The problem we solve: Close to 80 million are threatened with irreversible loss due to glaucoma. Important disease parameters can momentarily only gathered at infrequent eye center visits. Disease progression, therapeutic response and patient compliance between office visits are currently unknown, resulting in progressive vision loss.
About our solution: Implandata's EYEMATE system collects important disease parameters via biosensors and mobile data collection solutions with the patient under normal life conditions, enabling disease monitoring and timely disease management. The EYEMATE system provides remote patient care and data-driven therapy guidance.
Progress to date:The EYEMATE system is the first CE marked solution for remote monitoring and management of glaucoma patients. Safety, utility and efficacy have been extensively demonstrated in clinical studies and post-market surveillance.
With CE mark, the EYEMATE can be introduced into the Eurpean market place. The company is currently working also on the FDA regulatory process, expecting a Breakthrough Device Designation, which ensure an expedited regulatory process towards FDA approval.
Creator: Max Ostermeier
Location: Niedersachsen
Bio: Max G. Ostermeier (MBA), is a medical device serial entrepreneur and founder and CEO of Implandata Ophthalmic Products GmbH, which is the leader in digital transformation in the management of chronic eye diseases. Prior to that Max was CEO and founder of Cranium Telemetrics GmbH, a start-up which has developed the first implantable intracranial pressure sensor for better management of hydrocephalus patients. He also founded and managed Odicrain GmbH, a medical device company with a portable device for early detection of critical brain injuries. For both companies, a successful exit was accomplished with US based companies.
Title: CEO
Advanced Degree(s): MBA
Implandata Ophthalmic Products GmbH
Location: Kokenstrasse 5
Hannover, NI 30159
DE
Founded: 2020
Website: http://www.implandata.com
Twitter: @implandata
Facebook: https://www.facebook.com/Implandata/
Product Stage: Ready
Employees: 10-20
Intellectual Property Summary
Implandata owns 15 granted or pendind patent famiies and has extensive know and trade secrets.
See patent portfolio under: https://worldwide.espacenet.com/searchResults?ST=singleline&locale=de_EP&submitted=true&DB=&query=implandata+ophthalmic+products
Clinical Information
The EYEMATE system has been extensively tested in human, demonstrating safety, utility and efficacy.
See full list of literature under: https://infocenter.my-eyemate.com/publications.html
Regulatory Status
Implandata will submit for a Breakthrough Device Designation, which ensure an expedited regulatory approval process and with FDA approval CMS reimbursement for a period of 4 years. Implandata is very confident to attain Breakthrough Device Designation by early 2021.
How we will use the funds raised
- Execution of FDA regulatoy process
- Execution of reimbursement strategy
- Advancing pipeline of next generation technologies and products
- Focused market lauch for market validation
Thank You
The most exciting theme in our work is to help patients at threat of vision loss to better understand and manage their disease. The EYEMATE protects glaucoma patients vision and their quality of life. Patients will be empowered by self-monitoring and eye care specialists enabled to provide more efficacious therapies to their patients. And the healthcare system will benefit by more efficient use of resources and better care for patients with the chronic eye disease glaucoma.
Market Size
An external analysis by PwC revealed a market potential for the EYEMATE system of up to 1 billion Euro/USD per year.
Today there are close to 80 million patients with glaucoma worldwide. Because of growing and aging populations, we will have close to 120 million patients in 2040.
Projected 3 Year Growth
In three years, the company will be acquired by one of the larger and global players in the ophthalmic industry. The founders and investors are working towards this goal, by spending resources in the most critical and valuable activities to accomplish this goal.
Revenue Model
Implandata's business model is based on two components:
- Moderate one-time payment for the enabling devices
- Sustainable long-term revenues on a data provision subscription model
With expected Breakthrough Device Designation and FDA approval, Implandata's product will be covered by CMS for 4 years. Within this 4 years, the company will be able to establish extensive HEOR data to justify non-provisional long-term reimbursement.
Competitors
Implandata is the first company, offering remote monitoring and care of glaucoma patients via a proprietary mobile data collection and AI-backed digital platform and user interface. Implandata's EYEMATE system is CE marked. Competitors are still working on getting ready for clinical studies in order to start the regulatory approval process.
Implandata is seen as the clear technology leader in this area. Together with the first market mover advantage, Implandata will be able to establish itself as the leading company for remote glaucoma care. Based on this platform, Implandata may enter into other chronic eye disease indications, like macular degeneration or diabetic retinophaty, which are also diseases where patients are at risk to irreversibly lose eyesight.
Traction
Implandata has established certified user centers in Germany, Switzerland and the UK and will continue a focused market validation by the end of the year 2020.
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