Introduction to cjy nutas

NUTAS – Non-invasive Ultrasound

Tumor Ablation System

Shenyang Changjiangyuan Technology Development Co., Ltd.

Contents

NUTAS Introduction 1

NUTAS R&D Process Introduction

NUTAS Working Principal of Breast

Cancer Treatment 3

2

NUTAS Features and Advantages for

Breast Cancer Treatment

4

Current Industry Products Situation

on International Market 5

Appearance and Composition

Appearance and Composition

The design of NUTAS adheres to the simple, practical concepts. Both R&D process as well as manufacturing procedure is in strict accordance with China National Standards (YY0592-2005) and guiding principles for high-intensity focused ultrasound therapy system (SFDA2003) issued by China Food and Drug Administration (short for "CFDA"), and other relevant standards.

NUTAS mainly consists of FOUR parts •Console Unit •Therapy Body Unit •Water Process Unit •Ultrasound Positioning and Monitoring System

Generating tumor therapy

scheme in real time

Controlling therapeutic

ultrasound transmission

Monitoring the whole therapy

progress in real time

Console Unit

Console Unit

Console Unit

Therapy Body Unit

The front part is called

Treatment Bed It is the carrier when

NUTAS treating cancer

patients. The patients

lie prone on the bed

surface to receive

treatment. The back part is called Workstation.

On both sides of workstation, there is

Nurse Workstation including two scalable

LCD screens, which is

responsible for the real-time monitoring of patient status on the bed.

The main role of the upper central LCD of Workstation is to display the

therapeutic process in real time.

Therapy Body Unit

Tumor positioning and real-time

monitoring system,

Color Doppler Ultrasound

Diagnostic Instrument

Positioning of GTV

Real-time monitoring of the

therapeutic process

Tumor Positioning and Real-time

Monitoring System

Providing medium water to meet the standard for

ultrasound transmission in therapeutic process.

Water Process Unit

Contents




Cancer Treatment 3

2



4



Changjiangyuan Technology Development Co., Ltd. (short for "CJY Technology") is a nationally recognized high-tech enterprise specializing in

research & development, production and sales of large-scale sophisticated medical equipment. Since founding in 1999, CJY Technology has established long-term cooperation with Tsinghua University, Institute of Acoustics, Chinese Academy of Sciences, Harbin Institute of Technology, Beijing Jiaotong University, and other well-known domestic universities. We have built up integrative scientific research and production system of industry, academia, research; and developed the world's leading Non-invasive Ultrasound Tumor Ablation System (hereinafter referred to as "NUTAS").

CJY T echnology i s located in high-tech industrial development Zone, Shenyang City, Liaoning Province, China. Since its establishment, the company has been keeping innovation as development guidance, "healthy therapy" as direction, cutting-edge technology as foundation and benefiting mankind as ultimate goal. Taking advantage of existing technology, CJY Technology has built

modern enterprise integrating R&D, production, training and clinic of high-end medical equipment. The picture shows the company's manufacturing base in Shenyang.

Company Profile

The R&D center of CJY Ttechnology is supported by academicians of

International Academy of Medical and Biological Engineering Sciences

and Chinese Academy of Engineering as chief scientists, and composed of a

group of senior professors, young and middle-aged experts with outstanding

scientific research capacity, most of whom come from key universities including

Tsinghua University, Beijing Institute of Technology, Harbin Institute of

Technology, etc. These provide strong technical support for technological

upgrading and product evolution.

R&D Team

Ni Guangnan, academician of Chinese Academy of Engineering, and

Yang Zibin, academician of the International Academy of Medical and

Biological Engineering Sciences are

giving guidance in the technology.

R&D Process of NUTAS

2000

First generation

prototype

2005

Second generation

prototype

2006

• Proved by ISO9001 and 13485

preliminary inspection

• It is proved by the registration testing of

Wuhan medical instrument quality

supervision and Inspection Center of

CFDA.Clinical verifications are allowed.

core technology

upgrade

standardized

work

clinical

preparations

2007

Third generation

prototype

Animal experiments and

human body clinical

preparations

2008

Clinical verifications are carried

out in the First Affiliated Hospital

of China Medical University

clinical trials stage I

finished 2011

• Fourth generation

prototype

• Preparatory work for export

certification

2012

• Obtain CE certification

preparation

for export

With its original creativity, NUTAS is regarded as world's leading

digital medical product. Part of the patent certificates are

demonstrated.

