November 17, 2022 – Page 2 – Djibouti News Gazette

November 17, 2022

Impulse Dynamics Announces 100th Implant Milestone in China for CCM® Therapy

Experience Continues to Show CCM Therapy Addresses Clinical Need in Treating Heart Failure

MARLTON, N.J., Nov. 16, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced the 100th implant in China, signifying the opportunity for its innovative Optimizer® system delivering CCM® therapy in markets around the world. Cardiologist Prof. Guo Tao, Executive Director of Internal Medicine, Fuwai Cardiovascular Hospital, Yunnan Province, performed the 100th procedure and emphasized the role of this therapy in providing an option and hope to patients living with the debilitating reality of heart failure.

“It is quite a coincidental milestone for us that the 10th patient implanted in our center also happened to be the 100th patient treated in China. I have paid very close attention to CCM therapy for more than 20 years now, but it wasn’t until recently we could clinically apply this technology. Under close clinical observation, our 10 CCM patients have improved even more than we anticipated. All the CCM patients in our center improved both symptomatically and on various objective indicators, which made both us and our patients very happy. Therefore, it seems from our experience that CCM is performing exactly as described in the foreign research — specifically, by modulating the exchange of calcium ions and thereby enhancing contractility of the myocardium in the acute period, then normalizing the expression of contraction-related proteins, which leads to reverse remodeling of the heart. Based on these results, we are now planning to expand the application of CCM normatively and actively while continuing to closely follow our implanted patients to obtain more clinical evidence of CCM to optimize its application so more Chinese patients can benefit from this latest innovative treatment.”

Prof. Zhang Shu, Chief Physician of Fuwai Hospital of the National Center for Cardiovascular Diseases and the Chinese Academy of Medical Sciences, Honorary Chairman of the Electrocardiology and Pacing Branch of the Chinese Medical Association, Director of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia-Pacific Heart Rhythm Society further commented “Currently there are almost nine million patients with heart failure in China, and many of them have not been optimally treated. Heart failure has also become the leading cause of death among cardiovascular and other major chronic diseases in China. I believe CCM will bring good news to Chinese patients. These successful initial experiences provide our doctors with good prospects of bringing hope to the patients they care for.”

“We are proud to see the growing acceptance of this technology in markets around the world,” said Mateusz Zelewski, MD, Impulse Dynamics´ VP International. “In reaching this milestone, we have connected with physicians, patients, and their families. We are inspired by the benefits of this therapy to our patients and continue to reinforce our commitment to address the immense need for advanced heart failure options for patients around the world.”

CCM therapy was approved in China late last year, and the first implant in the country was announced on November 1, 2021. The Optimizer system delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.

To date, CCM therapy has been used to treat heart failure in more than 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer-reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 – 60 percent.

About Impulse Dynamics

Impulse Dynamics is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company is focused on delivering its proprietary CCM therapy, which is delivered by the company’s Optimizer device, the CE-marked, and FDA-approved treatment verified to improve the quality of life for heart failure patients. CCM therapy is a safe, effective, and minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them.[1] 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 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 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.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/

Attachments

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

Harris Currie, Chief Financial Officer (Investor Relations)
Impulse Dynamics
856-642-9933
hcurrie@impulsedynamics.com

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

GlobeNewswire Distribution ID 8698682

November 17, 2022

African Women Entrepreneurs Call for Support of Africa Free Trade

African women entrepreneurs from 35 countries have called for more support from lenders and governments to help them benefit from the African Continental Free Trade Area. Meeting in Cameroon’s capital for the U.N.-sponsored African Women Entrepreneur Forum, the women say their businesses are mostly small, informal, and suffer discrimination.

More than 200 women from 35 countries are meeting in Yaounde for the second African Women Entrepreneurs Forum under the theme, “Female Entrepreneurs, Challenges and Opportunities.”

The African Continental Free Trade Area that started in 2021 brought great hope that a market of 1.2 billion people would boost women-run businesses and reduce poverty.

But while Africa’s women entrepreneurs still see opportunities, they also face many challenges.

Former Interim President of the Central African Republic Catherine Samba-Panza spoke Wednesday night at the forum.

She said many women are missing out on the opportunities of trade integration because their small businesses have low productivity and get little or no funding from governments and lenders.

Panza says as CAR’s former president and an African female leader she wants African governments and funding agencies to know that a majority of Africa’s 30% of women entrepreneurs need assistance. She says the COVID-19 pandemic, climate disruptions, persistent armed conflicts in Africa and Russia’s war in Ukraine are affecting most female-owned businesses.

