InfuSystem Holdings, Inc. (NYSE American: INFU) (“InfuSystem” or
the “Company”), a leading national health care service provider,
facilitating outpatient care for durable medical equipment
manufacturers and health care providers, and its joint venture
partner Sanara MedTech Inc. (“Sanara”), announced today the
execution of an exclusive United States distribution agreement with
ChemoMouthpiece, LLC (“ChemoMouthpiece”).
Richard DiIorio, InfuSystem’s CEO, stated, “Sanara and
InfuSystem entered into our partnership in order to bring together
our combined technical, operational and commercial strengths to
deliver proprietary efficacious products to patients. We believe
this exclusive agreement, which builds on our partnership, will
allow us to do that by offering the Chemo Mouthpiece®, an oral
cryotherapy device, bringing potential relief to thousands of
cancer patients suffering from oral mucositis.”
Ron Nixon, Sanara’s CEO, stated, “Oral mucositis is a
debilitating condition impacting hundreds of thousands of oncology
patients annually. ChemoMouthpiece has developed a clinically
validated product with FDA 510(k) clearance that can bring relief
to affected patients. The American Medical Association has recently
issued the CPT code (effective July 2024) to be applied for
potential reimbursement by physicians and payers for the use of an
oral cavity device for cryotherapy procedure in conjunction with
chemotherapy. The product aligns well with Sanara’s skincare
strategy, which includes the licensed collagen peptides from Tufts
University that focus on radiation dermatitis. We look forward to
providing the Chemo Mouthpiece®, an oral cryotherapy device, to
oncology patients undergoing chemotherapy.”
Transaction Overview
- ChemoMouthpiece owns and manufactures a 510(k) cleared device
that uses cryotherapy to reduce the incidence and severity of oral
mucositis in patients undergoing stomatotoxic chemotherapy
treatments.
- SI Healthcare Technologies, LLC (f/k/a SI Wound Care, LLC) (“SI
Technologies”), a 50/50 joint venture between Sanara and
InfuSystem, will be the exclusive distributor of ChemoMouthpiece’s
kits in the United States.
- SI Technologies plans to market and distribute the product
through InfuSystem to approximately 3,000 cancer centers through
InfuSystem’s existing Oncology sales team.
- SI Technologies will purchase the product kits from
ChemoMouthpiece at a fixed price and pay a royalty on net revenues
for the use of the product intellectual property.
- Sanara invested $5 million for a 6.6% ownership position in
ChemoMouthpiece.
- SI Technologies will have a purchase option that expires on
January 31, 2029 to purchase the U.S. business of ChemoMouthpiece,
including all U.S. intellectual property related to the
product.
Oral Mucositis
Oral mucositis causes painful mouth ulcers, which are a common
complication of chemotherapy and radiation. In the U.S., there are
an estimated 500,000 - 1,000,000 patients who have oral mucositis
annually and the estimated market size exceeds $600 million. SI
Technologies believes this product will show material cost
reductions for oncology treatment centers, improve patient quality
of life and allow for continued treatment of cancer therapy for
patients. ChemoMouthpiece is planning to publish studies in the
future reinforcing the efficacy of their product.
David Yoskowitz, ChemoMouthpiece’s President and CEO stated, “We
are pleased to have selected SI Technologies as our exclusive
distribution partner in the United States. We believe that
InfuSystem’s experienced team of seasoned oncology professionals
currently calling on approximately 3,000 U.S. cancer centers will
accelerate the uptake of the Chemo Mouthpiece®, bringing a
much-needed option for patients that would otherwise suffer from
the debilitating effects of oral mucositis.” David added, “We
understand that the executive team of SI Technologies has a long
history of launching products into the oncology space, and coupled
with Sanara’s ownership position in ChemoMouthpiece, we are
confident that they will execute the successful launch of the Chemo
Mouthpiece® oral cryotherapy device.”
Pickwick Capital Partners, LLC, served as the exclusive advisor
to ChemoMouthpiece on this transaction.
About ChemoMouthpiece, LLC
ChemoMouthpiece, LLC is a privately held medical device company
that develops and commercializes propriety oral cryotherapy
products for cancer patients. The Chemo Mouthpiece® device was
developed based on the personal experience of inventor, founder and
CEO, David Yoskowitz, who when diagnosed with Hodgkin's Lymphoma,
experienced oral mucositis firsthand. His treatment options
included ice chips to mitigate and minimize the pain. Yet this
caused nausea, was difficult to maintain in his mouth, and did not
effectively cool the entire oral cavity which led him to search for
a better option. The Chemo Mouthpiece® cools down the entire oral
cavity, causing vasoconstriction, which in effect slows and reduces
the flow of chemotherapy in the oral cavity, thus greatly reducing
the risk of developing oral mucositis. The cryotherapy approach has
been positively studied for decades and the Chemo Mouthpiece® has
significant and improved advantages over conventional cryotherapy
interventions. For more information on ChemoMouthpiece, LLC, please
visit our website at www.chemomouthpiece.com.
