Press Release:

In Vivo Imaging Company, SOFIE Biosciences, Raises $5M Series A

CULVER CITY, CA – OCTOBER 15th, 2013 – Sofie Biosciences (SOFIE), a diagnostics company that provides molecular imaging probes and devices to help scientists and physicians investigate the biology of disease, announced today that it has raised $5M in a Series A financing.

Based on their belief in the SOFIE team, the founders, and the technology, Tata Industries through its wholly owned subsidiary, led the Series A round, with other existing investors including MRM Capital and the Cycad Group. These funds will be used to further develop technologies to reduce the cost and complexity, while increasing the availability of Positron Emission Tomography (PET) imaging and its application base. One of the most promising developments is a self-shielded microfluidic chip-based synthesizer for on-demand PET probe production.

“Closing the Series A is an important milestone for SOFIE. It will augment revenue from our growing instrument business, as well as funds brought in by grants and contracts, including $1.8M awarded this month by the NIMH. Together, these will enable the team to accelerate and expand SOFIE’s product pipeline,” said President & CEO, Patrick Phelps.

A spinout of UCLA and Caltech, SOFIE was founded in 2008 by a group of scientists, physicians, and industry professionals who have long worked toward increasing the diversity and value of PET imaging probes by removing barriers that limit access.

About Tata Industries
Tata Industries promotes the Tata group’s entry into new and high-technology businesses. It has initiated and promoted several Tata ventures in sectors like control systems, IT, auto components, advanced materials, telecom hardware and services. The Tata group, which champions deployment of technology for consumer-centric benefits, operates in seven business sectors: materials, engineering, IT and communications, energy, services, consumer products and chemicals.

About Tata Group
The Tata group comprises over 100 operating companies in seven business sectors: communications and information technology, engineering, materials, services, energy, consumer products and chemicals. The group has operations in more than 80 countries across six continents, and its companies export products and services to 85 countries. The total revenue of Tata companies, taken together, was $100.09 billion (around Rs. 475,721 crores) in 2011-12, with 58 percent of this coming from business outside India. Tata companies employ over 450,000 people worldwide. The Tata name has been respected in India for more than 140 years for its adherence to strong values and business ethics. Every Tata company or enterprise operates independently. Each of these companies has its own board of directors and shareholders, to whom it is answerable. There are 32 publicly listed Tata enterprises and they have a combined market capitalisation of about $100.54 billion (as on October 3, 2013), and a shareholder base of 3.9 million. The major Tata companies are Tata Steel, Tata Motors, Tata Consultancy Services (TCS), Tata Power, Tata Chemicals, Tata Global Beverages, Tata Teleservices, Titan, Tata Communications and Indian Hotels. For more information, visit: www.tata.com.

About Cycad Group
Cycad Group is a venture capital firm focused on investments in companies with enabling solutions, disruptive technologies and innovative products. We actively pursue investment opportunities in the life sciences, energy production, advanced materials and chemical processes. With experience investing in all phases of development, from start-up through PIPE transactions, Cycad Group seeks opportunities to work with exceptional entrepreneurs creating technology-driven businesses. For more information, visit: www.cycadvc.com.

Press Release:

SOFIE Bio recieves $1.8M Phase II SBIR grant

CULVER CITY, CA., October 2nd, 2013 – SOFIE BIOSCIENCES, an emerging in vivo imaging diagnostics company focused on Positron Emission Tomography (PET) probes, scanners and chemistry systems, announced today that the National Institute of Health has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase II award, for approximately $1.8M over three years, will be administered by the National Institute of Mental Health (NIMH) to support the development of the first digital chip technology for the rapid and easy synthesis of PET probes for neurobiology applications.

“This award is further validation of the potential for digital microfluidics to have a significant impact in research and patient care. It also comes in the wake of Illumina’s acquisition of Advanced Liquid Logic for next-generation sequencing based on the same digital fluidic handling principle known as electrowetting on dielectric (EWOD)”, said Patrick Phelps, President & CEO.

