The MedTech Emerging Growth Companies 2020 Virtual Roadshow will introduce 20+ emerging U.S. medical technology companies to a broad Japanese audience. Thematically grouped company presentations and virtual networking will provide unique insights into the latest developments in medical technology.
OCTOBER 12 – 14, 2020 (PDT)
INTRODUCTIONS/KEYNOTE
4:30 PM U.S. PT | 8:30 AM JP: Welcome and Opening Remarks
4:35 PM U.S. PT | 8:35 AM JP: Special welcome by Keith Kirkham, Minister Counselor for Commercial Affairs, US Embassy Tokyo
4:40 PM U.S. PT | 8:40 AM JP: Keynote: Andrew Cleeland, CEO of The Fogarty Institute for Innovation
COMPANY PRESENTATIONS
Agile Devices is commercializing a novel coaxial deflection microcatheter. We have developed the Angler™ as a first product, targeting vascular interventional use of microcatheters, which is a $300-400 million global market.
Our patented technology was designed to improve maneuverability with an actively controlled deflectable tip which can enable faster vessel navigation. Key anticipated benefits include reduced procedure times and cost, increased operating room availability, and improved patient outcomes.
We believe that several other segments within the very large overall global catheter market are also highly addressable by our novel patented coaxial deflection technology.
カテーテル先端を曲げ向きや角度を変えることができる同軸技術を開発。Anglerで5億ドルの市場規模をもつ血管用マイクロカテーテル市場参入を狙う。これによりカテーテル挿入が迅速になるとともに、ガイドワイヤ―やカテーテル交換を削減することができる。300億ドル（2019年）と言われる世界のカテーテル市場の一部をこの同軸技術で対応可能。
Centerline Biomedical is a Cleveland Clinic spinoff company commercializing the Intra-Operative Positioning System (IOPS™) technology — an innovative, non-x-ray based 3D GPS-like surgical navigation technology that improves endovascular procedure outcomes and reduces radiation exposure.
The goal to create the first and only 3D visualization and real-time navigation system that allows physicians to perform optimal, radiation-free image-guided endovascular surgery developed when Vikash Goel, current Chief Technology Officer at Centerline Biomedical set out to fulfill his mentor Dr. Roy K. Greenberg’s vision of advancing endovascular surgery. After years of hard work and dedication by vascular physicians and researchers at the Cleveland Clinic, IOPS was born, with a working prototype and first-in-man data.
Centerline Biomedicalは周術期位置情報システム（IOPS）を商用化すべくクリーブランド・クリニックからスピンオフした会社です。IOPSは、X線を使わずに3次元的に手術を可視化しナビゲーションをする技術で、血管手術の成功率を上げ放射線使用量を減らすことができます。
クリーブランドクリニックにおける血管系医師や研究者達の長年の努力の結果、IOPSが生まれ、既にプロトタイプが作成されて、ヒトに適用されデータ収集が始まっています。
Centese is a start-up Medical Device company modernizing the field of post-operative drainage following cardiac and thoracic surgery. Centese has developed Thoraguard, the most advanced technology available to replace the analog standard of care systems in use at nearly every cardiothoracic surgery center in the world. Using proprietary design, integrated sensors for data collection, and intelligent software control Thoraguard improves post-operative care following these life-saving procedures. Thoraguard has been clinically validated by word-class cardiothoracic centers Stanford University and NYU-Langone Medical Center and is preparing for commercialization.
Centeseが開発したThoraguard™は、インテリジェントセンサーとソフトウエアを活用したデジタルドレナージシステムで、手術のコスト削減と手術結果の向上に役立つ。年間260万件の術後ドレナージを必要としている心臓外科、胸部外科手術分野を対象市場とする。
Mitre Medical is a medical device company developing the Mitral Touch®, a less invasive surgical approach to provide cardiac surgeons a safer and more effective device to treat mitral valve regurgitation (MR) in patients with moderate to severe MR. These patients are the most undertreated patients in the operating room even though 70% will develop heart failure within 5 years. The present standard of care requires stopping and opening the heart. The complications and risks associated with this step limit the benefits offered by existing devices. Mitre Medical’s beating heart option eliminates these risks opening a new frontier for the cardiac surgeon and their patients.
