Issuu

IN THIS ISSUE:

06 FROM CHALLENGE TO CAPABILITY KEYSTONE SOLUTIONS GROUP

12 ADVANCING THE FUTURE OF MEDICAL DEVICE STERILIZATION STERILE STATE

22 EARLY COLLABORATION AND CLEANROOM PRECISION PLIANT MEDICAL

30 OVER 40 YEARS OF SUPERIOR SCIENCE OXFORD BIOMEDICAL RESEARCH

FALL 2026

A magazine showcasing Michigan’s biosciences industry

BIOSCIENCES IN ACTION Technologies, expertise, and partnerships powering Michigan’s bio-industry.

PRECISION MEDICINE. ROBUST RESOURCES. Michigan is pioneering the next generation of medicine thanks to innovators like Genemarkers. The bioscience company grew from a research startup to a nationally recognized precision medicine firm with support, guidance, and financial assistance from the Michigan Economic Development Corporation. Discover why Michigan is the ideal environment for your business breakthrough at MICHIGANBUSINESS.ORG

PRESIDENT’S MESSAGE Bioscience is often described through its defining moments: a promising discovery, an innovation, a treatment or product reaching the people who need it. Yet those moments are possible only because of the sustained, highly specialized work that comes before them. A customer challenge must be understood and translated into a practical solution. Materials must perform as intended. Processes must be precise, repeatable, and compliant. Risks that cannot be seen must be measured. Products must be validated, developed and manufactured to exacting standards. At every stage, progress depends upon people who know how to move from a difficult question to a reliable answer. The companies featured in these pages demonstrate the breadth of capabilities at work across Michigan’s bio-industry. Wacker reminds us that better outcomes often begin at the molecular level, with chemistry designed for a specific purpose. M3D is changing how radiation can be measured and understood, while Sterile State is addressing one of medical device manufacturing’s most critical requirements.

Thank you to our member companies that shared stories of how their work strengthens Michigan’s bioindustry every day. Together, they offer a clear picture of bioscience in action.

Pliant Medical illustrates the value of bringing manufacturing expertise into the conversation early, when informed decisions can improve design, cleanroom production, and the path ahead. Keystone Solutions Group shows how listening closely to customers can open an entirely new chapter for a company. NorthernBio and Oxford Biomedical Research reflect another essential strength: scientific experience developed over time and applied with consistency, discipline, and an understanding of what customers truly need. These stories span different technologies, markets, and stages of development, but they share a common principle. Strong results rarely come from one capability alone. They emerge when technical knowledge, specialized facilities, close collaboration, and careful execution come together. That combination is one of Michigan’s greatest strengths. Our state is home not only to researchers and product developers, but also to the manufacturers, testing organizations, technical specialists, and service providers that help promising work succeed in the real world. Their contributions may take place behind the scenes, but they are fundamental to the quality, safety, and reliability expected when delivering live-saving treatments and products. As you read this issue, I invite you to look beyond the individual technologies and consider the depth of expertise behind them. These organizations are solving immediate problems while building capabilities that will serve customers, patients, and partners for years to come. Sincerely,

STEPHEN RAPUNDALO, PHD President and CEO, MichBio

BIOMATTERS ® | FALL 2026

MICHBIO | michbio.org

MichBio is the biosciences trade association for the state of Michigan. Our goal is to drive the growth of the state’s bio-industry through advocacy, education, connections, and supportive resources.

PREMIUM MEMBERS GOLD full color

black

white

Stephen Rapundalo, PhD President and CEO Emily Brockman Director, Member Relations Carrie Hranko Manager, Administrative Services Jamie Krajny Editor Director, Marketing and Industry Engagement

MichBio 3600 Green Court, Suite 780 Ann Arbor, MI 48105-1175 734-527-9150 info@michbio.org michbio.org Designer: Daina Fuson Designs Printer: Progressive Printing © Copyright Michigan Biosciences Industry Association, DBA MichBio

MICHBIO BOARD OFFICERS SILVER

CHAIR Ken Massey, PhD Wayne State University Senior Director, Venture Development Technology Commercialization VICE CHAIR Kevin McLeod Everis Founder, President and CEO

PRESIDENT AND CEO Stephen Rapundalo, PhD MichBio President and CEO SECRETARY Vacant TREASURER Vacant

MICHBIO BOARD DIRECTORS BRONZE

Christy Bigelow Emergent Biosolutions Vice President and General Manager, Manufacturing Operations

Ken Massey, PhD Wayne State University Senior Director, Venture Development Technology Commercialization

Chuck Bird Neogen Corporation Senior Director of Government Relations and Industry Affairs

Kevin McLeod Everis Founder, President and CEO

Rhonda DeLuca Terumo Cardiovascular Group Chief Operating Officer & Chief People Officer Robert Donofrio, PhD BioScope Innovations CEO

PATRON

Rose Gillesby, DVM Zoetis Vice President, Veterinary Medicine Research and Development Christine Haakenson, PhD Bio-industry Executive Charles Hasemann, PhD Michigan State University Assistant Vice President for Innovation and Economic Development Laura Malagon Grand River Aseptic Manufacturing Vice President, Quality & Regulatory

Dave Morin Care Technology Advisors, President & Chief Operating Officer Kevin Packard Stryker Senior Director, Research & Development Kate Remus University of Michigan Senior Associate Director & Business Development Group Lead Stephen Rapundalo, PhD MichBio President and CEO Uma Sharma, PhD MMS Holdings Founder and CEO Ashlea Souffrou SxanPro Founder and CEO

BioMatters® is published bi-annually to showcase Michigan’s bioscience industry. Much of the content is submitted by MichBio member companies. Interested in submitting an article or advertising in a future issue? Contact Jamie Krajny at jamie@michbio.org.

BIOMATTERS ® | FALL 2026

MICHBIO PREFERRED PURCHASING PROGRAM The MichBio Preferred Purchasing Program leverages the collective purchasing power of our member companies to obtain steep discounts from our vetted and endorsed vendor portfolio. Members have saved upwards of 900 times their annual membership dues.

Science has the power to change lives for the better. Every day, from discovery to delivery, Avantor is an essential partner to the scientific community — pioneers, scientists, innovators and educators — relentlessly focusing on breakthroughs that help solve the world’s most complex challenges. Our proven expertise and trusted portfolio of products and services, combined with a global reach and ability to provide customized materials of the highest quality for highly regulated applications move science forward. As a global leader in life sciences, we fulfill our mission: to set science in motion to create a better world. Visit vwr.com or avantorsciences.com

Better world.

