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MONTANA BIOTECH COMPANIES TO WATCH 2020

COVID-19biotechCompanies To Watch
Nov 18
Written By MT High Tech Business Alliance

By Christina Henderson, Samuel Boudreau, and Martina Pansze



Amid the economic turbulence of 2020, Montana’s biotechnology industry has risen
to the unique challenges presented by COVID-19.

Many companies have adjusted their labs and office routines to safely continue
their work on cancer research, pain management solutions, or development of cell
culture media. Others have capitalized on the opportunity to create
technological solutions to the pandemic’s obstacles, such as Missoula’s Ahana,
which brings telehealth options to rural Montana communities.

Many Montanan ventures are working with the virus directly at the forefront of
research and testing improvement efforts. Missoula’s Rocky Mountain Biologicals
created Viral Transport Medium for coronavirus testing kits. Bozeman’s Golden
Helix developed bioinformatics software to automate the diagnostic process.
Missoula-based PatientOne is working with the county health department to
implement software that automatically updates patient symptoms and temperature
information to the government database. Also in Missoula, FYR Diagnostics has
developed a COVID sample processing system that cuts standard testing times by
half.

Since 2017, the Montana High Tech Business Alliance has released annual Montana
Companies to Watch lists. These articles have highlighted the state’s
fastest-growing and most innovative tech businesses, including 2019 Montana
Startups to Watch and 2019 Montana High-Growth Companies to Watch. 2020 is the
first year that the Alliance is publishing a Montana Biotech Companies to Watch
list in partnership with the Montana Bioscience Cluster Initiative. 

The caliber of companies selected as 2020 Montana Biotech Companies to Watch
reflects the steady long-term growth of the state’s bioscience ecosystem. This
phenomenon was recognized nationally at the end of 2019 when the U.S. Small
Business Administration made one of seven national awards to the Montana
Bioscience Cluster Initiative.

The 2020 Montana Biotech Companies to Watch reveal a number of key industry
trends:

 * Four of the 11 firms have raised venture capital investment, a sign of
   growing interest in Montana bioscience from investors like Michael Goguen,
   founder of Two Bear Capital in Whitefish.

 * Four companies were awarded SBIR/STTR grants, reflecting Montana’s #1
   position in securing NIH awards. In 2019, Montana’s SBIR/STIR Application
   Success Rate with NIH was 48.3 percent - more than double the national
   average - with support from organizations like TechLink in Bozeman.

 * The role of universities in fueling biotech growth is evident in the
   locations of company headquarters. Four firms are in Bozeman near MSU and
   four are in Missoula close to UM. Two firms call the Flathead Valley home,
   indicating the rise of that region as an emerging hub for biotech.

 * Montana’s biotech firms are innovators in a range of fields vital to the life
   sciences - vaccine development, diagnostic testing, bioinformatics,
   telemedicine, medical devices, cancer treatment, pain management, and
   development of cell culture media.

 * More than half of selected firms are rising up to meet new needs in
   healthcare driven by the coronavirus pandemic.

Here are our picks in alphabetical order:

Ahana, Missoula

FYR Diagnostics, Missoula

Golden Helix, Bozeman

NanoValent Pharmaceuticals, Bozeman

PatientOne, Missoula

PurCell Bio, Bozeman

Rocky Mountain Biologicals, Missoula

SOLO-DEX, Wolf Creek

Swan Valley Medical, Bigfork

Truwl, Whitefish

VIRIS Detection Systems, Bozeman



We received nominations from industry partners across Montana, including MonTEC,
Montana Bioscience Alliance, Missoula Economic Partnership, University of
Montana, Montana State University, Kalispell Chamber of Commerce, Two Bear
Capital, Next Frontier Capital, Goodworks Ventures, Blackstone LaunchPad, and
Montana World Trade Center. Our 11 finalists were selected based on the
following criteria:

 * Steep revenue growth and/or are working in a high-growth sector

 * Poised to launch high-potential products or services

 * Own or are developing valuable intellectual property

 * On track to land major clients or enter new markets

 * Plan to expand operations or add a significant number of jobs in the next
   year

 * Have management teams led by experienced entrepreneurs or top experts in
   their fields

 * Working to address unique challenges presented by COVID-19

--------------------------------------------------------------------------------


AHANA

Although only a year old, Ahana is providing pediatric care for many Montana
communities. This software and video-based platform allows patients to receive
care during non-traditional hours (like weekends and evenings), assists
healthcare facilities in keeping records of medically-complex and underserved
cases, and has a photo upload feature to keep doctors updated with current
conditions. Photo via Ahana.

