What changed in this filing

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Item 1. Business

2025-03-26 compared with 2024-03-26 · 72 added, 45 removed, 451 unchanged (21% of the section changed)

4 unchanged sentences

Throughout this report, “UTMD” or “the Company” refers jointly to Utah Medical Products, Inc.

and all of its subsidiaries.

and all of its corporate subsidiaries.

Success depends on 1) recognizing and responding to needs of clinicians and patients, 2) rapidly designing or acquiring economical solutions that gain premarketing regulatory concurrence, 3) reliably producing devices that meet those clinical needs, and then 4) selling through

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(OUS), devices are sold directly to end-users in Canada, the United Kingdom (UK), France, Ireland, Australia (AUS) and New Zealand (NZ), and through other medical device companies and independent medical products distributors in other countries.

UTMD has representation globally in the major developed countries as well as many underdeveloped countries through more than 200 distributors, 114 of which purchased at least five thousand dollars in UTMD medical devices during 2023.

UTMD has representation globally in the major developed countries as well as many underdeveloped countries through approximately 200 distributors, 104 of which purchased at least five thousand dollars in UTMD medical devices during 2024.

UTMD was formed as a Utah corporation in 1978.

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The corporate office telephone number is 01 (801) 566-1200.

Ireland operations are located at Athlone Business and Technology Park, Athlone, County Westmeath, Ireland.

Ireland operations are located at Athlone Business

and Technology Park, Athlone, County Westmeath, Ireland.

The Ireland telephone number is 353 (90) 647-3932.

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The CVX-RIPE™ catheter is designed to mechanically improve the favorability of the cervix of pregnant patients at term gestation, for whom induction of labor is medically indicated.

CVX-Ripe utilizes two adjacent conical silicone balloons, similar to the shape of an hourglass.

CVX-Ripe utilizes two adjacent

conical silicone balloons, similar to the shape of an hourglass.

This design is intended to allow the clinician to gently apply internal pressure to the cervical canal, as well as both the internal and external os, to reduce the time needed to allow induction as well as the total time to achieve a successful vaginal delivery.

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The catheters are also called umbilical artery catheters (UACs) when placed in one of the umbilical arteries to measure blood pressure or monitor metabolic processes through blood analysis.

In developing its UMBILI-CATH™ product line, Gesco pioneered the use of soft, biocompatible silicone catheters, helping to reduce the number of insertions required as well as other complications associated with invasive applications.

In developing its UMBILI-CATH™ product line, Gesco pioneered the use of soft, biocompatible silicone catheters, helping to

reduce the number of insertions required as well as other complications associated with invasive applications.

UTMD has expanded the UVC product line to include catheters made from a proprietary thermosensitive polyurethane (Tecoflex®) that offers many of the flexibility and biocompatibility advantages of silicone after insertion, with the greater rigidity of polyurethane preferred by many clinicians for insertion.

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a pre-assembled, closed urinary drainage system, called URI-CATH®, which reduces risk of infection and valuable nursing time, and a lumbar sampling kit with a tiny, specially-beveled needle for obtaining cerebral spinal fluid samples, called MYELO-NATE®.

GESCO’s first patented product, HEMO-NATE®, is a disposable filter designed to remove microaggregates from stored blood prior to transfusion into a neonate where any deficiency can have an overwhelmingly negative impact on a neonate’s chances for survival, given an under-developed vasculature and small total blood volume.

negative impact on a neonate’s chances for survival, given an under-developed vasculature and small total blood volume.

UTMD also introduced a new filter and an improved blood bag spike for HEMO-NATE, and a needleless version.

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A major incentive for performing the LETZ procedure is that it may be performed using local anesthetic in a physician's office, eliminating the time and expense of hospital or surgical center admittance.

Most importantly clinically, in contrast to laser (tissue ablation) and cryotherapy (freezing of tissue), LETZ provides a fine tissue specimen for pathological assessment and confirmation of diseased tissue removal.

Most importantly clinically, in contrast to laser (tissue ablation), cryotherapy (freezing of tissue) and thermal coagulation (thermal volumetric destruction of tissue), LETZ provides a fine tissue specimen for pathological assessment and confirmation of diseased tissue removal.

