BioBraille: A Stunning Disruptive Surface Technology for Orthopedic and Spinal Implants That Induces New Bone Growth With Incredible Rapidity
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Problem Worth Solving
Every year, 1 in 8 people receive treatment for spine issues, and 1 in 5 spine surgery patients develop a narcotics addiction. Despite this, most leading spine implant companies are not innovating. We have developed and FDA-cleared groundbreaking solutions for spine surgery, including a disruptive surface treatment poised to revolutionize the $5 billion U.S. bone graft market.
Delivering innovative spinal surgery solutions to surgeons and their patients
BIOBRAILLE: Innovative Surface Technology for Bone Growth
BIOBRAILLE™ is a revolutionary surface technology that leverages the body's natural mechanisms to grow new bone by "reading" the instructions in its macroscopic, microscopic, and nanometer-scale features. This technology promotes rapid and vibrant bone formation without the need for expensive and potentially hazardous bone grafts or synthetic materials. BIOBRAILLE™ has broad applications in the $55B global spine, orthopedic, and dental implant markets.
Cervical Cage Device
Interbody cages are structural supports that stabilize the spine and have a hollow to allow for bone growth through the middle. These cages have special design features to facilitate our surface treatment that stimulates bone growth in a manner never seen before, promising to reduce or prevent the need for expensive and potentially dangerous bone graft products. Anterior cervical fusion procedures are among the most common spine procedures. This system is FDA cleared and initial cases are scheduling now!
Lumbar Cage Devices
Low back fusion procedures can be done through surgical approaches from different angles. These are called Posterior or Transforamenal Interbody Fusions (PLIF or TLIF), Anterior Lumbar Interbody Fusion (ALIF) and Direct Lateral Interbody Fusion (DLIF). Our complete family of lumbar cages are in the FDA process and we expect clearance to sell from the FDA soon and will be ready for commercial sales.
Executive Team
Jim Robinson, MD, MBA- CEO/Founder
After 20+ years driving the clinical evolution of minimally invasive surgeries, Dr. Robinson observed the medical device industry’s bias shift from technology-based device development toward copycat devices, and valuing sales over innovation. Knowing his ideas could improve patient outcomes by further reducing the tissue damage that slows the body’s recovery process, he spent a sabbatical achieving his MBA and designing the products that he envisioned would overcome frustrations and failures of the available alternatives. The result of that time was a graduation at the top of his Emory MBA class, dozens of patents, and 7 new spinal surgical devices ready for market and U.S. FDA Cleared. The time has now come for this mature and valuable, self-funded collection of device systems to be brought to market. We will also work closely with the highest caliber spinal, orthopedic and oral surgeons to continue to innovate, and to remain at the pinnacle of technology development. Jim is also active with non-profit groups and has donated much time within the U.S. and in other countries providing expert neurosurgical care to those in need. He has spent years on the Board of Directors of HOI, Inc, an NGO active in Central America, and has been a leader for years in The Boy Scouts of America.
Inspiring Patient Story
Scott Baltsen- Chief Operating Officer
Scott Baltsen’s 25 years in the medical device industry has been focused on commercialization and operations for startup companies with unique solutions in the orthopedic space. He was an early employee at Arthrosurface, the innovator of partial resurfacing joint arthoplasty, which had a successful exit with Anika. There he established, onboarded, and managed their independent distribution network and regional sales managers. Following Arthrosurface, Scott was hired as the first employee to set up and run the US subsidiary for synthetic ligament innovator Surgicraft/LockDownMedical, establishing LockDown Surgical in 2012 and efficiently managing the US operations with more than 50 distributors.Throughout his career he has worked with distributors and vendors in US and internationally, while consulting with Biomet/Zimmer, Microaire, Quantum Ops, Tensor, Alignmed, Ossur, Oratec, and Surgical Solutions. He received his BS in Biomedical Engineering from The Johns Hopkins University.
