Fractyl Health Expands Leadership with Appointment of Adrian Kimber as Chief Commercial Officer to Spearhead Anticipated Launch Preparation as the Company Conducts Two Pivotal Studies for Revita in Obesity and Type 2 Diabetes
02 Abril 2024 - 9:00AM
Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic
therapeutics company focused on pioneering new approaches for the
treatment of obesity and type 2 diabetes (T2D), today announced the
appointment of Adrian Kimber as Chief Commercial Officer.
Mr. Kimber joins Fractyl with over two decades of experience in
the biotechnology and medical devices sectors. Throughout his
career, he has showcased a commendable history of introducing
groundbreaking therapies to worldwide markets. Renowned for his
adeptness in formulating go-to-market strategies, assembling and
leading commercial teams, and implementing operational excellence,
he has left a profound mark on the healthcare landscape.
“We are delighted to welcome Adrian to Fractyl, where his
breadth of commercial and strategic leadership experience will be
instrumental as we prepare for the launch of our Revita® system,”
said Dr. Harith Rajagopalan, CEO of Fractyl Health. “We believe
Revita has the potential to deliver sustained, durable benefit to
patients struggling with obesity and Type 2 diabetes and the
resulting health complications, and Adrian’s proven track record in
bringing transformational products to market will be critical to
help Revita achieve this goal.”
“I am excited to join the Fractyl team and for the opportunity
to work alongside leaders in the space with a shared mission to
transform the treatment of metabolic diseases and hopefully provide
a cure for obesity and Type 2 Diabetes (T2D),” said Mr. Kimber. “We
have several key Revita milestones approaching ahead of a potential
launch, and I look forward to leading our commercial strategy
during this pivotal time.”
Mr. Kimber most recently served as Global VP & Commercial
Head at Biotronik Neuro, where he spearheaded the introduction of
daily remote monitoring and Proactive Care for patients with spinal
cord stimulation devices. Under his guidance, the product journeyed
from inception to successful commercialization in the United
States. Adrian held progressively senior commercial roles at
prominent companies such as Biotronik, Abbott, Olympus, and
Medtronic, spanning across regions including the United Kingdom,
Australia, and the United States. Mr. Kimber holds a B.Sc. in
Sports Science from London Metropolitan University.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on
pioneering new approaches to the treatment of metabolic diseases,
including obesity and T2D. Despite advances in treatment over the
last 50 years, obesity and T2D 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 Burlington, MA. For more information,
visit www.fractyl.com or https://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 for the
treatment of T2D. 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. A pivotal study of Revita in
patients with obesity after discontinuation of GLP-1 based drugs,
called Remain-1, is anticipated to initiate in H2 2024.
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 obesity and
T2D. 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 potential of Revita to deliver sustained, durable
benefit to patients struggling with obesity and Type 2 diabetes;
and our strategic and product development objectives, goals, and
missions, including with respect to transforming the treatment of
metabolic diseases and providing a cure for obesity and T2D. 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
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;
additional time may be required to develop and obtain regulatory
approval or certification for the Company’s Rejuva gene therapy
candidates; 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 the materials for its Rejuva gene therapy platform
for preclinical studies and its ongoing clinical studies; changes
in methods of the Company’s Rejuva gene therapy candidate
manufacturing or formulation; any contamination or interruption in
the Company’s Rejuva gene therapy candidates’ manufacturing
process, shortages of raw materials or failure of the Company’s
suppliers of plasmids and viruses to deliver necessary components
could result in delays in the Company’s Rejuva gene therapy
candidates’ preclinical and clinical development or marketing
schedules; and the regulatory approval process of the FDA,
comparable foreign regulatory authorities and notified bodies, are
lengthy, time-consuming and inherently unpredictable, and even if
we complete the necessary clinical studies, we cannot predict when,
or if, we will obtain regulatory approval or certification for any
of our product candidates, and any such regulatory approval or
certification may be for a more narrow indication than we seek; and
the potential launch or commercialization of any of product
candidates or products and our strategic and product development
objectives and goals, and the other factors discussed under the
caption “Risk Factors” in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission (the “SEC”) on April 1,
2024, and in our other filings with the SEC. These forward-looking
statements are based on management’s current estimates and
expectations. 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 Contact Stephen Jasper Gilmartin Group
stephen@gilmartinir.com, 619.949.3681
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