INVOcell now cleared for 5-day incubation
period
Supporting data reflects improved patient
outcomes, similar to IVF
SARASOTA, Fla., June 27,
2023 /PRNewswire/ -- INVO Bioscience, Inc. (Nasdaq:
INVO) ("INVO" or the "Company"), a commercial-stage fertility
company focused on expanding access to advanced treatment worldwide
with its INVOcell® medical device and the intravaginal culture
("IVC") procedure it enables, today announced it has received U.S.
Food and Drug Administration (FDA) 510(k) clearance to expand the
labeling on the INVOcell device and its indication for use to
provide for a 5-day incubation period. The data supporting the
expanded 5-day incubation clearance demonstrated improved patient
outcomes.
"This is a momentous day for INVO as the FDA has provided
clearance for us to expand our labeling to cover a 5-day incubation
period for INVOcell," commented Steve
Shum, CEO of INVO. "This has been a multi-year effort to
demonstrate INVOcell's ability to improve patient outcomes using a
longer incubation period, similar to conventional IVF
results. We believe our ability to now communicate the
improved success rates using INVOcell to patients and physicians
will have a positive effect on the overall confidence and adoption
of the technology going forward."
|
|
INVO
Cycles
|
|
INVO
Cycles
|
|
Conventional
IVF
|
Summary
Data
|
|
Day
5*
|
|
Day 3
|
|
Day
5*
|
|
|
(INSEM
& ICSI)
|
|
(INSEM
& ICSI)
|
|
(INSEM
& ICSI)
|
Total Cycle
Starts
|
|
321
|
|
450
|
|
Not Avail
|
Total
Transfers
|
|
240
|
|
421
|
|
685
|
Clinical Pregnancies %
/ Per cycle Start
|
|
42.7 %
|
|
32.4 %
|
|
Not Avail
|
Birth Rate % / Per
cycle Start
|
|
34.9 %
|
|
23.8 %
|
|
Not Avail
|
Clinical Pregnancies %
/ Per Transfer
|
|
57.1 %
|
|
34.7 %
|
|
51.8 %
|
Birth Rate % / Per
Transfer
|
|
46.8 %
|
|
25.4 %
|
|
44.5 %
|
*Retrospective
(real-world data) collected from four separate clinics
(2017-2019). Not all conventional IVF was collected from the
four clinics. See updated Indication for Use (IFU) for
additional details.
|
"INVOcell originally received De Novo clearance from the FDA for
a day 3 incubation period," continued Shum. "Over time, industry
trends for conventional IVF have moved more towards a day 5
incubation period which has generally improved pregnancy success
rates. INVOcell was often being used off-label for 5-day, which
similarly showed improved outcomes, and which afforded the
opportunity to use real market usage data to support our
510k submission. Today's 510(k)
clearance by the FDA for INVOcell use with 5-day incubation is
a major accomplishment and now allows us to better showcase what
INVOcell and the IVC procedure can deliver to patients in need of
an affordable fertility solution. We sincerely appreciate the
significant effort by our team and the clinics that contributed
their real-world data."
The global fertility services market is a substantial,
multi-billion-dollar industry and growing, with a significant
underserved patient population. INVO's commercial strategy remains
focused on helping to expand affordable care to the underserved
patients in need. The Company's market approach includes the
opening of dedicated "INVO Centers" offering INVOcell® and IVC
procedure (three centers in North
America now operational), the acquisition of existing
profitable IVF clinics (signed binding agreements to
acquire Wisconsin Fertility Institute), and the continued
global distribution and sale of the INVOcell technology solution
into existing fertility clinics.
"We believe the recent 510(k) clearance will help further
support our overall commercial activities," concluded Shum.
The updated Indication for Use (IFU) is available upon
request.
About INVO Bioscience and INVOcell
We are a commercial-stage fertility company dedicated to
expanding the assisted reproductive technology ("ART") marketplace
by making fertility care accessible and inclusive to people around
the world. Our primary mission is to implement new medical
technologies aimed at increasing the availability of affordable,
high-quality, patient-centered fertility care. Our flagship product
is INVOcell®, a revolutionary medical device that allows
fertilization and early embryo development to take place in
vivo within the woman's body. This treatment solution is the
world's first intravaginal culture technique for the incubation of
oocytes and sperm during fertilization and early embryo
development. This technique, designated as "IVC", provides patients
a more natural, intimate, and more affordable experience in
comparison to other ART treatments. We believe the IVC procedure
can deliver comparable results at a fraction of the cost of
traditional in vitro fertilization ("IVF") and is a
significantly more effective treatment than intrauterine
insemination ("IUI"). Our commercialization strategy is focused on
the opening of dedicated "INVO Centers" offering the INVOcell® and
IVC procedure (with three centers in North America now operational), the
acquisition of existing, profitable IVF clinics and the continued
distribution and sale of our technology solution into existing
fertility clinics. For more information, please
visit invobio.com and invocell.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.