Location: Missoula, MT

What they do: A collaboration of Montana pediatricians bringing video visits to
children and parents during non-standard business hours.

Why we’re watching them: As a pediatrician, Chelsea Bodnar saw a problem for
many small, rural communities in Montana: families don’t have access to
effective, efficient, and convenient pediatric care.  

In 2019, Bodnar launched Ahana Pediatrics, a software that facilitates video
appointments for local and rural patients during evenings and weekends. Ahana’s
platform allows healthcare providers to keep detailed records of every patient,
including traditionally underserved, medically-complex cases.

Ahana offers a number of additional benefits to healthcare providers and
patients unavailable through the traditional model of in-office care. For
example, parents can contact a doctor on the weekend to address concerns about a
child's post-op recovery without having to make a trip to the ER. And physicians
can evaluate a patient's condition remotely through live video, or in photos
uploaded to the Ahana platform.

Due to COVID’s socially-distant restrictions, Ahana Pediatrics has seen an
uptick in use because of its virtual application. A parent company of Blue Cross
Blue Shield of Montana has recently invested in Ahana’s work. Ahana has been
approached by multiple states and healthcare organizations to implement their
software, but are currently only focusing on expanding in Montana communities.

A fifth-generation Montanan, Bodnar attended Harvard Medical School and The
University of Oxford as a Rhodes Scholar. After Residency at Seattle Children's
Hospital/University of Washington, she was also a health policy fellow at the
Institute of Medicine, and Director of Children's Healthcare quality at a large
consortium of Federally Qualified Health Centers. She returned home to Missoula
in 2018 when her husband, Seth Bodnar, became president of the University of
Montana.

With financial support from a Robert Wood Johnson Foundation grant, Bodnar
joined forces with pediatricians from across the state to use Ahana's platform
to create access to pediatric-specific care in Fort Peck, a rural community of
less than 300 people in eastern Montana. The predominant frontline health
facility in Fort Peck is based in the middle school health center, which has
unused, top-notch medical equipment. Ahana integrated their software into this
equipment to enable pediatric care and adequate screenings for all patients. 

Ahana is also planning on expanding their infrastructure beyond pediatrics to
include primary care patients. Ahana, Inc. currently employs 4 people and plans
to grow.

 

WHERE ARE THEY NOW? - INIMMUNE

Location: Missoula

What they Do: Discover and develop new therapeutics for allergy, autoimmunity,
infectious disease, and cancer

We covered Missoula-based biotech therapeutics company Inimmune in our 2018
Startups to Watch List. In the past two years, Inimmune has grown rapidly and
transitioned from a pre-clinical to clinical stage company set to advance four
lead programs to human clinical trials in the next 3-4 years. Since 2018, they
have also:

 * Secured $22 M Series A investment from Two Bear Capital to advance multiple
   lead programs through Phase I human clinical testing.

 * Awarded over $30 M in new NIH research grants and contracts through
   collaborative vaccine research partnerships.

 * Expanded and accelerated their drug discovery pipeline with lead programs in
   immuno-oncology, allergy, opioid addiction vaccines and infectious disease
   vaccines.

 * Expanded their research and development efforts in Missoula with key new
   hires across all research areas.

 * Received 4 Small Business Innovation Research grants from NIH totaling $3.7M
   in research funding.

--------------------------------------------------------------------------------


FYR DIAGNOSTICS

CEO Chris Booth (left) and President Sarj Patel (right) discussing their
simplified COVID-19 test with Governor Steve Bullock (center) this past April.
FYR’s test processing capabilities were expanded in October 2020. Photo via Tom
Bauer for The Missoulian.

Location: Missoula, MT

What they do: Develop novel diagnostic tools for human and agricultural
diseases.