Our company has obtained:

Intellectual Property of CJY Tech.

No. Description Type Appl.No.

1 A remote-control high intensity focused ultrasound

therapy system

Patent for

invention CN200510086302

2 Tumor positioning method and device designed for

high intensity focused ultrasound transducer

Patent for

invention CN200710123329

3 A high intensity focused ultrasound transducer Patent for utility

models CN200420059430

4 Water container structure of focused ultrasound

therapy system

Patent for utility

models CN201420406679

5 Spherical focused ultrasound transducer with

mobile focal region

Patent for utility

models CN201420427137

6 A high intensity focused ultrasound transducer

& B ultrasound transducer fixture

Patent for utility

models CN200520023221

7 Treatment bed Design patent CN201130358757

8 Water process case Design patent CN201130358759

9 Console unit Design patent CN201130358841

Since the beginning of 2015, as the performance of NUTAS being perfected,

protecting intellectual property has accordingly become a more important

task for our further development, as a result of which an all-around

intellectual property protection strategy has been initiated. The patent filing

work starting on June 2015 intends to declare the accumulated technology

achievements over the past R&D as a whole so as to make a complete

intellectual property rights protection system. The latest submitted undergoing

patents are as follows:


No. Description Type

1 Body position detecting method based on ultrasound

images Patent for invention

2 Control system based on spherical focused ultrasound

transducer with mobile focal region Patent for utility models

3 Torque measurement device of transducer lifting and

rotation mechanism Patent for utility models

4 A portable high precision sound field scanning system Patent for utility models

5 A whole water process unit of high intensity focused

ultrasound therapy system Patent for utility models

6 Water process unit pipeline system of high intensity

focused ultrasound therapy system Patent for utility models

7 Water process unit security system of high intensity

focused ultrasound therapy system Patent for utility models

8 High precision sound field scanning system Patent for utility models


The patent declaring has been continuously undergoing at the moment. The first

phase we intend to declare 84 patents, during which the patents will be divided

according to specific circumstances, thus achieving 150 China National Patents

(30 China National Invention Patents included) so as to forge a fully preservation

for our technology.


