Japan’s WAFUU.COM: 20-Language Global Expansion, 1200%+ Growth

Operated by QRESTIA Inc., WAFUU.COM is a Japan-based e-commerce site that offers a curated selection of Japanese cosmetics, snacks, anime, games, and gadgets. We aim to share the allure of Japan globally, offering multi-language support and extensive shipping options.

WAFUU.COM: Japan-Based Cross-Border E-Commerce Site Expands to 70 Countries with 20-Language Support

WAFUU.COM, a Japan-based e-commerce platform, breaks new ground by expanding its shipping network to 70 countries and providing a 20-language interface, bringing Japanese culture closer to a global audience.

WAFUU-JAPAN

TOKYO, Nov. 01, 2023 (GLOBE NEWSWIRE) — The world’s fascination with Japanese culture is far from waning, and WAFUU.COM, operated by QRESTIA Inc., has taken ambitious steps to meet this global demand. The growth rate of over 1200% (compared to the same month last year) is attributed to an expansive product range, multi-language support, the impact of a weaker yen, and an expanded target audience.

This initiative was brought to life by a team deeply passionate about sharing the beauty of Japan. WAFUU.COM has recently expanded its offerings by initiating shipping to 70 countries and adding support for 20 languages, breaking down previous challenges of restricted shipping zones, high shipping costs, and language barriers to reach an even wider audience than before.

This growth suggests that our multi-language platform is effectively reaching countries that previously had limited access to Japanese products. As we continue to refine the user experience, several future upgrades are planned to make the platform more user-friendly. “We have always aimed to build a bridge between Japan and the rest of the world, and this new initiative helps us do just that,” says FUKADA HIDEMASA, CEO of QRESTIA Inc.

Before pivoting to its current e-commerce model, WAFUU.COM was engaged in a business that actively utilized web marketing. This well-honed expertise and experience have been seamlessly transitioned into their new venture in cross-border e-commerce. Product selection is backed by comprehensive market research and AI technology, taking into account both global and local Japanese trends as well as online and offline purchasing data. Building on previous experience with multi-language business operations, the company has also accelerated its multi-language support, making Japanese products more accessible than ever. This multi-faceted approach ensures a product lineup that resonates with a diverse customer base.” For more information, visit https://wafuu.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8aecd815-8139-4240-a056-bf82abf32f15

CONTACT FUKADA HIDEMASA
COMPANY QRESTIA Inc.
PHONE +81-35726-9180
EMAIL pr@qrestia.com
WEB https://wafuu.com

GlobeNewswire Distribution ID 8967985

LeddarTech Announces Participation in Upcoming Fourth Quarter 2023 Investor Conferences

QUEBEC CITY, Canada, Nov. 01, 2023 (GLOBE NEWSWIRE) — LeddarTech®, an automotive software company that provides patented disruptive low-level sensor fusion and perception software technology for ADAS and AD, announces that Frantz Saintellemy, President and Chief Operating Officer, is scheduled to participate in the following upcoming investor events:

LeddarTech will participate in meetings with potential investors and industry analysts and in fireside chats. For more information or to register, please visit the “Events & Presentations” section of LeddarTech’s investor relations website.

On June 13, 2023, Prospector Capital Corp. (“Prospector”) (NASDAQ: PRSR, PRSRU, PRSRW), a Cayman Islands exempted company led by former Qualcomm President Derek Aberle and chaired by former Qualcomm Vice Chairman Steve Altman, announced a definitive business combination agreement with LeddarTech. Upon closing of the transaction, which is expected during the fourth quarter of 2023, the combined company formed through the business combination, LeddarTech Holdings Inc. (“Newco”), is expected to be listed on the NASDAQ under the ticker symbol “LDTC.”

About LeddarTech

A global software company founded in 2007 and headquartered in Quebec City with additional R&D centers in Montreal, Toronto and Tel Aviv, Israel, LeddarTech develops and provides comprehensive perception software solutions that enable the deployment of ADAS and autonomous driving (AD) applications. LeddarTech’s automotive-grade software applies advanced AI and computer vision algorithms to generate accurate 3D models of the environment, allowing for better decision making and safer navigation. This high-performance, scalable, cost-effective technology is available to OEMs and Tier 1-2 suppliers to efficiently implement automotive and off-road vehicle ADAS solutions.

