Montana Biotech Companies to Watch 2024
By Melissa Paulsen
Graphic by Nate Gorin.
May 30, 2024
Since 2017, the Montana High Tech Business Alliance has annually showcased top tech companies in Montana. This year, in partnership with the Montana Bioscience Cluster Initiative, we present the 2024 Montana Biotech Companies to Watch (see the first Biotech 2020 list). These companies are leading the charge in biotech innovation, from improving healthcare for underserved populations to using AI for remote health monitoring and revolutionizing drug discovery with advanced tools.
Key Industry Trends:
Female Entrepreneurship: Five of the six firms were founded or led by women, underscoring growing gender diversity in Montana’s entrepreneurial ecosystem.
Bozeman - A Biotech Hub: Five of the six companies are based in Bozeman, with two originating as spin-offs from Montana State University, highlighting Bozeman’s growing importance in the biotech sector.
Grant Success: Three firms secured SBIR/STTR grants, showcasing Montana’s high success rate in these competitive federal programs. From 2012 - 2021, Montana's success rate was 18%, surpassing the national average of 16%.
Bootstrapping Success: Two companies self-funded their ventures, reflecting Montana’s entrepreneurial history of bootstrapping.
Selection Criteria:
Nominations came from industry partners across Montana, including MonTEC, the Montana Bioscience Alliance, the Missoula Economic Partnership, and others. The six finalists were chosen based on:
Significant revenue growth or high-growth sector involvement
Potential to launch impactful products or services
Valuable intellectual property ownership or development
Prospects of acquiring major clients or entering new markets
Expansion plans or significant job creation in the next year
Management teams led by experienced entrepreneurs or top experts
These innovative businesses are not only advancing the life sciences but also enriching life in Montana.
Here are the 2024 Montana Biotech Companies to Watch:
IntelligHealth, Bozeman - Advancing remote health monitoring with AI.
KLEO, Missoula - Improving healthcare for underserved populations.
Montana Molecular, Bozeman - Enhancing drug discovery with advanced biosensors.
NanoMagnetic Solutions, Bozeman - Revolutionizing preclinical drug discovery for brain diseases.
Titin KM Biomedical, Bozeman - Transforming shoulder injury diagnosis and rehabilitation.
The Toothpick Company/ KUVU Bio Solutions, Kenya and Bozeman - Innovating biological weed control in agriculture.
IntelligHealth
IntelligHealth’s AI-driven technology platform objectively assesses a patient’s condition using real-time monitoring data and remote health-monitoring technologies.
Location: Bozeman
What They Do: Use AI-driven data analytics and remote health monitoring systems to detect, classify, and monitor respiratory diseases.
Why We’re Watching Them: The need for remote health technologies and patient monitoring has been on the rise in both urban and rural areas across the nation since the COVID-19 pandemic. IntelligHealth is meeting the increased demand through its AI-driven algorithm that detects, classifies, and monitors respiratory diseases through wearable technology (such as smart watches) and FDA-approved medical devices to help clinicians efficiently triage their patients without increasing their workload.
Within ten minutes IntelligHealth’s algorithm identifies the respiratory condition afflicting a patient and can alert providers securely. From the comfort of their home, the patient can send data and notes through their smartphone app directly to their medical provider. Additional uses for the system include revealing health patterns, creating alerts, or serving as a valuable decision tool for clinicians. Patients can also send updates monthly, weekly, or daily depending on their risk level.
Empathy drives co-founder Laura Stanley, Ph.D., and her work behind IntelligHealth. During her pregnancy, Dr. Stanley developed a heart arrhythmia that remains with her today. Her experience wearing heart monitors for more than eight years has helped her to design user-friendly devices.
“It allows you to have that empathy,” Stanley said. “You have to get in the shoes of your patient, whoever’s suffering, and that’s hard to do. I don’t know if I could have done that had I not had this heart condition.”