Better solutions. Better focus.

MICHBIO | michbio.org

TABLE OF CONTENTS Challenge to Capability: How Customer 06 | From Needs Inspired the Next Chapter Keystone Solutions Group

08 | The Bonds Behind Better Bioscience Wacker Chemical Corporation

10 | Seeing Radiation in a New Way M3D

the Future of Medical 12 | Advancing Device Sterilization Sterile State

14 | By the Numbers MichBio

16 | Michigan’s Bio-industry Map MichBio

18 | After the Elevator Pitch Emerging Companies

21 | Consultants to Meet

BioScope Innovations LLC

Collaboration and Cleanroom Precision 22 | Early Shape Manufacturing Approach Pliant Medical

Lives Begin Here: NorthernBio 24 | Better Expands Its Capacity for the Biosciences Community NorthernBio

26 | Over 40 Years of Superior Science Oxford Biomedical Research

26 BIOMATTERS ® | FALL 2026

KEYSTONE SOLUTIONS GROUP

From Challenge to Capability How Customer Needs Inspired the Next Chapter SUBMITTED BY KEYSTONE SOLUTIONS GROUP

For more than 20 years, Keystone Solutions Group has partnered with medical device companies to bring innovative products from concept to commercialization. Based in Southwest Michigan, Keystone is an FDA-registered, ISO 13485-certified contract manufacturer specializing in engineering support, cleanroom assembly, sterile barrier packaging, sterilization management, and commercial production for Class I and Class II medical devices. Throughout those two decades, one lesson has remained consistent: the best solutions often begin by listening to your customers. Over the last several years, Keystone noticed a clear shift in customer expectations. Medical device companies were no longer looking for a manufacturer to simply assemble products after the design was complete. They were asking for partners that could become involved earlier in development, help solve manufacturing challenges, reduce supply chain complexity, and accelerate commercialization. Those conversations highlighted a broader challenge facing the medical device industry. Traditionally, bringing a medical device to market requires coordinating multiple specialized suppliers. One company manufactures materials, another converts components, another performs assembly, while others manage sterile packaging and sterilization. Although each supplier contributes valuable expertise,

MICHBIO | michbio.org

every transition introduces additional planning, transportation, communication, quality oversight, and validation requirements. As products become more sophisticated and development timelines become shorter, those handoffs can create unnecessary delays and increased risk. Rather than accepting those challenges as part of the process, Keystone viewed them as an opportunity. The company began investing in capabilities that would allow customers to work with fewer suppliers while maintaining the quality and regulatory standards expected within the medical device industry. By expanding engineering support, cleanroom manufacturing, sterile packaging, and commercialization services, Keystone continued moving beyond traditional contract manufacturing toward becoming a more integrated manufacturing partner. The next milestone in that journey is K2 Fabricating, a joint venture established to manufacture advanced hydrophilic polyurethane foams for wound care, cosmetic, and specialty medical applications. For Keystone, the decision wasn’t simply about adding another manufacturing process. It was about solving a challenge customers face every day. Hydrophilic polyurethane foam is a critical component in many advanced wound care products, where material performance directly influences clinical outcomes. Historically, these materials have often been sourced independently from downstream

KEYSTONE SOLUTIONS GROUP

Earlier collaboration helps reduce technical risk, streamline communication, strengthen supply chain resilience, and provide customers with greater confidence as products move toward market. manufacturing operations, creating additional supplier coordination, longer lead times, and reduced flexibility during product development. By bringing advanced foam manufacturing together with converting, cleanroom assembly, sterile barrier packaging, and commercialization support, Keystone and K2 Fabricating have created a more collaborative development environment. Engineering teams can work together earlier, evaluate material options more efficiently, improve manufacturability, and simplify the transition from development into commercial production. The benefits extend well beyond manufacturing. Earlier collaboration helps reduce technical risk, streamline communication, strengthen supply chain resilience, and provide customers with greater confidence as products move toward market. This milestone reflects a larger trend across the medical device industry. Manufacturers are increasingly expected to contribute engineering expertise, support validation activities, invest in new technologies, and serve as strategic partners throughout the product lifecycle. Success is no longer defined by simply producing quality components – it is measured by helping customers bring innovative medical technologies to market faster and more efficiently.

For Keystone Solutions Group, the formation of K2 Fabricating represents another step in a long-term commitment to supporting medical device innovation while strengthening advanced manufacturing in Michigan. By continuing to invest in people, technology, and vertically integrated capabilities, the company is helping customers simplify increasingly complex supply chains without compromising quality or regulatory compliance. Every investment has been guided by the same principle that has shaped Keystone for more than two decades: listening to customers, understanding their challenges, and building solutions that create lasting value.

As the medical device industry continues to evolve, that philosophy will remain at the center of Keystone’s growth – helping innovators transform ideas into life-changing medical devices through stronger partnerships, smarter manufacturing, and a shared commitment to improving patient care.

keystone-pd.com

BIOMATTERS ® | FALL 2026

WACKER CHEMICAL CORPORATION

The Bonds Behind Better Bioscience BY MARK BUSCH, VICE PRESIDENT OF BIOSOLUTIONS, WACKER CHEMICAL CORPORATION

In bioscience, innovation often depends on materials and manufacturing capabilities that make a product work in real life. A wound dressing must adhere securely while remaining gentle on skin. A wearable medical device must perform through movement, moisture, and prolonged contact. A supplement or pharmaceutical formulation may need technologies that improve stability, solubility, delivery, or bioavailability. Biopharmaceutical developers may also need specialized support for advanced therapies, including nucleic acidbased medicines and recombinant proteins. These challenges sit at the intersection of chemistry, biology, engineering, and manufacturing. In Michigan, WACKER’s Ann Arbor Innovation Center helps advance bioscience-enabling materials through applied work in silicone chemistry and cyclodextrin technologies. Across WACKER’s broader U.S. bioscience network, that materials expertise connects with BioPharma capabilities at Wacker Biotech U.S. in San Diego, where the company supports biopharmaceutical customers through contract development and manufacturing services.

A Michigan hub for applied innovation Wacker Chemical Corporation, the North American subsidiary of WACKER, has deep roots in Michigan. The company began manufacturing silicones in Adrian in 1969, establishing the foundation for WACKER’s business in the Americas. Today, the Ann Arbor Innovation Center serves as a strategic hub for North and Central America, bringing technical, commercial, and customer support functions together with advanced laboratory capabilities.

