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Company Background

Firefly is introducing a universal technology platform for biomarker detection with a broad range of applications in life sciences, agriculture, veterinary medicine, and human diagnostics. Firefly BioWorks is a spin-out of the Chemical Engineering Department at the Massachusetts Institute of Technology (MIT), where the founders developed a novel method for high-throughput production of complex microparticles. The company began operations in 2010 and grew to seven full-time employees through a combination of SBIR awards and angel funding. The company is focused on developing multiplexed assays for biomarker detection that scale from discovery to clinical diagnostics. The company has adopted a lean startup approach. The first minimum viable product is being launched and operations will be scaled according to demand.

Technology Overview

Firefly develops and manufactures next-generation microparticles for biomolecule detection. The company’s first product, a kit for detecting microRNA aimed at the research market, has just been launched commercially. Firefly’s core technology, Optical Liquid Stamping, was developed by combining photolithography (typically used in microchip production) with microfluidics. This method allows fabrication of microparticles with virtually any shape, chemistry, and biofunctionality. Using Optical Liquid Stamping, Firefly developed a barcoded particle architecture that enables multiplexed biomarker detection on standard laboratory instrumentation. Through the support of the NCI SBIR Program, Firefly developed a particle-based assay for high-throughput profiling of microRNAs, a class of molecules with enormous potential for early diagnosis of cancer. 

Market Potential 

Firefly operates in the global market for biotechnology tools, a market that generates approximately $70 billion in worldwide sales. Firefly developed its first product for microRNA profiling, a market currently estimated at approximately $100 million and expected to grow very rapidly. Several market surveys indicate that bead-based assays for high-throughput/mid-multiplexing profiling are expected to address a critical need in the industry and grow at the fastest rate, especially in the area of microRNA.

Competitive Advantage

The Firefly platform enables detection of clinically relevant biomolecules with an unprecedented combination of performance, flexibility, throughput, and cost. Additionally, the assay developed by Firefly allows direct detection of miRNA in clinical samples without purification. This eliminates protocol discrepancies in RNA purification and will likely lead to more reliable diagnostics.

Beyond microRNA, Firefly’s platform has been used for the detection of disease-related proteins, mRNAs, and genomic DNA. The technology naturally lends itself to simple bedside or handheld devices that can be used in routine screens for early disease detection or point-of-care diagnostics.

Financial Overview

Initial funding was provided by two Phase I SBIR awards, for a total of about $500,000, followed by a seed round of $1 million from angel investors. In August 2011, Firefly was awarded a $2 million NCI SBIR Phase II award that catalyzed a $2 million second round of angel funding used for commercial development in the research market. Firefly seeks an industry partner to adopt the company’s technology and estimates additional funding in the $10 to $20 million range is required to expand its diagnostics capabilities.

Intellectual Property

Firefly has obtained an exclusive license from MIT for use of its technology in any research or clinical diagnostics application. The company’s current IP portfolio comprises four issued patents and 16 pending applications, covering the entire value chain of Firefly products from particle fabrication, encoding and bio-functionalization, to custom microRNA assays and readout in standard instrumentation.

Commercialization Strategy

Firefly’s long-term goal is to become a trusted provider of reliable and cost-effective solutions for clinical diagnostics. The company plans to first establish a presence in the research market and eventually enter the diagnostics field. Firefly intends to grow the company in three phases:

• Selling initial products to leading academic laboratories.
• Partnering with flow cytometry manufacturers for co-marketing of products.
• Expanding the product offering to include diagnostic applications by partnering with content developers in the cancer space.

Pipeline Products

Firefly’s first product is a custom 25-plex microRNA profiling kit that can be used on standard benchtop cytometers. The next generation of products will offer expanded multiplexing, a larger set of supported cytometers, and sensitivity that rivals polymerase chain reaction (PCR). Once the company has proven the technology in the field of microRNA, it will enter the protein market, with a set of companion products with relevance in both research and diagnostics.

Management Team

Firefly has built a team of executives and business advisors with deep expertise in molecular assays, microfluidics, materials, computer science, flow cytometery, and protein science, with roots in both start-ups and large life-science corporations. The team includes:

Operational Team:

Davide M. Marini, Ph.D., Co-founder, Chief Executive Officer

Daniel C. Pregibon, Ph.D., Co-founder, Chief Technology Officer

Andreas Windemuth, Ph.D., Chief Information Officer

Isaac B. Stoner, Vice President of Product Development

Andrea K. Bryan, Ph.D., Director of Engineering

Directors: 

Roger Dowd and Rick Ryan

Business Advisory Board: 

Joseph Gentile, Martin Madaus, Ph.D., Paul B. Manning, Ian Ratcliffe, and Michael P. Rubin, M.D., Ph.D.