1 Virtual control method applied for ultrasound therapy Patent for invention

2 Optimal selected treatment method based on cloud computing Patent for invention

3 A monitoring and controlling method for ultrasound emission power Patent for invention

4 A monitoring and controlling method for movement mechanism Patent for invention

5 A monitoring and controlling method for water process unit Patent for invention

6 A software architecture based on task scheduling module Patent for invention

7 A fast sound field scanning method Patent for invention

8 Real time fault diagnosis method applied for medical equipment Patent for invention

9 Multiple nodes system assessing method based on Ethernet Patent for invention

10 A symmetry protection method for upper and lower computer software system Patent for invention

11 A software protection method based on program slicing Patent for invention

12 Motion state monitoring method based on cloud computing Patent for invention

13 Interface details optimization method based on users ’behavior analysis Patent for invention

14 Optimal interface scheme generating method based cloud computing Patent for invention

15 Body position monitoring method based on ultrasound images Patent for invention

16 Serial port expansion method based on software stimulating Patent for invention

17 A method for optimizing heater’s function Patent for invention

18 A method for breast cancer treatment Patent for invention

19 Fast marking method for breast cancer Patent for invention

20 A airborne sensor images adjustment method for ultrasound tumor therapy system Patent for invention

21 A high precision tumor outline algorithm Patent for invention

22 A water process method for medical equipment Patent for invention

23 A method for ultrasound transducer driving circuits cascading Patent for invention

24 A sealed method for focused ultrasound transducer Patent for invention

25 A body model making method Patent for invention

26 An element connection process of focused ultrasound transducer Patent for invention

27 A laser tubes sealing method Patent for invention

28 An element installment method for focused ultrasound transducer Patent for invention

29 A body position detecting method Patent for invention

30 A voltage automatic adjustment method for focused ultrasound transducer Patent for invention

31 A skeleton structure of medical equipment Patent for utility models

32 A high precision three axis movement mechanism applied for medical equipment Patent for utility models

33 Degassed water applied for medical equipment Patent for utility models

34 A lifting and rotation mechanism applied for medical equipment Patent for utility models

35 A water tank structure applied for medical eqipment Patent for utility models

36 A clamp mechanism for holding Color Doppler Ultrasound probes Patent for utility models

37 A moveable bed surface applied for medical equipment Patent for utility models

38 Patients’ holding surface applied for medical equipment Patent for utility models

39 A focused ultrasound transducer bracket Patent for utility models

40 A Color Doppler Ultrasound probes installation mechanism Patent for utility models

41 A high precision swinging mechanism applied for medical equipment Patent for utility models

42 A monitor installation structure Patent for utility models

43 An energy feedback system for focused ultrasound transducer Patent for utility models

44 A cooler system for focused ultrasound transducer Patent for utility models

45 A shell monitoring system for large medical equipment Patent for utility models

46 Wire continuity testing case Patent for utility models

47 friction testing devices for rotating mechanism Patent for utility models

48 Navigation plug-in installment fastening device Patent for utility models

49 All-around fixers of vibration table Patent for utility models

50 The liner of stretch mechanism testing device Patent for utility models

51 Fast measurement device of wire rod radian Patent for utility models

52 Fast hole site measurement device Patent for utility models

53 Automation temperature cycling test device Patent for utility models

54 A sealed rubber and sealing box for focused ultrasound transducer Patent for utility models

55 A comprehensive performance device designed for testing for each medical equipment part Patent for utility models

56 A debugging box using for circuit board Patent for utility models

57 A focused ultrasound transducer array element conducting resin Patent for utility models

58 Hydrophone with temperature measurement function Patent for utility models

59 Temperature measuring device of thermocouple Patent for utility models

60 A high intensity focused ultrasound drive device based on single-end fly back converter Patent for utility models

61 A high intensity focused ultrasound drive device based on full bridge drive Patent for utility models

62 A high intensity focused ultrasound drive device based on half bridge drive Patent for utility models

63 A high intensity focused ultrasound drive device based on resonance frequency Patent for utility models

64 A high precision motion control system for medical equipment Patent for utility models

65 Water process control system Patent for utility models

66 A infrared temperature measuring device for surface Patent for utility models

67 A client access device applied to medical instrument Patent for utility models

68 A component coordinate the treatment of lymph nodes Patent for utility models

69 Patient position fixation device for medical equipment Patent for utility models

70 A fast packing box for NUTAS Patent for utility models

71 A control panel preventing touch errors applied to medical instrument Patent for utility models

72 A water container with camera Patent for utility models

73 A full adjustment bracket for camera Patent for utility models

74 A positioning equipment for color doppler ultrasound probe Patent for utility models

75 A non - standard quick pipe joint for medical equipment Patent for utility models

76 A patient body position detector Patent for utility models

77 A real-time monitoring device and system for a patient's posture Patent for utility models

78 A software protection method for HIFU system based on program slicing Patent for utility models

79 A water storage buffer device for focused ultrasound system Patent for utility models

80 A full range fixture for vibrating table Patent for utility models

81 A automatic sealing device for focused ultrasound transducer Patent for utility models

82 A fixing device for focused ultrasound transducer Patent for utility models

83 A ultrasound power control system Patent for utility models

84 An embedded software automatic upgrade system Patent for utility models

NUTAS is awarded the Liaoning Science and Technology Research

Achievement, which is identified as international advanced product in 2007.

Leadership Concern

NUTAS has drawn high and close attention from National

Development and Reform Commission, the Ministry of Science

and Technology and national leaders at all levels since its birth.

Over the years, leaders and relevant experts have spoken highly

of NUTAS, required active support from various fields in order to

form industrial scale as soon as possible.

In March 2007, as representative of Chinese high-tech

enterprises, CJY Technology was designated by the Ministry of

Science and Technology to participate in the "Sino-Russian

Friendship Year" in Moscow. At the meeting, Hu Jintao, former

State President and Putin, President of Russia made a special

trip to view the demonstration of NUTAS on site and listened to

our report. NUTAS gained the attention of two heads of states.

Hu Jintao, former State President and Putin, President of

Russia viewed NUTAS demonstration on site.

CJY Technology was designated by State Council to company with Wu Yi, Vice Premier of State Council to attend "World Economic Forum" held in St. Petersburg in June 2007. As delegation member of 19 Chinese enterprises, CJY Technology was the first to conduct business cooperation talks with the special representative of Russian President, and won a good reputation in the world.

