TOMORROW

Overview

1. Company Introduction

2. Organization Chart

3. Certification

4. Business Expertise

5. Core Expertise: Medical Device

6. CEO Introduction

7. About Us

8. HLT GEN-5500 : Ultrasonic dissection device

9. Product Specification

10. Brand Comparison

11. Clinical Product Testing Result

12. Histopathological Analysis

13. Related Literature

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We strive for your healthier tomorrow

• Ion/ Gas-based drug injector

• 3D microscope (diagnosis)

• Ultrasonic cutting device

• Skin regeneration & protection cream

• Natural-ingredients based disinfection

• Medical & Beauty Industry

• Medical Accident prevention

• National Health & Hygiene

Advancement

• National & Global Brand Production

Vision

Product & Service Activities

COMPANY OVERVIEW

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Company Introduction

Company Hi-Tomorrow., Co. Ltd

CEO Yoo Jun Hwi

Capital 200M Won

Year Established

March of 2007

ExpertiseMedical Equipment / Functional Products / S-W Development

Office293-19 Hyundai Tower 9F, Songpa-Gu, Seoul

2014. 12 $1.2M export capital achieved

2015. 10 Hyundai Asan Medical Center pre-clinical examination

(skin-ion transducer)

2015. 12 $2.5M export capital achieved.

2016. 01 establishment of branch research institute

2016. 05 Factory registration

2016. 07 Host for the National economic cooperation research project

(Ultrasonic cutting machine for medical use)

2016. 10 Patent registration: Medical Skin Ionic Injector

2016. 12 Evaluated as a first class device by the Ministry of Commerce

Industry & Energy (Harmonic Scalpel)

2017. 03 Designated as a venture enterprise

2017. 04 Acquired Certification of Excellence from NICE technology board

2018. 02 Started business in Eastern Korea

2014~2018

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CEO

Shareholders

Administration Special Business

Domestic Sales

International Sales

Branches &

Research centers

Gyeonggi Branch

Gangwon Research

Inst

Affiliations

Bio-care Networks

Levens Bourne

Pharmateutical

Hulust

Eastern Termite &

Pest Control(USA)

Konkuk University

Medical Centre

Organization Chart

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Domestic Patent Certificate

Technology Excellence Recognition Certificate

Standard Testing Compliance Certificate

Disinfection Company Report

Corporate Affiliation Certificate

Bench Enterprise Certificate

GMP Certificate Manufacturing Facility Registration

Certification

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Medical Cosmetics & Living Pest Control

⚫ Dermatology devices

- Ion injector- For Skin Rejuvenation/ Lifting- Gas/Drug Injector

⚫ Diagnostic Equipment

- 3D Electron Microscope for Medical

Diagnosis

⚫ Others

- Harmonic Scalpel (Clinical Trial) - Vein Illuminator (Under development)

⚫ Medical IoT & ICT Development

⚫ BLANC.D Cream

- Introduced the Lamella Formula™

Skin Protection , Moisturizing/WrinkleReduction

- 4 steps total solution to manage skinelasticity

⚫ Pure (SoonSoo)

- Food raw material (citric acid, chitosan)

- 100% natural edible disinfectant (w/ deodorizing function)

⚫ Natural antiseptic (Eastern Korea)

- used by USA’s Eastern Termite & Pest

Control as a natural disinfectant.

- Acquisition of Korean branch license- Unemployment rate reduction support project

BUSINESS EXPERTISE

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1

2

3

Ion-inducer (Dermatological Grade)Wrinkle reduction, skin regeneration, lifting, whitening function

- Medical device approval and patent completed

- Hyundai Asan Hospital pre-seminar completed

Gas / Drug Injector for Skin

Injection equipment for localized dermatological treatment such as Facial treatment containing small amount of carbon dioxide

- Current injectors in the market requires 2 devices to complete injection, this device can inject air/ drug using only one equipment and can be controlled digitally

- Trace amounts of control are possible

3D Microscope for Medical Diagnosis

Provides enlarged real-time image for conditions such as small lesions that are difficult to observe during diagnosis or surgery

Provides comfort and convenience to user, prevents strain, accident and back problems

