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Item 1. Business

2025-03-07 compared with 2024-03-08 · 95 added, 145 removed, 435 unchanged (36% of the section changed)

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Company Overview

We have developed an innovative suite of purpose-built handheld and desktop devices for the point-of-need chemical and biochemical analysis.

Leveraging our proprietary mass spectrometry, or Mass Spec, microfluidics, and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.

Our devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in life sciences research, bioprocessing, pharma/biopharma, forensics and adjacent markets.

The term “products” or “devices” used in this “Business” section each refer to the MX908, Rebel, ZipChip Interface, Maverick, and Maven and related sampling devices.

We have developed an innovative suite of purpose-built handheld and desktop devices for point-of-need chemical analysis.

Leveraging mass spectrometry, or Mass Spec, and optical spectroscopy, microfluidics, and analytics and machine learning technologies, we make devices that are significantly smaller and more accessible than conventional laboratory instruments.

Our devices are used at the point-of-need to interrogate unknown and invisible materials and provide quick, actionable answers to directly address some of the most critical problems in forensics, bioprocessing, pharma/biopharma, life science research and adjacent markets.

The term “products” or “devices” used in this “Business” section each refer to the MX908, ThreatID, ProtectIR, XplorIR, Rebel, ZipChip Interface, Maverick, and Maven and related sampling devices.

We create simplified measurement devices that our customers can use as accurate tools where-and-when their work needs to be done, rather than overly complex and centralized analytical instrumentation.

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These landmark proprietary advances have enabled the first truly handheld Mass Spec devices and compact desktops.

With our acquisition of CAM2 Technologies, LLC (d/b/a RedWave Technology), or RedWave, in April 2024, we obtained FTIR (Fourier Transform Infrared), an optical spectroscopy technology, that identifies and characterizes a broad range of sample types, including liquids, solids and gases.

FTIR complements Mass Spec as FTIR is highly regarded for its chemical identification of bulk materials while Mass Spec provides unparalleled detection and identification of trace chemical substances.

Sample preparation and separation can be a painfully slow hours-long process, and we have invested heavily in the development of microfluidic sample preparation and microscale separation technologies to reduce preparation and separation time from hours to minutes.

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Introduced in 2023, Maverick offers bioprocess scientists easy-to-integrate in-line analysis and control without the need for substantial expert configuration or setup.

We fundamentally believe that the technology platform we have built and the investments we are making will allow people to answer chemical and biochemical questions in times and places that were previously inconceivable.

We fundamentally believe that the technology platform we have built and the investments we are making will allow people to answer chemical questions in times and places that were previously inconceivable.

Given the market opportunity, we expect to face substantial competition from large established manufacturers of laboratory-based instruments and from new entrants;

however, our proprietary advances have enabled us to manufacture the first truly handheld Mass Spec devices and compact desktops and we believe we are well-positioned to face future competition.

We believe our technology platform can expand in future opportunities far beyond the conventional central laboratory market for Mass Spec and associated front-end separations.

We estimate our total addressable market, or TAM, for our devices was $5.7 billion in 2022 and is growing to an estimated $27 billion by 2027.

The TAM for our handhelds was estimated to be $1.3 billion in 2022 with expansion to over $3.9 billion with software application extensions for GxP cleaning validation, and other related quality control assays by 2027.

Our desktop devices supporting bioprocess development represented an estimated TAM of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy by 2027.

We see additional opportunity to service the estimated TAM of $3.6 billion in 2022 across the research chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into complex metabolomics and proteomics by 2027.

Our estimates of our TAM are based on potential customer research and development spending, addressable aspects of potential customers’ end product development process, and potential platform usage.

We also utilize estimated penetration and placement rates for our platform with potential customers in our target markets and historical patterns for consumables usage.

Our Strengths

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We have developed a proprietary Mass Spec platform and approach that allow us to move the capabilities of conventional Mass Spec beyond the central laboratory.

Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce significantly smaller, purpose-built Mass Spec devices that are better suited for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.

Our proprietary High-Pressure Mass Spec, or HPMS, technology enables us to produce

significantly smaller, purpose-built Mass Spec devices that are better suited for use in point-of-need settings, in contrast to conventional mainframe Mass Spec solutions.

The combination of HPMS, our proprietary microfluidic sampling and separation technology, and our data analytics, and machine-learning technology provides the foundations of an adaptable platform that can serve a growing number of new and adjacent applications and markets.

● Point-of-need technologies disrupting Mass Spec and creating new product categories .

Leveraging our Mass Spec platform, we have developed a portfolio of desktop and handheld devices that are reinventing the Mass Spec industry by accessing a variety of point-of-need market segments that were historically considered impossible for conventional Mass Spec manufacturers.

