Apollo Endosurgery Announces DDW 2019 Clinical Highlights
AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a leader in less
invasive medical devices for gastrointestinal and bariatric procedures,
today announced highlights from DDW 2019 which took place from May 18th
to May 21st in San Diego.
During the 3-day conference, there were over 40 clinical presentations
that described results from the use of Apollo’s products in various
clinical situations of which over 30 related to procedures that used the
OverStitch endoscopic suturing system. Some of the noteworthy abstracts
concerning OverStitch that were presented at DDW are highlighted below.
Endoscopic Sleeve Gastroplasty (ESG)
Long-Term Follow up and Outcomes After ESG for Treatment of Obesity
(5 Year Data). Authors: Kaveh Hajifathalian, Bryan Ang, Qais
Maher Dawod, Shawn Laxmikant Shah, Enad Dawod, Amit Mehta, Saurabh
Mukewar, SriHari Mahadev, Kartik Sampath, David L. Carr-Locke, Danny
Issa, Louis J. Aronne, Rekha Kumar, Alpana Shukla, Reem Z. Sharaiha. Cornell,
NYC, New York, United States.
This abstract included the first 5-year patient data on the ESG
procedure. Of those patients who had reached the 5 year follow-up mark,
69% of patients remained at least 10% below their initial total body
weight with an average total body weight loss (“TBWL”) of 14.5%.
Endoscopic Sleeve Gastroplasty: A Meta-Analysis of Weight Loss
Outcomes. Authors: Edward Villa, Christopher Grant Chapman.
Center for Endoscopic Research and Therapeutics, University of Chicago,
Chicago, Illinois, United States.
This meta-analysis evaluated the effectiveness of ESG in terms of TBWL,
excess body weight loss (“EBWL”), and body mass index (“BMI”). Five
studies with 550 patients showed pooled 6-month TBWL of 15.6% and five
studies with 365 patients were used for pooled 12-month TBWL of 17.0%.
For EBWL, six studies with 337 patients were used for pooled 6-month
EBWL of 56.3% and four studies with 223 patients were used for pooled
12-month EBWL of 67.8%. Finally, five studies with 301 patients were
used to derive pooled 6-month BMI decrease of 13.1% and five studies
with 332 patients for pooled 12-month BMI decrease of 14.5%.
Evaluation of Weight Loss and Adverse Events Associated with ESG: A
Pooled Analysis with Systematic Review. Authors: Zohair Ahmed1,
Najib Nassani1, Jean M. Chalhoub2,
Brian R. Boulay.11Gastroenterology and
Hepatology, University of Illinois at Chicago, Chicago, Illinois, United
States; 2Gastroenterology and Hepatology, University of
Massachusetts Medical Center, Springfield, Massachusetts, United States.
The pooled analysis included eleven studies (prospective and
retrospective) of ESG published between January 2013 and October 2018
and included 477 patients. The pooled TBWL was 16.5% at 6 months. The
review identified no serious adverse events or patient mortality.
ESG for Obesity: Improved Body Composition at 1-Year Follow-Up. Authors: Adrian
Sartoretto2, George Marinos2,
Zhixian Sui.1,21The University of New
South Wales, Randwick, New South Wales, Australia, 2The
BMI Clinic, Double Bay, New South Wales, Australia.
This study analyzed 121 consecutive patients who underwent ESG in an
outpatient setting from October 2016 to January 2018. At one year, the
average TBWL was 17% and 80% of patients had lost more than 10%. Unique
to this study was the evaluation of body composition. On average, there
was a reduction in body fat mass of 15.7 kg, and an increase in lean
body mass of 3.5 kg, and a reduction in visceral fat mass of 1.4 kg. The
authors suggested that the increase in lean body mass and improved body
composition lowers the risk of weight regain following an ESG. The
authors also reported that there were no major intra or post procedure
complications.
Safety and Efficacy of ESG for Obesity Management in New Bariatric
Endoscopy Programs: A Multicenter International Study. Authors: Avik
Sarkar1, Augustine Tawadros1,
Iman Andalib1, Haroon M. Shahid1,
Amy Tyberg1, Resheed Alkhiari1,
Monica Gaidhane1, Prashant Kedia2,
Keshav Kukreja2, Elizabeth S. John2,
Bryce Bushe2, Ma Guadalupe Martínez4,
Felipe Zamarripa4, Mine C. Carames5,
Juan C. Carames5, Fernando Casasrodriguez6,
Vincenzo Bove3, Guido Costamagna3,
Ivo Boskoski3, Michel Kahaleh.11Gastroenterology, Robert Wood Johnson, New Brunswick, New
Jersey, United States; 2Gastroenterology, Methodist Hospital,
Dallas, Texas, United States; 3Gastroenterology,
Fondazione Policlinico A. Gemelli, Roma, Italy; 4Gastroenterology,
Hospital Juarez de Mexico, Mexico City, Mexico; 5Gastroenterology,
Santander Hospital, Reynosa, Mexico; 6Gastroenterology,
Hospital Central de la Policia, Bogota, Colombia.
This was an international, multicenter, retrospective study reviewing
the outcomes of ESG in centers starting an ESG program. The study
reported technical success in 100% of the patients in all six centers, a
mean procedure time of 89 minutes, and no significant adverse events.
These results demonstrated equivalence in outcomes for new ESG centers
as compared to previous studies by experienced ESG centers.