Why we’re watching them: FYR Diagnostics is at the forefront of COVID-19 testing
in Montana. In October, the company announced that it would ramp up large-scale
COVID-19 test processing in its new high-capacity lab in Missoula to help
relieve testing bottlenecks in the state. 

FYR provides sample collection kits to businesses, universities, and healthcare
providers who then send the samples back for test processing. The team is also
working on a simplified COVID test, which takes only 30 minutes to run as
opposed to the standard 1.5-2+ hours.

Founded in 2016, FYR Diagnostics began as a laboratory developing a portfolio of
early-detection tests for cancers, neurological disorders, and other human
diseases. In 2018, they received a more than $300,000 SBIR grant from the
National Institutes of Health to create an advanced epilepsy diagnostic test. 

The fast-growing startup has also been supported by funding from Two Bear
Capital in Whitefish as well as other grants. FYR has licensed
biomarker-detecting technology in collaboration with Montana State University
and diversified into applications for crop and livestock diseases in
agriculture.

FYR’s leadership team boasts extensive experience in life sciences research and
entrepreneurship. CEO Chris Booth holds a PhD in Biochemistry, Cellular, and
Molecular Biology from Johns Hopkins School of Medicine. President Sarj Patel
earned his PhD in Neuropharmacology from the University of Montana. Senior
Research Scientist Vik Ghai earned his PhD in Molecular Biology from the
University of Calgary. And COO David Booth is a serial entrepreneur who founded
several previous companies, including Expesicor, a Montana biotech company
developing therapies and imaging agents for neurological disorders.

FYR anticipates rapid growth of the 15-person team over the next year as FYR
continues to address COVID and implement other detection tests. FYR is
developing a training program for certified clinical laboratory technicians to
help meet the demand. They also plan to implement an agricultural grant
beginning January 2021.

--------------------------------------------------------------------------------


GOLDEN HELIX

Golden Helix’s Cytoban Plot program displays a view of the bands within a
chromosome. The bioinformatics software company serves over 20,000 users,
including researchers at Johnson & Johnson, UCLA, Children’s Hospital of Los
Angeles, Rutgers, and the National Eye Institute. Photo via Golden Helix.

Location: Bozeman, MT

What they do: A bioinformatics company specializing in genomic data analysis. 

Why we’re watching them: Since 2017, Golden Helix has seen 110% growth. The
Bozeman-based venture was listed on Inc. 5000’s List of Fastest-Growing
Companies for the second consecutive year this August and secured the Global
Health and Pharma Award during the 2020 Biotechnology Awards.

Golden Helix’s software offers integrated and automated data reporting used to
diagnose and research diseases by matching them to a patient’s genetic makeup.

The software platforms, which have been cited in over 1,300 peer-reviewed
publications, are used for pharmaceutical research, agricultural genomics,
education, human genetic research, and laboratory testing.

Golden Helix programs can be used to automate the bioinformatics process for
COVID-19 and more rapidly turnaround diagnosis data. Golden Helix was recently
published in the Journal of Precision Medicine for their work diagnosing and
tracking coronavirus infections through next-generation gene sequencing.

In 2018 and 2019, Golden Helix was awarded two SBIR grants totaling over $3.3
million from the National Institutes of Health to investigate Next-Generation
Sequencing (NGS) for clinical testing and diagnostics. NGS is an umbrella term
for modern sequencing technologies that collect unique virus data. Using NGS, a
process called dendrogram analysis can determine infection chains useful in
identifying virus outbreaks. Used in tandem with old-fashioned contact tracing,
NGS offers a complete overview of the virus’ infection process and more detail
in studying mutations and isolates’ evolutionary lineage.

The global firm has grown to serve over 20,000 users. Golden Helix customers
include Johnson & Johnson, Lilly, University of Illinois, University of Iowa,
University of New Mexico, UCLA, Children’s Hospital of Los Angeles, Rutgers, and
the National Eye Institute.

Golden Helix’s most successful products include VarSeq, which was developed to
analyze data sets for tertiary analysis, and SNP & Variation Suite—an analytic
tool that allows researchers to perform complex analyses and visualizations on
genomic and phenotypic data. Sherer and his team are also working to embed AI
capabilities into their platforms.

In addition to expanding their work with clinicians focused on COVID-19, the
company plans to accelerate its engagement with international customers in
Europe, Asia, Australia, the Middle East, and South America.

