A Diagnostics & Imaging Week

SpectRx (Norcross, Georgia) reported that it plans to restructure the company, with that restructuring including an exit from the insulin pump business in order to put its entire focus on its noninvasive cancer detection technology.

The plan to reorganize the company follows the restructuring of $4.7 million of its debt into three-year convertible notes, which the company said it completed March 12.

As part of the reorganization, the company said it will sell its SimpleChoice insulin pump infusion set business in order to raise capital for the cervical cancer program.

The company said it also plans to continue its efforts to find a new partner for its continuous glucose monitoring technology and to explore oncology applications for its interstitial fluid collection technology.

The company said that certain aspects of the reorganization are subject to shareholder approval. The items will be voted on at the company's annual shareholders meeting set for May 24.

Pending shareholder approval, the company will change its name to better reflect the new business direction. The name to be adopted was not reported, and the company did not return calls seeking further details.

In a statement, Mark Samuels, CEO/chairman, said, "I believe that having the company focus its resources and talent on developing the noninvasive cancer detection technology is the best strategy for success in the marketplace and in the best interest of our shareholders. The reorganization should also provide a better means for acquiring additional capital resources to quickly complete our FDA pivotal clinical trials and to submit our application to the FDA, set up a sales and marketing organization, secure a CE mark and prepare to launch our first product in international markets."

The SpectRx cervical cancer detection test uses light to scan the cervix for disease, thus offering an alternative to the Pap test. The test is designed to be painless and to provide results immediately. It is also designed to be performed by a technician, freeing the physician to see other patients, according to the company. The system consists of a base unit and a single-patient-use disposable calibration and patient interface.

The test is in a pivotal trial stage.

The technology is designed to quickly eliminate false positive Pap and HPV results and discover cervical disease missed by existing tests, the company said. Unlike Pap and HPV tests, the device does not require a tissue sample and results are known immediately, SpectRx said.

The cervical cancer detection test could reduce unnecessary cervical biopsies by 55% while accurately detecting disease, according to results of a study published in the January 2007 edition of the Journal of Lower Genital Tract Disease.

In January, the company reported that it had held preliminary meetings with the FDA regarding its premarket approval applicaton for its noninvasive cervical cancer test.

The company said that the meetings were designed to ensure that the data, data format and documentation of the application will meet the agency's requirements, as well as the expectations of the advisory panel.

Also in January, perhaps signaling the restructuring to come, the company reported that Mark Faupel, PhD, was named president/COO "in response to the increasing importance of the company's … cervical cancer test."

Faupel was VP and CTO before his promotion.