LeddarTech is responsible for several remote-sensing innovations, with over 150 patent applications (80 granted) that enhance ADAS and AD capabilities. Better awareness around the vehicle is critical in making global mobility safer, more efficient, sustainable and affordable: this is what drives LeddarTech to seek to become the most widely adopted sensor fusion and perception software solution.

Additional information about LeddarTech is accessible at www.LeddarTech.com and on LinkedIn, Twitter (X), Facebook and YouTube.

About Prospector Capital Corp.

Prospector is a special-purpose acquisition company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses with a focus on companies with advanced and highly differentiated solutions for the technology sector. The company is led by a team of experienced investors and executives focused on identifying and investing in high-growth companies with strong management teams and attractive market opportunities. Prospector’s securities are traded on NASDAQ under the ticker symbols “PRSR,” “PRSRU” and “PRSRW.”

Important Information About the Proposed Transaction and Where to Find It

In connection with the proposed business combination, Prospector, LeddarTech and Newco will prepare and will file with the SEC the registration statement on Form F-4 (the “Registration Statement”), and Prospector will mail the proxy statement/prospectus contained within the Registration Statement to its shareholders and file other documents regarding the business combination with the SEC. This press release is not a substitute for any proxy statement, registration statement, proxy statement/prospectus or other documents Prospector or Newco may file with the SEC in connection with the business combination. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE REGISTRATION STATEMENT WHEN IT BECOMES AVAILABLE, ANY AMENDMENTS OR SUPPLEMENTS TO THE REGISTRATION STATEMENT AND OTHER DOCUMENTS FILED BY PROSPECTOR OR NEWCO WITH THE SEC IN CONNECTION WITH THE BUSINESS COMBINATION, BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the Registration Statement and other documents filed with the SEC by Prospector or Newco through the website maintained by the SEC at www.sec.gov.

Forward-Looking Statements

Certain statements contained in this press release may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act (which forward-looking statements shall also include forward-looking statements and forward-looking information within the meaning of applicable Canadian securities laws), including, but not limited to, statements regarding the business combination involving Prospector, LeddarTech and Newco, the ability to consummate the business combination and the timing thereof, the anticipated benefits from the business combination, the closing of the private placement financing and expected proceeds therefrom and statements relating to Newco’s anticipated strategy, future operations, prospects, objectives and financial projections and other financial metrics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) the risk that the conditions to the closing of the business combination are not satisfied, including the failure to timely or at all obtain shareholder approval for the business combination or the failure to timely or at all obtain any required regulatory clearances, including of the Superior Court of Justice of Québec; (ii) uncertainties as to the timing of the consummation of the business combination and the ability of each of Prospector, LeddarTech and Newco to consummate the business combination; (iii) the possibility that other anticipated benefits of the business combination will not be realized, and the anticipated tax treatment of the business combination; (iv) the occurrence of any event that could give rise to termination of the business combination; (v) the risk that shareholder litigation in connection with the business combination or other settlements or investigations may affect the timing or occurrence of the business combination or result in significant costs of defense, indemnification and liability; (vi) changes in general economic and/or industry-specific conditions; (vii) possible disruptions from the business combination that could harm LeddarTech’s business; (viii) the ability of LeddarTech to retain, attract and hire key personnel; (ix) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the business combination; (x) potential business uncertainty, including changes to existing business relationships, during the pendency of the business combination that could affect LeddarTech’s financial performance; (xi) legislative, regulatory and economic developments; (xii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and any epidemic, pandemic or disease outbreak (including COVID-19), as well as management’s response to any of the aforementioned factors; (xiii) access to capital and financing and LeddarTech’s ability to maintain compliance with debt covenants; and (xiv) other risk factors as detailed from time to time in Prospector’s reports filed with the SEC, including Prospector’s Annual Report on Form 10-K, periodic Quarterly Reports on Form 10-Q, periodic Current Reports on Form 8-K and other documents filed with the SEC, as well as the risk factors to be contained in the Registration Statement. The foregoing list of important factors is not exhaustive. Neither Prospector nor LeddarTech can give any assurance that the conditions to the business combination will be satisfied. Except as required by applicable law, neither Prospector nor LeddarTech undertakes any obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

No Offer or Solicitation

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Prospector or Newco, a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”).