MICHBIO | michbio.org

The center gives WACKER a collaborative environment for developing specialty materials for health care, medical devices, supplements, and pharmaceuticals. It also reflects an important reality about the bioscience economy: Breakthroughs rarely come from biology alone. Companies developing products for patients and consumers need materials that meet expectations for safety, comfort, durability, manufacturability, and regulatory alignment. WACKER’s Michigan work addresses those requirements through applied materials science.

Silicones for health care and medical devices Silicones play a significant role in health care because they offer flexibility, purity, biocompatibility, processability, and performance under demanding conditions. In medical applications, these characteristics can support products that contact the body, protect sensitive tissue, or help devices function more comfortably over time. WACKER has highlighted skin-sensitive silicone adhesives for wound care and portable medical devices among projects connected to its Ann Arbor Innovation Center. The company has also conducted research in Ann Arbor on silicone systems for the selective release of active ingredients in wound care. That work connects directly to needs across modern health care. As care moves beyond traditional clinical settings, patients use more wearable devices, patches, sensors, and home-based products that must remain reliable outside controlled environments. Materials must balance adhesion with gentle removal, stability with flexibility, and performance with comfort.

WACKER CHEMICAL CORPORATION

As care moves beyond traditional clinical settings, patients use more wearable devices, patches, sensors and home-based products that must remain reliable outside controlled environments. WACKER’s silicone portfolio also supports broader medical applications, including liquid silicone rubber and high-consistency rubber designed for wound dressings, medical adhesives, gels, IV administration sets, seals, drainage and feeding tubes, catheters, syringe seals, and respiratory masks. WACKER has stated that its SILPURAN products have met ISO 10993 standards and passed United States Pharmacopeia Class VI tests, with cleanroom filling and packaging through its CLEAN OPERATIONS program.

Cyclodextrins for formulation challenges Cyclodextrin technologies add another dimension to WACKER’s Michigan bioscience story. Ann Arbor is a site that specializes in silicone chemistry and cyclodextrin applications. Cyclodextrins are ring-shaped molecules derived from plant starch that can encapsulate other molecules within their structure. In formulation work, that capability can help improve solubility, stability, controlled release, taste masking, or bioavailability. For supplement and pharmaceutical developers, this technology can prove critical. Active ingredients may degrade, dissolve poorly, interact with other ingredients, or require delivery characteristics that conventional formulations cannot easily provide. Cyclodextrins offer a tool for addressing those barriers, helping developers create products with stronger performance, consistency, and usability. That formulation expertise also fits within WACKER’s larger BioPharma presence in the United States. While Ann Arbor supports applied work in specialty materials and cyclodextrin technologies, WACKER’s broader BioPharma capabilities expand the company’s offering for biopharmaceutical developers that need CDMO support. These capabilities include plasmid DNA manufacturing and support for advanced therapy development through technologies tied to pDNA, mRNA, and recombinant proteins.

Supporting Michigan’s bioscience ecosystem For WACKER, the story of bioscience in Michigan reaches beyond traditional drug manufacturing. It centers on the advanced chemistry that helps health care, medical device, wound care, supplement and pharmaceutical products perform safely and effectively.

In a field often defined by the next breakthrough, WACKER’s Michigan innovation hub helps supply the chemistry that helps those breakthroughs hold together.

wacker.com

BIOMATTERS ® | FALL 2026

M3D

Seeing Radiation in a NEW WAY

SUBMITTED BY M3D, INC.

Ann Arbor-based M3D has entered an exciting new phase of growth. Originally spun out of its sister company, H3D, Inc., the company builds on decades of innovation in radiation detection and gamma imaging to develop advanced imaging systems that move beyond traditional nuclear medicine suites and directly into everyday clinical workflows. Today, M3D is demonstrating how a single technology platform can improve care across multiple specialties, from helping radiation safety professionals visualize radioactive materials to giving surgeons clearer insights during cancer procedures.

MICHBIO | michbio.org

From radiation safety to surgical oncology, M3D is bringing real-time imaging to the point of care. From Innovation to Commercial Adoption M3D’s first commercial product, the handheld RAVIN CAM™, represents an important milestone for both the company and the field of radiation safety. Unlike conventional survey meters, the system provides realtime visualization, helping users quickly identify the location and distribution of radioactive materials. Since its launch, the RAVIN CAM has been adopted across a growing range of applications, including contamination response, radioactive waste management, radiopharmaceutical therapy monitoring, shielding verification, and scatter radiation visualization in cardiac catheterization laboratories. By allowing users to see radioactive material rather than simply detect its presence, the technology improves workflow efficiency and confidence in a variety of healthcare environments.

MD3

Commercial adoption is also driving new strategic partnerships. M3D is working with the interventional imaging teams at Canon, Philips, and Siemens to integrate the RAVIN CAM into their accessory catalogs and is partnering with Philips and a leading Michigan health system on what is expected to become the first permanent installation of the technology in a cardiac catheterization laboratory. These collaborations reflect growing interest in bringing advanced gamma imaging into routine clinical practice and provide a strong commercial foundation for the company’s next stage of growth.

Transforming Lymph Node Surgery Building on its commercial imaging platform, M3D has adapted many of the same core technologies for surgical oncology through the investigational Lympho Cam™. Sentinel lymph node mapping plays a critical role in the surgical treatment of breast cancer, melanoma, and other malignancies. Today, surgeons often rely on gamma probes that detect radiation but provide little visual information, requiring them to localize lymph nodes one point at a time. The Lympho Cam takes a different approach by generating real-time images that clearly show sentinel lymph nodes before dissection begins and throughout the procedure. Recent advances in M3D’s image reconstruction software also dramatically reduce background radiation noise, producing high-resolution images in less than 30 seconds and giving surgeons clearer visualization during procedures.

Growing Clinical Validation Following its first intraoperative cases at the University of Michigan and the University of Pittsburgh Medical Center, the clinical experience of the Lympho Cam has expanded rapidly. Thrity-two patients have now been imaged by 13 surgeons across three hospitals in three states, with each procedure helping refine both the technology and its clinical workflow. With an FDA 510(k) submission imminent, the Lympho Cam has reached another significant milestone toward making advanced intraoperative gamma imaging more broadly available. Continued collaboration with surgeons, medical physicists, and radiation safety professionals remains central to M3D’s product development strategy, ensuring each generation of technology reflects realworld clinical workflows.

