We recently spoke with Jean-Marc Wismer, CEO of Sensimed AG, a Swiss company with its principal focus on the design, development and commercialization of integrated microsystems for medical devices. The company's first product is a non-invasive solution for continuous monitoring of intra-ocular pressure (IOP) to aid the diagnosis and treatment of glaucoma. It is expected to complement existing devices that enable ophthalmologists to perform single pressure measurement snapshots on IOP but fail to capture "around-the-clock" dynamic behavior necessary for accurate diagnosis.
Glaucoma is a disease that leads to blindness unless adequate lifetime treatment is initiated early on. According to Mr. Wismer, there are 67 million people with glaucoma, including nearly 7 million each in the US and Europe. This number is expected to increase to 80-100 million by 2020. Glaucoma is the second cause of blindness after cataract.
MEMS Investor Journal: What is glaucoma – its cause and effect on vision?
Jean-Marc Wismer: Primary Open Angle Glaucoma, the “sneaky disease”, is a progressive damage to the optic nerve, initially destroying peripheral vision and potentially leading to blindness in one or both eyes unless lifetime treatment is provided. Asymptomatic, glaucoma has often been diagnosed when significant irreversible damage has already occurred. Little is known on the cause the glaucoma but current consensus and treatment focus on high or unstable intraocular pressure (IOP).
The soft contact lens like sensor, with its MEMS antenna (golden rings), its MEMS sensor (silver ring close to the outer edge), and microprocessor.
MEMS Investor Journal: What if any segment of the population is more likely to suffer from glaucoma, or is it a random affliction?
Jean-Marc Wismer: Glaucoma is a random affliction, yet there are significant risk groups. The main risks include age, race, and family history. While prevalence of glaucoma increases significantly with age, one also observes increasing prevalence in younger populations. Prevalence is about 3 to 5 times higher among the population of African or Hispanic ascent. Family history of glaucoma is another strong risk factor. Other risk factors include diabetes and nearsightedness. Glaucoma testing every five years is recommended starting at age 35 for people at low risk, and every one to two years for people at high risk or over the age of 60.
MEMS Investor Journal: On a global basis, what percentage of the population is suffering from it?
Jean-Marc Wismer: According to research of different sources, about 1 to 2% of population worldwide is affected by glaucoma. Glaucoma, currently the second cause of blindness after cataract, poses an enormous public health problem. The U.S. government estimates that 2.2 million Americans have been diagnosed with Primary Open Angle Glaucoma, the most common form of the disease. This number is estimated to rise to 3.36 million people by 2020, more than a 60% increase from today. The number of cases is expected to grow significantly because of aging population, longer life expectancy and for other lifestyle-related causes.
Sensor placed on the eye, centered on the cornea with no elements in the line of sight.
MEMS Investor Journal: What are the initial indications of glaucoma? How do symptoms first appear and how does the disease progress?
Jean-Marc Wismer: There are no initial indications or symptoms. The disease progresses very gradually, and damage to the optic nerve is irreversible. It is estimated that nearly half of the cases go undiagnosed.
MEMS Investor Journal: If untreated, what is the outcome?
Jean-Marc Wismer: There are different kinds of glaucoma, each requiring different treatment. If treated adequately, the loss of vision can be stopped or at least slowed down. Glaucoma may otherwise lead to unilateral or bilateral blindness. Studies show, however, that about one in three glaucoma patients are under inadequate treatment. Efficacy of treatments varies from one individual to another. Furthermore, the patient’s response to a treatment is likely to change over time. These changing conditions make it very difficult to treat glaucoma adequately.
MEMS Investor Journal: How is the disease diagnosed by ophthalmologists?
Jean-Marc Wismer: Ophthalmologists usually diagnose glaucoma during routine check-up tests. The main test is the measurement of intraocular pressure. Another test, called ophthalmoscopy, consists in looking directly at the optic nerve. Peripheral vision tests are also performed to determine potential damage to the optic nerve.
MEMS Investor Journal: What are the main obstacles to diagnosing glaucoma?
Jean-Marc Wismer: While checking nerve damage or loss of peripheral vision works, by the time these indications appear irreversible damage has occurred. The challenge is to prevent damage from happening and progressing. The main obstacle to earlier diagnosis is due to the fact that IOP has a dynamic behavior and will vary throughout the day in cycles that tend to be repeatable. This makes it very difficult to monitor in real time because the eye is very sensitive. Existing devices enable ophthalmologists to perform single pressure measurement snapshots on IOP but fail to capture the ”around-the-clock” dynamic behavior of IOP, particularly pressure peaks happening during sleep or outside of office hours.
