Bio-Heart Developer Bioheart Biotech Secures RMB 60M Series B Funding for Ultra-Thin Absorbable Drug-Eluting Stent

VCBeat (WeChat ID: vcbeat) has learned that Shanghai Bioheart Biotechnology Co., Ltd. (“Bioheart”) recently announced the completion of its Series B financing round, raising nearly RMB 60 million. The round was led by Chende Capital, with participation from Zhangjiang Sci-Tech Investment and Qianhai Fund of Funds.

It is reported that the proceeds from this round of financing will be primarily used to advance the Phase III clinical trials of Bioheart’s core product, the Bio-heart bioresorbable coronary stent, as well as to support its regulatory registration and market launch. The company will also decide whether to initiate a new round of financing based on the actual progress of its business operations and new product development.

Previously, Bioheart had completed cumulative Series A financing of approximately RMB 50 million, which was primarily targeted at industry investors. This Series B round marks the company’s first public fundraising.

Bioheart, established in July 2014, is a technology-driven enterprise dedicated to the research and development, manufacturing, and sales of next-generation fully bioresorbable coronary drug-eluting stents. The company’s founder, Mr. Wang Li, graduated from the University of California. He previously served as the Head of Interventional Products for Medtronic’s Greater China region, co-founded MicroPort Scientific Corporation and Kellytai Medical, and led both companies to successful public listings.

This marks Wang Li’s third entrepreneurial venture, driven by his strong confidence in the market prospects of bioresorbable drug-eluting stents. Currently, most drug-eluting stents on the market are non-degradable and non-absorbable; the long-term presence of non-absorbable materials in patients’ bodies remains a potential risk. “I have been considering developing bioresorbable drug-eluting stents for seven or eight years, and I have been searching for a suitable technical team to balance the shaping of polymer materials with adequate radial support,” said Wang Li.

Ultimately, Wang Li assembled a team comprising PhDs from Tsinghua University specializing in polymer materials and master’s degree holders with over a decade of experience in cardiovascular product R&D. More than 40% of the team members hold master’s degrees, and core personnel possess over eight years of experience in the development and management of cardiovascular devices. Bioheart has established a quality management system and team compliant with the international ISO 13485 standard.

Most non-absorbable drug-eluting stents on the market are made from stainless steel or cobalt-chromium alloys. While these materials ensure stability and support, their non-absorbable nature means they remain in the patient’s body long-term, causing concern for both physicians and patients. Bioheart has abandoned stainless steel, opting instead for polymer-based materials as the primary component of its drug-eluting stents. A key technical barrier for Bioheart lies in thinning the polymer wall thickness while still maintaining adequate structural support.

The Bio-heart bioresorbable coronary stent, currently in Phase III clinical trials, fulfills all of Bioheart’s design objectives. The Bio-heart bioresorbable coronary stent is a fully bioresorbable drug-eluting stent system that facilitates revascularization, ultimately restoring vessels to their normal physiological state and enabling them to dilate and constrict in response to hemodynamic demands. Typically, drug-eluting stents help restore vascular function within six months to one year; however, as a precautionary measure, Bioheart has extended the in vivo degradation period of the Bio-heart stent to two to three years.

If bioresorbability is the direction that most drug-eluting stent manufacturers are diligently pursuing, how can one stand out in this competitive field? The key lies in the “thinness” of drug-eluting stents. The thinner the strut thickness, the greater the lumen gain area, and the better the clinical outcomes.

Another distinguishing feature of Bioheart is its thinness; while meeting the requirements of the National Medical Products Administration (NMPA), it strives to be the “thinnest” on the market. Wang Li revealed that compared with recently launched bioresorbable drug-eluting stents, Bioheart’s stent struts are only 60% to 70% as thick, thereby providing patients with a favorable lumen space after implantation and reducing turbulence around the stent struts. Furthermore, the reduced amount of implanted stent material helps minimize inflammatory stimulation in the target lesion area during the later stages of stent degradation.

Achieving such “thinness” relies on the development of tubing materials. The thin-walled tubing used in Bioheart’s stents was jointly developed by the company and its international partners. Its advantage lies in providing higher radial support through reinforcement in the radial direction, thereby enabling a reduction in wall thickness.

As a drug-eluting stent, itsDrug Controlled-Release Efficacy、In Vivo Imaging PresentationandStent Delivery SystemThese are all indispensable and critical steps. Bioheart has conducted extensive in vitro and in vivo studies on the controlled drug release of its products. By leveraging substantial animal experimental data, the company has determined the formulation and ratio of the drug coating, achieving an optimal balance between drug release and neointimal coverage, as well as an optimal balance between carrier degradation and drug release.

