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Item 1. Business

2023-03-15 compared with 2022-03-11 · 120 added, 146 removed, 509 unchanged (34% of the section changed)

Analysis for Life

We are leading a revolution in measurement devices for chemical and biochemical analysis.

We are democratizing laboratory mass spectrometry instruments with our simple handheld and desktop devices, addressing critical-to-life applications.

We are leading a revolution in measurement devices for chemical and biochemical analysis with our simple handheld and desktop devices, addressing critical-to-life applications.

We are reimagining where Mass Spec technology can be used if it is sufficiently small in size, low in cost, and simple to operate.

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Leveraging our proprietary platform technology, we make the extraordinary analytical power of Mass Spec available in devices that are significantly smaller and more accessible than conventional laboratory instruments.

Our Mass Spec 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, industrial biotech, forensics and adjacent markets.

Our Mass Spec 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, quality assurance/quality control, forensics and adjacent markets.

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.

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

Since the launch of our first device, we have sold more than 1,900 handheld and desktop devices to over 450 customers in 42 countries, including all 20 of the top 20 pharmaceutical companies by revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

Since the launch of our first device, we have sold more than 2,300 handheld and desktop devices to over 550 customers in over 45 countries, including all 20 of the top 20 pharmaceutical companies by revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

Our current products are available for both battery powered handheld and desktop applications, including our flagship devices -- MX908 and Rebel.

Front-line workers rely upon our handheld devices to combat the opioid crisis and detect counterfeit pharmaceuticals and illicit materials in the air or on surfaces at levels 1,000 times below their lethal dose.

devices are accelerating development and production of biotherapeutics by identifying and quantifying extracellular species in bioprocessing critical to cell health and productivity.

They sit alongside bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology-derived products.

Our desktop devices are accelerating development and production of biotherapeutics by identifying and quantifying extracellular species in bioprocessing critical to cell health and productivity.

They sit either alongside or connected to bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology-derived products.

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

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The size of a business card, our microfluidic capillary-electrophoresis, or CE, chip has demonstrated world-class performance and speed in separating everything from small molecules such as metabolites and drugs, to biopharmaceutical proteins, antibodies, and oligonucleotides.

With our acquisition of TRACE Analytics GmbH (“Trace”) in August 2022, we obtained microfluidic aseptic sampling technology that enables on-line automated monitoring and control in bioprocess applications.

This validated technology provides cell-free and sterile bioreactor sampling with no volume or prep required.

We expect this technology to serve as the interface for future on-line devices, those directly connected to a bioreactor.

Lastly, it is imperative that a point-of-need solution is operable by the widest possible user base.

We have an industry-leading software automation and machine learning team comprised of five members, each with advanced scientific degrees, who have collective experience working on 30 commercial product launches and have won numerous research and innovation awards.

We have an industry-leading software automation and machine learning team comprised of nine members, each with advanced scientific degrees, who have collective experience working on 30 commercial product launches and have won numerous research and innovation awards.

They have applied advanced software automation and machine learning techniques to both control the hardware in our devices and interpret the incredibly rich and complex data streaming off of them.

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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.

As we democratize the extraordinary power of Mass Spec, we believe our technology platform can expand in future opportunities far beyond the current $8 billion market for Mass Spec and associated front-end separations.

We estimate our total addressable market, or TAM, for our devices was $4.8 billion in 2020 and is growing to an estimated $22 billion over the next few years.

The TAM for our handhelds was estimated to be $1.5 billion in 2020 with expansion to over $3 billion with software application extensions into GxP facilities for raw material inspection, counterfeit and adulteration inspection, contamination and cleaning validation, and other quality assurance and quality control assays.

Our desktop devices supporting bioprocess development represented an estimated TAM of $260 million in 2020 expanding significantly to approximately $12 billion with execution of our roadmap and the rapid growth of cell therapy.

We see additional opportunity to address the estimated $3.0 billion in 2020 across the research chromatography market space growing to more than $6.9 billion with further market growth and roadmap expansion into complex proteomics by 2025.