MEMS Investor Journal: How is the disease treated by ophthalmologists?
Jean-Marc Wismer: There is currently no cure for glaucoma, and lost vision cannot be regained. But it is possible to slow down the progression of the disease and thereby slow the further loss of vision. Glaucoma, being a chronic condition, must be monitored and treated for life. The cornerstone of the disease is believed to be elevated or unstable IOP. Current treatment focuses on reducing IOP either mechanically (laser, surgery, shunts) or chemically (medication such as IOP-reducing eye drops).
MEMS Investor Journal: Why did Sensimed decide to focus on means of overcoming these obstacles?
Jean-Marc Wismer: When Dr. Matteo Leonardi, CTO and co-founder of Sensimed was a postdoctoral fellow in biomedical engineering, he attended a meeting between doctors and engineers to identify unmet clinical needs. Continuous monitoring of IOP was the challenge that Matteo, together with Sacha Carboni, our co-founder and controller, decided to tackle.
MEMS Investor Journal: How does your approach differ from other diagnostic procedures for glaucoma?
Jean-Marc Wismer: Our solution is designed to achieve two objectives. The main objective is to help manage the treatment of glaucoma patients by obtaining “around-the-clock” IOP profiles and thereby enable tailoring personalized treatment. Our system lets ophthalmologists verify that the treatment is working and allows subsequent follow up measurements to monitor the efficacy of the treatment. The second objective is to provide new insights to earlier diagnosis in at-risk patients.
From a technical point of view, our approach differs in that we do not perform a measurement of IOP by applying a force such as by indentation, applanation or rebound techniques on the cornea. Instead, we developed a sensor that floats on the eye following changes in corneal curvature and with no physical connection to other system components. The sensor provides continuous monitoring information to identify peaks in IOP and when they occur. We believe this approach enables the device to be comfortable, convenient and easily produced while meeting all the norms and regulatory constraints.
MEMS Investor Journal: What are the components of your monitoring system and how do they work together?
Jean-Marc Wismer: The main component is the soft, disposable contact lens with an embedded MEMS sensor and microprocessor. The MEMS sensor includes circular active and passive strain gages to measure corneal curvature changes, and a loop antenna to receive power and to send back information to the external system. The microprocessor is a small full custom ASIC about 2mm square and 50 microns thick.
The other components include the adhesive external loop antenna worn around the eye, the data cable driving the antenna and connected to a portable rechargeable battery-powered recorder.
Finally, software on the ophthalmologist’s computer initiates the monitoring session to present IOP data collected up to a 24 hour period.
This illustration shows the various components of the solution placed on the body.
MEMS Investor Journal: Does monitoring continue when glaucoma is confirmed and if so for how long?
Jean-Marc Wismer: This is very dependent on the condition of the patient. IOP behavior, efficiency of and resistance to treatments vary among individuals. Typically, a 24-hour profile is first taken to adapt treatment to the patient’s condition. Another curve will be taken a few months later to verify that the patient responds well to the treatment. Follow-up curves may then be taken on a yearly basis to check that the treatment is still working.
MEMS Investor Journal: How does the Sensimed solution impact treatment procedures or does treatment remain the same?
Jean-Marc Wismer: A monitoring session will normally start and end with a regular gold-standard IOP measurement called "tonometry". The Sensimed monitoring data then provide additional information to the ophthalmologist on the dynamic behavior of IOP to help diagnose and treat glaucoma patients in a better way. Our solution does not replace current equipment, nor does it require the practitioner to change the basis for decision. Instead it complements current information and enhances the physician’s data for better patient care. However, the solution intends to replace expensive and cumbersome curves obtained by a series of single pressure measurement snapshots currently made in a sleep laboratory or by multiple office visits.
MEMS Investor Journal: Which, if any, components are reusable?
Jean-Marc Wismer: The data cable and the recorder are reusable equipment and belong to the ophthalmologist. The sensor and the antenna are disposable.
MEMS Investor Journal: What were some of the more difficult challenges Sensimed had in developing this solution and how were they overcome?
Jean-Marc Wismer: The product combines leading edge technologies in three different fields: microtechnology (the MEMS sensor), microelectronics (the telemetric microprocessor) and micropackaging (embedding it all in a soft contact lens). The first challenge was to design a sensor sensitive enough to measure the tiny changes in corneal curvature. A MEMS sensor based on a tiny circular strain gage was developed at the microtechnology department of the Swiss Federal Institute of Technology of Lausanne. The sensor will pick up intraocular pulsation, a tiny modulation of IOP due to blood pressure.