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Relevant Core Expertise: Medical Device

Surgical Harmonic Scalpel

Uses ultrasonic energy, that provides exfoliation, hemostasis and vessel sealing without tissue damage

Provides convenience of operation and significantly shortens recovery period (around 2~3 days)

demand and import of ultrasonic scalpels are expected to increase in the near future

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CTOChoi. Nak, Gu

‣ 1987 ~ 1998: Deputy Director of Hyundai Electronics IndustriesIndustrial Electronics Research Institute Agency Design Team, New Media (Book) Media Business TFT Team, Planning Office, Strategic Planning Team

‣ From 1999 to 2009: Managing Director of KIMS Optec Co., Ltd.Develop, manufacture and sell optical instruments (MTF, ellipsometer, confocal microscope, HP LED light meter)

‣2009 ~ 2014: Director of Mega Medical Research Co., Ltd.Developed .ENT Unit, Breathing Apparatus, HD Hard Endoscope System, Developed / commercialized ultrasonic wave, high frequency, drug injection device. 3D Laparoscopic Surgical System Development [Full HD 3D Endoscopic Imaging System Development]

‣ From March 2014 to 2018: Director, Hulust CorporationGMP conformity certification, ISO 13485 certification, medical device manufacturing license, patent.Skin / Obesity Medical Device - Ion Intensifier Level 2 Completion, Asan Medical Center Pre-registration completedImaging Diagnostic Equipment - Medical Microscope Level 1 Report Completed.Surgical Machine - Ultrasonic Surgical Machine 3 grade prototype finished.

‣ March 2016 to present:CTO of Hi-Tomorrow Co., Ltd.

CTO Introduction

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About Us

Hi-Tomorrow Co., Ltd.

❖ One of South Korea’s leading medical device developer, manufacturer, and distributor. ❖ One of South Korea’s foremost innovators, providers and developers of medical devices

designed for medical industries such as Plastic Surgery, General Surgery, and Diagnostic Imaging.

❖ Currently possess patents for design and products, and Hi-Tomorrow’s GMP certificate is currently scheduled for approval and will be released in Feb 2019.

❖ Hi-Tomorrow is planning to launch more products, and further enhance their R&D capacity to provide the medical industry more competitive and reliable options.

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GEN 5500 ultrasonic dissection device is an advanced equipment using ultrasound energy. Simultaneously dissecting and vessel sealing with minimal peripheral tissue damage. Hi-Tomorrow scalpel have varied blade sizes, designed for different surgical procedures.

Vessel Sealing

Multi function

Dissection

Model Blade(A) Jaw length(B) Diameter(Ø)

HSW-140 14cm

18.62mm 5.9mmHSW-230 23cm

HSW-360 36cm

HSW-450 45cm

Harmonic scalpel is considered by many experts to be a medical breakthrough, the simultaneous cutting and sealing function is starting to be recognized as an integral part of many basic and advanced surgeries worldwide.

However, despite these advances, the use of Harmonic scalpel is mainly limited due to cost factor.

Cost has been one of the limiting factors that have hindered the spread of Harmonic scalpel in the medical industry. Hi-tomorrow’s Harmonic Scalpel on the other hand, was developed to maximize the qualities and advances that leading brands such as Covidien and Ethicon posses but with a more competitive pricing.

*HSW-450 (45cm): is designed for robotic application and is currently under development.

HLT GEN-5500 : Ultrasonic dissection device

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Output mode Baseline Measured value

1

50 ~ 60 kHz

56.23 kHz

2 56.17 kHz

3 56.28 kHz

4 56.12 kHz

5 56.15 kHz

Ultrasonic frequency (standard : 50 ~60 kHz)

The Hi-Tomorrow device ligates tissue using high-frequency ultrasonic energy transmitted between the instrument blades.

The ultrasonic energy have a baseline frequency from 50 ~ 60 kHz. Each output setting increases the ultrasonic frequency, adapting to ligate and seal tissues of varying thickness.

Cited advantages of Harmonic (Ultrasonic) Scalpel:

1. Rapid Cutting Speed: Rapid cutting speed accelerates the

conventional surgical procedures.

