EDMONTON, Alberta, Jan. 10, 2020 /PRNewswire/ -- Tevosol, Inc., a clinical stage medical device company, and Texas Medical Center (TMC) Innovation, today announced that Tevosol has completed the TMCx accelerator program and established a base at TMC for FDA pivotal clinical trials and US commercial operations. Tevosol was one of 16 companies selected from more than 140 applicants for the TMCx09 cohort.
Tevosol is developing EVOSS™ (Ex-Vivo Organ Support System), a portable and affordable warm perfusion machine about the size and weight of a static storage cooler. In 2019, the University of Alberta completed a proof-of-concept trial using the company's proprietary negative pressure ventilation technology with an EVOSS prototype. The team performed 12 successful human transplants with lungs from 12 donors who had been ruled out because they did not meet the standard clinical criteria. The TMC-based trial will follow a similar protocol on a larger scale and accelerated schedule.
"Houston is maybe the only place where Tevosol could hope to conduct a trial of such intensity and efficiency," said Tevosol CEO Ron Mills. "We are fortunate to have the enthusiastic support of one of the nation's leading transplantation communities and to have a home in the largest medical city in the world. TMC gives our company unfair strategic and tactical advantages."
TMC Innovation provides startup companies with shared workspace and a curriculum tailored to the needs of health care entrepreneurs. Companies have access to the world's largest medical center and can engage with clinical stakeholders, business development advisors, and industry partners. With a campus of more than 50 million square feet, Texas Medical Center annually hosts 10 million patients and performs more than 180,000 surgeries.
The Tevosol trial will be coordinated by TMC member LifeGift organ procurement organization; managed by TMC partner Proxima Clinical Research, a CRO focused on emerging biomedical companies; and conducted by investigators at three TMC lung transplant programs and two remote centres.
"The TMC Innovation team is eager to connect Tevosol to the myriad resources and extensive infrastructure that it will need to conduct its clinical trial within Texas Medical Center—the largest medical city in the world. With access to this vast network, Tevosol will be able to prepare its product for market entry, directly benefiting TMC," said TMCx Associate Director Lance Black, MD, MBID. "This collaboration across member institutions is just the kind that TMC Innovation aspires to cultivate through the newly redesigned TMCx accelerator program."
"Tevosol shares our mission to reach more organ donors and facilitate more transplants to save as many lives as possible," said LifeGift President and CEO Kevin Myer. "This trial aims to demonstrate how design thinking, innovative technology, and shrewd logistics can help procurement and transplant teams significantly increase donor lung utilization in full-scale routine practice."
Trial investigators, sponsors, and managers will hold a kickoff meeting at TMC Innovation in late January.
About Donor Lung Utilization
Transplantation is the only cure for end-stage lung disease, which kills tens of millions every year. But 80 percent of donor lungs today go to waste. Ex-vivo lung perfusion (EVLP) has been shown to increase donor lung utilization, safely prolong preservation time, and improve transplant outcomes. Transplant centres have been slow to adopt the technology using currently available machines.
Tevosol is a medical device company developing EVOSS™ (Ex-Vivo Organ Support System), a portable and affordable warm perfusion machine about the size and weight of a cold static storage cooler. By presenting a naturally functioning organ for complete evaluation, EVOSS will help surgeons transplant more organs from more donors today and help scientists unlock new sources that will solve the organ shortage tomorrow. The company expects EVOSS Lung to enter US clinical trial and Canadian commercial pilot in late 2020. www.tevosol.com.
About Texas Medical Center
Texas Medical Center (TMC)—the largest medical city in the world—is at the forefront in advancing life sciences. Home to the brightest minds in medicine, TMC nurtures cross-cultural collaboration, creativity, and innovation among its 106,000-plus employees. Beyond patient care, TMC is pushing the boundaries of clinical research across its extensive network of partner institutions in pioneering effective health policy solutions to address the complex health care issues of today. For more information, please visit www.tmc.edu.
SOURCE Tevosol, Inc.