Detroit Thermal builds on sustainability commitment with DTE Energy’s MIGreenPower program

100% of Detroit Thermal’s electricity use will be attributed to renewable energy by 2030

Detroit, Sept. 15, 2021 (GLOBE NEWSWIRE) — Detroit Thermal, a clean steam energy supplier, today announced the company’s enrollment in DTE’s MIGreenPower program. One of the largest voluntary renewable energy programs in the United States, MIGreenPower enables DTE Electric customers to attribute a greater percentage of their energy use to Michigan-made wind and solar beyond the 15% DTE already provides. Detroit Thermal will gradually increase its MIGreenPower enrollment to attribute 100% of its electric usage to renewable resources by 2030. The company’s commitment will ultimately offset the carbon dioxide equivalent of greenhouse gas emissions from over 1,000 passenger vehicles driven for a year.*

Since 1903, Detroit Thermal’s steam distribution system has been an innovative energy solution for Detroit and a critical piece of the city’s infrastructure and economic recovery. Detroit Thermal delivers clean steam energy through an extensive underground network that runs throughout the greater downtown Detroit area and serves more than 100 buildings. Produced with clean natural gas and offering unique advantages, the system continues to provide clean, safe steam energy, now partially derived from renewable sources. For more than 100 years, Detroit Thermal has served most of Detroit’s noteworthy buildings, including GM Renaissance Center, TCF Center, Fox Theater, Detroit Medical Center, Ford Field, The Fisher Building, City of Detroit, and Wayne State University.

“Sustainability has always been at the center of what we do, and enrolling in MIGreenPower reinforces that commitment,” said Todd Grzech, CEO of Detroit Thermal. “Because of the customers we serve and the nature of our work, our enrollment will make a significant clean energy impact on the City of Detroit and the overall region. We’re thrilled to join DTE in the fight against climate change and continue working to build a cleaner future for all.”

Detroit Thermal joins over 400 businesses and nearly 40,000 residential customers who are using MIGreenPower to reduce their carbon footprint and accelerate the development of renewable energy in Michigan. Detroit Thermal customers, General Motors and Bedrock Detroit, are also part of the MIGreenPower program. Other prominent MIGreenPower program subscribers include Ford Motor Company, the University of Michigan, the Detroit Zoo and the State of Michigan. MIGreenPower subscribers annually support 1.8 million megawatt hours of clean energy, which has the environmental benefit equal to taking 277,400 passenger cars off the road for a year.*

“DTE’s MIGreenPower program is extremely popular with our residential, business and commercial customers,” said Brian Calka, director, Renewable Solutions for DTE Energy. “The program’s success is based on the value it provides to our customers. MIGreenPower offers an easy, affordable option for customers who want to reduce their carbon footprint without the upfront cost or ongoing maintenance involved with installing their own rooftop solar system. For business customers with clean energy goals, like Detroit Thermal, MIGreenPower provides a turnkey solution.”

For more information on DTE’s MIGreenPower program, please visit www.migreenpower.com

*Avoided emissions and equivalencies are based on the Environmental Protection Agency equivalencies calculator at epa.gov/energy/greenhouse-gas-equivalencies-calculator.

About Detroit Thermal

Unique among Detroit utilities, Detroit Thermal delivers clean steam energy through an extensive, redundant, underground network that runs throughout the greater downtown Detroit area and services more than 100 buildings. The steam is used for space heating, domestic hot water heating, absorption chilling, humidification, cooking, sterilization, and beer brewing. Produced with clean natural gas, our environmentally friendly system offers building owners and facilities managers several important advantages:

Detroit Thermal’s steam distribution system has been an innovative energy solution for Detroit since 1903. More than 100 years later, it is still providing clean, safe steam energy as effectively as ever–only now, it is partially derived from clean, renewable sources.

Detroit Thermal is a critical piece of Detroit’s energy infrastructure and economic recovery. The extensive network provides steam for cost-effective space heating, hot water heating and absorption cooling to customers throughout the greater downtown area.

Sometimes referred to as “district energy,” our service is an alternative to the cost and complexity of operating on-site steam boilers, water chillers or other energy systems.

About DTE Energy

DTE Energy (NYSE: DTE) is a Detroit-based diversified energy company involved in the development and management of energy-related businesses and services nationwide. Its operating units include an electric company serving 2.2 million customers in Southeast Michigan and a natural gas company serving 1.3 million customers in Michigan. The DTE portfolio includes energy businesses focused on power and industrial projects, renewable natural gas, and energy marketing and trading. As an environmental leader, DTE utility operations will reduce carbon dioxide and methane emissions by more than 80% by 2040 to produce cleaner energy while keeping it safe, reliable and affordable. DTE Electric and Gas aspire to achieve net zero carbon and greenhouse gas emissions by 2050. DTE is committed to serving with its energy through volunteerism, education and employment initiatives, philanthropy and economic progress. Information about DTE is available at dteenergy.com, empoweringmichigan.com, twitter.com/dte_energy and facebook.com.