The company is based in Silicon Valley with a team experienced in medical device innovation and a track record of multiple cardiovascular medical device commercialization successes.
Mitre Medicalは、中度から重度の僧帽弁閉鎖不全／僧帽弁逆流（MR）を治療し、左室（LV）の機能改善を図ることを目的とした、安全かつ低侵襲のMitral Touch®を開発した初期段階の医療機器スタートアップ企業です。
5:40 PM U.S. PT | 9:40 AM JP: Break
MITRx is a medical device company founded by classmates from MIT Sloan School, focused on a large unmet need in heart valve disease. Our unique “micro-invasive” approach to the treatment of mitral valve disease circumvents the open-heart surgery, reducing the procedure and recovery time significantly. Old or sick patients are often excluded from the open-heart surgery as they cannot withstand this very invasive procedure. MITRx’s innovative device technology coupled with its optimal physiological pathway allows delivering the safest and most effective way to treat the mitral valve disease while reducing the healthcare cost.
電磁波を利用したカテーテルやガイドワイヤの位置のトラッキング・可視化技術（IOPS）とスマートセンサ搭載の手術装置を利用して、IOPSと独自の画像分析技術を活用し、患者固有の３D血管マップをリアルタイムに作成し、僧帽弁開心術に適用。これまで開心術対象外だった高齢者にも適用可能。取得特許16件、出願中38件。FDA510kは経血管大動脈修復（EVAR）で2019年6月に取得。
PercAssist is a high-tech medical device company located in Silicon Valley California. The company was founded in 2019 and early 2020, the company started operations. We have developed, prototyped, and tested a minimally invasive approach designed for interventional cardiologists for the treatment of late-stage Congestive Heart Failure (CHF). In Japan, there are 1M people diagnosed with CHF. The minimally invasive, non-surgical, non-general anesthesia, non-anticoagulants, and outside of the blood path operation is ideal for the Japanese medical community. The rapidly aging population requires shorter treatments, shorter hospital stay, shorter recovery time, and lower cost. PercAssist technology offers all those benefits.
心拍と同期させた非血液接触型バルーンカテーテルを開発。左心室機能の強化と心筋の回復促進を目的とする。生体モデルを利用して試作、検証。
Radux Devices overcomes the inherent ergonomic limitations in the fluoroscopic suite with solutions that improve performance, workflow and health. Radux offers reusable and disposable systems that overcome challenges experienced during fluoroscopic surgery. Platform one minimizes the challenges of left radial access in coronary and peripheral intervention, and other complex access. The second platform maximizes scatter radiation protection without interfering with the operators by taking advantage of location.
Radux focuses on reproducibility, simplicity, and intuitive behavior to help redirect workflow between the patient, the operator and fluoroscope; simultaneously improving patient outcomes and satisfaction, decrease hospital costs and potentially prolonging physicians’ careers.
カテーテル室や手術室での医師やスタッフの姿勢や動線を考慮し、作業効率を上げるよう設計された各種医療器具を開発。左橈骨動脈からの血管アクセスや放射線散乱波シールドなどが代表的製品。システムソリューションとしての販売を目指す。バーチャルトレーニングや社内外のリソースを活用した販売流通モデルを採用。
6:20 PM U.S. PT | 10:20 AM JP: Closing Remarks/Remo Transition
6:25 PM U.S. PT | 10:25 AM JP: Networking Session (Remo)
INTRODUCTIONS/KEYNOTE
4:30 PM U.S. PT | 8:30 AM JP: Welcome and Opening Remarks
4:35 PM U.S. PT | 8:35 AM JP: Keynote: David Cassak, Editor-In-Chief of The MedTech Strategist
COMPANY PRESENTATIONS
AiM Medical Robotics is developing the world’s first MRI compatible surgical robot. Our surgical robotic platform simultaneously combines surgical planning and procedure with MR functional robotics that provide precise trajectory guidance for neurosurgical procedures. Our ability to provide predictable procedure planning is further enhanced by the system’s real time MR imaging support to compensate ft for movement of the target site during a procedure. As a Company, we aim to eliminate existing error and revision rates seen today, while reducing procedure time, to support better patient outcomes. Furthermore, our system is light weight, portable and will significantly reduce hospital costs and provide a new level of surgical excellence for today’s neurosurgeon.
