Simbionix Appoints Director of Newly Established Regulatory Affairs Department

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is pleased to announce the appointment of Dr. Yael Friedman to Director of the newly established Regulatory Affairs Department.

Simbionix has leveraged its leading position in the healthcare training and education market to expand its activities into the clinical market, having recently received market clearance for the PROcedure Rehearsal Studio™ software, the next generation in “patient specific simulation”. With a PhD in Biology and twenty years research experience in leading universities in the USA and Israel, Dr. Friedman has been with Simbionix for the past ten years as Chief Scientist for Medical Projects. Dr. Friedman’s deep understanding of the potential and requirements of medical simulation has led to a long track record of successful activities in the simulation market. By working closely with key opinion leaders, medical societies, and professional associations to create meaningful, effective and scientifically validated simulation products, her efforts have resulted in the publication of some 130 validation papers on Simbionix products, demonstrating and validating their value in medical education. For the past two years Dr. Friedman has also taken the lead in the company’s regulatory activities, successfully navigating the process of obtaining an FDA 510(k) clearance for Simbionix’s new and exciting PROcedure Rehersal Studio™ software.

“Yael represents the core values of Simbionix, namely creating innovative products that improve patient care and outcomes while responding to the market’s ever increasing simulation needs,” said Gary Zamler, CEO of Simbionix. “We are very pleased we are able to bring our innovative simulation technologies to the clinical market and have established the Regulatory Affairs Department to better serve the market, by accelerating future PROcedure Rehersal Studio™ products under development. To the best of our knowledge Simbionix is the only simulation company to be granted FDA 510(k) clearance for a simulation technique. We are building on our successful experience in the healthcare training and education market and expanding it to create simulation based products for the clinical market as well. Yael is the ideal person to lead our global Regulatory Affairs activities as we expand into the clinical market.”

Simbionix to Exhibit New LAP Mentor Nephrectomy Module at the Upcoming SAGES Annual Meeting

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, is happy to announce the release of their new Laparoscopic Nephrectomy module for the LAP Mentor simulator. Hands-on practice of this complex module will be available at the SAGES Annual Meeting between March 30 – April 2, 2011, at Simbionix booth #240 and in the Learning Center.

It has been estimated to take surgeons approximately 15 laparoscopic nephrectomy cases to become proficient with this procedure. The nephrectomy complete procedure module is intended to provide an alternative platform for shortening the learning curve involved with these procedures, in a risk-free environment, before proceeding to the clinical setting. The module has been designed to accommodate various procedure techniques, allowing trainees to choose their preferred method of action.

“We are very excited to add the complex nephrectomy training module to our LAP Mentor’s ever-growing library of modules,” said Mr. Ran Bronstein, Simbionix President. “The true-to-life virtual reality simulation of this highly advanced procedure is a breakthrough in simulation technology, providing an environment abundant in anatomy layers which interact smoothly with one another to simulate one continuous procedure. Simbionix continuously overcomes technological challenges to provide the best training tools for the medical community.”

Simbionix Welcomes New Vice President for US Business Development

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is pleased to announce that William Lewandowski has been promoted to the position of VP for US Business Development.

Mr. Lewandowski has over 21 years of experience in the design, development, implementation, and evaluation of simulation in healthcare, aviation and defense, including having served as the company’s US Director of Marketing for the past few years.  He has published and presented in a number of international peer-reviewed venues on both simulation and instructional design and has served in an advisory capacity on these subjects to various US and international clinical boards and societies. He holds a Masters of Science degree in instructional and performance technology from Boise State University and is pursuing a PhD in health sciences at the University of Liverpool.

“Bill embodies the core principle of Simbionix, that a world-class medical device combined with world-class simulation and curriculum results in a superior clinician who can deliver improved patient outcomes,” said Gary Zamler, CEO of Simbionix.  “Bill’s unique combination of experience within the medical simulation industry, and education makes him the ideal person to not only expand our industry business, but also to work with our industry partners to ensure that we are part of the solution for improving the quality of healthcare in North America.”

Simbionix Releases Innovative Module for Practicing the Essential Skills of Transseptal Puncturing

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, is happy to announce the release of their new Transseptal Puncture Module for the ANGIO Mentor simulator.

Due to the growing interest in catheter ablation of atrial fibrillation (AF), the transseptal puncture has become a required routine skill for the modern cardiac electrophysiologist. The Transseptal Puncture permits a direct route to the LA via the intra-atrial septum (by puncturing the fossa ovalis) and systemic venous system.

“Addressing our clients’ needs we developed a highly realistic module, providing a cost effective and efficient training solution for one of the most crucial skills required of electrophysiologists”, said Ms. Inbal Mazor, Simbionix VP of Marketing. “While the left atrium (LA) is the most difficult cardiac chamber to access percutaneously, it is an essential skill to master and plays an important role in the cardiac electrophysiologist’s daily practice”.