-
Founded in 2021, IntelligHealth has received a competitive SBIR Phase I grant for $256,000 from the National Science Foundation, a $30,000 grant from the Montana Department of Commerce, and small grants from the Montana Bioscience Cluster Initiative and the Montana Innovation Partnership powered by TechLink. In June of 2023, the company filed a non-provisional patent for its innovative algorithm with the goal of moving into the wearable market through commercial licensing.
IntelligHealth’s leadership team consists of three co-founders with extensive computer science and industrial engineering expertise. Dr. Laura Stanley, Chief Scientist, is an Associate Professor in the Gianforte School of Computing at Montana State University where she studies human-computer interaction. She also has over 15 years of leadership experience developing UX research, design, and digital health solutions. Data Scientist Dr. Vishnu Prabu is an Assistant Professor of Industrial and Systems Engineering at the University of North Carolina in Charlotte, and Machine Learning Engineer Apostolos Kalatzis is a recent graduate from Montana State University and Assistant Professor in the Department of Computer Science at Cleveland State University.
The next push for Dr. Stanley and her team includes securing phase two SBIR funding to produce a full prototype and furthering the validation process with hospitals to receive FDA 510(k) approval. IntelligHealth anticipates hiring software engineers, a business strategist, and sales and marketing roles after commercialization begins.
“I love Montana ... its vast open spaces are what attracts many of us here, but that remoteness often makes healthcare centers inaccessible, posing significant challenges for those requiring immediate and essential medical care,” Dr. Stanley said. “This is my community [and] these are my people. I want to help bring this technology here.”
KLEO
Location: Missoula
What they do: Support the research and development of products that improve the health and well-being of our communities and challenge the traditional thinking of the MedTech commercialization process by providing boutique clinical, regulatory, and market access services.
Why We’re Watching Them: KLEO provides high-quality consulting services and integrated expertise to the MedTech industry without massive overhead costs. The company supports all aspects of market entry for MedTech firms aiming to commercialize health innovations.
With three full-time employees and independent contractors across the United States, KLEO offers a wide range of professional services, including clinical operations, data management, market access, regulatory affairs, and medical writing.
Founded in 2019, KLEO began as a data management firm analyzing large clinical trial datasets. However, after working on ad hoc consulting projects for medical device companies, founder Karen Brown realized the need for integrated expertise in the MedTech industry. Through bootstrapping, Brown rebranded the company as a global contract research organization.
“In the last year and a half or so we really committed to bolstering what KLEO could do and growing into a full-service company,” Brown said. “Taking [KLEO’s] drive to bring clinical research and health innovation to underserved and minority populations and coupling it with experience in the industry [has] been really rewarding.”
-
KLEO has quickly doubled its annual recurring revenue and now operates in over 30 clinical research sites across the country. The company’s latest clinical trial is a post market registry involving an FDA-approved treatment for patients with intracranial aneurysms. KLEO monitors data collected at each site, supports the clinicians and coordinators enrolling patients in the study, and oversees data analysis to evaluate clinical efficacy and safety endpoints.
As a native Montanan from Fort Shaw, Brown is passionate about bringing industry-sponsored clinical trials to rural and diverse populations. Brown earned her PharmD from the University of Montana and completed a postdoctoral fellowship in pharmacogenomics. She remains active as a researcher at the University of Montana in Missoula.
KLEO plans to hire a high-level operator to help scale the company. Additionally, they aim to develop programs to train and employ candidates with broad biomedical or healthcare experience to oversee clinical trials, while maintaining the boutique consulting essence that sets them apart from larger competitors.
Montana Molecular
Montana Molecular’s Red Down DAG Assay Kit.
Location: Bozeman
What They Do: Reduce the risk and cost of drug development with a live cell platform of fluorescent biosensors, gene delivery vectors, analytic tools, and services.
