05.12.2007 19:47:00
|
SafeStitch Medical, Inc.; Name Changed from Cellular Technical Services Company
The shareholders of CTSC voted to approve a name change to SafeStitch
Medical, Inc. SafeStitch Medical is now a publicly-traded medical device
company developing endoscopic and minimally invasive surgical devices.
SafeStitch Medical’s trading symbol
(OTCBB:CTSC), will be changing too. SafeStitch Medical is headquartered
in Miami, Florida, and has a research and development office in Omaha,
Nebraska. It intends to apply to have its shares listed on the American
Stock Exchange (AMEX).
"We are very pleased to keep the SafeStitch
name, as it is already respected in the medical community,”
says Dr. Phillip Frost, SafeStitch Medical’s
largest shareholder.
In addition to its seasoned executive team consisting of Dr. Jane Hsiao,
Chairman, Jeffrey Spragens, CEO and President, Dr. Stewart Davis, COO,
and Dr. Charles Filipi, Medical Director, SafeStitch Medical has hired
Christian Martin to oversee Product Development and Mario Arbesu to
oversee Quality Assurance and Regulatory. Mr. Martin has over 17 years
of engineering experience including endoscopic devices and Mr. Arbesu
has over 13 years of engineering, quality and regulatory experience
including endoscopic devices.
SafeStitch Medical’s product portfolio
includes a device for endoscopic bariatric surgery (obesity surgery) and
endoscopic repair of gastroesophageal reflux disorder (GERD), as well as
an endoscopic device for excision and diagnosis of Barrett's esophagus.
The company also plans to market a novel standard bite block, as well as
the first airway bite block, to be used during endoscopy, and is
pioneering the Smart Dilator for esophageal strictures. SafeStitch
Medical also intends to develop products for hernia repair and natural
orifice transluminal endoscopic surgery (NOTES).
As we continue to work with Creighton University in Omaha, Nebraska,
SafeStitch has exclusive licenses for over 22 patents and patent
applications.
More detailed information on each of our products can be found below.
Our short term plans are:
FDA Registration of standard and airway bite blocks (We believe that
these are Class I, exempt devices which do not require FDA Approval)
Continued Product Development of gastroplasty device for obesity and
GERD
Manufacturing of gastroplasty devices for clinical trials and
engineering (performance, validation) testing
Feasibility trial of gastroplasty device and commencement of
multicenter US and international trials
Continued product development of Barrett's Excision Device
Final product development of Smart dilator and application for FDA
approval (Class II, 510(k))
Initial marketing and commercialization of standard and airway bite
blocks and Smart dilator
IRB clinical evaluation trials for standard and airway bite blocks and
Smart dilator
Early development efforts on hernia device and NOTES devices, of which
we have existing intellectual property and licenses
Intraluminal Gastroplasty Device for Obesity ("Obesity
Device”)
The Obesity Device is designed to perform incision-less, endoscopic
bariatric surgery. Bariatric surgery is generally performed through an
external abdominal incision, and sometimes laparoscopically. The
traditional surgery has the potential for significant complications,
requires an in-patient hospital stay and is expensive. The Obesity
Device is introduced through the mouth and esophagus and works by
suctioning two sides of the stomach lining into position for suturing,
impaling the mucosa or stomach lining, placing a row of sutures through
the two sides of the stomach, as commonly done during gastric surgery,
injecting adrenaline into the mucosa to elevate it for excision,
excising the top layer of the entrapped stomach wall, releasing this
tissue, removing the device and tightening the sutures. We believe that
this device will result in significantly less complications and expense,
both because of the manner in which the procedure will be performed and
the reduced recuperation time.
Intraluminal Gastroplasty Device for GERD (the "GERD
Device”)
The GERD Device contains the same features as the Obesity Device and is
designed to promote healing at the gastroesophageal junction to prevent
acid reflux. In GERD patients, the esophageal junction does not close
completely and acid or bile from the stomach enters the esophagus. Both
the hydrochloric acid or bile from the stomach can damage the esophagus.
Typically, surgery is performed through either an external abdominal
incision, or laparoscopically. The traditional surgery has the potential
for significant complications, requires a two-three day inpatient
hospital stay and is expensive. The GERD Device is inserted through the
mouth and esophagus until it reaches the esophageal junction, the
opening at the bottom of the esophagus that connects the esophagus to
the stomach. The GERD Device sutures the esophageal junction to make it
smaller. Usually two to four stitches are necessary on one or both sides
of the esophageal junction. The benefits are similar to those of the
Obesity Device. We believe that this device will result in significantly
more effective treatment and less complications and expense and will
permit the procedure to be performed on an outpatient basis.
Barrett’s Excision and Ablation Device for
Treatment and Diagnosis ("Barrett’s
Device”)
The Barrett’s Device is the only device we
are aware of designed to assist in both diagnosis of and treatment of
Barrett’s Esophagus. Barrett’s
Esophagus is the lining of the esophagus that imitates the stomach
mucosa, beginning at the esophageal junction and migrating upward.
Barrett’s esophageal tissue is pre-cancerous
and can result in difficulty in swallowing, spreading malignancy and
death.