Designing a telemetric system respecting norms and regulatory constraints such as electromagnetic spectrum or heat generation was not trivial. Norms strictly limit the maximum heat to which the eye can be exposed, as well as the maximum amount of harmonic frequencies emitted by the system.
Finally, bringing the prototype to an industrial, comfortable product was one of the main challenges. Mass production of our MEMS sensor is on the edge of technology for most MEMS manufacturers. Furthermore, the design of a comfortable shape of the lens, while encapsulating the MEMS, the micro-antenna and the microprocessor required combine efforts of a number of experts in the field of molding and of contactology.
MEMS Investor Journal: Where is your solution now being used and how is it being received by ophthalmologists?
Jean-Marc Wismer: Sensimed is currently at initial stages of clinical tests. The product is well received and generates high interest and expectations. Intraocular behavior is unknown territory. It presents numerous opportunities for research and there is a clear and large clinical unmet need for continuous IOP monitoring.
MEMS Investor Journal: How do patients react to the treatment? Is there any reluctance to the monitoring procedures?
Jean-Marc Wismer: People who are currently treated for glaucoma are gradually losing sight. Based on our limited experience, there is eagerness from these patients to understand what happens in their eyes and high hope that information gathered by our system will help them and their ophthalmologist keep the disease under control. We believe that patients will see the benefits of our monitoring system as far outweighing any resistance to the procedure.
MEMS Investor Journal: What does the diagnostic procedure cost and what is the general breakdown of the cost components?
Jean-Marc Wismer: It is premature for us to mention product pricing.
MEMS Investor Journal: How does this compare to the cost of other monitoring procedures?
Jean-Marc Wismer: It is also difficult to estimate the cost of current procedures as there are no direct comparables. Single or daytime repeat tonometry is less expensive but does not provide the required information. “Around-the-clock” sleep laboratory curves are clearly more expensive and constraining, hence performed only on a minority of patients. It is estimated that less then 1% of treated glaucoma patients do get IOP profiles, while our experts believe that 30 to 50% should get such “around-the-clock” curves.
MEMS Investor Journal: Who manufactures the equipment and what are your distribution channels?
Jean-Marc Wismer: The various parts of the solution are manufactured by different subcontractors around the planet. The final molding of the lens as well as the final primary and secondary packaging are performed by a Swiss-based strategic partner. The solution is currently available only to selected test centers, and will be sold directly in the short term.
MEMS Investor Journal: What are your shipment projections for 2010 or 2011?
Jean-Marc Wismer: We are currently at the pre-sales stage, with availability currently limited to our test centers. The company expects to ship about 20,000 sensors by 2010, and about 100,000 by 2011.
MEMS Investor Journal: Where else do you plan to market the system in the near term?
Jean-Marc Wismer: Initial focus is to validate the product in our home market (Switzerland, Austria and Germany) by year-end 2009, and to focus immediately thereafter on the U.S. We expect to open an office in Boston by mid-2009, and start our commercial activity outside of our test centers in the U.S. and progressively in Europe as of late 2009.
MEMS Investor Journal: What are your plans to build on this development in either diagnosing or treating eye disease?
Jean-Marc Wismer: The technology platform that Sensimed developed to realize the glaucoma monitoring solution can be used in various different vertical markets. While the company is currently focused on bringing the glaucoma monitoring solution to market, it will be considering opportunities to either license out the technology or co-develop other products in applications where small sensors with no battery and no direct connections are required, in particular in the field of medical devices.
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Jean-Marc Wismer has 20 years of experience in international growth management and financing. Formerly an executive with Silicon Microstructures Inc. and Medtronic, COO of Lysis (sold to Kudelski), CEO and founder of Neocast (sold to a major telecom company). Since 2003 Jean-Marc is active as a consultant and interim manager for innovative high-tech companies such as Innovative Silicon, Spinetix, Axsionics, Nexthink and Mnemis. He is also a coach and financial expert with the CTI start-up – a Swiss federal organization helping entrepreneurs start and grow their high-technology businesses, a lecturer with Venturelab and jury member with Venturekick. Jean-Marc holds a MSc in Electrical Engineering from the Federal Institute of Technology Lausanne and an MBA from the Institute of Management Development.
Copyright 2009 MEMS Investor Journal
Fascinating and exciting technology. Although I can see that engineering and production were difficult tasks, the article does not mention the largest hurdle to success in the US marketplace: obtaining a billing code (CPT) with an assigned reimbursement recognized by Medicare and insurance companies. Without this, I'm afraid this will be available only in academic centers. Price accordingly.
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Posted by: WEL | August 19, 2009 at 04:27 PM