Tag: South Africa

Impulse Dynamics Announces First Implant for CCM-D™ Clinical Trial

World’s First Device Combining CCM Therapy With an ICD in a Single Rechargeable Implant That Treats Both Heart Failure Symptoms and Sudden Cardiac Death

MARLTON, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

The journey of a heart failure patient often involves debilitating symptoms and declining quality of life.

CCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life-threatening arrythmias, should they occur. The INTEGRA-D trial is the first to evaluate the Optimizer Integra CCM-D System that combines both therapies into a single device, designed to last for many years.

“The first-in-the-world implant of this novel technology has potential to advance treatments for patients living with heart failure,” said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA-D clinical trial. “The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms.”

“We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure,” said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA-D trial. “The first implant went well, and we look forward to further studying this device.”

The INTEGRA-D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM-D System. The study will assess the performance of the CCM-D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the Optimizer Integra CCM-D System, and will be followed for at least two years.

“This clinical study is important in proving the potential benefit of combining CCM therapy, which improves quality of life in patients with heart failure, with gold-standard ICD technology that delivers lifesaving therapy for sudden cardiac death,” said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York-Presbyterian and National Co-Principal Investigator for the INTEGRA-D trial. Dr. Uriel is also a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons and an Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine.

“Today’s announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease,” said Simos Kedikoglou, M.D., Chief Executive Officer of Impulse Dynamics. “We are proud to partner with physicians at leading centers around the world to conduct important research on this first-of-its-kind rechargeable combination device designed to address a major unmet need of a large patient group.”

About the Optimizer Integra CCM-D System and CCM Therapy

The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. “Investigational” means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA).

Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

CCM is the brand name for cardiac contractility modulation — a therapy that delivers non-excitatory electrical pulses from the implantable Optimizer device to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.

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 LinkedIn, Twitter, 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, and CCM therapy combined with an ICD delivered via a single device (CCM-D), and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Integra CCM-D System and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. 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.

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

Harriss Currie, Chief Financial Officer
Impulse Dynamics
856-642-9933
hcurrie@impulsedynamics.com

GlobeNewswire Distribution ID 8841961

Chairman of Avia Solutions Group Gediminas Ziemelis: 10 big challenges for passenger aviation sustainability for the next 3 years

DUBLIN, Ireland, May 17, 2023 (GLOBE NEWSWIRE) — Ensuring sustainable operations has become a primary driver for aviation businesses in recent years. Nonetheless, this dynamic industry faces a multitude of challenges that can impede companies’ efforts to enhance profitability. While several factors contribute to the aviation industry’s struggles, certain key issues merit highlighting as primary culprits.

High market $ interest rates for heavily leveraged and drowning-in-debt airlines will be even higher

In recent years, the aviation industry has experienced a significant drop in demand for air travel, resulting in many airlines facing financial losses. To stay afloat during this time, airlines have taken on additional debt. However, this increased debt has resulted in higher risk for lenders, leading to higher market interest rates for the airlines.

In addition to the impact of the pandemic on the industry, other factors such as rising fuel costs and increased competition have also contributed to the financial struggles of many airlines. These factors have made it increasingly challenging for heavily leveraged airlines to generate profits and pay off their debt, leading to concerns about the sustainability of their business models.

The combination of these factors has led to a situation where heavily indebted airlines are now facing even higher market interest rates, which can exacerbate their financial difficulties.

Much higher insurance costs — worsening war risks could push insurance premiums higher

The aviation industry is grappling with rising insurance costs due to worsening geopolitical risks. This is highly influenced by the fact that, as stated by leading insurance companies, around 500 aircraft leased to Russian operators remain trapped in Russia. Insurers are facing potential liability issues due to the uncertain situation created by the Russian government’s refusal to release the aircraft.

As a result, insurers are struggling to assess the level of risk involved, leading to a wide range of potential losses estimated to be up to $30 billion, according to industry sources. This uncertainty is likely to drive up insurance premiums for airlines, impacting the industry as a whole.

Passengers will remember compensations for flight delays, and it will impact airlines’ unplanned costs

The EU regulation 261/2004 provides compensation for passengers who experience delays, cancellations, overbooking, or denied boarding. Depending on the specific circumstances and subject to certain conditions, affected passengers may be eligible for a compensation claim ranging from €250 to €600 per person. Before the COVID-19 pandemic, the rate of flight delays in the EU that fell under compensation was 1.5% of all flights, with an average compensation amount of €375 per delayed flight.

In 2019, EU airlines carried a total of 1.12 billion passengers, with 1.7 million flights experiencing delays and resulting in a total compensation pay-out of €6.3 billion. Only 10% of affected passengers currently file complaints directly with the airlines or via specialised service companies, such as Skycop or Airhelp.

