SARASOTA, Fla., Nov. 8, 2021 /PRNewswire/ -- INVO
Bioscience, Inc. ("INVO" or the "Company") (NASDAQ: INVO),
a medical device company focused on commercializing the world's
only in vivo culture system (IVC), today announced it will regain
full U.S. commercialization rights for its patented INVOcell®
device due to Ferring International Center S.A.'s termination
for convenience of that certain Distribution Agreement dated
November 12, 2018 with INVO, which
termination will officially take effect on January 31, 2022. Over the past three years, INVO
has been executing on a multi-faceted commercialization strategy
which includes partnering to open dedicated "INVO Centers" focused
on INVOcell and the IVC procedure, and establishing agreements with
distributors in key markets. The terms of the U.S. Distribution
Agreement had limited the number of INVO Centers that we were
allowed to operate. INVO can now further support U.S.
fertility clinicians directly as the exclusive provider of
INVOcell® in pursuit of our mission to bring advanced fertility
care to the millions of people that are without access to
treatment.
"The patients are at the core of our strategy, and we believe
that our partnerships and multi-channel business approach can most
effectively deliver treatment where it is needed," said
Steve Shum, CEO of INVO. "We believe
that direct access to the U.S. market enables us to aggressively
pursue our mission to address and improve capacity constraints in
the market, and to provide quality fertility care to the patients
who need it. We have assembled a strong team of industry leaders
who are highly experienced in commercializing advanced reproductive
technologies. With the capital we have raised, we are well
positioned to leverage their expertise and our infrastructure to
accelerate adoption of INVOcell throughout all channels in the U.S.
market. In our opinion, the clinical and commercial validation of
INVOcell has grown tremendously over the past few years and we
believe this provides a solid foundation for our strategy. Direct
control of the U.S. market should now enable us to sell directly
into the existing IVF clinics, expand the number of INVO Centers
free of any limitations, and to aggressively pursue our market
expansion to increase access to care.
"We thank Ferring for their valuable partnership and
contributions toward the advancement of the INVOcell technology
over the past three years," stated Mike
Campbell, COO and VP business development of INVO. "We are
excited, and INVO is fully prepared to support and execute on the
opportunities across our expanding customer base in the
U.S."
An Update on Recent Commercialization Milestones
- Initial treatment cycles have commenced at the Company's first
U.S.-based INVO Center in Birmingham,
Alabama following its opening in August 2021.
- The second U.S.-based INVO Center opened in Atlanta, Georgia in September 2021. The practice has begun seeing
patients and will perform initial treatment cycles this week.
- The first international INVO Center opened in Monterrey, Mexico on November 1, 2021. The Monterrey INVO Center has
begun seeing patients, with the first cycles scheduled to occur
later this year.
- Signed a partnership agreement with Lyfe Medical, LLC to
establish and operate a INVO Center in the San Francisco Bay area
to offer the INVOcell.
- Completed the acquisition of a Canadian-based entity formed to
offer INVOcell in Canada.
- Development efforts for new branding, logos and website are
underway, as well as an expanded social media presence. Rollout is
expected in the coming weeks.
- International distribution and INVO Center developments
continue across all continents.
Additional information regarding the timing and transfer of the
INVOcell U.S. commercialization rights can be found in the
Company's Form 8-K filed today with the Securities and Exchange
Commission and available at www.sec.gov.
About INVO Bioscience
We are a medical device and fertility clinic development company
focused on creating simplified, affordable treatments for patients
diagnosed with infertility. Our solution, the INVO® Procedure, is a
revolutionary in-vivo method of vaginal incubation that offers
patients a more natural and intimate experience. Our lead product,
the INVOcell®, is a patented medical device used in infertility
treatment and is considered an "assisted reproductive technology."
The INVOcell® enables the first intra-vaginal culture (IVC)
procedure in the world and is used for the natural, in-vivo
incubation of eggs and sperm during fertilization and early embryo
development. The INVOcell offers an alternative to traditional
in-vitro fertilization (IVF) and intrauterine insemination (IUI).
Our mission is to increase access to care and expand fertility
treatment across the globe with a goal to lower the cost and
increase the availability of care. For more information, please
visit invobio.com.
Safe Harbor Statement
This release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
The Company invokes the protections of the Private Securities
Litigation Reform Act of 1995. All statements regarding our
expected future financial position, results of operations, cash
flows, financing plans, business strategies, products and services,
competitive positions, growth opportunities, plans and objectives
of management for future operations, as well as statements that
include words such as "anticipate," "if," "believe," "plan,"
"estimate," "expect," "intend," "may," "could," "should," "will,"
and other similar expressions are forward-looking statements. All
forward-looking statements involve risks, uncertainties, and
contingencies, many of which are beyond our control, which may
cause actual results, performance, or achievements to differ
materially from anticipated results, performance, or achievements.
Factors that may cause actual results to differ materially from
those in the forward-looking statements include those set forth in
our filings at www.sec.gov. We are under no obligation to (and
expressly disclaim any such obligation to) update or alter our
forward-looking statements, whether as a result of new information,
future events or otherwise.
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SOURCE INVO Bioscience, Inc.