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.

As we democratize the extraordinary power of Mass Spec, 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.

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.

We see additional opportunity to address the estimated $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.

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

We believe the following competitive strengths provide us the ability to address point-of-need applications in forensics, life sciences research, bioprocessing, industrial biotech, and synthetic biology:

We believe the following competitive strengths provide us the ability to address point-of-need applications in forensics, life sciences research, bioprocessing, quality assurance/quality control, and synthetic biology:

● Our proprietary microscale Mass Spec platform leverages well established, gold-standard technology.

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

The combination of HPMS, our proprietary microfluidic 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.

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.

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.

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● Grow the installed base through expansion of commercial channels .

Since the commercial launch of our first handheld, the installed base of our handheld and desktop devices has grown to more than 1,900 devices across 42 countries.

With our handheld and desktop device installations now taking root in the United States, we will focus on expanding our commercial channels to better serve the forensics, life sciences research, bioprocessing, industrial biotech, and synthetic biology markets.

Since the commercial launch of our first handheld, the installed base of our handheld and desktop devices has grown to more than 2,300 devices over 45 countries.

We look to expand both our direct channel in the United States and our international reach.

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They sit alongside bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products.

We look to expand our product line into broader extracellular panels, intracellular analysis, such as cellular flux, and pathway analysis.

We look to expand our product line with additional panels, for example focused extracellular panels, and intracellular analysis, such as cellular flux, and pathway analysis.

Consistent with our thesis of driving simplicity and convenience of measurement, we will progress from an at-line measurement tool to an on-line integrated device with comprehensive bioprocess analytics and control.

Our novel aseptic sampling technology, obtained through our acquisition of TRACE Analytics GmbH, provides a measurable step forward in our goal to move from at-line to on-line devices.

We believe our technology platform can serve as the cornerstone of an integrated “bioprocess brain” by monitoring and managing the comprehensive extracellular environment.

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As our customers continue to prove out new applications in areas such as diagnostics and proteomics, we will look to incorporate select assays investigated by these customers into our handheld and desktop devices where those form factors can accelerate usage.

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,

industrial biotech 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.

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Together with its associated front-end separation technologies, Mass Spec can resolve and analyze the most complex of samples with high fidelity.

We believe Mass Spec has become the cornerstone of the chemical laboratory within academia, industry and government, serving an extremely wide range of markets including forensics, life sciences, environmental, and industrial.

However, while Mass Spec is an extremely powerful analytical technique, the capabilities of conventional Mass Spec instruments are largely relegated to centralized laboratory settings due to their size, complexity, and high price.

When compared in context to the computer industry, conventional Mass Spec instruments represent the mainframe computer of the analytical laboratory.

Mass Spec instruments contain three standard components:

an ionization source, a mass analyzer and an ion detector.

Utilizing these three components, the Mass Spec process is completed in three corresponding steps:

First, the molecular sample must be ionized so that it takes on one or more positive or negative charges.

This allows the charged molecule to be precisely manipulated by static or dynamic electric fields.

The means of ionization itself also allows the user to selectively evaluate certain molecular classes, such as acids vs.

bases, while ignoring others.

Following ionization, the ions are trapped under vacuum, manipulated, and sorted based on their mass-to-charge ratio (m/z) within the mass analyzer.

This is where the fine structural characteristics of the molecules begin to emerge with extraordinary levels of detail.

Finally, the detector converts the ion energy into electric signals as it carefully records the ion pattern representing the structure.

The recorded data is then typically interpreted by a computer and then manipulated, studied and analyzed by a specialist.

Conventional “Mainframe” Laboratory Mass Spec instruments

Employing and building upon these three process steps, conventional Mass Spec instruments have penetrated almost every analytical laboratory.

It is estimated there are thousands of laboratories employing more than 50,000 Mass Spec instruments according to a recent third party report.

As the needs of laboratory scientists have evolved, Mass Spec instrument manufacturers for decades have grown their franchise and stimulated capital equipment replacement cycles by orienting their research and development towards sustained improvements in raw analytical performance metrics such as resolution, sensitivity, and range.

