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Compassionate Colposcopy® Devices

Compassionate Colposcopy®

Kylon® Hooked-Fabric Biopsy Technology

Histologics LLC is proud to have developed Soft-ECC® endocervical curette, and the SoftBiopsy® exocervical gynecological biopsy device. Both devices employ a multipatented hooked fabric (Kylon®) that simultaneously biopsies with frictional raking/de-bonding of epithelium from stroma, and traps and stores the tissue for transport to the lab.

The Soft-ECC® and SoftBiopsy® were developed with the patient care experience in mind. The Soft-ECC® design is intended to fit into most endocervical canals and yield an abundant biopsy sample. The ECC procedure is usually performed to remove tissue from the endocervical canal for histological analysis during colposcopy or during the diagnostic work-up of abnormal peri-menopausal or menopausal bleeding. Unlike cytobrush sampling which is a cytologic screening modality, Soft-ECC® curettage produces diagnostic histological samples. 

Read more …Compassionate Colposcopy®

About Us

 

About Histologics LLC

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.

EULA

END USER CLICK WRAP LICENSE AGREEMENT

IMPORTANT READ CAREFULLY. The TERMS AND CONDITIONS of this END USER CLICK WRAP LICENSE AGREEMENT (EUCLA) APPLY to YOU either as an individual or as a corporate entity (hereinafter 'LICENSEE'). According to the terms and conditions of the EUCLA, the materials including PHYSICIAN / CLINICIAN PRIMER and VISUAL/AUDIO DISPLAY PRESENTATION (hereinafter 'PRESENTATIONS') are made available by the licensor, HISTOLOGICS, LLC (hereinafter 'HISTOLOGICS') for the private inspection of the LICENSEE.

The EUCLA is a legal contract between the LICENSEE and HISTOLOGICS for access to view the PRESENTATIONS. By CLICKING on the ACCEPT BUTTON BELOW you are undertaking a NON-VERBAL MECHANISM for MANIFESTING YOUR ASSENT to the TERMS AND CONDITIONS of this EUCLA.

a. License Terms: Grant of License. Provided LICENSEE is in material compliance with all the TERMS AND CONDITIONS of this EUCLA, HISTOLOGICS hereby grants to LICENSEE pursuant to the TERMS AND CONDITIONS of the EUCLA, a nonexclusive, nontransferable license (hereinafter 'LICENSE') to view the PRESENTATIONS.

b. Authorized Use: LICENSEE shall view and evaluate the PRESENTATIONS to make a potential BUSINESS DECISION (hereinafter 'BUSINESS DECISION') with HISTOLOGICS. The LICENSE granted allows the LICENSEE to view the PRESENTATIONS in order to evaluate HISTOLOGICS's ideas, procedures and method of operation in order to further the BUSINESS DECISION.

c. Restrictions on Use: LICENSEE agrees to view the PRESENTATIONS only for LICENSEE's own business either as an individual or as a corporate entity. Under no circumstances shall LICENSEE permit any third party to view the PRESENTATIONS. LICENSEE agrees to this restriction on use to preserve HISTOLOGICS's property interest in individual copies of the PRESENTATIONS.

d. Derivative Products: LICENSEE specifically agrees not to copy, print, alter, maintain, enhance or otherwise modify the PRESENTATIONS. LICENSEE shall not permit or assist any third party to copy, print, alter, maintain, enhance or otherwise modify the PRESENTATIONS.

e. Rights: HISTOLOGICS hereby reserves any and all rights not expressly and explicitly granted in this EUCLA.

f. Term of License: Unless otherwise terminated for breach, the term of this license shall be for seven days.

g. Intellectual Property: The PRESENTATIONS are copyrighted 2010. The LICENSEE agrees that HISTOLOGICS owns all property rights including copyright and trade secret rights associated with the PRESENTATIONS.

h. Governing Law: The EUCLA shall be governed by and construed under the laws of the State of California, without regard to choice of law provisions.

i. Termination: This LICENSE terminates if LICENSEE breaches the EUCLA. In such event LICENSEE must discontinue and cease viewing the PRESENTATIONS.

j. Disclosure: The LICENSEE agrees to be bound by a duty of non-disclosure to any third party with regard to ideas, procedures and methods of operation disclosed explicitly or implicitly in the PRESENTATIONS.

k. Mass Market Transaction: The EUCLA is not a contract for redistribution or for public performance or public display of the PRESENTATIONS, a transaction in which one or more of the PRESENTATIONS is customized, a site license or an access contract as defined in the Uniform Computer Information Transaction Act §102(a)(44).

l. Sale/Transfer: The PRESENTATIONS are not for sale. LICENSEE agrees not to transfer PRESENTATIONS in any form to a third party.

m. Competitor: LICENSEE affirms that it is not in the business of manufacturing cervical biopsy devices, is a contractor or otherwise retained by a business manufacturing cervical biopsy devices or otherwise a competitor of HISTOLOGICS.

n. Material Terms and Conditions: LICENSEE specifically agrees that each of the above terms and conditions are material and that failure of LICENSEE to comply with these terms and conditions shall constitute breach of the EUCLA.

Contact Us

Histologics, LLC
4095 E. La Palma Ave., Suite N
Anaheim, CA 92807 USA

Office: 888-738-9757
Fax: 888-738-9757
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.