A Medical Device Daily
SpectRx (Norcross, Georgia) yesterday reported that it plans to restructure the company, that restructuring including an exit from the insulin pump business and putting its focus entirely on its non-invasive 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 reported Monday.
As part of the reorganization, the company said it will sell its SimpleChoice insulin pump infusion set business in order to raise additional capital needed for the cervical cancer program.
The company 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. Pending shareholder approval, the company also plans to change its name to better reflect the new direction of the business. The name to be adopted was not reported, and the company did not return calls seeking further details.
In a statement, Mark Samuels, chairman and CEO, 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 necessary to apply for regulatory approval.
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.
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 at 10 a.m.
In January, the company reported that it had held preliminary meetings with the FDA regarding its premarket approval application 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 (Medical Device Daily, Jan. 31, 2007).
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.
In other dealmaking activity:
• AMCOL International (Arlington Heights, Illinois) reported that its Health & Beauty Solutions (HBS) subsidiary has acquired Microsponge technology from the Pharmaceutical Technology and Services (PTS) segment of Cardinal Health (Dublin, Ohio)
HBS will assume control of the technology and all related assets, including a customer base and a patent portfolio. Financial terms of the transaction were not disclosed.
Microsponge is a system of biologically inert particles used to deliver active ingredients in dermatological products such as lotions and ointments. HBS develops technologies that are designed to improve performance and enhance aesthetics in all forms of skin-care and sun protection products.
HBS has been supplying the product line to Cardinal under an exclusive supply agreement since 2003, and will continue to supply it for limited purposes, Cardinal said.
AMCOL produces specialty mineral products for industrial, environmental and consumer applications. The company operates in three industry segments: minerals, environmental and transportation.
• DentalCare Partners (Mayfield Heights, Ohio) a dental practice management company, reported that it has been acquired by an affiliate of MSD Capital in partnership with North Peak Capital, which will be a minority investor in the transaction.
The sellers were Blue Point Capital, which invested under an affiliated fund, and Beecken Petty O'Keefe & Co. Financial terms of the transaction were not disclosed.
DentalCare Partners provides management services to 70 dental practices in the Midwestern and Southeastern U.S. that offer general dentistry and orthodontic services under the Sears Dental and DentalWorks brand names. Among the services provided are administrative functions, including accounting, human resources, marketing and finance; recruitment of professional, administrative and support personnel in the practices; and equipment and facility leasing.