About

“Pleioflow” is a company with patented [disruptive] technology on Flow assist device(s) that are aiming at preventing renal failure, alleviating heart failure and preventing Diabetic Amputations. There are no similar alternative devices currently in use. Current Funding raised is at the range of 4.5 million Euros [to achieve key milestones on the way to product launch, expected in Q1 2022]. Pleioflow current company valuation is at the scale of 30 million USD. It is the 1st company of its kind in Greece, producing "Class III medical devices".

Solution & Product

Pleioflow Device(s) are miniaturized catheter based devices that can be easily inserted in the circluation even in emergency clinical setting, through the femoral artery. They feature 2-3 mm flow profile catheters and an an easy operating system. They can create/augment flow in any area of the circulation and treat almost any ischemic organ, sustaining low arterial flow. They are expected to treat more than one million every year in the westernized world, suffering from cardiogenic shock (severe heart failure post MI), acute kidney injury in the context of hypotension, ischemic stroke and diabetes. There are no other alternative devices in use. The expected company capitalization is at the scale of 20 Billion USD in 5-7 years time. More can be found on wwww.pleioflow.com

Innovation & Scalability

The Pleioflow Device(s) feature a tremendously low flow profile 2-3 mm, in comparison to other mechanical assist flow systems, that use extracorporeal mechanical circulation, or any other devices in the clinical "acute medicine field". They are essentially "flow creators". There are no other competitors in the market that can compete the Pleioflow Device(s) in flow profile (size) characteristics and flow augmentation result. Sale price per device averages 3-4,000 USD per Device, that is a very competitive price in the flow assist clinical market. The Flow assist Devices market is very concentrated in tertiary clinical centers featuring Cardiac Surgery and Interventional Cardiology capacity. Therefore it is an accessible market for rapid market infiltration. The companies' expected to reach an annual sale target of 1-2 million Devices (6 Billion USD annual turnover) by 2026. The company plans to establish at least three separate production lines in Germany and Greece to meet the production target above.

Traction & achievements

Pleioflow Founder is an accredited Entrepreneur (has obtained x2 Medical Devices Innovation Awards and obtained 0.56m European Funding for -previous to Pleioflow- developed medical devices). Pleioflow has already raised 4.5 million in Investment funding and it has already developed "In House" know-how in medical device research, development and production, and is completely independent by means of essential components production. Pleioflow has compiled a team of experienced engineers, and has created two mirrored facilities, one in Greece and one in Germany, including, but not limited to, two "clean rooms". QA, QC, Quality management system, testing and production capacity set up, in compliance with the new MDR.

Team & Why Us

Pleioflow has compiled a team of experienced engineers, and has created two mirrored facilities, one in Greece and one in Germany, including, but not limited to, two "clean rooms". QA, QC, Quality management system, testing and production capacity set up, in compliance with the new MDR. Pleioflow team is a strong and small, dynamic, resilient team, comprising of -a Metallurgist (Germany) who has worked for over 10 years in the Nitinol stent device industry (prototyping, manufacturing, testing, quality assurance) and has worked with the founder in producing his devices prototypes since 2008. -Germany based- engineers, experienced on the regulatory process and manufacturing of medical devices (a strong QA/QC/QMS/Regulatory team) -Greece based-engineers ,experienced on medical Device manufacturing, -A strong CRO team partnered with Pleioflow, -Two experienced corporate UK Attorneys, -Two experienced US Attorneys in the legal matters of medical devices, one with over a 15 years’ experience, as a partner in Venable LLP, the largest US company specializing in IP law of medical devices. Pleioflow has already established a Core team. At present is recruiting actively new people and train them, to meet the company's production portfolio, RD portfolio, and targets. Pleioflow has already entered in a "Scale up planning" face.

Funding Needs

At present Pleioflow has already raised all the Investment Funding required, up to CE marking of its 1st medical Device- so called “Pleioflow RF”. Pleioflow doesn’t require any Investment Funding at present, but it will require after Series C funding for Scale up production and Distribution. Pleioflow may require additional funding, in the future, for the Development of the Company’s other seven medical devices, that are in its pipeline for RD and production. However this may be raised from Global companies as exchange to Global Distribution rights, or in the context of a merger. Pleioflow may require additional Investment Funding of 10-15 million, in 2022, for Global Scale production, Global marketing and Distribution.