Bioheart Secures Tens of Millions of RMB in Series B+ Financing Led by Origin Ventures to Advance Bio-absorbable Stent Development

VCBeat (WeChat ID: vcbeat) has learned that Shanghai Bioheart Biotechnology Co., Ltd. (hereinafter referred to as “Bioheart”) announced the completion of its RMB tens-of-millions Series B+ financing round, led by YuanBio Venture Capital and participated in by Chende Capital. The proceeds from this round will continue to be used to advance the Phase III clinical trials of Bioheart’s bioresorbable coronary stent and to facilitate the registration and market launch of related products.

It is reported that this marks Bioheart’s second fundraising round in 2019. Combined with its Series B financing of nearly RMB 60 million secured a month ago, this latest round has brought Bioheart’s total capital raised to over RMB 100 million. Previously, Bioheart’s Series B round was led by Chende Capital, with participation from Zhangjiang Sci-Tech Investment and Qianhai Fund of Funds.

Regarding the company’s successive completion of two financing rounds, Wang Li, founder of Bioheart, joked, “Ultimately, it comes down to the quality of our products. Various funds place significant emphasis on our product advantages. Our clinical trial results have been highly favorable, which has attracted considerable interest from investors.” However, Wang also noted that this round of financing serves as a further enhancement to the Series B round, with the use of proceeds and the progress of clinical R&D remaining consistent with those outlined during the Series B financing.

Wang Li graduated from the University of California. He previously served as Head of Interventional Products for Medtronic’s Greater China region, later co-founding MicroPort Scientific and Kindly Tech. He held the positions of CEO at MicroPort Scientific and Director at Kindly Tech. Currently, he serves as a key senior executive at several biotechnology companies, including Yisheng Technology. He has over ten years of R&D experience in the field of interventional medicine.

In addition to founder Wang Li, Bioheart’s core team is composed of exceptional talent. For instance, Dr. Zhao Yinghong, Head of the Technology Department, graduated from Tsinghua University and brings 14 years of experience in research and development within the medical device industry. He previously oversaw the R&D and production of Yisheng Medical’s Aili drug-eluting stents and filed more than 20 patents during his tenure. Over 40% of Bioheart’s team members hold master’s degrees, and its key personnel have an average of more than eight years of experience in the development and management of cardiovascular devices.

The product highlighted by Wang Li as attracting interest from various investors is Bioheart’s independently developed Bio-heart bioresorbable coronary stent system. This system facilitates revascularization in patients, ultimately restoring vessels to their normal state, and can expand and contract in response to changes in blood flow demands. Currently, Bioheart is conducting a Phase III clinical trial of the Bio-heart system with 800 participants, which is expected to be completed in 2020. Subsequently, the company will undertake a minimum two-year clinical follow-up period, with the product anticipated to reach the market in 2022.

The most distinctive feature of Bioheart’s product 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, 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.

As a drug-eluting stent, its controlled drug release efficacy, radiopacity in vivo, and delivery system are all critical components. Bioheart has conducted extensive in vitro and in vivo studies on the controlled drug release of its stents. By leveraging substantial data from animal experiments, the company has optimized the formulation and ratio of the drug coating, achieving an optimal balance between drug release and neointimal coverage, as well as between carrier degradation and drug release.

In terms of radiopacity, since polymer 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 radiopacity issues, filed multiple patents, and ultimately achieved favorable clinical outcomes. Typically, drug-eluting stents help patients restore vascular function within six months to one year after implantation; however, as a precautionary measure, Bioheart has extended the in vivo degradation time of its Bio-heart stent to two to three years.

Furthermore, Bioheart has specifically developed a delivery system integrated with the Bio-heart platform. Featuring a tapered gradient design and an ultra-long hydrophilic coating segment, this system facilitates 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 has filed 14 invention patents (with 4 granted) and 21 utility model patents (all 21 granted). “Developing a brand-new drug-eluting stent involves significant technical barriers. While it is easy to create a drug-eluting stent, it is difficult to develop one that gains clinical recognition. This requires extensive exploration of fundamental parameters and performance metrics, such as determining the optimal drug dosage and identifying the most effective release profile. The cost of clinical trials alone is extremely high; therefore, developing a novel coronary drug-eluting stent demands substantial capital investment and the mental preparedness for a protracted effort,” stated Wang Li. He added that as the PCI market continues to expand, Bioheart’s Bio-heart stent aligns closely with market demands.

In 2017, the market share of domestically produced drug-eluting stents reached approximately 80%, with Lepu Medical, MicroPort Medical, and Jiwei collectively accounting for about 56% of the domestic market. As domestic brands mature technologically, drug-eluting stents are increasingly moving toward high quality, advanced technology, and lower prices. The market share of imported brands and smaller niche players is expected to further shrink, leading to continued growth in market concentration. The head effect will become more pronounced, granting significant advantages to leading enterprises with first-mover advantages.

Yin Jie, Partner at YuanBio Venture Capitalstated: “We concur that the future trend in cardiovascular interventional medical devices aligns with the ‘intervention without implantation’ philosophy, and bioresorbable scaffolds are consistent with this technological trajectory. In the field of drug-eluting stents, Chinese companies represented by Bioheart have taken a leading position in global innovation. We are optimistic about professional teams led by serial entrepreneurs like Wang Li, and we hope to continue supporting Bioheart in its journey to becoming a great medical innovation enterprise!”

YuanBio Venture Capital is an investment firm focused on the early and growth stages of the healthcare sector. Headquartered in Suzhou BioBAY, it maintains a global reach. Currently managing approximately RMB 5 billion in assets, YuanBio has invested in over 60 high-quality projects, primarily spanning new drug development, medical devices, in vitro diagnostics (IVD), and healthcare services. The firm has delivered substantial investment returns and has been repeatedly recognized as one of the Top 10 venture capital funds in China’s healthcare sector and as one of the most active healthcare investment institutions in China. YuanBio brings together a team of seasoned professional investors and world-class scientific advisors, possessing extensive experience in entrepreneurship, venture capital, and corporate operations within the biopharmaceutical industry and related fields. Leveraging its specialized focus and rich industry resources, YuanBio is committed to becoming one of the most successful healthcare and pharmaceutical venture capital funds in China.