02-01-2019 03:25 PM CET - Health & Medicine
Print

EvoCare® granted FDA-similar (DRV*) approval for its digitized EvoCare-Therapy

Press release from: EvoCare Holding AG
Approval for the digitized EvoCare®-Therapy
Approval for the digitized EvoCare®-Therapy


-EvoCare-Therapy can be used for every orthopedic post-surgeries therapy
-Approval creates options for patients and surgeons across a broad spectrum of multiple indications
-The market potential for EvoCare consists of more than 2.000.000 patients annually in Germany alone
-Association of Private Health Insurance Funds signalized cooperation
-Health is coming home

Nuremberg, Germany – Corporate News:
EvoCare Holding AG (the "Company"), specialized in digitized therapy, has announced that the German pension fund (DRV = FDA-similar) has granted marketing approval for its EvoCare®-Therapy for all patients in orthopedics. EvoCare submitted the first draft approval application (PMA) to the DRV in 2009. The DRV completed its response within a non-standard response period. This happened because EvoCare was the first digitized method ever applying for a regulatory approval.

This recent approval allows all physicians within the DRV to prescribe and use EvoCare-Therapy for Orthopedic patients. This means in particular the usage of the EvoCare-method, EvoCare-devices and -ecosystem and enables physicians to apply digitization for in- and outpatients.

Unavailability of therapy to perpetuate stationary treatment results is a major problem in healthcare systems worldwide. EvoCare is filling this gap.

EvoCare’s approval allows the Company to roll out its use of EvoCare-Therapy in a growing sizable market of about 2 million patients and 1.2 Bio. € per year in Germany (DRV only). EvoCare obtained a CE Mark for its devices and platform for the use in the EU-markets.

EvoCare’s represents state of the art digitized treatment at home and opens international markets like US and China.

"With the current approval of EvoCare-Therapy we have reached a unique regulatory milestone for treating patients at home in Germany. Post stationary therapy at home after surgeries did not exist until now. EvoCare stands out amongst the competition because it is the only evidence based approved method, easy to use, cost-efficient, applicable cross-indication and internationally scalable." said Dr. Ralf Kohnen, Chief Executive Officer of EvoCare Holding AG, "This approval provides a significant expansion of the addressable market which encompasses several specialties in inpatient and outpatient therapy as well as the care-sector. I want again thank our inventor Dr. Achim Hein and the regulatory affairs team for all their efforts. They have consistently demonstrated their ability to execute flawlessly on our regulatory roadmap."

About EvoCare-Therapy
EvoCare is a “digitized” therapy-product to a broad range of patients, such as cardiology, neurology, general and orthopedic surgeries, and give patients a better quality of life.

Unavailability of therapy to perpetuate stationary treatment results is a major problem in healthcare systems worldwide. Bringing the therapy to the patient’s home has been challenging because healthcare systems have not been prepared for such kind of digitized methods – until now.

In addition to the negative impact on patient’s health, this major hurdle causes cost impacts in all specialties of healthcare systems and is a burden for social systems budgets across the globe. EvoCare is the only validated application approved by the DRV demonstrating efficient therapy outcomes in a home treating setting. EvoCare has proven to secure faster patient recovery and enables elderly to live longer and healthier at home. Due to its efficacy, versatility and ease of use, EvoCare is quickly becoming a popular choice amongst doctors and therapists looking for new “digitized” options to treat their patients.

EvoCare’s approval allows the Company to roll out its use of EvoCare-Therapy in a growing sizable market of about 2 million patients and 1.2 Bio. € per year in Germany (DRV only). In addition EvoCare’s approval allows the company to expand the use of EvoCare-Therapy in an ambulatory (outpatient) market estimated approximately € 7 billion per year in Germany (health insurances). EvoCare obtained a CE Mark for its devices and platform for the use in the EU-markets.

EvoCare’s represents state of the art digitized treatment at home and opens international markets like US and China.

Currently the Company is working on expanding the range of applications for EvoCare-Therapy. In addition the company started sales and marketing activities and will initiate internationalization within 2019.

*Deutsche RentenVersicherung = German pension fund

About EvoCare Holding AG
Founded as a SIEMENS-spin off in 2002 and based in Nuremberg (Germany), EvoCare develops and commercializes therapy products, methods and services based on patented procedures. Designed to structure therapy processes and bring health to patient´s home in numerous specialties such as cardiology, neurology, orthopedic, oncology and so forth. EvoCare supports patients for a better quality of life. EvoCare brings health at personal home of the patients. The Company’s leading product, EvoCare-Therapy, is commercialized in Germany and Austria.

Since its creation, EvoCare has benefited from the support of prominent European investors. The Company’s shareholders today include the Company’s management team. The approval allows EvoCare to start its activities in marketing and sales since 01.01.2019. EvoCare prepares an IPO in 2022.

Until then, the Company will carry out a € 21 million capital increase. Actually, it is in work of € 6 million capital increase by means of a private placement to start activities.

EvoCare Holding AG, Muggenhoferstr. 136, D-90429 Nürnberg, Ansprechpartner: Dr. Achim Hein, Telefon: +49(0)911 323800, E-Mail: , Internet: www.telemedizin.de

This release was published on openPR.
News-ID: 1553703 • Views: 299
More releasesMore releases

You can edit or delete your press release here: