BWS Tech Files IPO Prospectus: Pioneering Fiber-Optic Sensing in Cardiovascular Intervention with Zero Domestic Competition

In recent years, fiber optic sensors, as a new type of sensor with significant advantages, have been applied in various high-end, precision, and cutting-edge fields. Particularly in the medical field, fiber optic sensors offer a novel approach to disease treatment due to their compact size, high precision, electromagnetic interference resistance, and biocompatibility.

The integration of fiber optic sensors with minimally invasive techniques has further propelled the advancement of modern medicine. Beijing Baiweishen (Medical) Technology Development Co., Ltd. (hereinafter referred to as“Baiweishen”) is a typical enterprise that applies fiber optic sensing technology to minimally invasive interventional therapy. It positions itself as “Provider of Precision Physiological Monitoring Solutions and Services Based on Micro-Optical Fiber and MEMS Technologies”。

BWS’s Cardiovascular Disease-FocusedMicro Fiber-Optic FFR System (Fractional Flow Reserve), it serves as the "stepping stone" for entering the healthcare market.

Fractional Flow Reserve (FFR) is a functional index used to evaluate coronary artery stenosis. It serves as a critical tool in cardiology for determining whether borderline coronary lesions require percutaneous coronary intervention (PCI), such as stent implantation.

FFR systems can functionally assess myocardial status, evaluate the necessity of intervention preoperatively, monitor during surgery, and assess surgical outcomes postoperatively. By utilizing pressure guidewires to measure FFR, the system serves as a highly effective adjunct to coronary angiography, enabling the formulation of optimal treatment plans for patients.

An FFR system comprises two components: a pressure wire (pressure sensor and guidewire) and a data processing system (terminal display device).The miniature optical fiber FFR system developed by Biweishen integrates a miniature optical fiber pressure sensor into the medical Fractional Flow Reserve (FFR) system, thereby enabling minimally invasive pressure measurement.

Reporters learned that Baiweishen’s decision to launch the miniature fiber-optic FFR system as its inaugural product was driven primarily by the following three factors:

First, the cardiovascular system imposes stringent requirements on sensors, which effectively demonstrates the value of fiber optic sensors. Products approved for cardiovascular applications can more easily gain entry into other clinical departments.

Secondly, interventional medicine represents a significant market within the cardiovascular sector, characterized by strong demand for pressure monitoring and substantial potential for further development.

As population aging accelerates and unhealthy lifestyles become more prevalent, the incidence of cardiovascular disease in China continues to rise. Currently, there are 20 million patients with coronary heart disease in China, with over one million new cases each year.

PCI, or percutaneous coronary intervention, is currently one of the important methods for treating coronary heart disease. The number of coronary heart disease interventional surgeries in China increased from 228,000 cases in 2009 to 640,000 cases in 2016, with a compound annual growth rate as high as 16.43%. It is estimated that in the next three years, the number of PCI surgery cases in China will reach 1 million.

With the continuous growth in the volume of percutaneous coronary intervention (PCI) procedures, market demand for fractional flow reserve (FFR) is also set to rise steadily. Against the backdrop of escalating healthcare and wellness needs, patients are increasingly opting for FFR testing to secure optimal treatment plans and improve surgical outcomes. According to conservative estimates by Baiweishen, the market size for micro fiber-optic FFR systems in China will reach RMB 600–900 million within three years. If micro fiber-optic FFR testing services aimed at improving surgical outcomes are included, the market size is projected to exceed RMB 2 billion.

Third, high-end products in China’s cardiovascular field are currently dominated by imports, resulting in persistently high examination costs for patients.

Therefore, Baiweishen decided to leverage its technological strengths by starting with the relatively challenging field of cardiovascular care, aiming to fill a market gap. After the product’s launch, it will also help reduce costly testing fees, thereby benefiting patients.

In terms of market competition, there are currently no commercially available micro-fiber optic FFR systems in the domestic market. The domestic market is monopolized by FFR systems utilizing traditional electromechanical pressure sensors, with St. Jude Medical holding over 90% of the market share.

Traditional electromechanical sensors generate weak internal electrical signals. To achieve a miniature size (approximately 2 mm in length and 200 μm in width), their temperature coefficient increases. Additionally, the pressure guidewire is relatively long (approximately 1.8 m). Consequently, even slight movements or weak electrical currents within the human body can compromise sensor performance.

Compared with traditional pressure-sensing FFR systems, miniature fiber-optic FFR systems offer significant advantages.

