908 Devices Inc. operates as a commercial-stage technology company. The company provides a suite of purpose-built handheld and desktop mass spectrometry devices for use in a broad array of markets.
The company has developed an innovative suite of purpose-built handheld and desktop devices for the point-of-need chemical and biochemical analysis. Leveraging its proprietary mass spectrometry, or Mass Spec, microfluidics, and analytics and machine learning technologies, the company makes devices th...
908 Devices Inc. operates as a commercial-stage technology company. The company provides a suite of purpose-built handheld and desktop mass spectrometry devices for use in a broad array of markets.
The company has developed an innovative suite of purpose-built handheld and desktop devices for the point-of-need chemical and biochemical analysis. Leveraging its proprietary mass spectrometry, or Mass Spec, microfluidics, and analytics and machine learning technologies, the company makes devices that are significantly smaller and more accessible than conventional laboratory instruments. The company's 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 company's products are available for both battery-powered handheld and desktop applications.
Front-line workers rely upon the company's 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. The company's 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 alongside or are directly connected to bioreactors and fermenters producing drug candidates, functional proteins, cell and gene therapies, and synthetic biology derived products.
Mass Spec is the gold-standard analytical technology for laboratory-based molecular analysis and can identify and quantify sample components via molecular weight measurements. Mass Spec is highly regarded for its ability to provide an extraordinarily detailed analysis of a wide variety of samples -- from small molecules to large complex proteins. While Mass Spec is an extremely powerful analytical tool, conventional Mass Spec instruments are very large, expensive, and highly complex, which has profoundly bottlenecked market opportunities and relegated them to the equivalent of mainframe computers in central facilities. The company is reimagining where Mass Spec technology can be used if it is sufficiently small in size, low in cost, and simple to operate.
The company's proprietary Mass Spec platform relies on extreme miniaturization of the core of Mass Spec -- the ion trap and its vacuum system. Using semiconductor microfabrication techniques, it designs and produces components that are more than a thousand-fold smaller in volume when compared with most laboratory Mass Spec instruments and costs only dollars to manufacture. The vacuum system alone in a typical laboratory instrument weighs hundreds of pounds and requires several hundred watts of power, 24 hours per day, 365 days per year. The company's miniaturized vacuum system weighs less than a pound, and its Mass Spec in total requires less power than a 20-watt LED light bulb. These landmark proprietary advances have enabled the first truly handheld Mass Spec devices and compact desktops.
Sample preparation and separation can be a painfully slow hours-long process, and the company has invested heavily in the development of microfluidic sample preparation and microscale separation technologies to reduce preparation and separation time from hours to minutes. The size of a business card, the company's 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 its acquisition of Trace Analytics GmbH, renamed 908 Devices GmbH, in August 2022, the company 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. The company expects this technology to serve as the interface for future on-line devices, those directly connected to a bioreactor.
Growth Strategy
The company's growth strategy includes the following key elements: a continued focus on simplicity, speed, convenience and cost increases measurement consumption; driving enterprise adoption in the company's seeded accounts; growing the installed base through expansion of commercial channels; deepening the company's footprint into the rapidly growing bioprocessing market; and expanding the company's customer-driven pipeline of new point-of-need applications.
Products
MX908
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.
The company has sold 2,422 MX908s into every U.S. state, in 56 countries and across five continents. More than 10,000 operators, including in numerous domestic and foreign government agencies, have been trained to use the MX908.
The MX908 detects trace quantities of more than 160 named dangerous materials, including fentanyl and its many derivatives, explosives, and hazardous chemical agents with sensitivity comparable to existing field-based technologies, but with much higher specificity. This allows users to conduct rapid field analysis for a broad range of unknown substances at trace levels that would typically lead to confusion and false positives in other instruments. The device is also able to identify a far greater number of substances than other trace technologies and with one million times the dynamic range of those other handheld or mobile technologies. Compared to a leading transportable Mass Spec product, the MX908 is up to 15x faster, up to 10x smaller and up to 2x cheaper. The MX908 is able to start up in less than a minute, completing analysis of gas and vapor materials in less than ten seconds, and solids, liquids, and aerosols in less than a minute.