Our products are small, purpose-built devices that avoid the typical size and complexity issues related to conventional Mass Spec while also offering real-time, actionable answers to new classes of users.

As we continue to expand the capabilities of our Mass Spec platform, we believe our devices will continue to penetrate new and adjacent opportunities in life sciences, quality assurance and control, diagnostics and applied markets.

● Point-of-need technologies disrupting conventional lab-based chemical analysis .

Leveraging our technology platform, we have developed a portfolio of desktop and handheld devices that are reinventing how and where lab-grade chemical analysis is conducted by accessing a variety of point-of-need market segments that were historically considered impossible.

Our products are small, purpose-built devices that avoid the typical size and complexity issues related to conventional analytical laboratory instruments while also offering real-time, actionable answers to new classes of users.

As we continue to expand the capabilities of our technology platform, we believe our devices will continue to penetrate new and adjacent applications and markets.

● Highly attractive business model validated by rapidly growing installed base of devices.

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Our Growth Strategy

We are making chemical and biochemical analysis simple, smart and speedy by incorporating our microscale Mass Spec, microfluidics, and analytics and machine learning technology platform into handheld and desktop devices that provide users with robust answers at the point of need.

We are making chemical analysis simple, smart and speedy by incorporating our microscale Mass Spec, optical spectroscopy, microfluidics, and analytics and machine learning technology platform into handheld and desktop devices that provide users with robust answers at the point of need.

Our growth strategy includes the following key elements:

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As an example, for our handheld device, it is typical for government organizations to conduct a one week or longer trial prior to purchase to test our technology in their real-world setting.

A trial generally results in budgeting for a pilot that can range in size from ten to more than 50 units.

A trial generally results in budgeting for

a pilot that can range in size from ten to more than 50 units.

During the pilot, we support our customers closely to ensure their success.

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We have already incorporated a number of customer-driven assays into both MX908 and Rebel and will continue to do so as we believe this will provide us with an expanding list of new point-of-need applications and market opportunities within forensics, life sciences research, bioprocessing, quality assurance/quality control and synthetic biology.

In addition, we continue to

make advancements in our core technologies to drive the evolution of our product portfolio beyond current applications and needs to enter new markets.

In addition, we continue to make advancements in our core technologies to drive the evolution of our product portfolio beyond current applications and needs to enter new markets.

Our Technology

Our Technology Platform

We have developed a core technology platform designed to bring Mass Spec out of the confines of central laboratories and to the point-of-need with high-fidelity handheld and desktop devices.

We have developed a core technology platform designed to bring Mass Spec and optical spectroscopy out of the confines of central laboratories and to the point-of-need with high-fidelity handheld and desktop devices.

We believe that providing simple, smart, and speedy devices that provide robust answers when and where people need them gives rise to:

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These results are possible as our handheld and desktop devices are designed for extreme convenience and speed, requiring minimal training and maintenance.

Our platform is centered around using proprietary microscale Mass Spec and microfluidic technologies to prepare, separate, and characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, purity, and quantity.

Our platform is centered around using proprietary microscale Mass Spec, optical spectroscopy, and microfluidic technologies to prepare, separate, and characterize species at the molecular level, with integrated machine learning and analytics to automatically provide answers regarding identity, purity, and quantity.

The core elements of our technology platform include:

● Our High-Pressure Mass Spec, or HPMS, approach, which enables Mass Spec at the point-of-need;

● microfluidics enable convenient sample preparations, fast separations, and aseptic sampling;

● Complementary analytical technologies, including Mass Spec and optical spectroscopy, purpose built for point-of-need applications;

● Microfluidics, which enable convenient sample preparations, fast separations, and aseptic sampling;

● Analytics and machine learning technology, which provides actionable answers versus raw data.

HPMS Approach Enables Mass Spec at the Point-of-Need

Analytical Technology Platform for Chemical Analysis at the Point-of-Need

Mass Spec is the gold-standard analytical technique for molecular analysis.

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The flexibility afforded by our approach provides access to existing and new market segments that were previously inconceivable for conventional Mass Spec instruments.

We added FTIR to our technology platform through the acquisition of RedWave in April 2024.

FTIR, an optical spectroscopy technology, measures the chemical composition of a sample.

The spectral data is acquired using an interferometer detecting all wavelengths simultaneously, which results in fast acquisition times and very high signal-to-noise ratios.

FTIR is an established analytical technology for chemical analysis of solids, liquids and gases.

It is highly regarded for its specific substance identification abilities across a broad range of bulk materials.

Our FTIR portfolio consists of purpose-built handheld devices that can rapidly identify tens of thousands of bulk chemical substances at the point-of-need.