Jack Buonanno
Detroit Thermal
313.963.3541

Lauren Owings
DTE Energy
313.235.5555

US Ecology’s Environmental Solutions Help Customers Achieve Sustainability Goals for a Better Tomorrow

Innovative Technical Services Improve ESG Performance

BOISE, Idaho, Sept. 15, 2021 (GLOBE NEWSWIRE) — US Ecology, a premier provider of comprehensive environmental and emergency response services, provides solutions to industrial, commercial and government customers that help protect human health and the environment. Our turnkey, customized solutions, when combined with customers’ own internal initiatives, help them achieve sustainability and improve ESG performance.

“US Ecology remains committed to being the premier solutions provider helping customers realize their sustainability and ESG goals,” said Jeff Feeler, President and CEO. “Our innovative technologies, secure waste disposal facilities and sustainable solutions allowed us to safely manage over 4.6 billion pounds of hazardous waste for customers in 2020. That’s 4.6 billion pounds of waste that is no longer a threat to our ecosystems or our communities and future generations. We are proud to play such an important role for our customers and all stakeholders in protecting the environment each and every day.”

With 70 years of experience, our teams are dedicated to developing technology and innovative treatment and disposal, recycling, field, industrial and emergency solutions to better manage our customers’ environmental needs and provide them a variety of sustainable solutions. Our Technical Services group identifies environmentally focused solutions that achieve regulatory compliance, while offering customers alternative sustainable solutions via new waste reduction, recycling or reuse technologies. These compliant and safe technologies allow customers the opportunity to achieve ESG performance improvements while protecting the communities in which they work and live.

“US Ecology understands the pressures customers are under today to conduct business in a way that reduces their environmental impact and supports social and cultural objectives while achieving their business goals. That is why our dedicated sales and customer service teams work in partnership with customers to understand their environmental needs, appreciate their sustainability goals and ultimately, find innovative, customized solutions that work,” said Steve Welling, Executive Vice President of Sales and Marketing.

Learn more about specific services that allow US Ecology to partner with customers to create a better tomorrow:

Aerosol Recycling Technology: 562,000 cans recycled in 2020

US Ecology operates a patent-pending aerosol recycling technology that is the most sustainable solution in the U.S. market, and the only solution to recycle or reuse 100% of the aerosol can and its components.

Our process is a fully enclosed, zero-emission process and will save hundreds of tons of aerosol hazardous waste from entering landfills and polluting our environment each year. This allows the aerosols and packaged goods industry to better manage a long-standing environmental challenge while producing new, compatible end products that can recirculate into the market for a broad array of reuse.

Sustainable Technology Investments

We have exclusive waste classification technology that gives customers a safer and more compliant categorization system for hazardous and non-hazardous waste. This technology found in stores, and on our trucks, easily identifies thousands of discarded products that are exempt from RCRA hazardous waste regulation, allowing for recycling and reuse of these products through alternative technologies. Specific products can be automatically identified for sustainable solutions like ethanol recovery, electronic recycling, paint recycling or surfactant blending, etc., saving tons of waste from entering landfills each year.

Realtime Results for Environmental Reporting

US Ecology’s Customer Online Resource (COR) is the industry’s leading online application that allows customers the ability to manage their industrial services and environmental waste needs through real-time, comprehensive dashboards. The COR platform is a difference maker in the waste industry and enables customers to more efficiently access data required by environmental platforms’ disclosure obligations. This ability to quickly pull in-depth levels of comprehensive data 24 hours a day allows customers to confidently prove they are operating sustainably, safely and compliantly which positively influences ESG performance.

Glycol Recycling: 2.7 million pounds recycled in 2020

US Ecology leverages our broad customer network to combine the links on a sustainable supply chain for glycols that help consumers achieve sustainability goals. In addition to these “downstream” benefits recognized through the distribution of recycled products, this program also protects our “upstream” natural resources by creating a socially responsible outlet, helping to prevent glycols from being introduced into local landscapes or surface waters. US Ecology currently de-waters and de-mineralizes collected raw materials to create a virgin-equivalent glycol, which can be used as a base fluid for blended products such as heat transfer fluid, windshield washer deicing fluid and diesel motor antifreeze.

Metals Recovery: 22 million pounds recycled in 2020

We provide a sustainable alternative to traditional stabilization and landfill disposal with metals recycling technologies that economically recover metals such as copper, cobalt, nickel, zinc, and tin. This results in a significant benefit to the environment while providing financial relief and recycling credits to our customers. Our effective reclamation of heavy metals from a variety of waste streams saves thousands of tons of metal bearing wastes from entering landfills each year.