Looking Ahead As commercial adoption of the RAVIN CAM continues to grow and the Lympho Cam advances toward commercialization, M3D is demonstrating how a single technology platform can improve patient care across multiple clinical specialties. Reflecting that momentum, M3D recently welcomed three new Michigan-based team members across engineering and commercial leadership as it continues to scale product development, customer support, and commercialization efforts. Rooted in Michigan’s innovation ecosystem and built on decades of imaging expertise, M3D continues to expand the reach of realtime gamma imaging – helping clinicians visualize what was previously difficult to see.

m3dimaging.com

BIOMATTERS ® | FALL 2026

STERILE STATE

Advancing the Future of Medical Device Sterilization SUBMITTED BY STERILE STATE

For decades, the medical device industry has relied on ethylene oxide (EtO) as a primary sterilization method, despite its well-documented drawbacks. EtO is not only a costly and logistically complicated way to sterilize, it also has carcinogenic properties, making it an unnecessarily highrisk form of sterilization. The industry has continued to rely on EtO because no fullscale alternative had successfully combined safety, efficiency, and scalability, until now. Sterile State, a Grand Rapids-based medical technology company, invented the nitric oxide (NO)based sterilization platform that brings sterilization directly into the packaging process, eliminating the need for EtO. By integrating sterilization into the packaging process, the company’s technology will transform how medical devices are manufactured, sterilized, and delivered to healthcare providers.

Sterile State’s Technology Sterile State was founded by Dr. Megan Frost, a Ph.D. chemist with more than two decades of expertise in nitric oxide generation, measurement, and delivery. Motivated to create uses of the technology for many applications, Dr. Frost developed Sterile State 78®. The Sterile State system avoids the toxicological concerns associated with conventional chemical sterilants. Nitric oxide is a molecule naturally produced in the human body and has a onesecond half-life in air. Nitric oxide is nature’s disinfectant. It has been used safely for decades in neonatal intensive care settings to help

MICHBIO | michbio.org

premature infants accelerate lung development. Due to fatal toxicity, no other sterilant would be considered for use in infants’ lungs, but the Sterile State system provides the unusual combination of safety and lethality to bacteria and viruses. Beyond assuring safety, Sterile State’s technology has the potential to reshape medical device manufacturing and supply chain operations. By enabling sterilization to occur within the package, manufacturers can end dependence on third-party sterilization facilities. This ends the current need to transport packaged products to and from sterilization facilities such as EtO or radiation. The Sterile State system thereby shortens the time-to-market for critical medical products. As healthcare systems continue to seek greater efficiency, Sterile State delivers speed, resilience, complete safety, and sustainability.

Michigan Made Grand Rapids was selected for the new Sterile State headquarters due to the region’s unique combination of world-class medical device expertise, leading universities, engineering talent, and collaborative life sciences community. Access to experienced chemists, packaging engineers, and healthcare partners will help the company accelerate commercialization while contributing to Michigan’s expanding biosciences economy. “Grand Rapids offers far more than a place to grow our business, it offers a collaborative, innovation ecosystem where industry, healthcare, and academia work together to solve complex challenges,” said Dr. Megan Frost, founder and CEO

STERILE STATE

As healthcare systems continue to seek greater efficiency, Sterile State delivers speed, resilience, complete safety and sustainability.

of Sterile State. “As we expand in Grand Rapids, we are excited to contribute to Michigan’s leadership in medical technology by developing solutions to improve patient safety around the world.” Since arriving in Grand Rapids, Sterile State has begun building relationships with local hospitals and healthcare organizations to expand the technology’s potential to reduce healthcare-associated infections. As part of Grand Rapids’ growing biotechnology community, Sterile State looks forward to strengthening Michigan’s position as a national leader in medical technology innovation.

Looking to the Future Sterile State is focused on expanding the applications of the Sterile State nitric oxide system across healthcare and beyond. While sterilization of newly manufactured medical devices remains a primary focus, the company is implementing the Sterile State system to create long-lasting antimicrobial bandages, indwelling devices, and food preservation.

Eliminating Ethylene Oxide EtO has long been a method to sterilize new medical devices. This system comes with significant drawbacks. The U.S. Environmental Protection Agency has classified EtO as a known human carcinogen, linked to elevated rates of children developing blood-borne cancers and other cancers, with emissions that linger in the environment around sterilization facilities. Despite these concerns, more than 20 billion medical devices each year continue to be sterilized using EtO. Once FDA-cleared, Sterile State’s approach offers manufacturers a viable alternative to EtO while delivering efficiency, operational flexibility, and safety.

As Sterile State establishes its headquarters in Grand Rapids, the company is advancing a new approach to medical device sterilization – one that has the potential to improve patient safety, simplify manufacturing, and further strengthen Michigan’s growing life sciences ecosystem.

sterilestate.com

BIOMATTERS ® | FALL 2026

BY THE NUMBERS

MICHIGAN A LIFE SCIENCES LEADER MICHIGAN BIO-INDUSTRY QUICK FACTS *

6 /10 th

Bioscience Jobs

47,815* 3,319*

+8%

SINCE 2022

Bioscience +27% Establishments SINCE 2022 Average * Bioscience Salary

$110,204

+8%

SINCE 2022

LARGEST

5 9 th /

BioPharma State by number of establishments / employment

Medical Device State by number of establishments / employment

LARGEST

Agri-Biosciences by number of establishments

LARGEST

Bioscience State by employment

BIOSCIENCE PERFORMANCE METRICS*

$55.8 BILLION In Economic Impact

+24%

SINCE 2022

$1.62 BILLION*

Academic R&D Investment

$991 MILLION*

10th in the U.S.

NIH Investment

+20%

SINCE 2022

*Employment, Establishments and Wages: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW), enhanced by Lightcast (Datarun 2024.3). **Academic R&D Expenditures: National Science Foundation (NSF), Higher Education Research and Development (HERD) Survey. ***Venture Capital: Pitchbook Data, Inc. ****Patents: U.S. Patents & Trademark Office data from Clarivate Analytics’ Derwent Innovation patent analysis database.

