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Gelesis’ FDA-Cleared Weight Management Approach, Plenity®, Now Broadly Available

Leading Nutrition Authority Joy Bauer, MS, RDN, CDN, Joins as Chief Nutrition Officer to Focus on Educating Healthcare Professionals & Offering Nutrition Counseling to Plenity Members

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Gelesis, a consumer-focused biotherapeutics company, announced 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.

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:

o For all medications that should be taken with food, take them after starting a meal.
o 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.

 

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