Thermal Recovery Organic Bearing Waste

Our state-of the-art Thermal Desorption Unit (TDU) provides sustainable waste solutions by recovering valuable organic material from wastes generated across multiple industry segments such as petroleum refining, automotive manufacturing, clean energy and aerospace. This process provides an alternative solution to incineration, stabilization and landfill. Oils and other organics are separated from wastes and recovered to be recycled as fuel in place of consuming virgin fossil fuels. Our thermal recovery process is also successful at removing organic contamination from metal bearing catalysts used in the refining industry. The catalysts, once processed, can either be returned to the generator or sent to recyclers to reclaim semi-precious metals such as cobalt, nickel and zinc. Our thermal process is used as a critical step to prepare certain materials like lithium batteries for further recycling and recovery.

Thermal Soil Remediation

US Ecology’s Moose Creek Facility (MCF) helps maintain Alaska’s breathtaking views, expansive wilderness and sensitive ecosystems by treating non-hazardous soils that have been impacted by industry and commerce thermally to standards five times cleaner than standards recommended by the Alaska Department of Environmental Conservation. Our Thermal Remediation technology treats thousands of tons of impacted soil each year, keeping harmful contaminants from entering Alaska’s land and watersheds. Once certified clean, the soils are 95% compactable fill and can be used in a variety of situations including topsoil and road projects.

Container/Drum Reuse

US Ecology offers a companywide program that inspects, refurbishes, tests and recertifies shipping containers in compliance with EPA and DOT regulations that allow for reuse of these containers within our organization or resale back to customers for reuse. Reuse of a qualifying non-bulk container can save as much as 50% over the cost to manufacture a new drum, resulting in a substantially lower environmental footprint, cost structure and economic impact. US Ecology inspects thousands of drums each month to reduce customer procurement needs, and to lower the overall carbon footprint associated with hazardous waste disposal. This initial pilot investment was made in 2021 and we plan to roll it out across our network in the coming years.

Emergency Response Services: 10,000 Responses in 2020

Our emergency response service’s paramount objective is to minimize a customer’s impact on the environment, whether it be in response to catastrophic oil spills, destruction from wildfires and natural disasters, biohazardous contamination, hazardous product releases, chemical fires or events involving an array of volatile substances. Our nationwide network provides rapid, safe, and effective containment, removal, and disposal and/or treatment of contaminants and hazardous waste 24/7/365. We help our customers return to normal business operations in a timely manner and ensure their environmental impact is minimized.

Renewable Energy Sector

US Ecology provides safe and compliant waste disposal and response services to the renewable energy sector as a key partner supporting their efforts to protect the environment. Our team provides services for solar panel and EV battery manufacturers, wind farm operators, as well as large scale wind turbine refurbishment programs in the United States. Our Technical Services team continues to research innovative, alternative solutions for waste generated by the renewable energy sector. Our turnkey services help these industries remain environmentally friendly.

Hazardous Waste Secure Disposal with Limited Greenhouse Gas Emissions

US Ecology operates six specialty disposal facilities across North America that provide safe and secure containment and disposal of hazardous and non-hazardous waste. The soil, debris and wastewater these facilities manage have limited to no recycling value. The highly engineered design, secure construction and regulatory compliance and monitoring systems in place at our facilities ensure the wastes disposed on-site are no longer a threat to the environment. Our secure disposal facilities manage inorganic materials and emit little to no methane or other gases that would be harmful to the environment.

Managed Services

In addition to utilizing sustainable technologies that isolate specific waste streams and individually manage them via sustainable methods that help customers achieve ESG performance improvements, we also offer wholistic, turnkey project management of all environmental needs through our Managed Services Group (MSG) to customers seeking a more customized program to help increase sustainability.

MSG has over 20 years of experience developing and supporting customized programs to help our customers reach their sustainability goals and improve ESG performance. Our Managed Services initiatives include:

  • Waste recycling and reuse opportunities for expanded recycling programs and the improvement of existing programs.
  • Landfill diversion and minimization – we move up-stream to reduce waste generation at its source.
  • Waste elimination and reduction – we evaluate new technologies to process wastes into commodities.

Our dedicated Managed Services Project Managers work with each customer to drive process enhancements and identify pollution prevention alternatives. We promote policies designed to enhance the environment and encourage waste reduction and recycling. US Ecology is an industry leader in understanding the best available recycling and disposal technologies and we find that this commitment to sustainability aligns our program with our client’s environmental goals and ESG objectives.

US Ecology’s ESG Initiatives

In addition to providing a comprehensive suite of innovative solutions to help our customers achieve sustainability and improve ESG performance, US Ecology remains committed to our mission of protecting human health and the environment by focusing on our ESG performance. We invest in technological and operational initiatives that allow us to be more sustainable while continuing to deliver unequaled service to our customers.

