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Coronavirus (COVID-19) Updates

Comac Medical Ltd. and its spin-offs – Comac Medical Phase I Unit, Laboratories, and International Research Network – have been monitoring the global COVID-19 pandemic since the beginning of this year and are constantly reviewing the risks based on the established company business continuity plan and actual situation. We want to assure our partners that we remain committed to business continuity, while at the same time protecting trial participants and employees.

We are keeping abreast of guidance from the World Health Organization (WHO), Food and Drug Administration (FDA), European Medicines Agency (EMA), the European Commission (EC), as well as other global health organizations.

We recognize that the situation is evolving and, therefore, we would like to share with you the official FDA, EC  and EMA (draft) guidance which we adhere to in relation to the conduct of clinical trials in the context of increased risk of COVID-19.

Stay safe!

On March 4, during an annual ceremony, Darik Radio presented the “Man of the Year” awards for 2019. Having received most of the online votes, Dr. Milen Vrabevski, CEO and owner of Comac Medical, was awarded the Man of the Year.

The nomination is for his overall philanthropic activities. Dr. Vrabevski is one of the biggest investors in the Bulgarian education not only in 2019 but in the last decade. He is actively involved in charity causes in Bulgaria, supporting initiatives that promote national identity and European citizenship values. Dr. Milen Vrabevski is a Founder and Chairman of the Bulgarian Memory Foundation, a non-profit organization established in 2007 – the year of the Accession of Bulgaria to the European Union – working for and with young people. The aim of the organization is to build on the modern concept of national identity in the light of the Bulgarian EU membership. The projects of the BGMF leverage on the Bulgarian contribution to the European cultural and historical heritage to increase national pride.

Comac Medical has the pleasure to announce that our Clinical Research Unit has successfully passed a pre-approval inspection from the US Food and Drug Administration (FDA).

The scheduled US FDA visit lasted 5 days – between 10th and 14th of February 2020; as a result, no FDA Form 483 has been issued.

During the inspection, the Clinical Research Unit was checked for compliance with the US FDA requirements. The inspection included extensive review of documentation and no FDA Form 483 has been issued.

The successful US FDA inspection of Comac Medical’s Clinical Research Unit facilities reflects the company’s commitment to deliver the highest quality services.

The inspected study enrolled 70 patients and successfully passed US FDA inspection once again confirms that the highest quality standards are followed”, stated Tsvetelina Ivanova, Comac Medical’s Chief Compliance Officer.

Thank you all for doing a fantastic job!”, commented the Vice-President of the Sponsor of the inspected study, congratulating the whole Comac Medical team.

The idea for the competition “Man of the Year” was born with the first issue of the magazine “Club M” – 1990. Since 2008, Darik Radio owns the brand. The same year the official website of the competition was created.

On December 23, 2019, the public voting for the 12th edition of the competition began. The award ceremony will be held at the end of February 2020, when Darik Radio will pay respect to the most successful Bulgarian men who have distinguished themselves in 2019.

The CEO of Comac Medical Milen Vrabevski, MD, is nominated in the “Man of the Year” competition for his philanthropic projects and investments in Bulgarian education!

You can vote for him by following the link here: https://manoftheyear.bg/vote/25

We wish Dr. Vrabevski the best of luck!

PCT Barcelona, 19-21 November 2019 – was the city and place to meet key players from the Pharmaceutical and Bio-tech world and build on partnerships, outsourcing, operations and technology strategies.

Attendees holding leading positions in global Medical, Pharmaceutical, Clinical Trials, Biotechnology and Medical Device companies showcased their business challenges, success stories and insights.

Comac Medical met with current and potential partners to discuss clinical trial needs and challenges and get insights about all of the technology innovations in the conduct of successful clinical trials.

The Partnerships in Clinical Trials (PCT) Conference is organized annually and takes place in different locations. This year, more than 1000 guests attended the event in Barcelona.

Comac Medical supported a team of medical students to attend the International Biomedical Congress in Sofia this November 2019.

The team of students from the Medical University “Prof. Dr. Paraskev Stoyanov “ in Varna presented two medical reports with focus on Pharmacology. The topics of the reports were “The dangers of medicines we can buy online” and “Are anabolic steroids worth the risk?”.

The first paper looked at the dangers of three illegally sold online prescription drugs – modafinil, sildenafil and sibutramine, the latter being banned for sale as a medicinal product. Very recently, a dietary supplement containing sibutramine was discovered on the Bulgarian market without being described in the contents, while sibutramine is banned for sale on EU territory. These three medicines can cause very negative side effects and pose a risk to their users if taken without a prescription.

