Full Press Release Details
ReShape Lifesciences
Inc. is a worldwide premier weight-loss solutions company, offering an integrated portfolio of proven products and services that manage
and treat obesity and metabolic disease.
Our current portfolio
includes the FDA-approved Lap-Band system, which provides minimally invasive, long-term treatment of obesity and is a
safer surgical alternative to more invasive and extreme surgical stapling procedures such as the gastric bypass or sleeve gastrectomy.
The recently launched ReShapeCareTM virtual health coaching program is a novel reimbursed telehealth weight-management program
that supports healthy lifestyle changes for all medically managed weight-loss patients, not just the Lap-Band, further expanding our reach
and market opportunity. The ReShape MarketplaceTM, an online store, that provides top of the line products with bariatric patients
in mind. Our ReShape OptimizeTM supplement options, purchased through the ReShape Marketplace, include multivitamins, probiotics,
calcium, vitamin D, protein, and other therapeutic offerings to optimize health. The Obalon Balloon system, recently acquired in
June of 2021, is the first and only swallowable, gas filled, FDA-approved balloon system. The ReShape VestTM system is
an investigational (outside the U.S.) minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating
the gastric volume reduction effect of conventional weight-loss surgery. It is designed to help enable rapid weight loss in obese and
morbidly obese patients without permanently changing patient anatomy. The DBSN device is a technology under development as a new personalized
treatment for type 2 diabetes mellitus. ReShape's DBSN device is expected to use bioelectronics to manage blood glucose in treatment
of diabetes and individualized 24/7 glucose control. Additional products and accessories from the Company, including calibration tubes,
facilitate alternative gastric surgical procedures and ongoing product support for healthcare practitioners and patients (adjustments, etc.).
Our Product Portfolio
Lap-Band System, which we acquired from Apollo Endosurgery, Inc. ("Apollo") in December 2018, is designed to
provide minimally invasive long-term treatment of severe obesity and is an alternative to more invasive surgical stapling procedures
such as the gastric bypass or sleeve gastrectomy. The Lap-Band System is an adjustable saline-filled silicone band that is
laparoscopically placed around the upper part of the stomach through a small incision, creating a small pouch at the top of the
stomach, which slows the passage of food and creates a sensation of fullness. The procedure can normally be performed as an
outpatient procedure and patients can go home the day of the procedure without the need for an overnight hospital stay.
has been in use in Europe since 1993. It was approved in Australia in 1994 by the Therapeutic Goods Administration ("TGA")
and received its CE mark in 1997. The FDA approved the Lap-Band System for use in the United States in 2001. The Lap-Band System has been
approved in 21 countries, with more than 1,000,000 Lap-Band Systems sold worldwide.
has been approved for use in the U.S. for patients with a Body Mass Index ("BMI") greater than or equal to 40 or a BMI greater
than or equal to 30 with one or more obesity-related comorbidity conditions.
System has been subject to more than 400 peer-reviewed publications and extensive real- world experience. Adjustable gastric banding
using the Lap-Band System has been reported to be significantly safer than gastric bypass while statistically producing the same
weight loss five years after surgery when accompanied by an appropriate post-operative follow-up and adjustment protocol. Studies
have reported sustained resolution or improvement in type 2 diabetes, gastroesophageal reflux, obstructive sleep apnea, asthma,
arthritis, hypertension and other pre-existing obesity related comorbidities following gastric banding. The gastric banding surgical
procedure is generally reimbursed by most payors and insurance programs that cover bariatric surgery.
Benefits. Lap-Band System offers
the following benefits:
ReShape Calibration Tubes
The ReShape Calibration
tubes are multifunctional devices compared to reusable bougies and disposable gastric tubes. The Calibration tubes are designed to be
less traumatic to the patient, as they are intended to fit the lesser curvature of the stomach more easily and quickly reach the pylorus.
In August of 2022, we announced FDA clearance of three new sizes - 32, 36, and 40 French - all designed to simplify bariatric
procedures such as laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding. We are ramping up production and moving
rapidly towards a full release of this product in early 2023.
ReShapeCare is a HIPAA-compliant,
virtual coaching program which enhances behavior change through engagement with ReShape's Welcome Specialists and Health Coaches.
The program is based on four established dimensions of successful behavior: change sleep, nutrition, exercise and stress. It is designed
to provide flexible structure and support from a live certified health coach in a manner that is simple, affordable and practical.