By developing a point-of-care radiosynthesizer that integrates the many unit operations for synthesis, purification, and quality control into a benchtop, affordable device, scientists and physicians in diverse fields may now have access to the vast library (3,000+) of PET probes without the normal infrastructure of prohibitively expensive equipment and specialized personnel that is currently a roadblock to using PET. The technology in this grant will provide researchers and clinicians additional tools to study the brain in normal and diseased states, and subsequently develop therapeutics to improve patient quality of life.

These funds will augment internal R&D investment, allowing the company to accelerate the commercialization of a microfluidic-based radiosynthesizer for synthesizing PET probes on-demand for brain imaging and other applications. Dr. Melissa Moore, Senior Director of Technology Development, who will be the Principal Investigator working in close collaboration with sub award investigator, Dr. R. Michael van Dam, at UCLA, commented, “We are so fortunate, especially in the current funding climate, to be awarded this Phase II from the NIMH, signaling their support to bring a revolutionary technology to market. We believe that miniaturizing all aspects of radiosynthesis, including shielding and reaction volumes, is a critical step to providing the freedom to synthesize PET probes on demand in a fully-automated, reasonably priced package.”

Press Release:

SOFIE Biosciences receives $1M Phase II SBIR grant from the DOE

CULVER CITY, Calif., July 11, 2012 — Sofie Biosciences, Inc., a molecular imaging company offering a comprehensive range of products from preclinical imaging systems to novel diagnostic PET imaging probes, announced today that the Department of Energy has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase II award, for approximately $1M, will support the development of a microscale technology for rapid, easy synthesis of PET probes.

Presently, scientists and clinicians must accept the limitations of the centralized radiopharmacy model of PET probe production and distribution, where a limited number of probes are available from radiochemistry cores or, more often, commercial radiopharmacies that provide an even smaller menu from which to choose. The end result is that the average investigator is restricted to a handful of PET probes, namely [18F]FDG, [18F]NaF, and occasionally [18F]FLT, leaving the 1,600+ probes that have been synthesized just out of reach, thus drastically limiting the translational power of PET to a few disciplines and applications.

“We are extremely pleased to be recognized with this highly competitive award from DOE,” said Patrick W. Phelps, President and CEO. “It’s an important step to further the development of a proprietary, game-changing technology that will provides researchers and clinicians with a first-generation device for the production of one-pot PET probes.”

These funds will be invested alongside Sofie resources to help broaden access to novel PET probes to answer fundamental biological questions in disease. “Winning this grant from DOE both supports and accelerates our efforts to bring radiochemistry-on-chip to market, a critical step in Sofie’s vision of creating a transformative technology of an affordable, compact, easy-to-use system for the on-demand production of PET probes,” commented Dr. Melissa Esterby, Director, Technology Development, who will be the Principal Investigator working in close collaboration with co-PI and inventor Dr. R. Michael van Dam at UCLA.

Press Release:

SOFIE Biosciences launches ELIXYS, a new generation of automated radiochemistry for producing PET imaging probes

CULVER CITY, CA., June 4, 2012 – Sofie Biosciences, Inc., specializing in the development of in vitro and in vivo PET imaging systems and probes, introduces ELIXYS, the newest addition to their product pipeline. Formally debuted at this week’s 2012 Society for Nuclear Medicine Annual Meeting, ELIXYS is an automated radiochemistry platform for the production of a diversity of PET probes, including [18F]FAC and analogs, SOFIE’s proprietary class of imaging probes.