Participants in Solicitation

Prospector, LeddarTech and Newco, and certain of their respective directors, executive officers and employees, may be deemed to be participants in the solicitation of proxies in connection with the business combination. Information about the directors and executive officers of Prospector can be found in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on March 31, 2023. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the business combination, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Registration Statement and other relevant materials when they are filed with the SEC. These documents can be obtained free of charge from the source indicated above.

Contact:
Daniel Aitken, Vice-President, Global Marketing, Communications and Investor Relations, LeddarTech Inc. Tel.: + 1-418-653-9000 ext. 232 daniel.aitken@LeddarTech.com

Leddar, LeddarTech, LeddarVision, LeddarSP, VAYADrive, VayaVision and related logos are trademarks or registered trademarks of LeddarTech Inc. and its subsidiaries. All other brands, product names and marks are or may be trademarks or registered trademarks used to identify products or services of their respective owners.

GlobeNewswire Distribution ID 8969420

King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes

King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes_01
King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes_01

RIYADH, Saudi Arabia, Oct. 31, 2023 (GLOBE NEWSWIRE) — King Faisal Specialist Hospital and Research Centre (KFSH&RC) has achieved a significant milestone by successfully conducting liquid biopsies on patients spanning various age groups. This innovative approach offers a safer alternative to conventional tissue biopsies. Notably, KFSH&RC stands out as the first healthcare facility in the Middle East to adopt this cutting-edge technology.

This groundbreaking method is distinguished by its ability to detect approximately 50 genes associated with cancer and over 3,000 genetic mutations. This represents a pivotal advancement in patient care, eliminating the need to extract tissue from the affected area for examination. This transformative step greatly enhances healthcare outcomes and elevates the overall patient experience.

Liquid biopsy offers advantages over traditional tissue biopsies. It’s less invasive, involving a simple 10 ml blood sample that can be repeated during treatment. Additionally, it provides high accuracy in swiftly detecting tumor biomarkers, predicting treatment responses, identifying emerging mutations, and confirming the absence of tumor recurrence, marking a significant advancement in cancer science.

This technology presents a safer alternative to traditional biopsies for patients facing challenges in accessing affected tissue without surgical intervention, as seen in cases like lung cancer. It is particularly beneficial for elderly patients, for whom a lung tissue biopsy may not be suitable due to the potential for severe complications associated with it.

King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes_02King Faisal Specialist Hospital and Research Centre Utilizes Early Cancer Detection Technology for 50 Genes_02

As a strategic health partner at the Global Health Exhibition in Riyadh from October 29 to 31, KFSH&RC will showcase its pavilion in the accompanying exhibition, where visitors can explore Liquid biopsy technology and various other healthcare solutions and technologies.

Liquid biopsy technology holds promise for other stages of cancer treatment at KFSH&RC. Through the routine use of the test, it is possible to build a database of tumor-causing mutations in the local community, which helps in early diagnosis of cancer before tumors form, in addition to tracking changes in the patient’s condition, frequently during treatment, allowing timely adjustments to treatment plans and preventing worsening of the condition.

This achievement is a part of KFSH&RC’s ongoing commitment to harness advanced technologies for enhancing operational excellence and patient care. The test facilitates swift clinical decision-making for cancer patient management and reduces both the testing time and its process through full automation.

KFSH&RC stands as one of the world’s prominent institutions in delivering specialized healthcare, leading the way in innovation, and serving as an advanced hub for medical research and education. Furthermore, it actively endeavors to advance medical technologies and elevate global healthcare standards through collaborations with significant local, regional, and international organizations, aiming to deliver world-class clinical, research, and educational services.