Wu Yi, former Vice Premier of the State Council, had a cordial

conversation with the leader of our company. She was listening to the

introduction of NUTAS.

Zeng Peiyan, former Vice Premier of the State Council, Li Keqiang former

Party Secretary of Liaoning province (current Premier of State Council), Chen

Zhengao, former Governor of Liaoning Province（current Minister of Ministry

of Housing and Urban-Rural Development）listened to the introduction of

NUTAS by our leader.

Xu Guanhua, former Minister of the Ministry of Science

and Technology took photos with our leader.

Xu Guanhua, former Minister of the Ministry of Science and

Technology had a cordial conversation with the leader of our company.

Sheng Guangzu, former Director of General Administration of

Customs learnt about NUTAS.

Zhang Wenyue, former Party Secretary of Liaoning province and Chen

Zhenggao, former Secretary of Shenyang Municipal Committee

visited our company.

Xu Weiguo, former vice Governor of Liaoning Province visited our

company.

Zengwei, former Secretary of Shenyang Municipal Committee

(Current Party Secretary of Liaoning province ) visited our company.

CJY Technology was invited to participate in "International Science, Innovation and

Technology Exhibition (INSITE) ".

1 In 2007, China high-tech enterprise representatives are chosen by the Ministry of Science and Technology to participate

in the "Sino-Russian Friendship Year". Among 400 outstanding enterprises in 54 high-tech Zone, 13 companies were

selected as high-tech enterprise representatives.Changjiangyuan Technology Development Co., Ltd is one of them,

which draw attention of heads of states during the exhibition.

2 From 2008 to 2009, NUTAS was listed in National Torch Plan of the Ministry of Science and Technology,

project number 2008GH040121.

3 In 2010, Changjiangyuan Technology Development Co., Ltd was identified as Ultrasound Research Center of Liaoning

province by provincial Science and Technology Department .

4 In 2007, NUTAS was listed in government science and technology plan of Liaoning province, project number

2007302001

5 In 2008, NUTAS was listed in government science and technology plan of Liaoning province, project number 2008226

6 In 2008, Changjiangyuan Technology Development Co., Ltd was listed in science and technology innovation

demonstration enterprises of Liaoning province, gaining strong suppot in two consecutive years.

7 From 2005 to 2008, NUTAS was listed in science and technology plan of Shenyang project number 1053112-1-

03 ,1071041-9-00

8 In 2006, NUTAS was listed in science and technology scheme of Shenyang Economic and Trade Commission, project

number released by Shenyang Economic and Trade Commission [2006]105

9 In 2008, NUTAS was listed in informatization and information industry development fund plan of Shenyang by

Shenyang Economic and Information Commission, project number 200801020

10 In 2007, NUTAS is listed in high-tech science scheme of Shenyang by Shenyang High-tech zone , project number

20071007

11 In 2009, NUTAS was listed in high-tech zone science and technology scheme of Shenyang high-tech zone, project

number 2009020

12 In 2010, NUTAS was listed in high-tech zone science and technology scheme of Shenyang high-tech zone, project

number released by High-tech Commission of Shenyang 【2010】2

13 In 2011, NUTAS was listed in information product manufacturing development special fund of Shenyang by Shenyang

Economic and Information Commission, project number Z201101024

14 In 2013, NUTAS was listed in Shenyang high-tech industry development project plan by Shenyang Development and

Reform Commission, project number released by Shenyang Development and Reform Commission [2013] 192

15 In 2013, NUTAS was listed in SME development fund project of central financial local characteristic industry by

Shenyang Finance Bureau.

NUTAS is listed in many national plans

Contents




Cancer Treatment 3

2



4



In 2012, there were 1.67 billion new breast cancer diagnoses, taking up 25% of all the new cancer cases. Altogether there were 458 thousand patients died of breast cancer in 2008, taking up about 14% of all the cancer death that year.

Currently, half of the world’s new patients and 60% of the death cases are from developing countries. On the whole, West Europe, North Europe and North America still share a high morbidity, while the Mid-Africa and East Asia are relatively low.

Source:

GLOBOCAN 2012.

