NEW VALUE AG
Sensimed enters into a strategic collaboration and financing agreement with SEED, a Japanese contact lens manufacturer. Raises CHF 10M through a convertible loan.
Lausanne, Switzerland, October 18th 2016, Sensimed announced the expansion of its current collaboration in Japan with SEED, a Japanese contact lens manufacturer. The agreement enables the companies to combine efforts to work to obtain registration of the SENSIMED Triggerfish®. Following approval and agreement with PMDA the companies will then work to conduct key pivotal clinical activities in Japan. A CHF 10M financing was completed through a convertible loan to support the registration in Japan and to further validate unique diagnostic and predictive clinical claims for the technology. SEED contributed half of these funds with current investors matching this amount.
Sensimed AG, a Swiss company, has developed a unique non-invasive soft contact lens-based solution, the SENSIMED Triggerfish®, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional changes over 24 hours. The contact lens itself is very well tolerated over the measurement period and uses telemetry in combination with a fully integrated sensor to measure volumetric changes of the eye. To date, Sensimed has published over 35 peer review articles in major ophthalmic journals to support these conclusions. The SENSIMED Triggerfish® is a platform technology which obtained a “first of a kind” FDA approval in March of 2016 and which can be used to support alternative sensors focused on other clinical measurement applications.
“We are very pleased to expand our partnership with SEED who have a solid organization to support the registration of our Smart Contact Lens technology in Japan” said David Bailey CEO of Sensimed.
Assuming agreement with PMDA and after formal approval of the technology the two companies intend to accumulate clinical data from specialized medical centers. In Japan these efforts will be directed toward the large number of patients who have normal tension glaucoma (NTG) where standard IOP measurement tools are inadequate and where there is a large unmet need for an additional diagnostic indicator. The 24 hour profiles provided by the SENSIMED Triggerfish® device will be analyzed and modeled to fully categorize the disease state and aid personalized treatment.
“The prevalence of normal tension glaucoma in Asia presents an additional challenge for doctors in managing their glaucoma patients. In this situation standard tonometry alone can often lead to miss-diagnosis and delayed treatment. This study is aimed at providing highly valuable information on the behavior of the eye during 24 hours in order to better categorize and diagnose this dominant group of NTG patients” said Mr. Bailey.
“Sensimed is pleased to partner with SEED to work toward obtaining such a break through approval in Japan. We are also delighted that SEED chose to become a shareholder in Sensimed by joining current investors to complete the 10MCHF convertible instrument to fund these efforts” added Mr. Bailey.
This first of a kind measurement parameter, ocular dimensional change over a 24 hour period, whilst closely correlated with IOP is a unique measure in itself. In addition to the breakthrough work on NTG classification Sensimed is also working toward validating the SENSIMED Triggerfish® device to actually predict the course of the disease so as to aid therapeutic choices. Data presented in peer review publications has evidenced this unique aspect of clinical utility. Early analysis of significant in house patient data from a more broad based population registry also strongly suggests that features in the SENSIMED Triggerfish® curves have the potential to be both a diagnostic and predictive tool.
To achieve this overall goal Sensimed is now seeking a strategic partner in the USA to execute a planned prospective study focused on predicting fast Vs slow progressive glaucoma in a representative patient population. Once validated this will provide a unique and valuable benefit to the physician to better manage Glaucoma patients.
About SENSIMED:
FROM DEVICE TO KNOWLEDGE — Sensimed AG, a Swiss company, has developed a unique non-invasive soft contact lens-based solution, the SENSIMED Triggerfish®, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional change over 24 hours.
The Company is now focused on expanding the knowledge of how this individual data can best be used in the clinical setting to deliver customized treatment. The 24 hour profiles are being centralized on a registry together with patient and treatment information. The data are analyzed and modeled on an ongoing basis to identify pathological patterns that can be used to differentiate between indications, personalize treatment and assess efficacy following treatment.
The Company is directly positioned at the convergence between devices, treatment and information. Sensimed believes that with this global knowledge based approach we will be able to provide valuable insights that will allow ophthalmologists to better understand and treat glaucoma.
For further information about Sensimed see: www.sensimed.ch
About SEED:
SEED has been supplying contact lenses designed for Japanese eyes and other eye care products for more than half a century. January 2011, SEED acquired ISO 13485:2003 certification, the international standard on quality management systems for medical devices, and received official approval to use CE marking, the EU’s safety regulation conformance mark. In 2014, SEED’s stocks transferred to second section of the Tokyo Stock Exchange.
For further information about SEED see: www.seed.co.jp/en/index.html
About glaucoma:
Glaucoma is an asymptomatic, progressive and irreversible disease that leads to blindness unless adequate treatment is provided. Glaucoma is the second most common cause of blindness worldwide and affects about 70 million people. Abnormal intraocular pressure is a known cause of glaucoma. This behavior is individual, has transient peaks and varies significantly over a 24 hour period. By providing ophthalmologists with the 24 hour profile of ocular dimensional changes related to intraocular pressure, the SENSIMED Triggerfish® helps the doctor to better understand the condition of the patient and to provide personalized treatment.
