The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO).
EASYX™ is CE-marked since December 2016 for the use in peripheral vasculature. The safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML) was proven in a clinical trial EASYX-1.

EASYX-1: A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications. Publication is planned very soon.

                   

Second clinical trial for the extention of the EASYX indications:

Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Liquid Embolic in Intracranial Interventions IDEALE Study.
This is a Prospective Study to Assess the Safety and Performance of the Easyx Liquid Embolic in Intracranial Interventions.

Qmedics has started a trial “HORIZON” A prospective, non-randomized, multi-center, multi-national, Monitored trial, conducted at several investigational sites in Europe. The HORIZON trial data will support safety and effective clinical performance of the Medics Exist and Falcor NiTi stent type Flex & Pull. Simultaneous Qmedics designed with the stent portfolio family a PTA Balloon family so that all lengths and diameters of the families are coordinated. The Exist is married with the Manatee BDC and the Falcor with the Nage BDC.

The investigational products Exist (6Fr) and Falcor (5Fr) have DE NOVO technology as they posses the Flex and Pull properties. Each one of them has identical technical properties over their entire lengths and diameter what is unique in the stent design world. This novel design is for treating each characteristic lesion in consideration with the specific movability of the arteries.

Flex: the Flex property is recommended to be used in complex and moderate calcified lesions with arteries subjected to bending deformation in combination with radial compression.

Pull: the Pull property is recommended to be used in highly calcified and difficult to cross lesions with arteries subjected to longitudinal deformation and radial compression.

Primary endpoint: Freedom of procedure- or stent-related Major Adverse Events (MAEs) at 30 days and 12-months post-index procedure rate of TLR, PP and MAEs at 6 and 12 months months. Secondary endpoint: procedural success, ankle- brachial index (ABI) pre- and several FU periods, patency of treated vessel at FU (loss of patency defined as target vessel revascularization (TVR), or ≥ 50% stenosis & QOL questionnaire Clinical follow up to 3 years.

Qmedics wants to become an innovator in the field of arterial peripheral interventions that aims to improve clinical outcomes and quality of life. A major milestone was reached in the development of its novel designed stent technology. A vascular stent portfolio specifically designed to provide superb vessel scaffolding, enhancing accurate stent deployment regardless of the movability of the artery and within each lesion characteristics by using two different types of stents: PULL & FLEX.

Parallel with this milestone Qmedics opened a PMS post market surveillance: Qmedics started the PMS “REVEAL”

The post-marketing surveillance is a regulatory necessity and provides continuous feedback about our stent portfolio on the market in order to maintain a high standard of product quality. It gives us at all times the data how the product performs. This data and the clinical professionals experience can help to improve our stent portfolio if needed.

The REVEAL is gathering data: pre-during the intervention, voluntary over the following 12 months and at 12 months a mandatory FU. Further the PMS will follow these implants over their entire lifetime on the quality, performance and safety by gathering feedbacks of the clinical professionals and patients them selfs. Qmedics want to be on the forefront of innovative technology and deliver these state- of- the- art products to imporve patient care.

Cathlab here we come!!!!!
Qmedics will be a friend of gathering as much as possible information on the stent portfolio and on the wellbeing of our patients. First results of the Reveal PMS is planned to be presented at Linc 2020.

We also will give an update in our website.

Qmedics reached the next milestone

In 2016 the Board of Directors decided to sell the sister company of Qmedics, who was at the same time the biggest customer for Qmedics and gave the management the task to acquire new technologies and business for Qmedics. This needed to be implemented during the transition time that was planned to up to two years- this goal was not reached and Qmedics stayed a pure contracted manufacturing company hereby losing his biggest customer.

Dr. A. Patteet who started at Qmedics July 2017, quickly found out there was no product pipeline and no planned innovation. So, she started implementing an R&D strategy immediately she hired some more engineers to get more intellectual input and speed into the R&D department with the task “design and develop” a new product portfolio”

In June 2018 the Board of Directors decided to re-organize the Qmedics management and strategy.

Former CTO of Qmedics, Dr. Anita Patteet was appointed by the Board of Directors as new CEO of Qmedics in July 2018. Her role was to make Qmedics attractive, with innovation, new technologies and a de novo product portfolio and this with the primary focus on the well-being of the patients, direct sales and a facility that produces state of the art products.