Global breast cancer

incidence and

mortality statistics

Current Situation of Clinical Breast

Cancer Treatment

All the traditional therapies on breast cancer, including most adopted radiotherapy, chemotherapy and the like not only fail to realize complete ablation of cancer cells, but also employ obvious side effects. However, the traditional surgery treatment is of high probability to cause implantation metastasis to the patients.

In medical world worldwide, there is still no way to completely ablate cancer cells so as to perform radical cure of breast cancer for good.

NUTAS realizes complete ablation of cancer cells, meanwhile it fulfills the

notion of

Healthy Treatment, should cause no damage or toxic/side effect to human body;

Non-invasive treatment, avoid damage to normal tissue or organs

caused by surgery or other invasive or interventional therapies;

Practicability, which achieves the complete ablation of cancer cells for only one

time treatment.

Being rigorous and responsible for the human beings and society as

always, CJY technology has been committed to NUTAS development for more

than 10 years, which makes it possible to ablate tumor non-invasively, safely

and quickly, thus truly realizing safety and effectiveness to cancer patients. As a

highly mature core technology and craftsmanship, NUTAS complies with the

standards of clinical trials to assess safety and effectiveness for medical

devices. For now, the system has achieved varieties of national patents, making

itself one of the latest digital medical equipment worldwide.

NUTAS Breakthrough on Breast Cancer

Treatment

NUTAS Working System

focal point

body surface

ultrasound source

target tumor tissue

ultrasound

emission

The working principle is to transmit ultrasound which is emitted

by focused ultrasound source through body surface with acceptable

energy of normal tissue, then energy is accumulated in a very small

area, so as to ablate diseased tissue instantly.

NUTAS Working System

Under the guidance of Color Doppler ultrasound images, NUTAS

automatically generates treatment scheme by using tumor

tomography recognition and 3D reconstruction technologies

according to the size, shape, boundary and position of tumor. Then,

by controlling the movement of focused ultrasound by Console Unit

to cover the whole tumor, the complete tumor ablation is

accomplished.

It can convert electrical

energy into mechanical

energy, which achieves

transmission of ultrasound

waves by vibration and

formation of focal point in

the target region.

The left picture shows

the phenomenon of water

column and water mist

occurring when ultrasound

focus is on horizontal plane.

Ultrasound Transducer

NUTAS Obtained CE Certificate in 2012

Contents




Cancer Treatment 3

2



4



1. Safety and No Side Effects NUTAS can realize complete ablation of cancer

cells in focal area through one time treatment and bring no damage to normal tissues both outside focus and in the ultrasound path, which is a non-invasive technology of tumor therapy without toxic or side effects in the real sense.



2. No Sugery Patients can fully avoid the pain and risk as well as damage to the body caused by surgery, and will not suffer implantation metastasis during process of surgery.



Breast Conservation

Treatment (complete response of

primary lesions)

Invasive Surgery (implantation metastasis

risks involved)

3. Non-invasive and traceless

Intact preservation of breast organ will make women

achieve perfect cosmetic effect, maintain f a m i l y

harmony and provide guarantee for happy marriages.

Necrotic cancer cells in human body will be

absorbed gradually, and does not need to take out or

remove during the entire treatment process. NUTAS

guarantees no change of breast appearance, and will

not lead to deformation of breast organ.





Advantages:

NUTAS can fully replace the functions of local

surgery during the treatment; enhance the possibility

of breast-conserving therapy substantially; realize

complete ablation of primary lesions; and avoid the

risks of implantation metastasis during the surgery

and harm to normal tissues. And it will also help

release the heavy psychological burden to patients

who are suffering from cancer. It is truly a technology

that can achieve non-invasive breast-conserving

treatment.

Contents




Cancer Treatment 3

2



4



Current Industry Products Situation on

International Market Currently, world existing traditional ultrasound tumor therapeutic products are

generally for the treatment of benign tumor only. Those devices can`t achieve the

goal of complete necrosis of tumor cells as a result of inaccurate control of

therapeutic dose in the process of treatment. Moreover, followed with frequently

occurred adverse events and other problems, there is no guarantee for safety and

definite effect. Some products produced by Chinese domestic manufacturers which

had the registration pass issued by China Food and Drug Administration (CFDA)

before 2000 can't really meet the needs of curing disease and saving lives since

their failure to fulfill the requirements of related industry standards.

