Shanghai Bio-heart Announces Registration of Iberis^® RDN System in Thailand

Key Takeaways for Investors

• Shanghai Bio-heart Biological Technology Co., Ltd. (Stock Code: 2185) has announced the successful registration of its Iberis^® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System (Iberis^® RDN system) in Thailand, marking a significant milestone in the company’s international expansion strategy.
• The registration was achieved through the combined efforts of Bio-heart’s subsidiary, Shanghai AngioCare Medical Technology Co., Ltd. (“AngioCare”), and its strategic partner, Biosensors International Group, Ltd. (“Biosensors”).
• This is a potentially price-sensitive development as it demonstrates tangible progress in product commercialization in new markets and highlights the company’s international growth trajectory.

Strategic Partnership and Global Expansion

AngioCare and Biosensors have established a strategic partnership that extends to a wide range of geographies, including but not limited to the European Union, the Asia–Pacific region, and Latin America (LATAM). The focus of this partnership is on the commercialization of the Iberis^® RDN system, which could significantly boost the company’s revenues and global market presence.

Product Differentiation and Competitive Advantage

• The Iberis^® RDN system is currently the only renal denervation (RDN) product globally that is approved for both transradial approach (TRA) and transfemoral approach (TFA).
• The TRA method is noted to make RDN procedures safer, more effective, and cheaper compared to other methods, potentially increasing adoption rates among healthcare providers and patients.
• The company’s ultimate vision is to enable outpatient RDN procedures for patients worldwide, which could revolutionize the treatment paradigm for hypertension and related conditions.
• AngioCare had previously achieved CE marking for the Iberis^® RDN system in Europe in 2016, providing a foundation for further global regulatory clearances and commercial roll-outs.

About Biosensors International Group

Biosensors is a Bermuda-incorporated company and operates as a subsidiary under the cardiovascular and cerebrovascular business division of Bule Sail Medical Co., Ltd. (listed on the Shenzhen Stock Exchange, Stock Code: 002382). With global operations headquartered in Singapore and European headquarters in Morges, Switzerland, Biosensors leverages a combination of direct sales networks and distributors worldwide.

The company is dedicated to meeting the needs of the healthcare community, supporting medical education, and advancing medical science through regular training, summits, and major cardiology congresses, in compliance with ethical and legal standards.

Potential Impact on Shareholders and Share Price

• Shareholders should note that successful registration in Thailand is a concrete milestone that could accelerate regional commercialization and revenue generation for the Group.
• As the only RDN system globally with both TRA and TFA approvals, the product holds a unique market position, potentially increasing its adoption and market share.
• Further expansion through the AngioCare-Biosensors partnership could open up additional markets, strengthening the company’s international foothold.
• Investors should, however, be aware of the risks involved: the company cannot guarantee that the Iberis^® RDN system will ultimately be successfully developed and marketed on a large scale.

Corporate Governance

The board of Shanghai Bio-heart is chaired by Mr. Philip Li WANG, who also serves as an executive director. The board includes both executive and independent non-executive directors, ensuring a balanced approach to governance and oversight.

The company is transparent in its disclosures and complies with the rules of the Hong Kong Stock Exchange.

Conclusion

The registration of the Iberis^® RDN system in Thailand represents an important step in Shanghai Bio-heart’s growth strategy. It underscores the company’s commitment to global expansion, innovation, and strategic collaboration. Investors should monitor further regulatory approvals and commercialization progress, as these could have material impacts on the company’s financial performance and share price.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The company has cautioned that there is no guarantee Iberis^® RDN system will be successfully developed and marketed. Investors should exercise due care and consult with professional advisors before making investment decisions. The author assumes no responsibility for any investment losses resulting from the use of this information.

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