient’s own body, significantly reducing surgical difficulty and harm to the patient, allowing more patients to benefit from the treatment and improving oral health levels, demonstrating significant clinical value.

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

# Product Introduction

The newly approved Neo Modulus® Gelatin-Polycaprolactone Layered Gingival Repair Membrane is a white, fibrous layered structure. It is a three-layer composite membrane made from gelatin and polycaprolactone using electrospinning technology, with the top and bottom layers composed of gelatin and the middle layer made of polycaprolactone. The membrane has no 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 challenges of autonomous soft tissue augmentation in periodontal applications while delivering outstanding 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.

# AboutNeo Modulus

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. was established on March 20, 2017.Since its establishment 6 years ago, Neo Modulus has been committed to product and technology research, andUniversity of Freiburg, GermanyThrough in-depth cooperation with research institutes, we have mastered the design and development of front-end raw materials and key process preparation technologies, achieved the domestic production of high-end core equipment, formed independent intellectual property rights, and broken through foreign technical barriers.

Through the introduction of domestic and international technologies and independent innovation in high-end equipment, Neo Modulus's 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, bones, gels, and agents, extending to multiple clinical departments such as dentistry, ophthalmology, otolaryngology, surgery, reproductive medicine, and sports medicine. Neo Modulus is one of the comprehensive solution providers with a complete range of advanced technologies in the fields of regenerative medicine and tissue engineering in China.

Neo Modulus has established three R&D and production bases in Suzhou, Weifang, and Taicang, a medical center in Beijing, and an overseas laboratory in Freiburg, Germany, forming a "3+1+1" R&D and innovation structure. Since its establishment,"Gelatin-Polycaprolactone Layered Gingival Repair Membrane," "Nasal Cavity Filling Sponge," and other high-end medical device products have successively been approved to enter the special review process for innovative medical devices.

Currently,Neo Modulus is developing joint cartilage regeneration products,Committed to promoting the regeneration of real transparent cartilage and its subchondral bone without the use of cells, growth factors, or other drugs; a new generation of degradable vascular graft products for dialysis patients with chronic kidney disease, aiming to address the durability and sustainability of artificial vascular grafts.

As of the date of publication, the company's financing history is as follows:

As of the date of publication, the following is a partial list of the company's patent information:

Editor | Zhao Qing Reviewer | Yi He Typesetter | Miya