As a result, conventional Mass Spec instruments:

● are extremely large and not readily mobile;

● are expensive (often ranging from $100,000 to $1 million);

● require a dedicated fixed power source;

● require onsite specialists to maintain and operate.

These significant limitations have profoundly bottlenecked market opportunities for conventional Mass Spec instruments.

Despite this, the conventional Mass Spec and associated front-end separations market is significant, with estimated annual revenues of $8 billion.

The Democratization of Mass Spec—Handhelds and Desktops

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

Microfluidics Enable Convenient Sample Preparations and Fast Separations

Microfluidics Enable Convenient Sampling and Fast Separations

Today, most central laboratory Mass Spec instruments are paired with large, complex solid and liquid handling systems for sample preparation and separation.

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This allows for highly complex separations with high resolution to be completed in minutes.

Examples shown below illustrate the versatility of our microfluidic CE chip and include separation of cell lysate with minimal sample preparation and a highly detailed characterization of an antibody drug conjugate:

Faster high resolution separations attainable in minutes using our microfluidic CE chip

In 2022, we strengthened our core microfluidic technology with the acquisition of Trace, which enables us to provide on-line aseptic sampling technology used in bioprocess monitoring and control.

Aseptic sampling allows for highly precise, on-line monitoring without any loss of bioreactor volume.

A reusable or single-use probe that incorporates a diffusion membrane is inserted in the bioreactor, preserving precious media and product in cell culture and fermentation processes.

Complementing our mass spec analysis, Trace also brings to us an enzyme-based electrochemical biosensor technology that generates an electrical signal proportional to concentration of targeted analytes enabling real-time monitoring and control of additional analytes, some of which are difficult to measure with mass spec (e.g.

glucose and lactate).

Aseptic sampling enables on-line automated monitoring and control of bioprocesses.

Aseptic sampling provides many benefits, including cell-free, sterile and safe sampling with no loss of volume or prep required, thereby saving operator time and reducing lab costs.

We expect our microfluidic aseptic sampling to serve as the interface for future on-line mass spec based devices.

Analytics and Machine Learning Technology Provide Actionable Answers, Not Just Raw Data

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An example of such a configuration panel is shown on the right below.

Our devices need to manage themselves autonomously for maximum

value to the customer.

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

They can manage themselves by adapting to environmental factors like elevation, humidity, temperature, and vibration, and by optimizing themselves for the analytical objectives of the user, such as looking for traces of potent drug substances or sniffing for airborne hazards.

This ability to automatically control the system reduces or eliminates the user’s responsibility and opportunity for error in set up, optimization, and troubleshooting.

Our product’s “settings” screen shown below on the left looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.

product’s “settings” screen shown below on the left looks very simple, but the embedded analytics and machine learning system controls and optimizes more than a hundred parameters continuously in real-time.

MX908 Settings/Configuration

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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.

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 severe limitation of specificity (ability to distinguish one chemical from another) and sensitivity (ability to detect minute amounts), respectively.

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

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

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 approximately 2,000 MX908s into every U.S.

state, in 42 countries and across five continents.

state, in over 45 countries and across five continents.

More than 8,000 operators, including in numerous domestic and foreign government agencies, have been trained to use the MX908.

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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.

These added capabilities are aimed to address gaps in responders’ workflows, increase engagement, and drive utilization.

We are currently working to expand the MX908’s mission add-ons to support the detection of adulterated and counterfeit pharmaceuticals, detection of pesticide residues, and applications in quality control and quality assurance such as raw material purity and GxP cleaning validation.

We recently added pesticide identification capability, which we developed in conjunction with the U.S.

Forest Service, an agency of the U.S.

Department of Agriculture.

Field agency personnel can now easily and safely identify toxic chemicals used in illegal marijuana growing operations on federal lands and quickly begin site remediation, instead of waiting weeks for lab results.

