Swan Valley Medical Inc.
Swan Valley Medical, Inc, is a mid-stage, U.S.-based, privately held medical device company with a unique hospital solution using its patented T-SPeC® technology and advanced analytics to replace an existing hospital-based Standard of Practice.
The company is engaged in changing a current Standard of Practice that was first initiated over 200 years ago with the invention of the flexible urethral catheter by Benjamin Franklin. Currently, over 17 million urethral Foley catheters are placed in U.S. hospitals annually. Catheter-Associated Urinary Tract Infections (CAUTI) are the single largest source of hospital-acquired infections worldwide, exceeding one million annually in the U.S. The Company’s T-SPeC® technology enables the replacement of urethral catheters with suprapubic catheters in the targeted critical care patient, eliminating CAUTI, urethral catheter placement injuries, urosepsis, and related mortalities.
T-SPeC® represents a disruptive technology that could fundamentally transform how hospitalized patients are catheterized for bladder and fluid management worldwide. The annual market exceeds $15 billion in the U.S. and $50 billion internationally with no competitors. The company projects over $800 million in annualized revenue with implementations in just 200 U.S. hospitals.
Swan Valley Medical developed a proprietary Analytics System for Predictive Informatics™ (ASPI), customized for each hospital, to identify predicted improved clinical outcomes and to quantify economic benefits that result from implementing the company’s solutions. This enables individual hospitals and hospital networks to better understand the predicted clinical and economic benefits for the company’s proposed changes to an existing Standard of Care.
The market value proposition results in shorter lengths of stay, reduced readmissions, prevention of mortalities, and ACA payment penalties while improving patient satisfaction, saving individual hospitals millions of dollars annually.
The company has been issued 32 patents for its T-SPeC® and related technology and has received regulatory clearances from FDA, SFDA, CE Mark, Health Canada, Cofepris, and ISO 13485. Market development has resulted in initial sales revenue in the U.S., E.U., Canada, and Mexico. Final device manufacturing assembly and fulfillment is currently located at its Denver location, with a U.S.-based supplier network. The company is looking to transfer manufacturing operations to Montana.
GSK Vaccines has the broadest portfolio of any company with vaccines for people of all ages and delivers over two million vaccine doses per day to people in more than 160 countries. In 2019, GSK announced $100 million of new investment in its Hamilton, MT site, which expands the production capacity of the adjuvant system used in several of GSK’s vaccines, including SHINGRIX.
For more than 20 years, GSK has been innovating in adjuvant systems and has developed vaccines to help prevent malaria and shingles that utilize adjuvant systems to help achieve a stronger immune response.
At the time of the announcement, Jack Bailey, then President of US Pharmaceuticals for USK said: “For more than a decade, our Hamilton facility has supported GSK’s adjuvant system development program. By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including SHINGRIX.”
GSK is dedicated to investing in and supporting communities by creating high-quality jobs in areas like R&D and manufacturing. Over the next few years, the Hamilton site expansion is expected to add a combination of temporary construction and contracting jobs, as well as new permanent positions, including scientists, engineers, and manufacturing and quality professionals.
The Hamilton site was founded in 1981 by Drs. Edgar Ribi, John Cantrell, Steven Schwartzman, and Reno Parker as Ribi ImmunoChem Research Inc. Corixa Corp. purchased Ribi’s company in 1999 and six years later, Corixa sold to GSK.
Center for Biofilm Engineering
At the Center for Biofilm Engineering (CBE), multidisciplinary research teams develop beneficial uses for microbial biofilms and find solutions to industrially relevant biofilm problems. The CBE was established at Montana State University, Bozeman in 1990 as a National Science Foundation Engineering Research Center. As part of the MSU College of Engineering, the CBE gives students a chance to get a head start on their careers by working on research teams led by world-recognized leaders in the biofilm field.
In the current research, Dr. Phil Stewart, longtime former director of the CBE, asks “Can we learn to prevent biofilm infections by engaging constructively with our body’s own immune system? So far clinicians have fallen back on surgeries and antibiotics to deal with infections on implanted medical devices. Surgery is traumatic and expensive, and antibiotics often don’t do the job. What if we could jump-start the immune system to clear contaminating bacteria from a biomaterial before a biofilm can get started?” Dr. Stewart was named Regents Professor of Chemical and Biological Engineering in 2019 and has been with the CBE since its founding.
–From the 2020 CBE Annual Report.
The Science and Conservation Center
One of the major efforts of the Science and Conservation Center (SCC) at ZooMontana involves the humane control of wildlife populations by means of fertility control. To that end, the Center was created in 1998, and it now is the world’s only dedicated facility for the development of wildlife contraceptives and methods of application. The Center produces and carries out quality control for a wildlife contraceptive vaccine, distributes the vaccine, and is the repository for all records and data required by the Food and Drug Administration and Environmental Protection Agency.
Additionally, the Center and its staff coordinate and, in some cases, carry out the field-based application of contraception to wildlife populations. The Center also works with the Association of Zoos and Aquariums Contraception Advisory Group at the St. Louis Zoo.
The porcine zona pellucida (PZP) vaccine stimulates the target animal to produce antibodies, which attach to the mammalian membrane surrounding its own egg, thus blocking fertilization and causing contraception.
The vaccine is used on the Bureau of Land Management, U.S. Forest Service, and National Park Service wild horse mares, as well as within several wild horse sanctuaries. It has been used on Assateague Island National Seashore to manage the wild horse population with immunocontraception since 1995.