Chief Executive Officer, Inventor
Mr. Novotny possesses 35 years of experience in biomedical engineering including starting, building, and managing multifaceted corporate entities in areas of human allograft tissue for clinical use, human clinical trials, and medical devices.
Intellectual property licensing, product and trade secret research and development applied to a few notable inventions include but are not limited to; a novel non-irradiated, terminally sterile tissue sterilization process utilizing Pressurized Super Critical CO2 w Peracetic Acid, a novel non-irradiated vacuum induced vapor Reactive Oxygen sterilization process for human tissue, Demineralized Bone Matrix bone void filler, 2-piece bone-derived cervical implant for spinal fusion, Spongy bone-derived bone filler for large or small boney defects, Fully adjustable patella tendon implant for ACL reconstruction, novel methods of bone milling utilizing CNC machines in a cleanroom environment, flexible solid cortical bone for use in mandibular reconstruction.
Vacuum induced Reactive Oxygen sterilization process “TheBOX” optimized for cellulose-based organic cellular material sterilization specifically including cannabis and hemp.
Regulatory experience includes holding commercial medical licenses in the State of Florida including as qualifying agent for; CA, OR, NY, FDA, ACHA, and AATB (American Association of Tissue Banks), Canada, European Union, Columbia, Greece, and Turkey. Complex product and equipment validations, clinical assessments, structural integrity, systemic toxicity designs, and protocols applying theories and practices of Six Sigma and ISO manufacturing protocols in a global marketplace.