MRI機能を装備した手術ロボットを開発。脳腫瘍やてんかん、パーキンソン病、膠芽腫などの脳機能性疾患等、神経外科分野用に提供。入念な計画と高精度、高性能の自動化された手技により、手術時間が短縮され、医療ミスが削減され、ひいては患者の転帰の改善につながる。AiM社の装置は、廉価、可搬型、保管可能で、病院にかかるコストも大幅に削減できる。
Our patented technology was designed to improve maneuverability with an actively controlled deflectable tip which can enable faster vessel navigation. Key anticipated benefits include reduced procedure times and cost, increased operating room availability, and improved patient outcomes.
We believe that several other segments within the very large overall global catheter market are also highly addressable by our novel patented coaxial deflection technology.
カテーテル先端を曲げ向きや角度を変えることができる同軸技術を開発。Anglerで5億ドルの市場規模をもつ血管用マイクロカテーテル市場参入を狙う。これによりカテーテル挿入が迅速になるとともに、ガイドワイヤ―やカテーテル交換を削減することができる。300億ドル（2019年）と言われる世界のカテーテル市場の一部をこの同軸技術で対応可能。
Invenio Imaging, Inc. based in Santa Clara, CA has developed and manufactures the NIO Laser Imaging System. The NIO is designed to streamline intraoperative histology, reducing downtime in the OR and allowing for examination of specimens from multiple sites in the surgical cavity. It has been used in over 1300 cases and is currently installed in sites across the United States.
術中の組織学検査の迅速化を実現する酸化ニッケル（NiO）レーザー画像システムを開発。術部の異なる部位から複数組織を採取、検査することができる。既に1300以上の症例で使用されている。
The goal to create the first and only 3D visualization and real-time navigation system that allows physicians to perform optimal, radiation-free image-guided endovascular surgery developed when Vikash Goel, current Chief Technology Officer at Centerline Biomedical set out to fulfill his mentor Dr. Roy K. Greenberg’s vision of advancing endovascular surgery. After years of hard work and dedication by vascular physicians and researchers at the Cleveland Clinic, IOPS was born, with a working prototype and first-in-man data.
Centerline Biomedicalは周術期位置情報システム（IOPS）を商用化すべくクリーブランド・クリニックからスピンオフした会社です。IOPSは、X線を使わずに3次元的に手術を可視化しナビゲーションをする技術で、血管手術の成功率を上げ放射線使用量を減らすことができます。
クリーブランドクリニックにおける血管系医師や研究者達の長年の努力の結果、IOPSが生まれ、既にプロトタイプが作成されて、ヒトに適用されデータ収集が始まっています。
Ischemia Care offers blood testing sold into hospitals under a program to identify and diagnose stroke patients.
ISC completed BASE (Biomarkers of Acute Stroke Etiology NCT02014896), 1700 patients, 20 hospital site, clinical trial resulting in a large clinical data set to support pipeline of products answering key clinical questions to identify stroke patients, causes of stroke, atrial fibrillation, transient ischemic attacks (TIA), and mimics (TNEs).
ISC’s first test “ISCDx” is used to determine cause of stroke targeting the 40% of US ischemic strokes diagnosed as unknown cause or “cryptogenic” that lead to increased stroke risk, poor outcomes and excessive cost.
