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Product: SEM, a medical scanner

CFO: Scott Hayashi

Year Founded: 2009

Location: Westwood

What Is It?

Scott Hayashi: The SEM scanner device is a handheld apparatus that measures subepidermal moisture as a means to detect and monitor the development of edema. Edema is a build-up of fluid in the skin tissue that can precede the development of pressure ulcers. The design has been developed specifically to enable the first low-cost solution allowing subjects to use the device in their residences or enable nursing home/clinical care. Subepidermal moisture content levels will be displayed, indicating whether a patient may be at risk of developing edema. The acquired data will dispel subjective variations that involve a visual assessment by a caregiver. This subjectivity often leads to misdiagnosis or failure to detect the onset edema, especially among darker-skin-toned patients where redness from the swelling is difficult to detect.

What was the idea that led to the creation of the technology?

There was an unmet medical need to provide caregivers and clinicians a diagnostic tool.

What were the biggest challenges?

We face regulatory approval issues from the Food and Drug Administration, and we had to raise sufficient capital to develop a product that faced clinical, regulatory and development challenges.

Why was it born at a university?

We were able to draw upon the technical, clinical and scientific expertise from a variety of disciplines needed to launch a medical device product.

What’s been the biggest change since spinning off?

The biggest change is dealing with various aspects of developing a new product, and adhering to changing laws and regulations regarding its approval.

How could it change society?

The SEM scanner has the potential to impact thousands of patients suffering from the onset of edema, which impacts costs to hospitals, nursing homes and tertiary care centers. Clinicians may be able to assess skin health in a more proactive manner and intervene to prevent further skin deterioration, which will help patients and lower health care costs.

If you could go back in time, what would you do differently?

We would partner with key opinion leaders on the technology to help us refine its aims and objectives.

What’s next?

We hope to gain regulatory approval of the SEM scanner in the next year and launch the product.

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