July 19, 2017 /SAN DIEGO — SpineOvations, Inc., a California-based medical device company developing novel minimally invasive therapies for spinal disc diseases, announced the appointment of Marc Bellotti, M.S., to its board of directors, effective immediately. Marc will serve as an independent director and member of the audit committee and serve as Chairman of the Board R&D Committee.
“Marc brings an impressive track record in medical device research and development and executive leadership in large and small companies to SpineOvations and will play a key role guiding SpineOvations as it develops novel minimally invasive therapies for patients suffering from lower back pain,” said Niv Caviar, SpineOvations CEO. “Marc’s experience with successfully managing medical device research and development processes to regulatory approval and commercialization will be an asset to our team as we move forward with the conduct of European CE Mark studies planned to begin early next year.”
Marc Bellotti is currently a partner at Fuel Source Partners, a management consulting and development execution company for the medical device industry. He has more than 35 years of medical device development experience working in both large and small companies. Prior to consulting, Marc was VP Research and Development for Sonendo, Inc. Earlier in his career, he held senior executive positions at Johnson and Johnson and Baxter Healthcare. At Johnson and Johnson, he was Worldwide VP of R&D for Advanced Sterilization Products and a member of the Board of Directors. He is a member of OCTANe and serves on the Launch Pad for new start-ups, is on the Board of Device Alliance, is an EIR at UCI Innovation Institute and is part of the Executive Next Practices Institute. Marc holds both undergraduate and graduate degrees in Biomedical Engineering from Rensselaer Polytechnic Institute and has over 100 patents and patents pending in addition to several publications.
“I am excited to join the SpineOvation’s board,” said Marc Bellotti. “The DiscSeal platform technology has the opportunity to change the way discogenic back pain is treated. The product has the potential to be the first minimally invasive solution for those patients who fail first line therapy for lower back pain and desire an alternative to surgery. Early results with DiscSeal have been very encouraging and I look forward to contributing to the board and working with the management team on the next steps in development as the product advances to human studies.”
The Company’s current board of directors are Neville Alleyne, MD; Marc Taylor, MD; Stuart Young, MD; Bill Nydam; and Niv Caviar.
DiscSeal, delivered via a simple percutaneous injection, is a patented, proprietary formulation of biocompatible synthetic microspheres and a viscous carrier specifically designed for disc augmentation, thereby minimizing progression of internal disc disruption and disc degeneration disease, one of the most common causes of lower back pain. In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the discs maintained their disc height.
In early 2018, The company plans to initiate human clinical trials sufficient for EU CE Mark application. The company plans to file for CE Mark after the study, which will lead to potential CE Mark approval of DiscSeal. CE Mark approval will enable commercialization in the EU. The company plans to conduct a US trial after the EU study.
SpineOvations (SO) is a mid-stage medical device company focused on developing innovative minimally invasive therapies for the intervertebral disc and lower back pain conditions. SO’s DiscSeal technology is patented. The company is founded by well-known spinal and neurosurgeons and led by experienced executives in the life sciences. For further information, visit the company’s website at www.spineovations.com.
Niv Caviar, Chief Executive Officer