PR96983

VILLANOVA, Italy , July 13, 2022 /PRNewswire=KYODO JBN/ --

Limacorporate S.p.A., a global orthopedic company focused on digital innovation

and patient-tailored hardware, and Orthofix Medical Inc, a global medical

device company with a spine and orthopedics focus, today announced a licensing

partnership for the U.S. market to provide a novel solution for patients with

the challenging condition of chronic high dislocation of the hip.

The partnership combines the unique limb-lengthening technology of Orthofix's

patented Fitbone(TM) intramedullary nail system with LimaCorporate's

proprietary, patient specific, 3D-printed pelvic fixation device. Once

surgically implanted, the devices work together with the aim of allowing

surgeons to distract the femur to an anatomically-correct position thereby

correcting the leg-length discrepancy, reducing strain on the spine, and

allowing for a total hip replacement to follow.

"We are excited to partner with LimaCorporate to bring together our

complementary technologies to satisfy the previously unmet needs of patients

requiring a personalized and unique complex hip replacement solution," said

Kimberley Elting, President of Orthofix Orthopedics. "This solution will be the

only offering in the U.S. for certain patients with hip dysplasia or

abnormalities of the hip leading to leg-length discrepancy, and reflects the

strength and versatility of the Fitbone platform."

"This new solution to treat chronic high hip dislocation is not currently

cleared by the U.S. Food and Drug Administration (FDA) and is only available

through an FDA Compassionate Use Exemption," added Elting.

Emmanuel Bonhomme, LimaCorporate CEO, stated, "This partnership is an important

opportunity for us to explore new segments and support even more U.S. surgeons

and their patients. Additionally, the collaboration with the ProMade Point of

Care Center (PoC Center), which opened last year, will bring added value in

terms of experience and knowledge combined with our market-leading technologies

in custom prosthesis."

LimaCorporate's ProMade 3D-printed custom service, which incorporates design

and manufacturing in its unique PoC Center, is located at the main campus of

Hospital for Special Surgery (HSS) in New York City.

"This new treatment method has shown compelling results demonstrating improved

patient outcomes in this challenging cohort, and I am pleased to see this

procedure now being made available to surgeons in the U.S.," said Professor

Rainer Baumgart, M.D., the surgeon-inventor of the Fitbone limb-lengthening

system.

About the Fitbone Intramedullary Lengthening System

The Fitbone system consists of the implanted intramedullary nail, a

subcutaneously implanted receiver, and an external control set that enables the

patient or their caregiver to manage the distraction phase at home. The system

is designed to provide accurate and controlled limb lengthening, with more than

3,500 cases performed in 15 countries since its development. With appropriate

preoperative planning, it allows achievement of axial and torsional bone

alignment intraoperatively, as part of the limb-lengthening procedure.

The Fitbone intramedullary lengthening system is available through a U.S. Food

and Drug Administration 510(k) clearance and in European Countries under the CE

Mark approval.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and

orthopedics focus. The Company's mission is to deliver innovative,

quality-driven solutions while partnering with health care professionals to

improve patient mobility. Headquartered in Lewisville, Texas, Orthofix's spine

and orthopedics products are distributed in more than 60 countries via the

Company's sales representatives and distributors. For more information, please

visit www.Orthofix.com　

About LimaCorporate

LimaCorporate is a global orthopedic company, focused on digital innovation and

tailored hardware, which advances patient centred care. Its pioneering

technological solutions are developed to empower surgeons, and to improve

patient outcomes from joint replacement surgery. Its primary focus is on

providing reconstructive and custom-made orthopedic solutions to surgeons,

enabling them to improve the quality of life of patients by restoring the joy

of movement.

Headquartered in Italy, the company operates directly in over 20 countries

around the world. LimaCorporate offers products ranging from large joint

revision and primary implants, to complete extremities solutions, including

fixation.

For additional information on the Company, please visit www.limacorporate.com　

Limacorporate spa

Via Nazionale, 52

33038 Villanova di San Daniele

Udine – Italy

t: +39 0432 945511

e.: info@limacorporate.com

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of

Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A

of the Securities Act of 1933, as amended, relating to our business and

financial outlook, which are based on our current beliefs, assumptions,

expectations, estimates, forecasts and projections. In some cases, you can

identify forward-looking statements by terminology such as "may," "will,"

"should," "expects," "plans," "anticipates," "believes," "estimates,"

"projects," "intends," "predicts," "potential," or "continue" or other

comparable terminology. These forward-looking statements are not guarantees of

our future performance and involve risks, uncertainties, estimates and

assumptions that are difficult to predict, including the risks described in

Part I, Item 1A under the heading Risk Factors in our Annual Report on Form

10-K for the year ended December 31, 2021 (the "2021 Form 10-K"). In addition

to the risks described there, factors that could cause or contribute to such

differences may include, but are not limited to: the risk that FDA approvals

may be delayed or not be obtained; the risk that surgeons may be slow to adopt

the Fitbone Intramedullary Nail System; the risk that future patient studies or

clinical experience and data may indicate that treatment with the Fitbone

Intramedullary Nail System does not improve patient outcomes as much as

previously believed, or otherwise call into question the benefits of its use to

patients, hospitals and surgeons; the risk that the product may not perform as

intended and may therefore not achieve commercial success; the risk that

competitors may develop superior products or may have a greater market position

enabling more successful commercialization; the risk that insurance payers may

decline to reimburse healthcare providers for the use of our products.

This list of risks, uncertainties and other factors is not complete. We discuss

some of these matters more fully, as well as certain risk factors that could

affect our business, financial condition, results of operations, and prospects,

in reports we file from time-to-time with the SEC, which are available to read

at www.sec.gov . Any or all forward-looking statements that we make may turn out

to be wrong (due to inaccurate assumptions that we make or otherwise), and our

actual outcomes and results may differ materially from those expressed in these

forward-looking statements. You should not place undue reliance on any of these

forward-looking statements. Further, any forward-looking statement speaks only

as of the date hereof, unless it is specifically otherwise stated to be made as

of a different date. We undertake no obligation to update, and expressly

disclaim any duty to update, our forward-looking statements, whether as a

result of circumstances or events that arise after the date hereof, new

information, or otherwise.

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Source: Limacorporate S.p.A.