The MX908 was designed to operate in harsh outdoor environments such as pervasive rain and dust, and scorching to freezing temperatures in a nimble 4.3 kg (approximately 10 lb) handheld form factor. The company's systems also undergo extensive mechanical shock, drop, vibration, and environmental testing as part of the development and certification process.
Designed with the non-technical user in mind, the user interface on the MX908 requires no Mass Spec knowledge for navigation, operation or interpretation of results. The MX908 user interface is very mission driven. These mission modes provide a categorization of functionality, allow the device to guide operators through proper procedures with visual cues, and present results in a manner most relevant for that operational intent. The mission modes also allow the software to optimize the hardware operation of the MX908 to maximize sensitivity and specificity for a given class of chemicals, much as a laboratory chemist would do by changing the settings on their conventional Mass Spec.
The MX908's machine-learning software, enabled by the company's proprietary technology platform, serves as a critical element of the device. For example, one of the challenges associated with analyzing fentanyl derivatives is that there are potentially thousands of pharmacologically-active variants for this same compound. However, MX908 is pre-programmed to evaluate against the dozen most common fentanyl variants and is then able to utilize a machine learning classifier to look for characteristic mass fragment loss patterns that are suggestive of the more than 2,000 fentanyl analogs.
Since introducing the MX908, the company has 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. The company 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. The MX908 Beacon accessory leverages the MX908 and Aerosol Module combined with a cloud-based solution to enable remote identification of toxic chemical hazards. All these added capabilities are aimed to address gaps in responders' workflows, increase engagement, and drive utilization.
The company has 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.
Rebel
The Rebel is a small desktop analyzer providing real-time information on the extracellular environment in bioprocesses. Rebel provides results within seven minutes, enabling critical on-the-spot decisions regarding bioprocess media optimization, accelerating process-development cycles and maximizing bioreactor efficiency. Customers are using Rebel in environments subject to U.S. 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, the company has 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. The company's focus has been on increasing U.S. placements, but the company also has a meaningful international opportunity and have sold Rebels in China, Japan, South Korea and Europe.
Cells have been harnessed to serve as microscopic factories producing myriad molecular species large and small. 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. Making these products in an efficient and reproducible way remains a challenge to the company's customers in bioprocessing. Cell culture media forms the critical growth environment for the cell. The company's customers' measurement of this extracellular environment in bioprocesses is critical to their development and operational efficiency.
Rebel is configured to report concentrations of 33 critical extracellular metabolites in cell culture media, such as amino acids, vitamins, and biogenic amines, which are known to substantially affect the growth profile and properties of the resulting biological entities and their expressed materials. Incorporating our microfluidic sample handling and CE technology, as well as the company's microscale Mass Spec technology, Rebel's internal autosampler is capable of queueing approximately 96 such samples for unattended analysis and delivering reported concentrations for each sample.
A fit-for-purpose at-line system, the Rebel is designed to be located within the same laboratory as a bioreactor, enabling more frequent monitoring of key cell media parameters. To run this analysis, the Rebel requires as little as one microliter of cell culture media with little sample preparation. This allows customers to run more tests while preserving precious cell culture media, which is extremely valuable for small batches as used in cell therapy and personalized medicine.
The Rebel, using its onboard algorithms, eliminates the need for manual calibration and delivers processed and actionable results in real-time. As runs are completed, users can access the report either as a PDF print out or a laboratory information system compatible file exported to the network. The Rebel software is compliant for operation in GxP environments.
Maverick
The Maverick, launched in September 2023 to complement the company's Mass Spec technology, is an optical in-line analyzer that provides real-time monitoring and control of multiple bioprocess parameters, including glucose, lactate and total biomass, in mammalian cell cultures. The device also provides rich process fingerprint data to support large-scale efforts in predictive bioprocess modeling.
The Maverick utilizes Raman spectroscopy, a largely non-invasive and non-destructive technology that provides rich, chemical data. The use of Raman spectroscopy for characterizing critical process parameters, or CPPs, and critical quality attributes, or CQAs, in bioprocessing has grown considerably during the last 10 years.
Unlike conventional spectroscopic methods that utilize a multivariate empirical calibration approach requiring expert configuration, Maverick requires no complex modeling and can be set up in minutes. The company has developed a proprietary approach that it refers to as the de novo model, which means 'from the beginning.' Maverick's purpose-built de novo model automatically processes Raman spectra from a wide variety of cell culture media types and cell lines, thereby delivering actionable process parameters or direct process control actions. The company also provides open access to the raw spectral data enabling spectroscopic experts to extend the device's capabilities for more advanced predictive control of CPPs and CQAs.
