BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Firm”), a clinical-stage biotherapeutics firm, famous as we speak that its Based Entity, Gelesis, Inc. (“Gelesis”) introduced that Plenity®, an FDA cleared weight administration strategy, is now broadly accessible throughout the USA to adults who meet the prescription standards. Gelesis additionally introduced the appointment of main well being and vitamin authority Pleasure Bauer, MS, RDN, CDN, as Chief Diet Officer. On this new function, Bauer will provide vitamin counseling and training for Plenity members and have interaction with and educate healthcare professionals concerning the product.
Bauer is among the nation’s main well being and vitamin authorities. She is a beloved media character and a #1 New York Instances bestselling creator with 14 bestsellers to her credit score. Within the earlier a part of her profession, Bauer was the Director of Diet and Health for the Division of Pediatric Cardiology at Mount Sinai Medical Heart in New York Metropolis, in addition to the scientific dietitian for his or her neurosurgical group.
She has labored intently with Plenity since spring 2021 on healthcare supplier assist, establishing consciousness and educating registered dietitian nutritionists (RDNs) on the protection profile and scientific proof for Plenity. As a part of her expanded function with the corporate, she is going to proceed to construct training and advocacy to assist RDNs in recommending Plenity to their sufferers by means of skilled academic content material, key occasions, and outreach to members of the Academy of Diet and Dietetics and different licensed vitamin professionals.
Plenity is on the market by prescription through a stigma-free telehealth session with a doctor skilled in weight administration assist, with free, limitless follow-up visits as wanted. The pandemic continues to show out the significance of handy entry to healthcare, and the Plenity expertise—together with each the digital mannequin and the sturdy efficacy to security profile—is constructed to handle that. A Plenity subscription prices $98 for a four-week provide ($1.75 per meal) and, if prescribed, the product arrives in two enterprise days.
The complete textual content of the announcement from Gelesis is as follows:
Gelesis’ FDA-Cleared Weight Administration Method, Plenity®, Now Broadly Accessible and Main Diet Authority Pleasure Bauer, MS, RDN, CDN, Joins as Chief Diet Officer
Plenity® is reworking weight administration with a clinically confirmed strategy produced from naturally derived constructing blocks
As Chief Diet Officer, Bauer will concentrate on educating healthcare professionals and providing vitamin counseling to Plenity members
BOSTON, December 1, 2021 – Gelesis, a consumer-focused biotherapeutics firm, is proud to announce Plenity®, an FDA cleared weight administration strategy, is now broadly accessible throughout the USA to adults who meet the prescription standards. The corporate can also be happy to announce the appointment of main well being and vitamin authority Pleasure Bauer, MS, RDN, CDN, as Chief Diet Officer. On this new function, Bauer will provide vitamin counseling and training for Plenity members and have interaction with and educate healthcare professionals concerning the product.
For adults who want to reduce weight, there may be typically quite a bit standing in the best way, like weight bias, fad diets, false guarantees, and the very actual feeling of starvation. Plenity challenges the notion that individuals ought to stay life feeling disadvantaged and combines an FDA-cleared prescription product with a supporting member expertise. Plenity shouldn’t be a food plan, a magic tablet, or a drug; it’s a clinically confirmed weight administration remedy that goals to assist adults on their journey.
Plenity is designed to assist individuals really feel glad with smaller parts to allow them to eat much less and reduce weight. It’s FDA-cleared to help in weight administration in adults with extra weight or weight problems, as outlined by a Physique Mass Index (BMI) of 25 to 40 kg/m², when used together with food plan and train. It’s taken orally as three capsules with 16 oz. of water twice a day, 20 minutes earlier than lunch and dinner. If a dose is missed, it may be taken with the meal or instantly following the meal. Plenity shouldn’t be a drug; it’s non-systemic and never behavior forming. Plenity as an alternative makes use of a novel biomimetic strategy impressed by the composition and mechanical properties of greens that makes adults really feel fuller sooner with smaller parts. In scientific trials, the protection profile was much like placebo.
