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Welcome to Gynesonics, developers of:

VizAblate™

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a minimally invasive treatment for

uterine fibroids

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VizAblate

Viz Blank

uterine fibroid treatment

with a Patient focus

The VizAblate system enables gynecologists to treat women suffering from uterine fibroids in a uterine-conserving and incision-less procedure using a thermal ablation device inserted through a woman's cervix.

VizAblate is the first system to integrate ultrasound, for imaging, with thermal ablation for the treatment of fibroids. The VizAblate system has gone through significant safety and performance testing and has received the CE mark.

Viz Bene

Benefits of VizAblate

An alternate to hysterectomy

Treats individual fibroids with radiofrequency (RF) energy while conserving the uterus

Performed by gynecologists in an outpatient setting where available

Cost effective - overall to the healthcare system

Procedure

the VizAblate procedure

The VizAblate handpiece is introduced into the uterus through the cervix.

From within the uterus, the physician visualizes and selectively targets each fibroid using the integrated ultrasound probe and the proprietary VizAblate RF ablation planning software. The electrodes are then inserted into the fibroid and RF energy is used to heat, and thus ablate, the fibroid. After the ablation has been completed, the handpiece is removed. The procedure is performed without incisions and the patient typically is able to return home within hours of the procedure.*

*Garza-Leal J, Toub D, León I, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting. Gynecological Surgery. 2011;8(3):327-334.

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Explore

VizAblate

Benefits

Procedure

Clinical Trial No Frame

Trial Sites

FASTEU Overview

Clinical Research Study evaluates VizAblate technology

VizAblate has been demonstrated to safely and predictably ablate fibroids with RF energy. The FAST-EU Trial is designed to demonstrate that VizAblate will effectively reduce symptoms such as heavy menstrual bleeding in patients with uterine fibroids, and improve a woman's quality of life.The FAST-EU trial has been accepted into the United Kingdom's National Institute of Health Research, Clinical Research Network (NIHR CRN) Portfolio database. Acceptance into the Portfolio is available only for studies perceived as being of high quality and of definite benefit to patients within the National Health Services.See more details about FAST-EU on clinicaltrials.gov

Study Sites No Frame

Netherlands

Mexico

United Kingdom

Pick Nation

select available nation

Mexico

Mexico

Jose Leal Garza, MD

Universidad Autonoma de Nuevo Leon

Monterrey, Mexico

United Kingdom

Professor Janesh Gupta, MD

Dr. Manjeet Shehmar

Birmingham Women's Hospital

Birmingham, UK

Professor Siân Jones, MD

Bradford Royal Infirmary

Bradford, UK

Netherlands

Professor Hans Brölmann MD, PhD, Head - Department of Obstetrics and Gynaecology, Vrije Universiteit Medisch Centrum in Amsterdam, Netherlands

Marlies Bongers MD, PhD, Gynecologist, Máxima Medisch Centrum, Eindhoven/Veldhoven, The Netherlands

Sebastiaan Veersema MD, Gynaecologist, Department of Obstetrics and Gynaecology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.

Patient Page

Patients

The FAST-EU Trial is, for the moment, the primary way patients can receive the VizAblate procedure. Patients can be part of the study if they qualify for health care services from one of the participating research centers as a resident of Mexico, United Kingdom, and the Netherlands. If you are considering participation in the trial, ask your physician about whether VizAblate is right for you.UK patients may be interested in reading further about participating in clinical trials

Physicians

The FAST-EU Trial Summary• Prospective, multicenter efficacy study• Evaluates improvement in quality of life scores and reduction of fibroid volumeEligible* patients:•Are diagnosed with fibroids•Have heavy bleeding•Do not intend to become pregnant now or in the future*additional criteria will applyIf you are in the United Kingdom, Netherlands, or Mexico and are interested in referring your patient, learning more about the study, or participating in the use of the VizAblate device, contact us at info_gynesonics.com or one of the study centers.
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Patients

Physicians

Announcements

Publications

Publications

Garza-Leal, Toub et al 2011.pdf

Garza-Leal J, Toub D, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting. Gynecological Surgery. 2011.

jones odonovan toub 2011.pdf

Jones S, O'Donovan P, Toub D. Radiofrequency Ablation for Treatment of Symptomatic Uterine Fibroids. Obstetrics and Gynecology International . 2012;2012:1-7

Press Releases

Press Releases

September 22, 2011, REDWOOD CITY, Calif. --(BUSINESS WIRE)

Gynesonics announces the start of the FAST-EU Trial to demonstrate effectiveness of the VizAblate® Procedure in treating uterine fibroids associated with heavy menstrual bleeding.