In terms of radiopacity, since polymeric materials are not visible under X-ray, precise positioning of the stent is required during surgical placement by physicians, making stent radiopacity particularly critical. Bioheart has devoted significant effort to addressing this issue of radiopacity, filed multiple patents, and ultimately achieved favorable clinical outcomes.

Furthermore, Bioheart has specifically developed a delivery system equipped with its proprietary technology. Featuring a tapered gradient design and an ultra-long hydrophilic coating segment, this system enables easier navigation of the stent to the target lesion, providing operators with a superior procedural experience and ultimately ensuring favorable therapeutic outcomes for patients.

Currently, Bioheart is conducting a Phase III clinical trial with 800 participants, which is expected to be completed in 2020. Subsequently, the company will conduct a clinical follow-up for at least two years, with the product ultimately anticipated to launch in 2022. Furthermore, Bioheart’s clinical trials are led by Fuwai Hospital, a renowned cardiovascular hospital in China. Wang Li revealed that at annual domestic and international academic exchange conferences, Fuwai Hospital consistently presents clinical data on Bioheart’s products, indirectly demonstrating that its products have gained consistent recognition from both domestic and international experts.

“In 2017, the market share of domestically produced drug-eluting stents reached approximately 80%, with Lepu Medical, MicroPort, and Jiwei collectively accounting for about 56% of the domestic market.” Wang Li concluded by sharing his insights on the drug-eluting stent market: “As domestic brands mature technologically, drug-eluting stents are progressively moving toward higher quality, advanced technology, and lower prices. The market share of imported brands and smaller niche players in the domestic market is expected to further shrink, while market concentration is likely to continue rising. The head effect will become more pronounced, granting significant advantages to leading enterprises with first-mover advantages.”

“Developing a brand-new drug-eluting stent involves significant technical barriers. While it is easy to manufacture a drug-eluting stent, creating one that gains clinical recognition as high-quality is considerably more challenging. This requires extensive exploration of fundamental performance parameters, such as determining the optimal drug dosage and identifying the most favorable release profile. Given the exceptionally high costs associated with clinical trials alone, developing a novel coronary drug-eluting stent demands substantial financial investment and the mental preparedness for a protracted effort,” added Wang Li.

Zhao Ruilin, Partner at Chende CapitalHe shared his perspective on the field: “After years of consolidation, the value of bioresorbable scaffolds is increasingly recognized by clinicians. A review of the history of coronary stent development reveals a process in which engineers and physicians have worked in close collaboration to continuously overturn past assumptions and challenge the impossible in structural design, materials science, and biomedicine. We are fortunate to have identified Bioheart as an outstanding company and to have joined its team. We will continue to provide full support for the company’s future development.”

Chende Capital is an investment firm focused on the life sciences and medical technology sectors. It manages multiple USD and RMB funds, with total assets under management exceeding RMB 4 billion. Led by a professional team with extensive experience in the healthcare industry, Chende Capital has completed investments in over 40 projects and achieved successful exits from several of them. The firm is committed to building top-tier companies in the healthcare sector and delivering optimal returns to its investors.

Zhangjiang Sci-Tech Investment, also known as the Zhangjiang Group’s “Investment-Loan-Incubation-Education” Platform, comprises member entities including Zhangjiang Sci-Tech Microcredit, Zhangjiang Incubator, Zhangjiang Pharma Valley Platform, Zhangjiang Med Valley Incubation and Innovation, and Zhangjiang Innovation Academy. The platform achieves sustained capital returns through financial services that integrate investment and lending: it has made direct investments in 61 projects, invested in 32 funds, and provided microloan services to over 1,200 enterprises, thereby establishing a preliminary new business system for “sci-tech innovation finance.”

Qianhai Fund of Funds, established in 2016 with a scale of RMB 28.5 billion, is currently the largest commercially raised fund of funds and a leading private equity investment fund in China. It places equal emphasis on fund investments and direct equity investments, and is managed by Qianhai Ark Asset Management Co., Ltd., led by Jin Haitao, a pioneering figure in China’s venture capital industry. Since its establishment, Qianhai Fund of Funds has cumulatively invested in 1,094 direct and indirect equity projects, with more than 20 portfolio companies listed on stock exchanges both domestically and internationally.