Co-Ablation

by Hygea Medical Technology Co., Ltd.  · Based in China → — Leading innovator in advanced medical devices for interventional oncology.
General Surgery Interventional Radiology Oncology
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Regulatory Status Disclosed

Overview

The Co-Ablation System by Hygea Medical Technology Co., Ltd. is a cutting-edge medical device designed for minimally invasive tumor treatment. It uniquely integrates ultra-low-temperature cryoablation (as low as -196 °C) with controlled high-temperature heating (up to +85 °C) within a single system. This combined approach aims to achieve more comprehensive tumor destruction while minimizing damage to surrounding healthy tissue. The system offers physicians enhanced control, procedural safety, and clinical flexibility across various tumor types. It is utilized in open, minimally invasive, or endoscopic surgical procedures, employing sterile, single-use probes to deliver cryogen (liquid nitrogen) to the target tissue under imaging guidance. This allows for precise visualization of ice ball formation and controlled treatment, making it a versatile tool in interventional oncology.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Integrates cryoablation (-196 u00b0C) and hyperthermia (+85 u00b0C) in one system
  • Achieves precise and comprehensive tumor destruction
  • Minimizes bleeding and reduces risk of tumor cell seeding via needle track ablation
  • Enables large-volume ablation with fewer probes and punctures
  • Features efficient vacuum-insulated probes to minimize non-target injury
  • Offers a wide probe portfolio and multi-channel capability for tailored treatments
  • Provides imaging-guided iceball visibility for accurate ablation margins
  • All-in-one design with built-in cryotank and warmtank for ease of use and mobility
  • Multiple models (AI Epic series: P40, S40, S20) available
  • Prolonged shelf life for better clinical application

Use Cases

  • Treatment of advanced lung cancer
  • Treatment of liver cancer and liver metastases
  • Treatment of kidney cancer
  • Treatment of pancreatic cancer
  • Treatment of bone and soft tissue tumors
  • Pain management by freezing nerve tissue