UTMD’s LETZ System includes disposable electrodes, the FINESSE® electrosurgical generators and other miscellaneous components.

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Furthermore, an independent study concluded that the EPITOME scalpel provides a significant improvement over other devices in wound healing.

EPITOME allows a rapid incision without countertraction, yielding limited morbidity, less post-surgical pain and cosmetically superior results.

EPITOME allows a rapid incision without countertraction,

yielding limited morbidity, less post-surgical pain and cosmetically superior results.

EPITOME is useful where minimization of thermal tissue injury is important but control of bleeding needed.

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A well-known and clinically-reported potential side effect of Filshie clip tubal ligation, as with any other surgical clip or implant, is subsequent clip movement, often called “migration”.

A clip-occluded fallopian tube eventually separates into two permanently closed stubs after tissue necrosis under a closed clip.

A clip-occluded fallopian tube

eventually separates into two permanently closed stubs after tissue necrosis under a closed clip.

Peritoneal tissue usually encapsulates an implanted clip while still in contact with the fallopian tube.

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In late 2021, after the Filshie clip had been used in the U.S.

for 25 years and implanted in millions of women, a clip migration lawsuit was filed in Texas.

Subsequently, the same law firm solicited and recruited claimants in other states.

As of the end of January 2024, there were a total of thirteen still open clip migration lawsuits initiated by the same law firm in eleven different states.

UTMD has either filed early dispositive motions to dismiss or has filed motions for summary judgement aimed at defeating cases before trial.

In UTMD’s view, the current lawsuits, all of which have not gone to trial yet, are without merit as UTMD believes that they are preempted by federal law and that plaintiffs will be unable to show that their complaints were caused by migrated clips.

for 25 years and implanted in millions of women, a clip migration lawsuit was filed in TX.

Subsequently, the same law firm solicited and recruited complainants in other states, filing cases around the country.

A copycat law firm added complaints in 2023 and 2024, predominantly in CT state court where Femcare’s previous distributor, CooperSurgical Inc.

(CSI), resides.

and its corporate parent Utah Medical Products, Inc.

have been dismissed as defendants in CT.

The original plaintiff law firm filed only two new lawsuits in 2024, another one in TX federal court and one with multiple plaintiffs in CT state court.

Aside from the CT state court cases, all remaining lawsuits are in federal courts.

As of March 25, 2025, five cases have been thrown out by summary judgment with several others dismissed prior to the summary judgment phase.

Three more summary judgment motions are pending in federal courts around the country, with decisions on those expected in 2025.

Other summary judgment motions will be filed in 2025 after mandated discovery has been completed.

UTMD and its lawyers believe that it has persuasive legal arguments in every case being put before courts.

But, in any case where a summary judgment motion is not considered completely dispositive it would have to go to trial.

There have been no trials as yet, and UTMD has confidence that the chance of avoiding trial is significant in every case.

FDA approved the Filshie clip for marketing in the U.S.

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(OUS), the patented Sterishot is used in the majority of Filshie clip ligation procedures OUS, but was not effectively marketed by CSI, Femcare’s distributor in the U.S.

Beginning in February 2019, UTMD began directly marketing the Filshie Clip System in the U.S., strongly recommending that all hospitals use a Sterishot kit for each procedure.

Beginning in February 2019, UTMD began directly marketing the Filshie Clip System in the U.S., recommending that all hospitals use a Sterishot kit for each procedure.

Beginning in 2017, UTMD began the process of transitioning the manufacture of clips from a UK third party subcontract manufacturer to its Ireland facility, which not only included investment in new equipment but also training of operators and regulatory approvals.

As of January 2025, UTMD Ltd in Ireland had received regulatory approvals for its manufacture of clips for distribution in the U.S., Canada, Australia, New Zealand and South Africa.

Approvals for Europe and the UK are pending.

PATHFINDER PLUS™

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The Add-a-Cath™ introducer is a Femcare device designed for easy and safe suprapubic introduction of a catheter for bladder drainage.