This technology can measure unknown powders and liquids using an attenuated total reflectance interface, and gases using absorption across a gas cell.

We believe the insights and answers our devices provide will accelerate workflows, reduce costs and offer transformational opportunities for our end users.

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Control/optimization:

Conventional Mass Spec configuration and tuning is highly complex.

Our devices need to manage themselves autonomously for maximum value to the customer.

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Several examples of these elements are highlighted below in the “Our Products” section.

We were founded on a vision to deliver high quality Mass Spec to a broad set of users at the point-of-need.

We were founded on a vision to deliver high quality chemical analysis to a broad set of users at the point-of-need.

We offer handheld and desktop devices, each of which are capable of providing quick, high-fidelity and actionable results.

These aspects are important to our customers, who previously have had to choose between a slow and thorough analysis by Mass Spec in a laboratory or a point-of-need result that may have been more timely, but provided only a partial measurement picture prone to false-positives.

For instance, forensics customers who do not have access to laboratory-based Mass Spec instruments have at best had access to the field techniques of Ion-mobility spectrometry and Raman/FTIR spectroscopy, each with its own limitation of specificity (ability to distinguish one chemical from another) and sensitivity (ability to detect minute amounts), respectively.

Our bioprocess customers have likewise only had access to a cropped measurement picture by largely relying on simple enzymatic and electrochemical sensors that can measure just a few simple gases and other analytes with poor accuracy.

These aspects are important to our customers, who previously have had to wait days or even weeks for a thorough analysis conducted in a laboratory.

Our devices are changing this paradigm and providing laboratory-like results at the point-of-need.

The 908 Devices suite of devices includes (from left to right):

MX908, ZipChip, Rebel, Maven and Maverick.

The 908 Devices product suite includes (from left to right):

Maverick, ThreatID, XplorIR, Rebel, ProtectIR, Maven, ZipChip, and MX908.

Handheld Devices

Launched in June 2017, MX908 is a handheld, battery-powered, Mass Spec device designed for rapid analysis of solid, liquid, vapor and aerosol materials of unknown identity.

It is an agile, multi-purpose device utilized by a wide spectrum of user segments for a variety of forensic field applications such as chemical, explosive, priority drug and HazMat operations, detecting materials at the trace level.

We have sold 2,422 MX908s into every U.S.

We have sold more than 2,800 MX908s into every U.S.

state, in 63 countries and across five continents.

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Since introducing the MX908, we have continued to expand the device’s capability through mission add-ons such as offering an Aerosol Module accessory to detect and identify aerosolized chemical hazards, adding targets to allow responders to identify additional priority drug substances, and providing a Bluetooth capability that enables seamless data transfer and accelerates support in the field.

We recently added the MX908 Beacon accessory, which is a remote area monitoring system secured in a rugged case that can detect and identify aerosolized and vapor threats.

We also offer the MX908 Beacon accessory, which is a remote area monitoring system secured in a rugged case that can detect and identify aerosolized and vapor threats.

The MX908 Beacon accessory leverages the MX908 and Aerosol Module combined with a cloud-based solution to enable remote identification of toxic chemical hazards.

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We have a roadmap to continue to expand the MX908’s mission add-ons to support the detection of adulterated and counterfeit pharmaceuticals and to develop applications in quality control and quality assurance, including GxP cleaning validation.

XplorIR and InterceptIR

The XplorIR is a handheld device that uses FTIR spectroscopy to identify, quantify and track gases and vapors.

The device can rapidly detect and identify 5,600+ unknown gas and vapor chemical hazards in seconds and quantify nearly 5,000 airborne chemicals in under a minute.

It then continually monitors and updates chemical composition every four seconds.

The XplorIR can automatically and accurately identify multiple components simultaneously at the part-per-million level.

Once detected, the XplorIR continually monitors and updates chemical composition every four seconds.

The XplorIR provides mission-critical information for fire departments, HAZMAT teams and other first responders, enabling them to make swift decisions around remediation efforts and to ensure public safety.

The InterceptIR device is integrated onto a variety of robotic platforms, including robotic canines, wheeled vehicles and unmanned autonomous vehicles and drones.

The device rapidly detects and identifies 5,600+ gas and vapor chemical hazards.

It is used primarily to screen large areas and inaccessible spaces.

The ThreatID is a portable FTIR device that rapidly detects and identifies 28,000+ unknown gas, vapor, powder and liquid chemical hazards.

The device can seamlessly transition from gas/vapor sampling to powder and liquid sampling in seconds, with no tools required.

The ThreatID is designed to be easily operated and no alignment, calibration or configuration is required.

The rugged diamond attenuated total reflection (“ATR”) sample interfaces provide reliable measurement in harsh environments.

