SAN
JOSE, Calif., May 17, 2024
/PRNewswire/ -- Meditrina, a key leader in women's health medical
devices, is thrilled to announce the FDA 510(k) clearance of its
Gen 2 bipolar RF hysteroscopy system. This new system features
bipolar radiofrequency technology, and a new bipolar RF device
called the Aveta Glo, representing a significant advancement in
minimally invasive gynecologic procedures.
The Aveta System 2.0 builds on the success of its
first-generation system, introduced in 2019, allowing physicians
full control of procedures from the hysteroscope handle with
integrated resection and fluid management. The system is
complimented by several pathology-optimized resection devices to
treat soft to calcified intrauterine pathologies resulting in
10-minute1 faster operating room turnover and
significantly faster resection time improving the procedural and
facility efficiency compared to existing modalities. The new
System's bipolar radiofrequency technology allows for more
controlled and efficient tissue removal with hemostasis,
potentially improving patient outcomes. Additionally, the new
bipolar RF device offers enhanced versatility, enabling physicians
to perform a wider range of diagnostic and therapeutic procedures
including the ability to address fibroids with deeper myometrial
wall penetration across any density tissue type and provide
hemostasis, when needed, expanding Meditrina's market opportunity
an additional $1.5B.
"The clearance of our Gen 2 system marks a significant milestone
for Meditrina and underscores our commitment to advancing women's
health through innovative medical technologies," said Csaba
Truckai, CEO of Meditrina. "We are dedicated to providing
healthcare professionals with the tools they need to deliver the
highest standard of care, and our new system exemplifies this
mission by offering unparalleled performance."
Meditrina remains committed to providing comprehensive training
and support for healthcare professionals to ensure the seamless
integration of the Aveta System into clinical practices. This
commitment reflects the company's dedication to empowering medical
professionals with the tools they need to deliver optimal patient
care.
In tandem with this regulatory achievement, Meditrina is also
excited to announce the completion of the last $5M tranche of the $77M series C investment led by Deerfield
Management Company, ShangBay Capital and other insiders. The
investment is combined with an additional $5
million debt financing by SLR Capital Partners. The company
is already approaching to be cash flow positive, and the additional
funds will accelerate new product introduction and expansion of the
sales force. This successful financing effort underscores strong
investor confidence in the company's vision and growth
trajectory.
"We are immensely grateful for the continued support of our
investors," said Csaba Truckai, CEO of Meditrina. "This financing
not only validates our strategic direction but also provides the
necessary resources to scale our operations and bring our
innovative solutions to a global market. We are poised for
substantial growth and are confident in our ability to achieve cash
flow positivity soon."
Meditrina will continue striving to better women's health, with
a focus on delivering cutting-edge medical devices that enhance the
quality of care for patients worldwide. Aveta System 2.0 is set to
redefine standards in the field, providing healthcare professionals
with advanced tools to improve outcomes and patient
experiences.
About Meditrina:
Founded in 2016, Meditrina, Inc. designs and develops innovative
medical devices for minimally invasive gynecology. For more
information, visit www.avetasystem.com.
1 Data on file at Meditrina inc.; survey conducted
Oct 2019-Aug 2020 of n56 OB/GYN
users and n38 Nurse users.
Contact:
Abbey Taylor
Associate VP of Marketing
abbeyt@meditrina-inc.com
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SOURCE Meditrina, Inc.