MEMS, Microfluidics and Microsystems Executive Review: How to launch a BioMEMS start up

CardioMEMS is an emerging company which has developed BioMEMS technology for treatment of Abdominal Aortic Aneurysm (AAA) and Heart Failure (HF) disease. The company announced last month that it has completed its series C round of financing, raising $16 million of equity funding.

Medtronic, a new investor, led the round and previous investors Boston Millennia Partners, Foundation Medical Partners, Johnson & Johnson Development Corporation, Guidant Corporation, and Arboretum Ventures also participated. Briefly prior to that, CardioMEMS announced the FDA clearance and U.S. market launch of the company’s EndoSure™ Wireless AAA Pressure Measurement System.

We recently spoke with CardioMEMS’ President and CEO David Stern.

MEMS Investor Journal: What medical problems does CardioMEMS’ system alleviate and how does it work?

David Stern: Aneurysms, a weakness or expansion of an artery wall, can be fatal if they are allowed to rupture. One method of treating aneurysms of the lower segment of the aorta is to insert a fabric covered tube (stent-graft) into the center of the aneurysm. This stent-graft acts to redirect the flow of blood and reduce the pressure on the weakened section of the artery. However, life-long monitoring is required to ensure that the stent-graft is functioning correctly. The CardioMEMS EndoSure™ Wireless Pressure Sensor is inserted into the aneurysm at the same time the stent-graft is introduced and can be used to wirelessly monitor the blood pressure within the aneurysm.

An electronics measurement system is used to communicate with the sensor and display the blood pressure information. The sensor is powered by low power radio-frequency energy transmitted by an external antenna. The antenna also receives pressure information from the sensor and displays the information on a large flat panel touch screen.

MEMS Investor Journal: What are the alternative approaches and how does your system compare?

David Stern: Currently, the majority of aneurysm patient monitoring is performed using CT (computed tomography) which is less accurate, more time-consuming, less safe and more expensive than the wireless pressure sensor. The EndoSure is the only passive, wireless, MEMS-based implantable sensor available in the United Stated to help aid in the management of aortic aneurysms.

MEMS Investor Journal: Why did you decide to pick MEMS-based technology?

David Stern: Miniaturization of the device is necessary in order to allow it to be inserted into the body using non-surgical techniques. In addition, MEMS fabrication allowed achievement of the critical performance requirements of the device within the specified size constraints. Finally, batch processing of MEMS-based sensors provides significant manufacturing advantages.

MEMS Investor Journal: How have you handled product manufacturing? What specific challenges have you encountered?

David Stern: The sensors are manufactured at a commercial MEMS foundry. As you would expect, accomplishing our product performance goals required developing several new and innovative fabrication methods. Not surprisingly, the lengthiest part of the manufacturing transfer program involved “teaching” the foundry these new techniques. Overall, however, the process was remarkably straight-forward and our manufacturing partner is doing a great job in keeping the sensor pipeline filled.

MEMS Investor Journal: How large is the market for procedures involving your system?

David Stern: We estimate the total market size of the initial commercial product line at more than $100 million dollars. Aggregate market size for all potential medical applications of the MEMS wireless sensor is well in excess of a billion dollars.

MEMS Investor Journal: You’ve recently announced that your product been approved by the FDA. What have been the main challenges that you’ve encountered in the application process and what advice would you have for other companies pursuing biomedical products that require FDA approval?

David Stern: From a clinical and regulatory perspective, most of the challenges we faced were due to the “newness” of both the technology and our specific application. In general, it is always easier to demonstrate that your device is designed, manufactured and used clinically similar to some other product already available to physicians. In our case, there was no comparable product that was constructed this way or had been used for this application. Thus, as we developed the implant, we also had to invent unique tests to demonstrate its safety and clinical utility.

The best advice I can give to other companies is to work closely with the FDA right from the beginning of the program. Open communication with the agency is critical to ensuring that they understand your technology and you know what the FDA’s expectations are from a bench, animal and clinical test perspective.

MEMS Investor Journal: Now that you have obtained FDA clearance, how do you plan to market your system?

David Stern: We have hired a nationwide, direct sales force that is targeting hospital based Vascular Surgeons, who are the main users of stent-graft technology. Initial demand for the product is very strong.

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Mr. Stern has over 20 years of experience in the medical device industry. He most recently served as Vice-President and Business Unit Manager of the Peripheral Technologies Division of C.R. Bard, Inc. where he was responsible for directing marketing, R&D and business development activities. His extensive experience includes product development and commercialization of cardiovascular, endovascular, endoscopic, surgical and gynecological products.

Mr. Stern received a BS degree in Biomedical Engineering from Rensselaer Polytechnic Institute and a Master of Biomedical Engineering from Worcester Polytechnic Institute.