Israeli-Developed Nephrospec Renal Shockwave Technology Enters Clinical Use in China Through Hainan’s Special Medical Access Program
Introduction at Boao Super Hospital highlights China’s evolving framework for international medical innovation and Guorun’s role in connecting global medical technologies with clinical opportunities
BOAO, CN / ACCESS Newswire / November 5, 2026 / Nephrospec, a non-invasive renal shockwave therapy system developed by Israeli medical technology company Curespec Ltd., has been introduced for clinical use at Boao Super Hospital in China’s Hainan province, marking another step in the adoption of international medical innovations through the country’s special regulatory framework.
The introduction was highlighted at a clinical launch event held on October 23 at Boao Super Hospital, where medical and industry representatives discussed the technology’s potential role in managing hypertension associated with chronic kidney disease (CKD).
The event was organized by Guorun International Medical and Health Industry Group (Hainan) Co., Ltd. (Guorun), as part of efforts to facilitate cooperation between international medical technology developers and healthcare institutions in China.
Nephrospec entered clinical use through the special-access provisions of the Boao Lecheng International Medical Tourism Pilot Zone, an initiative that enables eligible overseas medical innovations to be used at designated healthcare institutions before obtaining conventional marketing authorization in mainland China.
The introduction highlights both an emerging approach to renal disease management and the expanding opportunities for international medical technology companies within China’s evolving healthcare innovation ecosystem.
Exploring a Non-Invasive Approach to Chronic Kidney Disease and Hypertension
Chronic kidney disease is a significant global health challenge, particularly among patients who also have hypertension. The two conditions are closely interconnected. High blood pressure can damage the kidneys’ small blood vessels and contribute to progressive renal dysfunction, while declining kidney function can further complicate blood pressure control.
Standard management typically involves antihypertensive medications, lifestyle interventions and ongoing monitoring of cardiovascular and renal risk factors. Researchers are also investigating complementary approaches that target renal blood flow and microcirculation, areas that may play a role in the progression and management of kidney disease.
Developed by Curespec, Nephrospec uses low-intensity electrohydraulic acoustic therapy (eHAT) to deliver controlled shockwaves to targeted regions of the kidneys. Unlike conventional extracorporeal shockwave lithotripsy, which uses acoustic energy to fragment kidney stones, Nephrospec is designed to deliver lower-intensity mechanical stimulation to renal tissue.
The system uses ultrasound guidance to identify treatment areas and direct acoustic energy toward the kidneys. The procedure is non-invasive, requiring neither surgical incisions nor percutaneous access, and can be performed without anesthesia under the device’s treatment protocol.
Research into low-intensity shockwave therapy has explored its potential effects on vascular endothelial function, local blood circulation and biological pathways associated with tissue repair. For Nephrospec, the clinical objective is to investigate whether this approach can improve renal blood flow and contribute to the management of hypertension in patients with CKD.
A feasibility and safety study published in Frontiers in Medical Technology in March 2026 examined electrohydraulic acoustic therapy in patients with CKD and hypertension. The findings contribute to the emerging body of clinical research on the technology. However, larger controlled studies and longer-term follow-up remain necessary to establish its clinical effectiveness, safety profile and appropriate role alongside existing treatment strategies.
China’s Boao Lecheng Expands Pathways for Global Medical Innovation
Nephrospec’s introduction also reflects the growing role of Hainan’s Boao Lecheng International Medical Tourism Pilot Zone as a platform for international medical innovation. Located in southern China, the pilot zone operates under a special regulatory framework that allows designated medical institutions to apply for the use of certain imported drugs and medical devices that have not yet received standard marketing authorization in mainland China.
The framework is intended to address clinical needs while maintaining regulatory oversight of product eligibility, authorized use and patient safety. Recent policy developments have further strengthened the mechanisms supporting international medical innovation in Lecheng.
In December 2025, the Hainan Provincial Medical Products Administration introduced measures aimed at improving regulatory services, strengthening the review of innovative medical products and expanding support for real-world evidence generation. The measures also encourage greater integration between clinical research, product development and industrial commercialization.
In March 2026, provincial authorities issued procedures for preliminary regulatory review of urgently needed imported medicines and medical devices. The pre-review mechanism allows eligible applicants to seek early regulatory guidance before completing certain stages of the formal product introduction process, with the aim of improving submission quality and streamlining subsequent reviews.
Further guidance issued in April 2026 addressed the use of clinical real-world data generated in Lecheng to support registration applications for imported medical products. Together, these developments illustrate China’s efforts to establish a more connected pathway linking regulated clinical access, evidence generation and potential future market authorization.
Importantly, permission for clinical use under Lecheng’s special-access framework does not constitute nationwide marketing approval. Any subsequent registration or broader commercialization remains subject to the applicable regulatory requirements.