Contact information:
kfshrc@mcsaatchi.com

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/3ba7a2cd-ae09-4d9a-8658-a5efc2b198c3

https://www.globenewswire.com/NewsRoom/AttachmentNg/9de0dc61-7dc5-47e4-af70-09088ad689e1

GlobeNewswire Distribution ID 8969156

Henley & Partners hosts the 17th Global Citizenship Conference in Dubai

LONDON, Oct. 31, 2023 (GLOBE NEWSWIRE) — More than 400 delegates from over 35 countries are expected to attend the 17th annual Global Residence and Citizenship Conference, which takes place next week (8-10 November) at the Shangri-La Hotel DIFC in Dubai, UAE.

Hosted by world-leading international citizenship and residence advisory firm Henley & Partners, this annual event has become the world’s largest and most significant conference on private wealth and investment migration, bringing together presidents, prime ministers, senior government ministers and officials, leading academics, private client advisors, wealth management professionals, and top-tier financial and business media.

The 2023 conference program features sophisticated, cutting-edge content on the major developments shaping investment migration and geopolitics today, offering delegates the opportunity to engage with the world’s leading minds and latest ideas around the central themes of global citizenship and interconnectivity.

Dr. Christian H. Kalin, Group Chairman of Henley & Partners, who will also be speaking at the conference, points out that there could not be a more relevant and necessary time to connect across borders as citizens of the world. “At a moment in our history when our world seems increasingly fractured and polarized, it is more important than ever for us to focus our minds on our shared humanity and how we can be stronger together. While it may mean different things to different people, global citizenship is based on the principle that we all have responsibilities to the world as a whole, rather than just our own local communities or countries. This conference aims to expand our horizons through global learning and understanding so that we can effect change in a more meaningful sense on both a small and larger scale.”

Notable key speakers at the conference include the Prime Ministers of Montenegro, H.E. Dr. Dritan Abazovic, and of Grenada, the Hon. Dickon Mitchell, as well as the former President and Speaker of the Parliament of the Maldives, the Hon. Mohamed Nasheed. CEO of the Dubai Economic Development Corporation, Hadi Badri, along with Prof. Dr. Christian Joppke of the Institute of Sociology at the University of Bern in Switzerland, Dr. Titus Gebel, President of the Free Cities Foundation in Germany, Prof. Dr. Khalid Koser, Executive Director of the Global Community Engagement and Resilience Fund, Chief Partnership Officer of Women in AI, Middle East, Debbie Botha, and Dr. Parag Khanna, Founder and CEO of Climate Alpha in Singapore, among many others. They all will share their perspectives on the key social, economic, political and environmental trends shaping our world.

Another highlight of the conference will be the 2023 Global Citizen Award Dinner on 9 November to honor a remarkable individual working to advance one of the global challenges affecting humanity today. Hosted in collaboration with the Swiss non-profit humanitarian organization Andan Foundation, this year’s laureate will be announced at the gala event and the net proceeds of the evening will be donated to the foundation which focuses on self-reliance of refugees through education, entrepreneurship, and employment.

Notes to Editors

For further information and media accreditation to attend the 17th annual Global Residence and Citizenship Conference, please contact:

Sarah Nicklin
Group Head of Public Relations
sarah.nicklin@henleyglobal.com
Mobile: +27 72 464 8965

About Henley & Partners

Henley & Partners is the global leader in residence and citizenship by investment. Each year, hundreds of wealthy individuals and their advisors rely on our expertise and experience in this area. The firm’s highly qualified professionals work together as one team in over 40 offices worldwide.

The concept of residence and citizenship by investment was created by Henley & Partners in the 1990s. As globalization has expanded, residence and citizenship have become topics of significant interest among the increasing number of internationally mobile entrepreneurs and investors whom we proudly serve every day.

Henley & Partners also runs the world’s leading government advisory practice for investment migration, which has raised more than USD 12 billion in foreign direct investment. Trusted by governments, the firm has been involved in strategic consulting and in the design, set-up, and operation of the world’s most successful residence and citizenship programs.
https://www.henleyglobal.com

GlobeNewswire Distribution ID 1000896628

WadzPay Receives Initial Approval from Dubai’s Virtual Assets Regulatory Authority (“VARA”)

Pioneering fintech company stands out among hundreds of applicants with blockchain-based technology solutions with unique features, paving way for launch in the UAE

WadzPay Receives Initial Approval from Dubai’s Virtual Assets Regulatory Authority (“VARA”)

Pioneering fintech company stands out among hundreds of applicants with blockchain-based technology solutions with unique features, paving way for launch in the UAE.

