Halt Medical, Inc. Announces Podium Presentations at the 45th Annual AAGL Global Congress on Minimally Invasive Gynecology Meeting
Real-World and Three-Year Data on the Acessa(R) System to be Presented
BRENTWOOD, Calif.–(BUSINESS WIRE)–#Fox35News–Halt Medical, Inc., a privately held medical device company which
develops minimally invasive, uterine sparing solutions for women who
suffer from symptomatic fibroids, today announced five abstracts on the
Acessa System will be presented orally at the 45th
Annual Global Congress on Minimally Invasive Gynecology Meeting,
being held November 14-18 in Orlando, Florida.
New Instrumentation or Technology on November 16, 2016 from 12:10 PM –
12:48 PM
-
Dr. Nicole Williams, Gynecology Institute of Chicago, will present two
abstracts on post-market outcomes and ultrasound evaluations after
radiofrequency ablation of symptomatic uterine fibroids -
Dr. Keith Isaacson, Director of Minimally Invasive Gynecology at
Newton-Wellesley, will present clinical outcomes at three years from
the LUSTOR Study, a randomized controlled clinical trial of Acessa vs.
Myomectomy -
Dr. Kelly Braun, Associate Professor Augusta University, will present
on ten surgeons’ early experience and proficiency using the first
generation Acessa System in just two to five procedures
New Instrumentation or Technology on November 17, 2016 from 2:47 PM –
2:53 PM
-
Dr. Bruce Lee, inventor of the Acessa System, will present on the safe
and effective use of radiofrequency ablation of uterine fibroids in
symptomatic patients with uteri 15-weeks gestational size and greater
Dr. Nicole Williams at the Gynecology Institute of Chicago stated, “I
have treated well over 100 patients with Acessa and have been very
satisfied with the results. Equally important, Acessa has given the
patients in my practice facing hysterectomy an alternative. In most
cases, there is no need to remove the uterus. Acessa allows me to treat
the underlying problem (the fibroids), while leaving an otherwise
healthy organ unharmed.” This week, Dr. Williams will share real-world,
post-operative outcomes after the treatment of 81 women with symptomatic
fibroids.
What are uterine fibroids?
Uterine fibroids are benign, muscular tumors in a woman’s uterus that
can cause heavy bleeding, painful periods, pressure, and distension of
the abdomen [1]. At least 70% of women in the U.S. will develop fibroids
by the age of 50, with the prevalence even higher among African-American
women [2]. As a result, they remain a major women’s health issue with
significant economic and reproductive impact. The NIH has determined
that direct health care costs for the surgical treatment of fibroids are
more than $2.1 billion annually [3]. In a nationwide inpatient sample,
over half a million women underwent hysterectomy for benign gynecologic
conditions [4] and the American Congress of Obstetricians and
Gynecologists (ACOG) states that 39% of all hysterectomies are due to
fibroids [5]. Over time, patients and gynecologists are turning to less
invasive procedures, and laparoscopic options are becoming more popular
[6].
The Acessa System is a minimally invasive, uterine conserving,
laparoscopic procedure that delivers radiofrequency energy to destroy
the fibroids. After treatment, the fibroid is reabsorbed by the
surrounding tissue. The procedure allows the surgeon to treat only the
fibroids, while preserving normal function of the uterus. Patients
typically go home the same day with minimal discomfort, and enjoy a
rapid return to normal activities.
About Halt Medical, Inc. – The Company is focused on establishing a new
standard of care for women with symptomatic uterine fibroids. The Acessa
System is cleared by the FDA and has CE mark for use in percutaneous,
laparoscopic coagulation and ablation of soft tissue, including
treatment of symptomatic uterine fibroids under laparoscopic ultrasound
guidance. The Company is located in Brentwood, CA. For information about
the Acessa System, please visit www.acessaprocedure.com.
REFERENCES:
1. www.womenshealth.gov
2.
Baird DD et al. High Cumulative Incidence of Uterine Leiomyoma in Black
and White Women: Ultrasound Evidence. Am J Obstet Gynecol 2003; 188
(1):100-107.
3. National Institutes of Health fact sheet: http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50
4.
Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A.
Nationwide Use of Laparoscopic Hysterectomy Compared with Abdominal and
Vaginal Approaches. Obstet Gynecol 2009;114(5):1041-1048.
5. www.ACOG.org.
2011 Women’s Health Stats and Facts: p.18.
6. Twijnstra AR, Kolkman
W, Trimbos-Kemper GC, Jansen FW. Implementation of Advanced Laparoscopic
Surgery in Gynecology: National Overview of Trends. J Minim Invasive
Gynecol 2010;17(4):487-492.
Contacts
Halt Medical, Inc.
Investor Relations:
Jeremy McFadden,
925-348-9911
CFO
jmcfadden@haltmedical.com
or
Tyler
Holcomb, 847-624-9364
Director of Global Marketing
tholcomb@haltmedical.com
or
Halt
Medical
General Phone: 925-634-7943
Fax: 925-634-7841
http://www.acessaprocedure.com