PRESS RELEASE

GynesonicsCE-Mark2010.pdf

January 6, 2011, REDWOOD CITY, Calif.--(BUSINESS WIRE)

Gynesonics Receives the CE-Mark for the VizAblateTM System to Treat Uterine Fibroids

In the Press

UK news coverage

Recent Presentations

Recent Presentations

kroese bongers toub 2011.pdf

European Society for Gynaecological Endoscopy (ESGE), September 21-24, 2011: Etiology and Management of Heavy Menstrual Bleeding: Prevalence Results From a Single Clinic (Anja Kroese, MD, Marlies Bongers, MD, PhD, David Toub, MD, MBA)

European Society for Gynaecological Endoscopy (ESGE), September 21-24, 2011: Visualization of Essure Implants with Intrauterine Sonography for Confirmation of Placement (Sebastiaan Veersema, MD, Rajesh Varma, MD, PhD, David Toub, MD, MBA)

veersema varma toub 2011.pdf

American Association of Gynecological Laparoscopy (AAGL), November 6-10, 2011: The VizAblate™ FAST Trial: Early Efficacy Results of Transcervical, Intrauterine Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids with the VizAblate™ System (Siân Jones, MD, Janesh Gupta, MD, Sebastiaan Veersema, MD, Hans Brölmann, MD, PhD, Marlies Bongers, MD, PhD, Rajesh Varma, MD, PhD, Jose Gerardo Garza-Leal, MD, David Toub, MD, MBA)

Jones, Gupta, Veersema et al 2011 AAGL.pdf

Past Presentations

Past Presentations

VizAblate_safety_study.pdf

ESGE: September 30, 2010: Ultrasound-guided transcervical radiofrequency ablation of uterine fibroids: safety and preliminary clinical results in a prehysterectomy model

AAGL: November 11, 2010: Directed Targeting and Customized Treatment of Human Fibroids with the VizablateUltrasound- Guided Radiofrequency Ablation System: In Vivo Perihysterectomy Results

Gynesonics_2010_AAGL_abstracts.pdf

Publications
Press Releases
Recent Presentations
Past Presentations

About Us

Mission Statement

Gynesonics is dedicated to improving the lives of women suffering from uterine fibroids through the use of innovative, minimally invasive technologies.

Contact

Gynesonics

604 Fifth Avenue

Suite D

Redwood City, CA 94063

Phone: +1.650.216.3860

Fax: +1.650.299.1566

email: info_gynesonics.com

Management

Darrin

Darrin Uecker

President and CEO

Darrin Uecker brings more than 15 years of medical device experience to Gynesonics with a core expertise in high technology medical device product development. Previously Mr. Uecker was the Executive Vice President of R&D, Clinical Research, Regulatory Affairs and Operations at Conceptus Inc., a publicly held women's health care company. From 2004 to 2007, he served as Chief Technology Officer of RITA Medical Systems where he was responsible for R&D, operations, and business development functions. RITA was a publicly traded oncology device company specializing in radiofrequency ablation of solid tumors and was acquired in 2007 by AngioDynamics Inc. Prior to RITA Mr. Uecker served in roles of increasing responsibility with Computer Motion Inc., a pioneer in surgical robotic systems. He was Chief Technology Officer when the company was acquired by Intuitive Surgical Inc. in 2003.Mr. Uecker has extensive experience in product development, R&D, operations and business development in a variety of medical device markets. He is a named inventor on 51 U.S. patents and has led the development and launch of more than a dozen medical devices during his career. He received his Bachelor's and Master's degrees in Electrical and Computer Engineering from the University of California at Santa Barbara.

Jordan Bajor

Chief Operating Officer

Jordan has more than 24 years of manufacturing and operations experience in the regulated environment of both the DOD and medical industry with more than 20 years exclusively working with Medical Systems and Devices including many successful product launches, fundraisings, and mergers. Expertise includes all aspects of corporate definition, Strategic Planning and leadership as it applies to medical capital equipment as well as disposable medical devices design, development, manufacturing and deployment. Jordan is a multiple patent holder on many medical device technologies. Previous positions include: President and COO of Polymorfix, General Manager of ev3 Sunnyvale, VP of Operations of Appriva Medical, Senior Director of Operations at LocalMed, Inc., Surgical Manufacturing Engineering Manager at Coherent Medical, Inc., and Member of Technical Staff (Physics) at Hughes Aircraft Company.Jordan is a graduate of the University of California at Davis with a B.S. in Applied Physics.