脳卒中とその原因を調べる入院患者用血液検査の開発。ISCDxは、卒中患者をその原因によって分類化することで、治療におけるコスト決定に役立つ。20病院、1700人の患者を対象とした臨床試験の結果をもとに、卒中の有無、卒中原因、一過性脳虚血発作、一過性神経学的症状を判断する4つの試験を確立する予定。単独もしくは血液検査と統合したデジタルヘルスソリューションの展開も計画中。
Centeseが開発したThoraguard™は、インテリジェントセンサーとソフトウエアを活用したデジタルドレナージシステムで、手術のコスト削減と手術結果の向上に役立つ。年間260万件の術後ドレナージを必要としている心臓外科、胸部外科手術分野を対象市場とする。
5:40 PM U.S. PT | 9:40 AM JP: Break
osteolabs GmbH is an innovative in vitro diagnostics company who has been awarded the “Germany – Land of Ideas” prize in 2017 for its outstanding research achievements concerning the OsteoTest. The development of this novel and radiation-free testing procedure has been supported by the GEOMAR Helmholtz Centre for Ocean Research (Kiel) and the Helmholtz Association (Berlin). Based on clinical validation studies the OsteoTest is capable to detect osteoporosis at a very early stage and to monitor related therapies. The OsteoTest is protected by an international patent application WO 2020/043771A1.
骨粗しょう症の早期診断と治療に活用できる検査法を開発。この検査法は、放射線を使用せず、二重X線吸収測定法（DXA）よりも効果的で、腎機能障害や他の疾患の早期発見に応用できる可能性が期待される。
電磁波を利用したカテーテルやガイドワイヤの位置のトラッキング・可視化技術（IOPS）とスマートセンサ搭載の手術装置を利用して、IOPSと独自の画像分析技術を活用し、患者固有の３D血管マップをリアルタイムに作成し、僧帽弁開心術に適用。これまで開心術対象外だった高齢者にも適用可能。取得特許16件、出願中38件。FDA510kは経血管大動脈修復（EVAR）で2019年6月に取得。
Shape Memory Medical Inc., based in Santa Clara, California, is dedicated to developing innovative therapeutic solutions with its proprietary Shape Memory Polymers. Neurovascular embolization products include the TrelliX® Embolic Coil; CE marked for use in the EU. Peripheral embolization products include the IMPEDE® and IMPEDE-FX Embolization Plugs; both CE marked for use in the EU and cleared for use in the United States (US). IMPEDE is also approved for use in Japan.
形状記憶多孔質ポリマーを用いた治療法を開発。製品には、末梢塞栓用のIMPEDE®およびIMPEDE® FXデバイス、神経血管用のTrelliX®エンボリックコイルなどがあり、移植後これらは3倍以上の体積に膨張し、慢性炎症を起こさずに治癒を早めることができる。
心拍と同期させた非血液接触型バルーンカテーテルを開発。左心室機能の強化と心筋の回復促進を目的とする。生体モデルを利用して試作、検証。
Sway Medical provides mobile software for neurological assessment with patented tests that leverage the accuracy of sensors built into any mobile device. Sway’s FDA cleared testing platform allows users to test balance and cognitive performance in the clinic or remote on any mobile device. With over 60 research publications and over one million tests, Sway is the leader in mobile neurological assessment.
患者のモバイル端末に内蔵された高性能センサを活用して、患者の平衡感覚や認知能力を遠隔から測定できるモバイルアプリを開発。
6:20 PM U.S. PT | 10:20 AM JP: Closing Remarks/Remo Transition
6:25 PM U.S. PT | 10:25 AM JP: Networking Session (Remo)
INTRODUCTIONS
4:30 PM U.S. PT | 8:30 AM JP: Welcome and Opening Remarks
COMPANY PRESENTATIONS
Eyedaptic, is a software technology company addressing the large unmet need in the eye care field of AMD (Age Related Macular Degeneration). Over 170 million people worldwide have AMD, is the primary cause of blindness for people over 60, and robs them of their independence. Our visually assistive solutions are based on open market Augmented Reality (AR) glasses. Eyedaptic’s embedded proprietary simulated natural vision software optimizes the person’s functional peripheral vision and is adaptive to the user’s vision limitation, as well as their environment and habits with machine learning, thereby giving them the Freedom to Live their Life!