“Nobody ought to really feel disadvantaged of having fun with the meals they love. We now have the chance to share a weight administration assist that may assist enhance an individual’s probabilities at success, and that’s extraordinary,” says Bauer. “Plenity is completely totally different from every other weight reduction device: it’s easy, the know-how is spectacular, and it’s impressed by greens. Most significantly, the entire expertise is centered round enabling individuals to make sensible life-style decisions whereas persevering with to benefit from the meals they love. These two components are important for long-term weight administration success – I’ve seen it firsthand all through my profession in scientific, neighborhood and personal apply.”
Bauer is among the nation’s main well being and vitamin authorities. She is a beloved media character and a #1 New York Instances bestselling creator with 14 bestsellers to her credit score. Within the earlier a part of her profession, Bauer was the Director of Diet and Health for the Division of Pediatric Cardiology at Mount Sinai Medical Heart in New York Metropolis, in addition to the scientific dietitian for his or her neurosurgical group.
She has labored intently with Plenity since spring 2021 on healthcare supplier assist, establishing consciousness and educating registered dietitian nutritionists (RDNs) on the protection profile and scientific proof for Plenity. As a part of her expanded function with the corporate, she is going to proceed to construct training and advocacy to assist RDNs in recommending Plenity to their sufferers by means of skilled academic content material, key occasions, and outreach to members of the Academy of Diet and Dietetics and different licensed vitamin professionals.
Plenity is on the market by prescription through a stigma-free telehealth session with a doctor skilled in weight administration assist, with free, limitless follow-up visits as wanted. The pandemic continues to show out the significance of handy entry to healthcare, and the Plenity expertise—together with each the digital mannequin and the sturdy efficacy to security profile—is constructed to handle that. Go to MyPlenity.com to start out a web based session or speak to 1’s personal physician about whether or not Plenity is best for you. A Plenity subscription prices $98 for a four-week provide ($1.75 per meal) and, if prescribed, the product arrives in two enterprise days.
As a part of a Plenity prescription, members can entry a curated member expertise centered on lots of the obstacles that stand in the best way of sustainable weight administration. This contains evidence-based info from medical specialists, personalised content material, and a non-public on-line member neighborhood. Plenity members may also faucet right into a community of companions for behavioral assist. With this partnership, Bauer will create devoted content material for members, similar to vitamin training, stay digital occasions, recipes, and thought items on rethinking weight administration. A gaggle of Plenity members may even have the ability to entry one-on-one teaching in addition to occasions to reinforce their weight administration journey with Plenity.
“Pleasure understands that the load loss journey is deeply private, and all through her profession she’s helped numerous individuals attain their particular person targets. We share the identical core beliefs that it’s best to have the ability to get pleasure from meals you like with individuals you like, and that you shouldn’t have to decide on between loving your self and wanting to alter your self,” says Elaine Chiquette, Pharm.D., Chief Scientific Officer at Gelesis. “We’re honored to welcome Pleasure to this expanded function and to have the ability to provide our members entry to Pleasure’s information and experience.”
Gelesis and Capstar Particular Goal Acquisition Corp. (NYSE: CPSR) introduced in July that they entered right into a definitive enterprise mixture settlement. Upon completion of the transaction, the mixed firm’s securities are anticipated to be traded on the New York Inventory Trade beneath the image “GLS.” Gelesis will use the proceeds of the transaction to assist future broad client activation round Plenity.
Essential Security Details about Plenity
- Sufferers who’re pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide mustn’t take Plenity.
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To keep away from impression on the absorption of medicines:
- For all medicines that ought to be taken with meals, take them after beginning a meal.
- For all medicines that ought to be taken with out meals (on an empty abdomen), proceed taking up an empty abdomen or as beneficial by your doctor.
- The general incidence of uncomfortable side effects with Plenity was no totally different than placebo. The most typical uncomfortable side effects had been diarrhea, distended stomach, rare bowel actions, and flatulence.
- Contact a physician instantly if issues happen. When you’ve got a extreme allergic response, extreme abdomen ache, or extreme diarrhea, cease utilizing Plenity till you’ll be able to communicate to your physician.