Phil Powell- Executive VP of Sales
Founder of one of the largest medical distributorships in the country, Phillip Powell has over 23+ years of experience in the Medical Sales and Distribution in the healthcare industry. Mr. Powell’s sales expertise and experience as a sales executive in the healthcare and technology markets lead him to his successes in selling technical team solutions and surgical instruments and implants to the Orthopedic market. Mr. Powell is a trusted advisor of many organizations and has helped numerous senior executives define and execute strategies that have proven to dominate the market. His dependable and self-motivated characteristics along with his ability to adapt to changing situations led him to work with some of the largest medical device manufacturers in the world, delivering record sales and launching countless new products and technologies. Phil is a graduate of Stephen F. Austin State University, where he earned a Bachelor of Science in Business Administration. He is a proud member of the Sigma Chi Fraternity and a dedicated baseball player in his years at the University, and is a proud father of three girls. Through his education and decades of experience, Mr. Powell has become a well-known name in the industry and utilizes his knowledge and skill to be an inspired leader who pays close attention to detail, providing ongoing training and improvement goals for his team.
Advisory Board
Surgeon Advisors, Scientific Advisors, and Business Advisors
Steve McAnany, MD - Assistant Professor at The Hospital For Speical Surery
Dr. Steven McAnany is an Assistant Attending Orthopedic Surgeon at the Hospital for Special Services (HSS) and Co-Medical Director for HSS Spine Center with Stamford Health. He is an Assistant Professor of Orthopedic Surgery at Weill Cornell Medical College. Dr. McAnany's research interests lie in the cost-effectiveness analysis of spine surgery, including cervical disc replacements, discectomies, fusions and minimally invasive surgery. He has authored over 50 articles, book chapters, and text books. Dr. McAnany is involved in the design of innovative surgical technology with an emphasis on developing implants and techniques to improve surgical fusion rates. Dr. McAnany received his medical degree from Mount Sinai School of Medicine in New York, NY, and completed his orthopedic surgery residency at Mount Sinai Hospital. He then completed fellowship training in spine surgery at Emory University Hospital in Atlanta, Georgia. Dr. McAnany is a member of the North American Spine Society, American Academy of Orthopaedic Surgeons, and a reviewer for the Global Spine Journal.
Robert Eastlack, MD - Spine Surgery Division Head of Scripps Clinic Medical Group
Dr. Eastlack was born in Wyoming, and grew up primarily in Alaska, before attending Stanford University. He majored in Human Biology with focus on Neurophysiology, and while there was on the Stanford Men’s Swimming Team, serving as captain in his senior year. After finishing his undergraduate studies, he stayed and joined the research team in the Cardiology Department before attending medical school nearer his family in Texas. Following graduation from Baylor College of Medicine, he returned to California, where he and his wife both matched at UCSD for their residency training. The Orthopaedic Surgery residency was combined with a year of research fellowship, and under the tutelage of Dr. Steven Garfin, he decided upon undertaking a spine fellowship at Mayo Clinic in Rochester, Minnesota. Upon completion of the fellowship, Dr. Eastlack returned to San Diego, working with both UCSD and the San Diego Spine Foundation fellowship programs, as well as the UCSD Orthopedic Surgery Department as a Clinical Instructor. In 2008, he moved to Scripps Clinic in the Division of Orthopedic Surgery, and continues to serve as a Consultant there. He also acts as Co-Director for the spine fellowship training program that is managed by the San Diego Spine Foundation. He is a member of the International Spine Study Group, focused on adult deformity and minimally invasive research, and undertakes clinical and basic science research at Scripps Clinic as well. His clinical interests are in cervical reconstruction, minimally invasive spinal reconstruction, and complex deformity surgery. His wife Jennifer Eastlack is a Dermatologist in San Diego, and they have five children. His personal interests include coaching various sports teams (baseball, soccer, and basketball) on which his children play and playing golf, as well as co-managing a life science fund andmedical device development.
Stephen Hochschuler, MD - Founder and Chairman of Emeritus Texas Back Institute
Dr. Stephen Hochschuler is an orthopedic surgeon and co-founder of the Texas Back Institute. He specializes in the lumbar spine and has been a practicing spine surgeon for more than 40 years. Dr. Hochschuler is a leader in spine medicine, having founded and served as president for a number of medical associations and professional societies. He has written numerous articles published in peer-reviewed medical journals, such as The Spine Journal, Spine, and the Journal of Neurosurgery: Spine, and has delivered hundreds of presentations at medical conferences nationally and internationally. He is actively involved in patient education. He founded one of the first back schools to educate patients about spine care and has edited and contributed to dozens of books on back conditions and treatments. Dr. Hochschuler is a Medical Advisor for Veritas Health, providing oversight to ensure the accuracy and quality of its articles. Stephen Hochschuler has an impressive array of professional memberships and achievements. He has served as the Past President of the Spine Arthroplasty Society and the Past President of the International Society for the Advancement of Spine Surgery. Additionally, he founded the Spine Division at the Veterans Administration and is a Founding Member of the American Board of Spine Surgery. He is also a member of the North American Spine Society and the American Academy of Orthopaedic Surgeons.