Having developed the new transseptal module, Simbionix is now able to offer a complete training curriculum for electrophysiologists on the ANGIO Mentor, allowing the physicians a safe environment in which to train until proficient in the essential tasks they are required to perform. These tasks include advancing the EP catheter into the coronary sinus and the Josephson catheter in the HIS area, and performing two transseptal punctures, when needed. Practical aspects of this important technique include identifying the optimal transseptal puncture site and using correct and safe puncturing technique. During the simulation, life threatening complications such as aortic puncture, one of the common complications associated with these procedures, need to be attended to.

Simbionix Launches MentorLearn: Providing the Optimal Solution for Training Program Management

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, released its new MentorLearn system at the International Meeting on Simulation in Healthcare (IMSH) last week.

Simbionix’s exciting new MentorLearn platform now provides the optimal solution for managing all training and education needs for the Simbionix line of simulators. The easy to use system facilitates performing the administrative tasks of running a training course or workshop. The system includes a library of ready-to-use simulator based curricula and a platform to design new training curricula. Curricula may include online didactics, proficiency based hands-on training and performance review and assessment. Dr. Pasquale Berlingieri and Professor Owen Epstein from the Royal Free Medical Simulation Center in the UK said that “the Simbionix simulators are an outstanding example of thoughtful design and recognition that the virtual reality experience needs to be integrated with ease of use and automated recording of trainees’ metrics which trainers can use to assess progress”.

Training centers’ directors and delegates at the IMSH who had the chance to experience MentorLearn were extremely enthusiastic to find a comprehensive management system dedicated to simulators use. They commented on the ways they could see their centers benefiting by implementing such an advanced centralized system to manage their daily activities as well as support the creation and management of special courses and workshops.

“Simbionix is constantly designing and implementing innovative products to enhance the use of our medical simulators to support our customers and to add value to the learning process”, commented Mr. Ran Bronstein, Simbionix President. “The MentorLearn system provides a comprehensive infrastructure to assist administrators, directors and learners make the most out of the learning experience. We made sure to include online capabilities, since we believe that remote management is essential to ensuring the efficient management of simulator and training programs, allowing educators to follow and control the training process and learner attendance at all times.”

Simbionix Receives FDA Clearance to Take Medical Simulation Technology One Step Further into Clinical Settings

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Cleveland, OH, USA: Simbionix Ltd., a subsidiary of Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, is proud to announce the receipt of FDA clearance for the PROcedure Rehearsal Studio™ Software.

The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging data from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating and evaluating surgical treatment options. Unique to the Simbionix simulation systems, the 3D segmentation model can be exported to the Simbionix ANGIO MentorTM Simulator practice environment. The results are an advanced method of creating an ever expanding library of modules for training and post-operative debriefing.

Dr Karl A. Illig, Professor of Surgery and Neurosurgery and Chief, Division of Vascular Surgery, University of Rochester Medical Center comments: “We have been using the PROcedure Rehearsal Studio in our research and educational programs, and it has lived up to our fullest expectations. We began to practice using our carotid stents on the simulator before performing them in the operating room in 2008, and have been very impressed by its ability to improve our subsequent procedures. In my opinion, this is clearly the next step for medical simulation, where simulators will be able to be used to plan a procedure.”

“We are extremely pleased to have received the FDA clearance, allowing us to offer new and advanced technologies for use in daily clinical practice as well as in training”, says Gary Zamler, Simbionix CEO. “The PROcedure Rehearsal Studio software was designed to help clinicians deliver better patient care and to enhance patient safety through timely and realistic practice. Once again, we are able to prove that Simbionix is constantly innovating and stretching technological boundaries.”

Simbionix and AABIP Sign Collaboration Agreement

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation technology, is pleased to announce they have signed a collaboration agreement with the American Association
for Bronchology and Interventional Pulmonology (AABIP) on the development of a Bronchoscopic Essential Skills module.

Simbionix new Bronchoscopy essential skills module is being developed in conjunction with, and endorsed by the AABIP. The new module offers designated skill tasks covering the spectrum of Bronchoscopic skills required. This module is intended to provide the trainee with solid habits for safe and efficient performance, and to enhance hand-eye coordination, 3D perception and anatomical knowledge.

Gerard Silvestri, AABIP President, said that “The daily practice of clinicians is highly affected by the progression of medical technologies, as they are required to adapt to fast changes and developments. It is therefore essential to develop new training programs that utilize the advanced technologies, such as virtual reality simulators, to assure that the educational curriculum is entirely covered. We chose to work with Simbionix since we believe that only close collaboration between the medical community and companies that provide cutting edge technologies are essential to successfuly design these programs for the benefit of the physicians, the patients and the entire medical field.”

“We are very excited to have reached yet another collaboration agreement with a leading medical society” commented Mr. Ran Bronstein, Simbionix President. “All of our products are designed with the cooperation of the medical community, who play an active role in simulation design, content definition, and product testing and validation. Simbionix continuously provides the procedural and technological knowhow and actively joins forces with the leading medical associations and the medical industry to optimize training solutions and to advance clinical performance.”

