SciBase submits application for pre-market approval to FDA

The U.S. Food and Drug Administration (FDA) has confirmed that the organization
has received SciBase’s application for a pre-market approval (PMA) of the
Nevisense device for the US market.
“We have been working with the clinical studies and documentation that the FDA
requires for several years. It has been a long process that culminated in the
completion of the application during this quarter. The US market is the world’s
largest and represents a significant opportunity for SciBase. Even a limited
penetration of our method and Nevisense has the possibility to transform our
business”, says Simon Grant, CEO of SciBase.

The PMA is the FDA’s most rigorous process for approval of new medical devices
for the US market and is required for most so-called class III devices. Class
III devices are usually based on a new method that has not yet been approved by
the FDA. Due to the complex and resource-intensive process only about 30
companies apply for a PMA each year. If successful, SciBase will be one of only
a handful of Swedish companies to complete a PMA process.

A PMA application contains detailed information covering the device’s
development, manufacturing as well as the clinical trials that confirm the
device’s safety and effectiveness in use. In dialogue with the FDA, SciBase has
developed and conducted the world’s largest clinical study on detection of
malignant melanoma. In addition, SciBase presented the results from a so-called
Reader study during the third quarter. The Reader study was the final piece
needed in order to complete the application.

The FDA is now starting the review of SciBase’s PMA application. The company
estimates that a decision from the FDA will be reached by the end of 2016, a
more exact date is however hard to estimate.

Skin cancer is one of the most common cancers in the world, accounting for
nearly half of all cancers. It has been estimated that nearly half of all
Americans who live to age 65 will develop skin cancer at least once. Malignant
melanoma is the most fatal form of skin cancer causing the majority (75%) of
deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new
cases of melanoma yearly. The key to management is early detection, which is a
challenge due to lack of objective tools for diagnosis, a problem that Nevisense
addresses.

For more information, please contact:

Simon Grant, CEO

Phone: +46 72 887 43 99

Email: simon.grant@scibase.com

About SciBase and Nevisense

SciBase AB is a Swedish medical technology company, headquartered in Stockholm
that has developed a unique point-of-care device for the accurate detection of
malignant melanoma. Its product, Nevisense, helps doctors to detect malignant
melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig
Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden.
Nevisense is based on substantial research and has achieved excellent results in
the largest clinical study ever conducted on the detection of malignant
melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and
is awaiting FDA clearance in the United States. Nevisense is based on a method
called Electrical Impedance Spectroscopy (EIS), which uses the varying
electrical properties of human tissue to categorize cellular structures and
thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”).
Avanza is the certified advisor. Further information is available on
www.scibase.com.