However, this number is expected to increase significantly, as after COVID-19 the industry faces capacity shortages and other challenges. As a result, the number of claimable flights that experience delays could increase from 1.5% to 5%, potentially leading to a total compensation pay-out of €20 billion.

LEAP engines challenges will impact more aircraft on the ground and shortage of capacity;

According to our internal research, presently, the aviation industry operates a fleet of 1397 A320neo aircraft with LEAP-1A engines, totalling 3080 engines with an average of 2.2 engines per aircraft, and 1043 Boeing 737 MAX aircraft with LEAP-1B engines, totalling 2338 engines with an average of 2.2 engines per aircraft. To maintain these engines, there are 21 locations globally for LEAP-1A overhaul and maintenance and 22 locations for LEAP-1B engines.

However, the grounding of 16,000 aircraft (equivalent to 60% of the total fleet) in 2020-2021 has led to a staggering 60% postponement of LEAP engine maintenance. Consequently, there is now a significant maintenance gap across 43 locations, resulting in wait times of 9-10 months for engine maintenance, which could potentially disrupt airline operations.

OEM production and supply chain disrupted during 2023-2025 will cause a shortage of aircraft capacity;

The COVID-19 pandemic has had a profound impact on the aerospace industry. Original Equipment Manufacturers (OEMs) such as Boeing and Airbus have experienced significant disruptions in their production and supply chains. In response to the global economic slowdown and reduced demand for air travel, OEMs have cut their production levels by around half compared to pre-COVID levels. However, this has led to a shortage of aircraft capacity, which is hindering the industry’s recovery efforts.

The production cuts have affected over 5,000 suppliers in the supply chain, all of whom have had to reduce their volumes during the pandemic. Consequently, the recovery of the aerospace industry is projected to take 2.5-4 years to return to pre-COVID production levels. This prolonged period of disruption is likely to have significant consequences for the industry and its stakeholders.

In 2020-2021, the cancellation of pilot cadet programs and planned retirements caused a pilot shortage in 2023-2024 and a rapid increase in costs for airlines;

The aviation industry faces a constant demand for new pilots, as approximately 3% of pilots retire annually. However, the COVID-19 pandemic has caused a major setback in the industry, with all cadet programs being either postponed or cancelled.

Hence, there is now a significant pilot shortage issue, leading to rapid cost increases. It is estimated that industry will experience a shortage of 300,000 pilots within a decade. This shortage is expected to create significant challenges, particularly in India, which is anticipated to have the largest pilot shortage.

Challenges to book MRO slots after COVID-19, because scheduled maintenance events were postponed

Another issue caused by the COVID-19 pandemic is a significant accumulation of MRO services for aircraft worldwide. As a result of the unprecedented reduction in air travel and the grounding of many aircraft, scheduled maintenance was delayed or deferred.

Nonetheless, as air travel demand begins to recover and airlines return to full operations, the challenge of booking MRO slots to perform necessary maintenance on these aircraft has emerged. Many airlines are finding that MRO facilities are already operating at full capacity, resulting in long wait times and potential disruptions to airline operations. This accumulation of maintenance is expected to persist for some time, creating obstacles to the aviation industry’s recovery efforts.

Challenge to find engines maintenance slots for V2500, and RR engines due to deferred maintenance

Airlines that operate aircraft with V2500 and RR engines are also encountering difficulties in scheduling maintenance for their engines due to high demand and limited availability. This has created a challenging situation, particularly for airlines with large fleets of such aircraft.

The lack of available maintenance slots has forced airlines to ground some of their aircraft, leading to operational disruptions and revenue losses. In addition to the financial impact, the situation also poses safety concerns as delayed maintenance can compromise the safety and reliability of the engines, potentially leading to more significant problems in the future.

ESG requirements for greener aviation didn’t disappear in the medium term

The International Civil Aviation Organisation’s (ICAO) 41st Assembly, held in Montreal in October 2022, marked a significant milestone for the aviation industry’s commitment to sustainability. The assembly committed to a Long Term Aspirational Goal (LTAG) to achieve net zero CO2 emissions by 2050, which has brought Environment, Society, and Governance (ESG) issues to the forefront of the sustainable aviation conversation.

The LTAG’s ambitious target is challenging, but it has the potential to encourage airlines to accelerate the development and adoption of greener jet fuels and other technical improvements to decarbonise flying. This will require a significant shift in industry-wide mindset, investment in research and development, and collaboration between airlines, manufacturers, and governments to achieve the long-term goal.