DUBAI, Oct. 31, 2023 (GLOBE NEWSWIRE) — In a significant development, WadzPay has been granted “Initial Approval” by Dubai’s Virtual Assets Regulatory Authority (VARA), marking a pivotal step in Wadzpay’s journey towards obtaining a Virtual Asset Service Provider (VASP) License for virtual asset services and activities.

“We are immensely honored to have received initial approval from VARA,” said Mr. Anish Jain, Founder and Group CEO of WadzPay. “This recognition reaffirms our commitment to delivering cutting-edge blockchain-based solutions that not only revolutionize but also adhere to the highest regulatory standards. We are grateful for the opportunity to contribute to the growth of the fintech ecosystem in the UAE.”

This Initial Approval is a key milestone and allows WadzPay to commence preparations for the provision of virtual asset services and activities under the VASP License for Transfer & Settlement and Broker/Dealer activities.

“Receiving VARA’s initial approval is a testament to our unwavering dedication to regulatory and compliance excellence,” said Mr. Khaled Moharem, President – MENA at WadzPay. “We’ve built a robust ecosystem that not only meets but exceeds industry standards, guaranteeing a safe and efficient gateway to virtual assets for users in the UAE. We’re poised to launch with strict adherence to VARA’s requirements, ushering in a new era of secure and seamless access to the world of virtual assets.”

While the initial approval is a pivotal achievement, WadzPay emphasizes that it is still in the process of working towards receiving the final approval from VARA and the VASP license. This progression marks a crucial step towards obtaining the necessary regulatory green light to fully operate within the UAE and bring its innovative products and solutions to life.

About WadzPay: WadzPay Worldwide is a leading global provider of blockchain-based technology. The company’s innovative platform offers secure, efficient, and transparent services, catering to both businesses (B2B) and individual users (B2B2C). With a commitment to driving financial inclusion and revolutionizing the virtual asset landscape, WadzPay is at the forefront of digital transformation.

For more information, visit www.wadzpay.com

About VARA: Established in March 2022, following the effect of Law No.4 of 2022, VARA is the competent entity in charge of regulating, supervising, and overseeing VAs and VA Activities in all zones across the Emirate of Dubai, including Special Development Zones and Free Zones but excluding the Dubai International Financial Centre. VARA plays a central role in creating Dubai’s advanced legal framework to protect investors and establish international standards for Virtual Asset industry governance, while supporting the vision for a borderless economy.

For more information visit: www.vara.ae

For any media enquiries please contact:

Arijit Das

PR and Communications Manager

arijit.das@wadzpay.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b5b18fac-dfd1-4b62-922c-cbaeb9174a03

GlobeNewswire Distribution ID 8969063

Pixalate Announces General Availability of Ad Fraud Prevention API with Pay-As-You-Go Pricing for Website, Mobile and Connected TV App Developers

With a few clicks, developers can now sign up and integrate Pixalate’s advertising fraud prevention technology into their apps and websites without signing long-term contracts

London, UK, Oct. 30, 2023 (GLOBE NEWSWIRE) — Pixalate, the global market-leading ad fraud protection, privacy, and compliance analytics platform, today announced general availability of its self-service Ad Fraud Prevention API. With no annual commitments or upfront costs, developers and publishers of all sizes can access Pixalate’s reliable and low-latency solution to easily scale and grow.

Pixalate APIs are powered by the company’s MRC-accredited Analytics platform. Accreditation areas include sophisticated invalid traffic (SIVT) detection & filtration for both display and video across Connected TV (CTV), mobile app, mobile web, and desktop.

Access to MRC-accredited ad fraud prevention tools has historically been limited to large, enterprise sized publishers & developers. Pixalate’s self-service API gives smaller developers an upper hand to scale their platforms by protecting existing ad revenue streams and fortifying the integrity of their advertising inventory against bad actors.

Using most globally-accepted credit cards, customers can sign up in minutes, choose the plan that’s right for them, and immediately incorporate Pixalate’s ad fraud prevention insights into their apps. Subscriptions start at $99 a month and give developers the freedom to adjust based on usage. When a customer exceeds a plan’s usage quota, consumption-based pricing kicks in without any interruption to the service.