The Maverick hub can monitor up to six bioreactor models simultaneously, with independent analog/digital control of feed systems for each. Remote, real-time web access to bioreactor status and settings is also supported through the Maverick hub. As a spectroscopic-based device, Maverick is extensible to other analytes and parameters.
Maverick enables biopharmaceutical process development scientists and manufacturers to enhance understanding of their process and implement dynamic control strategies more quickly and easily, which can accelerate workflows and improve process efficiency.
Maven and Trace C2
The Maven, launched in January 2023, to complement the company's Mass Spec technology, is its 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.
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. The Maven is Good Manufacturing Practices, or GMP, compliant, takes up a small footprint, and in keeping with the company's focus on simplicity, is easy to use. Maven can be used in concert with its 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 Analytics GmbH, which the company acquired in August of 2022.
ZipChip
The company's ZipChip solution is a plug-and-play, high-resolution separation platform that optimizes Mass Spec sample analysis. The company's ZipChip platform consists of a ZipChip Interface, which is installed into a conventional Mass Spec instrument, and consumable microfluidic chips, or ZipChips. The company designed this technology to be compatible with third party Mass Spec instruments. Powered by its integrated microfluidic technology, the ZipChip platform allows researchers to consolidate a host of time-consuming biotherapeutic, metabolomic, and proteomic applications typically run on multiple instruments or configurations onto a single platform. 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, the company has sold 234 ZipChip Interfaces and have established 28 multi-unit accounts in leading, global pharmaceutical organizations and academic institutions. The company's 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 the company the ability to leverage the growing list of newly established applications and publications from customers who have incorporated the device into their projects. By incorporating select assays investigated on the ZipChip by customers into its MX908 and Rebel devices, the company can create an evolving pipeline of new customer-driven, point-of-need Mass Spec applications as the scope of analytes its devices can detect and analyze will continue to expand. The company has already incorporated a number of the customer-driven assays in its MX908 and Rebel devices, and it is investigating several more for its future product pipeline.
Consumables and Services
Handheld Device
The company's MX908 comes with a standard warranty for up to one year from purchase. The company's customers also can purchase extended warranty service plans, which include hardware repair and replacement coverage, technical support, and software updates. It designed the MX908 to be intuitive and easy-to-use, as it is critical to its customers to know that the MX908 is operating as intended. The annual and extended warranty service plans provide the customer the ability to contact the company to assist in validating their results given the severity and context of the situations in which its devices operate.
For simplicity and convenience, the company also sells single-use swab samplers for the analysis of liquid and solid materials. These swab samplers are most heavily used today by customers who are evaluating drug substances. However, the company designed the MX908 so that it does not require swab samplers or any other consumables for a number of other applications. The company's customers value the low-logistics tail of its MX908.
Desktop Devices
Annual and extended warranty and service plans are available for the Rebel, Maven, Maverick, ZipChip Interface, and Trace C2 devices.
Rebel's operation requires a consumable kit that includes a microfluidic and separation chip, electrolytes, and performance qualification and calibration standards. 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.
The company also offers an annual certification kit for the Rebel. The certification kit is shipped to the customer, who loads the provided samples, and executes a certification protocol. The system is remotely qualified and certified based on the data acquired meeting factory specifications.
Calibration kits are required for the Maverick.
The company offers 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, charge variance, metabolomics, peptide and oligonucleotides.
Consumable sets of buffers, probes and biosensors are required for the Maven, Trace C2 and related sampling devices.
Customers
The company sells its products worldwide through an experienced direct sales force as well as through domestic and international channel partners. The company's customers are primarily in the pharmaceutical and biotech market, the government market and to a lesser extent, the academic market. Primary users of its handheld device include law enforcement, military and civilian first responders, and customs and border protection personnel. Primary users of the company's desktop devices include process development scientists, process engineers, and research scientists.
