Shanghai Bio-heart Announces Iberis® RDN System Registration in Israel – Key Developments for Investors
Highlights and Details of the Announcement
- Shanghai Bio-heart Biological Technology Co., Ltd. (Stock Code: 2185) announced the successful registration of its Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System (“Iberis® RDN system”) in Israel.
- This registration was achieved through the efforts of its subsidiary, Shanghai AngioCare Medical Technology Co., Ltd. (“AngioCare”), in partnership with Biosensors International Group, Ltd. (“Biosensors”).
- The strategic partnership between AngioCare and Biosensors covers commercialization of the Iberis® RDN system across multiple key markets, including the European Union, Asia–Pacific, and Latin America.
- The Iberis® RDN system stands out as the only renal denervation (RDN) product globally approved for both transradial approach (TRA) and transfemoral approach (TFA). The TRA offers significant advantages, including improved safety, efficacy, and reduced costs, which may facilitate outpatient RDN procedures worldwide.
- The device previously obtained CE marking in Europe in 2016, validating its regulatory credentials in another major market.
About the Strategic Partner: Biosensors International Group
- Biosensors is a subsidiary of Bule Sail Medical Co., Ltd. (listed on the Shenzhen Stock Exchange, Stock Code: 002382), with global operations and headquarters in Singapore and European HQ in Switzerland.
- Biosensors has a robust global sales and distribution network, focusing on cardiovascular and cerebrovascular medical devices.
- The company is also committed to supporting medical education, scientific progress, and patient care through regular training courses, summits, and symposia.
What Investors and Shareholders Need to Know
- Completion of registration in Israel significantly expands the market potential of the Iberis® RDN system, providing access to the Israeli and potentially broader Middle Eastern markets.
- The Iberis® system’s unique approval for both TRA and TFA could be a competitive differentiator, enhancing the product’s market uptake by offering safer, more effective, and cost-efficient procedures.
- Outpatient RDN procedures, if adopted globally, could drastically alter the landscape for hypertension treatment and expand the addressable market.
- The company cautions, however, that there is no guarantee of ultimate commercial success for the Iberis® RDN system. Shareholders and potential investors should conduct due diligence and exercise care in trading the company’s shares, as the medical device sector is subject to clinical, regulatory, and market risks.
- This announcement could be price sensitive as it reflects progress in global commercialization and regulatory milestones, which are key value drivers for a medtech company.
Leadership Update
The current Board comprises: Mr. Philip Li WANG (Chairman and executive director), Mr. Yunqing WANG and Ms. Peili WANG (executive directors), and Mr. Yiqing CHEN, Mr. Xubo LU, and Mr. Yifei JIANG (independent non-executive directors).
Conclusion
The registration of the Iberis® RDN system in Israel is a significant milestone for Shanghai Bio-heart, potentially expanding its international footprint and enhancing its competitive positioning. Investors should monitor the company’s progress in global market access and commercialization closely, as further regulatory approvals and market penetration could drive future share value.
Disclaimer
The above article is for informational purposes only and does not constitute investment advice. All forward-looking statements are subject to risks and uncertainties, including but not limited to regulatory approvals, market adoption, and competitive developments. Investors should consult their own financial advisors before making investment decisions.
【廣東話版本】
上海心脈生物科技Iberis® RDN系統以色列註冊成功 – 投資者重點詳情
公告重點及詳情
- 上海心脈生物科技股份有限公司（股份代號：2185）宣布旗下Iberis®多電極腎動脈射頻消融導管系統（Iberis® RDN系統）已於以色列成功完成註冊。
- 註冊工作由子公司上海心護醫療科技有限公司（AngioCare）聯同合作夥伴生物傳感國際集團有限公司（Biosensors）共同推動完成。
- AngioCare與Biosensors的戰略合作涵蓋歐盟國家、亞太地區及拉丁美洲，針對Iberis® RDN系統的商業化推廣。
- Iberis® RDN系統是目前全球唯一同時獲批經橈動脈（TRA）及經股動脈（TFA）兩種入路方式的腎神經消融產品。TRA帶來更高安全性、有效性和更低成本，有望推動全球日間手術治療高血壓。
- 該產品早於2016年已獲歐盟CE認證，顯示其在國際市場上的合規實力。
合作夥伴簡介：生物傳感國際集團
- Biosensors為藍帆醫療股份有限公司（深交所上市公司，代號：002382）旗下子公司，總部設於新加坡，歐洲總部設於瑞士。
- 集團具備完善的全球銷售和分銷網絡，專注心腦血管醫療器械。
- 同時積極推動醫學教育，支持醫學科學發展及提升病人護理質素。
投資者及股東需知事項
- 以色列註冊成功將大大拓展Iberis® RDN系統的市場前景，打開以色列及潛在中東市場大門。
- 產品同時獲批TRA及TFA入路，或成為未來市場競爭關鍵，有助提升接納度及推廣日間高血壓消融治療。
- 如日間RDN手術於全球普及，將顛覆現有高血壓治療模式，擴大可服務市場。
- 公告同時提醒，公司不能保證Iberis® RDN系統最終能成功商業化，投資者應審慎評估相關風險，因為醫療器械行業受臨床、監管及市場多方面風險影響。
- 此消息具備潛在股價敏感性，因涉及公司全球商業化及監管重要里程碑，屬於醫療科技公司價值主導因素之一。
董事會更新
現任董事會成員包括：王立平先生（董事長及執行董事）、王雲清先生及王佩麗女士（執行董事）、陳宜青先生、魯旭波先生及蔣一飛先生（獨立非執行董事）。
總結
Iberis® RDN系統在以色列註冊成功，是公司國際化進程一大重要里程碑，有助加強市場競爭力及推動未來增長。投資者應密切關注公司未來在全球市場進展，因進一步監管批文及商業化落地，將有機會成為股價上升催化劑。
免責聲明
以上資訊僅供參考，並不構成投資建議。所有前瞻性陳述均存在風險和不確定性，包括監管審批、市場採納及競爭發展等。投資者應諮詢其財務顧問，審慎作出投資決定。