機械学習を活用した視野強化ソフト。主に加齢黄斑変性症（AMD）用。オープンマーケットのARグラスに埋め込んで機能的周辺視野を最適化。視野を狭めてしまう拡大表示だけの他社製品に対して、各自の視覚障害、環境、習慣に適応できるのが特徴。
InformAI is a startup AI healthcare company that develops clinician analytics tools that speed up medical diagnosis at the point-of-care and extract data insights to improve patient outcomes. Our products focus on high impact/ high spend medical conditions including cancer, cardiac/thoracic surgery, wound care and sinus. InformAI is currently going through FDA and CE mark approvals and is a recent recipient of a National Science Foundation contract award to build AI-enabled patient outcome predictors. InformAI is part of the JLABS innovation center location in the Texas Medical Center, which is the world’s largest medical provider with 10 million patient encounters every year.
InformAIは、ポイントオブケアでの医療診断をスピードアップし、データの洞察を抽出して患者の転帰を改善する臨床医分析ツールを開発する新興AIヘルスケア企業です。 当社の製品は、癌、心臓/胸部外科、創傷ケア、副鼻腔などの影響が大きく、支出が多い病状に焦点を当てています。 InformAIは現在、FDAおよびCEマークの承認を受けており、AI対応の患者転帰予測因子を構築するためのNational ScienceFoundation契約賞を最近受賞しています。 InformAIは、テキサス医療センターにあるJLABSイノベーションセンターの一部です。テキサス医療センターは、毎年1,000万人の患者と出会う世界最大の医療プロバイダーです。
Oracle Health is developing a Tiny Insertable Cardiac Device to monitor and prevent Heart Failure hospitalizations, a $21B problem.
This tiny device utilizes a Multi-Sensor approach and machine learning to monitor Chronic Heart Failure. Under the skin insertion approach brings simplicity, high compliance, accuracy, and existing reimbursement that the Wearable and Heart Procedure monitors lack. Inserted device securely sends cardiac data to a smartphone, then to a cloud-based machine learning for the physician to access.
心拍、心音、肺音、活動レベルがモニタできる埋め込み可能小型装置を開発。これら包括的なデータを長期（3年）に渡って収集できる。
Wound contamination is the root cause of surgical infection (SS), yet after nearly a decade of global SSI focus, hospital teams still struggle to gain control over this pervasive, invisible threat. Prescient Surgical developed and markets CleanCision, a first-in-class, advanced technology that continuously clears harmful bacteria from the incision, combining wound protection and irrigation into an intuitive and easy-to-use retraction system that has been shown to reduce SSI risk by as much as 100%.
世界各地の医療機関が10年近く、その削減に尽力しながらも苦戦している創部感染。術後合併症の根本原因の一つである創部の感染防止を目的としたCleanCisionを開発。創部の保護と洗浄を統合したシステムで術中連続的に創部の有害な細菌を除去し、その拡散を防止する。切開縫合部の感染リスクを100％削減できる症例もある。
5:15 PM U.S. PT | 9:15 AM JP: Break
Quantason is a post-seed stage MedTech company developing a novel, ultrasound-based, radiation-free, cost-effective, reimbursable, and patient-friendly platform (IDUS™) for Preventative Breast Screening. The technology consists of a fully automated dedicated ultrasound system with two modes of operation – whole breast imaging & real-time acoustic spectroscopy – for early detection, 3D location and follow-up monitoring of a marker that its progression leads to invasive ductal carcinoma. Such early warning allows for preemptive intervention, eliminating growth of a cancerous tumor. Women worldwide, without limitations of age, breast density & size, discomfort, compliance, pregnancy, lactation, implants, or radiation therapy would foremost benefit from the new breast care paradigm. USA and global scaled hospitals, community healthcare systems (i.e., Japan & China), imaging centers/clinics, doctors’ offices, and mobile units will be the other beneficiaries of the new modality, providing vital preventative care. The society will be the ultimate beneficiary of IDUS™ by saving lives, families, workforce, and cost.
