On September 23rd, the Medical Devices Roadshow was successfully held on 2019 China BioMed Innovation and Investment Conference (2019 CBIIC) in Suzhou Jinji Lake International Convention Center. The roadshow session was co-hosted by China Pharmaceutical Innovation and Research Development Association (PhIRDA) and China Association for Medical Devices Industry (CAMDI), aiming at establishing an efficient communication platform between investment and innovative medical devices and accelerating continuous innovative development of China’s medical devices industry.

Su Wenna, Deputy Secretary-General of CAMDI moderated the roadshow and gave a welcome remark. She shared the current domestic and global situation and development trend of medical device innovation and explicitly analyzed the policies and innovative service support that encourage the development of medical device industry innovation in China, bringing lots of good news to the participants.

 

Su Wenna, Deputy Secretary-General of China Association for Medical Devices Industry (CAMDI)

As the influence of the Medical Devices Roadshow expands in the industry, the CBIIC organizing committee receives a lot of roadshow applications of outstanding innovative medical devices projects from home and abroad each year. In this year, the number of roadshow applications is reaching another record high, after carefully reviewed and selected by the CBIIC Expert Review Committee, 22 outstanding excellent domestic and foreign innovative projects stood out and presented in the roadshow, attracting more than 500 investors. Many investors had established cooperative relationship with roadshow companies.

Medical Devices Roadshow Projects Introduction

1. Commercialization of Injectable Thermogel

Injectable Thermogel is a new type of medical implantable and degradable polymeric hydrogel. It has the reverse sol/gel transition property based on temperature. This material can be used as medical device products aiding surgery, or as a pharmaceutical excipient for drug sustained release. It is a biomaterial platform with broad application prospects. Based on the collaborative research of Professor Jiandong Ding at Department of Polymer Science, Fudan University, the thermogel used in this project has obtained many advances, which makes us lead globally in the competition of this kind of material technology and possess intellectual properties. Also, "injectable thermogel" project relying on Fudan University, won the first prize of science and technology progress of the Chinese Ministry of Education in 2014.

The first product line of thermogels will be registered in the form of Class III medical devices. Indications include injection for endoscopic submucosal dissection (ESD). At present, the research and development progress are to determine the formulation, packaging type, pilot-scale production process, quality testing items and methods of the thermogel. At the same time, a small sample was prepared to verify the biological safety of the material implanted in vivo. Financing is sought for self-built sites or commissioned pilot production for registration and clinical testing. The first batch of thermogel products for medical devices are expected to be on the market in three years, with an annual output value of 100 million yuan and a net profit of 50 million yuan in the short term. The follow-up products of the project are also under development, and will be gradually launched within the next decade, with a final market scale of 10 billion.

Yu Lin, Professor of Department of Polymer Science of Fudan University

2. Pulmonary Drug Delivery Performance Monitor System and Platform

The platform is an integrated system for the global 200 million asthmas and 300 COPDs, it includes end-user APP (Wechat program), monitoring device, doctor’s APP, cloud database, the monitoring device can detect the inhaling duration, flow rate, inhaling position, etc., the end-user app can collect the detected data and delivered to the cloud database, the data can be shared between the patient and the doctor, and can also be analyzed by the doctor to optimize the prescription. The APP can also a communication platform between the patients and the caregivers. The doctor can monitor and/or instruct the patient remotely.

Tong Zhenbo, Chief Scientist of SuZhou Elecomed Electronical Science and Technology Ltd.

3. Non-invasive Skin Closure Device

The non-invasive skin suture device is a second-class medical device, which is suitable for all skin wounds (including regular wounds and irregular wounds). It has great clinical significance and social benefits. For doctors, it greatly reduces the difficulty of suture, greatly improves the efficiency of operation, and reduces the probability of wound infection. For patients: non-invasive suture is conducive to rapid wound healing; eliminates the pain of thread removal; eliminates centipede foot scar. The evaluation of the clinical stage, including skin irritation test and viscous test, is very mature and easy to implement. Significant advantages are as follows: 1. Achieving incision cosmetic suture without removing stitches and leaving scars; 2. Improving the efficiency of doctor's operation; 30 billion-grade blue sea market, low competitive pressure; 4. One-time consumables, continuous profits; 5. Applying for related patents, establishing patent protection clusters (2 authorizations, 7 applications, Research & Development of products to four generations).

