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Building a Biotech Base Companies Advance Across the Region

Accelerate Diagnostics BAYER BD

Building a

Biotech Base

Companies Advance Across Region

Bioscience companies with a presence in Tucson are developing solutions to medical challenges that run the gamut from microbiology to devices. The following are companies located in Tucson and the products they’re developing.

Accelerate Diagnostics

Accelerate Diagnostics is an in-vitro diagnostics company that provides solutions for the challenge of antibiotics-resistant and hospital-acquired infections. Established in 1987, the company began research activity for microbiology solutions in 2004 and relaunched in 2012 as Accelerate Diagnostics Inc. to develop and commercialize its first diagnostic platform. Accelerate’s 2021 developments: • Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, a global non-profit partnership dedicated to accelerating research and development to fight the

By Rodney Campbell

rising threat of drug-resistant bacteria, awarded Accelerate Diagnostics up to $578,000 to develop fiber optic technology to diagnose or assess the risk of sepsis. Accelerate will be eligible for up to $2.1 million in additional funds from CARB-X if the project meets certain milestones. • A study published in Antimicrobial

Agents and Chemotherapy found that implementing the Accelerate

Pheno® system helped Albany Medical Center Hospital in New York significantly improve laboratory workflow and multiple clinical outcomes for patients with Gram-negative bacteremia.

Bayer

As natural resources diminish, climate rises, and our population grows. Bayer Crop Science is reimagining how corn is grown in light of these issues from a greenhouse in Marana.

In 2017, Bayer built a seven-acre climate-controlled seed production facility that promotes an efficient and sustainable farming system. Using robotics and automation, the Marana team produces about four crop cycles annually.

Since the Bayer Marana Greenhouse creates various climate conditions, farmers around the world can benefit from the latest innovations. Technology used in the greenhouse plays a vital role in allowing farmers to increase yields while using fewer resources.

The greenhouse team is constantly growing, with more than 140 employees from diverse backgrounds and skill sets, including agronomic research specialists, biologists, engineers, environmental specialists, and data scientists. Bayer often looks to hire University of Arizona graduates since they represent the top tier of future talent.

Virtual tours of the greenhouse are available; for more information, please

Critical Path Institute Edmund Optics Emagine Solutions Technology

visit https://www.bayer.com/en/us/ marana.

BD

The global medical technology company known as BD announced in April that it will construct a $65 million facility in Tucson that will be a hub for the company’s supply chain, serving as a final-stage manufacturing and sterilization center.

The 120,000 square-foot facility will be built on approximately 32 acres at the northeast corner of Valencia and Kolb Road and is planned to open in mid2022. BD plans to add approximately 40 new jobs, including engineers, scientists, quality control specialists and other skilled talent. Sun Corridor Inc., the region’s economic engine, projects that BD’s investment will have a $122 million economic impact on the region over the next decade.

BD operates more than 90 medical device and health care technology manufacturing and sterilization facilities globally and has a track record of sustainable operations. This facility will be one of the first in the world with an original design that will meet or exceed the most stringent environmental guidelines.

“Tucson is the ideal location for critical infrastructure and was selected after a careful review of a number of alternative locations in the southwestern U.S. and Mexico,” said Alexandre Conroy, BD’s executive VP, integrated supply chain. “Arizona’s favorable business climate, the strength of its workforce and Tucson’s centrality to other parts of BD’s supply chain were key factors in the decision.”

Critical Path Institute

The non-profit C-Path brings together patient groups, academic institutions, the pharmaceutical industry and regulatory agencies from around the world to improve public health. Together, these stakeholders work to identify or create tools that can accelerate the medical product development and regulatory review process.

C-Path manages collaborative teams and programs (currently 24), in which stakeholders combine intellectual and financial resources to generate solutions that facilitate the development of safe and effective medical products.

C-Path’s programs focus on specific areas, patient populations, therapeutic indications or drug development and data sharing challenges. These include Alzheimer’s disease, Parkinson’s disease, Type 1 diabetes, rare/orphan diseases, neonatology data science, modelinformed drug development and drug safety testing.

Founded by Dr. Raymond L. Woosley in 2005, C-Path opened in Tucson with six employees. Today, more than 100 scientists, pharmaceutical industry leaders and medical professionals are on staff at C-Path and make up its board. The institute’s global presence includes a European headquarters in Dublin.

Edmund Optics

Edmund Optics is a leading supplier of optics, imaging and photonics technology that has served a variety of markets including life sciences, biomedical, industrial inspection, semiconductor, research and development and defense since 1942. Edmund designs and manufactures a wide array of optical components, multi-element lenses, imaging systems, and optomechanical equipment, while supporting applications with volume production of stock and custom products.

In February, Edmund opened an assembly and advanced design facility in Tucson, where the company has had a presence since 1998. The 21,225 square-foot facility expansion supports advanced design efforts and high-volume manufacturing services, including cleanroom assembly and incoming inspection with numerous testing capabilities such as MTF, straylight, thermal cycle, shock and vibration.