For international medical device manufacturers, the framework offers a distinctive opportunity to explore authorized clinical applications in China while generating experience and, where appropriate, scientifically evaluated evidence that may inform future development.
Nephrospec’s Clinical Introduction at Boao Super Hospital
At the October 23 event, Dr. Rivka Fanta, Clinical Affairs Manager at Curespec, presented an overview of Nephrospec’s technology, clinical research developments and experience from international applications.
The system has been introduced through the Lecheng special-access pathway at both West China Lecheng Hospital, Sichuan University, and Boao Super Hospital. Its authorized use in Lecheng focuses on improving renal blood flow for the treatment of hypertension in patients with diagnosed chronic kidney disease, subject to the specific conditions of the relevant approval.
The introduction at Boao Super Hospital provides an additional setting for clinicians to evaluate the technology’s application among Chinese patients. Patient eligibility and treatment decisions must be determined by qualified medical professionals in accordance with the approved scope of use, contraindications and individual clinical circumstances.
As clinical experience develops, structured observation and real-world research may contribute to a better understanding of the technology’s safety, applicability and potential therapeutic value. The project also demonstrates how international medical innovation can be connected with China’s clinical resources through a regulated early-access environment.
Guorun Connects International Medical Innovation With Clinical Opportunities in China
The Nephrospec clinical introduction event was organized by Guorun International Medical and Health Industry Group (Hainan) Co., Ltd., a company focused on connecting international medical technologies with healthcare and industry partners in China.
Operating within the Boao Lecheng medical innovation ecosystem, Guorun’s business activities focus on international medical technology cooperation, clinical application pathways and commercialization opportunities. Its involvement in the Nephrospec project illustrates the importance of coordination among overseas technology developers, Chinese healthcare institutions and local industry partners.
For international medical device companies, entering a new market requires more than identifying a potential distributor. It also involves understanding the regulatory environment, identifying appropriate clinical partners, assessing medical needs and developing a sustainable approach to market access.
Through its work with international medical technology partners, Guorun seeks to facilitate these connections and support the progression of eligible innovations from initial market engagement toward clinical and commercial opportunities. The Nephrospec project provides an example of how cooperation among international developers, medical institutions and local industry participants can support the introduction of innovative healthcare technologies under an established regulatory framework.
Building Clinical Evidence for Future Development
Although Nephrospec has entered clinical use at designated institutions in Lecheng, its broader clinical potential remains subject to continued scientific evaluation. Further research will be important in determining which patient populations may benefit, how the technology performs under different clinical conditions and whether improvements in renal blood flow translate into meaningful long-term outcomes.
For healthcare professionals, patients and medical technology developers, the distinction between authorized early clinical use and established clinical effectiveness remains essential. At the same time, the project reflects a broader shift in international healthcare innovation: moving beyond product introduction toward a more integrated process involving clinical evaluation, evidence generation and responsible market development.
As Hainan continues to refine its regulatory and clinical research infrastructure, Boao Lecheng is positioning itself as a point of engagement between international medical innovation and China’s healthcare system. The introduction of Nephrospec at Boao Super Hospital offers a practical example of that approach, bringing together overseas medical technology development, China’s special-access policies and industry collaboration in support of further clinical investigation.
About Curespec
Curespec Ltd. is an Israel-based medical technology company developing non-invasive electrohydraulic acoustic therapy for kidney-related conditions, including hypertension associated with chronic kidney disease. Its Nephrospec system is designed to deliver low-intensity acoustic stimulation to targeted renal tissue as part of ongoing efforts to explore complementary approaches to kidney disease management.
About Boao Lecheng International Medical Tourism Pilot Zone
The Boao Lecheng International Medical Tourism Pilot Zone is a healthcare innovation initiative located in Hainan province, China. Under designated regulatory provisions, the pilot zone enables eligible imported medical products to be introduced for authorized clinical use at approved healthcare institutions. It also supports clinical research, international medical cooperation and the development of real-world evidence that may contribute to future regulatory evaluation.
About Guorun International Medical Group
Guorun International Medical Group is a healthcare commercialization company with operations in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China. The company works with international medical technology developers to support their entry into the Chinese market. Its services encompass market entry consultation, regulatory registration support, clinical research collaboration, strategic partnerships, distribution and localization. Guorun focuses on connecting global healthcare innovation with China’s clinical and commercial opportunities, supporting the development and market adoption of innovative medical devices, pharmaceuticals and healthcare products.
Media Contact
Company: Guorun International Medical
Contact: limuyang
Email: contac@guorunmedical.com
Website: https://www.guorunmed.com
SOURCE: Guorun International Medical
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