Jack Huang, Inventor of Kangshengweichuang

4. A New Generation Product of Cross-linked Hyaluronic Acid Combined with Botulinum Toxin

SciVision Biotech Inc., which was established in 2001 and listed in 2013, is a global technology leader in hyaluronic acid. The core technology of cross- linked hyaluronic acid platform (CHAP) is protected by multinational patents. Dermal fillings, single-injection viscosupplements and absorbable anti- adhesive gels produced through the self-developed CHAP technology have been sold to more than 30 countries worldwide. Moreover, SciVision Biotech Inc. has also formed a strategic alliance with international pharmaceutical companies, e.g. Galderma and Kalbe. At present, SciVision Biotech Inc. has combined CHAP technology with high-purity botulinum toxin to develop a new generation product that can avoid the reduction of efficacy and allergies caused by long-term injection of traditional botulinum toxin products. Furthermore, through the cross-linked hyaluronic acid, the botulinum toxin can be stably released which allows the effective period increase and the spreading accurately. The combination and application of SciVision Biotech Inc. core crosslinked hyaluronic acid technology and botulinum toxin are applying for the patent currently.

 

Chen Chun-Chang, R&D Project Manager of SciVision Biotech Inc.

5. Ankon Magnetic-controlled Capsule Endoscopy Contributes to Healthy China

The "Magnetic Capsule Gastroscope System" has achieved breakthroughs in the comfort, systematic and all-round accurate stomach examination of the human body without intubation. It has considerable potential for gastric cancer screening. However, each time the capsule is inspected, it will produce thousands of capsule endoscopic images. Ankon has developed an artificial intelligence remote reading platform. On the basis of capsule endoscopy, it can realize the collection, safe transmission and cloud storage of digestive medical images, and enable the doctor to read images on mobile; using deep learning technology to utilize a large amount of image data to model typical lesions and model training, and constitute a valuable diagnostic tool for doctors, and finally achieve auxiliary diagnosis and disease screening of digestive diseases. The combination of AI and medical instruments produces smart medical, making local inspections, rapid diagnosis and off-site diagnosis a reality, making large-scale gastric cancer screening possible. Smart medical will be an important boost to Healthy China.

Huan Dandan, Vice President, Secretary of the Board of ANKON Technologies Co., Ltd.

6. Leader in tissue engineering and medical biomaterials medical 3D printing

Zhongda Medical is a backbone enterprise of Sun Yat-sen University.

Based on the strong scientific research capabilities of Zhongda University, it focuses on the R&D and production of innovative Class III implanted medical devices. Company's first product: Decellularized allogeneic nerve repair material - Shenqiao® is the only and the world's second peripheral nerve repair material in the world. It has high biosafety and clinical curative effect. It has entered a period of rapid sales growth; Subsequent product layout: (1) 3D titanium metal print funnel chest orthopedic bracket product, used to replace the traditional stainless steel forging process steel strip, can achieve personalized design for different funnel chest shape, get the registration test in September 2019 to enter the clinical; (2) Corneal patch for repairing corneal stromal defects caused by trauma and inflammation, and half of the clinical trials have been completed.

Hu Hongxia, Secretary of the Board, GuangZhou ZhongDa Medical Equipment Co., Ltd.

7. Blood Purification: Anywhere, Anytime

Qidni's core technology: World's smallest wearable blood purification system that:

(i) replaces dialysis and significantly improves quality of life for millions of patients with kidney failure currently on dialysis; (ii) provides access to therapy for tens of millions more who currently do not have access to dialysis.

Current stage: Raising funds for completion of (i) Pre-clinical tests in large animals, (ii) Clinical tests in small group of patients and (iii) support strategic partnership activities.

Qidni/D is world's smallest blood purification device that is wearable and fits in the palm of your hand. It replaces dialysis, provides more frequent therapy and significantly improves the quality of life for patients with kidney failure. The company can charge more based on the added clinical values and lifestyle change.

Qidni Labs was featured at Nobel Prize ceremony in Sweden in December 2018 where Professor Donna Strickland received 2018 Nobel Prize in physics (3rd woman in history). Morteza was student of Professor Strickland.

Morteza Ahmad, Founder of Qidni Labs

8. A Low-cost, Portable Ultrasound- Guided FUS System for Tumour Treatments

The platform will be able to accurately target and treat tumors through advanced phased array technology while monitoring and controlling tissue damage through the proprietary Local Harmonic Motion (LHM) technology or through MRI. The result is the highest throughput, most accurately focused ultrasound system for non-invasive treatment. The system does not require a sterile operating room, and through the LHM technology can be delivered in a portable system that does not require large-scale capital equipment.

