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Successful First-in-Human Testing of Implandata’s Next Generation EYEMATE™ Micro-Sensor for Improved Monitoring of Glaucoma Patients

22.12.2017
Hannover, Germany, November 17, 2017 / B3C newswire / -Implandata Ophthalmic Products GmbH (Implandata) is a privately held, ISO 13485 certified medical device company founded in 2010 in Hannover/Germany. [+]
Implandata’s EYEMATE™ system for continuous monitoring of intraocular pressure (IOP) and improved disease care at glaucoma patients is providing vastly improved quality and quantity of information on patient’s IOP, which is key for personalized glaucoma care and therapy control. Remote patient care will increase glaucoma management efficiency, thus contributing to cost savings for all stakeholders. The compelling advantage of the EYEMATE™ system is that measurements can be obtained conveniently at home or at work whenever necessary. There is no need for the patient to have the measurements performed at the doctor’s office.

Implandata now reports that its optimized next generation EYEMATE™ micro-sensor implant for intraocular placement has successfully passed first-in-human validation. Max Ostermeier, CEO of Implandata explains “This opens up the path to proceed forward towards design finalization, expanded clinical validation and regulatory approval. Eventually this will further increase the use of the EYEMATE™ system.”

Successful in-human validation of the miniaturized next generation EYEMATE™ micro-sensor implant represents another pivotal milestone for Implandata. While the current sensor implant requires a surgical incision size of at least 4 mm, the next generation EYEMATE™ micro-sensor device reduces incision size for implantation down to 2.7 mm and less. Prof. Burkhard Dick/Director of the University Eye Hospital of Bochum/Germany, who carried out the first-in-human validation states: “Reduction of incision size is one major advancement, easier insertion and positioning of the micro-sensor another benefit. In eye surgery, less invasive methods mean lower risk of surgical or post-surgical complications, resulting in higher surgeons’ acceptance, also by less experienced ophthalmic surgeons.”

Intraocular pressure (IOP = eye pressure) control is a considerable challenge for glaucoma patients. Current methods for IOP control require in-office measurements, to be performed by trained medical staff. However, these measurements are obtained just a few times each year, even though the eye pressure is known to change throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE™ system provides actionable IOP readings throughout the day and outside the eye care specialist office, enhancing treatment options and reducing progressive vision loss in glaucoma patients. In addition, as the EYEMATE™ system provides direct feedback to the patient in a home setting - information previously unavailable to the patient - therapy adherence will be improved, as demonstrated in pre-market studies.

The EYEMATE™ system includes a surgically implantable micro-sensor (to be implanted in conjunction with cataract, glaucoma or corneal surgery, ultimately also in a stand-alone procedure) for direct measurement of eye pressure. A patient hand-held device for sensor implant powering and data read-out is communicating real-time via internet with eye care specialists (and the patient as well). Most recently published long-term patient follow-up data confirmed product safety and utility(1).In June 2017, Implandata’s EYEMATE™ system for enhanced monitoring and management of glaucoma patients received European CE mark approval with its current micro-sensor implant. A first European market launch of this product is planned for 2018.


About Glaucoma
Glaucoma is a chronic eye disease and the leading cause for irreversible vision loss. IOP is the only modifiable risk factor to reduce the risk of vision loss. Reduction and control of IOP at glaucoma patients lowers the risk of disease progression significantly. Close to 80 million patients are affected by the disease globally; because of aging populations the number of patients is expected to increase to 112 million patients by 2040(2). Thus, Implandata is with its products for improved glaucoma care addressing a pressing need in a further growing market.

Contact
Implandata Ophthalmic Products GmbH
Max G. Ostermeier
Kokenstrasse 5
30159 Hannover
Phone:+49 551 2204 2581
Fax: +49 511 2204 2589
mostermeier@implandata.com
CE Mark for Implandata’s EYEMATE™ System for Improved Monitoring and Management of Glaucoma Patients

02.06.2017
CE Mark for Implandata’s EYEMATE™ System for Improved Monitoring and Management of Glaucoma Patients Hannover/Germany, May 31 2017: Implandata’s EYEMATE system for enhanced monitoring and care of glaucoma patients has attained CE certification and is available for commercial use within the EU. The system was developed and is produced by Implandata Ophthalmic Products GmbH (Implandata), an emerging Hannover/Germany based ophthalmic device company. [+]
Intraocular pressure (IOP = eye pressure) control is a key challenge for glaucoma patients. Current methods for IOP control require in-office measurements that are performed by trained medical staff. However, these measurements are obtained just a few times each year, even though the eye pressure is known to change throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP readings throughout the day and also day to day. Such information is not obtainable with any other method. Having IOP measurements throughout the 24 hour day and also every day, provides information that will enhance treatment and reduce progressive vision loss in glaucoma patients.