MICHBIO | michbio.org

MICHBIO: BY THE NUMBERS

DISTRIBUTION OF MICHIGAN BIOSCIENCES INDUSTRY * 29%

Agri-Biosciences

33%

20%

27%

EMPLOYMENT

MedTech

ESTABLISHMENTS

24%

BioPharma

R&D/Testing

36%

18% 2%

Distribution

DISTRIBUTION OF RESEARCH FUNDS BIOSCIENCE-RELATED VENTURE CAPITAL INVESTMENTS $ MILLIONS, 2019-2023

BIOSCIENCE ACADEMIC R&D $ MILLIONS, FY 2022 Agricultural Sciences Bioengineering and Biomedical Engineering

PHARMACEUTICAL & BIOTECHNOLOGY

$131.10 $55.60 $516.30

Biological and Biomedical Sciences

Natural Resources and Conservation

$37.00

Other Life Sciences

$69.40

Bioinformatics and HealthTech Biological Sampling and Analysis Biopolymers Drugs & Pharmaceuticals Genetic Engineering

Pharmaceuticals Novel Animal Types Novel Plant Types

$192.6

Discovery Tools

$29.1

Pharmaceuticals

$46.7

Drug Delivery

$21.9

Other

$15.3

Healthcare Technology Systems

$468.2

Other Software

$16.3

Other

$233.6

MEDICAL DEVICES & SUPPLIES

Diagnostic Equipment

373 150

Medical Supplies Monitoring Equipment

123 12 519 111 144 408 2 387

$114.6 $7.2 $19.9

Surgical Devices

$37.3

Therapeutic Devices

$99.9

Other

$16.7

BIOBASED PRODUCTS

2,218

Medical and Surgical Devices Microbiology and Enzymes

Drug Discovery

DIGITAL HEALTH

BIOSCIENCE-RELATED PATENTS 2019-2023

Biochemistry

$70.4

$926.50

Health Sciences

Agricultural Chemicals

Biotechnology

Agricultural Chemicals

$0.0

Biofuels and Bio-oils

$2.8

Biopolymers and Other Bioproducts

$9.3

OTHER

Healthcare Distribution

$0.0

Healthcare Lab Services

$20.5

BIOMATTERS ® | FALL 2026

MICHIGAN'S BIO-INDUSTRY Anchored by several large hubs, this representative sample of Michigan life sciences companies illustrates the breadth of the industry footprint.

TR AVERSE CIT Y

MUSKEGON

GRAND RAPIDS

HOLLAND

K AL AMA ZOO

B AT T L E C R E E K / J AC KS O N

MICHBIO | michbio.org

UPPER PENINSULA

MID-MICHIGAN

OAKL AND/MACOMB/ S T. C L A I R

G R E AT E R D E T R O I T

ANN ARBOR

LANSING

BIOMATTERS ® | FALL 2026

AFTER THE

ELEVATOR PITCH

Blue Arbor Technologies is a medical device company devoted to the development of next-generation robotic control systems for people with limb loss. Founded in 2023, Blue Arbor Technologies is a company developing novel neuromuscular interfaces that allow patients with limb loss to intuitively, accurately, and reliably control a prosthetic device with unparalleled degrees of freedom. The company was established by seasoned University of Michigan researchers and is grounded in nearly 20 years of foundational research, over $60 million in research funding, and more than 200 peer-reviewed publications. Blue Arbor Technologies’ flagship product, the RESTORE™ Neuromuscular Interface System, is a first-of-its-kind platform that directly connects advanced prostheses to a patient’s residual muscles and peripheral nerves. The RESTORE™ System is designed to enable independent, simultaneous, and naturalistic control of the fingers, wrist, and elbow to provide unparalleled prosthetic control. In early feasibility human trials, the system has demonstrated stable, high-quality prosthetic control for more than seven years.

MICHBIO | michbio.org

Michigan continues to be a leader in advancing biosciences research and commercialization, thanks to its rich pipeline of intellectual property. A whole new crop of startups are germinating in the state, which is good news for the regional cluster of established companies that are focused on innovation in therapeutics, medical devices, healthcare technologies, clinical diagnostics and agri-/industrial biotechnology.

Surgeons at the Medical University of Vienna have now implanted two patients with the RESTORE™ System. Within days, the patients were able to demonstrate functional use of the system with a state-of-the-art prosthetic – highlighting both the intuitiveness of the interface and the efficiency of its integration. The company’s momentum as a disruptor in the field of prosthetics continues to accelerate. In 2026, Blue Arbor Technologies announced a strategic partnership with Ottobock, the global leader in prosthetic devices. This collaboration was anchored by a $5 million investment from Ottobock, who served as lead investor to kick off Blue Arbor’s Series A round of financing. Additionally, the RESTORE™ System received FDA Breakthrough Device Designation and has been accepted into the FDA’s Total Product Life Cycle Advisory Program. Both achievements will streamline market approval and widespread commercialization.

bluearbortech.com

Gripping Gloves is developing a family of grip assist “exoglove” devices aimed at reducing fatigue and overuse injuries in workers who spend hours each shift holding tools, materials, or controls. Our near-term focus is on occupational prevention in highrisk environments such as meat processing and automotive manufacturing, where repetitive, forceful grasping contributes to cumulative trauma disorders, lost time injuries, and rising ergonomic costs. Building on patented self tensioning, releasable gripping glove technology, the current design concept provides mechanical assistance that helps workers maintain a secure grasp with less sustained effort, while allowing them to deliberately release and reposition objects as tasks change. By offloading a portion of the grip demand to the device, the exoglove aims to support safer long-duration gripping

Signal Bioscience is an Ann Arbor based life science tools company in the molecular diagnostics space. The company is developing chemistries to dramatically increase multiplexing in existing PCR instruments. PCR (polymerase chain reaction) is a dominant method in molecular biology research and diagnostics, with more than 300,000 instruments installed globally; yet this method is typically limited by the five to six spectral channels available. Signal is developing drop-in chemistry solutions to enable 20 to 30 targets in a single reaction on the existing instrument installed base. This increased functionality opens new applications in infectious disease, oncology, and research while allowing laboratories to maximize capabilities of their existing equipment. The company is pursuing an early partnering model with this enabling technology and is engaged with a leading global PCR instrument manufacturer to demonstrate high multiplexing for infectious disease applications, a multi-

tasks – such as butchering, material handling, and line work – without motors, batteries, or complex electronics. Our development roadmap starts with industrial prototypes tailored to specific job roles, user tested in collaboration with ergonomists and safety professionals to quantify effects on fatigue, performance, and risk of repetitive motion injury. As we validate the core occupational platform and build field data, we plan to extend the technology to medical applications, adapting features to support selected patient populations where preserving or augmenting functional grasp could meaningfully improve daily activities. Gripping Gloves’ long term vision is to bridge industrial ergonomics and clinical rehabilitation with practical, wearable grip assistance that can be deployed both on the factory floor and, in time, in patient care settings.

