New Devices Improve Spinal Fusion Surgery with help from Innovative Test Solutions

Anterior Cervical Plate and Interbody Cages are Currently Progressing to Trial Phase at Albany Medical Center and the Cleveland Clinic as ReVivo Seeks FDA Clearance

Innovative Test Solutions (ITS), a Schenectady N.Y. company with an international reputation for excellence in materials and component testing, today announced it worked to support ReVivo Medical, a Loudonville, N.Y. company as ReVivo develops new products designed to improve spinal fusion surgery. The FDA and ReVivo have agreed on clinical trial parameters and a 50-patient clinical study is scheduled to take place at the Albany Medical Center and the Cleveland Clinic.

ITS’s exhaustive testing included static and fatigue testing as well as compression and torque testing of the company’s prototype implants and instruments. The test results were used during product development and played an important role in optimizing design configurations.

Gary Mittleman, President and Chief Executive Officer of ReVivo Medical LLC. said, “Our company has developed, tested and patented a family of unique products that are designed to significantly improve outcomes for patients undergoing spinal fusion surgery and make it easier for surgeons performing these procedures. The company retained ITS to provide testing services for their next generation design of anterior cervical plate and interbody cages. These devices are used in over 400,000 surgical procedures each year.”

ITS Co-owner Lou Fiorini said, “We take great pride in providing the best testing services available and we are extremely happy to work with ReVivo Medical, another Capital Region company, to provide testing for their innovative spinal implants. We love working with all our clients, but helping companies innovate is a true passion of ours and we are excited to see ReVivo continue through the development process.”

ReVivo’s products have received numerous patents. The company’s cervical plate and cage implants are designed to improve bone formation and achieve a superior rate and quality of fusion as compared to today’s commonly used devices. Additionally, the designs of these implants incorporate unique features that are intended to make them easier for the surgeon to use. ReVivo Medical will now begin a 50-patient clinical study scheduled to take place at the Albany Medical Center and the Cleveland Clinic – building upon the foundational role Capital Region companies are playing in bringing this innovative technology to market.  Study participants will receive ReVivo Medical’s next generation design anterior cervical plate and interbody cages used in anterior cervical discectomy and fusion procedures.

None of ReVivo Medical’s devices are currently cleared for use in the United States.

About ReVivo Medical, Inc

ReVivo Medical, head-quartered in Albany, New York, is developing implantable medical devices for use by surgeons on patients with spinal pathology. The founders, neurosurgeon Darryl DiRisio, MD and biomedical engineers Eric Ledet, Ph.D. and Glenn Sanders, Ph.D. teamed up with the aim of developing products that improve patient health, facilitate easier surgery and reduce costs in this ever-competitive healthcare arena.

Cautionary Statement Regarding Forward Looking Statements: This press release contains forward-looking statements that are not purely historical regarding ReVivo Medical’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to the development, cost, size, intended use and technical specifications of the medical products, the potential impact on outcomes and costs associated with spinal surgeries, and the potential profits to be made by ReVivo Medical pursuant to the successful commercialization of their product(s) and the size of market and market share of products. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from ReVivo Medical’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: the inability to successfully develop new products and obtain regulatory approval; insufficient outcomes in a clinical trial to achieve clearance; a lack of acceptance in the marketplace by physicians and patients; the inability to manufacture products in commercial quantities at an acceptable cost; possible delays in the company’s development programs; the inability of patients or hospitals to receive reimbursement from third-party payors; inadequate protection from patents to prohibit competitors from making similar devices; and inadequate financial and other resources. All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to ReVivo Medical, and ReVivo Medical assumes no obligation to update any such forward-looking statement or reasons why results might differ.