As of March 18, 2015, Histologics has an exclusive worldwide license under U.S. Patent No. 6,258,044 and the rights to manufacture and sell Spirabrush CX^® for use in the Gynecological Body Area.

Since the rights to Spirabrush were just recently transferred to Histologics on March 18th, (following the resolution of Shared Medical Resources (SMR) legal action and SMR exiting the business), the transition through regulatory and manufacturing channels will take some time to navigate.
 
Spirabrush is a time honored exocervical biopsy brush that was developed in the 1990's and marketed until 2005 by the same inventor and team that now manage Histologics. Spirabrush users should be aware that Histologics currently markets the FDA-compliant and patented Kylon^® fabric-based brush technology for exocervical tissue biopsy sampling. It also has the added FDA registered benefit of trapping and retaining the tissue removed, resulting in a research proven consistent, abundant, reliable, and diagnostic sample.
 
As Histologics evaluates the future of the Spirabrush, we encourage all colposcopists to use the SoftBiopsy^®.
The SoftBiopsy® device provides a minimally invasive approach with greater value (reprints of fabric based colposcopy research evidence is available upon request). The list price of SoftBiopsy® is lower than Spirabrush; $4.25 per disposable device with additional price/volume discounts available. Pathology labs that have processed both Spirabrush and Soft-Biopsy^® samples report to Histologics that the fabric-based specimens are of higher diagnostic yield.
 
Many labs nation-wide have received fabric based biopsy specimens, and some buy in volume and provide superior pricing to their colposcopist clients. Thus, the colposcopist could reach out to their lab, and if fabric-based biopsy is not yet available, encourage the lab to contact Histologics to purchase in volume and pass along savings based on their purchase advantages over smaller or group clinical practices.  
 
Furthermore, many Spirabrush users have requested a minimally invasive brush for endocervical curettage (ECC).  The fabric-based Soft-ECC^® is similarly priced, comes in two sizes (regular and small), and is the only minimally invasive simultaneous biopsy device combined with a tissue trap system available for this use.  The 2014 ASCCP Meeting Award winning research on fabric ECC showed a simple single insertion/ rotation/withdrawal method with simultaneous tissue trapping, increases the diagnostic specimen yield that returns to the laboratory, nearly eliminating insufficient samples, while remaining a very gentle approach to ECC that patients appreciate.
 
Finally, Histologics LLC did not acquire the Shared Medical Resources (SMR) company, it only obtained the rights to the gynecologic applications for Spirabrush CX^®. Any purchases made prior to March 18, 2015 from SMR that have not been fulfilled should be directed to SMR.
 
We welcome questions and value your business during this transition period.
 
Thank you.
 
Neal M. Lonky, MD, MPH
Inventor and Founder; Histologics LLC