grippinggloves.com

billion-dollar segment in molecular diagnostics. PCR is a gold standard method for rapidly diagnosing pathogens and providing information about how to best treat disease. Adding more targets to a test allows physicians to more precisely identify and treat pathogens in respiratory diseases, gastrointestinal diseases, and sexually transmitted diseases, among others. Signal Bioscience is led by an experienced team with a strong track record of building successful life science companies. CEO John Cunningham previously founded RapidBio and served as COO of Functional Fluidics, a Wayne State University spin out. The company’s co-founder and CSO, Dr. Vladimir Makarov, was co-founder of Rubicon Genomics and Swift Bioscience, both of which were successfully acquired. Building on Michigan’s legacy of molecular biology innovation, Signal Bioscience aims to advance the next generation of molecular diagnostics from Ann Arbor.

signalbioscience.com

BIOMATTERS ® | FALL 2026

Drug-induced liver injury (DILI) is a leading reason promising drugs fail in the clinic – after years of work and hundreds of millions invested. Torch Bio is the screening partner built to catch it earlier. A University of Michigan spinout, Torch Bio runs highcontent phenotypic screens in human liver organoids, including lines derived from patients who experienced liver injury. Built from these patients’ cells, the organoids reproduce complex human liver biology and reveal toxicity that animal models and standard cell assays often miss. We have profiled over 5,000 compounds across three patientderived lines on a suite of Yokogawa confocal systems (the CV8000, CQ1, and CQ3000), capturing over 500,000 images and characterizing more than a billion cells. That reference dataset sets us apart: we screen your compounds in the same models and interpret their responses against thousands already characterized, flagging liver-toxicity signals before they reach the clinic.

The same engine reaches well beyond the liver. We design and run custom phenotypic assays across iPSC-derived models, 2D monolayers, and co-culture systems, supporting disease-model efficacy screening and mechanism-of-action profiling. Assay design and image analysis are where we add the most value. Whether you need an assay developed, a screen run, or images analyzed, Torch Bio becomes a turnkey extension of your team. With the FDA Modernization Act 2.0 and the push to reduce animal testing, demand for human-relevant screening is accelerating. Torch Bio delivers it today. Specialized DILI screening. Custom phenotypic assays. Expert image analysis. To put them to work in your pipeline, contact us at admin@torch-bio.com.

torch-bio.com Image: Confocal image of dispersed human liver organoid culture in high-content screening format. Cells are stained for nuclei (cyan), ER/Golgi (green) and cytoskeleton (magenta).

Nurturing our world and humankind by advancing care for animals.

Visit www.zoetis.com to learn more

MICHBIO | michbio.org

CONSULTANTS TO MEET

CONSULTANTS TO MEET BY ROBERT S. DONOFRIO MS, PHD, PRINCIPLE CONSULTANT, FOUNDER AND CEO AT BIOSCOPE INNOVATIONS LLC

BioScope Innovations LLC is a Michiganbased consultancy that helps life science, food safety, and diagnostics companies turn early-stage science into commercially viable products. Through his work at BioScope, Dr. Donofrio partners with startups and established organizations on R&D strategy, regulatory pathway navigation (USDA, FDA, EPA, AOAC, ISO), lab and operational audits, IP evaluation, product and assay development, and go-to-market planning, from prototype through commercial launch. Dr. Donofrio’s approach is shaped by 25-plus years of experience leading global R&D in food safety diagnostics and industrial microbiology. As Chief Science Officer at Neogen Corporation, he led global R&D across food safety diagnostics, genomics, biosecurity, and instrumentation, building an innovation culture and guiding scientific integration through numerous acquisitions. Earlier, he directed NSF International’s Applied Research Center and Microbiology Department, building testing capabilities and accreditation programs across food, water, and health markets. He currently serves as Chief Life Sciences Officer at HyperSpectral, leading scientific strategy for a spectral AI/ML diagnostics platform, and as CEO of Taza Aya, commercializing a nonthermal plasma wearable PPE technology born at the University of Michigan. As Mentor in Residence with MSU’s Spartan Innovations, he guides faculty and researchers from lab discovery to fundable ventures.

Dr. Donofrio holds a Ph.D. from Michigan Technological University, an M.S. from Duquesne University, and a B.S. from the University of Dayton. He is President of the Society for Industrial Microbiology and Biotechnology and a longtime MichBio board member.

Whether you’re a founder navigating your first regulatory submission or a company scaling toward commercialization, BioScope Innovations helps translate scientific promise into market-ready reality. bioscopeinnovations.com

Breakthroughs that change patients’ lives

BIOMATTERS ® | FALL 2026

PLIANT MEDICAL

Early Collaboration and Cleanroom Precision Shape Manufacturing Approach SUBMITTED BY PLIANT MEDICAL

Combining early engineering collaboration, cleanroom manufacturing, and crossfunctional expertise to support the path from concept to commercialization. As the medical device industry evolves, manufacturers face increasing pressure to accelerate development while meeting rigorous quality and regulatory expectations. As a result, manufacturing partners are becoming earlier collaborators in the development process. Pliant Medical, based in Spring Lake, Michigan, reflects this evolution through an approach centered on early engineering engagement, ISO Class 7 cleanroom manufacturing, and coordinated technical expertise. Pliant Medical was established to focus exclusively on medical applications, emerging from the foundation of Pliant Plastics and its decades of precision manufacturing experience. Central to its approach is a guiding principle the company refers to as the Journey of a Lifeline – an acknowledgment that the components it produces may ultimately be used in life-critical medical applications. That perspective shapes how programs are developed, how manufacturing processes are controlled, and how collaboration with customers is structured across the product lifecycle. While Pliant Medical is a dedicated medical manufacturing division, it is built on decades of experience in precision injection molding. Backed by Pliant Plastics, which has served the medical industry for more than 30 years, the team has developed long-

standing partnerships with global medical leaders like Stryker and Thermo Fisher, as well as emerging innovators bringing new technologies to market. That experience provides a strong foundation for supporting customers from early development through scalable production. A distinguishing aspect of Pliant Medical’s model is its emphasis on early-stage collaboration. By engaging during concept development rather than at production handoff, the company works with customers to evaluate designs through a manufacturability lens. Its engineering team conducts design for manufacturability (DFM) assessments to identify potential risks, improve part performance, and align designs with scalable production strategies. This approach helps reduce latestage design changes and supports a more efficient path to commercialization. Cross-functional collaboration supports every program. Account managers, engineers, tooling specialists, and quality teams work together from early engagement through production, providing continuity and responsive technical support. Pliant Medical operates three ISO Class 7 cleanrooms dedicated to medical production. Two cleanrooms support injection molding, while a third is dedicated to assembly, providing controlled environments throughout the manufacturing process, from molding through finished product.

