HONG KONG, Aug 11, 2025 - (ACN Newswire) - Cryofocus Medtech (Shanghai) Co., Ltd. ("Cryofocus" or the "Company," Stock Code: 6922.HK), a global innovator in minimally invasive interventional cryotherapy, last friday announced its unaudited interim results for the six months ended June 30, 2025. The Company demonstrated robust growth momentum and significant operational optimization during the reporting period, with key financial metrics delivering exceptional performance. Notably, its respiratory intervention product portfolio fueled a substantial revenue surge, marking accelerated commercialization progress.

Respiratory Intervention Products Emerge as Core Growth Engine, Highlighting Global Competitive Edge

The Company recorded revenue of RMB51.1 million for the first half of 2025, a 162.4% increase from RMB19.5 million in the same period of 2024, setting a new historical high. This growth was primarily attributable to the strategic focus on respiratory intervention products entering a harvest phase: The Malignant Stenosis Cryoablation System, approved by China’s National Medical Products Administration (NMPA) in March 2025, and the previously commercialized Cryoadhesion System, experienced rapid sales expansion, becoming the dominant revenue drivers. Additionally, the distribution partnership with Boston Scientific’s China affiliate, BSC International Medical Trading (Shanghai) Co., Ltd. (“BSC”), contributed significant incremental revenue from other respiratory intervention products in mainland China.

Of particular significance, the Company’s Asthma Cryoablation System received "Breakthrough Medical Device" designation from the U.S. Food and Drug Administration (FDA) – the first such international recognition for a Chinese enterprise in the respiratory interventional cryotherapy field – laying a foundation for global market expansion.

Cryofocus has established a highly competitive respiratory intervention portfolio addressing critical indications, including malignant stenosis, benign stenosis, asthma, chronic obstructive pulmonary disease (COPD), peri-pulmonary nodules, chronic cough, and airway tuberculosis. Among these: The Malignant Stenosis Cryoablation System has been successfully commercialized in China; systems for asthma and COPD are in confirmatory clinical trials with expected approvals in 2026; products for cough, tuberculosis, and peri-pulmonary nodules are in various R&D stages; and the Cryoadhesion System (including disposable and re-sterilizable cryoprobes) is approved and marketed. These innovations mainly stem from Cryofocus’s two core technology platforms: unique liquid nitrogen-based cryoablation technology (utilizing liquid nitrogen as the cryogenic energy source) and advanced flexible catheter technology. This integrated platform enables deep low-temperature treatment, precise control, and minimally invasive intervention, offering superior therapeutic efficacy and safety while creating significant technological barriers for competitors.

Platform Value Multiplies as Multi-Segment Strategy Accelerates Commercialization

Cryofocus’s core value extends beyond its respiratory pipeline, underpinned by its distinction as an innovative cryotherapy platform enterprise. Leveraging its liquid nitrogen and flexible catheter technologies, the Company has successfully expanded into multiple high-potential therapeutic areas:

In the vascular intervention segment: The Atrial Fibrillation (AF) Cryoablation System (for atrial fibrillation treatment) was commercialized in China in September 2024. The Cryofocus Renal Denervation (Cryo-RDN) System (for hypertension treatment), granted FDA Breakthrough Device designation, is in confirmatory clinical trials. The Pulmonary Hypertension Cryoablation System is currently in the stage of pre-clinical study. The market space for all these related cardiovascular indications is very huge.

In the Natural Orifice Transluminal Endoscopic Surgery (NOTES) segment: The respiratory intervention portfolio, as detailed, is rich and leading. The cancer intervention portfolio includes the commercialized Bladder Cryoablation System; the Gastric Cryoablation System and Esophageal Cryospray System are in clinical trials targeting gastric and esophageal cancer markets.

In non-cryotherapy products: Commercialized items such as the Pulmonary Nodule Localization Needle and Endoscopic Clip for Anastomosis, alongside pipeline products like the Atrial Fibrillation Pulsed Field Ablation (PFA) System and Anti-Gastroesophageal Reflux System, create complementary synergies.