Why We’re Watching Them: Drug development is fraught with high costs and risks, especially with clinical trials ending in failure about 90% of the time. Montana Molecular addresses this challenge by enabling biotech companies and pharmaceutical firms to efficiently test their compounds in living cells that are relevant to disease. Montana Molecular’s proprietary platform enables observation of specific cellular responses and drug signaling pathways, and delivers high-quality, clinically relevant information early in development
Montana Molecular, a certified woman-owned business by the Women’s Business Enterprise National Council (WBENC), offers nearly 100 products and services, primarily for therapeutic drug development. Researchers worldwide also use these products to study basic cell biology as well as various diseases, including substance use disorders, asthma, cancer, obesity, and diabetes.
Founder and CEO Anne Marie Quinn earned her master’s in public health from Yale University School of Medicine. She launched Montana Molecular in 2007 after working in the pharmaceutical industry and noticing the challenges of bringing new drugs to market.
“I noticed a disconnect in [drug development] decisions based on information that was acquired in artificial biochemical or chemical assays,” Quinn said. “There really wasn't any consideration of the biology of the drug until you got into animal testing, which is way down the line, after a lot of investment. It is so much more effective to test candidate drugs in a biological process, so that’s what drove the idea behind [Montana Molecular].”
-
Montana Molecular started with an STTR grant from the NIH in 2008. The company has received over seven million dollars in STTR and SBIR funding from five NIH institutes, supporting the R&D of its extensive product collection. The company holds five patents for its genetically encoded fluorescent sensor technologies.
Committed to local employment, the company now has 15 employees, and is hiring for roles in R&D, production, and assay services. Montana Molecular offers employees the opportunity to hold a stake in the company through its employee ownership program and is 100% employee-owned. The company maintains an average annual revenue growth rate of 60% through direct sales of products and services, worldwide distribution partners, and strategic partners in Austin, Texas, and San Diego, California.
Montana Molecular's integrated platform for drug discovery in living cells.
NanoMagnetic Solutions
Location: Bozeman
What they do: Develop advanced tools using force modulation to revolutionize preclinical drug discovery for brain diseases.
Why We’re Watching Them: NanoMagnetic Solutions manufactures cutting-edge research tools that mimic physiological forces in the human body, helping scientists generate more reliable preclinical drug discovery data for brain diseases. Their primary product is a 3-D-printed magnetic ring that attaches to standard 35-millimeter Petri dishes. This ring exerts a consistent magnetic field gradient over millions of cells, enabling alterations in cell structure and activity, and facilitating tissue engineering.
“The tool is really versatile and goes with every type of cell you want to grow in a Petri dish, but the big advantage is that you get an additional force signal into your standard tract testing approach,” said co-founder Dr. Anja Kunze.
Dr. Kunze’s post-doctoral brain tissue research served as the catalyst for NanoMagnetic Solutions. Encouraged to market the technology after exhibiting it at a science fair at Montana State University (MSU), Kunze and her two co-founders established the company in 2019 as a spin-off from the lab at MSU.
In 2020, NanoMagnetic Solutions placed second overall for traditional ventures in the Montana State University $50K Venture Capital Competition hosted by the Jake Jabs College of Business & Entrepreneurship. The company has raised approximately $42,000 to date between multiple grants from the National Science Foundation and a seed grant from MSU's Blackstone Launchpad. They have also filed three provisional patents through MSU’s Technology Transfer Office.
-
NanoMagnetic Solutions’ three founders are experts in electrical and computer engineering. Dr. Kunze holds a Ph.D. in microsystems and microelectronics from École Polytechnique Fédérale de Lausanne in Switzerland, (which she called the “MIT of Europe”), and a master’s in electrical engineering from the Technische Universität Dresden in Germany. She received an NSF CAREER award in 2019 for her work using nanomagnetic forces to modulate calcium signals in brain cells. Co-founder Mackenna Landis earned her bachelor’s degree in bioengineering mathematics from Carroll College and co-founder Connor Beck holds a B.S. in chemical engineering from MSU. Both are graduate students in MSU’s electrical and computer engineering program.