Contact Sensimed:
Sensimed AG
Coralie Felden, Personal Assistant & Marketing Manager
coralie_felden@sensimed.ch
Tel: +41 21 621 9191
Sensimed AG, a Swiss company, has developed a unique non-invasive soft contact lens-based solution, the SENSIMED Triggerfish®, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional changes over 24 hours. The contact lens itself is very well tolerated over the measurement period and uses telemetry in combination with a fully integrated sensor to measure volumetric changes of the eye. To date, Sensimed has published over 35 peer review articles in major ophthalmic journals to support these conclusions. The SENSIMED Triggerfish® is a platform technology which obtained a “first of a kind” FDA approval in March of 2016 and which can be used to support alternative sensors focused on other clinical measurement applications.
“We are very pleased to expand our partnership with SEED who have a solid organization to support the registration of our Smart Contact Lens technology in Japan” said David Bailey CEO of Sensimed.
Assuming agreement with PMDA and after formal approval of the technology the two companies intend to accumulate clinical data from specialized medical centers. In Japan these efforts will be directed toward the large number of patients who have normal tension glaucoma (NTG) where standard IOP measurement tools are inadequate and where there is a large unmet need for an additional diagnostic indicator. The 24 hour profiles provided by the SENSIMED Triggerfish® device will be analyzed and modeled to fully categorize the disease state and aid personalized treatment.
“The prevalence of normal tension glaucoma in Asia presents an additional challenge for doctors in managing their glaucoma patients. In this situation standard tonometry alone can often lead to miss-diagnosis and delayed treatment. This study is aimed at providing highly valuable information on the behavior of the eye during 24 hours in order to better categorize and diagnose this dominant group of NTG patients” said Mr. Bailey.
“Sensimed is pleased to partner with SEED to work toward obtaining such a break through approval in Japan. We are also delighted that SEED chose to become a shareholder in Sensimed by joining current investors to complete the 10MCHF convertible instrument to fund these efforts” added Mr. Bailey.
This first of a kind measurement parameter, ocular dimensional change over a 24 hour period, whilst closely correlated with IOP is a unique measure in itself. In addition to the breakthrough work on NTG classification Sensimed is also working toward validating the SENSIMED Triggerfish® device to actually predict the course of the disease so as to aid therapeutic choices. Data presented in peer review publications has evidenced this unique aspect of clinical utility. Early analysis of significant in house patient data from a more broad based population registry also strongly suggests that features in the SENSIMED Triggerfish® curves have the potential to be both a diagnostic and predictive tool.
To achieve this overall goal Sensimed is now seeking a strategic partner in the USA to execute a planned prospective study focused on predicting fast Vs slow progressive glaucoma in a representative patient population. Once validated this will provide a unique and valuable benefit to the physician to better manage Glaucoma patients.
About SENSIMED:
FROM DEVICE TO KNOWLEDGE — Sensimed AG, a Swiss company, has developed a unique non-invasive soft contact lens-based solution, the SENSIMED Triggerfish®, with the aim of revolutionizing glaucoma management by providing an automated recording of continuous ocular dimensional change over 24 hours.
The Company is now focused on expanding the knowledge of how this individual data can best be used in the clinical setting to deliver customized treatment. The 24 hour profiles are being centralized on a registry together with patient and treatment information. The data are analyzed and modeled on an ongoing basis to identify pathological patterns that can be used to differentiate between indications, personalize treatment and assess efficacy following treatment.
The Company is directly positioned at the convergence between devices, treatment and information. Sensimed believes that with this global knowledge based approach we will be able to provide valuable insights that will allow ophthalmologists to better understand and treat glaucoma.
For further information about Sensimed see: www.sensimed.ch
About SEED:
SEED has been supplying contact lenses designed for Japanese eyes and other eye care products for more than half a century. January 2011, SEED acquired ISO 13485:2003 certification, the international standard on quality management systems for medical devices, and received official approval to use CE marking, the EU’s safety regulation conformance mark. In 2014, SEED’s stocks transferred to second section of the Tokyo Stock Exchange.
For further information about SEED see: www.seed.co.jp/en/index.html
About glaucoma:
Glaucoma is an asymptomatic, progressive and irreversible disease that leads to blindness unless adequate treatment is provided. Glaucoma is the second most common cause of blindness worldwide and affects about 70 million people. Abnormal intraocular pressure is a known cause of glaucoma. This behavior is individual, has transient peaks and varies significantly over a 24 hour period. By providing ophthalmologists with the 24 hour profile of ocular dimensional changes related to intraocular pressure, the SENSIMED Triggerfish® helps the doctor to better understand the condition of the patient and to provide personalized treatment.
Contact Sensimed:
Sensimed AG
Coralie Felden, Personal Assistant & Marketing Manager
coralie_felden@sensimed.ch
Tel: +41 21 621 9191
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