Yueze Medical Enters the Grassroots Market with Affordable PRP Preparation Kits

Platelet-Rich Plasma (PRP) TherapyIn this procedure, physicians draw a small amount of the patient’s own blood and process it via ex vivo centrifugation to obtain a platelet-rich concentrate, which is then injected into the affected area to promote injury repair and tissue healing. This is known as Platelet-Rich Plasma (PRP) therapy. It is understood that once PRP is injected into the lesion site, it rapidly activates the body’s self-repair mechanisms. Growth factor release peaks within 4 hours, driving the processes of coagulation, anti-inflammation, proliferation, repair, and remodeling. This alleviates pain and facilitates recovery, with the therapeutic effects of a single injection lasting up to six months.

As a highly effective therapeutic technique, platelet-rich plasma (PRP) technology is currently widely applied in multiple fields, including acute and chronic wound repair, sports injuries, aesthetic medicine, and burn treatment. In 2018, Miao Song, founder of Yueze Medical, was first introduced to PRP technology and was immediately drawn to its remarkable clinical efficacy and broad application prospects. He stated to VCBeat, “This field holds immense potential for development.”

Based on extensive research and insights from peer products, Miao Song engaged in in-depth discussions with clinical experts. He identified significant room for improvement in PRP products, particularly in optimizing preparation materials, enhancing the precision and efficacy of treatments, and expanding application scenarios. This led him to conceive the idea of developing a new PRP product.In July 2022, Suzhou Yueze Medical was established as a startup specializing in the production of PRP preparation kits. Its first-generation product is expected to obtain regulatory approval this year.

Miao Song revealed to VCBeat that, in order to simplify the PRP preparation process and ensure its safety, Yueze Medical has strategically deployed multiple patented technologies in its PRP preparation kits, providing patients with high-quality PRP. These innovations include volume-adjustable PRP centrifuge tubes, separable self-sealing PRP sampling tubes, three-stage rotary-seal centrifuge tubes, and meticulously designed packaging boxes.

Patent Description for Separable Self-Sealing PRP Sampling Tube, Image Source: Patent Star

Taking the PRP separation process as an example, traditional methods often require personnel to perform a secondary separation to extract the desired components from whole blood. This process presents two major challenges: First, during the preparation of L-PRP, red blood cells are often inadvertently mixed in. Furthermore, the process of changing centrifuge tubes is quite cumbersome. Second, when personnel insert a syringe from the top of the second centrifuge tube for aspiration, platelet-poor plasma (PPP) is easily drawn in, resulting in insufficient purity of the extracted PRP.

To address this issue, Yueze Medical has redesigned its PRP collection tubes.This sampling tube is divided into three sections from top to bottom: an upper rigid tube, a middle flexible tube, and a lower rigid tube. This unique design eliminates the need to withdraw and replace the centrifuge tube during the second centrifugation step for PRP preparation. Notably, PRP can be accessed directly through the side wall rather than by aspiration from the top, significantly enhancing operational convenience and safety.

Miao Song told VCBeat that, after more than two years of innovation and improvement, the first-generation PRP preparation kit is expected to obtain its registration certificate this year. In addition to the first-generation product, Yueze Medical is also developing a second-generation product that will enable personalized customization, including adjustable white blood cell depletion rates, adjustable platelet enrichment levels, adjustable volumes, and precise aspiration, to meet the treatment needs of different patients.

Recalling the product development process, Miao Song sighed with some emotion: “As a startup that relies entirely on its own funds for R&D, we can hardly compare with large enterprises in terms of either the scale of capital available for investment or the margin for error during the development process.”

Fortunately, Yueze Medical’s product R&D has been backed by Dongmai Medical. “From project initiation and feasibility studies, through prototype development, all the way to regulatory certification guidance and assisted manufacturing, Dongmai Medical has provided us with one-stop, end-to-end services. This has helped us both reduce trial-and-error costs and accelerate the product registration process,” said Miao Song.

Miao Song, who transitioned from being a medical device supplier, candidly stated that his entry into the R&D and production of PRP was driven by two key factors: one was the adjustment of the industrial structure, where traditional suppliers would see their weight and survival space within the system continuously reduced; the other was the positive development of medical innovation. In his previous work, Miao Song had encountered numerous direct, authentic, and urgent feedback from doctors and patients.

During an exchange with primary care physicians, Miao Song learned that despite PRP being a highly effective treatment modality, its adoption rate in primary healthcare institutions remains low, and the application scenarios and scope of PRP technology are still significantly limited.

“PRP product applications are far from mature, with many areas requiring improvement and refinement. For years, there has been a lack of strict, quantitative guidelines and standards regarding the standardization and regulatory compliance of physicians’ operational procedures during the preparation phase. These factors have directly impacted patient perception and acceptance of the efficacy and role of PRP products, leaving the vast market in a prolonged state of needing to be awakened, guided, and cultivated,” added Miao Song.

Thus, Miao Song began to shift his perspective,The plan is to focus the development of key channels on primary care markets with insufficient medical resources.“As a new product entering the market, it is difficult for us to establish a foothold in areas with concentrated medical resources. Instead, we have targeted medium-sized hospitals in third- and fourth-tier cities and primary care institutions at the county level as our market scope,” said Miao Song. In his view, as a startup brand, Yueze still lags significantly behind products from large enterprises and established brands in various aspects. Only the primary care market can offer Yueze greater inclusivity, acceptance, and room for growth.

To develop the grassroots market,Miao Song does not wish to position Yueze merely as a PRP manufacturer; he also aims to disrupt traditional market models by leveraging Yueze’s PRP products as a vehicle to gradually transform the company into a comprehensive service provider for medical device technologies.。

Currently, the top priority for Yueze Medical is to rapidly bring its products to market to ensure the stability of the company's operations.“Once the product is launched, we will immediately deploy a professional sales team to optimize the entire sales process and strive to achieve a virtuous cycle of cash flow.”Miao Song said so.

To ensure successful product launch and meet market demands, Yueze Medical has established a robust support system: on the clinical front, it collaborates with clinical experts to identify unmet clinical needs, providing solid support for product development and clinical application; on the R&D front, it has entered into a strategic partnership with Dongmai Medical to ensure the secure and efficient acquisition of product registration certificates.

It is understood that Dongmai Medical has built an industrial service cluster comprising a full-process regulatory affairs service platform, an R&D validation and remediation platform, and a marketing authorization holder (MAH) contract manufacturing platform. This achievement stems from the successful operation of its subsidiary Suzhou Dongmai’s “CDMO + CRO + Testing Center” industrial service base and its Changsha CDMO industrial service base.

Specifically, the clinical side provides market demand and feedback, the marketing side is responsible for product promotion and sales, and the R&D side conducts technological innovation and product development based on market needs. Miao Song stated: “We have closely integrated the clinical, marketing, and R&D sectors to form a robust ‘collaborative golden triangle’.. This collaborative model ensures that our products consistently align with market demands while maintaining technological advancement and innovation.”

Looking ahead, Miao Song told VCBeat that the team will continue to explore collaborations with other departments and clinicians, focusing on innovating and promoting products with market demand. He emphasized, “We start with PRP, but we are not limited to it. As the nation begins to encourage the translation of clinical research achievements, we also plan to apply this collaborative model to more products and technologies, continuously expanding our business scope.” Through this model, Suzhou Yueze Medical Technology Co., Ltd. is committed to providing patients with more efficient and safe medical solutions.