Antwerp, Belgium, 04 April, 2018
A patient friendly tool for diagnosis and monitoring of men, women and children with voiding disorders; set for commercialization after obtaining ISO and CE certifications.
The world’s leading urology congress was the scene for the official launch of Hospiflow and Homeflow – the first products of Belgium- based Minze Health. Hospiflow and Homeflow make it possible for men, women and children with urinary symptoms or bladder dysfunction to be diagnosed and monitored in a natural and comfortable way, both in the hospital or at home. Minze’s system is the world’s first uroflowmeter for use on a normal toilet that can be linked to an automated voiding diary app. Clinicians can consult the patients’ data on an online platform. After an extensive series of safety testing and clinical trials, Minze Health has obtained the all important ISO13485 and CE certifications for medical devices. Subsequently, the first commercial deliveries are scheduled for May 2018. Minze Hospiflow and Homeflow increase the comfort of the patient and contribute to better results and time and cost-efficiencies for clinicians.
“One out of every two men over 40 will experience urinary symptoms and one out of every five adults—male or female—suffer from a disorder such as an overactive bladder or waking up at night to urinate”, says Jiri Vermeulen, CEO of Minze Health. “Today, all urological examinations happen at a doctor’s practice or the hospital with uncomfortable devices. The delivery of a void on such uroflowmeters, instead of on a normal toilet, often causes inconveniences to the patient that may influence the results of the measurement. Above all, doctors have to make diagnoses and recommend treatment based on limited data that are often not representative. With Homeflow, we make it possible for urologists to diagnose and follow-up on their patients at home. Basing their diagnoses on multiple new measurements enables urologists to focus more on patients and their treatment during consults. Hospiflow, on the other hand, is a solution for use in the hospital or practice that makes a patient feel more comfortable because the tests can be performed on any normal toilet.
“In order to bring a medical device to market, it is crucial that safety and proper functioning of the device can be guaranteed. After a series of extensive audits and examinations of both device and software, SGS has granted Minze Health the ISO13485 and CE Class 1(m) certificates. This demonstrates, among other things, that we have the necessary quality processes in place to guarantee safety and that the device does indeed measure what it should,” says Josef Sageder, CTO of Minze Health. “Achieving ISO and CE certification is a particularly important milestone in the life of every company that manufactures products for the medical sector, as this officially indicates that the product is safe and compliant and can therefore be placed on the market.”
The past couple of months, Minze Homeflow and Hospiflow have been extensively tested in various hospitals in the Netherlands and Belgium. Doctors involved in these clinical trials were very enthusiastic and visibly impressed by the ease of use and the positive reactions of their patients. Nurses, for their part, were very satisfied with the flexibility, ease of use and hygiene of Minze Hospiflow and Homeflow.
Minze Health officially presented its first products at EAU18, with more than 10,000 physicians and people from the medical world the world’s largest urology congress. Urologists from all corners of the world have shown great interest in becoming ‘early adopter’ and industry, pharma and academia are also looking forward to starting clinical studies and scientific research. Physiotherapists specialized in the pelvic floor have also enthusiastically expressed their interest.
“From May 2018, commercialization will start in a first phase in Belgium and the Netherlands, but given the huge demand from potential users around the world, Homeflow and Hospiflow will also be sold internationally at a later stage,” says Gilles Tas, CCO of Minze Health. “For the international phase, we’re not only looking at countries within the EU, but after approval by the FDA, the United States will also follow soon.”
About Minze Health
Based in Antwerp – Belgium, Minze Health is a digital health company that develops medical devices and services with a focus on urology. Minze’s first products are Homeflow and Hospiflow, a user friendly and representative approach to diagnosis and monitoring of men, women and children with voiding disorders. Current customers are hospitals, urologists and physiotherapists with a focus on the pelvic floor in Belgium and the Netherlands. Further European expansion is foreseen as of Q3 2018.
Minze Health is part of the renown imec.istart program that was recently granted first place in the European ‘Top University Business Accelerators’ ranking by UBI.