NanoMagnetic Solutions plans to hire a CEO with a biotech background to help the company become independent of MSU and market its tool to research labs nationwide. Eventually, they aim to reach larger corporate markets, including pharmaceutical companies interested in integrating their tool into drug testing platforms.
Titin KM Biomedical
Titin KM Biomedical’s Humero Tech C1 machine helps patients regain shoulder strength and recover quickly from injury.
Location: Bozeman
What They Do: Manufacture biomedical machines to diagnose debilitating shoulder injuries and assist with patient rehabilitation.
Why We’re Watching Them: Shoulder injuries are common, especially in athletics due to repeated and intense movements. Named after the protein found in skeletal muscle, Titin KM Biomedical (Titin) helps patients regain shoulder strength and recover quickly from injury with its groundbreaking Humero Tech C1 machine.
Built-to-order at its 10,000-square-foot Bozeman facility, Titin’s Humero Tech C1 machine revolutionizes the recovery process. The machine uses sensors and mechanical technology to track a patient’s efforts through strength-based exercises, providing in-depth metrics to inform the next steps in their recovery.
Co-founders Kole and Kam Mickolio, born and raised in Belgrade, Montana, have first-hand experience with severe injuries and the rehabilitation process. At 26, Kole suffered a stroke while studying biomedical engineering. After years of rehabilitation, Kole developed the idea for Titin during his second year of medical school at Dartmouth College. He earned his Master of Science in Molecular Medicine from Montana State University and is currently a radiology resident at Dartmouth.
Kam Mickolio played professional baseball in the MLB and Japan until a rotator cuff injury while pitching for the Minnesota Twins cut his career short. With his extensive experience in shoulder injury and rehabilitation, Kam oversees the sales and marketing division of Titin. The brothers’ experiences led to the founding of Titin in 2020, along with their cousin, Chad Sukit, and Chief of Engineering Rory Maughan.
-
Funded by private investors across the United States, Titin took a unique approach to raising capital, accepting small amounts of money to start and grow.
“Being patient with getting the right [investors] and tapping into [their resources and] contacts has helped us grow organically,” Kole said. “It's a lot easier to go and get a huge lump sum of money and plan ahead, but we did everything in reverse as we developed ahead of ourselves, and then we knew exactly what we needed, and we would go and get it piece by piece. We didn't want to take more money than we needed.”
With a non-provisional patent and two international non-provisional patents for its sensor and mechanical technology, Titin is preparing for early-stage luminary sites in the medical, therapeutics, and professional athletics markets to rigorously test its machines. Additionally, Titin is conducting clinical trials and has received invitations to demonstrate its product at the NFL combine, MLB winter meetings, the American Academy of Orthopedic Surgery, and various biomedical conferences.
Titin has increased its workforce by 40% this year, hiring approximately 40-50 full-time employees, many from Montana State University. The company plans to employ more local manufacturing, mechanical, and software engineers. Titin’s next steps involve expanding manufacturing capabilities to fill orders faster and broadening its market to Japan and the European Union.
The Toothpick Company / KUVU Bio Solutions
Location: Kenya and Bozeman
The Toothpick Company’s award-winning bioherbicide technology's active agent is a locally sourced host-specific fungus selected for high levels of excretion of specific amino acids. This innovation is poised to disrupt weed management globally, a $34 billion industry dominated by synthetic chemical herbicides.
What they do: Develop natural biological herbicides to exterminate weeds threatening crop yields.
Why We’re Watching Them: Striga witchweed devastates staple crops across approximately 40 million farms in sub-Saharan Africa, leading to widespread malnutrition. The Toothpick Company combats this parasitic weed using selected strains of the fungus Fusarium oxysporum, (FOXY) to provide host-specific biological crop protection, eliminating the need for toxic synthetic chemical herbicides.