Suprapubic catheterization is generally well-recognized as a drainage method with fewer complications than with urethral catheterization.

Suprapubic catheterization is generally well-recognized as a drainage method

with fewer complications than with urethral catheterization.

In 2013, UTMD introduced suprapubic catheterization procedure kits featuring the Add-a-Cath introducer, which UTMD now distributes directly to end-users in the U.S.

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BioPharm HP-PRT™

Over 15 years ago, on behalf of an OEM customer, UTMD was the original developer of high pressure, piezo-resistive transducer assemblies used in accurately sensing static and dynamic fluid pressures in biopharmaceutical manufacturing systems including filtration processes, chromatography processes, bioreactors, and filling operations, among other key processes in the rapidly growing biopharmaceutical industry.

Beginning in 2024, UTMD will begin offering its technology directly to biopharmaceutical manufacturing companies worldwide.

Over 16 years ago, on behalf of an OEM customer, UTMD was the original developer of high pressure, piezo-resistive transducer assemblies used in accurately sensing static and dynamic fluid pressures in biopharmaceutical manufacturing systems including filtration processes, chromatography processes,

bioreactors, and filling operations, among other key processes in the rapidly growing biopharmaceutical industry.

UTMD is now offering its technology directly to biopharmaceutical manufacturing companies worldwide.

Pressure Monitoring Accessories, Components and Other Molded Parts.

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After the acquisition of Femcare in 2011, UTMD began a transition to marketing directly to end-users in countries where the Filshie Clip System had achieved significant acceptance.

This also allowed increased distribution opportunities for other UTMD devices which previously did not have significant third-party distributor interest.

This also allowed increased distribution opportunities for other UTMD devices which

previously did not have significant third-party distributor interest.

In 2024, UTMD distributed directly to OUS medical facilities in Canada, the UK, France, Ireland, Australia and New Zealand.

In addition, the Company’s devices are sold in other countries OUS through over 200 independent regional distributors.

In addition, the Company’s devices are sold in other countries OUS through approximately 200 independent regional distributors.

UTMD’s website provides information that frequently results in unsolicited contacts from OUS entities.

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In addition to its direct representatives, UTMD utilizes third party consulting clinical specialists to augment its customer training programs.

Additionally, UTMD sells component parts as well as finished devices to over 100 other companies for use with their product lines.

Additionally, in 2024 UTMD sold component parts as well as finished devices to 134 other companies for use with their product lines.

This OEM distribution channel is simply maximizing utilization of manufacturing capabilities that are otherwise needed for UTMD's primary business, and does not compete with or dilute UTMD’s direct distribution and marketing programs.

UTMD’s largest OEM customer represented 7% ($2.7 million) of total consolidated sales in 2024, compared to 17% ($8.6 million) in 2023 and 22% ($11.6 million) in 2022.

OUS, the Company and its subsidiaries distribute directly to end-user facilities in Canada, the UK, France, Ireland, NZ and AUS, and in 2023 sold to more than 200 regional distributors and OEMs (other medical device manufacturers and/or distributors) in over a hundred countries.

OUS, the Company and its subsidiaries distribute directly to end-user facilities in Canada, the UK, France, Ireland, NZ and AUS, and in 2024 sold to 193 regional distributors and OEMs (other medical device manufacturers and/or distributors) in over a hundred countries.

Ten percent of UTMD’s independent OUS distributors comprised 77% of UTMD’s indirect OUS sales in the years of 2022 - 2024.

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Only a small percentage of ideas survive feasibility screening.

For internal development purposes, projects are assigned to a project manager who assembles an interdisciplinary, cross-functional development team.

development purposes, projects are assigned to a project manager who assembles an interdisciplinary, cross-functional development team.

The team’s objective is to have a clinically acceptable, manufacturable and regulatory-released product ready for marketing by a specific date.

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1) augmentation and internal manufacturing of existing UTMD devices, 2) neonatal intensive care, 3) specialized procedures for the assessment and treatment of cervical/uterine disease, 4) labor and delivery procedures, 5) pressure sensors needed for biopharmaceutical manufacturing processes and 5) product and process development for OEM customers.

