Vascular Surgeons Agree: Case Rehearsal Improves Outcomes

Surgeons at the University of Rochester Medical Center, NY indicated that patient-specific CTA data can be converted to an endovascular simulator (ANGIO Mentor™, Simbionix US) with high face validity. The surgeons “strongly agreed” that the simulation improved the operative flow, increased patient safety and efficiency of instrument use, decreased overall operative and fluoroscopy time and the amount of contrast used, and that the operative and simulator outcomes were similar.

New Colorectal Module from Simbionix Advances Laparoscopic Cancer Treatment

Simbionix USA Corp, an international company using leading edge simulation to advance clinical performance, announces the world-wide release of a breakthrough training simulation of the laparoscopic colorectal procedure.

Although minimally invasive surgical (MIS) techniques provide many advantages over traditional open surgery, surgeons have been slow to adopt laparoscopic colon resection, because it is a very challenging procedure to learn without potentially putting patients at risk. Colorectal resection is the most common treatment for colorectal cancer, which accounts for almost 10% of all cancer deaths in the US annually. The US National Institutes of Health (NIH) ranks colorectal cancer as the 4th most common type in the United States, with over 148,000 Americans diagnosed in 2008.

This new, virtual reality simulation, properly used, will significantly assist surgeons in mastering and perfecting their skills, in performing this critical cancer procedure, without posing a risk to patients during the learning process. The Laparoscopic Colorectal Procedure simulation joins the suite of training simulations available on Simbionix’s critically acclaimed LAP Mentor™ which now offers training opportunities on seven different laparoscopic procedures and over 60 different patient scenarios.

Our new laparoscopic colorectal module is definitely a revolution in the world of virtual reality medical simulation,” explains Simbionix President, Ran Bronstein. “We’ve created a virtual 3D environment featuring the complex anatomical structures a surgeon would encounter in a real laparoscopic colorectal resection. Combined with the unique simulation capabilities that I believe only Simbionix can provide, the virtual module allows unlimited procedural interaction and is a definite leap forward in medical simulation.”

The Simbionix Laparoscopic Colorectal Procedure simulation received international praise at the September 2008, 11th World Congress of Endoscopic Surgery and the Japanese Society of Endoscopic Surgery (JSES), and at the American College of Surgery (ACS) in San Francisco, CA in October. Professor Watanabe, head of the JSES, said: “It is very exciting to have a way of training how to perform and master this critical procedure. I am sure we will use it to train our surgeons.”

Conor P. Delaney, Professor of Surgery, Chief, Division of Colorectal Surgery at Case Western Reserve University, is also excited about the new module. “The laparoscopic colorectal module will transform the way we teach laparoscopic colorectal surgery. I see this as an important part of training, where trainees learn the basic steps on a simple trainer, and then practice their first 20 cases on the Simbionix simulator. That way, by the time they need to perform in a clinical situation, they are already experienced with the procedure.”

William E. Lewandowski to Lead Simbionix US Marketing Team in Simbionix’s Strategic Expansion in the US Market

Cleveland, OH and Lod, Israel: Simbionix USA Corporation (Simbionix), a developer of medical simulators and hands-on curriculum for training medical professionals, today announced that William E. Lewandowski will join the company as the US Marketing Director on November 10th, 2008. Gary Zamler, Simbionix CEO stated, “Over the past two consecutive years, Simbionix has enjoyed double digit revenue growth in both our International and Domestic markets. We are particularly pleased to have someone of Bill’s caliber join our expanding US organization to increase the momentum as we rollout new and exciting products such as ‘PROcedure Rehearsal Studio’ the Simulation Industry’s first patient specific technology.”

Bill brings to Simbionix a unique background with over 20 years of experience in the business of training and simulation in the aviation, defense and medical industries. For the last 3 years, Bill has been an independent consultant in the acquisition, development, use and validation of simulation and training devices to a wide range of clients in Asia, Europe, and the United States. Inbal Mazor, Simbionix Corporate VP Marketing stated, “Bill’s experience and knowledge will assist us to maintain our market leadership position within the medical education and simulation markets. We are pleased to have Bill join Simbionix and lead our US marketing efforts.”

