2020 Agenda

DAY 2 UPDATED 10-11-2020
Times are Approximate — May Not Reflect Actual Running Time

**All U.S. Times are Pacific Time (PDT)**


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

5:00 PM U.S. PT | 9:00 AM JP: Agile Devices Inc.

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.


5:10 PM U.S. PT | 9:10 AM JP: Centerline Biomedical, Inc.

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。


5:20 PM U.S. PT | 9:20 AM JP: Centese

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.


5:30 PM U.S. PT | 9:30 AM JP: Mitre Medical

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

5:50 PM U.S. PT | 9:50 AM JP: MITRx, Inc.

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.


6:00 PM U.S. PT | 10:00 AM JP: PercAssist, Inc.

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.


6:10 PM U.S. PT | 10:10 AM JP: Radux Devices LLC

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.


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)


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

5:10 PM U.S. PT | 9:10 AM JP: AiM Medical Robotics

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.


5:20 PM U.S. PT | 9:20 AM JP: Invenio Imaging

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.


5:30 PM U.S. PT | 9:30 AM JP: Ischemia Care

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.


5:40 PM U.S. PT | 9:40 AM JP: Break

5:50 PM U.S. PT | 9:50 AM JP: osteolabs GmbH

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.


6:00 PM U.S. PT | 10:00 AM JP: Shape Memory Medical Inc.

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。

6:10 PM U.S. PT | 10:10 AM JP: Sway Medical Inc.

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.


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)

Day 3 Agenda Title


4:30 PM U.S. PT | 8:30 AM JP: Welcome and Opening Remarks

Company Presentations

4:35 PM U.S. PT | 8:35 AM JP: Eyedaptic

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!


4:45 PM U.S. PT | 8:45 AM JP: InformAI

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。

4:55 PM U.S. PT | 8:55 AM JP: Oracle Health, Inc.

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.


5:05 PM U.S. PT | 9:05 AM JP: Prescient Surgical

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%.


5:15 PM U.S. PT | 9:15 AM JP: Break

5:25 PM U.S. PT | 9:25 AM JP: Qidni Labs

Qidni Labs is aiming to serve millions of patients with kidney failure without owning any dialysis clinics. We achieve this goal through miniaturization of blood purification technology and creating wearable/portable blood purification devices with a cloud-based remote patient monitoring system that replaces the tasks performed at the dialysis clinics. We want to operate as an independent dialysis provider.

5:35 PM U.S. PT | 9:35 AM JP: QUANTASON, LLC

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.


5:45 PM U.S. PT | 9:45 AM JP: Regentys

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.


5:55 PM U.S. PT | 9:55 AM JP: Slate Therapeutics, Inc.

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.


6:05 PM U.S. PT | 10:05 AM JP: Smartlens, Inc.

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)

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