Rx Solely. For the secure and correct use of Plenity or extra info, speak to a healthcare skilled, learn the Patient Instructions for Use, or name 1-844-PLENITY.
About Gelesis
Gelesis is a consumer-centered biotherapeutics firm advancing a novel class of therapies for weight administration and intestine associated continual ailments. Our non-systemic superabsorbent hydrogels are the primary and solely made completely from naturally derived constructing blocks, and they’re impressed by the composition (i.e., water & cellulose) and mechanical properties (e.g., elasticity or firmness) of uncooked greens. They’re conveniently administered in capsules to create a a lot bigger quantity of small, non-aggregating hydrogel items that turn out to be an built-in a part of the meals, and act domestically within the digestive system. Our portfolio contains Plenity®, an FDA-cleared product to help in weight administration, in addition to potential therapies in growth for sufferers with Sort 2 Diabetes, Non-alcoholic Fatty Liver Illness (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Practical Constipation. For extra info, go to gelesis.com, or join with us on Twitter @GelesisInc.
Further Data and The place to Discover It
In July 2021, Gelesis entered right into a enterprise mixture settlement with Capstar Particular Goal Acquisition Corp. (NYSE: CPSR) (“Capstar”), a particular function acquisition firm, as amended in November 2021.
Capstar has filed a Registration Assertion on Kind S-4 with the SEC, which features a proxy assertion/prospectus, that can be each the proxy assertion to be distributed to Capstar shareholders in reference to its solicitation of proxies for the vote by Capstar shareholders with respect to the proposed enterprise mixture and different issues as could also be described within the Registration Assertion, in addition to the prospectus regarding the issuance of sure securities to be issued within the proposed enterprise mixture. After the Registration Assertion is said efficient, the proxy assertion/prospectus and different related paperwork can be despatched to Capstar and Gelesis shareholders. Capstar additionally will file different paperwork concerning the proposed transaction with the SEC. This press launch doesn’t comprise all the data that ought to be thought of regarding the proposed enterprise mixture and isn’t supposed to type the premise of any funding determination or every other determination in respect of the proposed enterprise mixture. Earlier than making any voting determination, Capstar’s shareholders and different individuals are suggested to learn, when accessible, the preliminary proxy assertion/prospectus included within the Registration Assertion, the amendments thereto and the definitive proxy assertion/prospectus and all different related paperwork filed or that can be filed with the SEC in reference to the proposed transaction as they turn out to be accessible as a result of they may comprise necessary details about Gelesis, Capstar and the proposed transaction.
When accessible, the definitive proxy assertion/prospectus and different related supplies for the proposed enterprise mixture can be mailed to shareholders of Capstar as of a document date to be established for voting on the proposed enterprise mixture. Buyers and safety holders may even have the ability to get hold of free copies of the Registration Assertion, the proxy assertion/prospectus and all different related paperwork filed or that can be filed with the SEC by Capstar, with out cost, as soon as accessible, by means of the web site maintained by the SEC at www.sec.gov. The paperwork filed by Capstar with the SEC additionally could also be obtained freed from cost at Capstar’s web site at www.capstarspac.com, or by written request to: Capstar Particular Goal Acquisition Corp., 405 West 14th Road, Austin, TX 78701, Consideration: R. Steven Hicks, Chief Government Officer, (512) 340-7800.
Members within the Solicitation
Capstar and its administrators and govt officers could also be deemed members within the solicitation of proxies from Capstar’s shareholders with respect to the proposed enterprise mixture. The names of these administrators and govt officers and an outline of their pursuits in Capstar is contained in Capstar’s closing prospectus dated July 6, 2020 regarding its preliminary public providing and in subsequent filings with the SEC, which can be found freed from cost on the SEC’s website at www.sec.gov. To the extent such holdings of Capstar’s securities might have modified since that point, such modifications have been or can be mirrored on Statements of Modifications in Helpful Possession on Kind 4 filed with the SEC. Further info concerning the pursuits of such members can be contained within the proxy assertion/prospectus for the proposed enterprise mixture when accessible.