Dr. Anita Patteet joined Qmedics in 2017. Before joining QMEDICS, she held various international leadership positions within Sonova, Biotronik and Terumo. In her last position, she acted as Global Vice President (GVP) Regulatory, Clinical and Quality Affairs. She brings more than 18 years of international know- how in Life Sciences industry. Especially experienced in the domain R&D, Regulatory, Clinical, and Quality for active implantable, Implantable Class II, III devices and combined products.

Before here industrial carrier she worked for many years in the Cardio-Vascular Surgery department of the University of Leuven Belgium. Studied and worked at Harvard and Kyoto University.

Asked what her ultimate challenge, as CTO was Dr. Patteet said, “manage to  attract highly qualified and talented staff to quickly develop a broad and  innovative product line of peripheral stents and balloons for various vascular  indications.” Asked what Dr. Patteet sees as CEO in 2018 as her ultimate  challenge she said “This is a challenge where I don’t know if I can replace the  sales lost during this transfer time.

Qmedics has lost an important part of its personality, distinctiveness and  turnover.  A big part of my work is to give Qmedics another identity, a purpose and a focused future with a healthy turnover. This I only can reach with the uninterrupted support of our investors, and with the loyalty of our employees.

Asked what your focus is over the next two years Dr. Patteet said:” I want us to stay focused on the development of innovative products, start clinical trials, launch International the Qmedics new product portfolio and parallel implement an incredible pipeline of new products and get a new technology as soon as possible into our facility”.

My intention is to realize a democratic management style, where all employees have their place and responsibility and are equally respected.

To create a company where people like to come to work, where professionals can give their input and work with our engineers on improved devices so that the patients can have the best of the best vascular implants.

Further she said: “Despite we have difficult years in front of us, with the newly developed business strategy and the determination to succeed, Qmedics shall prevail and will become a company where professionals will enjoy cooperating with, where employees are proud to work for and all this focused on the well-being of the patients.

She added with a smile “and this hopefully before I go on pension”.

Deutsch:

2016 beschloss der Verwaltungsrat, die Schwesterfirma und gleichzeitig grösster Kunde von Qmedics zu verkaufen. Gleichzeitig beauftragte er die Geschäftsleitung neue Technologien zu suchen und eine Qmedics’ eigene Produktemarke zu schaffen. Dies sollte während einer Übergangszeit von zwei Jahren in die Tat umgesetzt werden. Dieses Ziel wurde nicht erreicht, Qmedics blieb ein Auftragshersteller und verlor damit seinen grössten Kunden.

Als Dr. Anita Patteet im Juli 2017 in die Firma eintrat fand sie schnell heraus, dass es keine neue Produktelinie gab und auch keine Innovationen geplant waren. Also begann sie sofort eine neue F & E Strategie zu implementieren, indem sie zusätzliche Ingenieure anstellte, um mehr neues Fachwissen und mehr Tempo in die F & E Abteilung einzubringen, mit der Aufgabe „Planung und Entwicklung eines neuen Produktportfolios“.

Im Juni 2018 entschied der Verwaltungsrat, das Management und die Strategie von Qmedics zu reorganisieren.

Im Juli 2018 ernannte der Verwaltungsrat den früheren CTO Dr. Anita Patteet zum CEO von Qmedics.

Sie wurde beauftragt, aus Qmedics eine attraktive, innovative Firma zu machen, die mit neuen Technologien arbeitet und ein einzigartiges de Novo Produkteportfolio hat, fokussiert auf das Wohlergehen der Patienten, den Direkt-Verkauf und den neuesten Stand der Produktionstechnik.

Vor Qmedics bekleidete Frau Dr. Patteet verschiedene – internationale – Führungsfunktionen bei Sonova, Biotronik und Terumo. In ihrer letzten Stelle agierte sie als Vizepräsidentin und war weltweit verantwortlich für die regulatorischen, klinischen und Qualitäts-Angelegenheiten von Sonova AG. Sie hat mehr als 18 Jahre Erfahrung in der Life-Science Industrie, im speziellen in den Gebieten Forschung und Entwicklung, Zulassung, Klinische Studien und Qualitätskontrolle von aktiven Implantaten, nicht-aktive Implantate und kombinierte Medizingeräte der Klassen II und III.