All these added capabilities are aimed to address gaps in responders’ workflows, increase engagement, and drive utilization.

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

Services and Consumables

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chemists and forensic scientists expert in the operation of the MX908 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.

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.

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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.

Cell culture media forms the critical growth

environment for the cell.

Cell culture media forms the critical growth environment for the cell.

Our customers’ measurement of this extracellular environment in bioprocesses is critical to their development and operational efficiency.

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● performance qualification and calibration standards.

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

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.

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Annual and extended warranty and service plans are available for the Rebel.

Maven™ and Trace C2

The Maven, launched in January 2023, 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.

Glucose and lactate are critical parameters that biopharmaceutical process development scientists must monitor to ensure optimal cell viability and to improve product yield, quality, efficacy and safety.

Taking measurements as frequently as every two minutes, Maven operates without having to manually draw samples out of the bioreactor due to its aseptic sampling probe.

This approach preserves precious media and product and reduces the risk of cell culture contamination.

Maven precisely monitors nutrient and metabolite concentrations at low levels—0.01 g/L of glucose and 0.05 g/L of lactate.

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

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

The Maven is GMP compliant, takes up a small footprint, and in keeping with our focus on simplicity, is easy to use.

Maven can be used in concert with our at-line Rebel device, which quantitates over 30 analytes, to improve and optimize cell culture feeding strategies.

The Trace C2 provides on-line monitoring of methanol or ethanol and control of substrate feeding in fermentation processes.

Integrated into the device is an aseptic sampling probe that enables sampling with no loss of bioreactor volume and no increased risk of process contamination.

The device includes a dedicated on-board peristaltic pump and an integrated PID controller that can be used for feeding substrates without any additional auxiliary equipment.

The Trace C2 and related sampling products were developed by Trace, which we acquired in August of 2022.

Consumables and services

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

Annual and extended warranty and service plans are available for these devices.

Our ZipChip solution is a plug-and-play, high-resolution separation platform that optimizes Mass Spec sample analysis.

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Since launch of the ZipChip platform in March 2016, we have sold 215 ZipChip Interfaces and have established 25 multi-unit accounts in leading, global pharmaceutical organizations and academic institutions.

Our ZipChip platform is compatible with market-leading conventional Mass Spec instruments currently installed in laboratories, and we intend to continue to expand the ZipChip platform to become compatible with any conventional Mass Spec instrument.

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

As an open-access discovery platform that can interface with more than 10,000 conventional Mass Spec instruments, ZipChip provides us the ability to leverage the growing list of newly established applications and publications from customers who have incorporated the device into their projects.

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We have already incorporated a number of the customer-driven assays in our MX908 and Rebel devices, and we are investigating several more for our future product pipeline.

ZipChip Consumables

Consumables and Services

We offer a variety of kits for the ZipChip Interface that include microfluidic ZipChips and different reagents optimized for a wide scope of applications.

These kits include intact antibody, metabolomics, peptide and others.

We recently launched an oligonucleotides analysis kit for ZipChip.

Oligonucleotides represent a distinct class of therapeutics that include RNA, DNA and their structural analogues, and are effective against a wide range of disease conditions.

Traditional workflows for oligonucleotides analysis are lengthy, often requiring the use of extensive liquid chromatography method development along with ion pairing reagents, which are harsh chemicals.

Our ZipChip device coupled with a mass spectrometer provides an easy method for simple and fast analysis of oligonucleotides with minimal

sample prep and no need for ion pairing reagents.

We also expect to grow our revenue from warranty and annual certification related to the ZipChip platform as the product sales expand.

These kits include intact antibody, charge variance, metabolomics, peptide and oligonucleotides.

Annual and extended warranty and service plans are available for the ZipChip interface.

Market Opportunities

We have developed ultracompact, high-fidelity Mass Spec devices to interrogate the unknown and invisible and provide actionable results in critical-to-life 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 $4.8 billion in 2020, and is growing to an estimated $22 billion over the next few years.