Bryan Armitage, MD - Orthopedic Surgeon at Synergy Health
Dr. Armitage earned his medical degree from the University of Minnesota. He received his Master of Science degree in Biomedical Engineering from the University of Minnesota. He completed an orthopedic residency at the University of Hawaii, Honolulu. He is spine fellowship trained by the Twin Cities Spine Center, Minneapolis. He is trauma fellowship trained by Swedish Hospital in Englewood, Colorado. Prior to his medical degree, Dr. Armitage was a medical device engineer at Boehringer Laboratories and Synthes USA. During his engineering career, Dr. Armitage was awarded multiple patents covering both biologics and implant designs. Dr. Armitage currently resides in the Minneapolis/St. Paul Area, and when he is not seeing patients or operating on acute trauma patients, he can usually be found at his other place of business: Paradise Arcade. Dr. Armitage is a world-renowned developer of arcade games and parts.
Vahan Simonyan, Ph.D. - Chief Scientist at DNAHIVE and Embleema
Dr. Vahan Simonyan has expertise in biotechnology and biomedical informatics, previously serving at the FDA as a lead scientist of HIVE (FDA robust and AI-capable data collection and analysis platform), as well as serving as R&D Director of Bioinformatics. Additionally, Dr. Simonyan is an adjunct professor at the George Washington University, where he teaches and develops the curriculum for biomedical big data informatics and biostatistics research and development courses. Vahan has a solid scientific background in varied academic disciplines: MS in Physical Organic Chemistry, Ph.D. in Quantum Physics and Mathematics, post-doctoral training in Nanotechnology and Quantum Statistical Thermodynamics. He is a prolific author of scientific publications in physics, chemistry, quantum chemistry, nanotechnology, biotechnology, population dynamics, and bioinformatics; and he is a recipient of multiple awards, and multimillion dollar grants for excellence in number of health informatics and biomedical informatics projects. Vahan is an advisor to several biotech companies as well as to national governments in digital healthcare. His accomplishments in academic and R&D technology carriers have been complemented with the success of technology leadership roles in government, academia and industry where he establishes large-scale and complex, science-heavy R&D infrastructures capable of serving worldwide communities for research and regulatory purposes.
Jeff Dunkel- CEO of Optain
Jeff was Chief Strategy Officer for Titan Spine, and led their acquisition of a unique designation of Nanotechnology in spinal implants. He also led the organization of studies showing the clinical benefit of code for procedures where their implants are used. He is one of the most knowledgeable individuals in the United States in nanotechnology in medical devices. Jeff appreciates the unique and powerful nature of our BioBraille surface and will aid us with strategic initiatives and regulatory issues related to its success and value development.
Tim Ganey, Ph.D. - Chief Science Officer of Vivex Biologics
Dr. Tim Ganey is the inventor or Spectrum Spine Inc's BioBraille technology. He is a senior advisor to Spectrum, and is currently employed at Vivex as Chief Technical Officer. He has served as the Director of Orthopedic Research and Director for the residency program at Atlanta Medical Center and Director of the Atlanta Learning Center. Prior to his time at Atlanta Medical Center and Atlanta Learning Center, Dr. Ganey served as the President of the U.S. division of CO.DON Tissue Engineering, where he and his team developed and commercialized a portfolio of cell-based therapeutics for cartilage and bone. Dr. Ganey has been instrumental in the development of numerous technological advancements, including the use of cell-based therapeutics, electric field transduction, 3D printing, and prescribed matrices for regenerative medicine. His numerous patents include work in pulse-field delivery, artificial matrices for bone regeneration, electro-spinning methods and materials, mimetic material modification using photoactive lasers, and stem cell procurement and purification. Apart from his work at VIVEX Biologics, Dr. Ganey is the founder and CTO at SpinPlant GmbH in Leipzig, Germany. He also maintains a faculty appointment at the TRM Facility in Leipzig and is an associate faculty member at Nova Southeastern in Ft. Lauderdale.
Investor Information
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