We participate in the EcoVadis and SASB (Sustainability Accounting Standards Board) sustainability reporting platforms, and recently published our 2020 ESG data supplement. Based upon our classification within SASB’s Sustainability Industry Classification System, we evaluated the Waste Management Sustainability Accounting Standard (IF-WM) and published our report setting out the topics addressed by that standard, the related SASB code and accounting metric and our related disclosures. US Ecology remains committed to ESG initiatives for 2021 and beyond.

Please visit https://www.usecology.com/page/ESG to learn more about our sustainability and ESG efforts.


ABOUT US ECOLOGY, INC.

US Ecology, Inc. is a leading provider of environmental services to commercial and government entities. The company addresses the complex waste management and response needs of its customers offering treatment, disposal and recycling of hazardous, non-hazardous and radioactive waste, leading emergency response and standby services, and a wide range of complementary field and industrial services. US Ecology’s focus on safety, environmental compliance, and best-in-class customer service enables us to effectively meet the needs of US Ecology’s customers and to build long lasting relationships. US Ecology has been protecting the environment since 1952. For more information, visit www.usecology.com.

Contact: Steven Park (208) 871-1653
[email protected]  www.usecology.com



LM Funding Expands Into Cryptocurrency Mining Business


Purchases 1,000 Bitcoin S19J Pro Antminers from Bitmain for $6.3 Million

First delivery of the pro miner machines is expected during the second quarter of 2022

TAMPA, Fla., Sept. 15, 2021 (GLOBE NEWSWIRE) — LM Funding America, Inc. (NASDAQ:LMFA) (“LM Funding” or “LMFA”) today announced that it is expanding and diversifying its business operations by launching a cryptocurrency mining business. In furtherance of this move, LMFA announced the purchase of 1,000 S19J Pro Miner Machines (S19J) (100 TH/s) from Bitmain for total purchase price of $6.3 million. The S19J is a high efficiency, high hash rate machine mining SHA-256 algorithm produced by Bitmain that generates a maximum hash rate of 100 TH/s and has a power consumption of 3,000 W.

Bruce M. Rodgers, Chairman and CEO of LM Funding, commented, “In April, we announced our intention to purchase up to $2 million in digital assets as part of our capital allocation strategy. After careful consideration and due diligence, we also believe that mining for bitcoin ourselves is a cost effective way to purchase the asset at a risk-adjusted exposure to the ecosystem while generating positive operating income. For our initial investment of 1,000 machines, our purchase price will range between $6,000 to $6,500 per machine as compared to $11,000 to $15,000 per machine currently available on the spot market. We believe that buying the machines at scale, as we have done, significantly increases our expected margin per bitcoin and potentially de-risks our exposure to downward Bitcoin price volatility.”

LM Funding has established a new subsidiary, US Digital Mining and Hosting Co., LLC, to operate the new mining business and is in the process of establishing a data center to host the pro miner machines. The Company expects all 1,000 newly purchased miners to be delivered between the second and third quarter of 2022, and the Company anticipates the cryptocurrency mining operations could commence as soon as the second quarter of 2022. The Company is pursuing opportunities to accelerate the start of its mining operations.  

Mr. Rodgers continued, “We believe that China’s exit from Bitcoin mining has created an opportunity for U.S. public companies like ours to enter Bitcoin mining to take advantage of our low cost of capital, reliable and affordable energy supply, and stable regulatory and corporate environment.  We believe Bitcoin mining operations will provide opportunities to vertically integrate our operations in hosting, finance, and other areas of the Bitcoin ecosystem.”

About LM Funding America:

LM Funding America, Inc., together with its subsidiaries, is a technology-based specialty finance company that provides funding to nonprofit community associations (Associations) primarily located in the state of Florida, as well as in the states of Washington, Colorado and Illinois, by funding a certain portion of the associations’ rights to delinquent accounts that are selected by the Associations arising from unpaid Association assessments. LMFA has also announced that it is entering the cryptocurrency mining business through a new subsidiary, US Digital Mining and Hosting Co., LLC.

Forward-Looking Statements:

This press release may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” and “project” and other similar words and expressions are intended to signify forward-looking statements. Forward-looking statements are not guaranties of future results and conditions but rather are subject to various risks and uncertainties. Some of these risks and uncertainties are identified in the company’s most recent Annual Report on Form 10-K and its other filings with the SEC, which are available at www.sec.gov. These risks and uncertainties include, without limitation, uncertainty created by the COVID-19 pandemic, the risks of entering into and operating in the cryptocurrency mining business, our ability to acquire new accounts in our specialty finance business at appropriate prices, the need for capital, our ability to hire and retain new employees, changes in governmental regulations that affect our ability to collected sufficient amounts on defaulted consumer receivables, changes in the credit or capital markets, changes in interest rates, and negative press regarding the debt collection industry. The occurrence of any of these risks and uncertainties could have a material adverse effect on our business, financial condition, and results of operations.