Panza added that many female businesses in the C.A.R., Cameroon, Chad, Mali, Niger, and Nigeria have been forced to close because of armed conflicts.

Women entrepreneurs say they often face harassment and discrimination in Africa’s male-dominated trade.

Niger’s director for the promotion of rural enterprises Bissso Nakatuma led a 15-member delegation to the three-day Yaoundé forum.

She says women who want to export their farm produce and benefit from opportunities offered by the African Continental Free Trade Area are targeted by customs and police officers who want bribes. Nakatuma says women are forced to depend on their families and communities to fund their businesses because banks refuse to give loans to female investors.

The forum demanded a stop to discriminatory practices against women entrepreneurs. It also called for more access to financing for women-led businesses, including export credits and guarantees.

Achilles Bassilekin is Cameroon’s Minister of Small and Medium Sized Enterprises. He says Africa’s economic ministers are committed to solving the challenges for women that were raised at the forum.

“I am convinced that women entrepreneurs from various countries of Africa will go back to their respective countries with a clearer vision, a clearer picture of what the continental FTA [Free Trade Area] is about and how they can take advantage of this wonderful opportunity, which happens to be the [African] Continental Free Trade Area,” said Bassilekin.

Despite the challenges, the forum said female entrepreneurs this year contributed an estimated $350 billion to Africa’s economic growth, about 13% of the continent’s Gross Domestic Product, or GDP.

The U.N. says the female economy is the world’s largest emerging market with the potential to add $12 trillion to global GDP by 2025.

Source: Voice of America

November 17, 2022

East Africa Regional Force to Counter M23 Rebels’ Advance

The East African Community’s armed force, led by Kenya, has vowed to protect the city of Goma in the eastern Democratic Republic of Congo as M23 rebels advance toward the city, which is home to one million people.

Kenya sent hundreds of troops to Goma this week to quell the violence after rebels clashed with the Congolese army.

The Kenyan commander of the force, Jeff Nyagah, said the city will be safe.

“We are here to protect and defend the Goma international airport, including the force headquarters, as the rest of the processes continue,” he said.

The commander said the regional force was an intervention force, not a peacekeeping one.

M23 fighters are reported to have advanced to within 20 kilometers to Goma, the capital of North Kivu province, after the Congolese army abandoned their defensive positions.

East African countries agreed in April to send troops to the DRC to help stabilize the country’s eastern region, which has seen decades of conflict sparked by the presence of foreign rebel groups and fighting among local groups over control of the area’s mines, which produce gold, diamonds, tin and other valuable resources.

Blaise Karege, an independent political and security researcher in eastern Congo, said M23 is mainly concerned about fighting foreign rebels, who are terrorizing the local population.

They won’t come to Goma, he said, adding that they are fighting in the parks and with the Rwandan rebel group FDLR and other militias used by the FDLR. They are there to protect their people and properties against those rebels, and are not interested in Goma, he said.

There is an ethnic component to the fighting in North Kivu. M23 is made up mainly of Tutsis and has accused the Congo government of failing to protect their families against other rebel groups in the region led by Hutus.

Great Lakes Region security expert Dismas Nkunda said using force to manage the DRC conflict will create more instability. A confrontation between M23 and the East African peacekeeping force would derail the entire process of peace in Congo, he warned.

Experts say M23 is one of the country’s most heavily armed groups and remains a real threat to the region’s stability.

The Kinshasa government believes Rwanda to be behind the resurgence of the rebel group in the east of the country, an accusation denied by Kigali.

The regional force is also tasked with disarming rebel groups in the country, a move Nkunda sees as impractical, if not impossible.

There are about 133 rebel groups in DRC, some allied to the government, others allied to individual companies that are exploiting the Democratic Republic of Congo minerals and other natural wealth, and others belong to various countries, he said. The Allied Democratic Forces, or ADF, which is Ugandan, runs a vast territory, Nkunda said, adding that for a force of 900 soldiers that Kenya has sent in, in the DRC which has nine borders and stretches to the Atlantic Ocean with various rebel groups operating in the country, it is not possible they will be able to disarm those rebel groups.

This week, former Kenyan president Uhuru Kenyatta visited the eastern DRC. He called for increased humanitarian aid and for warring parties to engage in peace talks to find a solution to the conflict that has killed hundreds of thousands of people and displaced millions.

Source: Voice of America