Key Benefits Include: 

  • Reduce clawbacks. Protects publishers & developers’ revenue by taking steps to improve ad traffic quality.
  • Align with major exchanges. Enable developers to use the same ad fraud technology as major exchanges.
  • Combat ad fraud. Prevents 40+ types of invalid traffic (IVT) & fraud vectors that harm app traffic quality.
  • Prevent getting blocklisted. Bake fraud prevention into apps from the ground up.
  • Billing Dashboard. View real-time API usage and charges on the billing dashboard.
  • Ease of Integration. With just a few clicks, any developer can sign up with a freemium plan and begin integrating the APIs with a few lines of code.

API Input Parameters:

  • IP address: Analyzes an IP address (either IPv4 or IPv6) to check for any associated risks.
  • Device Identifier: Examines the device identifier to detect any abnormalities or signs of fraudulent activity.
  • User Agent: Evaluates the user agent data to identify potentially malicious software or bots.

API Output Parameters:

  • Fraud Risk Assessment: Subscribers can request a risk score from Pixalate’s servers to gauge the likelihood of an IP, Device ID, or User Agent being compromised or engaged in malicious activity.

Platforms Supported

  • Websites
  • Mobile (iOS, Android)
  • Connected TV (Roku, Fire TV, Samsung, LG, tvOS and more)

SDKs

  • iOS
  • Android

To learn more about the Ad Trust & Safety API suite, visit https://developer.pixalate.com.

About Pixalate
Pixalate is the market-leading fraud protection, privacy, and compliance analytics platform for Connected TV (CTV) and Mobile Advertising. We work 24/7 to guard your reputation and grow your media value. Pixalate offers the only system of coordinated solutions across display, app, video, and CTV for better detection and elimination of ad fraud. Pixalate is an MRC-accredited service for the detection and filtration of sophisticated invalid traffic (SIVT) across desktop and mobile web, mobile in-app, and CTV advertising.

Media Contact: press@pixalate.com

Disclaimer

As used herein, and per the Media Rating Council, Inc. (MRC), “‘Fraud’ is not intended to represent fraud as defined in various laws, statutes and ordinances or as conventionally used in U.S. Court or other legal proceedings, but rather a custom definition strictly for advertising measurement purposes;” and “‘Invalid Traffic’ is defined generally as traffic that does not meet certain ad serving quality or completeness criteria, or otherwise does not represent legitimate ad traffic that should be included in measurement counts. Among the reasons why ad traffic may be deemed invalid is it is a result of non-human traffic (spiders, bots, etc.), or activity designed to produce fraudulent traffic.”

Press
Pixalate Inc.
press@pixalate.com

GlobeNewswire Distribution ID 8968701

Impulse Dynamics Receives Full-Body MRI-Conditional Approval for Optimizer Smart Mini System

Reflecting Company Commitment to Innovation in Support of Patient Need

MARLTON, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.

“We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,” said Jason Spees, CEO of Impulse Dynamics. “This furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.”

“Full body MRI capability is part of our promise to deliver an ongoing pace of innovation,” said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics. “This advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options.”

The Optimizer Smart Mini delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.1 CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA (New York Heart Association) Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT (cardiac resynchronization therapy), and have a left ventricular ejection fraction ranging from 25 to 45 percent.

The Optimizer Smart Mini incorporates a rechargeable battery with 20-year battery life, offering HF diagnostic monitoring that provides important clinical insights to providers to assist in managing their patients with heart failure. This latest generation also offers internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.

Reference

1    Kuschyk J, Falk P, Demming T, et al. Long‐term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system. European Journal of Heart Failure. 2021;23(7):1160-1169. doi:10.1002/ejhf.2202

 # # #

About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com or follow the company on LinkedInTwitter, and Facebook.

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

ID-A358-US  

Attachments

Rohan More, Global Vice President of Marketing
Impulse Dynamics
856-642-9933
rmore@impulsedynamics.com

Ian Segal, Public and Media Relations
Impulse Dynamics
856-642-9933
isegal@impulsedynamics.com

GlobeNewswire Distribution ID 8968472