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Decentralized clinical trials: Current developments in CEE and Turkey
The rapid development of technologies and solutions in the healthcare sector is contributing to the proliferation of decentralised clinical trials (“DCTs”). The aim of DCTs is for clinical trials to be conducted more effectively and conveniently – for patients, sponsors and investigators – through the use of digital technologies. In addition, with hospital visits temporarily limited and staff capacities overwhelmed, the challenges associated with the Covid-19 pandemic have significantly underscored the necessity of performing certain elements of clinical trials remotely. Download in English:
Žurić i Partneri Kinstellar advises OTP banka d.d. on the financing for the acquisition of Fiziodent Polyclinic
Our team in Croatia has once again advised OTP banka d.d., this time on the financing for the acquisition of Fiziodent Polyclinic through the sale of a majority ownership stake to Adria Dental Group. Fiziodent operates two polyclinics in the Croatian capital, Zagreb, and employs a total of 40 employees. It was founded in 2003 and is the leading clinic in the field of transparent and mobile braces in the region. OTP banka d.d. continues to support the growth of Adria Dental Group. As the largest dental group in Croatia and the wider region, Adria Dental Group now has more than 450 employees and 180 dental specialists and includes seven clinics and five laboratories in the cities of Zagreb, Solin, Rijeka and Poreč.
Žurić i Partneri (ŽIP) Kinstellar advises OTP Banka d.d. on the financing for the acquisition of Dentum Dental Clinic
Our team in Croatia has advised OTP Banka d.d. on the financing for the acquisition of Dentum Dental Clinic via the sale of a majority ownership stake to Adria Dental Group. With this transaction, OTP Banka d.d. continues to support the expansion of Adria Dental Group, which has now positioned itself as the largest dental group in Croatia and the wider region. The group has more than 420 employees, more than 70 practices and over 160 dental specialists, with annual revenues above 30 million euros. The group includes five clinics and five laboratories (Zagreb, Solin, Rijeka and Poreč) with a plan to further expand to the domestic and regional markets. The Kinstellar team in Zagreb was led by Mihovil Granić (Partner)
Kinstellar advises Powerful Medical on EUR 6.2 million seed funding
Kinstellar’s Bratislava office has recently advised Powerful Medical, a Slovak artificial intelligence and machine-learning MedTech company, in its negotiation of new financing agreements with investors. Powerful Medical successfully raised a total of EUR 6.2 million in seed funding from several US and EU investors, including Arieli Capital, Venture To Future Fund (VFF), CB ESPRI Impact One, bpd partners, and several angel investors. Powerful Medical has developed a software medical device that automates ECG analysis using artificial intelligence and machine-learning modules, which enables timely and cost-effective arterial fibrillation diagnosis and enhanced quality of treatment. Kinstellar has been supporting
Kinstellar advises a syndicate of banks led by Komerční banka on the acquisition financing for FutureLife
Kinstellar has successfully advised a syndicate of major Czech banks led by Komerční banka on the acquisition financing for FutureLife, a European leader in reproductive medicine and women’s healthcare. Kinstellar provided complex advice to a banking syndicate (comprising Komerční banka, Česká spořitelna and ČSOB) that provided the financing for the acquisition of the Centre for Reproductive and Genetic Health, the largest reproductive clinic in the United Kingdom, and for future expansion by FutureLife Group. Our advice included the preparation and negotiation of the finance documents under Czech law, including a loan syndicate agreement and security package. The Kinstellar team was led by Martina Březinová
Kinstellar advises Kyivstar on the acquisition of a controlling stake in Helsi, in Ukraine
Kinstellar has successfully advised Kyivstar on the acquisition of a controlling stake in Helsi. Kyivstar is the largest digital operator in Ukraine with about 25 million mobile subscribers and over 1.2 million home internet subscribers as of June 2022. The company provides services based on a wide range of mobile and fixed-line technologies, including 4G. Helsi is the largest medical information system and a leading digital provider in the field of healthcare in Ukraine. More than four million people are already users of the Helsi mobile application, with 10 million consultation bookings and three million online consultations per month. More than 1,300 healthcare institutions and over 49,000 doctors throughout