--------------------------------------------------------------------------------


NANOVALENT PHARMACEUTICALS

An illustrated example of the 70nm wide nanoparticles used in NanoValent
treatments. CEO Timothy Enns lovingly refers to the antibody-clad fat bubbles as
“death stars for cancer.” Photo via PBS.

Location: Bozeman, MT

What they do: Research and develop targeted nanosphere therapies for cancer
treatments

Why we’re watching them: Co-founded by a board-certified pathologist with
expertise in childhood tumors and a PhD organic chemist with 7 patents to his
name, NanoValent is developing new therapies for hard-to-fight cancers.

Timothy Triche MD, PhD, co-director of the Center for Personalized Medicine at
the Children's Hospital of Los Angeles, partnered with Jon Nagy, PhD, a veteran
of Bozeman-based vaccine-maker Ligocyte Pharmaceuticals, to launch NanoValent in
2006. Dr. Triche was also a principal and founder in several previous ventures
that have raised a total of $70M.

NanoValent Pharmaceuticals’ Bozeman lab is advancing a novel generation of
nanoparticle-based drugs called targeted nanosphere (TNS) products.
Nanoparticles are microscopic fat bubbles targeted with antibodies to attack
cancer without the drug affecting the patient’s healthy, non-cancerous cells. 

NanoValent has raised over $5 million, including two National Institutes of
Health SBIR grants awarded in 2018 totaling $4 million. The first grant, carried
out primarily with the Children’s Hospital of Los Angeles, supports development
of a safer and more effective therapeutic for adolescents with Ewing sarcoma.
The second grant, in collaboration with Boston University, applies NanoValent’s
core technology to non-oncology surgical adhesions.

Additional funding has come from direct management investment, angel investors
and grants from the National Science Foundation, the National Cancer Institute,
and the Montana Chamber of Commerce.

Much of NanoValent’s TNS technology is protected by intellectual property law.
Most recently, in January of 2020 NanoValent announced the publication of US
Patent Targeted Polymerized Nanoparticles for cancer treatment.

NanoValent’s team, which includes three employees at their Bozeman lab,
collaborates with healthcare and academic partners to develop therapies using
their technology. Funded mostly through grant work, NanoValent advances their
products to the point of commercial feasibility and then works with contract
research organizations or partner labs to move products out of the scientific
advancement phase and into the commercial realm. 

NanoValent has created a proprietary platform that can also target other cancers
and medical conditions.The company creates a particularly useful nanoparticle
known as Hybrid Polymerized Liposomal Nanoparticles (HPLN) that enhances
existing cancer therapies. HPLN targeted nanospheres work well for antibody,
immunotherapy, and antibody-drug conjugate treatments. NanoValent has so far
developed three HPLN-based TNS candidates with the Children’s Hospital of LA
that are focused primarily for use in pediatric oncology.

CEO Timothy Enns, who joined the company in 2016, offers experience with
entrepreneurship and sales from his 34 years in the pharmaceutical industry and
related business development positions. Although much of the company’s
leadership, including Triche and Enns, work virtually from out-of-state,
NanoValent maintains its headquarters in Bozeman.

NanoValent’s leading drug candidate, NV103 for treating Ewing Sarcoma, is
approaching Phase I clinical trials in 2021.

--------------------------------------------------------------------------------


PATIENTONE

PatientOne Co-Founder John O’Connor, CEO Jeff Fee, and CTO Erik Guzik (left to
right) after securing a $1.2M Seed Round led by Dundee Venture Capital and
Revolution’s Rise of the Rest Seed Fund in 2019. Although initially known for
their videos preparing patients for operations, PatientOne is expanding into the
Remote Patient Monitoring (RPM) software sector. Photo via The Missoulian.

Location: Missoula, MT

What they do? Develop virtual tools and operational remote monitoring technology
for primary care.

Why we’re watching them: If you’ve had surgery in or around Missoula recently,
you probably watched a video outlining how to prepare and recover from your
operation. This training was brought to you by PatientOne, a company that
specializes in technology for operative care. The software start-up is now
branching out into the telemedicine and Remote Patient Monitoring (RPM) worlds
and will be implementing RPM software across hospitals and healthcare facilities
across the country in a matter of weeks.

