Fractyl Health Appoints Samuel Conaway to Its Board of Directors, Bolstering New Product Commercial Expertise During Revita® Pivotal Clinical Trials
20 Fevereiro 2024 - 10:38AM
Fractyl Health, Inc. (Nasdaq: GUTS) (“Fractyl Health” or the
“Company”), a metabolic therapeutics company focused on pioneering
new approaches for the treatment of Type 2 Diabetes (T2D) and
obesity, today announced the appointment of Samuel Conaway to its
Board of Directors. Mr. Conaway's extensive background in the
commercialization of medical technologies and leadership in new
product launches will provide valuable insight and experience as
Fractyl Health advances through pivotal clinical studies for T2D
and weight loss maintenance and continues its ongoing pilot launch
and real-world registry study of Revita in Germany.
"Sam Conaway's proven track record in the
successful launch of novel products and therapeutic procedures is a
critical addition to our Board of Directors at this juncture," said
Dr. Harith Rajagopalan, Co-Founder and CEO of Fractyl Health. "As
we progress with our pivotal trials and look towards the future,
Sam's strategic vision and commercial acumen will be invaluable,
and his appointment underscores our commitment to developing and
commercializing new treatment options for people with T2D and
obesity."
Mr. Conaway currently serves as President of U.S.
Sales in the Cardiology Group at Boston Scientific Corporation and
as Chairman of Close the Gap, the Boston Scientific Health Equity
initiative. His leadership roles have cemented his reputation as a
driving force in the medical device sector.
"I am deeply honored and excited to join the Board
of Directors at Fractyl Health, a company at the cutting edge of
addressing some of the most pressing healthcare challenges of our
time," said Mr. Conaway. "Fractyl Health's novel approach has the
potential to significantly impact patient lives, and I look forward
to contributing my experience to support Revita through its
clinical milestones and as the company seeks approval for this
innovative technology."
Mr. Conaway's expertise is expected to play a key
role in Fractyl Health's ongoing efforts to complete its pivotal
clinical studies in T2D and weight loss maintenance.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company
focused on pioneering new approaches to the treatment of metabolic
diseases, including T2D and obesity. Despite advances in treatment
over the last 50 years, T2D and obesity continue to be rapidly
growing drivers of morbidity and mortality in the 21st century.
Fractyl Health’s goal is to transform metabolic disease treatment
from chronic symptomatic management to durable disease-modifying
therapies that target the organ-level root causes of disease.
Fractyl Health is based in Lexington, MA. For more information,
visit www.fractyl.com or www.twitter.com/FractylHealth.
About Revita
Fractyl Health’s lead product candidate, Revita,
is based on the company’s insights surrounding the potential role
of the gut in obesity and T2D. Revita is designed to remodel the
duodenal lining via hydrothermal ablation (i.e., duodenal mucosal
resurfacing) to edit abnormal intestinal nutrient sensing and
signaling mechanisms that are a potential root cause of metabolic
disease. Revita has received a CE mark in Europe and, in January
2022, received reimbursement authorization through NUB in Germany.
In the United States, Revita is for investigational use only under
US law. A pivotal study of Revita in patients with inadequately
controlled T2D despite multiple medicines and insulin, called
Revitalize-1, is currently enrolling in the United States and
Europe.
About Rejuva Fractyl Health’s
Rejuva® platform focuses on developing
next-generation adeno-associated virus (AAV)-based, locally
delivered gene therapies for the treatment of T2D and obesity. The
Rejuva platform is in preclinical development and has not yet been
evaluated by regulatory agencies for investigational or commercial
use. Rejuva leverages advanced delivery systems and proprietary
screening methods to identify and develop metabolically active gene
therapy candidates targeting the pancreas. The program aims to
transform the management of metabolic diseases by offering novel,
disease-modifying therapies that address the underlying root causes
of disease.
Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including without limitation statements regarding the
Fractyl Health's ongoing efforts to complete its pivotal clinical
studies in T2D and weight loss maintenance, Fractyl Health’s
expectations regarding its lead product candidate, Revita, the
status of its studies of Revitalize-1, and Mr. Conaway’s expected
impact on the Company. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause the Company’s actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: the Company’s limited operating history;
the incurrence of significant net losses and the fact that the
Company expects to continue to incur significant net losses for the
foreseeable future; the Company’s need for substantial additional
financing; the Company’s ability to continue as a going concern;
the restrictive and financial covenants in the Company’s credit
agreement; the lengthy and unpredictable regulatory approval
process for the Company’s product candidates; uncertainty regarding
its clinical studies; the fact that the Company’s product
candidates may cause serious adverse events or undesirable side
effects or have other properties that may cause it to suspend or
discontinue clinical studies, delay or prevent regulatory
development, prevent their regulatory approval, limit the
commercial profile, or result in significant negative consequences;
the fact that there can be no guarantee that Revita’s Breakthrough
Device designation will benefit the development and regulatory
approval process; additional time may be required to develop and
obtain regulatory approval or certification for the Company’s
Rejuva gene therapy candidates; the Company’s dependence on the
success of its lead product candidate, Revita; the Company’s
reliance on third parties to conduct certain aspects of the
Company’s preclinical studies and clinical studies; the Company’s
reliance on third parties for the manufacture of
sub-assembly components for Revita and for the materials for
its Rejuva gene therapy platform for preclinical studies and its
ongoing clinical studies; the Company’s dependence on third-party
sole-source suppliers for certain sub-assembly components
of Revita; and changes in methods of the Company’s Rejuva gene
therapy candidate manufacturing or formulation. These and other
important factors discussed under the caption "Risk Factors" in the
Company’s prospectus filed with the Securities and Exchange
Commission (the “SEC”) on February 2, 2024, and its other filings
with the SEC, could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management's estimates as of the date of this press release. While
the Company may elect to update such forward-looking statements at
some point in the future, the Company disclaims any obligation to
do so, even if subsequent events cause its views to change.
Contacts
Corporate Contact Lisa Davidson, Chief Financial
Officer ir@fractyl.com, 781.902.8800
Media Contact Beth Brett, Corporate Communications
Bbrett@fractyl.com, 720.656.6544
Investor ContactStephen JasperGilmartin
Groupstephen@gilmartinir.com, 619.949.3681
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