Healthcare Industry News: Balloon Catheter
News Release - April 21, 2015
IlluminOss Medical Appoints Amy Orlick Berman as Vice President of Clinical AffairsIndustry Expert Will Oversee Clinical Research Trials of First-of-Its-Kind Technology for Complex Fracture Repair
EAST PROVIDENCE, RI--(Healthcare Sales & Marketing Network) - IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced the appointment of Amy Orlick Berman as the company's vice president of clinical affairs. Berman brings almost two decades of clinical affairs experience and has extensive expertise leading global research programs from inception through product approval. In her new position, she will be responsible for the global clinical trial program at IlluminOss, including the U.S. Lightfix trial towards securing approval for the treatment of impeding and actual fractures of the humerus in patients with metastatic bone disease.
Prior to joining IlluminOss, Berman was at Cordis, Johnson & Johnson for nearly 10 years where she held roles of increasing responsibility and oversaw a number of high-profile clinical research programs in the U.S., Europe and Japan.
"Ms. Berman has an impressive track record of fostering successful partnerships with the FDA, clinical research organizations (CROs), vendors, and international scientific advisors to ensure approval and release of new medical devices and drug therapies," said Robert Rabiner, president and CEO of IlluminOss Medical. "We are pleased to make her a part of the IlluminOss Medical team and are confident she is the right fit to support the clinical trial efforts for the IlluminOss System."
The IlluminOss System is the world's first and only system of its kind. It utilizes a light-curable polymer, contained within an expandable Balloon Catheter, resulting in an intramedullary patient-conforming implant to achieve almost instant bone stabilization for the treatment of complex fractures. The IlluminOss System has proven successful in the treatment of over 700 patients in Europe, where it is commercially available and has been in clinical use since 2010. IlluminOss also now has conditional FDA approval for its first U.S. clinical trial.
"It's a pivotal time for IlluminOss Medical and I am excited to be a part of the effort to validate its groundbreaking technology, which is expected to revolutionize fracture repair by providing a much less invasive option that can benefit both the orthopedic surgeon and their patient," said Berman.
Berman holds a Master's Degree in public health from Columbia University.
IlluminOss Medical is a privately-held, commercial stage medical device company focused on designing, developing and marketing orthopedic fracture repair products that leverage its proprietary bone stabilization technology, the IlluminOss System. This minimally invasive technology allows for fracture fixation through patient specific intramedullary implants. The system utilizes a light-curable polymer, contained within an expandable Balloon Catheter, to achieve bone stabilization. The revolutionary procedure is made through a small percutaneous surgical approach providing patients and clinicians with a fast, patient-specific, method of orthopedic bone stabilization. The company currently markets its products in international countries under a CE Mark for approved clinical applications through both a direct sales force and distribution networks.
The IlluminOss products are Investigational Devices; limited by Federal law to Investigational Use and are not approved for sale in the USA.
Source: IlluminOss Medical
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