Our desktop devices supporting bioprocess development represented a total addressable market of $260 million in 2020 expanding significantly to approximately $12 billion with execution of our roadmap and the rapid growth of cell therapy.

We see additional future opportunity to address an estimated $3.0 billion in 2020 across the laboratory chromatography market space growing to more than $6.9 billion with further market growth and roadmap expansion into complex proteomics by 2025.

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 total addressable market of $0.8 billion in 2022 expanding significantly to approximately $15 billion with execution of our roadmap and the rapid growth of cell therapy.

We see additional future opportunity to address an estimated $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.

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According to the latest available data from the Bureau of Justice, U.S.

criminal forensic laboratories

handled approximately 4 million requests, roughly 1.2 million of which were controlled substances-related.

criminal forensic laboratories handled approximately 4 million requests, roughly 1.2 million of which were controlled substances-related.

We believe that this increase in requests will be even more acute for the point-of-need setting.

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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.

Unfortunately, overdose deaths involving lethal drugs like fentanyl and methamphetamine are on the rise.

At the end of September 2021, the Drug Enforcement Administration issued a public safety alert warning Americans of the sharp increase in fake prescription pills containing fentanyl and methamphetamine.

This was the first advisory the DEA had issued in six years.

According to the advisory, the number of DEA-seized counterfeit pills with fentanyl has jumped a staggering amount - by nearly 430 percent - since 2019.

Today, two out of every five pills with fentanyl contain a potentially lethal dose.

The potency and diversity of these emerging classes pose a major challenge for point-of-need measurements, as depicted in the graph below.

Fentanyl is considered to be the deadliest drug threat facing the United States today according to the Drug Enforcement Administration (DEA).

In November 2022, the DEA issued a public safety alert warning of a sharp increase in the lethality of fentanyl-laced fake prescription pills.

The alert noted that DEA testing found six out of 10 pills contained a potentially lethal dose, an increase from the DEA’s September 2021 alert that four out of 10 pills were found to contain a potentially lethal dose.

In addition, the DEA announced in December 2022 that it had seized over 50.6 million fentanyl-laced fake prescription pills in 2022, more than double the amount of fentanyl-laced fake prescription pills it had seized in 2021.

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.

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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 over $3 billion with use cases in GxP facilities for raw material inspection, counterfeit and adulteration inspection, contamination and cleaning validation, and other quality assurance and quality control assays.

These use cases would be accessed through release of additional software apps or mission modes for our base hardware.

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

Life Sciences

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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.

Democratization of Mass Spec will allow for significant efficiencies and new applications for the technology within life sciences.

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:

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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.

End market sales of biologics across mAbs, cell, and gene therapies were estimated at $150 billion in 2020, growing to approximately $250 billion by 2025 at a 11% compounded annual growth rate according to third party reports and analyst sources.

While mAbs are forecasted to continue to dominate end-product sales in 2025, it is estimated that the pipeline of cell and gene therapies will be nearly 6,000 assets, representing more than 50% of the total biologics pipeline.

A massive expansion of global bioprocessing capacity is underway to accommodate the needed small batched production.

We estimated Rebel’s TAM to be $260 million in 2020, representing more than 1,700 device placements and 1.6 million media tests to support process development, and is expected to expand to approximately $12 billion TAM by 2025 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 online and, ultimately, a real-time “bioreactor brain”.

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 online Rebel system could have a uniquely comprehensive assessment of the present state and trajectory of the extracellular environment.

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”.

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Our research customers incorporate our ZipChip Interface into their projects due to its preparation convenience and separation speed.

These customers prove-out new assays spanning a range of markets from diagnostics to consumer health and beauty, to agrochemical, oil and gas, and defense.

They measure such things as novel therapeutics, metabolites, and quality and process attributes, and explore complex proteomics.

We estimate our ZipChip platform was able to address $3.0 billion in 2020 across the research chromatography market space growing to more than $6.9 billion with further market growth roadmap expansion into complex proteomics by 2025.

These customers prove-out new assays spanning a

range of markets from diagnostics to consumer health and beauty, to agrochemical, oil and gas, and defense.