Company Contact:

Bruce M. Rodgers, Chairman and CEO
LM Funding America, Inc.
Tel (813) 222-8996
[email protected]



Sera Prognostics Appoints Dr. Michael R. Foley as Chief Medical Officer

SALT LAKE CITY, Sept. 15, 2021 (GLOBE NEWSWIRE) — Sera Prognostics Inc., The Pregnancy Company™ (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced that Dr. Michael R. Foley has been appointed to the position of Chief Medical Officer beginning in January 2022. Dr. Foley will lead all medical activities for Sera as the company executes its vision to be the Pregnancy Company™. He joins a group of talented clinical operations and medical professionals who support Sera’s collaborations with research teams across the globe.

“We are honored to have Dr. Foley bring his extensive Maternal-Fetal Medicine and leadership experience to the Sera Prognostics team to help us achieve our vision to improve the lives of women and babies through individualized prenatal care,” said Gregory C. Critchfield, M.D., M.S., Chairman and CEO of Sera Prognostics. “Mike is highly respected for his expertise, his judgment, and his commitment to the health of mothers and babies. His leadership will provide important insights and perspective, as we actively educate payers about the impacts of the PreTRM Test-and-treat strategy for improving pregnancy outcomes through expanded access to valuable individualized PreTRM® risk information.”

Dr. Michael Foley initially practiced Maternal-Fetal Medicine in private practice for more than 20 years and retires on December 31, 2021 from the role of Chairman of Obstetrics and Gynecology at the University of Arizona College of Medicine Phoenix/Banner Good Samaritan Regional Medical Center, where he served for nearly a decade and now is working with both the university and Sera in an orderly transition that is to be completed at year-end. Dr. Foley received his medical degree from Chicago Medical School in 1984. He completed an Obstetrics and Gynecology residency and a Maternal-Fetal Medicine fellowship at The Ohio State University Hospital in 1988 and 1990, respectively. He is also an award-winning teacher, author, and has published numerous scientific articles while also serving as a reviewer for several medical journals. Dr. Foley is the Lead Editor of Obstetric Intensive Care: A Practical Manual (McGraw-Hill), which is currently in its fifth edition (2018). He is also a Co-editor for Critical Care Obstetrics-Fifth and Sixth Editions (Wiley-Blackstone).

“I am inspired to work with such an amazing ensemble of talented leaders and scientists at Sera to empower obstetric providers with novel and impactful precision pregnancy biomarker information that enables improved health for moms and babies,” said Dr. Foley. “I am looking forward to sharing my passion for medical leadership, mentoring, and professional development with Sera Prognostics’ vision to provide groundbreaking pregnancy diagnostic information to patients and physicians worldwide.”

About Sera Prognostics, Inc.

Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera’s mission is to deliver early, pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s precision medicine PreTRM® test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is located in Salt Lake City, Utah.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks’ gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of approximately 3.8 million babies born annually in the United States, more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.

About the PreTRM
®
Test

The PreTRM® test is the only broadly clinically validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® test empowers physicians to better identify, during the 19th or 20th week of pregnancy, women are at increased risk for preterm birth, enabling more informed, personalized clinical decisions based on each woman’s individual risk. The PreTRM® test is ordered by a medical professional.

Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc in the U.S. and/or other countries.

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s conversations with payers potentially expanding access to the PreTRM® Test; and the company’s strategic directives under the caption “About Sera Prognostics, Inc.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; the ongoing COVID-19 pandemic and its impact on our operations, as well as the business or operations of third parties with whom we conduct business; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading “Risk Factors” contained in our Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

Contact

Investor Contact
Peter DeNardo, CapComm Partners
[email protected]
+1 (415) 389-6400

Media Contact
Erich Sandoval, Lazar FINN
[email protected]
+1 (917) 497-2867

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/846f8301-14db-4654-b350-6aef538cd259



Fate Therapeutics Announces Publication of FT538 Preclinical Data Demonstrating Enhanced Serial Killing and Functional Persistence without Cytokine Support

Peer-Reviewed Cell Stem Cell Publication Highlights Shared Metabolic, Transcriptional, and Functional Features of FT538 and Adaptive NK Cells

SAN DIEGO, Sept. 15, 2021 (GLOBE NEWSWIRE) —  Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today the publication of preclinical data demonstrating that its off-the-shelf, multiplexed-engineered, iPSC-derived NK cell product candidate FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative stress, and induce transcription of proteins that control NK cell activation and effector function. The data were published in Cell Stem Cell in an online article entitled “Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy”.

