MassDevice Q&A: Jean-Marc Wismer

You literally cannot see glaucoma coming.

Although it’s one of the leading causes of blindness in the world, frighteningly little is known about a disease group that affects 4 percent of the world’s population over the age of 40. No cure is on the horizon. And due to the insidious nature of the disease, which stars gradually affecting sight from the periphery, most people don’t even know they’re suffering from glaucoma until it’s too late.

Swiss diagnostics company Sensimed AG sees this mysterious disease as a real opportunity.

Representatives from the firm, in Boston last week for the World Glaucoma Congress, say the company is developing a new type of contact lens-based diagnostic tool, designed to generate more accurate blueprints for the treatment of glaucoma. Current clinical solutions are dominated by large pharma companies like Pfizer and Allergan (which made news in January when it repackaged its Lumigan eye drops for glaucoma into Latisse, an FDA-approved treatment to help grow thicker eyelashes).

Unlike the several companies developing contact lenses as a platform for drug delivery, Sensimed’s idea is to use them as a platform for diagnostics.

The company’s first product, the Sensimed Triggerfish, uses micro-electro-mechanical systems technology embedded in a regular-sized soft contact lens. When connected to a loop-antenna and a micro-processor with an analog/digital telemetric system, it takes 24-hour, continuous measurements of the eye. It’s designed to allow patients to sleep in their own homes, rather than dossing down in a sleep lab, with an eye toward beginning to provide some answers to this mysterious disease.

MassDevice spoke with Sensimed CEO Jean-Marc Wismer about the technology, its upcoming date with the FDA and a possible U.S. headquarters in Boston.

MassDevice: What is the standard of care for glaucoma patients and how does Sensimed fit into that?

Jean-Marc Wismer: We’re a little agnostic about the standard of care. We want to provide more visibility about how patients are treated. We hope to provide a better management of the treatment process. But we know that one in three patients has inadequate treatment for the disease. So no matter if its drugs or surgery the patient will keep losing their vision unless we know more about the disease and the appropriate treatment.

MassDevice: What are the current testing methods for glaucoma?

JMW: The eye is a breathing machine. It produces and evacuates fluids, which is what maintains the eyeball’s intra-ocular pressure. The balance of producing and evacuating fluids is what maintains a healthy amount of intra-ocular pressure. With glaucoma, that balance is disrupted. However, it’s not constantly broken. It moves in cycles.

There are many differences in intra-ocular pressure — for example, intra-ocular pressure peaks at night. The high peaks are detrimental to the optic nerve. But these peaks are not random; they move in cycles. But there are great individual differences that are difficult to detect. There is little that is understood about the eye, so there are lots of question marks.

Currently the only thing available to track this is having the patient go to a sleep lab, where they take a series of snapshots. But there are limitations to this. First, it’s annoying for the patient and it’s very expensive. Further, the setting will bias the results, because you have to wake the patient up to take the measurements, which will change the intraocular pressure.

MassDevice: Your product looks like a normal contact lens with what looks like a microchip in it. How does it work?

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Wismer_JeanMarc_100x100.jpg}JMW: It is a regular contact lens with a microchip, which is 50 microns thick. It’s very small; if you stacked 20 on top of each other it would be about one millimeter thick. There’s a strain gauge, which is a thin wire that goes over the eye. As the eye expands it stretches the lens to measure the cornea. Then the gold ring is a MEMS micro antennae which sends a signal to the flexible antennae that sends an electromagnetic pulse that sends the signals back to a data recorder. After 24 hours you take it back to the optometrist.

MassDevice: How was the technology created and when was the company founded?

JMW: Our founder, Matteo Leonardi, was a student at the Swiss Federal Institute of Technology. It was a result of listening to a meeting between bio-engineers and doctors who were voicing their unmet needs about 10 years ago. The company was a result of his thesis. It was created as a legal entity in 2003 and started operations in 2007. [Editors note: click here to see a video with Leonardi on about the development of the Sensimed.]

MassDevice: How did you come on board and how is the company funded?

JMW: We have raised $8 million [Swiss francs] from Wellington Ventures and Vinci Capital. I got involved in 2007 when I helped the company get funded and the investors asked me to stay on. I’m a Medtronic vet and I was active in the field of coaching startups to get financing. There’s a sense of mission here that is very appealing.

MassDevice: Where are you with the various regulatory agencies, and what brings you here to Boston?

JMW: We have the CE mark, which we received in February. We’re currently working on application trials to explore the best opportunity where the value is greatest. We’re a new tool on the market, so we have to turn to the professionals now to tell us how this is best used and to broaden its commercial appeal. We’re also applying for FDA approval later in the summer. We’re here in Boston because we’re also looking for a U.S. base of operations, which will most likely be in Boston.

MassDevice: What do you think the price point will be for the product? What do you think the total market is for a product like this?

JMW: It’s too soon to determine pricing. We’re still waiting for the trials to be completed and we’ll determine pricing later in the year.

They predict that there about 60 million people in the world suffering from glaucoma, with up to 100 million people being affected in the next 10 years. For us the environment is big.There is a desperate, highly motivated population of people who are losing their eyesight.

MassDevice: What will your sales approach be,and how will you get over the reimbursement hurdle?

JMW: The speed of adoption is unknown at this point. Our reimbursement picture is that we’re a new technology.

We’re looking at a specialized access to the market. We will probably be for the home care prescription market; we’re not targeting optometrists on the street. We’ve segmented the United States into entry points of California, Texas, Florida and most of the East Coast, which is where 50 percent of the population of people suffering from glaucoma live.

We don’t want to build our own distribution channels. We’re looking for partners.

RSS From Medical Design & Outsourcing

  • Emuge expands solid carbide thread mill program with new 3XD sizes
    Emuge is now offering an expanded line of Solid Carbide Thread Mills in their popular THREADS-ALL Program, to include new 3XD sizes designed for maximum reach. A total of 17 new sizes have been added, from miniature to standard size tools, providing maximum versatility in a wide range of thread milling applications. The 3XD THREADS-ALL […]
  • Start of helpful humanoid robots? CITEC uses compact LDS component as sensor array
    Editor’s Note: LaserMicronics, a service provider for laser-based manufacturing, has released the whitepaper “Robot hand with a sensitive touch: LDS tactile sensors for sensorimotor skills.” The paper describes a 2014 project from the CITEC department at Bielefeld University in Bielefeld, Germany, where researchers created a tactile sensor resembling a human fingertip. The sensor was then […]
  • Nature meets technology: Festo’s BionicANTs cooperate to solve a common task
    Editor’s Note: Festo, an industrial control and automation company, has released the whitepaper “BionicANTs: Cooperative behavior based on a natural model.” The paper describes the BionicANT, a creation of Festo engineers that duplicates the physical anatomy of its natural counterpart and reproduces the insect’s cooperative behavior. Festo engineers have used the delicate anatomy of an […]
  • Acorn Regulatory streamlines approval process drug-device manufacturers
    Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, is streamlining procedures for U.S. manufacturers of drug-device combinations with customized programs that successfully overcome challenges in meeting European regulatory approvals. Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical […]
  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]

Leave a Reply