PulseMed Announces First Clinical Data for BIOMAGIC Bioresorbable Scaffold, Advancing Iterative Innovation Through Long-Term R&D

In late May 2021, the 15th Oriental Congress of Cardiology (OCC2021) was held in Shanghai. At the "Original Research Session" on May 28, Shanghai BIOMAGIC Medical Device Co., Ltd. (hereinafter referred to as "BIOMAGIC") announced key clinical research data for the "BIOMAGIC Rapamycin-Eluting Bioresorbable Coronary Stent System".

Preliminary data have confirmed the safety and efficacy of the BIOMAGIC bioresorbable scaffold in patients with coronary artery disease presenting with single-vessel lesions. It is reported that BIOMAGIC will soon initiate a multi-center, prospective, randomized controlled clinical trial in China to further validate the clinical efficacy and safety of the BIOMAGIC bioresorbable scaffold on a larger scale and over a longer follow-up period.

This marks a significant milestone in product development for BIOMAGIC, founded in 2013.

A clinical study announced on the same day was led by Professor Huo Yong of Peking University First Hospital as Principal Investigator (PI), with Academician Ge Junbo serving as Co-Principal Investigator (Co-PI). Conducted successively across three centers—Peking University First Hospital, Zhongshan Hospital Fudan University in Shanghai, and Wuhan Asia Heart Hospital—the study enrolled 30 subjects. All patients underwent implantation of a single BIOMAGIC bioresorbable scaffold at a single coronary stenosis site. The trial achieved a 100% device success rate and a 100% procedural success rate.

Professor Huo Yong delivered a special report at the conference, presenting for the first time the 180-day imaging and one-year clinical follow-up results of this multicenter exploratory clinical trial. The data showed that the 180-day in-stent late lumen loss was 0.16 ± 0.13 mm, with 99.83% of stent struts achieving complete endothelialization. Furthermore, zero Patient-Oriented Composite Endpoint (POCE) events occurred (i.e., an incidence rate of 0%); POCE encompasses all-cause death, all strokes, all myocardial infarctions, and all revascularization events.

Following Prof. Huo Yong’s report, Prof. Qian Juying from Zhongshan Hospital, Fudan University, presented in detail the 180-day and 2-year imaging follow-up results of the first-in-human implantation of the BIOMAGIC bioresorbable scaffold, for which she served as the operator. Coronary angiography and optical coherence tomography (OCT) findings revealed that at 180 days post-implantation, the BIOMAGIC scaffold was completely endothelialized, maintained a regular geometry, and the vessel remained patent. The same results were observed at the 2-year imaging follow-up.

Prof. Qian provided a detailed overview of the patient's condition, surgical procedure, device selection, and operational details, and highlighted the importance of the "PSP procedural protocol" in bioresorbable scaffold implantation: adequately pre-dilating the lesion (Pre-dilate the lesion), selecting the appropriate scaffold size guided by OCT imaging (Size appropriately), and post-dilating the implanted scaffold with a high-pressure non-compliant balloon to ensure optimal wall apposition (Post-dilate).

During the conference discussion session, clinical experts fully acknowledged the safety and efficacy data achieved by the BIOMAGIC bioresorbable scaffold, provided specific recommendations for the clinical application of bioresorbable scaffolds already marketed in China, and shared industry insights and personal experiences regarding patient selection, lesion management, procedural standards, and postoperative anticoagulation therapy.

The BIOMAGIC bioresorbable scaffold utilized in the study is a second-generation, polylactic acid-based thin-strut scaffold, serving as the flagship product independently developed by BIOMAGIC. BIOMAGIC was founded by Mr. Robert and Mr. Miao Yongsheng based on a patented technology for next-generation coronary intervention. After more than eight years of continuous research and development, the BIOMAGIC bioresorbable scaffold has entered the NMPA’s “Green Channel for Innovative Medical Devices”.

It is reported that the BIOMAGIC bioresorbable scaffold incorporates a unique directional polymer alignment processing technology in its design and manufacturing. This approach enhances mechanical properties while reducing strut thickness, thereby minimizing degradation products and inflammatory responses, and simultaneously improving the device's handling performance during clinical procedures. Additionally, the stent delivery system ensures precise positioning, and its proprietary anti-dislodgement scaffold design further enhances procedural safety.

In 1977, American physicians successfully performed the first percutaneous transluminal coronary angioplasty (PTCA), ushering coronary artery disease treatment into the era of minimally invasive intervention. Since then, interventional therapy has undergone four technological revolutions: balloons, bare-metal stents, drug-eluting stents, and bioabsorbable scaffolds. In 2011, the Absorb GT1 bioabsorbable scaffold (BVS), developed by Abbott, received marketing approval in the European Union, marking the debut of fourth-generation interventional technology.

BVS refers to a class of scaffolds that utilize materials capable of gradual degradation and absorption by the human body as the scaffold backbone. In vivo, BVS primarily undergoes three phases: revascularization, restoration of vascular function, and resorption. Studies have demonstrated that BVS exhibits excellent biocompatibility. Following its degradation and absorption by the body, vasomotor function is effectively restored, thereby avoiding a series of complications and potential risks associated with the permanent retention of metallic stents within the vasculature.