Focused Ultrasound: Image-guided focused ultrasound surgery is a method that allows energy to be focused deep in the body noninvasively such that targeted tissue can be thermally coagulated or mechanically destroyed. Thus, this method can be used to ablate tumors in a fashion similar to open surgeries but without the associated side effects and need for a sterile operating environment. These benefits will have a huge positive impact on patients’ quality of life while reducing health care costs.

James O'Reilly, CEO of Harmonic Medical

9.Identification and Protection of Parathyroid Plands During the Operation: Near Infrared Autofluorescence Imaging

According to the consensus of experts on parathyroid protection in 2015, 14%-60% and 4%-11% of patients with thyroid surgery will have temporary and permanent hypoparathyroidism respectively. Thanks to the team's efforts in fluorescence technology, Microsmart have successfully developed a second- class innovative medical device. This device can realize real-time imaging of parathyroid gland in thyroid surgery without any fluorescent contrast agent through autofluorescence imaging technology. Thyroid surgeons' Puzzlement on parathyroid glands is expected to be thoroughly solved through this effort. In addition, the difficulty and problem of autotransplantation of parathyroid gland is that it can not identify parathyroid gland quickly and accurately. During the operation, the survival rate of parathyroid gland implantation was more than 90% within 15 minutes after excision. It is emphasized here that parathyroid glands are transplantable. If the company can quickly and accurately find the parathyroid glands that have been incised, it will undoubtedly provide the last line of defense for the protection of parathyroid glands, and completely eliminate the medical staff trembling.

Yu Zhengyang, Chief Expert of Jinan Microsmart Technology Co., Ltd.

10. The New Era of Tissue Engineering and Regenerative Medicine

In the past decades, scientists have been searching for a technology to retain the natural collagen scaffolds for human tissue engineering. Traditional decellular methods involving using acidic or alkaline solution, organic solvents or ionic detergents may damage the collagen or leave the organic chemicals in the scaffold materials, which elicit some potential drawbacks in preparing the biomaterials for human medical uses. ACRO Biomedical has successfully developed a platform technology using supercritical CO2 (SCCO2) extraction to remove the fats, cells and non-collagenous proteins from animal tissues and organs, while keeping the intact collagen scaffold as biomaterials for tissue engineering. So far, the company has applied the technology on porcine tissues and organs such as skin, bone, cornea, cartilage, artery, heart, kidney and liver. Some products have received regulatory approval from US, Taiwan, Singapore, Philippine and Vietnam. The cornea product is under human clinical trial in Taiwan and is expected to be in the market in 2020.

Dar-Jen Hsieh, CEO of ACRO Biomedical Co., Ltd. 

11.Multivariable Risk Classification of Pelvic Mass Ovarian Cancer -AI Driven Multi-Omics and Multi Parameter In Vitro Diagnosis

The company developed and preliminary verified a new multi-biomarker in vitro diagnosis method using artificial intelligence technology, assessing the risks on women diagnosed with ovarian cancer.

Zhang Zhen, Professor of School of Medicine of Johns Hopkins University

12. Prospects of Compact Proton Therapy System in China Market

Mevion Medical Systems, Inc. is the leading provider of compact proton therapy systems for use in radiation treatment for cancer patients. Its core technology comes from MIT. Mevion’s proton therapy system is the smallest integrated single room system in the world with much lower capital and operating costs than multiroom proton therapy systems. The MEVION S250 Series has an elegant and streamlined footprint of less than 2,000 sq. ft per room, operates with up to 75% fewer staff members, uses up to 90% less energy, has capital costs that are 80% lower than traditional systems and can ramp up to full capacity in as little as three months. In addition, its world-leading HYPERSCAN pencil beam scanning (PBS) technology and exclusive Adaptive Aperture technology has been used for clinical treatment in many well-known cancer centers in North America and Europe (including 6 National Cancer Institute Designated Cancer Center), which contributes to Mevion’s No.1 market share in the U.S. in single room proton systems treating patients. Mevion has completed treatments for over 3600 patients.

Yu Tianning, CEO of Mevion Medical Systems, Inc.

13. Drug-loaded alginate microsphere vascular embolization product for interventional embolization treatment of gynecological benign and malignant tumor

This project is a technical breakthrough, based on ShengYiYao’s previous successful KMG product. Wrapped with sodium alginate, the danazol drug for benign tumors is prepared as a danazol-alginate microsphere vascular embolization agent (D-KMG), which is mainly used during interventional embolization treatment for uterine fibroids, adenomyoma, endometriosis and some other common or frequently-occurring gynecological diseases. Similarly, paclitaxel drugs for the treatment of gynecological malignancies are coated with sodium alginate to prepare a paclitaxel-alginate microsphere vascular embolization agent (P-KMG) for sustained release. P-KMG targets on endometrial cancer, ovarian cancer and other common high-grade gynecological malignant tumors.

