Plenity® is transforming weight management with
a clinically proven approach made from naturally derived building
blocks
As Chief Nutrition Officer, Bauer will focus on
educating healthcare professionals and offering nutrition
counseling to Plenity members
Gelesis, a consumer-focused biotherapeutics company, is proud to
announce Plenity®, an FDA cleared weight management approach, is
now broadly available across the United States to adults who meet
the prescription criteria. The company is also pleased to announce
the appointment of leading health and nutrition authority Joy
Bauer, MS, RDN, CDN, as Chief Nutrition Officer. In this new role,
Bauer will offer nutrition counseling and education for Plenity
members and engage with and educate healthcare professionals about
the product.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20211201005156/en/
Leading nutrition authority and beloved
media personality Joy Bauer, MS, RDN, CDN, joins as Chief Nutrition
Officer of Plenity. (Photo: Business Wire)
For adults who are looking to lose weight, there is often a lot
standing in the way, like weight bias, fad diets, false promises,
and the very real feeling of hunger. Plenity challenges the notion
that people should live life feeling deprived and combines an
FDA-cleared prescription product with a supporting member
experience. Plenity is not a diet, a magic pill, or a drug; it is a
clinically proven weight management treatment that aims to help
adults on their journey.
Plenity is designed to help people feel satisfied with smaller
portions so they can eat less and lose weight. It is FDA-cleared to
aid in weight management in adults with excess weight or obesity,
as defined by a Body Mass Index (BMI) of 25 to 40 kg/m², when used
in conjunction with diet and exercise. It is taken orally as three
capsules with 16 oz. of water twice a day, 20 minutes before lunch
and dinner. If a dose is missed, it can be taken with the meal or
immediately following the meal. Plenity is not a drug; it is
non-systemic and not habit forming. Plenity instead uses a novel
biomimetic approach inspired by the composition and mechanical
properties of vegetables that makes adults feel fuller faster with
smaller portions. In clinical trials, the safety profile was
similar to placebo.
“No one should feel deprived of enjoying the foods they love. We
now have the opportunity to share a weight management aid that can
help improve a person’s chances at success, and that’s
extraordinary,” says Bauer. “Plenity is entirely different from any
other weight loss tool: it’s simple, the technology is impressive,
and it’s inspired by vegetables. Most importantly, the whole
experience is centered around enabling people to make smart
lifestyle choices while continuing to enjoy the foods they love.
These two factors are essential for long-term weight management
success – I’ve seen it firsthand throughout my career in clinical,
community and private practice.”
Bauer is one of the nation’s leading health and nutrition
authorities. She is a beloved media personality and a #1 New York
Times bestselling author with 14 bestsellers to her credit. In the
earlier part of her career, Bauer was the Director of Nutrition and
Fitness for the Department of Pediatric Cardiology at Mount Sinai
Medical Center in New York City, as well as the clinical dietitian
for their neurosurgical team.
She has worked closely with Plenity since spring 2021 on
healthcare provider support, establishing awareness and educating
registered dietitian nutritionists (RDNs) on the safety profile and
clinical evidence for Plenity. As part of her expanded role with
the company, she will continue to build education and advocacy to
support RDNs in recommending Plenity to their patients through
professional educational content, key events, and outreach to
members of the Academy of Nutrition and Dietetics and other
certified nutrition professionals.
Plenity is available by prescription via a stigma-free
telehealth consultation with a physician trained in weight
management support, with free, unlimited follow-up visits as
needed. The pandemic continues to prove out the importance of
convenient access to healthcare, and the Plenity
experience—including both the digital model and the strong efficacy
to safety profile—is built to address that. Visit MyPlenity.com to
start an online consultation or talk to one’s own doctor about
whether Plenity is right for you. A Plenity subscription costs $98
for a four-week supply ($1.75 per meal) and, if prescribed, the
product arrives in two business days.
As part of a Plenity prescription, members can access a curated
member experience centered on many of the barriers that stand in
the way of sustainable weight management. This includes
evidence-based information from medical experts, personalized
content, and a private online member community. Plenity members can
also tap into a network of partners for behavioral support. With
this partnership, Bauer will create dedicated content for members,
such as nutrition education, live virtual events, recipes, and
thought pieces on rethinking weight management. A group of Plenity
members will also be able to access one-on-one coaching as well as
events to augment their weight management journey with Plenity.
“Joy understands that the weight loss journey is deeply
personal, and throughout her career she’s helped countless people
reach their individual goals. We share the same core beliefs that
you should be able to enjoy foods you love with people you love,
and that you should not have to choose between loving yourself and
wanting to change yourself,” says Elaine Chiquette, Pharm.D., Chief
Scientific Officer at Gelesis. “We are honored to welcome Joy to
this expanded role and to be able to offer our members access to
Joy’s knowledge and expertise.”