They measure such things as novel therapeutics, quality and process attributes, and explore metabolomics and complex proteomics.

We estimate our ZipChip platform was able to address $3.6 billion in 2022 across the research chromatography market space growing to more than $8.1 billion with further market growth roadmap expansion into metabolomics and complex proteomics.

The resulting pipeline and market multiplier for subsequent point-of-need products has not been considered and may be significant.

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

Representative organizations using our products in each of our primary markets are as follows:

Pharma/Biotech:

Bristol-Myers Squibb Co.

Boehringer Sohn AG & Ko.

Takeda Pharmaceutical Company Limited

GlaxoSmithKline plc

Teva Pharmaceutical Industries

Medicines Discovery Catapult

Transcenta Holding Limited

Novartis International AG

Federal Emergency Management Agency Center for Domestic Preparedness

United States Department of Homeland Security

The National Institute for BioProcessing Research and Training

Centers for Disease Control and Prevention

The National Institute for Innovation in Manufacturing Biopharmaceuticals

Food and Drug Administration United States

United States Army

United States Marine Corps

Clemson University

North Carolina State University

Dana-Farber Cancer Institute

Stanford University

Duke University

University of Kentucky

Johns Hopkins University

The Ohio State University

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

We are always looking for new opportunities to engage directly with our customers.

To that end, in September 2021, we hosted our first integrated user meeting, Critical MASS 2021, which covered the full breadth of our product platforms and their applications.

This event brought more than 150 attendees together, both virtually and in person, to hear our customers share their success using our handheld and desktop devices to democratize access to mass spectrometry.

To that end, we held user meetings in 2021 and 2022, which covered the full breadth of our product platforms and their applications.

These events brought more than 175 attendees together, both virtually and in person, to hear our customers share their success using our handheld and desktop devices to provide rapid and robust actionable information at the point of need.

These customer talks spanned the breadth of our customer base:

from pharma – with Amgen, Merck, AstraZeneca and Sartorius – to top research institutions – with Johns Hopkins University and Dana Farber Cancer Institute – to government agencies – with the USDA, Maine Drug Enforcement Agency and the Quincy Police Department.

The executive director of product integrity at Merck was the keynote speaker for the event and discussed the critical role forensic testing plays in criminal enforcement against counterfeit drugs.

from pharma – with Amgen, Boehringer Ingelheim, Merck, AstraZeneca and Sartorius – to top research institutions – with MIT, Johns Hopkins University and Dana Farber Cancer Institute – to government agencies – with the USDA, Maine Drug Enforcement Agency, Ohio Bureau of Criminal Investigation and the Fresno, California Police Department.

It was inspiring to hear the impact our technology is having across a range of topics, from bioprocess monitoring to identification of counterfeit pharmaceuticals to high-throughput drug discovery.

And, perhaps even most importantly, the event gave our customers the opportunity to engage in discussion together – not only to share their experiences but also to increase awareness and educate each other on the value of our technology across these different application areas.

And, perhaps even most importantly, these user meetings give our customers the opportunity to engage in discussion together – not only to share their experiences but also to increase awareness and educate each other on the value of our technology across these different application areas.

Manufacturing and Supply

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

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 Trace acquisition, we also have in-house manufacturing facilities in Braunschweig, Germany.

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

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

Several custom components are fabricated by third party suppliers, including printed circuit boards and cables, and metal and plastic mechanical components.

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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 and/or ZipChip Interface when third party

demand for our products outpace our current manufacturing capacity.

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

The autosampler subassembly of the Rebel is supplied by a single supplier, Spark Holland B.V.

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The final testing and shipment of ZipChip Interfaces has been and will continue to be completed from our Boston facility.

Additionally, we maintain resources to handle all warranty and service of our installed base.

Additionally, we maintain resources to handle all warranty and service of our devices.

We are continuously evaluating and updating our supply chain to ensure our ability to respond to customer demand for our products.

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In North America, we use distribution partners to provide our products to end customers where a contract vehicle is required.