2. Vessel sealing:

3. Cutting precision:

4. Very minimal thermal spread:

5. Few instrument replacements and exchanges:

6. Smoke/ mist reduction: A function that significantly increases

surgical field visibility.

The Hi-Tomorrow Harmonic scalpel uses ultrasonic energy while simultaneously sealing the edges of the tissues or muscles it cuts. The system is composed of the following parts:

• Hand-held ultrasonic transducer• Generator• Handpiece & scalpel• Foot Pedal

The harmonic scalpel may have similarities with surgical diathermy but with enhanced and entirely unique functions. Meanwhile, conventional Harmonic Scalpels are infamously difficult to maneuver.

The Hi-Tomorrow ultrasonic scalpel boasts of its user-friendly design that allows full device control and maneuverability.

Fig 2. Actual Handpiece

Product Specifications

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Model Sonicision™ J&J Harmonic™ ACE Olympus Thunderbeat™ HLT GEN-5500

Shaft Length

- 13 cm- 26 cm- 39 cm- 48 cm

- 14 cm- 23 cm- 36 cm- 45 cm

- 10 cm- 20 cm- 35 cm- 45 cm

- 14 cm- 23 cm- 36 cm- 45 cm

Method of Activation

Hand 1 button, 2 stage

Hand 2 buttons Hand 2 buttons Hand 2 buttons

Frequency 55.5 khz 55.5 khz 47.7 khz 55.5 khz

Jaw Length 14.5 mm 11.1 mm 16.5 mm 14.5 mm

Total Weight of entire device

394.25 grams 337.47 grams 386.86 grams 330 grams

Brand Comparison

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GUI (Interface): Switching and matching the length of handpiece through the interface button(a function which is often absent in many brands available in the market)

• Cutting Time: Averaging 7 sec. • Lateral Tissue Damage: Minimal (2mm<)• Hemostasis: 100% complete• Suture (sealing): Outstanding

• Competitive pricing: 40% cheaper than the leading brands

• Product is developed to be compatible with the next generation surgical robot “Da Vinci” → Currently Ethicon is exclusively marketed together with the Da Vinci, but compared to Hi-Tomorrow, it is more expensive

Brand Comparison

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Overview: A clinical and a product testing were conducted using the Hi-Tomorrow Harmonic Scalpel under the supervision of 2 major institution in South Korea. Konkuk University Medical Center:Department of Surgery under the supervision of Dr. Yun, Ik-Jin and Dr. Park, Kyoung-Sik

Clinical Product Testing Result:

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Overview: The most recent clinical product testing study was conducted to determine the quality of dissection usingswine intestine, as well as the device status under different device setting using 5 major parameters:

Fig A. Actual image of test subject (pork small intestine) indicating the parts dissected using the Hi-Tomorrow harmonic scalpel under max and min setting with varying degree of exposure:

From left to right. Max Setting: Observed how the tissues dissected under max. setting are far and are completely separated and sealed, complete coagulation of the edges with no visible bleeding or leakage is also achieved.

Min Setting: Under min. setting, length of time it takes to complete dissection is relatively longer compared to max. setting.

Based on the actual testing, it takes around 21 sec, under min. setting to achieve complete dissection (21 secs)

Also observe that less time exposed to the heat of the blades resulted to incomplete dissection of the tissues (17 secs)

MAX: 11 sec

MAX: 6 sec

MAX: 6 sec

MIN: 21 sec

MIN: 17 sec

MIN: 17 sec

Device Setting Cutting Mode Sealing Quality Tissue Damage Tissue Quality Device Quality

Max Setting

A total of 3 dissection setting was conducted with increasing exposure ( 6, 6, 11 sec)

High quality and integrity of tissue. Complete sealing

No visible peripheral tissue damage

No visible burn marks and no tissue sticking on the blade surface

Relatively good and consistent cutting strength, no pre-heating required

Min Setting

A total of 3 dissection setting was conducted with increasing exposure (17, 17, 21 sec)

Sealing quality is relatively good but minimal tissue smears sticking to the blade can be observed

Complete dissection takes relatively longer to achieve. Very minimal tissue damage

No visible burn marks but minimal tissue damage was observed 2mm from the dissection point

Pre-heating the device is not required and the power input is consistent.