This "one-platform, multi-therapy" model endows Cryofocus with exceptional adaptability for indication expansion and pipeline sustainability. The Company currently boasts a robust portfolio of 23 products and candidates: 14 cryotherapy and 9 non-cryotherapy items, with 11 already commercialized. Such platform-based diversification is rare among single-therapy medical device firms, highlighting substantial long-term growth potential and risk resilience.

Strong Financial Performance and Sustained Growth Momentum

Beyond the revenue surge driven by respiratory products, Cryofocus’s interim results signal positive ongoing growth. The Company’s technological advantages further translated into financial resilience. Gross profit reached RMB34.3 million for the first half of 2025, up 124.5% year-on-year, with a solid gross profit margin of 67.1%. Enhanced R&D efficiency led to significantly reduced losses. R&D expenses optimized to RMB17.9 million (down 51.9% year-on-year), while the period loss narrowed 51.4% to RMB27.2 million, demonstrating a clear trend toward profitability. Cash reserves increased 40.1% from year-end 2024 to RMB63.7 million, providing a solid foundation for sustained R&D and market expansion.

Revenue diversification and quality improved as high-value self-developed products (e.g., Malignant Stenosis Cryoablation System) launched and scaled, complemented by deepening collaboration with BSC. The significant reduction in R&D expenses reflects improved efficiency and reduced consumable needs as products advance, driven by optimized personnel costs and management enhancements. This establishes a sound framework for balancing innovation intensity with cost control.

Furthermore, the Company increased investment in sales network development, with selling and distribution expenses rising 174.4% year-on-year to RMB9.2 million, underscoring proactive resource allocation to build marketing teams and promote newly launched products (e.g., Malignant Stenosis Cryoablation System), laying groundwork for future sales scale expansion.

Global Peer Benchmark Highlights Valuation Potential

Cryofocus’s technological strength in respiratory interventional cryotherapy, particularly in FDA-designated areas like asthma treatment, positions it competitively against global leaders.

Benchmarked against Inspire Medical Systems (INSP) (focusing on OSA neurostimulation, differing in indication but similar in respiratory neuro-intervention): Inspire currently holds a market capitalization of US$2.279 billion and a trailing-twelve-month (TTM) P/E ratio of 44.28x. Cryofocus’s Asthma Cryoablation System similarly targets pulmonary vagal nerves via minimally invasive ablation, with an innovative pathway validated by FDA Breakthrough status. Yet, as a diversified platform innovator with a broad pipeline and multiple commercialized products, Cryofocus’s current Hong Kong market valuation (Inspire’s market cap is 12.8x Cryofocus’s) significantly trails Inspire’s.

This substantial valuation gap, while influenced by factors such as differing markets (US vs. HK), stages of development (Inspire being profitable and established in the US market), and a single-product focus versus a platform model, nonetheless clearly underscores the significant upside potential in Cryofocus Medtech's current market valuation relative to its technological capabilities, the breadth of its product pipeline, and its potential for globalization breakthroughs. With the advancement of clinical progress for its respiratory intervention products (particularly the Asthma Cryoablation System COPD Cryospray System Peri-Pulmonary Nodule Cryoablation System), the clarification of overseas registration pathways, and the continued high-speed growth in its revenue scale, a market re-rating of its value represents a high-probability event. The current valuation level presents an attractive window of opportunity for investors bullish on the long-term prospects of the minimally-invasive interventional cryotherapy sector and the value inherent in a platform company model.

Looking ahead, Cryofocus maintains a clear strategy: rapidly advance clinical development and commercialization of pipeline products; deepen focus on minimally invasive interventional cryotherapy while expanding the portfolio leveraging its core platforms; continuously invest in underlying and supporting technologies; and selectively expand global operations. The Company is steadily transitioning from R&D-driven to a dual-engine model integrating R&D and commercialization, advancing resolutely toward its vision of becoming a "global platform for minimally invasive interventional cryotherapy medical devices."

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