Since the commercial launch of our first handheld, the installed base of our devices has grown to more than 1,900 devices across 42 countries.

Since the commercial launch of our first handheld, the installed base of our devices has grown to more than 2,300 devices across more than 45 countries.

Our domestic sales force and international partners inform our current and potential customers of current product offerings, new target applications, and advances in our technologies and products.

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Research and development expense totaled $17.5 million in the year ended December 31, 2022.

We expect our research and development expense to increase significantly for the foreseeable future as we 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 increase for the foreseeable future as we enhance 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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Our R&D and marketing teams also receive input from two Scientific Advisory Boards (SAB) implemented in 2021, one SAB board 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.

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, FLIR, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.

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, PerkinElmer, Shimadzu, Thermo Fisher Scientific, and Waters Corp.

Many of these companies have greater resources and market presence than we do.

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As of December 31, 2022, our owned patent assets included approximately 19 U.S.

patents, one pending U.S.

patent application, 15 foreign patents and five pending foreign patent applications in various foreign jurisdictions, including Australia, Canada, China, the European Union, Hong Kong, Israel, Japan, South Korea, Singapore and Taiwan.

patents, no pending U.S.

patent applications, 41 foreign patents and five pending foreign patent applications in various foreign jurisdictions, including Australia, Austria, Canada, China, France, Germany, the European Union, Hong Kong, Israel, Japan, South Korea, Singapore, Switzerland and Taiwan.

The subject matter covered by our owned patent assets includes core aspects of compact Mass Spec technology, a design for a handheld Mass Spec device, a design for a modular Mass Spec chamber, patents for multiple ionization modes and adaptive pressure operation within survey period, the determination of preferred ionization mode, adaptive resolution control, adaptive operation to reduce power consumption, and the detection of positive and negative ions.

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patents, two pending U.S.

patent applications, 18 foreign patents, and five pending foreign patent applications.

patent applications, 18 foreign patents, and three 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, 2021, we owned eight registered trademarks in the United States, nine registered foreign trademarks, and one U.S.

pending trademark application.

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

As of December 31, 2022, we owned eight registered trademarks in the United States, nine registered foreign trademarks, and two U.S.

pending trademark applications.

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

In order to supplement protection of our brand, we have also registered several internet domain names.

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Department of Energy, pursuant to which UTB granted us an exclusive, sublicensable, worldwide license under certain patent rights owned by UTB related to Mass Spec technology to develop, manufacture, use and commercialize products, services and methods that are covered by such patent rights, or the Licensed Products, in the defined fields of use within forensics, life sciences, industrial process monitoring and food and environmental testing and safety.

patents are related to the design and operation of microscale ion traps and ion sources with flexible operating pressures, and were the first patents that enabled us to reduce the size of our Mass Spec platform.

The patents are related to the design and operation of microscale ion traps and ion sources with flexible operating pressures, and were the first patents that enabled us to reduce the size of our Mass Spec platform.

We refer to these two licenses as the UTB Agreements.

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There are current patent applications pending under the UNC Agreements so we expect the UNC Agreements will continue through at least 2039.

We may terminate the UNC Agreements by providing advance written notice of 60 days as

specified therein.

We may terminate the UNC Agreements by providing advance written notice of 60 days as specified therein.

UNC may terminate the UNC Agreements if we violate or fail to perform any terms of the UNC Agreements and we fail to cure such violation or failure within 90 days of notice thereof from UNC.

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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.

including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.

A product labeled RUO but intended to be used diagnostically may be viewed by the FDA as adulterated and misbranded under the Federal Food, Drug, and Cosmetics Act and subject to FDA enforcement activities.

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The health and safety of our employees, customers and communities are of primary concern.

During the COVID-19 pandemic, we have taken significant steps to protect our workforce including but not limited to, at various times during the pandemic, working remotely, enforcing vaccine and masking requirements, conducting weekly testing, and implementing social distancing and contact tracing protocols consistent with guidelines issued by federal, state, and local law.

Corporate Information

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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