Gelesis and Capstar Special Purpose Acquisition Corp. (NYSE:
CPSR) announced in July that they entered into a definitive
business combination agreement. Upon completion of the transaction,
the combined company’s securities are expected to be traded on the
New York Stock Exchange under the symbol “GLS.” Gelesis will use
the proceeds of the transaction to support future broad consumer
activation around Plenity.
Important Safety Information about Plenity
- Patients who are pregnant or are allergic to cellulose, citric
acid, sodium stearyl fumarate, gelatin, or titanium dioxide should
not take Plenity.
- To avoid impact on the absorption of medications:
- For all medications that should be taken with food, take them
after starting a meal.
- For all medications that should be taken without food (on an
empty stomach), continue taking on an empty stomach or as
recommended by your physician.
- The overall incidence of side effects with Plenity was no
different than placebo. The most common side effects were diarrhea,
distended abdomen, infrequent bowel movements, and flatulence.
- Contact a doctor right away if problems occur. If you have a
severe allergic reaction, severe stomach pain, or severe diarrhea,
stop using Plenity until you can speak to your doctor.
Rx Only. For the safe and proper use of Plenity or more
information, talk to a healthcare professional, read the Patient
Instructions for Use, or call 1-844-PLENITY.
About Gelesis
Gelesis is a consumer-centered biotherapeutics company advancing
a novel category of treatments for weight management and gut
related chronic diseases. Our non-systemic superabsorbent hydrogels
are the first and only made entirely from naturally derived
building blocks, and they are inspired by the composition (i.e.,
water & cellulose) and mechanical properties (e.g., elasticity
or firmness) of raw vegetables. They are conveniently administered
in capsules to create a much larger volume of small,
non-aggregating hydrogel pieces that become an integrated part of
the meals, and act locally in the digestive system. Our portfolio
includes Plenity®, an FDA-cleared product to aid in weight
management, as well as potential therapies in development for
patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
(NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional
Constipation. For more information, visit gelesis.com, or connect
with us on Twitter @GelesisInc.
Additional Information and Where to Find It
In July 2021, Gelesis entered into a business combination
agreement with Capstar Special Purpose Acquisition Corp. (NYSE:
CPSR) (“Capstar”), a special purpose acquisition company, as
amended in November 2021.
Capstar has filed a Registration Statement on Form S-4 with the
SEC, which includes a proxy statement/prospectus, that will be both
the proxy statement to be distributed to Capstar shareholders in
connection with its solicitation of proxies for the vote by Capstar
shareholders with respect to the proposed business combination and
other matters as may be described in the Registration Statement, as
well as the prospectus relating to the issuance of certain
securities to be issued in the proposed business combination. After
the Registration Statement is declared effective, the proxy
statement/prospectus and other relevant documents will be sent to
Capstar and Gelesis shareholders. Capstar also will file other
documents regarding the proposed transaction with the SEC. This
press release does not contain all the information that should be
considered concerning the proposed business combination and is not
intended to form the basis of any investment decision or any other
decision in respect of the proposed business combination. Before
making any voting decision, Capstar’s shareholders and other
interested persons are advised to read, when available, the
preliminary proxy statement/prospectus included in the Registration
Statement, the amendments thereto and the definitive proxy
statement/prospectus and all other relevant documents filed or that
will be filed with the SEC in connection with the proposed
transaction as they become available because they will contain
important information about Gelesis, Capstar and the proposed
transaction.
When available, the definitive proxy statement/prospectus and
other relevant materials for the proposed business combination will
be mailed to shareholders of Capstar as of a record date to be
established for voting on the proposed business combination.
Investors and security holders will also be able to obtain free
copies of the Registration Statement, the proxy
statement/prospectus and all other relevant documents filed or that
will be filed with the SEC by Capstar, without charge, once
available, through the website maintained by the SEC at
www.sec.gov. The documents filed by Capstar with the SEC also may
be obtained free of charge at Capstar’s website at
www.capstarspac.com, or by written request to: Capstar Special
Purpose Acquisition Corp., 405 West 14th Street, Austin, TX 78701,
Attention: R. Steven Hicks, Chief Executive Officer, (512)
340-7800.
Participants in the Solicitation
Capstar and its directors and executive officers may be deemed
participants in the solicitation of proxies from Capstar’s
shareholders with respect to the proposed business combination. The
names of those directors and executive officers and a description
of their interests in Capstar is contained in Capstar’s final
prospectus dated July 6, 2020 relating to its initial public
offering and in subsequent filings with the SEC, which are
available free of charge at the SEC’s web site at www.sec.gov. To
the extent such holdings of Capstar’s securities may have changed
since that time, such changes have been or will be reflected on
Statements of Changes in Beneficial Ownership on Form 4 filed with
the SEC. Additional information regarding the interests of such
participants will be contained in the proxy statement/prospectus
for the proposed business combination when available.