Gelesis and its administrators and govt officers can also be deemed to be members within the solicitation of proxies from the shareholders of Capstar in reference to the proposed enterprise mixture. A listing of the names of such administrators and govt officers and knowledge concerning their pursuits within the proposed enterprise mixture can be included within the proxy assertion/prospectus for the proposed enterprise mixture when accessible.
Ahead-Trying Statements
Sure statements, estimates, targets and projections on this press launch might represent “forward-looking statements” throughout the which means of the federal securities legal guidelines. The phrases “anticipate,” “consider,” proceed,” “may,” “estimate,” “anticipate,” “intend,” “might,” “may,” “plan,” “doable,” “potential,” “predict,” “venture,” “ought to,” “try,” “would” and related expressions might determine forward-looking statements, however the absence of those phrases doesn’t imply that assertion shouldn’t be ahead trying. Ahead-looking statements are predictions, projections and different statements about future occasions which are based mostly on present expectations and assumptions and, in consequence, are topic to dangers and uncertainties. Ahead-looking statements embrace, however usually are not restricted to, the aggressive setting during which Gelesis operates, the anticipated future working and monetary efficiency and market alternatives of Gelesis and statements concerning Gelesis’ expectations, hopes, beliefs, intentions or methods concerning the long run. As well as, any statements that consult with projections, forecasts, or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking statements. Ahead-looking statements communicate solely as of the date they’re made. Readers are cautioned to not put undue reliance on forward-looking statements, and Gelesis and Capstar assume no obligation and don’t intend to replace or revise these forward-looking statements, whether or not because of new info, future occasions, or in any other case. Gelesis and Capstar give no assurance that any expectations set forth on this press launch can be achieved. Numerous components may trigger precise future outcomes, efficiency or occasions to vary materially from these described herein. Among the components that will impression future outcomes and efficiency might embrace, with out limitation: (i) the dimensions, demand and development potential of the markets for Plenity®, Gelesis’ different product candidates and its skill to serve these markets; (ii) the diploma of market acceptance and adoption of Gelesis’ merchandise; (iii) Gelesis’ skill to develop progressive merchandise and compete with different firms engaged within the weight reduction business; (iv) Gelesis’ skill to finish efficiently the total industrial launch of Plenity® and its development plans, together with new doable indications and the scientific knowledge from ongoing and future research about liver and different ailments; (v) the lack of the events to efficiently or well timed consummate the proposed enterprise mixture, together with the chance that any required regulatory approvals usually are not obtained, are delayed or are topic to unanticipated situations that would adversely have an effect on the mixed firm or the anticipated advantages of the enterprise mixture or that the approval of the shareholders of Capstar shouldn’t be obtained; (vi) failure to understand the anticipated advantages of the enterprise mixture, together with because of a delay or issue in integrating the companies of Capstar and Gelesis; (vii) the quantity of redemption requests made by Capstar shareholders; (viii) the power of Capstar or the mixed firm to concern fairness or equity-linked securities or get hold of debt financing in reference to the proposed enterprise mixture or sooner or later; (ix) the end result of any authorized proceedings which may be instituted in opposition to Capstar, Gelesis, the mixed firm or others following the announcement of the proposed enterprise mixture and any definitive agreements with respect thereto; (x) the power to fulfill inventory alternate itemizing requirements at or following the consummation of the proposed enterprise mixture; (xi) the chance that the proposed enterprise mixture disrupts present plans and operations of Gelesis because of the announcement and consummation of the proposed enterprise mixture, and because of the post-transaction firm being a publicly listed issuer; (xii) the regulatory pathway for Gelesis’ merchandise and responses from regulators, together with the FDA and related regulators outdoors of the USA, (xiii) the power of the mixed firm to develop and handle development profitably, preserve relationships with prospects and suppliers and retain Gelesis’ administration and key workers; (xiv) prices associated to the proposed enterprise mixture, together with prices related to the post-transaction firm being a publicly listed issuer; (xiv) modifications in relevant legal guidelines or rules; (xv) the chance that Gelesis or the mixed firm could also be adversely affected by different financial, enterprise, regulatory and/or aggressive components; (xvi) Gelesis’ estimates of bills and profitability; (xvii) ongoing regulatory necessities, (xviii) any competing merchandise or applied sciences that will emerge, (xix) the volatility of the telehealth market usually, or inadequate affected person demand; (xx) the power of Gelesis to defend its mental property and fulfill regulatory necessities; (xxi) the impression of the COVID 19 pandemic on Gelesis’ enterprise; (xxii) the restricted working historical past of Gelesis; and (xxiii) these components mentioned in Capstar’s closing prospectus dated July 6, 2020, Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2020 and the Registration Assertion on Kind S-4, in every case, beneath the heading “Danger Elements”, and different paperwork of Capstar filed, or to be filed, with the SEC, by Capstar. These filings handle different necessary dangers and uncertainties that would trigger precise outcomes and occasions to vary materially from these contained within the forward-looking statements.
