Company
Portfolio Data
Back to Company SearchVirtech Bio, Inc.
UEI: DX5PHGT3N4U9
Number of Employees: 6
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2016
2
Phase I Awards
1
Phase II Awards
50%
Conversion Rate
$387,058
Phase I Dollars
$1,752,422
Phase II Dollars
$2,139,480
Total Awarded
Awards
Enhanced Canine Performance, Protection and Survivability
Amount: $148,088 Topic: SOCOM172-002
The goal of this Proposal is treatment of hemorrhage in SOCOM canines using a novel hemoglobin resuscitation fluid with oxygen carrying and plasma expansion properties (VIR-VET, a product of VirTech Bio). VIR-VET is designed to provide immediate hemodynamic stability and oxygenation to injured canines with blood loss. The product has advantages over traditional military fluid therapies: 1) As cell-free hemoglobin, blood donors are not required. 2) It is a colloid that expands intravascular volume with high oxygen carrying capacity. 3) It has high MW to prolong circulating time. Logistical benefits include temperature stability and ease of administration. It is packaged in oxygen-impermeable bags as an iso-osmotic salt solution and administered using standard blood infusion sets so that specialized equipment is not necessary. The Statement of Work includes two protocols to test safety and efficacy in rats with a dose-ranging study of VIR-VET and Lactated Ringers as control. Evaluations will include hemodynamics, blood gases, microvascular visualizations and interstitial oxygen measurements. Aim 1 is to show safety in a 10% top-load infusion model. Aim 2 is to look toward efficacy using more severe exchange transfusion models in which rat blood is isovolemically hemodiluted with either test (VIR-VET) or control solution.
Tagged as:
SBIR
Phase I
2018
DOW
SOCOM
Enhanced Canine Performance, Protection and Survivability
Amount: $1,752,422 Topic: SOCOM172-002
Currently, there is no resuscitation fluid with oxygen carrier and plasma expansion capabilities to treat hemorrhagic shock in combat canines. Under SOCOM SBIR Phase 1, VirTech Bio developed a new hemoglobin-based oxygen carrier, VIR-VET, and performed successful feasibility safety and efficacy tests in rat models. In those studies, VIR-VET demonstrated prolonged vascular retention, without adverse hemodynamic effects, and longer survival times in a hemorrhagic shock model. In Phase 2, Technical Issues will be addressed under four Tasks: 1) Finalize processing of the prototype VIR-VET to be used for stability studies in accordance with FDA guidelines and for use in pre-clinical tests. 2) Acute toxicity studies will be performed in vivo in canines. 3) Experimental mechanism of action studies, based on preliminary Phase 1 studies in rats, will be assessed in a PK study to evaluate circulating half-life in canines and a hemorrhage and resuscitation model in canines using the pre-clinical grade material. Efficacy will be evaluated in canines through measures of oxygen transport and survivability in the hemorrhagic shock model. The hemorrhagic shock model is designed to mimic battlefield treatment of canine hemorrhage before hospital care is available.
Tagged as:
SBIR
Phase II
2018
DOW
SOCOM
Human-derived hemoglobin based oxygen carrier for utilization in organ and tissue preservation
Amount: $238,970 Topic: 400
This project aims to develop a human derived Hemoglobin Based Oxygen Carrier HBOC solution Phase I to be utilized in numerous ex vivo applications Phase II where an oxygen delivery solution is required machine perfusion MP systems for organ and tissue preservation MP systems for the discovery of biomarkers and perfusate in human microchips for drug discovery This is the first HBOC to be developed specifically for ex vivo applications with the novel approach being an excipient that balances for ex vivo fluid shifts Furthermore this new product will be developed within a streamlined highly efficient commercial process that will allow a seamless transition to cost effective Contract Manufacturing Organizations CMO VirTech Bioandapos s HBOC and manufacturing process were conceived following successful proof of concept ex vivo studies with an HBOC Hemopure Unfortunately the company OPK Biotech went bankrupt in Hemopure had a complex and expensive manufacturing process that precluded the use of any CMO The main issues were related to bovine contamination hydrogen gas toxicity and the need for expensive and specialized equipment VirTech Bioandapos sandapos s new process developed for this SBIR Phase I proposal addresses all these concerns while creating a more cost effective commercial production of this component The initial source of human hemoglobin molecules will be expired human blood obtained through a process already approved by regulatory bodies The outdated human red blood cells will be `washedandapos via ultrafiltration lysed by osmotic shock and purified by a three step tangential flow filtration system to remove cellular impurities Subsequently polymerization will be with glutaraldehyde followed by Schiff base stabilization The Specific aims include biophysical characterization to demonstrate similarity with the original HBOC stability testing of the molecular weight and storage parameters and compatibility testing with machine perfusion without the organs for hours at relevant conditions This product once developed and validated will be coupled with a machine perfusion device in Phase II and utilized for liver preservation according to our previous experience The new HBOC for utilization in organ preservation should have a significant positive impact in clinical transplantation Effective organ oxygenation ex vivo will enhance the current standards of organ preservation and increase the number of transplants It should have additional positive downstream effects by decreasing the morbidity and the mortality on the transplant waiting list improving post operative outcomes and decreasing the length of stay All these benefits should have a direct impact in the ability to decrease the overall costs in clinical transplantation !Project Narrative VirTech Bio is developing a human derived oxygen transport solution designed for machine perfusion MP medical devices and it will be utilized ex vivo for organ and tissue preservation Preliminary proof of concept pre clinical experiments have been performed successfully with a similar bovine derived product Anticipated benefits include enhancement of organ and tissue viability increased organ availability for transplants and improved overall transplantation outcomes
Tagged as:
SBIR
Phase I
2016
HHS
NIH