Navigation Links
Initial Studies of Channel Medsystems' Cryothermic Therapy Demonstrate Preliminary Safety and Tolerability; Results Presented at the 42nd AAGL Global Congress
Date:11/21/2013

SAN FRANCISCO, Nov. 21, 2013 /PRNewswire/ -- Results from histopathology and initial tolerability studies of Channel Medsystems' novel technology for endometrial ablation were presented at last week's AAGL Global Congress in Washington, D.C. The findings represent a first indication of the safety and effectiveness of this device, which is intended for use in the treatment of heavy menstrual bleeding, a condition that affects one in five women in the United States.  The published data demonstrate that the Company's cryothermic therapy had preliminary safety, created a favorable ablation profile, and was well-tolerated by subjects.  Evidence from these initial studies forms the foundation of a data set designed to prove that Channel Medsystem's device is an appropriate technology for the physician office setting.

(Logo: http://photos.prnewswire.com/prnh/20131111/SF14418LOGO)

These initial studies were performed in subjects undergoing a planned hysterectomy. Histopathology data from these studies were analyzed by Dr. James Coad, a pathologist from West Virginia University and co-author of the published data.

The studies demonstrated that Channel Medsystems' cryothermic therapy (1) had an acceptable safety profile, (2) can be performed in a clinically appropriate timeframe, and (3) was well-tolerated by the subject without the need for general anesthesia or conscious sedation.  In addition, evaluation of the removed uteri revealed excellent cavity coverage and an ablation profile that mirrors currently-available hyperthermic therapies.  "This procedure appears to facilitate an appropriate depth of ablation of the endometrium, from a full-thickness ablation of the body of the uterus to a thinner ablation that is desirable in the cornua and lower uterine segment," said Dr. Coad.  "The precision in the depth of ablation is a key factor in achieving an effective outcome without compromising the function of the underlying uterine tissue."

"These results are promising and indicate that our cryothermic therapy is ready for the next stage of evaluation," said Ric Cote, President and CEO of Channel Medsystems.  "We are looking forward to beginning enrollment in our Cryoablation Feasibility Trial (CRYSTAL), where we will focus on assessing outcomes in women with heavy menstrual bleeding up to six months after the procedure."  The CRYSTAL study is designed to further evaluate the effectiveness and tolerability of Channel Medsystems' in-office cryothermic procedure at leading centers in Canada and will begin enrollment this month.

About the Cryothermic Technology Platform: Channel Medsystems' novel cryothermic technology and streamlined delivery system were developed with feedback from leading clinicians and biomedical engineers at the healthcare incubator, Theranova. The technology integrates cryothermic energy and the user controls into a self-contained, handheld device, eliminating the need for a separate control unit or capital equipment.

About Channel Medsystems:  Channel Medsystems is a venture-backed company that was founded to bring innovation to the delivery of women's healthcare. The Company strives to develop treatments to meet the unique needs of female patients and the high standards of their healthcare providers. Channel Medsystems is committed to ensuring that patients have access to high quality outcomes that can be delivered in the convenience and comfort of their healthcare provider's office. For more information, please visit www.channelmedsystems.com.

CAUTION: This device is available for investigational use in Canada.  It is not available for sale or investigational use in the United States.


'/>"/>
SOURCE Channel Medsystems
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Montage Healthcare and Mammography Reporting Systems to show initial results of partnership to enrich mammography quality efforts at RSNA 2013
2. Tandem Diabetes Care Announces Closing of Initial Public Offering
3. Tandem Diabetes Care Announces Exercise of Option to Purchase Additional Shares in Initial Public Offering of Common Stock
4. Epizymes EPZ-5676 DOT1L Inhibitor Demonstrates Encouraging Initial Findings in an Ongoing Phase 1 Dose Escalation Study
5. Tandem Diabetes Care Prices Initial Public Offering
6. American Red Cross Contributes an Initial $6 Million to Support Typhoon Haiyan Response Efforts in Philippines
7. Cara Therapeutics Files Registration Statement for Proposed Initial Public Offering
8. Veracyte, Inc. Announces Pricing of Initial Public Offering
9. Genocea Reports Positive Initial Phase 1/2a Results for GEN-003, its Pioneering Therapeutic Vaccine Candidate for the Treatment of Herpes Simplex Virus-2 (HSV-2), at ICAAC 2013
10. Regado Biosciences, Inc. Announces Closing of Initial Public Offering
11. Regado Biosciences, Inc. Announces Pricing of Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , May 26, 2016 Since ... matured into an essential life science tool for conducting ... applications. BCC Research reveals in its new report that ... growth phase, one powered by a range of new ...      (Logo: http://photos.prnewswire.com/prnh/20140723/694805 ) , ...
(Date:5/25/2016)... PARIS , May 25,2016 ... with the near-infrared Cellvizio platform for urological and ... MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary ... important regulatory milestone in the US with the ... Food and Drug Administration (FDA). This new FDA ...
(Date:5/25/2016)... 25, 2016 According to a ... (3D, 2D, 4D), by Therapeutic Area (Oncology, Cosmeceutical/Plastic Surgery), ... (Medical Device Manufacturers, Hospitals/ Clinics) - Forecast to 2021", ... Animation Market for the forecast period of 2016 to ... Million by 2021 from USD 117.3 Million in 2016, ...
Breaking Medicine Technology:
(Date:5/26/2016)... NJ (PRWEB) , ... May 26, 2016 , ... ... recognized as an NJ Top Doc! Along with his wonderful accolades and stellar ... in podiatry. Congratulations, Dr. Batelli! , Dr. Eugene Batelli is a highly ...
(Date:5/26/2016)... ... May 26, 2016 , ... Power Systems, ... the first PowerWave Instructor Certification Course in Stoughton, Massachusetts. The course was led ... professional through the 8 hour interactive course to qualify participants as certified PowerWave ...
(Date:5/26/2016)... ... May 26, 2016 , ... Bunion Bootie , the manufacturer ... treatment was more than humbled by customer demand over the Mother’s Day Weekend promotion. ... sale. Now that Bunion Bootie has completely replenished its inventory levels, it hopes to ...
(Date:5/26/2016)... ... May 26, 2016 , ... OncLive® , a ... Cancer Institute-designated University of Virginia (UVA) Cancer Center to its quickly ... and marketing teams will publicize and promote public awareness of UVA Cancer Center’s ...
(Date:5/26/2016)... ... May 26, 2016 , ... On May 23rd during the National Eye ... and international water advocate, was honored by Ashram, Inc. as the world’s foremost water ... knelt on the banks of the Nile to fill their red clay pots with ...
Breaking Medicine News(10 mins):