Hong Hong, General Manager of Beijing Shengyiyao Technology Development Co, Ltd. 

14. Innovation Lab 2020

PDD is a design and innovation consultancy creating physical and digital products and experiences. PDD have been winning awards and serving the long-standing clients since 1980. With labs in London, Hong Kong and Shanghai, and working in 6 continents, the experienced managers and talented researchers, designers and engineers help companies in the Medical & Healthcare to grow their businesses through innovation. Drug delivery system design and development is one of the core competencies. Innovation Lab 2020 is the name for growth plan and PDD is seeking investment for expanding Shanghai R&D lab and supporting continental Europe expansion following Brexit.

Karsten Fischer, CEO of PDD GROUP LTD.

15. An Outstanding Analyzer Which Greatly Increasing the Efficiency of Thrombosis Prevention and Treatment and An Innovative Perfect Auto POCT Chemistry Analyzer

Thrombosis is the most harmful disease on the globe. Two of most serious shortages in thrombosis control are: 1) Almost Impossible to precisely find thrombosis risk in advance by any other method/analyzer; 2) Antiplatelet medicine is the cornerstone for thrombosis prevention and treatment, but unfortunately in the past no analyzer/method can provide accurate and really useful information: When? what type? and What dosage of antiplatelet medicine should be used for each different and changing Patient correctly. In the past twenty years, more than 20 analyzers developed, but not any of them really success to solve these problems. The Great Aggrestar Analyzer well proved can very easily solve both of the problems: 1) can find out 82%- 100% high risk thrombosis risk patients in advance; 2) can also very easily provide very accurate test report for precisely prescription for each patient. Aggrestar now works for more than 400 famous hospitals and universities China, US and Europe.

Chemifastar is a new concept automatic POCT chemistry analyzer, with the advantages of high-quality result, perfect test menu, complete test methods, standardized as the main stream big chemistry analyzer, very convenient and economic. Suitable for small lab/clinic, ICU, CCU, Emergency Dept of hospitals, Rescue and military medical service.

Zhang Kai, Vice General Manager of SINNOWA Medical Sci. & Tech. Co. Ltd.

16. The Venous Stent

The venous stent is the third category Medical device, it is indicated for the iliac and femoral vein stenoses and occlusions. Domestically, there is no indication for this indication stent. Most of the patients with iliac and femoral vein stenoses and occlusions are implanted artery stent now, which are off- label use and High clinical risk. The venous stent is designed based on the anatomical structure, size and biomechanical properties of iliac vein. two patents of venous stent system had been issued, one is for stent and another is for delivery system. Innomed’s product was also awarded as “Innovative Medical Device” by NMPA, and it will be prior approved to the market. Now Innomed is performing multicenter clinical trial in China, before that, 13 patients had implanted stents in FIH (First in Humen) experiment, and the results preliminary prove stents’ efficacy and safety in the treatment of iliac and femoral veins vein stenoses and occlusions.

Liu Hao, R&D Manager of SUZHOU INNOMED MEDICAL DEVICE CO., LTD.

17. Empowering People to Take Control of Glaucoma – Anytime and Anywhere

People with glaucoma are at risk of going blind, and managing Intraocular Pressure (IOP) is the ONLY way to prevent blindness. Standard IOP measurement (Applanation Tonometry) is insufficient EyemateTM Empowering people to take control of glaucoma – anytime and anywhere. It is an AI- powered, cloud-based, data- centric platform for 24/7/365 monitoring and predictive modelling of disease progression. Big data analytics combine IOP with other vital parameters to enable real-time, personalized therapies. Microsensor can be co-implanted in glaucoma or cataract surgery, integrated in smart intraocular lenses, and enable (closed- loop) sustained release therapies. Eyemate is more value and more available in market and its advantage include 10 years longest use in humans, strong IP portfolio (17 issued & pending patent families), significant trade secrets, CE Marks in 2017 and 2019; FDA- process initiated; First-to-market.

Leo Luo, Managing Director of Hangzhou Angine Biotech Co., Ltd. 