The second report looked at the risks of anabolic steroids use. Anabolic steroids are drugs sold only with a prescription. These substances have long been used to improve the performance of athletes – i.e. used as doping. Unfortunately, they have many side effects, some of which are irreversible. Despite the serious consequences and injectable use, these substances are marketed in exactly the same way as the substances in the first report.

A record number of doctors and students attended the 3rd edition of International Biomedical Congress Sofia this November. The event which presented the newest scientific achievements in the field of medicine and welcomed a number of inspirational speakers took place from 15th to 18th of November in Sofia Tech Park.

Dr. Milen Vrabevski, the Bulgarian Memory Foundation , and Comac Medical sponsored the participation of students from Varna by providing accommodation, airline tickets, and participation fees.

We wish the young ambitious team a lot of professional success!

Comac Medical’s Business Development team visited Boston to attend the 2nd Meridian Clinical Trial Summit on 7th and 8th of November for pharmaceutical biotech companies and Clinical Research Organizations. The aim of the event was to support participating organizations in increasing their overall performance, knowledge, and industry influence. The focus of the discussions was on early clinical development, clinical outsourcing, clinical operations and development, patient-centricity, clinical monitoring, site-less clinical trials, best available technologies and Artificial Intelligence in clinical trials. The set-up of the event was a combination of case study presentations, interactive workshops, informative panel discussions, and face-to-face meetings. The workshop sessions enabled the participants to discuss the issues they face while conducting clinical trials. The face-to-face meetings, organized well in advance before the event, allowed the participants to pre-decide who and when they want to meet, to utilize networking time as effectively as possible.

The CPhI worldwide took place 05 to 07 November 2019 in Frankfurt. Described by the participants as another record-breaking event, the event gathered more than 45,000 Pharmaceutical professionals for collaboration, information dissemination, and discussions with the ultimate goal of helping to define the future of the pharmaceutical industry and showcasing latest innovative products and technology. Comac Medical used the occasion to meet potential new partners and strengthen existing relationships.

“It was an outstanding opportunity to reach new markets and increase our international presence. Further, it created enormous synergy between the world’s most prominent pharma executives and the relevant exhibitors engaged in a range of therapeutic areas. ” Says Mr. Goranov, Comac Medical’s CFO, who was part of Comac’s team attending the event.

CPhI Worldwide is one of the largest pharmaceutical trade shows worldwide gathering together leaders and experts from the pharmaceutical industry. Held once a year at different locations around the world, it takes pride of 30 years of history as an international chemical and pharmaceutical trade fair. This is the place to meet key suppliers and customers in the chemical and pharmaceutical industry.

Photo Credit: Twitter

Comac Medical’s North Macedonia branch has received a Certificate for exceptional financial achievement. The company has met the highest business criteria in 2018. This ranks the company among the most successful organizations in the country.

Based on a national analysis, Comac Medical is among the top 2% of the companies in the Republic of North Macedonia that meet all 18 key criteria for company efficiency, liquidity, solvency, lawsuits, etc. According to the survey, Comac Medical met the highest requirements in terms of financial performance for 2018, taking the 1st place for credit rating. The Certificate presented to Comac Medical has once again endorsed the company as a model for business success and sustainability.

Congratulations to the entire Comac Medical family and congratulations to the Comac Medical North Macedonia Team on the achievement!

The ERS International Congress is the world’s largest meeting for respiratory physicians, scientists, allied health professionals and all areas of respiratory medicine. Held in Madrid, Spain between 28 September – 02 October 2019 the Congress welcomed over 20,000 delegates. The annual event boasted an outstanding scientific and educational programme to address the needs of researchers, clinicians, general practitioners and allied health professionals.

Comac Medical’s CFO Mr. Vladimir Goranov shared that one of the key benefits of the Congress is that it offers an excellent opportunity for business and science to share innovative ideas and collaborate. “It is an exceptional occasion to meet peers, colleagues, experts and organizations worldwide in the areas of science and education. It also enables experts to discuss projects in person, boosting forward new concepts and possibilities”.

This year the key topics discussed during the Congress programme covered respiratory medicine from across the spectrum of 8 disease areas, including TB, lung cancer, chronic and acute respiratory failure, sleep breathing disorders, interstitial lung diseases, pneumonia, cystic fibrosis, COPD and asthma, amongst others. Set to deliver the best advances in both science and education, the event specifically highlighted the importance of vaccination, smoking cessation, rehabilitation and clean air.

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