“Early engagement is where manufacturability – and ultimately successful commercialization – takes shape.” 22

MICHBIO | michbio.org

PLIANT MEDICAL

“Pliant Medical is a full-service partner that truly understands what it takes to bring medical technology to market. Their exceptional engineering engagement and cleanroom contract manufacturing capabilities provided the structural backbone Veracron needed to commercialize the VERABAND™. They have seamlessly bridged the gap between our vision and a scalable, market-ready medical device.” – Grant Kruger, CEO & Founder, Veracron Wellness Systems

Within these controlled settings, Pliant Medical produces precision components for a range of applications, medical devices, biotechnology applications, diagnostic technologies, medical equipment, disposables, and medical-grade packaging. Its capabilities extend beyond molding to include laser welding, ultrasonic welding, electronic testing, and packaging. Integrating these processes within a single controlled environment allows for greater production continuity while supporting traceability and overall quality management. As regulatory expectations continue to evolve, structured quality systems remain integral to medical manufacturing. Pliant Medical holds MedAccred accreditation for plastic injection molding, reflecting conformance to industry-defined process and quality criteria. The company also maintains ISO 9001:2015 and ISO 14001:2015 certifications and is progressing toward ISO 13485 certification, with completion anticipated in the fourth quarter of 2026. Together, these frameworks support disciplined manufacturing and continuous improvement. The company’s approach can be seen in its work with a Michigan-based startup, Veracron Wellness Systems, developing an activity-tracking wearable device. Following an introduction at an industry trade show, Pliant Medical engaged early in the program, supporting design refinement, tooling development, and production planning. The team implemented injection molding and advanced joining processes to manufacture key components and was subsequently selected to provide contract manufacturing services. Production is currently ramping, with demand expected to scale over the next two years – illustrating how early engineering involvement and integrated manufacturing can support a more efficient path to commercialization.

As medical device companies continue to evaluate how and when to engage manufacturing partners, models that emphasize early collaboration, integrated capabilities, and controlled production environments are becoming increasingly relevant. Pliant Medical’s approach reflects these priorities, combining engineering involvement, cleanroom manufacturing, and coordinated team execution within a single organizational structure. As medical technologies continue to advance, manufacturers increasingly need partners who can engage early, scale confidently, and execute with precision.

By combining engineering collaboration, cleanroom manufacturing, and integrated production capabilities, Pliant Medical helps customers navigate the journey from concept to commercialization – recognizing that every component produced may ultimately become part of someone’s lifeline.

pliantmedical.com BIOMATTERS ® | FALL 2026

NORTHERNBIO

Better Lives Begin Here SUBMITTED BY NORTHERNBIO

NorthernBio Expands Its Capacity for the Biosciences Community A new, purpose-built Muskegon facility gives the 30-year-old preclinical research company and the sponsors it serves far more room to grow. Long before a novel therapeutic reaches human trials, it faces its most critical test: proving efficacy in early discovery and delivering ironclad safety data for IND regulatory filing. For over three decades, NorthernBio has guided biopharma sponsors through that high-stakes boundary. The preclinical CRO supports programs from early non-GLP proof-of-concept through rigorous, regulatory-ready GLP safety studies. By combining deep expertise in targeted drug delivery, molecular biology, and bioanalysis with advanced surgical procedures, NorthernBio works in close, transparent collaboration with sponsors worldwide to maximize therapeutic impact for devastating diseases.

Scaling Capacity to Accelerate Development In 2025, the company made its biggest investment yet: a new, purpose-built facility to expand its specialized preclinical research services, including in vivo nonGLP and GLP safety assessments and bioanalysis, to support regulatory approval of novel therapeutics.

MICHBIO | michbio.org

Serving as NorthernBio’s corporate headquarters, the new 125,000-square-foot facility was designed from the ground up to mirror clinical procedures. Equipped with 22 animal rooms, two dedicated surgical suites, a necropsy suite, and an on-site MRI, it allows programs to flow seamlessly from surgery to imaging to sample analysis – keeping the entire workflow in-house to save sponsors critical time. The buildout also created more than 50 new positions across research, surgery, and veterinary care. The expanded footprint dramatically increases NorthernBio’s scientific throughput. With total capacity scaling to over 2,500 rodents, 800 non-human primates, 200 canines, 150 swine, and additional rabbit and sheep space, the facility strengthens the broader preclinical infrastructure – giving device, cell, and gene therapy developers a high-capacity partner.

Deep Expertise in Key Therapeutic Areas In neuroscience, capabilities include support for specialized delivery routes such as intracerebroventricular, intrathecal, and intracisternal administration. Custom MRI-compatible stereotaxic frames and a Philips 3T MRI confirm precise placement, underpinning today’s advanced gene therapy and neurotherapeutic programs. In ophthalmology, NorthernBio specialists provide a comprehensive range of targeted ocular delivery routes – including intravitreal, subretinal, and suprachoroidal administration – supported by advanced ocular imaging and electrophysiology to evaluate novel treatments for blinding eye diseases.

NORTHERNBIO

In cardiovascular research, dedicated surgical and interventional teams establish disease models such as myocardial infarction, heart failure, and peripheral artery disease across large-animal species to evaluate novel therapeutics, cell and gene therapies, and medical devices.

Proven Scientific Leadership and Regulatory Excellence Decades of specialized experience power every study NorthernBio executes. The study director team brings a combined 50-plus years of GLP study design experience. The surgical team brings more than 60 years of combined targeted-delivery expertise. And a dedicated quality assurance group operates under FDA GLP, AAALAC accreditation, USDA registration, OLAW assurance, and DEA licensing. NorthernBio also maintains an explicit commitment to the 3Rs (replacement, reduction, and refinement) in how it designs and conducts animal studies. This principle sits at the core of scientific integrity.