PatientOne has partnered with the Missoula County Health Department (MCHD) to
combat COVID-19. The company is developing software that will automatically
update MCHD with patient symptoms and temperatures, thereby reducing nurse and
healthcare worker exposure to the virus. As hospitals face resource constraints,
Patient One hopes this public/private collaboration will decrease the pressure
on Montana’s healthcare system.

In 2019, PatientOne raised a $1.2M seed round led by Dundee Venture Capital and
Revolution’s Rise of the Rest Seed Fund, which was co-founded by former America
Online (AOL) CEO Steve Case. Next Frontier Capital of Bozeman and Goodworks
Ventures of Missoula also invested.

PatientOne completed the competitive BoomTown HealthTech Accelerator program in
Boulder, Colorado in 2018 and was a part of the inaugural 2018 cohort of
Blackfoot’s C2M Beta technology accelerator. PatientOne was also awarded
$106,731 from the Big Sky Economic Development Trust Fund in May of 2019 to
support the creation of 9 local jobs. 

CEO and co-founder Jeff Fee was inspired to create PatientOne in 2018 after
noticing inefficiencies during his 25 years of experience in the healthcare
industry. Fee served a decade as chief executive for Providence Health and
Services, Western Montana region. PatientOne’s co-founder and CTO, Erik Guzick,
has a background developing virtual learning software for veteran PTSD research.
Guzick is also the founder and CEO of VAST: Next Generation Learning, a SaaS
online learning platform. 

In a webinar hosted by the MHTBA in April, Fee said, “The COVID pandemic and
crisis created almost an overnight understanding of the clinical and public
health benefits of remotely monitoring at-risk patients in their home. My
prediction is, I don't think that genie’s going back in the bottle.”

--------------------------------------------------------------------------------


PURCELL BIO

PurCell founder Dr. Elizabeth Corbin entered the stem cell research world when
her son was diagnosed with a rare genomic disorder. On the way, she developed an
alternative to fetal bovine serum supplements. Photo via Elizabeth Corbin.

Location: Bozeman, MT

What they do: Create supplements free from animal products that can replace
blood products in cell culture.

Why we’re watching them: Fetal bovine serum (FBS), which is extracted from the
blood of cow fetuses, is the main additive used in the majority of cell
cultures. 

Fetal bovine serum introduces at least nine different types of toxins and
contaminants to cell lines, so products supplemented using FBS undergo a battery
of sterility tests. PurCell’s cultures largely sidestep that costly process by
eliminating the variability and contamination issues of animal serum.

CEO Dr. Elizabeth “Tess” D Corbin founded PurCell Bio in 2018 as she finished up
her PhD in Biochemistry at Montana State University. 

After years as a musician and entrepreneur, Corbin returned to her hometown of
Bozeman as a divorced mother to finish a degree in finance at MSU. However, her
son was diagnosed with a congenital enzyme disorder in 2006. Following the
prognosis, Corbin began researching advanced metabolics and biochemistry to try
to develop a cure for the rare condition and others like it. She eventually
attended graduate school where she researched how to improve stem cell
efficiency to support therapies for genetic disorders. As a doctoral student,
Corbin won a Ford Foundation Dissertation Fellowship for her research
supplementing cell culture media with fatty acids. 

PurCell Bio’s methodologies eliminate fetal bovine serum from their cell culture
by replacing it with precise mixes of fats and other nutrients tailored to
different cell types. The challenge in developing alternatives to animal-derived
serum is to ensure solutions support cell growth and proliferation. Initial
tests of PurCell Bio’s research prototypes show equivalent or better
proliferation than serum and available serum substitutes. 

In May, PurCell Bio was the first place winner of the “traditional” category in
the annual Montana State University $50k Venture Competition hosted by the Jake
Jabs College of Business and Entrepreneurship, netting $15,000. The company has
also secured funding through the ASCEND regional pitch event sponsored by
Vertici of Seattle, the MSU CATalyst Gap Fund program, ITREP College of Medicine
at the University of Vermont, and MSU’s TechLink office, and the Montana
Bioscience Cluster Initiative’s 4th F Fund grant program. SiteOne Therapeutics
has also contributed substantial in-kind support.