The device’s interactive, on-screen prompts guide emergency and military responders through the sampling process.

Once samples have been collected, and a Wi-Fi connection is established, the results can be uploaded to our Team Leader mobile app for remote personnel to assist in making rapid, informed decisions based on a clear understanding of the chemical hazards.

The ProtectIR is a handheld FTIR device that can identify 23,000+ solid and liquid chemical hazards.

The device is compact, lightweight and rugged as it is specifically designed for field use.

ProtectIR enables hazmat response teams, military, and first responders to analyze bulk substances in seconds and requires with minimal user inputs.

Desktop Devices

The Rebel is a small desktop analyzer providing real-time information on the extracellular environment in bioprocesses.

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Food and Drug Administration, or FDA, and other regulatory guidelines regarding biological and pharmaceutical product quality, or GxP environments, to evaluate fresh media for conformity to standards, track the extracellular environment and metabolic flux during growth cycles, monitor performance during stress experiments, and characterize spent media.

Since the launch of the Rebel in November 2019, we have sold 165 units and 52 of those units have been placed with the top-20 pharmaceutical companies by revenue and 25 organizations have purchased multiple units.

Since the launch of the Rebel in November 2019, we have sold more than 170 units and 55 of those units have been placed with the top-20 pharmaceutical companies by revenue and 27 organizations have purchased multiple units.

Our focus has been on increasing U.S.

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The markets for cellular-derived products include therapeutics, including cell therapy and personalized medicine, new and sustainable foods and beverages, and industrial materials.

Many of these products, such as protein-based therapeutics, can only be economically produced by cells in a bioreactor.

Many of these products, such as protein-based

therapeutics, can only be economically produced by cells in a bioreactor.

Making these products in an efficient and reproducible way remains a challenge to our customers in bioprocessing.

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Maven and Trace C2

The Maven, launched in January 2023, to complement our Mass Spec technology, is our first on-line device for bioprocess monitoring and control.

Maven is our first on-line device for bioprocess monitoring and control.

Connecting directly to a single bioreactor, Maven provides real-time continuous monitoring and control of glucose and lactate in cell culture and fermentation processes.

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This is especially beneficial in cell therapy applications where tight control of cell culture conditions is vital.

Since the launch of Maven in January 2023, we have sold more than 50 devices to global pharmaceutical organizations and to collaboration partners.

In addition to providing real-time measurements, Maven comes with integrated proportional-integral-derivative, or PID, and on/off controllers that enable out-of-the-box feeding automation.

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With ZipChip, researchers can switch applications in minutes, instead of hours typical with an alternative such as liquid chromatography.

Since launch of the ZipChip platform in March 2016, we have sold 234 ZipChip Interfaces and have established 28 multi-unit accounts in leading, global pharmaceutical organizations and academic institutions.

Since launch of the ZipChip platform in March 2016, we have sold more than 245 ZipChip Interfaces and have established 28 multi-unit accounts in leading, global pharmaceutical organizations and academic institutions.

Our ZipChip platform is compatible with market-leading conventional Mass Spec instruments found in laboratories worldwide.

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Consumables and Services

Handheld Device

Our MX908 comes with a standard warranty for up to one year from purchase.

Handheld Devices

Our MX908 and FTIR devices come with a standard warranty for up to one year from purchase.

Our customers also can purchase extended warranty service plans, which include hardware repair and replacement coverage, technical support, and software updates.

We designed the MX908 to be intuitive and easy-to-use, as it is critical to our customers to know that the MX908 is operating as intended.

We designed our handheld devices to be intuitive and easy-to-use, as it is critical to our customers to know that their device is operating as intended.

The annual and extended warranty service plans provide the customer the ability to contact us to assist in validating their results given the severity and context of the situations in which our devices operate.

Our technical support, also known as our Reachback program, allows any participating MX908 user to email, text, or call a 908 Devices Scientific Support Team member to receive support 24 hours per day, 365 days per year to ensure the MX908 is working as intended.

Our technical support, also known as our Reachback program, allows any participating MX908 and FTIR device user to email, text, or call a 908 Devices Scientific Support Team member to receive support 24 hours per day, 365 days per year to ensure their device is working as intended.

The Scientific Support Team is staffed by M.Sc.

chemists and forensic scientists expert in the operation of the MX908 and other field analytical technologies.

chemists and forensic scientists expert in the operation of our handheld devices and other field analytical technologies.

Our extended warranty service plans are sold with multiyear commitments, which allows us to deepen our relationship with customers and provides us with an upfront payment, a predictable recurring revenue stream, and an opportunity to offer additional future services.