Kinstellar promotes Mert Elçin to Counsel in Istanbul
Kinstellar is delighted to announce the promotion of Mert Elçin to Counsel in our Istanbul office. Mert has more than 10 years of experience in corporate, M&A and banking and finance transactions as well as regulatory matters and has represented clients from a wide range of sectors, in particular banks, brokers, insurers, asset managers, investment funds and other market participants from the financial services industry, venture capital firms, founders, angel and private equity investors, and companies focusing on life sciences and healthcare, technology, media and telecommunications, retail and manufacturing. He is also experienced handling international arbitration. Mert joined Kinstellar in 2019 as
Kinstellar hosts webinar on current developments in the CEE life sciences & healthcare sector
On 14 June 2022, Kinstellar hosted a webinar centred on current developments in the life sciences & healthcare sector across Central and Eastern Europe. We covered some of the most relevant and pressing topics currently impacting the life sciences & healthcare landscape, including (i) sector inquiries by local competition authorities in the area of life sciences; (ii) price reduction announcements and their relevance for the CEE pharma sector; and (iii) legal challenges on the use of artificial intelligence across the life sciences industry. Presentations were made by Tomáš Čihula, Eszter Takácsi-Nagy, Péter Vörös and Petr Bratský. Below we provide a brief summary: Sector inquiries
Update of current eHealth trends in CEE and Turkey
As previously reported, eHealth (including telemedicine) has been one of the fastest growing areas within the healthcare sector over the last two years. Governments as well as healthcare sector operators across Central and Eastern Europe and Turkey continue to implement new solutions with a view to improving the provision of healthcare services and to enhance the digitalization of healthcare systems. Private healthcare providers and the various newly created eHealth providers and start-ups are crucial in pushing development in this highly dynamic area. Innovative solutions include online consultations and health examinations, the possibility of remote patient health data monitoring as well as electronic drug prescriptions.
Peter Kováč leads expert medical congress co-sponsored by Kinstellar
Peter Kováč, Of Counsel and head of the Life Sciences & Healthcare sector at Kinstellar’s Bratislava office, served as lead organiser for the expert medical congress “Legal, Forensic and Economic Aspects of the Medical Profession”, which took place online on 18 November 2021. The event, co-sponsored by medical education specialists SOLEN, forensic.sk and Kinstellar, is organised for medical doctors, managers and other healthcare professionals in Slovakia and is officially recognised by the Slovak Health Care Surveillance Authority as an expert event. Renáta Bláhova, Chairman of the Slovak Health Care Surveillance Authority, gave the opening speech at the congress, while Zuzana Baťová, Director of
New rules for the cultivation and export of medical cannabis and increased limits for THC concentrations in industrial hemp in the Czech Republic
On 8 October 2021, an amendment to the Act on Addictive Substances (the “Amendment”) was published. The Amendment is designed to expand the possibilities for cultivating medical use cannabis to a broader range of subjects, including natural person entrepreneurs, thus increasing its availability to Czech patients. It is expected that increased production will lead to a fall in the price of cannabis for medical use. A new licensing system is being created under the Amendment, enabling entities or natural person entrepreneurs to cultivate plant-based cannabis for medical use, provided that they obtain: a licence to cultivate cannabis for medical use issued by the State Institute for Drug Control (the “Institute”)
Romania sets out new rules on medical devices
On 11 June 2021, the Government Emergency Ordinance no. 46/2021 (“GEO no. 46/2021”), which establishes the institutional framework and measures for the implementation of Regulation (EU) 2017/745, entered into force. The aim of GEO no. 46/2021 is to ensure the proper functioning of the placing and making available on the market of medical devices for human use and the accessories for such devices. Below is a summary of the key changes introduced by GEO no. 46/2021: The information provided by the manufacturer together with the medical device must be in the Romanian language, without excluding the presentation of such information in other official languages of the European Union. Instructions of use for