“The NK cell community has long sought to improve NK cell activation, cytotoxicity, functional persistence, and tumor targeting for cancer immunotherapy. Our preclinical data demonstrate that the synthetic features of FT538 uniquely harness all these therapeutic attributes and significantly improve NK cell anti-tumor activity,” said Bob Valamehr, Ph.D., Chief Research and Development Officer of Fate Therapeutics. “We are excited to bring FT538 to patients for off-the-shelf treatment of hematologic malignancies and solid tumors, and to continue to leverage its multiplexed engineered backbone as the foundation for development of multi-antigen, CAR-targeted product candidates.”

The studies in the Cell Stem Cell publication were conducted as part of a collaboration between scientists at Fate Therapeutics and the laboratory of Jeffrey S. Miller, M.D., University of Minnesota, and were led by Frank Cichocki, Ph.D., University of Minnesota. The Miller laboratory has previously shown that a rare subset of NK cells with memory-like properties that arise in response to cytomegalovirus, known as adaptive NK cells, have a genome-wide epigenetic profile and recall response that parallel cytotoxic effector CD8+ T cells. These adaptive NK cells persist long term, exhibit a unique metabolic profile with elevated mitochondrial oxidative phosphorylation and glycolysis as well as increased levels of ATP, and have enhanced cytotoxicity.

The peer-reviewed paper describes preclinical studies showing that FT538 shares metabolic, transcriptional, and functional features with adaptive NK cells. The data demonstrate that FT538 persists in vivo at high levels for more than six weeks in the absence of cytokine support after adoptive transfer, whereas adoptively-transferred peripheral blood NK cells required the co-infusion of either IL-2 or IL-15 to achieve low-level persistence for up to two weeks. Additionally, in sequential killing assays, FT538 was shown to have robust serial killing and functional persistence, which were not observed with peripheral blood NK cells. FT538 also incorporates a novel high-affinity, non-cleavable CD16 Fc receptor as a third functional component, which was shown to mediate potent in vivo anti-tumor activity in combination with the CD38-targeted monoclonal antibody daratumumab against MM.1S myeloma cells.

FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia and in combination with daratumumab for the treatment of multiple myeloma (NCT04614636). In addition, the Company has initiated patient enrollment in a multi-dose Phase 1 clinical trial of FT538 in combination with certain monoclonal antibodies targeting EGFR, HER2, and PDL1 for the treatment of solid tumors.

About Fate Therapeutics’ iPSC Product Platform

The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT538

FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636).

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s clinical studies and preclinical research and development programs, its ongoing and planned clinical studies, including its clinical investigation of FT538, and the safety and therapeutic potential of the Company’s product candidates, including FT538. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s product candidates may not demonstrate the requisite safety or efficacy to achieve regulatory approval or to warrant further development, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation of, or enrollment of patients in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:

Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
[email protected]



Oportun Congratulates Board Member Jo Ann Barefoot for Being Named Fintech Woman of the Year by Finovate

SAN CARLOS, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) — Oportun Financial Corporation (NASDAQ: OPRT), an A.I.-driven financial services and technology company that provides hardworking people with access to responsible and affordable credit, today announced that its independent board member, Jo Ann Barefoot, was named Fintech Woman of the Year by the Finovate Awards.

The Finovate Fintech Woman of the Year award is given to a woman whose achievements and work in fintech-related areas of financial services have helped enhance the sector or raise its profile as a career for women through education, leadership, mentoring, coaching or acting as a role model. 

“I am very proud to have our board member, Jo Ann Barefoot, be recognized for her unwavering commitment to financial inclusion and to helping enact regulatory platforms that have been instrumental in the advancement of fintech for the benefit of traditionally underrepresented communities,” said Raul Vazquez, Oportun CEO. “We are fortunate and thankful to have Jo Ann’s leadership and experience to help us expand our mission.”

Oportun was named a finalist for the 2021 Finovate Awards for Excellence in Financial Inclusion and Best Consumer Lending Platform, and the company’s CEO, Raul Vazquez was a finalist for Finovate Executive of the Year.

“Congratulations to all of the finalists. We were honored to be considered, and even more honored to serve our hardworking customers as they build a brighter financial future for themselves,” Vazquez added.

As an A.I.-driven provider of inclusive, affordable financial services, Oportun is guided by a mission to provide affordable and responsible credit to low- and moderate-income individuals. Since 2006, Oportun has lent over $10.5 billion through more than 4.3 million affordable loans that have saved customers an estimated $1.9 billion in interest and fees, according to a study commissioned by Oportun and conducted by the Financial Health Network, a leading nonprofit authority on consumer financial health.

To find about more about the Finovate Awards and all of the finalists and winners, visit: https://informaconnect.com/finovate-industry-awards/awards-categories/

About Oportun

Oportun (Nasdaq: OPRT) is a financial services company that leverages its digital platform to provide responsible consumer credit to hardworking people. Using A.I.-driven models that are built on 15 years of proprietary customer insights and billions of unique data points, Oportun has extended more than 4 million loans and over $10 billion in affordable credit, providing its customers with alternatives to payday and auto title loans. In recognition of its responsibly designed products which help consumers build their credit history, Oportun has been certified as a Community Development Financial Institution (CDFI) since 2009.