For simplicity and convenience, we also sell single-use swab samplers for the analysis of liquid and solid materials.

For simplicity and convenience, we also sell single-use swab samplers for our MX908 device or the analysis of liquid and solid materials.

These swab samplers are most heavily used today by customers who are evaluating drug substances.

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Currently, customers of Rebel who are actively utilizing the device are consuming on average approximately half of a 200-sample kit per month.

With continuous operation, the Rebel is capable of consuming approximately one 200-sample kit a day.

With continuous operation, the Rebel is capable of consuming approximately one 200-sample kit per day.

We also offer an annual certification kit for the Rebel.

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Consumable sets of buffers, probes and biosensors are required for the Maven, Trace C2 and related sampling devices.

Market Opportunities

We have developed ultracompact, high-fidelity Mass Spec devices to interrogate the unknown and invisible and provide actionable results in life-altering point-of-need applications.

Our first products are purpose-built handheld and desktop Mass Spec devices that currently address a range of applications and markets.

We estimate our TAM for our devices was $5.7 billion in 2022, and is growing to an estimated $27 billion by 2027.

Our desktop devices supporting bioprocess development represented a TAM of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy by 2027.

We see additional future opportunity to service an estimated TAM of $3.6 billion in 2022 across the laboratory chromatography market space growing to more than $8.1 billion with further market growth and roadmap expansion into metabolomics and complex proteomics by 2027.

We also utilize estimated penetration and placement rates for our platform with potential customers in our target markets and historical patterns for consumables usage.

Our TAM for all device placements in 2022 and expanding in 2027 with product roadmap and market growth

Our Initial Market—Field Forensics

Forensic labs have historically used conventional Mass Spec instruments to chemically analyze a diverse array of submitted samples.

Testing for controlled substances is one of the major drivers for the use of Mass Spec in the field forensics setting.

In the field forensics setting, high accuracy and fidelity can be just as important at the point-of-need as it is in the laboratory.

Simple and inexpensive colorimetric tests are being abandoned in many jurisdictions due to their extremely narrow and poor performance capabilities, in favor of handheld technologies with broad lab-like capabilities.

This is creating an expanded market of individual users that is a multiple of the centralized laboratory Mass Spec instrument market.

The need for such field technologies is acute for controlled substances and identification of other priority chemicals and hazards at trace levels.

The toxicity of fentanyl and its analogs is 100 to 10,000 times the potency of morphine, creating an opioid crisis of unprecedented scale and breadth.

Fentanyl is considered to be the deadliest drug threat facing the United States today, according to the U.S.

Drug Enforcement Administration, or DEA.

The DEA also seized more than 77 million fentanyl-laced fake prescription pills in 2023, up from 50.6 million such pills in 2021.

DEA laboratory testing also showed that seven out of ten pills tested contained a potentially deadly dose of fentanyl, an increase from four out of ten pills in 2021 and six out of ten pills in 2022.

In addition, in March 2023, the DEA issued its third public safety alert in just three years warning the American public of a sharp increase in pills containing fentanyl mixed with xylazine, a powerful sedative that the U.S.

Food and Drug Administration approved for veterinary use.

The alert noted that xylazine and fentanyl drug mixtures place users at a higher risk of suffering a fatal drug poisoning.

The potency and diversity of these emerging classes pose a major challenge for point-of-need measurements.

Near invisible quantities of opioids can be fatal, and street drugs are often heavily obscured with filler materials, making trace detection with high-fidelity technologies an imperative for success.

The diversity of the problem also drives the need for agility with devices that can be rapidly updated in the field with new machine learning updates.

There are thousands of variants of these highly potent opioids, and other emerging classes such as cathinones and cannabinoids that will further exacerbate the problem.

In addition to controlled substances, point-of-need Mass Spec instruments can address a wide variety of other use cases, including:

● first responders and local, state, and federal law enforcement;

and international defense and homeland security;

● forensic laboratories’ case management and triage;

● package inspection for postal services, couriers, customs agencies, and corporate mail rooms;

● facility safety for hotels, local, state and federal government facilities, and private enterprises;

● quality assurance and control.

We estimate that the TAM for our handhelds was $1.3 billion per year in 2022 for trace detection of drugs, explosives, priority chemicals, and other hazards on surfaces and in the air.

Our TAM expands to $3.9 billion with software application extensions for GxP cleaning validation, and other related quality control assays.

Life Sciences

Mass Spec addresses a significant number of applications along the life sciences research and biopharma value chain.

It is integral in research and discovery, drug development, product validation and quality control.

Biologic therapeutic modalities and all cell-based products more broadly, use bioreactors to manufacture product in two stages – process development and clinical and GxP manufacturing.