Formerly known as OptimaLabs, PurCell’s cultures have myriad uses downstream in
the market including advanced human therapies, vaccine development and "lab
meat". The venture hopes to begin commercializing their product line of four
different nutrient mixes in January. In preparation for launch, the company is
currently fine-tuning their manufacturing process, including implementing
partial automation of complexation and ensuring compliance with national
standards. 

PurCell Bio currently employs 4 people, including two MSU students, and Corbin
has plans to hire more Montanans as the company expands. PurCell Bio has huge
potential for growth in a $1.3 billion annual industry for sera and other
reagents.

--------------------------------------------------------------------------------


ROCKY MOUNTAIN BIOLOGICALS

The sterile fill room in the RMBIO facility is used to bottle products without
introducing contaminates. The company’s cell culture media eventually become
components of vaccines, clinical diagnostics, and cosmetics. Photo via RMBIO.

Location: Missoula, MT

What they do: Manufacture cell culture media and protein fractions for
pharmaceutical and biotechnology industries

Why we’re watching them: Since late March, Rocky Mountain Biologicals (RMBIO)
has been producing medium used for COVID-19 testing kits. When patients are
tested, the swab is placed in a tube with a small amount of liquid customized to
preserve the viral RNA while the sample is transferred to a testing facility.
The liquid, called Viral Transport Medium (VTM), is manufactured under CDC
protocol and tested at RMBIO for final sterility. RMBIO is conducting internal
validation studies that aim to extend the amount of time that the VTM can be
stored without refrigeration—making the medium more widely usable at non-lab
facilities such as drive-up testing sites. 

VTM production has allowed RMBIO to tap into the medical supply industry and
create partnerships with distributors that cater directly to hospitals and
clinics. In doing so, the company has broadened their customer base
exponentially and created new outlets for their standard line of products.

RMBIO’s lab creates cell culture media components and animal protein fractions.
Much of the Missoula-based company’s products are used in cell culture and stem
cell research, living up to the company’s tagline: “our science makes your
science better.” Protein fractions and serum products are also sold to
downstream manufacturers to become components of vaccines, clinical diagnostics,
veterinary care, and even cosmetics. RMBIO’s clients include Google, Stanford
University, National Institutes of Health, 3M, and Pfizer.

The Missoula facility has 13 full-time employees, including production, quality
assurance, quality control, sales, and customer service departments. COO Jeremy
Amberson describes the small team as nimble and able to respond to market needs
quickly. The team is currently developing a protein-free media line of products
that don't rely on extensive processing.

Founded in 2004 by Suresh Daniel and  V.K. Daniel, pioneers of the serum and
supplement fields, RMBIO was purchased in 2019 by a South Korean group seeking
to gain a foothold in the protein side of biopharma. The acquisition created an
opportunity for RMBIO to develop a larger market in Asia.

International investment has not changed RMBIO’s commitment to the growth of
biotech in Western Montana. RMBIO helped found the Missoula Vaccine Partnership,
an initiative that leverages local assets like research labs, universities, and
thriving startups to establish the region as a hub for vaccine production. 

“A key tenant of RMBIO is that Missoula has what it takes to house a biotech
sector that is successful and competitive on a global scale,” said Amberson.

--------------------------------------------------------------------------------


SOLO-DEX

An animated representation of SOLO-DEX’s Fascile® Catheter System. The catheter
takes 5 minutes to implement and works for 72 hours post-procedure, eliminating
the need for opioid pain management in most procedures. Photo courtesy of Steve
Eror.

Location: Wolf Creek, MT

What they do: Designed an opioid-free catheter device for post-surgical pain
relief

Why we’re watching them: Founded in Wolf Creek, Montana by two
anesthesiologists, SOLO-DEX’s primary product is a patented Fascile® Catheter
System that simplifies and accelerates continuous Peripheral Nerve Block (cPNB)
placement in a 5-minute procedure. 

In a country struggling with widespread opioid use and misuse, SOLO-DEX allows
patients to experience comfort for up to 72 hours after their medical procedure
without opioid use. After the 72 hour period, most patients using SOLO-DEX
reported only needing over-the-counter pain relievers. 

