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 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, 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

Transport sets record straight on Karpowership’s access to three ports

The National Department of Transport has today pronounced on the approval of the application to grant Karpowership access to the three Ports of Ngqura, Durban and Saldanha Bay for a period of 20 years. The application was approved by the Minister on 26 February 2023.

The approval is in line with the National Ports Act No. 12 of 2005, which gives powers to the Minister to approve applications of this nature.

The Minister considered the application in terms of National Ports Act Section 79 (1) (a) and (b) to safeguard the national security of the Country and to discharge the international obligations of the Republic.

The Transnet National Ports Authority (TNPA) was consulted and supported the approval of the application.

It is for this reason that the Minister gave the TNPA latitude to make necessary decisions in implementing this Directive, such as considering the safety measures and operation ability of this Directive.

As a result, the following conditions were attached in the approval:

a) “TNPA reserves the right to include all the necessary commercial and safety requirements or agreements that are considered necessary during the period of this Directive”

b) “The Directive is also subject to all other government approvals such as Environmental approvals from competent government departments and/or authorities”.

Source: Government of South Africa

SA grants Turkey’s Karpowership to deal with load shedding

The national Department of Transport announced on Thursday that South Africa has granted Turkey’s Karpowership access to the three ports of Ngqura, Durban and Saldanha Bay for 20 years.

The statement said the Minister approved the application on 26 February 2023, in consultation with and supported by the Transnet National Ports Authority (TNPA).

The Turkish-owned company seeks to supply 1 220 megawatts (MW) of electricity to South Africa.

The company secured the deal after the Department of Mineral Resources and Energy’s December 2019 call for 2 000MW of emergency power.

However, according to reports, in March, its environmental application to moor a ship-mounted power plant at the port of Saldanha Bay was suspended after allegations that the views of small-scale fisheries were misrepresented.

The approval, according to the department, is in line with the National Ports Act No. 12 of 2005, which gives powers to the Minister to approve applications of this nature.

“The Minister considered the application in terms of National Ports Act Section 79 (1) (a) and (b) to safeguard the national security of the country and to discharge the international obligations of the Republic.”

The statement read: “It is for this reason that the Minister gave the TNPA latitude to make necessary decisions in implementing this directive, such as considering the safety measures and operationality of this directive.”

In addition, as a result, there are several conditions attached to the approval.

These include the TNPA reserves the right to include all the necessary commercial and safety requirements or agreements that are considered necessary during the period of this directive.

“The directive is also subject to all other government approvals such as Environmental approvals from competent government departments and/or authorities,” it added. – SAnews.gov.za

Source: South African Government News Agency

Electricity Minister visits OEM plant in KZN

The Minister in the Presidency responsible for Electricity, Dr Kgosientsho Ramokgopa, will today visit Original Equipment Manufacturers (OEM) in KwaZulu-Natal.

Joined by KZN Economic Development MEC, Sboniso Duma, the Minister will visit the Toyota Plant based in Prospecton, eThekwini.

“The Minister’s visit to the OEM’s is part of his continuous engagements with the automotive industry on their challenges caused by the current electricity crisis and possible short to medium term solutions on the demand side,” the Ministry of Electricity said in a statement. – SAnews.gov.za

Source: South African Government News Agency

Minister Naledi Pandor hosts Meeting of BRICS Ministers of Foreign Affairs and International Relations, 1 Jun

Minister Naledi Pandor hosts Meeting of BRICS Ministers of Foreign Affairs and International Relations, 1 Jun

The Minister of International Relations and Cooperation, Dr Naledi Pandor, will host the Meeting of BRICS Ministers of Foreign Affairs and International Relations on 01 June 2023 in Cape Town.