Clinical studies prove
that online health coaching leads to higher patient satisfaction, more successful weight loss outcomes, improvements in metabolic health
and enhances quality of life. ReShapeCare is appropriate for all weight loss patients, medical weight loss patients, and pre- and post-surgical
The program is designed
to reshape the patient's life through better sleep, nutrition, exercise, and stress management. Patients get paired with a ReShapeCare
certified health coach who will be with them every step of the way through their journey, including through daily text messaging or live
phone or video calls. The web and mobile app make it easy to increase positive actions and awareness by receiving daily educational content,
personalized exercise, and progress reports. This program creates an atmosphere of community with social support from peers and by joining
group sessions. When it comes to nutrition, patients can utilize an easy-to-follow, personalized nutrition plan with a recipe library
and restaurant guide. Tracking your food is as easy as taking a snapshot from your phone and sending it to your coach. Patients can connect
their own devices to automatically track sleep, stress, and weight. This real-time health data can be used to optimize the program to
get the best possible results.
is an online store developed with bariatric patients in mind in order to focus on the four dimensions of successful behavior changes.
Within the ReShape Marketplace we have ReShape Optimize, which meets all the nutrient needs to stay healthy. The ReShape Marketplace provides
the highest quality products for exercising, that can have immediate and long-term health benefits, sleep which plays a vital role in
good health and well-being, and stress to effectively manage stress to make your life happier, healthier and more productive.
ReShape has partnered
with ProCare Health to provide premium supplements to optimize health and well-being. ReShape Optimize is a supplemental
option which will include multivitamins, probiotics, calcium, vitamin D, protein, and other therapeutic offerings. Our multivitamins utilize
easy to absorb ingredients, meet updated ASMBS guidelines, and are made in the USA.
Obalon Balloon System
System consists of a swallowable capsule that contains an inflatable balloon attached to a microcatheter; the Obalon Navigation System
console, which is a combination of hardware
and software used to dynamically track and
display the location of the balloon during placement; the Obalon Touch Inflation Dispenser, which is a semi-automated, hand-held inflation
device used to inflate the balloon once it is placed; and a disposable canister filled with our proprietary mixture of gas. We continue
to explore the compliance requirements, manufacturing viability and quality system controls necessary for re-introducing the Obalon Balloon
Placement of the Obalon
balloon typically occurs in less than 15 minutes and can be accomplished in an outpatient setting. To place the Obalon balloon, the patient
swallows the capsule, which has the Obalon balloon folded inside. No sedation or anesthesia is required. Once swallowed, placement of
the capsule is confirmed in the stomach using the Obalon Navigation System. Balloon placement can also be confirmed using x-ray. The microcatheter,
which is attached to the Obalon balloon, is then connected to the Obalon Touch Inflation Dispenser. The Touch inflation system provides
real-time pressure measurements to confirm that the Obalon balloon is both properly placed and able to be correctly inflated in the stomach.
A pre-filled canister of gas is inserted into the inflation system and then the gas is discharged to fill the balloon to a volume of 250cc.
Once the inflation of the Obalon balloon is confirmed, the microcatheter is detached from the balloon via hydrostatic pressure and is
removed through the patient's mouth. The patient is intended to return two more times over the following 8 to 12 weeks to receive
a second and third Obalon balloon, expanding total balloon volume within the stomach to approximately 750cc.
are removed in a single procedure no more than six months after the placement of the initial balloon. The balloons are removed endoscopically
under light conscious sedation, using standard commercially available endoscopy tools. The endoscopic procedure to remove the balloons
typically requires approximately 15 minutes.
a technology under development as a new treatment for type 2 diabetes mellitus (T2DM). It combines ReShape Lifesciences' proprietary
Vagus Nerve Block (vBloc) technology platform in combination with Vagus nerve stimulation. This new dual Vagus nerve neuromodulation system
selectively modulates vagal block and stimulation to the liver and pancreas to manage blood glucose. ReShape's DBSN device is expected
to use bioelectronics to manage blood glucose in treatment of diabetes and individualized 24/7 glucose control. The goal is to reduce
costs of treatment and complications that arise from poorly controlled blood glucose and non-compliance to T2DM medication.
technology is in preclinical development. It has demonstrated effectiveness and has been well tolerated through experiments in diabetic
swine utilizing Phase I funding from an NIH Small Business Innovation Research Grant.
Develop and Commercialize a Differentiated
Portfolio of Products/Therapies
Lifesciences Inc. is the premier physician-led weight-loss and metabolic health-solutions company, offering an integrated portfolio
of proven products and services that manage and treat obesity and metabolic disease. An overarching strategy for our company is to