Existing treatments include medication, laposcropic surgery and
cauterization. The Barrett’s Device allows
the mucosa to be suctioned, sliced off and tested. The device also
allows for cauterization of the affected area. If the Barrett’s
Esophagus covers all four quadrants of the esophagus, at least two
procedures are necessary, each covering up to one half of the
circumference, as a 360° excision would
create a stricture that would cause difficulty swallowing. We expect
that the procedures will be done two months apart. No incision is
required, and the procedure will be an outpatient procedure. We expect
this device to be more effective and less costly than existing
procedures.
SMART Dilator
Dilators are used when an endoscopy demonstrates the narrowing of the
esophagus. Narrowing may be treated by medication for GERD or by using a
dilator to expand the esophagus. Studies indicate that there are
approximately 10,000 perforations of the esophagus per year resulting
from dilation. According to peer-reviewed literature, dilation results
in a 0.5-1.0% perforation rate. Approximately 800,000 dilations are
performed in the United States each year. Untreated perforation of the
esophagus is fatal; usually within two days. Our testing has shown that
there should be no greater than two pounds of pressure on the dilator.
The Smart Dilator signals the physician as to how close he or she is to
this amount of pressure through change in the color of the dilator
handle from green to yellow to red. The Smart Dilator handle also locks
in place when the pressure exceeds 2.5 pounds. While there are numerous
dilators on the market, none provide a safety mechanism similar to what
will be provided by the Smart Dilator. Disposable dilators range in
price from $100-$250.
Standard Bite Block
A bite block is used to protect the endoscope used in transoral
gastrointestinal procedures and is required in all such procedures. A
number of bite blocks are on the market. Our Standard Bite Block
provides a higher level of protection as it is less easily expelled from
the mouth. The Standard Bite Block is designed with a bigger lip and
slightly different aperture than other bite blocks.
Airway Bite Block
The Airway Bite Block has an oropharyngeal airway built into the bite
block to assist patients with larger tongues or smaller throats, usually
because of obesity, in breathing during an endoscopic procedure. The
Airway Bite Block will come in two sizes.
T Fasteners for Upper GI Bleeding ("T
Fastener Gun”)
The T Fastener Gun delivers small metal fasteners at the end of an
endoscope. We believe that our T Fastener Gun can provide full-thickness
stomach wall suturing for control of gastric bleeding. Existing devices
apply energy or clips that are often too superficial, resulting in
rebleeding. The T Fastener suture end is tightened, and because it is
full thickness bite, a larger amount of tissue will compress the
bleeding vessel.
Novel Surgical Fasteners for Hernia Repairs and Other Surgical
Procedures ("Surgical Fasteners”)
This Surgical Fastener is an absorbable staple with a stapler for the
repair of inguinal or groin hernias. The staples are utilized to fix
mesh in place. The mesh helps prevent the recurrence of a hernia. The
absorbable nature of the staples will reduce the incidence of chronic
postoperative pain, which affects approximately 20% of patients. The
staples will also decrease operative time as they are easier and faster
to apply.
Novel Devices for Natural Orifice Transluminal Endoscopic Surgery ("NOTES”)
Natural Orifice Transluminal Endoscopic Surgery or NOTES is a new method
of operating in the abdominal cavity without making an incision in the
abdominal wall. This surgery is also referred to as NO SCAR surgery. The
natural orifices used in this type of procedure are the mouth and the
rectum and, in females, the vagina. If the mouth is used, instruments
are passed through this natural orifice out of the stomach and into the
abdominal cavity.
NOTES includes surgeries for gallbladder removal, appendectomy, tubal
ligation, removal of intestinal and reproductive organ cancer and hernia
repair, all through the gastric or vaginal walls as indicated above.
Surgery utilizing the NOTES approach requires stabilization of long
flexible instruments and the organs to be operated upon. SafeStitch has
a magnetic gallbladder retractor that would enable improved operative
exposure for gallbladder removal as well as a method and istrument to
open and close the gastrotomy necessary for NOTES.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), regarding product development efforts and other
non-historical facts about our expectations, beliefs or intentions
regarding our business, technologies and products, financial condition,
strategies or prospects. Many factors could cause our actual activities
or results to differ materially from the activities and results
anticipated in forward-looking statements. These factors include those
described in our filings with the Securities and Exchange Commission, as
well as risks inherent in funding, developing and obtaining regulatory
approvals of new, commercially-viable and competitive products and
treatments. In addition, forward-looking statements may also be
adversely affected by general market factors, competitive product
development, product availability, federal and state regulations and
legislation, the regulatory process for new products and indications,
manufacturing issues that may arise, patent positions and litigation,
among other factors. We do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking
statements be subject to the safe-harbor provisions of the PSLRA.
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
JETZT DEVISEN-CFDS MIT BIS ZU HEBEL 30 HANDELN
Handeln Sie Devisen-CFDs mit kleinen Spreads. Mit nur 100 € können Sie mit der Wirkung von 3.000 Euro Kapital handeln.
82% der Kleinanlegerkonten verlieren Geld beim CFD-Handel mit diesem Anbieter. Sie sollten überlegen, ob Sie es sich leisten können, das hohe Risiko einzugehen, Ihr Geld zu verlieren.
Nachrichten zu Cellular Technical Services Company Inc. (CTSC)mehr Nachrichten
Keine Nachrichten verfügbar. |