Non-Solicitation
This press launch shouldn’t be a proxy assertion or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed enterprise mixture and shall not represent a suggestion to promote or a solicitation of a suggestion to purchase the securities of Capstar, Gelesis or the mixed firm, nor shall there be any sale of any such securities in any state or jurisdiction during which such provide, solicitation, or sale can be illegal previous to registration or qualification beneath the securities legal guidelines of such state or jurisdiction. No provide of securities shall be made besides via a prospectus assembly the necessities of the Securities Act of 1933, as amended.
About PureTech Well being
PureTech is a clinical-stage biotherapeutics firm devoted to discovering, creating and commercializing extremely differentiated medicines for devastating ailments, together with inflammatory, fibrotic and immunological situations, intractable cancers, lymphatic and gastrointestinal ailments and neurological and neuropsychological issues, amongst others. The Firm has created a broad and deep pipeline by means of the experience of its skilled analysis and growth group and its intensive community of scientists, clinicians and business leaders. This pipeline, which is being superior each internally and thru PureTech’s Based Entities, is comprised of 25 therapeutics and therapeutic candidates, together with two which have acquired each U.S. FDA clearance and European advertising authorization, as of the date of PureTech’s most not too long ago filed Half Yr Report and corresponding Kind 6-Ok. All the underlying packages and platforms that resulted on this pipeline of therapeutic candidates had been initially recognized or found after which superior by the PureTech group by means of key validation factors based mostly on the Firm’s distinctive insights into the biology of the mind, immune and intestine, or BIG, programs and the interface between these programs, known as the BIG Axis.
For extra info, go to www.puretechhealth.com or join with us on Twitter @puretechh.
Cautionary Observe Relating to Ahead-Trying Statements
This press launch comprises forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995. All statements contained on this press launch that don’t relate to issues of historic truth ought to be thought of forward-looking statements, together with with out limitation statements that relate to the aggressive setting during which Gelesis operates, the anticipated future working and monetary efficiency and market alternatives of Gelesis, Dr. Bauer’s function with Gelesis, training and advocacy packages associated to Plenity and related Gelesis methods, Plenity subscription prices, the enterprise mixture settlement between Gelesis and Capstar Particular Goal Acquisition Corp. (NYSE: CPSR) or issues associated thereto, and Gelesis’ future prospects, growth plans, and techniques. The forward-looking statements are based mostly on present expectations and are topic to recognized and unknown dangers, uncertainties and different necessary components that would trigger precise outcomes, efficiency and achievements to vary materially from present expectations, together with, however not restricted to, these dangers, uncertainties and different necessary components described beneath the caption “Danger Elements” in our Annual Report on Kind 20-F for the 12 months ended December 31, 2020 filed with the SEC and in our different regulatory filings. These forward-looking statements are based mostly on assumptions concerning the current and future enterprise methods of the Firm and the setting during which it would function sooner or later. Every forward-looking assertion speaks solely as on the date of this press launch. Besides as required by regulation and regulatory necessities, we disclaim any obligation to replace or revise these forward-looking statements, whether or not because of new info, future occasions or in any other case.
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