Media Contact

George Gonzalez
650-769-0441
[email protected]



NuCana Announces Enrollment of Required Number of Patients to Conduct First Interim Analysis in the Phase III Biliary Tract Cancer Study

Enrollment of 418 Evaluable Patients Expected to Enable First Interim Analysis in the First Half of 2022

Data from First Interim Analysis May Support an NDA Submission in the United States under the FDA’s Accelerated Approval Program

EDINBURGH, United Kingdom, Sept. 15, 2021 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ: NCNA) announced it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis. The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

“We are very pleased to achieve this important enrollment milestone which brings us closer to our goal of developing more effective and safer medicines for patients with cancer,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “Biliary tract cancer is a devastating disease and there is a significant need for more effective medicines. We are especially grateful to all of the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study.”

Mr. Griffith continued: “The primary objective of the first interim analysis is to demonstrate at least a 14% improvement in the ORR in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm. In the ABC-08 study of Acelarin plus cisplatin as a first-line treatment for patients with biliary tract cancer, an ORR of 44% was achieved among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. We look forward to announcing the outcome of this first interim analysis in the first half of 2022.”

About NuTide:121

NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

About NuCana

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s robust pipeline includes three ProTides in clinical development. Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is in a Phase 3 study for patients with advanced biliary tract cancer. NUC-3373 is in a Phase 1 study for the potential treatment of a wide range of patients with advanced solid tumors and a Phase 1b/2 study for patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) and is in a Phase 1 study for patients with advanced solid tumors.


Forward-Looking Statements


This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company’s ability to submit an NDA for Acelarin under the FDA’s accelerated approval program, or at all; the Company’s goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission (“SEC”) on March 4, 2021, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

For more information, please contact:
NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131 357 1111
[email protected]

Westwicke, an ICR Company
Chris Brinzey
+1 339-970-2843
[email protected]

RooneyPartners
Marion Janic
+1 212-223-4017
[email protected]

 



Catalyst Biosciences Participating in a Fireside Chat with LifeSci Capital

Management to discuss CBIO’s complement portfolio including the potential of CB 2782-PEG in dry AMD

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2021 (GLOBE NEWSWIRE) — Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that the members of its management team will participate in a fireside chat hosted by LifeSci Capital on Wednesday, September 15, 2021 at 1:00 pm Eastern Time.

Catalyst Biosciences’ management team will discuss the progress made in the Company’s complement portfolio including CB 2782-PEG (C3 degrader), CB 4332 (enhanced CFI), and selective degraders of C4b/C3b and C3a/C5a.

To register for the call, please e-mail [email protected]. The replay will also be available on the Events and Presentations section on the Company’s website for approximately 90 days.

About Catalyst Biosciences, the Protease Medicines company

Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and proteases from our ProTUNE™ C3b-C4b degrader and ImmunoTUNE™ C3a-C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways as well as other complement programs in development.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, statements about the product candidates of Catalyst Biosciences, Inc. (the “Company”) and the benefits of its protease engineering platform; plans to complete the ConFIrm and ConFIdence studies; plans to submit an IND and initiate a global clinical trial for CB 4332 in CFI deficiency in 2022; the potential markets for and advantages of the Company’s complement product candidates, including CB 2782-PEG, CB 4332 and complement degraders; and plans for the Company’s collaboration with Biogen.

Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed or halted as a result of COVID-19, competitive products and other factors, that trials may not have satisfactory outcomes, the risk that the ConFIrm and ConFIdence trials will not validate the potential market for CB 4332; the risks that CB4332 and the Company’s complement degraders have not yet started human clinical trials, the risk Catalyst may elect to terminate or postpone ongoing development programs, including development of MarzAA or any of the Company’s complement assets; the risk that the Company will need to raise additional capital, which may not be available on favorable terms if at all; the risk that Biogen may terminate the Company’s agreement, and other risks described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 4, 2021, the Quarterly Report on Form 10-Q filed with the SEC on August 5, 2021 and in other filings filed from time to time with the SEC. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

Contact:

Ana Kapor
Catalyst Biosciences, Inc.
[email protected]



electroCore Announces New Patent Expanding Claims Related to Delivery of Non-Invasive Vagus Nerve Stimulation Therapy Using Mobile Devices

ROCKAWAY, NJ, Sept. 15, 2021 (GLOBE NEWSWIRE) —  electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office has issued US Patent No. 11,097,102 to electroCore, relating to devices, systems and methods integrated with, or coupled to, smartphones that allow patients to self-treat medical conditions, such as migraine headache, by electrical non-invasive stimulation of nerves. The ‘102 patent is the 8th US patent issued to ECOR in the company’s mobile connectivity platform, with additional US and International matters pending.

electroCore is building a portfolio of Intellectual Property (IP) around smartphone-integrated and smartphone connected non-invasive therapy. This IP may provide a foundation for combining the company’s clinically proven non-invasive Vagus Nerve Stimulation (nVNS) with application-based digital health platforms that could enable health care providers to use Remote Patient Monitoring or Remote Therapeutic Monitoring reimbursement codes. That combination, in turn, may enable future business models and revenue streams for the company’s products.