About Sanara MedTech Inc.
Sanara MedTech Inc. is a medical technology company focused on
developing and commercializing transformative technologies to
improve clinical outcomes and reduce healthcare expenditures in the
surgical, chronic wound and skincare markets. The Company markets,
distributes and develops surgical, wound and skincare products for
use by physicians and clinicians in hospitals, clinics and all
post-acute care settings and offers wound care and dermatology
virtual consultation services via telemedicine. Sanara’s products
are primarily sold in the North American advanced wound care and
surgical tissue repair markets. Sanara markets and distributes
CellerateRX® Surgical Activated Collagen, FORTIFY TRG® Tissue
Repair Graft and FORTIFY FLOWABLE® Extracellular Matrix as well as
a portfolio of advanced biologic products focusing on ACTIGENTM
Verified Inductive Bone Matrix, ALLOCYTE® Plus Advanced Viable Bone
Matrix, BiFORM® Bioactive Moldable Matrix, TEXAGEN® Amniotic
Membrane Allograft, and BIASURGE® Advanced Surgical Solution to the
surgical market. In addition, the following products are sold in
the wound care market: BIAKŌS® Antimicrobial Skin and Wound
Cleanser, BIAKŌS® Antimicrobial Wound Gel, and BIAKŌS®
Antimicrobial Skin and Wound Irrigation Solution. Sanara’s pipeline
also contains potentially transformative product candidates for
mitigation of opportunistic pathogens and biofilm, wound
re-epithelialization and closure, necrotic tissue debridement and
cell compatible substrates. The Company believes it has the ability
to drive its pipeline from concept to preclinical and clinical
development while meeting quality and regulatory requirements.
Sanara is constantly seeking long-term strategic partnerships with
a focus on products that improve outcomes at a lower overall
cost.
About InfuSystem Holdings, Inc.
InfuSystem Holdings, Inc. (NYSE American: INFU), is a leading
national health care service provider, facilitating outpatient care
for durable medical equipment manufacturers and health care
providers. INFU services are provided under a two-platform model.
The first platform is Patient Services, providing the last-mile
solution for clinic-to-home healthcare where the continuing
treatment involves complex durable medical equipment and services.
The Patient Services segment is comprised of Oncology, Pain
Management and Wound Therapy businesses. The second platform,
Device Solutions, supports the Patient Services platform and
leverages strong service orientation to win incremental business
from its direct payer clients. The Device Solutions segment is
comprised of direct payer rentals, pump and consumable sales, and
biomedical services and repair. Headquartered in Rochester Hills,
Michigan, the Company delivers local, field-based customer support
and also operates Centers of Excellence in Michigan, Kansas,
California, Massachusetts, Texas and Ontario, Canada.
Forward-Looking Statements
Certain statements contained in this press release are
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, such as statements
relating to future actions, business plans, strategic partnerships,
growth initiatives, objectives and prospects, future operating or
financial performance, guidance and expected new business
relationships and the terms thereof (including estimated potential
revenue under new or existing contracts). The words “believe,”
“may,” “will,” “estimate,” “continue,” “anticipate,” “intend,”
“should,” “plan,” “goal,” “expect,” “strategy,” “future,” “likely,”
variations of such words, and other similar expressions, as they
relate to the Company, are intended to identify forward-looking
statements. Forward-looking statements are subject to factors,
risks and uncertainties that could cause actual results to differ
materially, including, but not limited to, our ability to
successfully execute on our growth initiatives and strategic
partnerships, our ability to enter into definitive agreements for
new business relationships on expected terms or at all, our ability
to generate estimated potential revenue amounts under new or
existing contracts, our dependence on estimates of collectible
revenue, potential litigation, changes in third-party reimbursement
processes, changes in law, global financial conditions and
recessionary risks, rising inflation and interest rates, supply
chain disruptions, systemic pressures in the banking sector,
including disruptions to credit markets, the Company’s ability to
remediate its previously disclosed material weakness in internal
control over financial reporting, contributions from acquired
businesses or new business lines, products or services and other
risk factors disclosed in the Company’s most recent annual report
on Form 10-K and, to the extent applicable, quarterly reports on
Form 10-Q. Our strategic partnerships are subject to similar
factors, risks and uncertainties. All forward-looking statements
made in this press release speak only as of the date hereof. We do
not undertake any obligation to update any forward-looking
statements to reflect future events or circumstances, except as
required by law.
Additional information about InfuSystem Holdings, Inc. is
available at www.infusystem.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240911916604/en/
Joe Dorame, Joe Diaz & Robert Blum Lytham Partners, LLC
602-889-9700
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