The EYEMATE system includes a permanent implantable micro-sensor (to be implanted during cataract, glaucoma or corneal surgeries, ultimately also in a stand-alone procedure) for direct measurement of eye pressure. A patient hand-held device for sensor powering and data read-out is communicating real-time via internet with eye care doctors (or the patient as well). These measurements can be obtained conveniently at home or at work, and there is no need for the patient to have the measurements at their doctor’s office.

Patients can take eye pressure readings themselves easily and at any chosen frequency under normal life conditions. Instead of just a few IOP measurements per year, the system can provide numerous ones throughout the day and day after day. With such information, glaucoma medications can be tailored to the patient’s specific need. As the EYEMATE system also provides a direct feedback to the patient in a home setting - information previously unavailable with standard methods - patient therapy adherence is improved, as demonstrated in pre-market studies.

Professor Hagen Thieme, Director of the Ophthalmology Department of the Otto-von-Guericke University Magdeburg and principal investigator of the pivotal ARGOS-02 trial, that lead to the CE mark, summarized the clinical experience obtained during the trial “Based on our clinical experience with the EYEMATE system it can be well handled by the ophthalmic surgeon. The device can be safely implanted in the sulcus during normal cataract surgery and has proven to be highly beneficial for both the clinician as well as the patient. I firmly believe that the EYEMATE system will open up new horizons towards our clinical and scientific understanding of intraocular pressure and help us to advance our treatments towards individualized and better glaucoma care.”

The current EYEMATE system version is CE marked for use with primary open angle glaucoma patients. Implandata is also working on other versions to be used in other glaucoma situations.

Professor Robert N. Weinreb, Director of the Shiley Eye Institute of University San Diego, California, USA and Implandata’s Scientific Advisor comments “24 hour monitoring of intraocular pressure with an implantable sensor is transformative for management of glaucoma patients as it provides a plethora of data and deeper insight for enhanced management of their disease.”



Glaucoma is a chronic eye disease and worldwide the leading cause for irreversible vision loss. Reduction and control of IOP demonstrated to be the only effective treatment to reduce the risk of disease progression. Globally close to 80 million patients are affected by the disease now; by 2040 then number is expected to increase because of the aging population and life-style to 112 million patients worldwide*. With its products for improved glaucoma management, Implandata is addressing a pressing need in a global, further growing market,

About Implandata Ophthalmic Products GmbH

Implandata Ophthalmic Products GmbH is a privately held, ISO 13485 certified medical device company founded in 2010 in Hannover/Germany. Implandata’s product for continuous monitoring of intraocular pressure and e-Health is providing vastly improved quality and quantity of intraocular pressure data, which is key for personalized care and therapy control. Remote patient management will increase glaucoma treatment efficiency and will contribute to cost savings for all stakeholders

Contact Implandata:
Implandata Ophthalmic Products GmbH
Max G. Ostermeier
Kokenstrasse 5
30159 Hannover
Phone: +49 551 2204 2581
Fax: +49 511 2204 2589
mostermeier@implandata.com

* “Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040”; Tham, YC et al
Implandata Announces Closing of €3M Series B-Round, Establishment of Fully Owned USA Subsidiary and Progress in Clinical Program

27.10.2014
Hannover, Germany, October 27, 2014 / B3C newswire / - Implandata Ophthalmic Products GmbH (Implandata) an ophthalmic surgical product and e-Health start-up company announces the closing of a €3M Series B-Round. Born2Grow Venture Partners, a private fund based in Heilbronn/Germany joins in as new investor. Previous investors Peppermint Charité Beteiligungsfonds/Berlin, Hannover Beteiligungsfonds/Hannover, High-Tech Gründerfonds/Bonn, KfW/Bonn and a group of Business Angels complete the Series B funding round.