“This latest patent supports our IP portfolio focused on using mobile phone systems and methods to deliver non-invasive therapy,” said JP Errico, founder, board member and investor of electroCore, and co-inventor of the new patent. “By merging smartphones and medical devices, we hope to change how external neuromodulation devices are configured to deliver therapy, creating the potential for connected devices and/or smartphones that can not only monitor biomarkers like EKGs and EEGs, but can actually deliver therapy, thereby expanding the potential reach of our platform non-invasive vagus nerve therapy to millions of patients across the globe.”

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About
gammaCore

TM


gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the treatment of paroxysmal hemicrania and hemicrania continua in adults, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

  • Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric patients (less than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of US and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential combining of nVNS and smartphone or application-based technologies; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.



Investors:
Rich Cockrell
CG Capital
404-736-3838
[email protected]

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected]

Hyundai Translead Taps PowerFleet Telematics to Launch HT LinkSense Platform

Partnership will Leverage PowerFleet LV-300 Solution to Provide Real-Time Visibility and Cost-Effective Operations 

WOODCLIFF LAKE, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) — PowerFleet, Inc. (Nasdaq: PWFL), a global leader and provider of subscription-based wireless IoT and M2M solutions for securing, controlling, tracking, and managing high-value enterprise assets, today announced Hyundai Translead, the leading van trailer manufacturer in North America, will be leveraging the PowerFleet LV-300 trailer tracking gateway solution to launch HT LinkSense. Through this integration with PowerFleet, HT LinkSense will be able to provide fleet managers with the flexibility to choose sensor and telematics solutions that meet their needs. Initially, the HT LinkSense solution will be available for the Hyundai Translead dry van line, but future expansion into refrigerated, flatbed, chassis and aftermarket products is planned.

“We are excited to partner with PowerFleet as we expand possibilities for customers in fleet data strategy by providing a scalable, open platform solution with HT LinkSense,” said Sean Kenney, Hyundai Translead’s Chief Sales Officer. “Through our partnership, we offer flexibility through universal connectivity of sensors for maximum fleet operational efficiency, making smart fleets smarter.”

The PowerFleet LV-300 asset tracking solution provides continuous real-time visibility while in transit, and more accurate arrival and departure information to better plan supply chain resource allocation. Connected by 4G LTE, it provides wireless reporting to ensure clients can receive continuous updates on the status and condition of their assets and important cargo. The LV-300 tethers to a power source and also utilizes a long-lasting rechargeable battery for untethered operation and features tamper detection for increased security.

“We are honored that Hyundai Translead has selected PowerFleet as a key part of its HT LinkSense solution for trailers,” explains Chris Wolfe, CEO of PowerFleet. “Our integrated logistics solutions will enable customers to access a more holistic view of their trailers and freight status by capturing critical sensor and telematics data. By leveraging our trusted telematics platform, analytics and real-time reporting capabilities, Hyundai Translead will raise the bar with its’ HT LinkSense offering by delivering high-value asset information to the transportation industry.”

About PowerFleet

PowerFleet® Inc. (NASDAQ: PWFL; TASE: PWFL) is a global leader and provider of subscription-based wireless IoT and M2M solutions for securing, controlling, tracking, and managing high-value enterprise assets such as industrial trucks, tractor trailers, containers, cargo, and vehicles and truck fleets. The company is headquartered in Woodcliff Lake, New Jersey, with offices located around the globe. PowerFleet’s patented technologies address the needs of organizations to monitor and analyze their assets to increase efficiency and productivity, reduce costs, and improve profitability. Our offerings are sold under the global brands PowerFleet, Pointer, and Cellocator. For more information, please visit www.powerfleet.com, the content of which does not form a part of this press release.

About Hyundai Translead

Hyundai Translead is the leading van trailer manufacturer in North America. The company manufactures dry and refrigerated van trailers as well as flatbeds, chassis, and dollies. Founded in 1989, Hyundai Translead is 100% owned by Hyundai Motor Group and is headquartered in San Diego, CA. For more information, please visit www.hyundaitranslead.com

PowerFleet Company Contact

Ned Mavrommatis, CFO 
[email protected]
(201) 996-9000 

PowerFleet Investor Contact

Matt Glover
Gateway Investor Relations
[email protected]
(949) 574-3860

PowerFleet Media Contact

Jacqueline Agudelo
[email protected]