In addition to his consultant work, Bill has held key positions in the training and simulation industry. Bill held the position of Vice President for Simulation Systems, and later Business Development, for a producer of medical simulations. He oversaw the development of medical simulation products and established development contracts with leading medical device companies. At FlightSafety International (a major international producer of flight simulators and commercial aviation training), Bill managed a division that developed Federal Aviation Administration (FAA) certified training products, which included instructor-led courseware, eLearning, and non-motion simulations. He was also instrumental in winning curriculum development contracts with major airplane manufacturers in Brazil, Canada, France, Israel, and the United States.

Bill rounds out his business experience with solid academic credentials. He holds a Master of Science (MS) degree in Instructional and Performance Technology from Boise State University, Idaho, and he is currently pursuing a research Doctor of Philosophy (PhD) degree in Health Science at the University of Liverpool, UK. He has published and presented in professional medical society venues and has served on publication peer review committees for instructional design and medical societies. Bill is a member of the American Society for Training and Development, the International Society for Performance Improvement and the Society for Simulation in Healthcare.

Simbionix Raises Largest Amount in Company’s History in Venture Capital to Accelerate Growth

Cleveland, OH and Tel Aviv, Israel: Simbionix USA Corporation is pleased to announce the completion of a Series C round of growth capital financing led by River Cities Capital Funds, along with incumbent investor Early Stage Partners and other existing shareholders, as well as Western Reserve Partners who served as the company’s investment bankers. The investment will enable Simbionix to accelerate the already rapid growth of its medical simulation technology via the introduction of innovative new products and expanded distribution channels. “This significant funding will help us continue the company’s momentum and support Simbionix’s commitment to maintain its position as the global leader in medical simulation technology,” stated Dr. Avshalom Horan, Chairman.“We are excited about the market’s validation of our technology as well as the strong financial support of River Cities and the continuing support of our existing investors,” commented Gary Zamler Simbionix CEO. “This infusion of new growth capital will fuel further domestic and international growth of our existing products as well as our emerging products – that includes the recently launched PROcedure Rehearsal Studio, a truly revolutionary virtual reality endovascular simulator with unprecedented hands-on, “patient-specific training capabilities,” he added. “Simbionix works closely with global leaders in healthcare, both on the medical device side and the provider side. They take comfort with Simbionix as a partner because of our size, profitability, and the resources to bring innovative products to market,” Mr. Zamler concluded.

Ran Bronstein, Simbionix President and one of its founders commented “funding of this sort is an important achievement for the Simbionix team. It’s an additional indication demonstrating the growth and the validity of the medical education and simulation market since River Cities has experience in both fields. We welcome River Cities’ involvement to boost our efforts to improve patient safety and medical outcomes through advanced simulation. “

“We have been very impressed with the Simbionix team and its best-of-breed technology in an attractive, emerging global marketplace – the combination of people and technology at Simbionix looks tough to beat,” stated Mr. Murray Wilson, Managing Director of River Cities. “The impressive rate of adoption of the new e-Learning initiatives makes us confident that the company can build on its already-demonstrated success with the simulation platform.

About River Cities
River Cities Capital Funds is a venture capital firm based in Cincinnati, Ohio with an office in Raleigh, North Carolina. It has raised nearly $400MM in four venture funds since being founded in 1994, and has backed over 80 portfolio companies, located mainly in the Midwest and Southeastern regions of the U.S. River Cities invests behind exceptional management teams in expansion stage companies in healthcare and information technology that have unique technology or services and strong market positions, with a special emphasis on recurring revenue business models. For more information, please visit www.rccf.com.

About Early Stage Partners
Early Stage Partners is an early stage venture capital firm based in Cleveland, Ohio. The company invests in promising opportunities in instrumentation and control technology, life sciences, advanced materials, energy, information technology, and electronics. The company’s principals have over one hundred years combined experience in early stage company formation and development, with a significant network of relationships throughout the United State that can be used to attract management, develop strategic partnerships, and provide later stage funding. For more information, please visit www.esplp.com.

Simbionix Launches Innovative Patient-Specific Simulation

Cleveland, OH, USA: Simbionix, the world’s leading developer of medical simulation systems, advances procedural simulation from theoretical promise to operating room reality. The PROcedure Rehearsal Studio™, Simbionix’ latest innovative medical simulation system, is the world’s first medical simulator that enables clinicians to create practice scenarios based on their patient’s unique pathology and anatomy.