Therefore, China Food and Drug Administration（CFDA）issued "the

announcement of issuance of the requirements of related technology on High

Intensity Focused Ultrasound Ablation Devices”, Regulation SFDA.ME [2003] No.

222, which is used to standardize the supervision and management of high

intensity focused ultrasound treatment equipment; and in early 2010, clear notes

have been made on the official website of CFDA for those manufacturers who

haven`t carried out independent clinical research in accordance with its

requirements. The following is the important content of the original:

After finishing the product registration, the enterprises should continue to make a thorough

research on the clinical use of the device and complete the following work: the clinical trials

made after registration should be made for each indication, such as the independent clinical

trials on liver tumor, bone tumor, soft tissue tumor, breast tumor, and uterus tumor.

Analysis and process of adverse events and complaints (including measures, effects and

measures taken to the market in-use products). (the following picture is the screen shot

of CFDA official website)

However, till 2014 the manufacturers who had domestic registration pass in

early time have not carried out independent clinical research on single

disease in accordance with the requirements of above mentioned documents

and regulations, therefore, their registration certificates have been canceled

by CFDA and relevant products are not allowed for sales in domestic market.

(the following picture is the screen shot of CFDA official website)

(picture taken from CFDA official website)

So far, the only two domestic manufacturers with registration pass are

respectively from Chongqing and Beijing, whose ultrasound tumor treatment

products only treat with one single kind of benign tumor--uterine fibroid, and require

patients to give up fertility rights. Regarding Chongqing products for breast cancer

treatment, the note of CFDA official website was: "for breast cancer, indications

should be further refined and clinical research should be made after registration. The

clinical research scheme shall refer to the request of " Medical Equipment Clinical

Trial Regulations”... , clinical research report..., submit the file when extending the

registration."

——This shows that Chongqing products has not carried out

independent clinical research on breast cancer until now.

In the international market, ultrasound tumor treatment products produced by

GE, Philips, Siemens and other traditional medical manufacturing

giants are only for treatment of uterine

Current Industry Products Situation on

International Market

As the only enterprise who perform the real independent

clinic for breast cancer, till 2015 CJY Technology is one and

the only company to carry out independent clinical trials on

single disease strictly in accordance with CFDA guiding

principles for ultrasound tumor treatment system (SFDA.ME

[2003] No.222). After years of clinical validation, on the

condition of safety guarantee, the whole process of NUTAS

treatment requires no surgery, no side effects, no radiation,

no epidermis injury, and no trauma to tissues around the

tumor. NUTAS can not only complete ablation of tumor

cells in the target region, in the meantime, it can also avoid

implantation metastasis caused by surgery. NUTAS

treatment efficacy is proved to be precise and effective.

Especially for malignant tumor -- the treatment of breast

cancer, NUTAS, with international leading technology, can

effectively destroy malignant tumor cell structure and achieve

complete ablation through only one time treatment so that

the goal to perform radical cure of breast cancer has been

accomplished. Currently, NUTAS has already met the conditions of

breast-conserving therapy for breast cancer patients, which brings

health and hope to them, especially to young women, and has

become the preferred method of breast-conserving treatment.

Above all, different from traditional ultrasound tumor treatment products, NUTAS uses a number of exclusive technologies such as digitization, ultrasound control system, multi-axis and high precision motion control system to guarantee the safety of treatment. Clinical results has shown there is no adverse reactions of NUTAS treatment, which is far superior to similar products and completely eradicates the damage problems caused by inaccurate dose control of other products. NUTAS is the only safe, effective and non-invasive tumor ablation system all over the world.

As the leading product of CJY Technology, NUTAS owns the entire

independent intellectual property rights. Identified by experts, NUTAS has

integrated microelectronics, computer science, digital technology, medical imaging

and processing, precision machinery manufacture and physics, biomedical

engineering, electronics, mechanics, materials science, and many other advanced

technologies, which fills the blank of domestic and abroad in using ultrasound to

treat tumors, and the technology has reached the world leading level. The

popularization and application of this technology will be of great significance in

improving the level of cancer treatment technology, and promoting "healthy

therapy" as well as the sustainable development of digital medical industry.

Conclusion

Thank you for your attention！

Introduction to cjy nutas

Healthcare

Transcript of Introduction to cjy nutas