Within a cell, thousands of intertwined processes govern the cells ability to produce various proteins, its ability to perform a specific function, and its energy and waste expenditure.

But efficient intracellular operations are also highly reliant on the extracellular environment – the cell culture media.

In bioreactors, the timely influx of raw materials, environmental controls, and management of waste can be not only essential to efficiency, but literally to the life or death of the cells.

The worldwide cell culture media market itself was estimated to be a $6.2 billion business in 2023.

Regardless of how carefully the starting cell culture media has been designed and selected, bioprocessing is by definition a dynamic and inhomogeneous process.

Cellular biology is complicated and unpredictable.

Due to issues with both the existing point-of-need solutions and alternative laboratory-based workflows, development scientists currently lack an ideal solution to accurately analyze the extracellular environment during or after the growth cycle without having to compromise between timing or completeness.

High-pressure Mass Spec combined with microfluidic sampling and separations will allow for significant efficiencies and new applications for these technologies within life sciences.

With real-time access to comprehensive media profiles, bioprocess development scientists can:

● accelerate their product development cycles with feedback in minutes rather than weeks;

● improve process yield and lower costs throughout their value chain;

● enable a broad range of complex therapeutic modalities in biopharmaceuticals;

● increase the probability of successfully developing cell-based products.

We believe these efficiencies will lead to substantial growth opportunities in biologic-based therapeutics where a better understanding of the extracellular environment is a crucial element of bioprocessing.

For antibody therapeutics, a key requirement is that monoclonal production cell lines not only produce high titers of antibody but with acceptable Critical Quality Attributes, or CQAs.

The extracellular media properties can greatly impact both the titer and the CQAs of the produced antibody.

Likewise, for cell and gene therapeutics, management of the complex mammalian cell culture system and measurement and control of the extracellular environment is crucial.

Historically, bioprocessing has been focused on large-scale batched production of monoclonal antibodies, or mAbs, using genetically stable clones, whose production has largely been optimized over many years of refinement.

Today, newer advanced modalities, like cell and gene therapies, are fueling growth in the market while introducing variability of input materials (e.g., patient or donor cells, transient transfected cell lines), higher cost of goods sold, and the necessity for small-batched production – driven by smaller patient populations and the need to scale out.

This change is driving manufacturers toward increased monitoring and optimization at a level of intensity beyond what is seen historically.

While mAbs are forecasted to continue to dominate end-product sales over the near term, it is estimated that by 2027 the pipeline of cell and gene therapies will be approximately 7,000 assets, representing more than 50% of the total biologics pipeline.

A massive retooling of global bioprocessing capabilities is underway to accommodate the needed small batched production – one per patient in some cases.

We estimated our bioprocessing TAM to be $0.8 billion in 2022, across approximately 1,800 sites and 175,000 batches to support process development, and this is expected to expand to approximately $15 billion TAM by 2027 with the execution of our roadmap and the rapid growth of cell therapy.

Our product development roadmap for the Rebel platform includes the extension of current capabilities and move to an on-line and, ultimately, a real-time “bioreactor brain”.

In process development today, smaller scale bioreactors are outfitted with a variety of disconnected multi-party simple sensors and controllers.

With the increasing trend toward highly parallelized systems with many small-scale bioreactors running simultaneously, manual sampling becomes a significant bottleneck.

The roadmap expansion of Rebel’s analyte panel to address core culture kinetics (e.g., glucose, lactate, ammonium, pH, dissolved oxygen) and attributes like cell count, and viable cell density means that this future on-line Rebel+ system could have a uniquely comprehensive assessment of the present state and trajectory of the extracellular environment.

Historical data profiles across parallel bioreactors and designed experiments form an excellent basis for machine learning and multivariable predictive control to optimize experimental variables to maximize yield, minimize risk of loss, and improve kinetics – the “bioreactor brain”.

An outsize portion of this opportunity is driven by testing in autologous cell therapies and is commensurate with the total expected cell batches produced.

We sell our products worldwide through an experienced direct sales force as well as through domestic and international channel partners.

Our customers are primarily in the pharmaceutical and biotech market, the government market and to a lesser extent, the academic market.

Primary users of our handheld device include law enforcement, military and civilian first responders, and customs and border protection personnel.

Primary users of our handheld devices include law enforcement, military and civilian first responders, and customs and border protection personnel.

Primary users of our desktop devices include process development scientists, process engineers, and research scientists.

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to outsource subassemblies or assemblies to domestic contract manufacturers where it is cost and capital favorable, and to use our internal manufacturing facilities for the balance of our production needs.

Our primary in-house manufacturing facilities are located at our headquarters in Boston, Massachusetts.