Dr. Karl Illig, Chief of Vascular Surgery at Strong Medical Center in Rochester, NY, explains why physicians are eager to start using the new simulator: “PROcedure Studio helps us identify pitfalls and problems and solve them on the machine. If we’re going to make a mistake, let’s make it on the simulators first.”

Gary Zamler, CEO of Simbionix, sees the launch of Procedure as “a quantum leap in the world of medical simulation that has the potential to significantly improve patient outcomes while reducing health care costs.”

“Our leading technology has made Simbionix the industry leader in medical simulation. PROcedure Rehearsal Studio shows where that leadership will be taking everyone”

Mr. Zamler also announced that Strong Medical Center in Rochester, NY, Imperial College, UK, and Sheba Hospital, Israel have already signed agreements with Simbionix to use PROcedure Rehearsal Studio in their simulation centers.

“These leading hospitals will use and test PROcedure Rehearsal Studio in accordance with Simbionix’ philosophy and mission to collaborate with the medical community developing leading-edge technologies for training and education while promoting patient safety.

Simbionix will unveil this next generation of medical simulation on October 12th at the Annual Transcatheter Cardiovascular Therapeutic symposium (TCT) in Washington, DC.

Simbionix Releases Powerful New Learning Management System with Enhanced True Assessment System™

Cleveland, OH and Denver CO: Simbionix’ eLearning division, eTrinsic, announced the release of version 6.0 of their enhanced Learning Management System (LMS), incorporating the True Assessment System™ (TAS) for data reporting. Simbionix’ LMS already delivers state-of-the-art online medical education modules to tens of thousands of users.

V6.0 adds enhanced administration and reporting functions so new users can grasp basic functionality immediately and experienced administrators can perform/carry out common management tasks faster. A streamlined GUI integrates all the features into an easy-to-use interface.

The architecture has been refined for enhanced scalability, greater speed, and superior performance.

Improvements to current features include enhanced rules-based self-registration, manager approval, event scheduling, unlimited group and manager levels, wait-list management, prerequisite management, updated certification management and accreditation reporting.

The new Data Visualization Reports Suite allows administrators to visualize user data quickly so they can easily manage and understand user capabilities and knowledge.

V6.0 also integrates Simbionix simulator data into reports. And by the end of 2008, complete integration of the LMS with the Simbionix Mentor line of virtual reality simulators will be available.

Announcing the release of the new version 6.0 LMS, eTrinsic President Jacques Devaud commented: “We developed the LMS to offer corporations rapid deployment, customized data collection and detailed reporting capabilities not found in other platforms. Version 6.0 offers even more power and flexibility to users and managers, while setting the stage for the first ever integration of simulator and didactic performance data into one seamless product.”

Simbionix Takes Non-Invasive GYN Surgical Training to the Next Level

Simbionix has announced the release of a new and exciting module for its LAP Mentor simulator that gives trainees hands-on experience with different techniques and alternative approaches to the treatment of ectopic pregnancy, tubal sterilization and oophorectomy. The GYN module is the latest addition to the suite of laparoscopic procedures developed for the LAP Mentor, the world’s most advanced laparoscopic surgery simulator. The GYN module makes full use of the LAP Mentor’s 3-D real-life graphics and ergonomically designed hardware to provide the most realistic experience of training and learning possible.

The module includes an expandable library of virtual patients with a variety of anatomical anomalies and complications, a complete set of laparoscopic instruments including those unique to GYN procedures, exceptional audio and visual learning aids and a comprehensive set of performance metrics.

In announcing the release of the new module, Simbionix President Ran Bronstein commented: “This demonstrates Simbionix continued commitment to our LAP customers. We are committed to continuous on going development that will keep the LAP Mentor the most advanced laparoscopic system on the market. Our goal is to assure customers unsurpassed value and maximum benefits from their purchase of Simbionix Simulators.”