After COVID-19, debts for spare parts, MRO services, and aircraft leasing will impact that some aircraft will still be grounded, which will cause capacity demand

The challenging situation in the industry has pushed airlines to take on additional debt to finance various aspects of their operations, such as spare parts, MRO services, and aircraft leasing. However, the increase in outstanding debt for the industry could have significant implications, with some airlines potentially struggling to pay off their debts, which could result in a reduction in capacity as airlines are forced to ground some of their aircraft or cut routes to minimise costs.

Insider data shows that the industry’s outstanding debt has jumped over 20% since 2020, reaching more than $300 billion. To raise capital, global air carriers have sold $63 billion in bonds and loans so far this year.

Media contact:
Silvija Jakiene
Chief Communications Officer
Avia Solutions Group
silvija.jakiene@aviasg.com
+370 671 22697

GlobeNewswire Distribution ID 1000810732

Sweegen’s Rebaudioside M receives full authorization for use in the United Kingdom

Bestevia Reb M expands sugar reduction solutions in the U.K.and is now available to food and beverage producers.

Rancho Santa Margarita, Calif., May 17, 2023 (GLOBE NEWSWIRE) — Global sweetness and flavor innovator, Sweegen has announced that its Bestevia® Rebaudioside M (Reb M) has been fully authorized for use in the United Kingdom (U.K.) This regulatory approval marks a significant milestone for Sweegen, as it becomes the first and only company to receive authorization for any steviol glycosides produced using alternative technologies in the U.K.

Reb M, a high-purity steviol glycoside derived from the stevia plant, is renowned for its clean and sugar-like taste profile. It offers a natural, zero-calorie sweetness solution, making it an ideal choice for food and beverage manufacturers seeking to reduce sugar content and provide healthier options to consumers. Sweegen’s nature-based sweeteners, including its Reb M, offer a scalable and cost-effective alternative to traditional sugar.

Brands in the U.K. have eagerly anticipated the authorization of Sweegen’s Bestevia Reb M during the initial formulation phase and tastings. They are actively collaborating with Sweegen’s food and beverage applications experts based at its EMEA U.K. Innovation Studio in Reading, England, to integrate this highly sought-after stevia ingredient, along with Sweegen’s outstanding taste modulation and unique sweeteners, into their formulations.

Damian Bellusci, Vice President of Sales EMEA/APAC at Sweegen, expressed his excitement about the authorization, stating, “We are extremely proud to be the pioneers in securing full authorization for Bestevia Reb M in the U.K. This milestone reaffirms Sweegen’s commitment to providing innovative, nature-based, and sustainable sweetening solutions to the industry. Reb M offers food and beverage manufacturers an exceptional tool to meet consumer demands for healthier products without compromising taste.”

The decision to authorize the bioconversion manufacturing method for steviol glycosides, including Reb M, was made by the Minister for Primary Care and Public Health in relation to England, the Welsh Ministers in relation to Wales, and the Minister for Public Health, Women’s Health and Sport in relation to Scotland. The authorization is per Article 10(1) of retained Regulation 1333/2008, fulfilling the requirements.

The authorized manufacturing method allows for using steviol glycosides, including Reb M, in the Great Britain (GB) market. The Regulations provide updated terms of authorization for using this method in GB, with the terms being similar to those in the European Union (EU) and Northern Ireland. For the latest information, referring to the relevant EU Regulations on the EUR-Lex website is recommended.

Casey McCormick, Vice President of Global Innovation at Sweegen, emphasized the significance of Reb M in driving product innovation. “The approval of Bestevia Reb M in the UK represents a very positive step forward for brands looking to improve the nutrition profile of their products. The clean, sweet taste of our Bestevia Reb M enables new approaches to reduce and eliminate sugar in a way that exceeds consumers’ expectations  and supports public health objectives to reduce sugar consumption.”

Hadi Omrani, Vice President of Technical and Regulatory Affairs at Sweegen, highlighted the rigorous safety and compliance standards behind Bestevia Reb M’s authorization. Omrani stated, “At Sweegen, we prioritize safety, quality, and regulatory compliance. Obtaining full authorization for Bestevia Reb M in the U.K. required thorough scientific evaluations and stringent assessments to ensure its safety for consumption. This achievement reflects our commitment to delivering superior products that meet the highest industry standards.”

Sweegen is dedicated to revolutionizing the sweetener market with innovative solutions that promote healthier choices without compromising taste. The full authorization of Bestevia Reb M in the U.K. reinforces Sweegen’s leadership in the nature-based sweetener space and positions the company as a trusted partner for food and beverage manufacturers worldwide.