Positron Emission Tomography (PET) is a medical imaging modality that utilizes radiolabeled molecules (“probes”) to target and measure biological and pharmacological processes. Basic scientists can use the same probes to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy in cells and mice as clinicians do in patients. Over 1,600 PET probes have been developed, but only a few are routinely used. This is largely due to the complexity of synthesis, which inhibits the probe discovery and development processes in research and clinical trials. The solution to this problem requires technology innovation in radiosynthesizers, as well as breakthroughs in synthesis methods to provide rapid, site-directed labeling with high yields on a single platform capable of synthesizing a diversity of PET probes. This is also a requirement for the transition from R&D to a standardized protocol for routine production in commercial PET radiopharmacies.

ELIXYS is a novel approach to radiosynthesis. Its multi-reactor system features disposable cassettes for simplicity of operation, high-temperature and high-pressure capabilities, on-demand reagent delivery, radiation sensors and reactor vial cameras to monitor synthesis processes, between-reactor purification, an automated HPLC injection valve, and intuitive, unit operation-based software for use on tablets and smartphones, such as the iPad and iPhone. With very little effort, ELIXYS enables the end user to quickly transition between different syntheses by simply changing cassettes, reagents, and selecting software protocols.

“Fundamentally, ELIXYS is a different way to approach radiochemistry,” said Patrick Phelps, SOFIE’s President and CEO. “ELIXYS was born out of our own need to develop and synthesize diverse classes of probes. SOFIE, with our collaborators at UCLA and Caltech, are excited to share this novel technology platform with a large community of scientists and clinicians interested in expanding the diversity of PET probes to answer a vast array of biological questions.”

Learn more about ELIXYS >>>

Press Release:

SOFIE Biosciences receives Phase I SBIR grant from the NIH/NIMH

CULVER CITY, CA., April 24th, 2012 – Sofie Biosciences, Inc., a molecular imaging company offering a comprehensive range of products from pre-clinical imaging systems to new PET diagnostic imaging probes, announced today that the National Institute of Health has awarded the company a grant under the Small Business Innovation Research (SBIR) program. This Phase I award, for approximately $150,000, will be administered by the National Institute of Mental Health (NIMH) to support the development of a microscale technology for the rapid and easy synthesis of PET probes for neurobiology applications.

Presently, scientists and clinicians must accept the limitations of the centralized radiopharmacy model of PET probe production and distribution, where a limited number of probes are available from radiochemistry cores or, more often, commercial radiopharmacies that provide an even smaller menu from which to choose. The end result is that the average investigator is restricted to a handful of PET probes, namely [18F]FDG, [18F]NaF, and occasionally [18F]FLT, leaving the 1,600+ probes that have been synthesized just out of reach, thus drastically limiting the translational power of PET to a few disciplines and applications.

“We are extremely pleased to be recognized with this highly competitive award from NIH,” said Patrick W. Phelps, President and CEO. “It’s an important step to further accelerate the development of a proprietary, game changing PET probe synthesizer that provides researchers and clinicians with an affordable, compact, easy-to-use, disposable, chip-based radiosynthesizer for on-demand production of PET probes on the bench.”

These funds will be invested alongside SOFIE resources to help broaden access to novel PET probes to answer fundamental biological questions in disease, especially with respect to those relevant for brain imaging. “Winning this grant from NIMH both supports and accelerates our efforts to bring radiochemistry-on-chip to market, a critical step in SOFIE’s vision of creating a transformative technology that ultimately expands the use of PET imaging beyond the few probes that are commercially available,” commented Dr. Melissa Moore, Director of Technology Development, who will be the Principal Investigator working in close collaboration with co-PI Dr. R. Michael van Dam at UCLA.

Press Release:

SOFIE Biosciences is awarded a US patent on a family of novel PET probes for use in oncology and immunology

CULVER CITY, CA., January 11, 2012 – Sofie Biosciences, Inc., offering a comprehensive range of technologies from pre-clinical imaging systems to the development new molecular imaging probes to better understand human disease, will be granted a U.S. Patent (Number 8,101,740) from the United States Patent Office. The patent, which will issue on January 24, 2012, covers a family of novel PET probes, including 1-(2’-deoxy-2’-[18F] FluoroArabinofuranosyl)Cytosine ([18F]FAC).

