ViVita Technologies, Inc. (www.vivitatechnologies.com), a life science startup developing bioactive biomaterials for tissue and organ regeneration, has been awarded a $1.5 million SBIR (Small Business Innovation Research) Phase II grant by the NHLBI (National Heart, Lung, and Blood Institute) of NIH (National Institutes of Health). This funding enables the final characterization and evaluation of the BARE (Biocompatible and Regenerative Extracellular Matrix) Patch™ product towards FDA 510(k) clearance for clinical cardiovascular indications and the foundational dataset of an Investigational Device Exemption (IDE) application for heart valve indications. It follows a successful $225K Phase I NIH SBIR grant for which flexural properties, hydrodynamic properties, and in vivo immune and regenerative properties of BARE Patch™ were evaluated for heart valve tissue engineering applications.
Current animal-derived, biological heart valve replacements are far from ideal due to their limited longevity. These devices average 10-15 years in adults before requiring repeat replacement procedures. In children, re-operation is necessary 35-85% of the time and at only 6-7 years post-implantation. Structural deterioration and failure of replacement valves is due to the chemical fixation process used to delay immune rejection of the bioprosthetic and the eventual immune rejection of the chemically fixed biological implant. Further, current biological valve replacements are unable to grow with juvenile patients, resulting in multiple valve replacement procedures throughout the child’s lifetime. Valve re-operations increase the total cost of treatment and are associated with reduced quality of life and additional surgical complications.
ViVita’s patented SPEAR (Solubilization-Promoted Elimination of Antigenic Residues) Platform™ is a revolutionary tissue preparation approach that will bolster use of animal tissues and organs in medical applications. Leveraging the principles of protein chemistry, the SPEAR Platform™ eliminates the molecular triggers of immune rejection from animal-derived tissues and organs. Applied to bovine pericardium tissue, the SPEAR Platform™ yields a novel unfixed biomaterial—BARE Patch™—with enhanced immune-compatibility and maintained mechanical and regenerative properties.
“A replacement valve engineered from BARE Patch™ will be able to function like a normal heart valve immediately upon implantation due to the robust animal tissue scaffold. Over time, it will be replaced with the patient’s cells and patient’s scaffold, integrating with the surrounding tissues and turning over into the patient’s own tissue,” explains ViVita CEO Dr. Maelene Wong.
Manufacture of replacement valves from BARE Patch™ will address the limited longevity and growth issues preventing current bioprostheses from being lifetime solutions for both children and adults. “BARE Patch™ has the potential to be a life-long cure,” summarizes Wong.
Successful completion of the SBIR Phase II project will enable product manufacturing, FDA 510(k) clearance for use of BARE Patch™ in clinical vascular indications, first-in-man studies, and FDA IDE for use of BARE Patch™ in heart valve indications.
Disclosure: Research reported in this publication was supported by the NIH (R43HL136003, R44HL164140). The content is solely the responsibility of the authors and does not necessarily represent official NIH views.
ViVita Technologies, Inc. is a medical device company committed to restoring human health by leveraging the inherent regenerative processes of the body. By providing the necessary framework for healthy tissues and organs through their bioactive biomaterials, ViVita’s products are designed to promote tissue regeneration and recapitulation of function lost to injury or disease to improve patient morbidity and mortality.