Sweegen recently attained FEMA GRAS status for sweet proteins brazzein and thaumatin II, complementing steviol glycosides in food and beverage production. With the addition of brazzein and thaumatin II, Sweegen continues to expand its portfolio of safe and effective taste-modulating flavors that can help food and beverage manufacturers meet the demand for healthier and delicious products to align with consumers’ holistic approaches to wellness. Brazzein is the star ingredient in Sweegen’s newly launched Sweetensify flavors for taste modulation, an ideal flavors tool for brands seeking to create sugar-like tastes in food and beverages.

About Sweegen

Sweegen provides sweet-taste solutions for food and beverage manufacturers around the world.
We are on a mission to reduce sugar and artificial sweeteners in the global diet. Partnering with customers, we create delicious zero-sugar products that consumers love. With the best modern sweeteners in our portfolio, such as Bestevia® Rebs B, D, E, I, M, and N, and sweet proteins brazzein and thaumatin, along with our deep knowledge of flavor modulators and texturants, Sweegen delivers market-leading solutions that customers want, and consumers prefer. Well. Into the Future.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1996. Sweegen’s actual results may differ from the estimates, assumptions, and other illustrative material contained herein, and consequently, a reader should not rely on these forward-looking statements as predictions of future events. These forward-looking statements include, without limitation, illustrative information regarding Sweegen’s bottom-up assumed market potential, assumed hit rate, and the resulting revenue based on these model inputs. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results.

Industry, Market, and Other Data
In this press release, we rely on and refer to information and statistics regarding market participants in the sectors in which Sweegen competes and other data. We obtained this information and statistics from our own internal estimates and third-party sources, including reports by market research firms and company filings. We do not expressly refer to these sources. All of this information involves a number of assumptions and limitations, and the sources of such information cannot guarantee the accuracy or completeness of such information. The industry in which Sweegen operates is subject to a high degree of uncertainty and risk due to a variety of important factors, any of which could cause results to differ materially from those expressed in the estimates made by Sweegen or third parties.

Cautionary Statement Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener, brazzein, and thaumatin. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and beyond Sweegen’s control.

Relevant risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements and, therefore, should be carefully considered. Sweegen assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

Attachments

Ana Arakelian
Sweegen
+1.949.709.0583
ana.arakelian@sweegen.com

GlobeNewswire Distribution ID 8841398

Zoom Partners with Anthropic to Expand Federated Approach to AI

Zoom announces investment in Anthropic to support research roadmaps and build steerable AI systems; Anthropic’s AI model will help strengthen Zoom’s federated approach across its platform, including Zoom Contact Center integrations

SAN JOSE, Calif., May 16, 2023 (GLOBE NEWSWIRE) — Today, Zoom announced a strategic partnership with and investment in Anthropic, an AI safety and research company working to build reliable, interpretable, and steerable AI systems. The collaboration with Anthropic will further bolster Zoom’s federated approach to AI by allowing Anthropic’s AI assistant, Claude, to be integrated with Zoom’s platform (which includes Team Chat, Meetings, Phone, Whiteboard, Zoom IQ), starting with Zoom Contact Center.

“Anthropic’s Constitutional AI model is primed to provide safe and responsible integrations for our next-generation innovations, beginning with the Zoom Contact Center portfolio. With Claude guiding agents toward trustworthy resolutions and powering self-service for end-users, companies will be able to take customer relationships to another level,” said Smita Hashim, chief product officer for Zoom. “Partnering with Anthropic also furthers our commitment to providing customers with our federated approach to AI, optimized to deliver outstanding customer experience outcomes. Additionally, with our investment, we are advancing leading-edge companies like Anthropic and helping to drive innovation in the Zoom ecosystem and beyond.”

“Partnering with a leading collaboration platform like Zoom allows us to put robust, steerable AI into the hands of more people and unlock its potential to help streamline everyday processes,” said Dario Amodei, CEO and co-founder of Anthropic. “We look forward to working together to showcase Anthropic’s capabilities and our joint commitment to enhancing productivity through intelligent solutions.”

Zoom’s federated approach to AI leverages its own proprietary AI models, along with those from leading AI companies — such as Anthropic — and select customers’ models. With this flexibility to incorporate multiple types of models, Zoom can provide the most value for its customers’ diverse needs. Zoom will be able to customize these models to perform better for a customer, based on their specific business needs.

As the next step in evolving the Zoom Contact Center portfolio, (Zoom Virtual Agent, Zoom Contact Center, Zoom Workforce Management), Zoom plans to incorporate Anthropic AI throughout its suite, improving end-user outcomes and enabling superior agent experiences. The Zoom Contact Center suite of solutions elevates the quality of customer experiences through better self-service and the ability to accurately understand customer intent. It intelligently guides customers to the best resolution, surfaces actionable insights that managers can use to coach their agents, and improves productivity by providing a unified communications and contact center experience. In the near future, Zoom will also use AI to provide the right resources to agents, so customers receive exceptional service experiences regardless of their reason for calling.