In September 2017, Abbott unexpectedly announced the market withdrawal of the Absorb GT1, momentarily plunging the BVS sector into a downturn. At the time, Abbott's research indicated that, compared to metallic drug-eluting stents (DES), the Absorb GT1 bioresorbable scaffold might carry a slightly elevated risk of thrombosis. Mr. Miao Yongsheng pointed out that extensive research has demonstrated that, aside from the inherent room for improvement in the Absorb scaffold itself, the primary factors contributing to this risk included: the enrollment of a considerable number of patients with small vessels (lesion vessel inner diameter < 2.5 mm) in several core clinical trials of the Absorb scaffold; a very high proportion (over 80%) of procedures that failed to adhere to the subsequently internationally promoted and currently widely accepted "PSP procedural protocol"; and an insufficient duration of dual antiplatelet therapy (DAPT) for patients following bioresorbable scaffold implantation.

In fact, prior to the market withdrawal of Abbott's Absorb GT1, physicians had already formulated the "PSP procedural protocol" for BVS by integrating practical clinical experience with data from extensive clinical studies. This provided direction for subsequent clinical research and practice. In recent BVS-related studies, the proportion of cases adopting the PSP protocol has steadily increased, and the incidence of thrombosis has decreased to the level of metallic drug-eluting stents (DES).

With the successive approval and market launch in China of Lepu Medical’s NeoVas bioresorbable stent in February 2019 and Hua’an Biological’s Xinsorb bioresorbable stent in March 2020, coupled with the ongoing release of clinical efficacy and safety data for polylactic acid (PLA)-based bioresorbable stents such as MicroPort’s Firesorb, Bioheart’s stent, and BIOMAGIC’s stent, the bioresorbable stent sector is beginning to emerge from a downturn. Mr. Miao Yongsheng pointed out that the development of BVS through challenges further validates, from another perspective, the value of evidence-based medicine in the R&D of high-end medical devices and clinical practice. The continued advancement of BIOMAGIC’s bioresorbable stent following the market withdrawal of Abbott’s BVS is also grounded in comprehensive and in-depth preclinical research and testing of the company’s product, objective and rigorous analysis of all relevant data, and a thorough understanding of global clinical research data in the BVS and drug-eluting stent (DES) fields.

Mr. Miao Yongsheng told VCBeat that BIOMAGIC is a typical innovative enterprise co-founded by scientists and entrepreneurs. His co-founder, Mr. Robert, previously served as a Senior Product Development Engineer and Project Manager at leading global coronary intervention companies such as Boston Scientific, Medtronic, and Abbott, and has witnessed firsthand virtually every technological revolution in the coronary intervention field.

Among them, Robert was personally involved in the design and development of balloons, metal stents, and BVS, understanding the key technical requirements of each product generation and how they were constrained by the materials and processing technologies of the time. Robert possesses a profound understanding of product performance requirements, the characteristics and limitations of various testing methods, the detailed specifications for each manufacturing stage, and the clinical risks and benefits associated with different combinations of parameter variations. "He is thoroughly familiar with the technical rationale behind the market launch and eventual discontinuation of each product generation," Mr. Miao Yongsheng stated. "The unique characteristics and complexity of BVS require designers to possess extensive relevant experience."

Mr. Miao Yongsheng is a research-driven entrepreneur. Early in his career, after earning his bachelor’s degree in Pharmacology from Shanghai Medical College of Fudan University, he stayed on as a teaching assistant for two years. He later pursued his studies in the United States, obtaining a Ph.D. in Neurobiology and Molecular Biology from the University of Wisconsin, followed by an MBA from the University of Chicago Booth School of Business. Prior to studying abroad, Mr. Miao had already accumulated nearly four years of sales experience at BASF China. After completing his MBA, he has held senior executive positions at companies including Johnson & Johnson, Abbott, and Tai Mei Medical, amassing extensive expertise in the commercialization of cardiovascular and other medical devices.

“Having served multinational medical device companies for nearly 20 years, one of the most memorable experiences was helping Johnson & Johnson expand the drug-eluting stent market in China around 2005,” Mr. Miao Yongsheng recalled to VCBeat. At that time, the market scale held by international giants such as Johnson & Johnson, Medtronic, and Boston Scientific in China was quite limited, and Abbott had just entered the Chinese market. Mr. Miao was responsible for formulating and executing strategies tailored to the Chinese market, encompassing drug-eluting stent product positioning, marketing planning, physician training, and commercial operations. “At that time, J&J placed great importance on promoting this product across the Asia-Pacific region and naturally placed particular emphasis on applying the logic of evidence-based medicine to market practices.”

During that period, Mr. Miao Yongsheng and his team frequently engaged with doctors in China. Through learning and exchange, they jointly advanced multiple collaborative clinical studies, laying the foundation for clinical promotion. The commercialization model they established was subsequently adopted by an increasing number of high-end medical devices entering the Chinese market.

This strategy of driving the commercialization of innovative products based on clinical evidence-based medicine has also been applied by Mr. Miao Yongsheng at BIOMAGIC. “Innovative medical devices can only be successfully applied to patients once they are integrated into the clinical workflow of physicians,” Mr. Miao Yongsheng pointed out. “From the very beginning of its design and development, the BIOMAGIC bioresorbable stent incorporated considerations for clinical pain points, which to some extent facilitated the smooth progression of subsequent clinical studies.”

Regarding the upcoming large-scale prospective clinical study of the BIOMAGIC bioresorbable scaffold, Mr. Miao Yongsheng expressed great anticipation, “We will obtain a substantial amount of high-quality clinical data, accumulating valuable experience for subsequent product design optimization and technological iteration, to create innovative products that truly elevate clinical treatment standards and deliver long-term benefits to patients.”