2018.06.15 Clinical Testing Result

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Test subject: Swine small intestine.

Test Analysis: Histological analysis performed using HE stain viewed under x40 magnification. Evaluation of tissue sample by comparing a control variable against a tissue sample that was dissected using the Hi-Tomorrow Harmonic scalpel under the maximum setting.

Control: Before dissection, intestinal tissues are densely packed.

Max Max

controlcontrol

Sealing & Coagulation

Dissection under maximum power setting:

Upon contact with the blades of the harmonic scalpel, heat is instantly generated resulting to both the simultaneous cutting and sealing of the tissue. As with all

- Complete dissection of the tissue can be observed.

- Vessel sealing function prevents the dissected portions from loosening and scattering. Clear boundary of the dissected tissues can be observed.

- Coagulation as a result of protein denaturation on the tissues in contact with the blades then prevents the flow of blood out of the vessel.

Product Clinical Test: Histopathological Analysis

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OPEN PROCEDURES LAPARSCOPIC PROCEDURES

Colorectal Pediatrics

• Abdominoperineal Resection

• Appendectomy

• Colectomy

• Low Anterior Resection

• Splenectomy

General Thoracic

• Axillary Node Dissection

• Pneumonectomy

• Liver Resection • Pulmonary Lymph Node Dissection• Mastectomy

General Urology

• Total Abdominal Hysterectomy • Prostatectomy

• Myomectomy

Colorectal Thoracic

• Colectomy

• Lobectomy

• Minimally Invasive Esophagectomy

Gynecology General

• Hysterectomy • Adrenalectomy

• Lysis Pelvic Adhesions• Appendectomy

• Cholecystectomy

• Salpingo-Oophorectomy

• Splenectomy

• SupracervicalHysterectomy

• Nissen Fundoplication

Bariatric Urology

• Gastric Band • Cystectomy

• Roux-en-Y

• Nephrectomy• Sleeve Gastrectomy

Procedural Applications

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Related Literature

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Related Literature

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The use of FOCUS Harmonic Scalpel compared to conventional hemostasis for Thyroid Surgery: prospective randomized study.

Cannizzaro, M.A.. Bianco, S.L, Borxi, L. Cavallaro, A. Buffone A. Published in Springer Plus.

Objectives:To evaluate the real benefits of the Harmonic Scalpel when compared with conventional ligation, in terms of the following parameters:

Preoperative: • Operative Time (between skin incision and the end of

wound closure)• Postoperative Blood Loss

Post-operative• Length of Hospital Stay• Operative complications (measured through serum calcium

level for a period of 48 hours after surgery).

Methodology: ▪ 124 patients are included for the conventional group. ▪ 141 patients were included for the Harmonic scalpel

group. ▪ Brand A was used for the Harmonic Scalpel.

Terminology: HT: Harmonic scalpel groupCT: Conventional groupt: t test result. p: p-value result.

Results: analyzed through statsoft STATISTICA software:

• Preoperative parameters: Operation time

• The surgical time was significantly shorter in the harmonic group(HS) right graph than in the conventional technique group (CT yielding the following results:

• Operation time range: HS: 79.36 ± 21.88 mins vs 110 ± 25.80 mins respectively;

• t =6.5, P < 0.00001

•Operation Time Min (minutes) Max (minutes)

HS 57.49 101.24

CT 84.2 135.8

Source: https://springerplus.springeropen.com/articles/10.1186/2193-1801-3-639 21

ResultsPostoperative Parameters: Blood Loss

• post-operative blood loss volume appeared to be further reduced in HS group, compared to CT.

• Blood volume range: (HS) 68.72 ± 40.86 ml vs (CT) 97.38 ± 35.55 ml.