Diane

Diane King

Vice President of Regulatory Affairs

Diane has served in senior management of medical device regulatory affairs for more than ten years. Previously, she was the Vice President of Regulatory Affairs with Alara, Inc. in Fremont, CA. Before joining Gynesonics, her experience covered FDA collaboration, pre-market submissions, clinical studies, compliance planning, and European regulatory requirements in the fields of digital imaging, bone densitometry, and light-based cosmetic therapy. She also has more than fifteen years of experience in the development and management of quality systems in FDA regulated industries. Diane is Regulatory Affairs Certified by the Regulatory Affairs Professional Society and holds Quality Manager Certification from the American Society for Quality. She received her B.S. in Chemical Engineering with distinction from the University of Rochester.

David

David Toub, MD, MBA, FACOG

Medical Director

David received AB and MD degrees from the University of Chicago, and earned an MBA with a concentration in management information systems from Drexel University. David is a Fellow of the American College of Obstetricians and Gynecologists and a Diplomate of the American Board of Obstetrics and Gynecology. After postgraduate medical training in obstetrics and gynecology at Brigham and Women's Hospital, Massachusetts General Hospital and Albert Einstein Medical Center, David completed a fellowship in pelvic surgery at Graduate Hospital. He also served as an attending physician at Pennsylvania Hospital, where he held faculty appointments at both Thomas Jefferson University and the University of Pennsylvania.A laparoscopic surgeon with a special interest in providing alternatives to hysterectomy, David has been a faculty member at several conferences organized by the American Association of Gynecologic Laparoscopists. He recently presented at the 19th Annual Congress of the European Society for Gynaecological Endoscopy and was a Keynote Speaker at a recent course on hysteroscopy at the Royal College of Obstetricians and Gynaecologists. David serves as an expert reviewer for the journal Obstetrics and Gynecology and is a member of the Editorial Advisory Board of The Journal of Minimally Invasive Gynecology. Prior to joining Gynesonics, David served as Chief Medical Officer at MedCases and VP, Medical Director at SciFluent, where he combined his clinical and information technology backgrounds to develop innovative continuing medical education programs for the Web.

Dave

Dave Danitz

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Vice President, Research and Development

David Danitz has been working in research and development for over 15 years. He last served at Novare Surgical Systems as VP of R&D where his team brought medical devices to the market in the areas of cardiac, vascular, general, urologic and gynecologic surgery. While at Novare, he invented the RealHand articulating technology which received a 2008 Medical Design Excellence Award and prompted Design News magazine to name Mr. Danitz a finalist for the 2008 Engineer of the Year. Prior to that, Mr. Danitz worked at Computer Motion as a project manager for the Zeus Surgical Robotic System which received a Medical Design Excellence Award in 2003. He also held a research engineering position at Exxon Production Research Center. Mr. Danitz earned a BSME degree with high honors from the University of California at Santa Barbara, and an SMME degree from the Massachusetts Institute of Technology. He is a named inventor on multiple patents.

Mike

Michael Munrow

Vice President, Systems Engineering

Before joining Gynesonics, Mike spent 14 years in the field of Ultrasound at Acuson/Siemens. There he held a variety of positions, including individual contributor, functional and project manager. He contributed to all of Acuson's platforms from the 128 to the Sequoia platform. After Acuson, he joined Optiscan as Director of Software and Electronics. Opticsan was a startup which was developing a non-invasive blood glucose monitor for home use by diabetics. Mike was promoted to VP of Engineering while at Optiscan. He was instrumental in defining and realizing several generations of the spectrometer prototypes made by Optiscan. Mike has several patents in glucose measurement. Mike earned his B.S. in Electrical Engineering from Massachusetts Institute of Technology.

Darrin
JB
Diane
David
Dave
Mike

Advisors

Medical Advisors

Andrew Brill, MD - California Pacific Medical Center, San Francisco, CA

Steven Goldstein, MD - New York University, New York, NY

Jose Gerardo Garza Leal, MD - University of Nuevo Leon, Monterrey, Mexico

Alison Jacoby, MD - University of California, San Francisco, CA

Barbara Levy, MD -St. Francis Hospital, Federal Way, WA

Malcolm Munro, MD - University of California, Los Angeles/ Kaiser Hospital, Los Angeles, CA

Elizabeth Stewart, MD - Mayo Clinic, Rochester, MN

Thierry Vancaillie, MD - Royal Hospital for Women, Sydney, Australia

Investors

Investors

Abingworth, LLP - Palo Alto, CA

ATV Capital - Palo Alto, CA

InterWest Partners, LLC - Palo Alto, CA

About Us
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