2007 a “Record Year” for Successful Validation Studies of Simbionix Simulators

Cleveland, OH, USA: Ten new validation studies were published during 2007 on the Simbionix Mentor series of training simulators, bringing the total number of studies published to 65. “This year we have seen a considerable increase in interest from US and European institutes” said Gary Zamler, Simbionix’ CEO. “Some of the world’s most highly respected academic medical institutions and teaching hospitals have completed studies measuring the efficacy of using Simbionix Mentor simulation products.”

The studies published this year include two new studies on the GI Mentor, two on the URO/PERC platform, three on the LAP Mentor and three on the ANGIO Mentor. Some of the studies were carried out at multiple sites, something that typically increases the reliability of study results. The institutes which conducted studies include the University of Texas, Catharina Hospital of the Netherlands, the British Imperial College of London and the Graduate School of Medical Sciences in the Kyushu University of Fukuoka, the first study by a Japanese institute to date.

The study carried out by experts at Catherina Hospital’s Department of Gastroenterology concluded that the GI Mentor II simulator offered a convincing, realistic representation of colonoscopy that can discriminate between different levels of colonoscopy expertise. As a result, the product was granted both construct validity and expert validity. The study carried out by Kyushu University of Fukuoka concluded that the LAP Mentor was able to differentiate between subjects with different laparoscopic experience.

One of the key value points for medical institutions to use Simbionix products is the ability to offer clinicians and medical students the required hands-on surgical experience at zero patient risk. Validation studies are critical to prove the efficacy of the simulation experience, so that institutions can rely on simulators to advance clinician training and improve patient safety. Yael Friedman Ph.D., Simbionix Chief Scientist over Medical Projects noted “We are happy to see that all of the institutes which have validated our products continue to demonstrate the effectiveness and advantage of using our Mentor products for surgical training.”

Simbionix Announce Collaborative Agreement with the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and the Fundamentals of Endoscopic Surgery (FES) Task Force

After extensive review, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Fundamentals of Endoscopic Surgery (FES) task force has selected Simbionix to collaboratively develop a simulation-based endoscopic hands-on skills assessment system.

After extensive review, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Fundamentals of Endoscopic Surgery (FES) task force has selected Simbionix to collaboratively develop a simulation-based endoscopic hands-on skills assessment system.

One of the major challenges in training physicians to perform flexible endoscopy is the need for a standardized and efficient assessment tool to verify proficiency and identify deficiencies in a trainee’s skills. In response to this concern, SAGES formed a committee to design a Fundamentals of Endoscopic Surgery (FES) Program. To address the requirements of the program, both multimedia and simulation-based educational elements need to be included, followed by a high-stakes validated exam to assess both knowledge and hands-on proficiency.

Simbionix’ sophisticated GI Mentor technology platform will be used to develop the hands-on endoscopic simulation component specified by the FES Program. The hands-on component will feature skills training on the basic tasks needed for flexible endoscopy.

Gary Zamler, Simbionix’ CEO, noted that “this is clearly evidence of Simbionix leading position in the medical education market; we see this as a landmark step in the maturing of the medical simulation market. Simbionix appreciates the involvement of SAGES, a leading professional association, to advance the field of medical education through simulation-based programs for its membership. Simbionix is committed to this exciting and innovative project.”

Simbionix Launches Portable LAP Simulator at Surgeons Congress in New Orleans

Cleveland, OH, USA,: Last week, Simbionix unveiled the newest member of its extraordinarily successful LAP Mentor simulator line to members of the American College of Surgeons in New Orleans, LA, the compact LAP Mentor Express™. The LAP Mentor Express runs the same robust, realistic software as the larger LAP Mentor II, offering integrated training on complete laparoscopic procedures, practice of basic skills and validated performance metrics, all in a sleek cost-efficient, and completely portable package. To support the continuing value of the platform, Simbionix will continue its rapid release of new, advanced procedural software for the LAP simulators to meet market demands.

This “personal trainer” for laparoscopic surgery comes complete with a high-performance laptop and all necessary surgical tools, contained in a wheeled case for easy entry and use in clinics, small-scale courses, local meetings, etc.

Dror Paz, Director of US Sales for Simbionix, reported that participants in the ACS Congress received the new system with great enthusiasm. “We expect that the LAP Mentor Express will open the door to more medical centers, training programs and clinicians that have been waiting to enjoy the benefits of a top-quality laparoscopy simulator with training modules that accommodate budgetary constraints.”