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Implandata announces successful implantation of micro-sensor for intraocular pressure measurement in glaucoma patient

23.07.2014
Hannover, Germany, June 23, 2014 / Implandata Ophthalmic Products GmbH (Implandata) reports the successful implantation of the first patient within the ARGOS-02 clinical study at Augenklinik Bellevue in Kiel, Germany. In the ARGOS-02 clinical study, six eye centers in Germany are currently recruiting primary open angle glaucoma patients, undergoing cataract extraction. These patients are eligible to receive the implantable micro sensor for wireless intraocular pressure measurement.
Implandata successfully launched pre-clinical studies for new to the world implantable extraocular sensor for 24h intraocular pressure measurement at glaucoma patients

03.06.2014
Hannover, Germany, June 3, 2014 / Implandata Ophthalmic Products GmbH (Implandata) and Professor Peter Szurman, Head of “Section Experimental Ophthalmic Surgery” at Eye Hospital of University Tübingen, have started pre-clinical studies for the first implantable, permanent extraocular sensor, measuring intraocular pressure. The primary objective of the study is to show proof of concept and to demonstrate product and procedure safety. It is expected that the studies will provide additional design input, before early feasibility studies are started at human patients.
Implandata Ophthalmic Products successfully completes clinical pilot study for 24h intraocular pressure sensor at glaucoma patients.

10.01.2014
Hannover, January 10th, 2014: Implandata Ophthalmic Products GmbH (Implandata) has successfully completed its ARGOS-01 pilot study for the first implantable, permanent intraocular pressure sensor. Implant safety and functionality has been demonstrated in this study. In addition important information was gained, which will result in new and additional product versions and alternate implantation procedures.
Video on scientific work with Implandata intraocular pressure sensor wins Grand Prize ASCRS & ASOA 2013 annual meeting film festival

23.04.2013
The video “Telemetric IOP measurement, deciphering glaucoma’s blind spot“ was awarded with the 2013Grand Prize of the American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) annual meeting film festival.
Implandata Ophthalmic Products GmbH successfully completes the second closing of its A-round with Peppermint Venture Partners, Enjoy Ventures and KFW, bringing the total amount to €3.0m.

24.08.2012
Hannover/Berlin, Germany, August 24, 2012 - Implandata Ophthalmic Products GmbH (IOP), a specialist in diagnostic systems for monitoring chronic eye diseases such as glaucoma, todayannounced the completion of the second closing of its A-financing round. Peppermint Venture Partners together with Enjoy Venture led this second closing of the A-round and were joined by the ERP Startfonds of the KfW. The €3.0 million A-round funding will be used to run a CE trial to achieve early market access for its new diagnostic system. The IOP product will, for the first time, make it possible to continuously measure intraocular pressure in glaucoma patients.
1.4 million series A financing of Implandata Ophthalmic Products GmbH: new kind of diagnosis tool for glaucoma therapy shortly before market launch

15.01.2012
Hanover-based Implandata Ophthalmic Products GmbH distinguishes itself with innovative medical technology and will soon be executing the market launch of a promising system for monitoring the chronic eye disease of glaucoma. In a first closing round, Hannover Beteiligungsfonds, High-Tech Gründerfonds and a group of private investors are investing approx. 1.4 m in the young medical technology company…
High tech for eye patients: start-up team develops a new kind of diagnosis tool for glaucoma therapy

21.06.2010
Bonn / Hanover, 21 June 2010 - Recently established Implandata Ophthalmic Products GmbH, based in Hanover, has come up with a convincing, innovative piece of medical technology and will be launching a system for monitoring the chronic eye disease glaucoma. High-Tech Gründerfonds, hannover innovation fonds (hif), a Munich ophthalmologist as private investor as well as the two founders have invested about EUR 700,000 in this new technology business…
Implandata Ophthalmic Products GmbH
Kokenstraße 5
30159 Hannover / Germany
Telefon: +49 (0) 511 - 2204 2580
Fax: +49 (0) 511 - 2204 2589
info@implandata.com
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