About the American Association for Bronchology and Interventional Pulmonology:
AABIP is dedicated to promoting excellence in clinical care, education, and research in the rapidly expanding fields of Bronchoscopy, Interventional Pulmonology, and
Interventional Bronchoscopy. For more information on the AABIP, visit www.aabronchology.org

Simbionix Relocates its Courseware Business to its Corporate Headquarters in Cleveland, Ohio

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, will consolidate its eTrinsic custom courseware business currently located in Denver, Colorado and relocate those operations to its Corporate Headquarters in Cleveland, Ohio under its expanding Medical Education Division (MED).

The move will enable Simbionix to better focus on its strategic direction, enhance its mobile and web-based medical education products and services, and improve reaction to customer and market needs. “This is a very exciting time for Simbionix”, stated Paul Jensen, the GM of the new and expanding Medical Education Division, “we are developing a number of innovative products. Having everyone in one location will facilitate collaboration across the team and improve our ability to rapidly deliver high-quality solutions.”

The company recently announced the expansion of its Corporate Headquarters. The move will be completed by the end of September 2010.

Simbionix Continues its Global Expansion

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Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is pleased to announce the company’s continued global expansion. Simbionix has increased the size of two of its major facilities with an expansion of its Corporate Headquarters in Cleveland, OH, and an entirely new, modern facility for its R&D Center of Excellence and International Operations in Israel.

Simbionix increased its investment at a time when many companies in our industry have decided to hold back on such activities, in order to further demonstrate our ongoing commitment to R&D, new product development and global customer support. The creation of the Simbionix Medical Education Division (MED) was one of the driving forces behind the expansion of the company’s headquarters in Cleveland, OH, as well as the need to support increasing market demand. The R&D Center of Excellence and International Operations in Israel moved to new offices in the new, high tech Airport City Business Complex to support the company’s strategic growth objectives and further enhance global reach.

“The demand for our products and services continues to grow as medical simulators and e-learning become a more common element in the training and education of surgeons and healthcare clinicians,” commented Gary Zamler, CEO of Simbionix. “Based on record sales over the last three years, increasing market demand for our innovative simulations and training solutions and services, as well as our internal company growth forecasts, we decided to invest in larger facilities to enable us to provide even faster response and better service to our clients worldwide. Everyone at Simbionix is thrilled and excited. These investments in our new facilities reinforce the company’s ongoing commitment to provide exceptional products and services to the medical community.”

Simbionix and USF Receive Grant to Support Development of Laproscopic Hysterectomy Simulation

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Cleveland, OH, USA: Simbionix Ltd., a subsidiary of Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, and USF Health, an organization dedicated to creating a model of health care based on understanding the full spectrum of health, are proud to announce that together they received a BIRD (Binational Industrial Research and Development) Grant to support the development of a Laparoscopic Hysterectomy simulation module.

The BIRD Foundation was established by the U.S. and Israeli governments in 1977 to generate mutually beneficial cooperation between the private sectors of the U.S. and Israeli high tech industries, including start-ups and established organizations. BIRD provides both matchmaking services between U.S. and Israeli companies, as well as funding covering up to 50 percent of project development and initial product commercialization costs.

Developing this new Laparoscopic Hysterectomy module supports Simbionix’ goal for including complex advanced procedures in their comprehensive LAP Mentor™ Simulator. It also reaffirms Simbionix’ commitment towards improving the quality of care in the field of Women’s Health. Approximately 600,000 hysterectomies are performed annually in the US, making it the second most frequently performed major surgical procedure. The Laparoscopic Hysterectomy procedure requires greater surgical skills than the vaginal and abdominal methods, and as such necessitates performing approximately 15 procedures before surgeons become proficient. Since this procedure is difficult to teach using conventional methods, practicing Ob-Gyns may have never received laparoscopic training during their residency. The new module will use medical simulation teaching methods to provide the necessary complex skills acquisition and training for surgeons.

Dr. Stephen K. Klasko, CEO of USF Health and Dean of the USF College of Medicine stated: “As simulation technology expands its use as a driver for quality and safety in medicine, it will take great organizations working together. At USF Health, we have been a leader in applying technology to improve the health of our community. Over the past year, USF Health has had the opportunity to work with Simbionix, the world’s leading provider of medical education and simulation products to deliver training for medical students, residents, practicing physicians and other healthcare professionals to enhance technical competence and improve patient outcomes. The award of the BIRD grant provides a fantastic opportunity for us to work with Simbionix to develop the first laparoscopic hysterectomy simulation module for training GYN surgeons in minimally invasive surgery techniques. This project has the potential to have a huge impact on the quality of practice of gynecologists worldwide. Through us working together, our doctors, our patients and the health of our communities will stand to be the winners.”

“Simbionix makes it a priority to cooperate with the medical community on a regular basis for the advancement of medical education and training” says Simbionix President Ran Bronstein. “We are honored to have received this grant and to be working on this exciting project in conjunction with USF. Simbionix’ unique, advanced simulation technology, combined with the clinical and educational expertise of USF Health’s collaborating physicians, and USF Health’s experience in integrating medical simulation into certifiable curricula, will ensure that the advanced GYN – Hysterectomy simulation module will truly be an innovative and critical contribution to improving women’s healthcare.”