In 2007, co-founder John Sands, a retired U.S. Navy surgeon, learned about the pernicious weed while volunteering in Kenya. He returned to the United States and enlisted his brother, Dr. David Sands, a plant pathologist and biotechnologist, to address malnutrition through crop protection. Dr. David Sands developed the biotechnology to prevent Striga through research at Montana State University (MSU) and in collaboration with scientists at the Kenya Agricultural and Livestock Research Organization. After receiving a Grand Challenges Exploration Grant from the Bill and Melinda Gates Foundation in 2013, the team conducted proof of concept trials in Western Kenya. With consistent results showing crop yield increases of 35-85%, the pilot social enterprise Toothpick Company was founded in 2018.
Originally, the fungal strains were grown on toothpicks (hence the company name) that were used to make a live, fresh inoculum at the village level. This product received regulatory approval in 2021, making it one of the first bioherbicides to be commercialized in the world. In 2023, the second product iteration using the FOXY strains as a seed coating was approved, reducing the price by 60% and extending shelf life. The company will break even in 2025 and is currently expanding into Uganda.
The team from Toothpick Company Ltd., headquartered in Kakamega, Kenya, celebrated the launch of the new seed coating product at a large stakeholder event in December 2023. In addition to co-founder Claire Sands Baker, women hold the three top positions (Managing Director, Head of Administration and Finance, and Scientist).
The Toothpick Company has received various grants and participated in MSU’s Blackstone Launchpad 406Labs Accelerator, the UN World Food Program Innovation Accelerator, and the Stanford University Global Innovation Catalyst Go-To-Market Strategy course created specifically for African enterprises. It has gained major international recognition, including the 2024 Sankalp Africa Award, 2024 MassChallenge Alumni Award, and the 2021 UN Food Systems Summit Best Small Business Award. The Toothpick Company was also shortlisted for the 2023 Food Planet Prize and was a finalist for the Milken-Motsepe Prize in Agri-tech. The United Nations World Food Program and the German NGO Welthungerhilfe have the Toothpick Company listed in their innovation portfolios.
-
Dr. Sands and his daughter, Claire Sands Baker, are establishing Bozeman-based KUVU Bio Solutions. KUVU, which means “fungus” in Swahili, is a bioherbicide platform company that is positioned to expand the technology to other weeds around the world. The company monitors the environmental impact of the chemical herbicide industry and explores ways to replace damaged ecosystems.
KUVU has started a pre-seed fundraising round to raise $2.5 million dollars to support its research and commercialization efforts. The company plans to investigate 14 invasive weeds, including pigweed, a major economic threat in the United States due to its resistance to most synthetic chemical herbicides.
Baker, the CEO and director of Toothpick Company and KUVU, has her eyes on expanding both teams. When additional funding is secured, KUVU plans to open a lab to train and hire scientists and employ a general manager to assist with operations and regulatory processes.
With a B.A. in art history from Scripps College and 30 years of nonprofit management experience, Baker brings a transdisciplinary approach to her roles. She recently won the 2024 Distinguished Alumnae award from her alma mater.
“Right now, [KUVU is] trailblazing,” Baker said. “As we build the platform, there'll be new ways arising of how to select the [fungal] strains, how they can be applied to weeds, and a lot of knowledge will be built up over the next decade.”
About the Publisher: Launched in 2014, the Montana High Tech Business Alliance is a nonpartisan nonprofit association of more than 200 high tech and manufacturing companies and affiliates creating high-paying jobs in Montana. For more information, visit MTHighTech.org or subscribe to our newsletter.
About the Author: Melissa Paulsen is the communications coordinator for the Montana High Tech Business Alliance. She graduated from the University of Montana in 2022 with a BFA in creative writing and a minor in history.
About the Graphic Designer: Nathaniel Gorin is a former content creator intern for the Montana High Tech Business Alliance. He graduated from the University of Montana with a degree in marketing and creative writing.