Vor ihrer Industrie-Karriere arbeitete sie viele Jahre lang in der Kardio-Vaskulären Chirurgie der Universität Löwen. Zudem arbeitete sie an den Universitäten von Harvard und Kyoto.

Gefragt, was sie als CTO als ihre besondere Herausforderung ansieht, antwortete Dr. Patteet:
“Die Abteilung so zu führen, dass hoch-qualifizierte und talentierte Mitarbeiter gewonnen werden können, die schnell eine breite und innovative Produktelinie für periphere Stents und Ballone für unterschiedliche vaskuläre Indikationen entwickeln.”

Gefragt, was sie als CEO als ultimative Herausforderung im 2018 ansehe, sagte sie:
“Das ist die Herausforderung, bei der ich nicht weiss, ob ich die in der Übergangsphase verloren gegangenen Umsätze ersetzen kann. Qmedics hat ausserdem einen wichtigen Teil ihrer Persönlichkeit und Unterscheidbarkeit verloren.”   Ein grosser Teil meiner Arbeit wird also dahin gehen, Qmedics eine neue Identität, einen Zweck und eine Zukunft mit gesunden Verkäufen zu geben. Das kann ich nur erreichen mit dem ungebrochenen Support der Investoren und der Loyalität der Mitarbeiter.»

Auf die Frage, worauf sie sich in den nächsten drei Jahren besonders fokussieren wird, antwortete Frau Dr. Patteet: «Wir werden uns auf die Entwicklung von innovativen Produkten konzentrieren, neue klinische Studien durchführen, das Produktportfolio international lancieren, parallel dazu eine einzigartige Pipeline von neuen Produkten realisieren und neue Technologien in unsere Produktion integrieren.

Meine Absicht ist es, einen demokratischen Managementstil zu pflegen, wo alle Mitarbeiter egal in welcher Position und Verantwortung gleichwertig respektiert und gehört werden. Mit diesem neuen Stil will ich eine Kultur schaffen, wo die Mitarbeiter gerne arbeiten, wo alle Fachkräfte ihren Input geben und mitentscheiden können und so mit den Ingenieuren gut zusammenarbeiten, damit am Schluss die Patienten das Beste vom Besten bekommen.»

Frau Dr. Patteet meinte auch:
«Wir werden einige schwierige Jahre vor uns haben. Aber mit der neuen Geschäftsstrategie und dem Willen zum Erfolg wird sich Qmedics durchsetzen und zu einer Firma werden, mit der die Fachkräfte gerne kooperieren, auf die die Mitarbeiter stolz sind und immer das Wohlergehen der Patienten im Fokus haben.»

Mit einem Lächeln fügte sie hinzu: „und dies alles hoffentlich bevor ich in Pension gehe.“

Our travel did start with a strike of the taxi drivers, a delay in our shipment of workshop material- but as a team we finally made it.

In the middle of the night one of the engineers who stayed at the office- took the largest suitcase, filled it with material, took a flight and came one hour before the first workshop started, he saved our image. Although there were not a lot of people at the symposium, the word was out.

Qmedics comes with three variants and two types of stents with innovative specifications, with a promising therapy for our patients.

Qmedics team at Cirse

With the organization of workshops the professionals get to understand the two stent types “ Pull & Flex”.

The first workshop “Endovascular treatments of PAD: tips and tricks on new devices and techniques” born from a collaboration between Qmedics and Doctor Robert Bonvini (Clinique des Grangettes, Geneva) was a success and an extremely valuable experience in terms of knowledge sharing and networking.

We want to thank the international pool of participants hoping that this event is just the beginning of a long path.

As a Swiss company we are very pleased that our improved QM1 “Exist” a product entirely developed at our facility “made in Switzerland” is being implanted for the first time in Swiss hospitals with success.

The DE NOVO approach is the two types of stents (Pull) one with a higher radial force, a low chronic outward force and an extreme longitudinal movebility, and the second type (Flex) is the stent with the lower radial force but a higher flexibility.

Qmedics thanks the professionals who really care of the wellbeing of the patients and believe in the innovation of Qmedics products.
Qmedics does follow up all patients to watch how the quality of live actualy improves.
This is for all Qmedics employees the most important message. In the pipeline are two new variants the 5Fr and 4Fr sizes.