“This new facility will allow Edmund Optics to build a larger collaborative partnership with Arizona Optics Initiative and the Arizona Technology Council,” said Robert Edmund, CEO and board chairman. “It solidifies our commitment to Tucson and AZTEC Optics Valley initiatives.”

HTG Molecular Diagnostics

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Emagine Solutions Technology

Emagine Solutions Technology is a certified Women’s Business Enterprise by the Women’s Business Enterprise Council and was founded to expand access to diagnostic ultrasound technology.

Last year, Emagine announced that it had received clearance from the U.S. Food & Drug Administration to market its VistaScan mobile ultrasound platform, which transforms a clinician’s cell phone or tablet into a portable ultrasound solution. The system consists of compatible FDA-cleared ultrasound probes that interface with the VistaScan software application. VistaScan’s proprietary patent-pending Dynamic Precise Point Measuring System enables a healthcare provider to maximize the accuracy of a mobile device’s touchscreen to make highly precise measurements on the ultrasound image, thereby increasing diagnostic performance and speed.

“The velocity and complexity of modern medicine is becoming overwhelming, and putting the power of ultrasound into the pockets of clinicians so they can use it for real-time diagnosis right at the bedside is liberating and transformative,” said Dr. Berndt Schmit, section chief of emergency radiology at Banner-University Medical Center Tucson and president of Humanitarian Radiology Development Corps. Kelpac Medical NuvOx Pharma

HTG Molecular Diagnostics

HTG is focused on next-generationsequencing-based molecular profiling. The company’s proprietary EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries and identify treatments. HTG’s highlights for the second quarter of 2021 include: • Total revenue increased by approximately 45% from the first to the second quarter. • Formed a new drug discovery business unit, HTG Therapeutics. This business unit is expected to leverage the company’s existing capabilities and expand upon the utility of the

HTG EdgeSeq platform technology in the discovery of early stage drug candidates. By leveraging these profiling technologies earlier in the drug discovery process, HTG Therapeutics is expected to generate lead compounds faster, and with superior efficacy and toxicity profiles. • In July, HTG announced Dr. Vinodh

Pillai, assistant professor of pathology and laboratory medicine at the

Children’s Hospital of Philadelphia, and Dr. Thomas Dörner, professor of rheumatology and hemostaseology at Charité University Hospitals in Berlin, as recipients of its 2020

HTG EdgeSeq Autoimmune Panel

Research Grants. Pillai was awarded the grant for his research, Autoimmune Basis of Castleman Disease, which examines important questions in this rare disease, with limited sample material, in the areas of novel biomarkers for diagnostics and classification and potential novel therapeutic targets. Dörner was awarded the grant for his research, alterations of key immune pathways in distinct

B-cell subsets of patients with systemic lupus erythematosus, which is intended to identify key pathways and possible biomarkers and therapeutic targets in different B-cell subsets, ultimately helping to refine the understanding of the role and relevance of different B-cell populations in SLE patients.

Kelpac Medical

Founded in 1949, Kelpac Medical is the nation’s leading extruder of medical tubing and packaging. The company offers focused expertise in thermoplastic tubing extrusions and flexible films, pouches and bags for the medical devices industry.

Its acquisition of Apollo Medical Extrusion enhances the company’s commitment to providing medical device manufacturers with innovative device continued on page 44 >>>

Reglagene Reglagene

continued from page 42 component technologies. By combining engineering excellence, customized solutions and a global manufacturing footprint, Kelpac Medical delivers high-performance tubing and packaging for medical devices, while ensuring supply chain efficiencies in critical customer markets.

NuvOx Pharma

NuvOx is a clinical stage pharmaceutical company developing a drug that improves the flow of oxygen from lungs to blood and from blood to tissue. More than 30 animal studies have shown therapeutic effect in seven different indications. Phase Ib/II clinical trials in stroke and oncology demonstrated safety and evidence of efficacy, and the company is preparing to run a trial in COVID-19 patients with acute hypoxemic respiratory failure.

This past April, NuvOx completed construction and initiated operation of its production facility for manufacturing its injectable pharmaceutical products at its Tucson facility on East 18th Street. The building features an 1,800 square-foot hard shell exterior space addition to the existing building. A 900-square-foot ISO 5 cleanroom is housed within the exterior space.

Reglagene

A product of Professor Laurence Hurley’s research at the University of Arizona, Reglagene’s mission is to develop low-cost and non-invasive therapeutic solutions that program genes exploited by cancer to keep patients responsive to treatments.

Hurley, now Reglagene’s CSO, discovered that unusual DNA structures called “quadruplexes,” found in many genes exploited by cancer and other diseases, are actually master controllers of gene expression.

Sensing an opportunity to use this discovery for the benefit of patients, Hurley pioneered Quadruplex Master Switch Technology to enable the development of medicines that fight disease by controlling gene expression.