First, shorten the measurement time.Traditional FFR exhibits a certain degree of signal drift, which prolongs procedural time; in contrast, micro fiber-optic sensors offer stable performance (no drift), thereby reducing measurement time.

Second, high safety and low risk.Traditional FFR systems employ electrical sensors, where even minor current leakage can stimulate organs. In contrast, miniature fiber-optic sensors utilize optical pathways for measurement, offering a risk-free profile and enhanced safety for human organs.

Third, it has good compatibility and stability.Traditional FFR exhibits poor biocompatibility; the optical fiber, made of quartz, is resistant to acid and alkali corrosion, demonstrates excellent biocompatibility, and allows for long-term intracorporeal intervention.

Fourth, strong lesion penetration capability.Traditional pressure guidewires offer limited support, resulting in poor trackability and suboptimal crossing performance at lesion sites. In contrast, fiber-optic pressure guidewires provide superior support and demonstrate excellent lesion-crossing capability.

Looking at the international market, Canada’s Opsens is currently the only global provider of fiber-optic FFR systems and a direct competitor to Baiweishen. Its fiber-optic FFR system has received FDA clearance. Opsens’ sales reached $5.2 million in fiscal year 2016, representing a tenfold increase compared to the previous year. In 2016, Opsens also obtained certifications in multiple countries. By the third quarter of 2017, its quarterly sales had reached $3 million, indicating very rapid growth.

Compared with Opsens, Baiweishen possesses independently developed, differentiated core technologies. Meanwhile, the Baiweishen FFR system offers a lower cost structure. Coupled with the favorable macroeconomic environment in China, the company is poised for rapid growth amid robust market demand. Furthermore, as Opsens’ current strategy does not include entry into the Chinese market, it has effectively forfeited this significant market opportunity.

VCBeat has learned that Baiweishen plans to develop a series of products, which will have a broader range of applications compared to imported alternatives. Furthermore, the guidewires manufactured by Baiweishen offer superior performance and a more comprehensive range of models. This not only enhances the company’s market competitiveness but also facilitates greater ease of use for physicians.

In terms of reducing examination costs, Baiweishen stated that the current cost of an FFR test using St. Jude Medical products in China is approximately RMB 10,000. Once domestically produced FFR systems, such as those from Baiweishen, become available, the cost will be significantly reduced, allowing patients to undergo FFR testing for only a few thousand yuan.

Moreover, with increasing market demand and supportive national policies, FFR is expected to be incorporated into routine clinical examinations and covered by medical insurance, thereby reducing patients’ out-of-pocket costs. However, there is still a long way to go for a technology to progress from domestic development by Chinese manufacturers, through market entry and clinical validation, to ultimately gaining reimbursement support under the national medical insurance system.

In fact, in addition to the cardiovascular field, Baiweishen has also made strategic layouts in areas such as pulmonary pressure, renal pressure, urodynamics, intestinal pressure, and intra-abdominal pressure.

The company is currently collaborating with China Patent Technology Development Corporation and Liu, Shen & Associates to file international patent applications. It is expected that, within approximately two years, the company will complete its international patent portfolio strategy based on product market considerations. In addition, Baiweishen has partnered with several hospitals to complete animal trials and plans to initiate a Series A financing round of RMB 15–20 million.

Bioway Deep is highly optimistic about the FFR market in China. The company stated that current demand for FFR in China is robust. As medical examinations become more standardized and domestically produced medical devices continue to mature, an increasing number of physicians will adhere to clinical guidelines and employ diagnostic tools with accurate, scientifically grounded guidance, thereby avoiding overdiagnosis, overtreatment, and inappropriate medical procedures.

Meanwhile, national health and payment authorities will provide policy support and prioritize diagnostic medical devices with high cost-effectiveness ratios, subsequently incorporating them into the scope of medical insurance coverage. As the only domestic manufacturer of such devices, Baiweishen will emerge as a pioneer, capturing market share and shaping the competitive landscape.

In addition to its FFR products for coronary artery stenosis, Baiweishen is deeply engaged in the medical field, developing urgently needed solutions such as pressure-temperature sensor guidewires for urology and intracranial pressure monitoring systems. With patient health as its primary objective and physician convenience as its guiding principle, Baiweishen aims to cover all areas of physiological monitoring in its strategic layout.

As a platform technology, fiber optic sensors can be applied in numerous fields such as industry, mineral resources, and military defense. With its precise, compact, and world-leading technology, Baiweishen is poised for significant success. Whether it can build a global fiber optic network and emerge as a leading enterprise in the new generation of medical devices remains to be seen.