The Company is seeking $10M equity capital for clinical prototyping ahead of the pilot study, followed by productization, marketing and commercialization.
乳がん（浸潤性乳管癌）の早期発見・予防、進行追跡を目的とした完全自動型超音波診断技術を開発。初めは、40歳未満や十分な検診が受けられていない40歳以上で、特に乳房密度の高い女性を対象にしている。放射線、年齢、乳房密度と大きさ、妊娠／授乳中、インプラント、放射線治療中と言ったX線マンモグラフィに関わる制約を排除することができる。検査は10分ほどしかかからず、完全デジタル化されており、コスト効率の良さや操作性、患者への負担が少ないなどが利点である。
Regentys is an early stage medical device company creating a first in class, non-surgical, non-drug treatment option for patients with ulcerative colitis and other gastrointestinal diseases. Our technology has already been successfully commercialized in multiple other medical applications. We offer a novel application of a proven technology to a billion-dollar market in need of alternative treatments.
潰瘍性大腸炎他の消化器疾患に対し、手術や薬物以外の治療選択肢を提供する。この技術は既に他の治療用途で商用化されており実績がある。代替治療を必要とする市場は10億ドル規模。
The Slate Therapeutics team has invented and developed the novel Effervescent Foam System, delivering therapeutics to the oral-nasal pharynx addressing chronic rhinosinusitis patient pain points. It is an easily administered, non-surgical treatment that can replace drug eluting stents and drug coated balloons. Slate’s founding team has been working together for over 15 years, with extensive experience founding and growing MedTech businesses. Together they have 150 patents and patent applications and their products have generated sales in excess of $800M worldwide. Over the past 10 years, the founders have completed 5 transactions to large multinational companies. The technology behind Slate Therapeutics addresses a clear, unmet clinical need and has the ability to positively affect lives from the US to Japan and everywhere in between. Slate is currently raising a $5M Series A to support regulatory submission, a pivotal clinical study and eventual commercialization of the stent replacement system.
泡状薬剤を患部に送達し持続的な薬物治療の実現を目指す。慢性副鼻腔炎の術後に使われる薬剤投与用ステントに代わる非侵襲的な治療方法を提供する。また布製マスクの代わりに殺菌フォームを使ったCOVID-19薬用マスクや脳への薬剤デリバリーへの適用も検討されている。
Smartlens is a clinical-stage company with a vision of preventing blindness due to Glaucoma. Smartlens has developed a non-invasive, electronics-free, ultra-sensitive, soft contact lens capable of monitoring intraocular pressure, the primary risk factor of Glaucoma.
Smartlens’ intuitive technology helps improve the understanding of disease progression, efficacy of treatments and better decisions about managing the disease. Our platform provides seamless telehealth and remote patient monitoring capabilities and helps improve clinical workflow reducing treatment costs.
Our intuitive technologies enable measurements of IOP anywhere any time, which are shared with the medical provider as actionable insights through their easy-to-use and customized dashboard.
非侵襲的で、電子機器を使わず、正確で、使いやすく、低価格で眼圧（IOP）を測定できるソフトコンタクトレンズを開発。主に緑内障向け。これまでは3～6ヶ月に一度の診察時にしか測定できなかった眼圧をいつでもどこでもモニタすることができる。既に前臨床試験を終了しており、3件の試験をNature Medicineを含む査読学会誌で発表。国内外で10件の特許を申請、4件は既に取得済。
6:15 PM U.S. PT | 10:15 AM JP: Closing Remarks/Remo Transition
6:20 PM U.S. PT | 10:20 AM JP: Networking Session (Remo)