Regional Footprint and Specialized Facilities Beyond the new headquarters, NorthernBio maintains specialized sites in Norton Shores and Portage to support distinct phases of preclinical drug discovery and safety assessment. The Norton Shores facility focuses on rodent-based studies with specialized surgical suites and dedicated ocular research infrastructure, giving sponsors direct access to a comprehensive, multi-species research network.

Advanced Bioanalytical Capabilities Complementing in vivo operations, NorthernBio’s Portage facility houses a dedicated bioanalytical team that delivers essential lab testing to move therapeutics toward IND filing. The site specializes in high-sensitivity assay development, validation, and sample analysis supporting pharmacokinetics (PK), biodistribution, biomarker evaluation, and immunogenicity. By maintaining tight integration between in vivo sampling and bioanalytical processing, the team helps cell and gene therapy sponsors evaluate tissue tropism, viral vector clearance, and immune response with rapid turnaround times.

With expanded capacity, advanced delivery capabilities, and an integrated multi-site network, NorthernBio reinforces its position as a trusted preclinical research partner for biopharma sponsors worldwide. For teams navigating the high-stakes journey toward regulatory approval, NorthernBio delivers the technical precision, scale, and collaborative approach needed to transform complex science into viable human therapies.

northernbiolab.com

BIOMATTERS ® | FALL 2026

OXFORD BIOMEDICAL RESEARCH

Over 40 Years of Superior Science SUBMITTED BY OXFORD BIOMEDICAL RESEARCH

Oxford Biomedical Research has been a local leader in immunoassays and biomedical reagents in Michigan for over 40 years. Over the decades, we have developed a diverse portfolio of over 800 products as well as performed contract research, assay services, and contract manufacturing for many companies and institutions in the state and across the globe. Located in Rochester Hills, Michigan, Oxford Biomedical Research was started by Oakland University Professor Dr. Denis Callewaert in 1984 as a way to bring local scientists’ ideas into reality. Using the latest technology, we have worked with many scientists and professors to finalize their ideas into marketable products for other life sciences researchers. We have since continued this legacy, working with scientists both locally and internationally to bring immunoassays to a global market through our diverse distribution network. Our contract manufacturing services are mutually beneficial by design. We have aided many research scientists in bringing their developed research tools to fruition as fully realized product ready to ship globally. Developing manufacturing protocols, optimizing assays, scaling up component production, designing packaging, writing instructions, and maintaining strict quality control methods are just some of the areas in which we excel.

More than Oxidative Stress Known for oxidative stress and chronic inflammation research tools for decades, like our Isoprostane and Urinary Isoprostane immunoassays, Oxford has also branched out to provide reagents for many other fields. Most recently, we are now offering products to researchers in the drug metabolism, drug discovery, and NETosis fields.

MICHBIO | michbio.org

CypExpress™, a novel Cytochrome-P450 system grown in yeast is available in many common isoforms Our CYP Express™ product line has been of interest to many pharmaceutical companies and Universities for its stability and selfcontained NADPH recycling mechanism Glutathione S-Transferases, full complement of recombinant human cytosolic GSTs and a selection from other species including murine, canine, and bovine Additionally, we have monoclonal and polyclonal antibodies for a number of isoforms that have been validated for IHC, Western Blotting and ELISA development NETosis reagents like citrullinated core histones and fibrinogen An interesting cell death mechanism in which neutrophils release chromatin modified with proteins to help trap and kill pathogens is an emerging research field Therapeutic Antibody Assays for IgG1 and IgG4 These assays provide quantification of human recombinant therapeutic antibodies, an emerging drug category, without species cross reactivity from common primate testing species

OXFORD BIOMEDICAL RESEARCH

Our experienced team of scientists supports customers from the beginning to ensure they get the most out of their sample testing using our assay kits Reliable Results from Our Lab to Yours

Fostering STEM in Oakland County

We have also supported many research studies through our assay services team, using our own assays to test biological samples for researchers. This is especially helpful for teams that may lack the equipment, facilities, or time to learn a new assay for their studies. Our experienced team of scientists supports customers from the beginning to ensure they get the most out of their sample testing using our assay kits for Isoprostane, Cortisol, Creatinine, and more. Assay services are customizable for a variety of sample matrices, analytes, and data analysis. Contact us at info@oxfordbiomed.com for a quote or more information!

Through the years, we have maintained our connection with nearby Oakland University. Our staff members have been guest speakers for multiple student organizations, discussing careers in industry and Michigan’s life science ecosystem with students. We have also worked with student organizations and faculty to recruit and provide internships during the summer and the school year to interested students, providing them lab experience and sharing knowledge in our fields of expertise.

Providing the same product quality and expertise outside of the life sciences, our sister company, Oxford Laboratories, specializes in veterinary diagnostic products. Our canine thyroglobulin autoantibody immunoassay has been providing veterinarians with a reliable test for canine autoimmune thyroiditis in all breeds of dogs for over 30 years.

We also support STEM education locally and foster a love of science through outreach programs. We have partnered with the biomedical pathways program of a local high school to allow for long-term shadowing opportunities for students interested in science and medical careers.

These high school students have learned hands-on lab skills and gained industry experience from our laboratory technicians. We feel it is critical to foster STEM-minded students of all ages in Michigan to continue the growth and strength of the science industry in our state.

oxfordbiomed.com

BIOMATTERS ® | FALL 2026

TRANSFORMING RESEARCH INTO REAL-WORLD IMPACT Wayne State University's Office of Technology Commercialization partners with innovators, entrepreneurs, and industry to move breakthrough discoveries through laboratories and into the commercial marketplace.

LOOKING FOR YOUR NEXT INNOVATION? techtransfer.wayne.edu

WHERE MICHIGAN'S NE X T BRE AK T HROUGH BEGINS. 28

MICHBIO | michbio.org

Dykema......................................................................................2 BIO/MichBio.........................................................................IBC MEDC..................................................................................... IFC MichBio Preferred Purchasing Program.............................4 Pfizer........................................................................................21 Stryker.......................................................................................2 University of Michigan............................................................2 VWR............................................................................................4 Wayne State............................................................................28 Zoetis.......................................................................................20

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BioMatters® Fall 2026