Bariatric Surgery Revisions
Endoscopic Suturing for Weight Regain After Sleeve Gastrectomy:
Mulitcenter Series. Authors: Eric J. Vargas1,
Jose Nieto2, Andrew C. Storm1,
Lea Fayad3, Fateh Bazerbachi1,
Reem Matar1, Vivek Kumbhari3,
Barham K. Abu Dayyeh.11Gastroenterology
and Hepatology, Mayo Clinic , Rochester, Minnesota, United States; 2Borland
Groover Clinic, Jacksonville, Florida, United States; 3Johns
Hopkins Medicine, Baltimore, Maryland, United States.
Weight regain is a common occurrence following sleeve gastrectomy weight
loss surgery. This was a multicenter retrospective cohort study that
reported on the use of endoscopic suturing to address patient weight
regain following sleeve gastrectomy. Mean percentage TBWL at 1, 2, 3, 6,
and 9 months was 5.8%, 9.9%, 10.2%, 12.7%, and 18.5%, respectively
following the revision. The study showed that using OverStitch for
revision of sleeve gastrectomy after weight regain was safe and an
effective treatment as an adjunct to lifestyle and pharmacotherapy.
Comparison of Endoscopic and Surgical Revisions in the Treatment of
Weight Regain Following Roux-en Y Gastric Bypass. Authors: Pichamol
Jirapinyo, Ethan Dwane Maahs, Christopher C. Thompson. Brigham &
Women’s Hospital, Boston Massachusetts, United States.
Weight regain is a common occurrence following Roux-en Y gastric bypass
(“RYGB”) surgery. Revision options for these patients include Transoral
outlet reduction (“TORe”), an endoscopic procedure that uses endoscopic
suturing, and surgical RYGB revision. The authors conducted a matched
cohort study of patients who underwent either endoscopic or surgical
revision of RYGB for treatment of weight regain. At six months the
endoscopic and surgical groups had lost on average 11.2% and 10.3%,
respectively, of their total body weight and at twelve months the
endoscopic and surgical groups had lost on average 13.9% and 12.6% of
their total body weight. The rates of serious adverse events were 5.6%
and 38.9% for the endoscopic and surgical groups, respectively.
Endoscopic revision using suturing offered greater safety and comparable
weight loss to surgical revision.
Non-bariatric intervention
Determining Appropriate Reimbursement for Innovative Endoscopic
Devices Using Cost-Minimization Analysis: Endoscopic Suturing to Prevent
Stent Migration for Benign Esophageal Strictures. Authors: Eric
Dinesh Shah1, Amy E. Hosmer2,
Arpan H. Patel3, Shannon Morales1,
Ryan Law.31Gastroenterology,
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United
States; 2The Ohio State University, Columbus, Ohio, United
States; 3Division of Gastroenterology, Michigan
Medicine, Ann Arbor, Michigan, United States.
The authors developed a decision analytic model comparing fully-covered
metal stent placement with or without stent anchoring using an
endoscopic suturing device for non-malignant conditions (fistula, leak,
perforation or stricture) from a payer perspective. The model accounted
for technical success rates of suture placement, clinically significant
adverse events with suturing and stent migration rates with or without
endoscopic suturing based on a recent systematic review. The authors
concluded that a defined reimbursement pathway for endoscopic suturing
is justified to prevent stent migration.
Endoscopic Rectal Reconstruction After Removal of Large Rectal
Lesions. Authors: Sergey V. Kantsevoy, Shira Levihim, Alan Chen,
Amit Raina, Paul J. Thuluvath. Mercy Medical Center, Baltimore,
Maryland, United States.
The study evaluated the technical feasibility and effectiveness of
endoscopic reconstruction of rectal mucosa using the OverStitch
endoscopic suturing system to prevent immediate and delayed adverse
events after the en bloc endoscopic removal of large rectal
lesions. Reconstruction of the rectal mucosa in all patients was
successful and all patients were discharged home with rectal
reconstruction and none of the study patients had either immediate or
delayed adverse events. The study concluded that endoscopic rectal
reconstruction was effective in preventing immediate and delayed adverse
events after the endoscopic removal of large rectal lesions.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less
invasive therapies to treat various gastrointestinal conditions, ranging
from gastrointestinal defect repairs to the interventional treatment of
obesity. Apollo’s device-based therapies are an alternative to invasive
surgical procedures, thus lowering complication rates and reducing total
healthcare costs. Apollo’s products are offered in over 70 countries
today and include the OverStitch™ Endoscopic Suturing System, the
OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric
Balloon.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol
“APEN”. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements
that are subject to risks and uncertainties that could cause results to
be materially different than expectations. Important factors that could
cause actual results to differ materially include: reports of adverse
events related to our products, outcomes of clinical studies,
developments in medical technology, regulatory approvals and extensive
regulatory oversight by the FDA or other regulatory bodies, unfavorable
media coverage related to our products or related procedures,
reimbursement decisions by private or government payors, physician
adoption and recommendations of procedures utilizing our products and
other factors detailed from time to time in the reports Apollo files
with the Securities and Exchange Commission, or SEC, including its Form
10-K for the year ended December 31, 2018 and its Form 10-Q for the
three months ended March, 31, 2019. Copies of reports filed with the SEC
are posted on Apollo’s website and are available from Apollo without
charge. These forward-looking statements are not guarantees of future
performance and speak only as of the date hereof, and, except as
required by law, Apollo disclaims any obligation to update these
forward-looking statements to reflect future events or circumstances.
Contacts
Media Contact:
Jen Cook, 512-279-5158
jen.cook@apolloendo.com
Investor Contact:
John Gillings, 512-279-5100
investor-relations@apolloendo.com