Sales and Marketing
The company distributes its devices and consumables via direct field sales and support organizations located in North America and through a combination of its own sales force and more than 42 third party channel partners in domestic and international markets which include Australia, Canada, China, Czech Republic, Germany, Japan, Saudi Arabia, Singapore, Turkey, and the United Kingdom, or the U.K. In North America, the company uses channel partners to provide its products to end customers where a contract vehicle is required. Since the commercial launch of its first handheld, the installed base of its devices has grown to more than 2,800 devices across more than 56 countries.
The company's domestic sales force and international partners inform its current and potential customers of product offerings, new target applications, and advances in its technologies and products. As its primary point of contact in the marketplace, the company's sales force focuses on delivering a consistent marketing message and high level of customer service, while also attempting to help it better understand the evolving market and customer needs.
The company intends to expand its sales, support, and marketing efforts in regions with a concentrated life sciences presence, including large pharmaceutical and biopharma companies. For example, in 2023, the company established a direct sales footprint in Europe for its desktop products, and have developed a sales, training and support network in China. The company plans to continue to expand into these regions via initial penetration with channel partners and then subsequent support with direct sales and support personnel.
The company's 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. As a result of these factors, and the budget cycles of its customers, the company's sales cycle can often be six to twelve months, or longer. The company's Rebel and Maverick devices are relatively new to the life science marketplace and require a capital investment by its customers.
Research and Development
The company's research and development expense totaled $21.9 million in the year ended December 31, 2023.
Competition
The company has 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.
Intellectual Property
As of December 31, 2023, the company's owned patent assets included approximately 19 U.S. patents, no pending U.S. patent applications, 45 foreign patents and four pending foreign patent applications in various foreign jurisdictions, including Australia, Austria, Canada, China, France, Germany, the European Union, or EU, Hong Kong, Israel, Japan, South Korea, Singapore, Switzerland and Taiwan. The subject matter covered by the company's 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.
As of December 31, 2023, the company's in-licensed patent assets included approximately 29 U.S. patents, one pending U.S. patent application, 22 foreign patents, and two pending foreign patent applications. The subject matter covered by the company's 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. Excluding any patent term extension, the issued 908 Devices-owned patents are expected to expire between 2032 to 2038. The issued in-licensed patents are expected to expire from 2023 to 2039.
As of December 31, 2023, the company owned six registered trademarks in the United States, 17 registered foreign trademarks, three U.S. pending trademark applications, and two pending foreign trademark applications. The company's registered trademarks and pending trademark applications include trademarks for 908 Devices, Rebel, MX908, ZipChip, Maven, Maverick, and its logo. In order to supplement protection of the company's brand, it has also registered several internet domain names.
Licensed IP
University of North Carolina, Chapel Hill
In June 2012, the company entered into a license agreement, which was subsequently amended in April 2013 and August 2014, and then amended and restated in May 2015, which it refers to as the UNC Agreements, with the University of North Carolina, Chapel Hill, or UNC, pursuant to which UNC granted the company an exclusive, sublicensable, worldwide license to develop, manufacture, use, and commercialize products, services and methods, covered by certain patent rights owned by UNC, including patents related to a microfabricated ionization source and a microfabricated ionizer chip. The company is obligated to use commercially reasonable efforts to develop, manufacture and commercialize the Licensed Products and achieve defined milestones within the UNC Agreements.
Regulations
The company's products are dual-use items with both military and civilian applications. These products are subject to the U.S. Export Administration Regulations, or EAR. The company must determine whether ITAR or EAR governs each of its products, services, and technologies.
With the commencement of the initial production phase of the company's Aerosol and Vapor Chemical Agent Detector, or AVCAD, program to support safety missions for the U.S. military and Coast Guard, it determined that certain spectral databases, algorithms, libraries and alarm set point levels built into its AVCAD software were subject to International Traffic in Arms Regulations (ITAR), and it registered as a manufacturer with the Directorate of Defense Trade Controls, or DDTC, of the Department of State.
Under generally applicable U.S. trade regulations administered by the Office of Foreign Assets Control, or OFAC, of the U.S. Department of the Treasury, the company is generally prohibited from engaging in transactions involving sanctioned countries, as well as certain persons and entities that have been designated for targeted sanctions by OFAC. EAR and ITAR also impose export restrictions targeted at identified persons and entities, and the company is required to comply with these restrictions as well.
History
908 Devices Inc. was founded in 2012. The company was incorporated in the state of Delaware in 2012.
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