Reglagene is applying QMST to the development of orally administered medicines that target abnormal genes and regulate their expression. Through regulating abnormal genes, Reglagene is facilitating abatement of life-threatening diseases such as prostate cancer and glioblastoma.

Sandvik Materials Technology Sandvik Materials Technology

Sandvik Materials Technology

Recruited to Tucson during the pandemic, Sandvik is a Sweden-based developer and manufacturer of advanced stainless steel and special alloys.

The company’s local facility manufactures fine medical wire and components. Sandvik agreed to establish an office here in September 2020, working out details through video conferencing. No member of the team visited Tucson during the recruitment process, said Sun Corridor Inc. President & CEO Joe Snell. Sandvik leased 8,800 square feet of space near Tucson International Airport. Sunquest Information Systems Sunquest Information Systems

“The decision by Sandvik to expand its operations in Southern Arizona really validates that our position as a biotech center is strong and growing,” said Snell. “Sandvik is an incredible company whose presence benefits us greatly.”

“We needed a West Coast location near our customers and a superior technical workforce, which we found at the University of Arizona, Pima Community College and Arizona State University,” said Sandvik Business Unit Medical Manager Gary Davies. “Tucson checked all the boxes for us.” Sandvik is among the world leaders in manufacturing ultra-fine wire and provides services that include: • Wire refinement (reduction, alloy composition and forming). • Surface treatment (wire coating, plating in nickel and gold, anodizing and electropolishing). • Value-added operations (clean-room processing, cut to length, coiling, mechanical assembly, lead finishing, twisting and stranding, straightening and packaging services). • Operational services (custom processes, product development, metallurgy consulting, lab testing, lean process optimization, rapid prototyping for custom cable solutions and technical training).

“The Tucson area and our new facility have several important features,” Davies said. “This adds to our manu-

SynCardia Systems Vante BioPharm Sunquest Information Systems

facturing flexibility and brings us close to our customers, which is why we plan to use this site as our official showplace. The facility has a superior technical workforce and local support from the universities and small automation equipment manufacturers. That will be critical to our growth plan long-term as we continue to add operations beyond what is currently planned.”

Sunquest Information Systems

Sunquest provides diagnostic informatics solutions to laboratories across the world. With wide-ranging technical and cross-discipline expertise, and equally deep business acumen, Sunquest transforms labs to meet today’s complex healthcare challenges and deliver next-level performance.

Since 1979, Sunquest has helped laboratories and healthcare organizations enhance efficiency, improve patient care and optimize financial results. Its capabilities include multi-site, multi-disciplinary support for complex anatomic, molecular and genetic testing, and support engagement with physicians and patients outside the hospitals at the point-of-care. Sunquest also provides solutions for public health organizations through disease surveillance and outbreak management.

Sunquest is headquartered in Tucson with offices in Calabasas, Calif., and India.

SynCardia Systems

SynCardia Systems’ mission is to give end-stage heart failure patients more time outside the hospital while awaiting a transplant. Headquartered in Tucson, SynCardia was founded in 2001 by renowned cardiothoracic surgeon Jack G. Copeland, biomedical engineer Richard G. Smith and interventional cardiologist Marvin J. Slepian. SynCardia is the sole manufacturer and provider of the world’s only commercially approved total artificial heart.

In clinical use for more than 35 years, the SynCardia temporary Total Artificial Heart is the most widely used and extensively studied total artificial heart in the world.

By partnering with, training and supporting healthcare teams at more than 140 transplant hospitals and heart failure programs in more than 20 countries, SynCardia helps create better outcomes for critically ill adults and adolescents whose best chance of survival is total heart replacement. When a donor heart isn’t available or isn’t an option, SynCardia provides a new heart without the wait for patients at risk of dying or becoming too sick to receive a transplant.

Vante BioPharm

As a pioneer in radio frequency technology, Vante patented the first handheld plastic tube sealer more than 25 years ago and continues to be one of the world leaders in advancing technology for sealing, molding and welding plastic.

Vante is a global company dedicated to the development of innovative technology and quality products for the medical manufacturing and biopharmaceutical industries. The company serves more than 500 customers in catheter manufacturing and biopharmaceutical companies, and works with more than 20 global partners to distribute equipment that improves product quality, process reliability and production output. Its dedicated research and development team designs all of its products and has been awarded more than 50 patents.

Xeridiem Medical Devices

Xeridiem has been involved in the design and manufacture of minimally invasive delivery and access devices for more than 25 years. It partners with customers to offer solutions by using extensive development, engineering, QA & RA and manufacturing capabilities.

As an outsourcing partner for product design and development, Xeridiem develops device concepts into a manufacturable design and creates the pathway to transfer the design into initial and full-scale production at its assembly and manufacturing facilities in Tucson.

Xeridiem, founded in 1986, is part of the Spectrum Plastics Group.

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