Scientific Advisory Board: 

David P. Bartel, Ph.D., and Patrick S. Doyle, Ph.D.

Company Background

Nortis is dedicated to developing a new generation of in vitro systems that are based on small segments of tissues and organs grown from human-derived cells in disposable, chip-like devices. Such human “body-on-a-chip” systems represent urgently awaited alternatives to laboratory animals and are expected to become the gold standard for the testing of drugs, vaccines, toxic compounds, cosmetics, and warfare countermeasures.

The Nortis project started in 2005 as a division within VisionGate, a bio-imaging company. In 2011, Nortis, Inc., was officially spun-off and subsequently moved into its new facilities at a biotech incubator on the University of Washington campus. As of January 2012, the Nortis team consists of 10 full- and part-time employees and consultants.

Technology Overview

Nortis is developing products that will overcome a crucial bottleneck in the development of therapeutic drugs and vaccines. Due to the lack of reliable in vitro assays, drug development depends heavily on animal testing for predicting efficacy, safety, and pharmacokinetics in humans. This is problematic for several reasons. Testing in animals is expensive and fraught with ethical concerns. Most importantly, the results obtained with animals often don’t translate to humans. 

Nortis has pioneered proprietary techniques for the in vitro creation of human tissues and organs in disposable chip-like devices. These organ microenvironments are designed as disposable modules, to be used as single assays or integrated in fluidic circuits that connect several different organ modules in various configurations as needed for the testing of drug/vaccine efficacy, toxicity, and pharmacokinetics. Nortis established proof-of-principle for their technology through a completed SBIR Phase I grant. Nortis anticipates their first products to enter the market within two to three years.

Market Potential 

Market analysis for the first two Nortis assays, a model of the blood-brain-barrier assay and an angiogenesis assay, were prepared by Foresight Science & Technology, a leading technology commercialization and transfer firm. The combined yearly revenue potential for the two assays was predicted to exceed $400 million. The market potential of the other tissue/organ assays has not yet been evaluated, but is expected to have the same magnitude.

Competitive Advantage

Nortis’ tissue and organ models differ significantly from other body-on-a-chip approaches. The competitive advantage of Nortis’ technology arises from the integration of living vasculature, which can be directly perfused to mimic blood flow. This unique feature allows for the study of vascular growth and function in real time, reducing the need for expensive and laborious animal testing. Vasculature is a structural and functional key element of almost every tissue. Thus, Nortis’ assays are poised to produce test results that better replicate in vivo conditions and predict clinical outcome. Notably, the Nortis system is ideally suited for administering test compounds either through the vessel lumen or through the surrounding microenvironment. This is especially important for the testing of drugs, toxins, and vaccines. Nortis’ assays are modular and can be set up in flexible configurations with anticipated widespread adoption in various research areas, including high-throughput drug screening.

Financial Overview

The development of Nortis’s first commercial assays were supported by three NCI SBIR Phase I grants. The company aims to raise an additional $1 million in private investment this year to support R&D efforts until SBIR Phase II grants are secured in 2013. 

Intellectual Property

Nortis owns two issued U.S. patents, and two U.S. applications that were filed on this technology to cover additional features and techniques. International patent applications in important global markets are currently undergoing the examination process. Nortis is the sole owner of all related IP. 

Commercialization Strategy

Nortis plans to introduce the first assays and basic perfusion platforms into the scientific research market during the second half of 2014 — ideally by partnering with a company with established sales structures in this area. Nortis anticipates that the success in the scientific research market will translate to adoption in the area of commercial drug development. 

Pipeline Products

The first line of products will include a blood-brain-barrier assay, an angiogenesis assay, a metastasis assay, as well as a perfusion platform in which the assay modules can be inserted. 

Management Team

Thomas Neumann, M.D., is President and CEO of Nortis. His career path includes clinical work, academic appointments, and leadership positions in industry, where he has gained extensive experience in directing multidisciplinary teams. He and Dr. Nelson are the founders of Nortis.

Alan Nelson, Ph.D., Chairman, held multiple prestigious academic positions. He is a dynamic serial entrepreneur. His first biomedical company, Neopath, won landmark FDA approval in 1995, had an initial public offering (IPO) in 1996 and was sold to Becton Dickinson in 2000.