• t=5.73, p <0.00001

ResultsPostoperative Parameters: Length of Hospital Stay

• The length of hospital stay was measured to be shorter in the harmonic group (HS) than in the conventional technique group (CT) with the following results:

• Hospital stay measured in days unit range: HS: 1.93 ± 0.496 days vs 2.75 ± 0.739 days;

• t=6.5, p < 0.00001

Blood loss volume Min (ml) Max (ml)

HS 27.86 109.58

CT 61.83 132.93

Hospital Stay Min (day) Max (day)

HS 1.434 2.426

CT 2.011 3.489

Postoperative parameter: (Surgical Complication) Permanent postoperative Hypocalcemia.

• Determined by identifying the presence of Serum calcium in the drainage fluid which is a major predictor of hypocalcemia.

• 27 cases of Hypocalcemia has been reported. • Count: 14 from HS group and 13 in CS group.

Conclusion: According to the results, the Harmonic scalpel reduces the operative time, postoperative blood loss and length of hospital stay. Post operative parameter based on surgical complication showed no significant statistical difference.

The use of Harmonic scalpel for thyroid surgery may lead to cost advantages because of the shorter length of hospital stay and shorter time of anesthesia duration/operatory room use thus increasing the number of daily procedures.

However, no significant difference was observed between HS and CT in terms of surgical complication.

The use of FOCUS Harmonic Scalpel compared to conventional hemostasis for Thyroid Surgery: prospective randomized study.

Cannizzaro, M.A.. Bianco, S.L, Borxi, L. Cavallaro, A. Buffone A. Published in Springer Plus.

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• Yoo, J†. Kim, T. Lee, E. Choi, N.G. Hoy,S.J. (2017) “Physical Properties of PNN- PMN-PZT Doped with Zinc Oxide and CLBO for Ultrasonic Transducer”. TRANSACTIONS ON ELECTRICAL AND ELECTRONIC MATERIALS.

• Cannizzaro, M.A.. Bianco, S.L, Borxi, L. Cavallaro, A. Buffone A. (2014). “The use of FOCUS Harmonic scalpel compared to conventional haemostasis (knot and tie ligation) for thyroid surgery: a prospective randomized study” Published in Springer Plus.

• J. H. Yoo, Y. H. Lee, D. H. Kim, I. H. Lee, J. S. Kwon, and D. S. Paik, J. Kor. Inst. Electr. Electron. Mater. Eng., 21, 126 (2008). [DOI: https://doi.org/10.4313/ JKEM.2011.21.2.126] [2]

• D. H. Lee, S. H. Lee, S. G. Lee, K. T. Lee, and Y. H. Lee, J. Kor. Inst. Electr. Electron. Mater. Eng., 24, 543 (2011). [DOI: https://doi.org/10.4313/JKEM. 2011.24.7.543] [3]

• I. Y. Kang, I. T. Seo, Y. J. Cha, J. H. Choi, S. Nahm, T. H. Sung, and J. H. Paik, J. Eur. Ceram. Soc., 32, 2381 (2012). [DOI: https://doi.org/10.1016/ j.jeurceramsoc.2012.01.030] [4]

• F. Gao, R. Hong, J. Liu, Z. Li, and C. S. Tian, Ceram. Int., 35, 1863 (2009). [DOI: https://doi.org/10.1016/j.ceramint.2008.10.029] [5]

• X. Chao, Z. Yang, X. Huang, D. Ma, and J. Zeng, Curr. Appl. Phys., 9, 1283 (2009). [DOI: https://doi.org/10.1016/j.cap.2009.02.012] [6]

• H. Li, Z. Yang, L. Wei, and Y. Chang, Mater. Res. Bull., 44, 638 (2009). [DOI: https://doi.org/10.1016/j.materresbull.2008.06.024] [7]

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Reference

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OURBELIEFS

We believe our company’s most important

asset is quality people.No matter how simple one’s position may be,people who are skilled and motivated to do their best make all the diff

erence. These people, when well-managed, inspired and supported,allo

w us to achieve the results required to move our company forward.

OURMISSION

To be the best in what we set out to do

, totally focused on our business, ensuring the best products

and services to our customers, solidity to suppliers, satisfactory

profitability for shareholders and the certainty of a better

future for all employees.

2018 HI TOMORROW All Rights Reserved. ㈜하이투모로 서울특별시 송파구 올림픽로 293-19 현대타워 903