Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced the appointment of Antonella Favit-Van
Pelt, M.D., Ph.D. to the position of Chief Medical Officer.
“I am very pleased to welcome Dr. Favit-Van Pelt
to Helius, who joins our team with a clinical and academic
background in Neurology, as well as 20 years of experience advising
and leading medical programs for healthcare companies – including
both large, globally-diversified corporations and smaller,
earlier-stage companies,” said Helius CEO, Dane Andreeff. “I look
forward to her future contributions as we continue our efforts to
raise awareness of PoNS technology and its therapeutic benefits
among clinicians, patients and payors in the U.S. market, while
planning to enter the next phase of our clinical and regulatory
strategy.”
“Helius is breaking new ground in the field of
neurology with its PoNS technology, which has great potential as a
non-invasive, non-drug therapy for patients suffering from a
variety of chronic and debilitating neurological conditions,” said
Dr. Favit-Van Pelt. “I am excited to join Helius on the heels of
its first U.S. regulatory clearance in multiple sclerosis and look
forward to continuing the Company’s recent market development,
clinical and regulatory progress.”
Prior to joining Helius, Dr. Favit-Van Pelt led
U.S. Medical Strategy for the Neurology program of H. Lundbeck A/S
(LUN.CO, LUN DC, HLUYY), a global pharmaceutical company that
specializes in the treatment of brain diseases, from 2018 to 2021.
In this position, she oversaw the U.S. medical and life-cycle
program activities related to therapies for movement disorders and
epilepsy.
In 2013, Dr. Favit-Van Pelt founded Synaerion
Therapeutics (“Synaerion”) and, in 2016, its affiliate Thera
Neuropharma, Inc. (“Thera”), two privately-held biotechnology
companies developing a small molecule regenerative therapy and
RNAi-based integrated technology platform for ALS and traumatic
brain injury (“TBI”). She oversaw all aspects of Synaerion’s and
Thera’s management and strategy as Chief Executive Officer,
President & Chairwoman of the Board from 2014 to 2017 and she
continues to serve as President & Chairwoman. In 2009, she
founded StratMedica, LLC, a privately-held company designed to
provide corporate clients with contract senior management support.
As Principal of StratMedica from 2009 to 2016, she directed
clinical development and medical programs for eight healthcare
companies, including Johnson & Johnson (NYSE: JNJ) and Teva
(NYSE: TEVA). Dr. Favit-Van Pelt served as Senior Director and
Global Medical Lead at Shire Pharmaceuticals (Nasdaq: SPHG) from
2007 to 2008, as Director of Medical Strategy at Bristol-Myers
Squibb (NYSE: BMY) from 2005 to 2007, and as Global Clinical
Development Lead at GE Healthcare (formerly Amersham Health) from
2001 to 2005.
Dr. Favit-Van Pelt is a Board-certified
neurologist who began clinical practice activity in 1994, with a
focus on patients with rare neuromuscular disorders. She holds a
graduate degree in Medicine and Surgery and a Ph.D. in Pharmacology
from the School of Medicine and Surgery at the University of
Catania, Italy.
As a material inducement to entering into
employment with Helius, Dr. Favit-Van Pelt, who was not
previously an employee or director of Helius, received options
to purchase 18,000 shares of the Company’s Class A common stock
under Helius’ Inducement Plan. The equity award under Helius’
Inducement Plan was approved by the Company’s independent directors
in accordance with Nasdaq Listing Rule 5635(c)(4), which also
requires a public announcement of equity awards that are not made
under a stockholder approved equity plan.
The options awards have an exercise price
of $16.45 per share, the closing price of Helius’ Class A
common stock on July 7, 2021, the date of the grant. The
options have a ten-year term and vest over a period of four years,
with 25% vesting per year on the anniversary date of grant,
provided Dr. Favit-Van Pelt’s employment is continuing on each such
date, and subject to acceleration or forfeiture upon the occurrence
of certain events as set forth in Dr. Favit-Van Pelt’s option
agreement.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on
neurological wellness. The Company’s purpose is to develop, license
and acquire unique and non-invasive platform technologies that
amplify the brain’s ability to heal itself. The Company’s first
commercial product is the Portable Neuromodulation Stimulator
(PoNS™). For more information,
visit www.heliusmedical.com.
About the PoNS™ Device and PoNS Treatment™
The Portable Neuromodulation Stimulator (PoNS™)
is an innovative non-surgical device, inclusive of a controller and
mouthpiece, which delivers electrical stimulation to the surface of
the tongue to provide treatment of gait deficit. The PoNS device is
indicated for use in the United States as a short term treatment of
gait deficit due to mild-to-moderate symptoms from multiple
sclerosis (“MS”) and is to be used as an adjunct to a supervised
therapeutic exercise program in patients 22 years of age and over
by prescription only. It is authorized for sale in Canada as a
class II, non-implantable, medical device intended as a short term
treatment (14 weeks) of gait deficit due to mild and moderate
symptoms from MS, and chronic balance deficit due to
mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used
in conjunction with physical therapy. PoNS is an investigational
medical device in the European Union (“EU”) and Australia (“AUS”).
It is currently under premarket review by the AUS Therapeutic Goods
Administration.
Cautionary Disclaimer Statement:
Certain statements in this news release are not based on
historical facts and constitute forward-looking statements or
forward-looking information within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and Canadian securities
laws. All statements other than statements of historical fact
included in this news release are forward-looking statements that
involve risks and uncertainties. Forward-looking statements are
often identified by terms such as “believe,” “continue,” “looking
ahead,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope”
and similar expressions. Such forward-looking statements include,
among others, statements regarding the Company’s future strategic
and operational execution, the next phase of the Company’s market
development activities, the Company’s ability to spread awareness
of of PoNS technology, clinical and regulatory development plans
for the PoNS device, and the timing and success of the Company’s
commercialization efforts in the United States.
These statements involve substantial known and unknown risks and
uncertainties. There can be no assurance that such statements will
prove to be accurate and actual results and future events could
differ materially from those expressed or implied by such
statements. Important factors that could cause actual results to
differ materially from the Company’s expectations include
uncertainties regarding the Company’s capital requirements to
achieve its business objectives, the impact of the COVID-19
pandemic, the Company’s ability to train physical therapists in the
supervision of the use of the PoNS Treatment, the Company’s ability
to secure contracts with rehabilitation clinics, the Company’s
ability to obtain national Medicare coverage and to obtain a
reimbursement code so that the PoNS device is covered by Medicare
and Medicaid, the Company’s ability to build internal commercial
infrastructure, market awareness of the PoNS device, future
clinical trials and the clinical development process, manufacturing
and supply chain risks, potential changes to the MCIT program, the
product development process and FDA regulatory submission review
and approval process, other development activities, ongoing
government regulation, and other risks detailed from time to time
in the “Risk Factors” sections of the Company’s Annual Report on
Form 10-K for the year ended December 31, 2020, its Quarterly
Report on Form 10-Q for the quarter ended March 31, 2021 and its
other filings with the United States Securities and Exchange
Commission and the Canadian securities regulators, which can be
obtained from either at www.sec.gov or www.sedar.com.The reader is
cautioned not to place undue reliance on any forward-looking
statement. The forward-looking statements contained in this news
release are made as of the date of this news release and the
Company assumes no obligation to update any forward-looking
statement or to update the reasons why actual results could differ
from such statements except to the extent required by law.
The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this
news release.
Investor Relations Contact:
Westwicke on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com
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