Bionano Announces Full Commercial Release of the Stratys™ System for High Throughput Optical Genome Mapping

Bionano has completed the early access program for the Stratys™ system and is now making it available in a full commercial release
The Stratys instrument can enable up to a four-fold increase in raw data generation rate compared to the Saphyr® instrument and can process up to 12 single access chips, accessible as they complete runs, without the need to batch multiple samples on a consumable
Data analysis for the Stratys system is powered by Stratys™ Compute, a high-performance workstation developed in collaboration with NVIDIA
10 users across Canada, the United States, Europe, and Saudi Arabia have adopted a total of 11 Stratys systems as part of an early access program

SAN DIEGO, Jan. 23, 2024 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the full commercial release of the Stratys™ system, the Company’s system for high throughput optical genome mapping (OGM).

As part of an early access program, the following 10 sites have adopted a total of 11 Stratys systems:

BC Cancer – Vancouver (Vancouver, British Columbia)
Hamilton Health Sciences (Hamilton, Ontario)
Henry Ford Health System (Michigan, United States)
National Guard Hospital (Riyadh, Saudi Arabia)
NHS Northwest Genomic Laboratory Hub (Manchester, United Kingdom)
Radboud University Medical Center (Nijmegen, Netherlands)
UZ Brussel and Cliniques universitaires Saint-Luc (Brussels, Belgium)
Vancouver General Hospital (Vancouver, British Columbia)
Additional sites that Bionano is not able to name publicly include a United States-based high-volume centralized reference laboratory and a United States-based leading academic medical center specializing in cancer treatment

Alexander Hoischen, PhD, associate professor of genomic technologies at Radboud University Medical Center, commented, “The data quality for Stratys matches the high standards of the established Saphyr^® system, and the newly achieved throughput is amazing. Stratys is the next evolution of OGM, with significantly and impressively improved throughput. This scalability aligns nicely with recently achieved automated lab workflow for DNA isolation and improved automated analysis and reporting through VIA™ software. Smart design also allows higher flexibility and faster processing per sample when compared to the Saphyr system. I am convinced Stratys will enable even more innovative clinical research applications, particularly medium to high throughput analysis, and may even have the potential to enable diagnostic applications in the future. At Radboud University Medical Center, we are excited to stay at the forefront of OGM use for heme-oncology as well as rare disease discoveries.”

Bionano’s Stratys system for OGM offers increased flexibility and throughput capabilities to address the needs of mid and high-volume users. The throughput of the Stratys instrument is up to four times greater than that of Bionano’s Saphyr^® instrument, it is compatible with the latest G2 chemistries, and has a potential sample-to-answer time of 3 days for hematological samples interrogated across the whole genome at high sensitivity to rare variants. The system is designed for maximum lab flexibility by enabling up to 12 single sample chips, each with the ability to collect data for a different application, accessible as they complete runs, and without the need to batch multiple samples on a consumable.

The Stratys system is supported by the Stratys™ Compute workstation, which offers accelerated data processing powered by NVIDIA graphics processing units (GPUs). Stratys Compute provides advanced computational technology at the bench with the potential to enable faster and more accurate genome analysis without a requirement to be installed in a data center.

“The Stratys system’s intuitive design was created with customer feedback in mind, in order to offer flexibility that can accommodate labs’ irregular workflows. Stratys uses the latest imaging and data processing technologies, and it is compatible with all current and planned automated elements in Bionano’s comprehensive sample to report workflow. We look forward to seeing how Stratys will transform the way labs approach genome analysis. I want to congratulate everyone who was involved in this exciting product launch,” stated Mark Oldakowski, chief operating officer of Bionano.

Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “We believe today marks an important day for anyone seeking to implement OGM at scale, with the announcement of commercial availability of Stratys, the first high throughput OGM system, which can shorten time-to-results, reduce hands-on-time and help reveal new actionable insights across research applications including heme malignancies, constitutional genetic disorders and cell and gene therapy. We launched an early access program for our Stratys system in 2023 to great enthusiasm, with orders exceeding our initial offering of 10 systems, many from new OGM adopters. We are excited to see these early access sites partner with us as we extend Stratys adoption across the world.”

About Bionano

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.

Bionano’s OGM products are for research use only and not for use in diagnostic procedures.

Forward-Looking Statements of Bionano

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “can,” “plan,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of the Stratys system to increase sample throughput compared to the Saphyr system; the ability and utility of the Stratys system workflow to provide a sample to answer time of 3 days; the ability and utility of the Stratys system to maximize lab flexibility; the ability and utility of Stratys Compute to enable faster and more accurate genome analysis; the ability and utility of the Stratys system to shorten time-to-results, reduce hands-on-time and help reveal new actionable insights in research applications including heme malignancies, constitutional genetic disorders and cell and gene therapy; the potential of the Stratys system to accelerate the adoption of OGM and overcome barriers to adoption of OGM by medium- and high-volume users; our ability to drive adoption of the Stratys system; the potential of the Stratys system to enable diagnostic applications; and execution of our stated strategies and plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, supply chain disruptions, global pandemics, inflation and the ongoing conflicts between Ukraine andRussian and Israel and Hamas, on our business and the global economy; general market conditions; the failure of the Stratys system to increase sample throughput; the failure of the Stratys system to increase sample throughput compared to the Saphyr system; the failure of the Stratys system workflow to provide a sample to answer time of 3 days; the failure of the Stratys system to maximize lab flexibility; the failure of Stratys Compute to enable faster and more accurate genome analysis; the failure of the Stratys system to shorten time-to-results, reduce hands-on-time and help reveal new actionable insights in research applications including heme malignancies, constitutional genetic disorders and cell and gene therapy; the failure of the Stratys system to accelerate the adoption of OGM and overcome barriers to adoption of OGM by medium- and high-volume users; the failure of our ability to drive adoption of the Stratys system; the failure of the Stratys system to enable diagnostic applications; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our need and ability to obtain sufficient financing to fund our strategic plans and commercialization efforts, our ability to effectively manage our uses of cash, and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com