Ranging from $70-100, SOLO-DEX is more affordable than other pain-relieving
options, which can cost more than $300. SOLO-DEX is FDA cleared, CE marked for
sale in the European Union, and has been used to treat more than 7,000 patients
to date. 

The device was originally created by Dan Kopacz, MD and Sundar Rajendran, MD,
who were working with Olympic athletes seeking quicker recovery times without
steroid use. Kopacz was responsible for changing residency requirements in
anesthesiology to include mandatory regional anesthesia training. Rajendran has
had 20 years of practice focused on nerve block procedures for surgery. SOLO-DEX
has unique features based on the founders’ doctoral experience, such as the
ability for anesthesiologists to place a catheter with one hand as an ultrasound
device is maneuvered in the other. 

SOLO-DEX is clinically proven and validated by top healthcare and governmental
organizations like Harvard Medical School, Stanford School of Medicine, Duke
Medicine, The United States Army, and The United States Air Force. 

CEO Steve Eror, who has had 26 years in the medical industry, hopes to begin
widespread shipment from Wolf Creek to local and national healthcare facilities
later this month.

--------------------------------------------------------------------------------


SWAN VALLEY MEDICAL



Swan Valley Medical has been issued 32 U.S. and International patents with 4
patents pending on its T-SPeC® and related technology. Photo via Swan Valley
Medical.

Location: Bigfork, MT

What they do: A mid-stage, privately held medical device company with a unique
hospital solution using its patented T-SPeC® technology and advanced analytics
to replace existing hospital-based Standards of Practice

Why we’re watching them: Swan Valley Medical was founded in Montana in 2006 by
Ron Zook, a Montana native, MSU engineering graduate, MBA, and serial
entrepreneur, and Dr. Kenneth High, a Montana urologist. 

Zook was an aerospace design engineer before launching seven startups from
concept, including a VC funded turn-around. Zook, also managed an international
Japanese investment fund, focusing on M&A transactions and technology licenses.

Swan Valley Medical 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 infections, urethral catheter placement injuries, urosepsis
and related mortality.

T-SPeC® represents a disruptive technology that could fundamentally transform
how hospitalized patients are catheterized for bladder and fluids management
worldwide. The annual market exceeds $15 billion in the U.S. and $50 billion
internationally, with no competitors.  The company projects over $700 million in
annualized revenue with implementations in 230 U.S. hospitals.

Swan Valley Medical is using advanced analytics to develop customized
informatics solutions. This enables individual hospitals and hospital networks
to better understand the predicted clinical and economic benefits for the
company’s proposed changes to existing Standards of Care.

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 with initial sales
revenue in the U.S., E.U., Canada and Mexico. Final device manufacturing
assembly and fulfillment is handled by its Denver location, with a U.S. based
supplier network. The company is looking to transfer manufacturing to Montana.

The market value proposition results in shorter length of stay, reduced
readmissions, prevention of mortality and ACA payment penalties, while improving
patient satisfaction, saving individual hospitals millions of dollars annually.

--------------------------------------------------------------------------------


TRUWL

Funded by Two Bear Capital and the National Human Genome Institute, Truwl has
built an online platform that allows researchers to share genomic data analysis
methods. Photo via Truwl.

Location: Whitefish, MT

What they do: Develop bioinformatics software for sharing data analysis in
genomic research.

Why we’re watching them: Technological advances in gene sequencing in the last
decade have transformed the life sciences into a data-centric field. To gain
insights from this new proliferation of data, however, biological researchers
must navigate complex computational tools. Truwl is simplifying the process by
building a platform that allows users to share their best methods for genomic
data analysis with the wider scientific community.

In 2017, Truwl secured a seed round of funding from Michael Goguen, founder of
Two Bear Capital in Whitefish.

In November 2019, the National Human Genome Research Institute, part of the
National Institutes of Health Library (NIH), awarded Truwl $150k for the first
phase of a Small Business Technology Transfer (STTR) grant. Truwl is
collaborating with the ENCODE (ENCyclopedia Of DNA Elements) Data Coordinating
Center (DCC) at Stanford University to demonstrate the ability to run advanced
computational analyses through the online platform.