These facilities are ISO 9001:2015 certified and include approximately 5,100 square feet of configurable production assembly floor, 1,800 square feet of advanced machining space, and 2,000 square feet of configurable cleanroom.

Inventory is held in our Boston facilities in a 700 square foot controlled-access cage.

As a result of the acquisition of Trace Analytics GmbH, we also have in-house manufacturing facilities in Braunschweig, Germany.

Our primary in-house manufacturing facilities are located at our headquarters in Boston, Massachusetts, in Danbury, Connecticut, for our FTIR products and in Morrisville, North Carolina, for our desktop consumables.

Our Boston and Morrisville facilities are ISO 9001:2015 certified and include approximately 7,800 combined square feet of configurable production assembly floor, 1,800 square feet of advanced machining space in Boston, and 3,500 combined square feet of configurable cleanroom.

The MX908, Rebel, Maverick and ZipChip Interface are manufactured, tested and shipped from our Boston facility.

The ThreatID, ProtectIR and XplorIR are manufactured, tested and shipped from our Danbury facility.

The Maven and related sampling devices are manufactured, tested and shipped from our Braunschweig facility.

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When our annual sales exceed 2,000 units, we expect that we would need to either expand our in-house production operations, or transfer some or all aspects of assembly to contract manufacturers, to accommodate larger run-rates.

We believe there are numerous domestic and international contract manufacturers that could be qualified to produce the MX908, Rebel, Maverick and/or ZipChip Interface when third party demand for our products outpace our current manufacturing capacity.

In addition, our Danbury manufacturing facility can support the production of approximately 1,000 ThreatID, ProtectIR and XplorIR units combined per year and has additional capacity to support expansion of our handhelds, including manufacturing the MX908.

We believe there are numerous domestic and international contract manufacturers that could be qualified to produce the MX908, ThreatID, ProtectIR, XplorIR, Rebel, Maverick and/or ZipChip Interface when third party demand for our products outpace our current manufacturing capacity.

The autosampler subassembly of the Rebel and ZipChip are supplied by a single supplier.

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We plan to continue the diversification of our supply chain as we scale.

We use our annual demand planning to assess initial device needs for

each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.

We use our annual demand planning to assess initial device needs for each year, and we update and reassess those estimates as needed, including with respect to the levels of inventory that we believe will be required to support anticipated customer demand.

In November 2024, we announced that we plan during 2025 to move our handheld manufacturing, including the MX908, to our existing facility in Danbury, CT, and to move our desktop manufacturing, including the Rebel, Maverick and ZipChip interface, to our existing facility in Morrisville, NC.

These actions will allow us to materially reduce the size of our facility in Boston, MA, and the higher costs associated with this location.

The NC and CT locations can absorb this additional manufacturing without the need to expand their facilities.

The MX908 incorporates a number of non-proprietary consumables that are commercial-off-the-shelf available and sourced from a number of reputable suppliers.

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While we believe that alternatives are available, it would take time to identify and validate replacement swab samples, which could compromise our ability to supply these to our MX908 customers on a timely basis.

In 2024, we completed the transfer of our consumable kit and microfluidic chip manufacturing from our Boston cleanroom facilities to our Morrisville cleanroom facilities.

Consumable kits for the Rebel and ZipChip Interface include electrolytes, standards, and microfluidic chips.

All assay kits and standards are assembled in our Boston cleanroom facilities.

As of December 31, 2024, all assay kits and standards are assembled in our Morrisville cleanroom facilities.

Component reagents and standards are widely available from multiple suppliers.

Our microfluidic chips are produced and assembled in our Boston cleanroom facilities.

As of December 31, 2024, our microfluidic chips are produced and assembled in our Morrisville cleanroom facilities.

The substrate is supplied by a single supplier.

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This staff is primarily located in the United States, but we have also hired internationally at our facility in Braunschweig, Germany, and in other countries using a professional employment organization, to support our sales and applications efforts.

We intend to expand our sales, support, and marketing efforts in regions with a concentrated life sciences presence, including large pharmaceutical and biopharma companies.

For example, in 2023, we established a direct sales footprint in Europe for our desktop products, and have developed a sales, training and support network in China.

Additionally, we believe that there is significant opportunity in other Asia-Pacific countries such as India and South Korea as well as other areas such as Australia and South America.

We intend to expand our sales, support, and marketing efforts in regions where we believe that there is significant opportunity, including Europe, the Middle East, Asia-Pacific countries such as India and South Korea as well as other areas such as Australia and South America.

We plan to continue to expand into these regions via initial penetration with channel partners and then subsequent support with direct sales and support personnel.

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This is enabled through customer trials and partnerships that allows us to further understand the critical applications for our technology and inform our future developments and market expansion.