Positron Emission Tomography (PET scan) is an advanced scanning technology that utilizes labeled molecules (“probes”) to target and measure biological processes. Basic scientists can use the same probes to examine cells and mice as physicians do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy.

Researchers and clinicians at UCLA identified this novel PET probe, [18F]FAC, which was created by altering the molecular structure of gemcitabine, one of the most common chemotherapy drugs. Its action is based on the DNA salvage pathway – a fundamental biochemical pathway that helps with DNA replication and repair. For example, cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. These cancer cells no longer have the normal checks and balances in place limit cell division. FAC measures this process of malignant transformation from normal to disease. By preventing DNA replication and repair, cancer drugs may shutdown the spread of disease. Ultimately, FAC could help find physicians find tumors that will respond to certain drugs (like gemcitabine), thus enabling more patient-specific treatments. Cells that initiate immune response also use this pathway and show differentiation uptake of FAC. Such a non-invasive imaging tool could help doctors more effectively model and measure the immune system over time.

“FAC is an amazing probe. It targets one enzyme and when you take that one enzyme out, the molecule is not promiscuous. Compound displays fast in vivo clearance, rapid accumulation, sufficient in vivo stability, good bioavailability, and low (or zero) immunogenicity and toxicity in humans. Making FAC available for broad use in both academic and commercial research communities will be fundamental to success.” said Patrick Phelps, Sofie’s President and CEO.

Sofie has obtained an exclusive license from The Regents of the University of California. Three investigational new drug (IND) applications have been approved for these probes and clinical trials are ongoing.

Press Release:

SOFIE Biosciences is awarded a DOE Phase II SBIR to commercialize microscale radiochemistry

CULVER CITY, CA., July 7th, 2011 – Sofie Biosciences, developer of molecular imaging systems and probes, has been awarded a 2011 Phase I Small Business Innovation Research grant from the Department of Energy. Of the 2,163 applications received in response to their funding notice, only 197 were selected to receive Phase I grants.

Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (“probes”) to target and measure biological processes. Basic scientists can use the same probes to examine cells and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Over 1,600 PET probes have been developed to help answer a variety of biological questions, but only the glucose analog ([18F]FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel.

A decentralized approach to PET probe development is essential to give scientists and clinicians the freedom to determine what probes they want to use to solve the problems of their interest. This goal can be achieved by building a benchtop, PC-controlled, microscale chip-based commercial device for the on-demand production of PET probes, as is the focus of the grant.

“Winning this award enables our company to further accelerate the development of a truly disruptive technology that will allow researchers and physicians to make whatever PET probe they desire, onsite, and in a cost effective fashion,” said Patrick Phelps, Sofie’s President and CEO.

Creating a point-of-research/point-of-care distribution model is a transformational solution that empowers scientists and clinicians to control the development and use of PET probes as an alternative to the well-established centralized model. Sofie’s line of molecular imaging systems, radiochemistry modules, and probes enable PET to be more widely accessible, cost-effective, and convenient for integration into a variety of labs.

Press Release:

SOFIE Biosciences raises $2M to support development of diagnostic imaging agents and devices

CULVER CITY, CA, Tuesday, December 7th, 2010 – Sofie Biosciences, a developer of agents and devices for the molecular imaging of disease, announced today the closing of an additional $2 million from new and existing investors. Funds will be used for the development of new PET imaging agents and for enhancements to their PET imaging systems and chemistry units. The round includes the first institutional and large corporate financing to the firm including investment by the Cycad Group.

“This investment represents an important step towards achieving our goal of rapidly commercializing new PET technologies and imaging agents in an effort to make PET more widely accessible to more physicians and scientists,” said Patrick Phelps, President and CEO of Sofie.

Sofie Biosciences’ efforts are largely geared toward the development of novel PET probes, which physicians use to diagnosis, stage, and monitor a variety of diseases as well as for better management of a patient’s treatment.