Truwl serves both the content producers inventing new ways to analyze genomic
data and consumers who need to use them. Researchers from a variety of fields –
agriculture, medicine, synthetic biology, conservation - can share
bioinformatics content and get community feedback.

Truwl is search-engine-optimized, allows browsing without sign in, and tags
content to link relevant information. The vision is to empower researchers at
all levels to analyze their own data without having to become computer science
experts.

Truwl president and co-founder Karl Sebby earned his PhD in Chemistry at Montana
State University in Bozeman. Later, he worked as a postdoc at the National
Institute of Standards and Technology in Boulder, CO and taught at Gonzaga
University before moving to his wife’s hometown of Whitefish, Mont. Sebby met
co-founder Tim Thompson, a software engineer, while working on a cancer research
project in Whitefish. The pair launched Truwl (formerly xD Bio) in 2016 to
address the barriers they faced trying to reproduce computational techniques in
published research.

Thompson left Truwl in October 2020. In addition to Sebby, the team now includes
two full-time software engineers and four contractors.

--------------------------------------------------------------------------------


VIRIS DETECTION SYSTEMS

Dr. Blake Wiedenheft holding a CRISPR protein in his office in 2017. After
working in the UC Berkeley lab of 2020 Nobel Prize winner Jennifer A. Doudna,
Wiedenheft started his own research lab at MSU and launched VIRIS Detection
Systems, a biotech startup using CRISPR to develop new detection tests for
viruses like HIV, Ebola, and COVID-19. Photo taken by Kelly Gorham, MSU.

Location: Bozeman, MT

What they do: Develop viral diagnostics using CRISPR-based technologies.

Why we’re watching them: Since its discovery eight years ago, the precise
gene-editing technology known as CRISPR has revolutionized the life sciences.
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic
Repeats, is used by researchers around the globe to create hardier plants and
develop new treatments for diseases like sickle-cell anemia and cancer. In
October 2020, Emmanuelle Charpentier and Jennifer A. Doudna shared the Nobel
Prize in Chemistry for their discovery of CRISPR.

Dr. Blake Wiedenheft, associate professor in Microbiology and Immunology at
Montana State University, has had a front row seat to this scientific
breakthrough. Wiedenheft contributed to Dr. Doudna’s research as a postdoc in
her lab at the University of California, Berkeley from 2007 to 2012.
Wiedenheft’s doctoral research took him to Yellowstone National Park where he
studied how bacteria fight off viruses in the boiling acid hot springs. Later,
he returned to Montana to start his own CRISPR research program at MSU.

In April 2020, Wiedenheft launched VIRIS Detection Systems, a biotech startup
using CRISPR to develop new diagnostic tools. VIRIS (Viral Identification
Rapidly Issued Strips), Detection Systems is creating an adaptable detection
test that is quick, accurate, and inexpensive. Near term goals are to develop a
test for SARS-CoV-2 (the cause of COVID19), but the platform is versatile and
can be quickly reprogramed for detection of other viruses (e.g., Ebola,
Influenza, or HIV), genes associated with non-infectious diseases (e.g.,
oncogenes) or disease important to the agricultural industry. 

In August 2020, VIRIS raised a seed funding round with Khosla Ventures, Next
Frontier Capital, and MSU.

--------------------------------------------------------------------------------

About the Publisher: Launched in 2014, the Montana High Tech Business Alliance
is an nonpartisan nonprofit association of highly-engaged high tech and
manufacturing companies and affiliates creating high-paying jobs in Montana. For
more information, visit MTHighTech.org or subscribe to our biweekly newsletter.

About the Authors:

Samuel Boudreau is the Writer and Digital Content Coordinator Intern at the
MHTBA. He graduated from Middlebury College with a degree in Gender, Sexuality
and Feminist Studies and Psychology and is currently pursuing his MFA at The
University of Montana while teaching Introductory and Intermediate Writing
Courses.

Martina Pansze is the Communications Director for the Montana High Tech Business
Alliance. She graduated from Whitman College with a degree in Film and Media
Studies, and has worked as a freelance journalist and grant writer.

Christina Quick Henderson is founding executive director of the Montana High
Tech Business Alliance and an instructor in the College of Business at the
University of Montana.

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MT High Tech Business Alliance

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