Gelesis and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
shareholders of Capstar in connection with the proposed business
combination. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
business combination will be included in the proxy
statement/prospectus for the proposed business combination when
available.
Forward-Looking Statements
Certain statements, estimates, targets and projections in this
press release may constitute “forward-looking statements” within
the meaning of the federal securities laws. The words “anticipate,”
“believe,” continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “might,” “plan,” “possible,” “potential,” “predict,”
“project,” “should,” “strive,” “would” and similar expressions may
identify forward-looking statements, but the absence of these words
does not mean that statement is not forward looking.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Forward-looking statements include, but are not
limited to, the competitive environment in which Gelesis operates,
the expected future operating and financial performance and market
opportunities of Gelesis and statements regarding Gelesis’
expectations, hopes, beliefs, intentions or strategies regarding
the future. In addition, any statements that refer to projections,
forecasts, or other characterizations of future events or
circumstances, including any underlying assumptions, are
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and Gelesis and
Capstar assume no obligation and do not intend to update or revise
these forward-looking statements, whether as a result of new
information, future events, or otherwise. Gelesis and Capstar give
no assurance that any expectations set forth in this press release
will be achieved. Various factors could cause actual future
results, performance or events to differ materially from those
described herein. Some of the factors that may impact future
results and performance may include, without limitation: (i) the
size, demand and growth potential of the markets for Plenity®,
Gelesis’ other product candidates and its ability to serve those
markets; (ii) the degree of market acceptance and adoption of
Gelesis’ products; (iii) Gelesis’ ability to develop innovative
products and compete with other companies engaged in the weight
loss industry; (iv) Gelesis’ ability to complete successfully the
full commercial launch of Plenity® and its growth plans, including
new possible indications and the clinical data from ongoing and
future studies about liver and other diseases; (v) the inability of
the parties to successfully or timely consummate the proposed
business combination, including the risk that any required
regulatory approvals are not obtained, are delayed or are subject
to unanticipated conditions that could adversely affect the
combined company or the expected benefits of the business
combination or that the approval of the shareholders of Capstar is
not obtained; (vi) failure to realize the anticipated benefits of
the business combination, including as a result of a delay or
difficulty in integrating the businesses of Capstar and Gelesis;
(vii) the amount of redemption requests made by Capstar
shareholders; (viii) the ability of Capstar or the combined company
to issue equity or equity-linked securities or obtain debt
financing in connection with the proposed business combination or
in the future; (ix) the outcome of any legal proceedings that may
be instituted against Capstar, Gelesis, the combined company or
others following the announcement of the proposed business
combination and any definitive agreements with respect thereto; (x)
the ability to meet stock exchange listing standards at or
following the consummation of the proposed business combination;
(xi) the risk that the proposed business combination disrupts
current plans and operations of Gelesis as a result of the
announcement and consummation of the proposed business combination,
and as a result of the post-transaction company being a publicly
listed issuer; (xii) the regulatory pathway for Gelesis’ products
and responses from regulators, including the FDA and similar
regulators outside of the United States, (xiii) the ability of the
combined company to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain Gelesis’
management and key employees; (xiv) costs related to the proposed
business combination, including costs associated with the
post-transaction company being a publicly listed issuer; (xiv)
changes in applicable laws or regulations; (xv) the possibility
that Gelesis or the combined company may be adversely affected by
other economic, business, regulatory and/or competitive factors;
(xvi) Gelesis’ estimates of expenses and profitability; (xvii)
ongoing regulatory requirements, (xviii) any competing products or
technologies that may emerge, (xix) the volatility of the
telehealth market in general, or insufficient patient demand; (xx)
the ability of Gelesis to defend its intellectual property and
satisfy regulatory requirements; (xxi) the impact of the COVID 19
pandemic on Gelesis’ business; (xxii) the limited operating history
of Gelesis; and (xxiii) those factors discussed in Capstar’s final
prospectus dated July 6, 2020, Annual Report on Form 10-K for the
fiscal year ended December 31, 2020 and the Registration Statement
on Form S-4, in each case, under the heading “Risk Factors”, and
other documents of Capstar filed, or to be filed, with the SEC, by
Capstar. These filings address other important risks and
uncertainties that could cause actual results and events to differ
materially from those contained in the forward-looking
statements.
Non-Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
the securities of Capstar, Gelesis or the combined company, nor
shall there be any sale of any such securities in any state or
jurisdiction in which such offer, solicitation, or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211201005156/en/
Media Relations Katie
Sullivan ksullivan@gelesis.com
Investor Relations Lynne
Collier, ICR lynne.collier@icrinc.com
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