Sofie has obtained an exclusive license from the University of California to a family of PET molecular imaging agents collectively referred to as FAC. FAC has been shown in preclinical animal research and early patient studies to have promise as a whole-body, noninvasive means of determining whether a cancer patient will respond to a class of therapeutics known as nucleoside prodrugs. At present, this class of drugs is widely used in patient care, and is the subject of a large number of current clinical trials. FAC also shows early indications that it will be the first means available to image the activation of the immune system and the organ distribution of immune response to diseases, immunotherapies, infections, and organ rejection over time.

Rather than focusing its initial commercialization efforts on the expensive clinical development of imaging probes, Sofie has made it a priority to first make PET imaging technology, like its bench-top small animal PET scanner, GENISYS, and the preclinical use of its FAC agent, more widely accessible to researchers. They hope this will lead to further utilization of PET, increased adoption of Sofie’s agents into cutting edge research, and eventually in the clinic, which will further fuel the adoption of this potentially life saving medical imaging technology.

Press Release:

SOFIE Biosciences and OsiriX announce the release of open source transitional image analysis software

CULVER CITY, CA., Friday September 3, 2010 – Sofie Biosciences, a molecular imaging company focused on empowering people with new PET technologies, announces a partnership with the image analysis software group the OsiriX Foundation. Under the agreement, researchers and clinicians will now be able to review preclinical and clinical image data on one comprehensive analysis platform across multiple modalities.

Recently, Sofie Biosciences introduced GENISYS™, the first high-performance, benchtop, cost effective small animal PET system. GENISYS offers a PET imaging solution to complement existing preclinical experiments. By delivering turnkey operation and streamlined workflow, GENISYS uncouples researchers from their dependency on others, allowing for study design and data output on their terms. With the integration of GENISYS and OsiriX, researchers and clinicians now have a valuable translational image analysis tool.

“Sofie Biosciences believes in the mission of OsiriX to lead a paradigm shift in software development with a trend toward sharing and cooperation in the development of imaging software applications,” said Patrick Phelps, President & CEO, Sofie Biosciences. “Sofie worked closely with the OsiriX team to deliver a preclinical tool kit to enhance their existing suite of advanced analysis features. Together, GENISYS and OsiriX address the unmet needs of researchers and clinicians in molecular imaging. This is an important first step in building a community of developers around GENISYS.”

Press Release:

SOFIE Biosciences unveils a new generation of preclinical PET imaging – The GENISYS

CULVER CITY, CA, Thursday October 1, 2009 – Sofie Biosciences, a molecular imaging company focused on next generation PET technologies, launched its GENISYS system last week at the 2009 World Molecular Imaging Congress in Montreal.

PET continues to be one of the fastest growing techniques in imaging with widespread adoption into preclinical research. GENISYS is not just another high performance preclinical PET system; it’s a novel class of PET imaging designed for a new generation of user.

Investigators from biology and medicine are looking for a research tool that provides an in vivo assay to compliment the wide array of in vitro assays. As a high throughput, benchtop PET system, GENISYS provides critical information with minimal infrastructure and cost. Turnkey installation and user-friendly operation mean GENISYS delivers in all University, biotech, and pharmaceutical settings. Integration of physiologic control with measurement output provides researcher’s with reproducible, quantitative information without the use of traditional, expensive hardware architectures. GENISYS is a valuable alternative to conventional preclinical systems.

“PET should be less complicated and available to anyone who wants to incorporate it into their research routine,” said Patrick Phelps, President & CEO, Sofie Biosciences. “Sofie worked closely with the UCLA Crump Institute to develop a next generation PET system that provides people with beautiful images and the output they desire, all within an imaging device that manages the health of your animal. I believe the GENISYS system meets a major unmet need in the maturing field of molecular imaging.”

Update: Please note that SOFIE no longer manufactures the GENISYS PET scanner. The updated product is the G4 PET/X-RAY.