The mid-term meeting provides an opportunity for BRICS Foreign Ministers to reflect on regional and global developments. Minister Pandor, as the Chair of the BRICS Ministerial Meeting, will continue with the policy of inclusive engagement by inviting 15 Foreign Ministers from Africa and the global south to a “Friends of BRICS” meeting to be held on 02 June 2023. The ministerial meetings will be preceded by the meeting of Sherpas and Sous- Sherpas from 29-30 May 2023.

Members of the media interested in covering the meeting are requested to send the following information to Patience Mtshali, mtshalip@dirco.gov.za(link sends e-mail) and Kgopotso Rapakuana, RapakuanaK@dirco.gov.za(link sends e-mail)

Full Names and Surname

ID/Passport Number (for passport holders, please provide date of issue, country of issue and date of expiry)

Name of Media House

Designation

The deadline for the submission of the above information is 26 May 2023. Late applications will not be accepted.

NB: Due to space limitations, media houses are advised to assign not more than two journalists to the event.

Source: Government of South Africa

ONH: Awarding of best Tunisian extra virgin olive oil for 2023

Four gold medals, 4 silver medals and 4 bronze medals were awarded, on Wednesday, to the best producers and exporters of extra virgin olive oil, during the award ceremony of the 6th edition of the National Oil Office (ONH) Prize for the “Best Tunisian extra virgin olive oil”.

The prizes are distributed according to four categories of olive oil namely:

Ripe fruity

-Gold Medal: Domaine Ben Smail (Tuckabeur-blend of varieties)

-Silver medal: Seitounis (Megrine-blend of varieties)

– Bronze medal: Ralikis international (Ariana – blend of varieties)

-4th finalist: Huilerie RTIBA (TAkelsa – Cheibi variety).

-5th finalist: Frères Bouachir (Nabeul – Cheibi variety)

Light fruity

-Gold medal: La Perla (Kalaa Kébira – Chemlali variety)

-Silver medal: TAOOC (Le Kef – Chetoui variety)

-Bronze medal: Olea Kotti (Sousse- Chemlali variety)

– 4th finalist: Ben Safta (Bouarada – Chetoui variety)

-5th finalist: Saraya Natural Products Tunisia (Mornaguia – Chetoui variety)

Medium fruity

-Gold Medal: A and S (amateur blend of varieties)

-Silver medal: CHO (Sfax-Chemlali variety)

-Bronze medal: Rivière d’or (Moknine-Chetoui variety)

-4th finalist: CRDA (Siliana – Chetoui variety)

-5th finalist: STE Jaballah Zitouna (Kalaa Kebira – Chemlali variety)

Intense green fruity

– Gold Medal: Domaine Adonis (Testour – Sayali variety)

-Silver medal: Sangaris (Jedaïda – Chetoui variety)

– Bronze medal: Domaine UM El Janna (Mateur variety)

-4th finalist 2023: Domaine Boubaker (Oued Ellil – blend of varieties)

-5th finalist: Farid JEBABLI (Sousse – Sehli variety).

Speaking at the ceremony, Minister of Agriculture, Water and Fisheries, Abdelmonem Belati, called on all those involved in the olive oil sector to continue their efforts to distinguish themselves in national and international competitions and to promote the sector.

On this occasion, he highlighted the efforts made to improve the quality of olive oil and to increase the value and quantity of exports.

Source: Agence Tunis Afrique Presse

Tunisia’s date exports down by 2.3% in volume and 4.4% in value

Exports of Tunisian dates have decreased by 2.3% in volume to 100,100 tonnes and by 4.4% in value to TND 599,400 million, from the beginning of the season until the end of April 2023, compared to the same period of the 2021-2022 campaign.

According to the National Agricultural Observatory (ONAGRI), the Deglet Ennour variety accounts for 88.1% of the quantities exported, or 88200 tonnes with a value of 569.4 million dinars.

Morocco is the main importer of Tunisian dates, accounting for 21.1% of the quantities exported during the first seven months of the 2022-2023 campaign, followed by Italy (7.3%) and France (6.9%).

Source: Agence Tunis Afrique Presse