Histologics LLC’s primary objective is to advance the field of tissue sampling into the 21st century. Proper tissue sampling and care during colposcopic practice and other medical settings should serve to save lives, worldwide.
Histologics LLC was established in 2008 out of a dedication to women undergoing evaluation for abnormal cervical cancer screening and a need for better histologic sampling. The founders, including Ob/Gyn inventor Dr. Neal Lonky, developed Speculoscopy (PapSure ®) and Spirabrush CX® in the 1980's and early 1990's (respectively). Years of dedication to improving women's healthcare led the company to innovate a different approach to obtain tissue samples from the cervix, lower genital tract, and other epithelium. Histologics developed a medical fabric called KYLON®, comprised of fenestrated loops that create unique shaped hooks woven into nylon fabric. When applied to tissue with pressure, the hooks flex downward exposing the hook tip to the tissue face when rotated or agitated on the epithelial surface. Histological samples are both removed and stored inside the fabric, unlike conventional metal tip punch biopsy or curette devices where the clinician removes the sample from the tip and places the tissue into a vial of fixative.. Therefore, the fabric is a "system" comprising a tissue collection function resultng in: 1. a tran-epithelial biopsy sample, and, 2. a container that traps the dislodged tissue, which is stored on the device tip. The tissue-filled device tip is snapped free from the handle to be transported to the lab. There is no need for the colposcopist clinician to handle the specimen or clean biopsy devices, reducing the risk of contamination during the colposcopy procedure and assuring the lab technicians recieve the entire collected sample for the Pathologist's analysis after processing.
Unlike bristle brushes, fabric can literally be applied to any device contour, shape, or surface to match the tissue surface sampled. Gynecological biopsy devices are registered with the FDA, and are after research validation, are dually listed as Gynecological biopsy devices, curettes, and systems which are containers for specimen storage and trasport as “Class 1, exempt from 510k registration". SoftBiopsy® and Soft ECC® are compliant, manufactured and labeled according to high quality standards guided by the FDA. Recent demand for a smaller device pad tip for the short, shallow, or stenotic endocervical os has led to a second Soft-ECC®-s product that addresses that need.
It should be noted that neither SoftBiopsy® nor Soft-ECC® are listed as a cytobrush or more specifically “spatula” devices, which are “Class 2” and do require 510k clearance. Thus their exclusive use should be in settings where intact histological samples are obtained (not cytology samples).
The Soft-ECC® endocervical curette, and the Soft-Biopsy®, gynecological biopsy device, when employed in the lower genital tract, result in the hook tip shearing off strips of tissue to a depth just below the basement membrane of the cervix, resulting in curettage or small punch biopsy histological slides in the lab. The fabric is designed to not only remove, but also collect and store the tissue harvested within its straight rows of hooks. The tissue-filled fabric FDA compliant tissue container can be placed in a vial of formalin fixative and be transported to the lab, where the tissue can be removed safely, effectively, and efficiently (within seconds). The laboratory process is simplified by the design of the Kylon® fabric to easily release the tissue in the lab.
Multiple clinical trials have been published and are summarized on the website. For more information on the existing research evidence, or to use and conduct research in concert with Histologics, please contact us through our Contact US page on the site.
SoftBiopsy® and Soft-ECC® are distributed to physicians and licensed clinicians by Histologics LLC, several distributors, and Labs providing anatomical pathology services across the United States who continue to validate the quality, safety, and efficacy of the devices. More clinical trials are forthcoming. Licensed clinicians who peform colposcopy or gynecological tissue sampling interested in evaluating the product can obtain a sample upon request. Histologics will continue to develop and innovate new products and tissue based technologies to improve the level of care, improve the patient care experience, and help save lives worldwide.