What Physicians Need to Know

Key Capabilities
The AI Epicu2122 series Co-Ablation System integrates ultra-low-temperature cryoablation (-196 u00b0C) with controlled high-temperature heating (+85 u00b0C) within a single minimally invasive system. It offers enhanced precision, powerful cryoablation performance, and an integrated high-intensity hyperthermia function to minimize probe tract bleeding and reduce the risk of tumor seeding metastasis. The system enables large-volume ablation with fewer probes and punctures, features an efficient vacuum-insulated probe to minimize non-target injury, and provides a wide probe portfolio with multi-channel capability for tailored treatment strategies. Imaging-guided iceball visibility facilitates accurate ablation margins and confident tumor coverage. The all-in-one compact unit includes a built-in cryotank and warmtank for easy use and agile mobility, complemented by a wireless full-featured tablet with intuitive UI and surgery planning features.
Clinical Utility
The Co-Ablation System is designed to destroy solid tumors in various surgical fields, including general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery. It is effective for treating prostate and kidney tissue, liver metastases, tumors, skin lesions, warts, and for the palliation of tumors in the oral cavity, rectum, and skin. Clinical evidence supports its safety and feasibility for malignant lung tumors, demonstrating acceptable adverse event rates, favorable local tumor control (especially for tumors u22643 cm), and significantly lower rates of pleural effusion and hemoptysis compared to conventional cryoablation. The system also shows promise in improving disease control in advanced non-small cell lung cancer (NSCLC) patients with oligo-residual disease when combined with anti-PD-1/L1 therapy, and provides rapid, significant, and durable pain relief for patients with painful bone tumors.
Integration Options
The Co-Ablation System is a mobile medical equipment that requires guidance by computerized tomography (CT) or ultrasonic diagnostic instruments for precise targeting. It includes a cryotank, warmtank, valves, insulated pipes, a control/display system, and sterile temperature probes for monitoring. The ELITE Sterile Co-Ablation Probe is compatible with the system's broad ablation range.
Compliance Status
The Co-Ablation System obtained the CE Marking Certificate in 2020, enabling its marketing in European countries. It received FDA 510(k) premarket notification approval on January 29, 2025, classifying it as a Class II device (Cryosurgical Unit And Accessories). The device is subject to FDA requirements, including registration and listing, labeling, medical device reporting, and Quality System (QS) regulation (21 CFR Part 820). Non-clinical testing, including electrical safety, electromagnetic compatibility, usability, software verification, sterilization validation, biocompatibility, shelf life, ex-vivo, and animal testing, confirmed its safety and effectiveness.
Pricing Model
The system aims for cost-effectiveness through lower probe consumption and the use of liquid nitrogen with ethanol, which helps reduce procedural costs. Studies suggest that co-ablation treatment can result in shorter hospital stays and lower total hospitalization expenses compared to traditional surgery and three-dimensional appropriate radiotherapy for lung cancer. For hospitals, the device has a predicted payback period of 2.2 years, with potential for significant net income increase.
User Experience
The system is designed for ease of use and agile mobility, featuring an intuitive user interface and surgery planning capabilities. It offers physicians advanced control during procedures. Patients benefit from faster recovery, shorter average hospital stays, and minimal impact on daily life. Procedures can often be performed under local anesthesia, reducing patient discomfort, and studies have shown a lower rate of postoperative analgesic medication use compared to microwave ablation.
Support Quality
Hygea Medical is a National High-tech Enterprise involved in R&D, production, sales, and marketing, indicating comprehensive support for its products. The company has a global reach, with its systems installed in over 100 top hospitals across more than 25 Chinese provinces. Contact information for support is readily available.
Implementation Complexity
As a mobile medical equipment, the Co-Ablation System requires professionals qualified in co-ablation techniques, with a thorough understanding of the technology, accurate control of indications and contraindications, and extensive experience in perioperative patient management. It necessitates guidance from CT or ultrasonic diagnostic instruments. The all-in-one design with integrated cryotank and warmtank suggests a relatively self-contained system, potentially simplifying setup.
Evidence Base
The Co-Ablation System has a growing evidence base, including numerous clinical cases for lung, bone, liver, and pancreas cancers. Published clinical data in the European Journal of Radiology demonstrates its safety and feasibility for malignant lung tumors based on a retrospective study of over 200 treatment sessions. A prospective, noninferiority, randomized, controlled trial (RCT) showed co-ablation to be noninferior to argon-helium cryoablation for stage III-IV NSCLC in terms of efficacy and safety, with reduced probe usage. Short-term efficacy and safety have been demonstrated for CT-guided percutaneous compound cryoablation for liver malignancies, with a 95% complete remission rate in radical ablation cases. The BOOSTER study provides evidence for improved disease control when combined with immunotherapy for advanced NSCLC. The company holds over 150 Chinese and international patents and has treated over 10,000 cumulative patients.
Physician Tip

Consider the Hygea Co-Ablation System for solid tumor ablation, especially in cases where both extreme cold (cryoablation) and controlled heat (hyperthermia) can optimize tumor destruction while minimizing collateral damage and reducing the risk of tumor seeding. Its demonstrated efficacy in lung, liver, bone, and pancreatic cancers, along with its FDA and CE approvals, supports its use in a broad range of minimally invasive interventional oncology procedures. Leverage the imaging-guided iceball visibility for precise treatment planning and execution. The system's potential for lower procedural costs and faster patient recovery may also be beneficial for both practice economics and patient satisfaction.

The Co-Ablation System is primarily a hardware-based medical device that integrates with standard imaging modalities like CT and ultrasound for real-time guidance. While it features an intuitive UI and surgery planning on a wireless tablet, explicit details on software integration with broader hospital IT systems (e.g., EHR, PACS for automated data transfer or AI-driven diagnostic support) are not highlighted in the available information. Implementation will focus on physical integration within interventional suites and ensuring compatibility with existing imaging equipment.