Announced today, Zoom Ventures has made an investment in Anthropic, strengthening the relationship between both companies. Anthropic’s research and development aims to create steerable, trustworthy, and responsible large-scale AI systems. Zoom did not disclose the amount of the investment.

About Zoom
Zoom is an all-in-one intelligent collaboration platform that makes connecting easier, more immersive, and more dynamic for businesses and individuals. Zoom technology puts people at the center, enabling meaningful connections, facilitating modern collaboration, and driving human innovation through solutions like team chat, phone, meetings, omnichannel cloud contact center, smart recordings, whiteboard, and more, in one offering. Founded in 2011, Zoom is publicly traded (NASDAQ:ZM) and headquartered in San Jose, California. Get more info at zoom.com.

Zoom Public Relations
Lacretia Taylor
press@zoom.us

GlobeNewswire Distribution ID 8840480

Impulse Dynamics Announces 9,000th Patient Milestone Achieved With CCM® Therapy for Heart Failure

Momentum Continues as Depth of Clinical Experience Expands Worldwide

MARLTON, N.J., May 15, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today a worldwide milestone achievement with the 9,000th patient receiving the Optimizer® system for the treatment of moderate HF. The Optimizer system is the only device approved by the U.S. Food and Drug Administration (FDA) in the United States to deliver CCM therapy. Dr. Steven Gubin, a cardiologist and the President of Stern Cardiovascular, is part of the care team that completed the procedure at Baptist Memorial Hospital-Memphis, offering CCM therapy to a patient living with the debilitating effects of HF. This milestone highlights the momentum building globally for CCM therapy, using the Optimizer platform to improve quality of life in HF patients.

“I am excited to have a new therapy option for heart failure patients,” said Dr. Gubin, who has been practicing for 30 years. “One of my heart failure patients, Aubretta Bean, who is a cancer survivor, continued to have symptoms despite her compliance with guideline-directed medical therapy for heart failure. She let me know that she felt better almost immediately after receiving the implant and continues to improve daily. It has been extremely rewarding to see such improvement in her quality of life. Her lab work four weeks later showed her BNP (a common test to diagnose heart failure) decreased by 81%, which is consistent with improvement in her heart failure symptoms.”

“Before my CCM implant, I could not walk from one room to the other without gasping for air. It was like being underwater and trying to breathe through a straw,” said Aubretta Bean. “Heart failure changed my life so quickly. You might think housework is a chore, but when you can’t make your bed or do the dishes, you realize how quickly you would love to do that again. Now after my Optimizer implant, I can do all these things! I look forward to planning my days again and not just trying to get through them. I have eight grandkids and two great-grandkids that I can travel to see!”

Drs. Eric Johnson, David Lan, and Chris Ingelmo are all electrophysiologists at Stern Cardiovascular that have treated ten patients at Baptist Memorial Hospital-Memphis with CCM therapy since March 2023. Dr. Chris Ingelmo completed the milestone procedure for the 9,000th patient treated with CCM therapy. The results have been encouraging, with significant improvement in patient symptoms.

“We are inspired by such stories highlighting the potential for clinicians to use CCM therapy to make a positive impact on HF patients’ lives,” said Simos Kedikoglou, MD, CEO of Impulse Dynamics. “The growing cadence of implants and the emergence of such inspiring stories reinforces our commitment to delivering meaningful advances in CCM technology and clinical data.”

CCM therapy is now available in 44 countries, and the technology has continued to advance based on the needs of patients and physicians. The latest generation of Impulse Dynamic’s proprietary Optimizer platform is the Optimizer Smart Mini, which offers a rechargeable battery with 20-year battery life and a smaller size designed to make the implant procedure faster and easier for patients and physicians.

About the Optimizer® and CCM® Therapy

The Optimizer Smart system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

CCM is the brand name for cardiac contractility modulation — the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period. In doing so, CCM helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.

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 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. CCM therapy has proven 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 LinkedIn, Twitter, 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, the continued momentum for the adoption of CCM therapy and use of the Optimizer Smart system globally; the ability for CCM therapy and our products and technology to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer system and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. 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; company’s ability to expand and grow its business into new geographic markets; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for its 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.

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

Harriss Currie, Chief Financial Officer
Impulse Dynamics
856-642-9933
hcurrie@impulsedynamics.com

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

GlobeNewswire Distribution ID 8839792