Our MX908 devices often are sold to governmental institutions and other customers that require participation in a tender process that involves preparation of extensive documentation and a lengthy review process.

Our MX908, ThreatID, ProtectIR and XplorIR devices often are sold to governmental institutions and other customers that require participation in a tender process that involves preparation of extensive documentation and a lengthy review process.

As a result of these factors, and the budget cycles of our customers, our sales cycle can often be six to twelve months, or longer.

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We have made substantial investments in product and technology development since our inception.

We expect our research and development expense to be maintained at this level as we balance resources to enhance our existing products, develop new products for our current markets and introduce new products in new markets.

We expect our research and development expense to be maintained at this level as we balance resources to expand our existing products, develop new products for our current markets and introduce new products in new markets.

We consider the holistic nature of our internal product development teams critical to our products’ success.

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● microfluidic design, and volume fabrication at the micro- and meso-scale.

The majority of our research and development operations are conducted in our Boston facility.

We also conduct additional research and development operations out of our facility in Morrisville, North Carolina to support assay development for Rebel, Maverick and ZipChip, and out of our facility in Braunschweig, Germany to support assay development of our Maven and related products and aseptic sampling development.

Our R&D and marketing teams also receive input from two Scientific Advisory Boards, each an SAB, one SAB with deep expertise in bioprocess development, and cell and gene therapy processes and production, and the other SAB board made up of thought leaders in proteomics who will be invaluable to the continued advancement of our platform mass spec and microfluidic technology and its application to contemporary problems in proteomics-oriented life science research.

The majority of our research and development operations are conducted in our Boston facility and our Danbury facility.

We also conduct additional research and development operations out of our facility in Morrisville to support assay development for Rebel, Maverick and ZipChip, and out of our facility in Braunschweig, Germany to support assay development of our Maven and related products and aseptic sampling development.

We have a range of competitors extending from small, privately held companies with single-point solutions to large, publicly-held corporations, including those with a portfolio of Mass Spec products, such as Agilent, Bruker, Danaher, Inficon, Teledyne, Endress & Hauser, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.

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Our ability to compete successfully will depend on a number of factors including our ability to:

● offer differentiated point-of-need Mass Spec devices;

● offer differentiated point-of-need chemical analysis devices;

● translate market requirements into an engineering roadmap of new software and hardware features to remain competitive;

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We provide our products to customers pursuant to terms and conditions that impose restrictions on use and disclosure.

We also seek to avoid disclosure of our intellectual property using contractual obligations, by requiring employees, consultants and contractors with access to our proprietary information to execute nondisclosure, non-competition and

assignment of intellectual property agreements.

In addition, we generally control access to our proprietary and confidential information through the use of internal and external controls.

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As of December 31, 2024, our in-licensed patent assets included approximately 30 U.S.

patents, one pending U.S.

patent application, 22 foreign patents, and two pending foreign patent applications.

patents, no pending U.S.

patent applications, 22 foreign patents, and two pending foreign patent applications.

The subject matter covered by our in-licensed patent assets includes a microfabricated ionization source and a microfabricated ionizer chip, microscale Mass Spec systems, devices and related methods, a miniature charged particle trap with an elongated trapping region for Mass Spec, high pressure Mass Spec signal enhancement by means of convective transport, electrospray ionization interface to high pressure Mass Spec, a method of sample injection for chemical separations in microfluidic devices, integrated sample processing for electrospray ionization devices, and microchips with integrated multiple electrospray ionization emitters and related methods, systems and devices.

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We also seek to protect our brand through procurement of trademark rights.

As of December 31, 2023, we owned six registered trademarks in the United States, 17 registered foreign trademarks, three U.S.

pending trademark applications, and two pending foreign trademark applications.

As of December 31, 2024, we owned nine registered trademarks in the United States, 17 registered foreign trademarks, four U.S.

pending trademark applications, and one pending foreign trademark application.

Our registered trademarks and pending trademark applications include trademarks for 908 Devices, Rebel, MX908, ZipChip, Maven, Maverick, and our logo.

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Our products are currently marketed as research use only, or RUO.

Products such as ours that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For

Research Use Only.

Products such as ours that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For Research Use Only.

Not for use in diagnostic procedures.” Products that are intended for RUO and are properly labeled as RUO are exempt from compliance with the FDA’s requirements applicable to medical devices more generally, including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.

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We have elected to use this extended transition period for complying with new or revised accounting standards until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

result, our financial statements and the reported results of operations contained therein may not be directly comparable to those of other public companies.

As a result, our financial statements and the reported results of operations contained therein may not be directly comparable to those of other public companies.

We are also a “smaller reporting company,” as defined in Regulation S-K.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business