18. Wearable Targeted Neuromodulation Product Series

WAT Medical Technology Inc. (WAT Med) is a manufacturer devoted to innovating the medical devices for personal use with the registered capital of RMB 20 million. More than 36% of people around the world have frequent carsickness, and 25% of people suffer from migraine headaches. WAT Med focuses on the non-drug treatment field of emesis and migraine control. The core technology of targeted neuroregulation is internationally advanced, and WAT possess 56 global patents in this field and medical device registration certificate in seven countries. In 2019, it recently obtained the registration certificate of medical devices in China, with the serial number 20192090318. WAT’s team consists of many overseas scientific research experts and marketing experts, who have many years of experience. Currently, the company has signed cooperation agreements with the medical product dealers from 12 countries. The company cooperate with CVS and Walgreen, the two largest medical chain institutions in America, and reach the strategic cooperation with Guangzhou Phar. Holdings so as to realize the sales in their channels of pharmacy and oncology department. The company obtained angel-round investment of RMB 3 million in 2017, and now is planning to get the A-round financing of RMB 15 million, with sales revenue of 10 million yuan in2018.

Ji Hualei, Chairman of WAT Medical Technology Inc

19. One-time Pre-Filling Sealer with Heparin Sealing Fluid Containing a Specific Amount

With the clinical application of various Indwelling Transfusion pipelines, such as indwelling needle, PICC, CVC and transfusion port, etc. This product is designed to prevent obstruction and thrombosis, which is the first difficult problem in clinical nursing. It successfully prevents and skillfully solves the problems of obstruction and venous thrombosis caused by indwelling pipeline in clinic. Because of the control of the blood volume of physiological saline and the amount of heparin sodium in the catheter, it effectively innovates the existing products and can be widely used. Once it comes out, it can be welcomed by medical staff and patients, and it is a necessary product for clinical use.

Li Dan, Nurse of People's Hospital of Wuhan University

20. Readitec Arcbot

Registration classification: Class 2 equipment and Class 3 equipment Therapeutic field: brachytherapy Clinical stage and results: Product G3 in the registration stage, Product G4 in clinical trials Project highlights: The image processing module follows the international DICOM standard and can be seamlessly connected with the imaging equipment of various manufacturers to realize flexible display of 3D medical images, automatic tracking and calibration of human body orientation and images, and registration of surgical navigation systems and medical images. Fusion, intraoperative synchronized image compensation. Artificial intelligence surgery planning, unique physical center, ultra-high precision intraoperative navigation device, real-time monitoring of treatment process, postoperative on-site effect evaluation, etc., finally complete automated puncture by robot to achieve unmanned internal radiotherapy, revolutionizing radioactivity Particles are implanted into clinical pain points.

William Qu, CEO ofReaditec Technology (Chengdu) Co., Ltd.

21. Iron-based Bioresorbable Vascular Scaffold

As the fourth technology revolution in vascular intervention, bioresorbable scaffold is the development direction of next generation technology. Iron-based bioresorbable vascular scaffold developed by Yuanxin is the only stent made of iron that has been under clinical study. After solving the problem of slow corrosion, iron-based bioresorbable vascular scaffold has the potential to replace permanent metallic stents, due to its excellent mechanical performance, full specifications and reasonable degradation profile. Now Yuanxin have three types of iron-based bioresorbable vascular scaffolds, for the treatment of coronary artery stenosis, pulmonary stenosis and below-the-knee artery stenosis, respectively. After implantation, the iron-based bioresorbable vascular scaffold could keep intact at 3 months, and nearly totally degrade around 1.5 years.

Wen Taoyuan, Head of Public Relations/Administration of Yuanxin Scientific (Shenzhen) Co., Ltd.

22. Non-invasive,Continuous Hemodynamic Monitoring

The non-invasive hemodynamic monitoring system is an international advanced product. It can non-invasively monitor blood pressure and hemodynamic synchronously. This system is certificated by FDA, CE and CFDA as classes II medical device and more than 100 international invention patents. The main clinical application areas are anesthesia, cardiology, ICU, intensive care and any other departments to achieve prediction, prevention, accurate intervention in blood pressure fluctuations, individualized volume management and drug treatment. It is used in more than 300 first class hospitals such as Chinese PLA General Hospital, China West Hospital, Xiangya Hospital Center South University. The system exempts patients from complications caused by arterial puncture, greatly reducing mortality, medical risks & expenses, on the other hands, improving surgical safety, postoperative rehabilitation, hospital bed turnover and benefit.

Chen Yaoyong, Vice President of Zhejiang Shanshi Biological Medical Devices (Shangqiu) Co., Ltd.