Details

Category Oncology AI, Surgical AI
Pricing Unknown
DeploymentOn-premise (medical device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Co-Ablation System with Sterile Co-Ablation Probe received FDA 510(k) clearance (K243042) on January 29, 2025. It is intended to destroy solid tumors and abnormal tissue using extreme cold temperatures in various surgical fields.
Integrations
EHR Not specified
Specialties General Surgery, Interventional Radiology, Oncology

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Press & Coverage

The Nation
Mayo Hospital becomes first to adopt China's Co-ablation cancer technology
Mayo Hospital in Lahore, Pakistan, has become the first in South Asia to introduce China's Co-ablation cancer treatment technology, a minimally invasive technique that has successfully treated five patients. The breakthrough follows Chief Minister Maryam Nawaz Sharif's study tour to China and aims to provide new hope for cancer patients in the region.
2025-09
Hygea Medical Technology Co., Ltd.
Co-Ablation System's first commercial use in Turkey has been successfully completed!
Professor Yilmaz successfully performed the first clinical applications of the Co-Ablation System in Turkey on two cancer patients at Varisson Interventional Radiology Clinics. The procedures were successful, and Professor Yilmaz praised the system's technical advantages, including clear treatment boundaries and extreme temperature differentials.
2026-03
The Nation
Punjab launches first Co-Ablation cancer treatment facility
Punjab has inaugurated its first Co-Ablation treatment facility at Mayo Hospital Lahore, a significant step in cancer care for the region. Chief Minister Maryam Nawaz Sharif launched the advanced treatment, which has already shown positive results in treating liver, lung, and breast cancers.
2025-09
Journal of Cancer Research and Therapeutics
Efficacy and safety of the CT-guided co-ablation system in the treatment of malignant melanoma with hepatic metastasis
A retrospective study analyzed the efficacy and safety of the CT-guided co-ablation system in treating hepatic metastases from malignant melanoma, finding significantly longer progression-free and overall survival in the co-ablation group compared to PD-1 treatment alone. The co-ablation system combines low-temperature cryoablation and high-temperature thermal ablation for tumor destruction.
2024-XX
Beijing South Region Oncology Hospital
u3010New Technologyu3011AI Epic Co-Ablation System: Tumor Intervention, Clearing Cancer without Incisions
Beijing South Region Oncology Hospital has introduced the AI Epic Co-Ablation System, an innovative technology that uses deep freezing (-196u00b0C) and heating (above 80u00b0C) via a 2mm-diameter ablation needle to destroy tumor cells. This minimally invasive treatment is suitable for various benign and malignant tumors, offering advantages over traditional methods.
2026-01
The News International
Maryam launches first public-sector co-ablation centre
Punjab Chief Minister Maryam Nawaz inaugurated Pakistan's first public-sector Co-ablation Centre at Mayo Hospital, marking a significant advancement in the country's healthcare. The technology freezes cancer cells at u2013198 u00b0C and then heats them to 83 u00b0C, with initial success reported in treating liver, lung, and breast cancers.
2025-09
Hygea Medical Technology Co., Ltd.
Co-Ablation System: New Generation of Cryoablation
Hygea Medical highlights its Co-Ablation System as a new generation of cryoablation in a detailed video, showcasing its precision and effectiveness in low-temperature cryosurgery procedures. The company emphasizes its cutting-edge technology and exceptional performance in transforming the field of cryosurgery.
2023-11
JMIR Cancer
Co-Ablation System for Pain Management in Bone Metastases: Retrospective Exploratory Study
A retrospective exploratory study investigated the use of the Co-Ablation System for pain management in patients with bone metastases, demonstrating its effectiveness in cancer treatment. The study, conducted from January to October 2024, analyzed patients with histologically confirmed bone metastases treated with the system.
2026-02

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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