Internal product development expenses are expected to be closer to 2% of sales in 2024 as UTMD validates and qualifies its BioPharm HP-PRT devices.

Internal product development expenses are expected to be between 1% and 2% of sales in 2025.

EMPLOYEES AND OTHERS

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Almost all of UTMD’s internally-manufactured devices are made either in Utah or in Ireland.

At the end of 2023, the average tenure with the Company of the combined 169 full-time employees worldwide is over 13 years.

In Utah, 20% of full-time employees have been with the Company for more than 30 years.

At the end of 2024, the average tenure with the Company of all 140 full-time employees in Utah and Ireland is 13 years.

In fact, 35% of those employees have been with the Company for more than 25 years.

This experience conveys an important benefit due to the level of training required to produce consistently high-quality medical devices and appreciation of how UTMD’s devices provide unique benefits for clinicians and patients.

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PATENTS, TRADEMARKS AND TECHNOLOGY LICENSES

The Company currently owns seven unexpired U.S.

The Company owns seven currently unexpired U.S.

patents, numerous associated patents in sovereignties OUS and is the licensee of certain other technology.

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As a matter of policy, UTMD has acquired and will continue to acquire the use of technology from third parties that can be synergistically combined with UTMD proprietary product ideas.

During 2023, royalties included in cost of goods sold were $172.

During 2024, royalties

included in cost of goods sold were $159.

Other royalties have been previously paid as a lump sum, or were incorporated into the price of acquisitions or into the cost of purchased components which practice certain patents of third parties.

Also as a matter of policy, UTMD licenses its proprietary technology to others in circumstances where licensing does not directly compete with UTMD's own marketing initiatives.

During 2023 the Company received $20 in royalty income compared to $20 in 2022 and $15 in 2021.

During 2024 the Company received $15 in royalty income compared to $20 in both 2023 and 2022.

GOVERNMENT REGULATION

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The Company’s most recent Utah FDA QSR inspection was in July 2014, which did not result in the issuance of any FDA-483 observations.

Femcare’s most recent UK FDA QSR inspection was in July 2019, which also did not result in the issuance of any FDA-483 observations.

Since 2019, UTMD’s manufacturing facilities in Utah have been annually audited and certified by a recognized authorized auditing organization under the Medical Device Single Audit Program (MDSAP).

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UTMD and Femcare have received CE Mark certifications (demonstrates proof of compliance with the European Community’s ISO standards) for all major products.

Femcare’s most recent UK FDA QSR inspection was in July 2019, which also did not result in the issuance of any FDA-483 observations.

SOURCES AND AVAILABILITY OF RAW MATERIALS

Most of the components which the Company purchases from various vendors are available from a number of sources and in a number of locations worldwide.

That notwithstanding, the Company maintains safety stocks that anticipate potential disruption to its supply chain from changes in government policies including tariffs, including the time required to source and qualify new vendors.

That notwithstanding, the Company maintains safety stocks that anticipate potential disruption to its supply chain from changes in government policies including tariffs, and including the time required to source and qualify new vendors.

Fortunately, given availability of its significant cash reserves, UTMD has had the financial ability to mitigate supply chain risk by carrying extra inventories during periods of increased uncertainty.

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Vendors are qualified by UTMD’s Quality Assurance.

In the few cases where the Company has a sole source, it either maintains or has agreement with the supplier to maintain excess safety stocks that would cover the time required to develop and qualify a new source.

The Company has a vendor quality monitoring program that includes routinely checking incoming material for conformance to specifications, as required per written procedures.

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to OUS customers were $3,995 in 2024 compared to $4,516 in 2023 and $4,256 in 2022.

exports represented 21% of total OUS trade sales in both 2023 and 2022, and 22% in 2021.

exports represented 23% of total OUS sales in 2024 compared to 21% of total OUS trade sales in both 2023 and 2022.

export numbers exclude Utah intercompany sales of components and finished devices to UTMD foreign subsidiaries, which then distribute Utah-made components and finished devices as part of their sales to OUS customers.

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Backlog shippable in less than 90 days was $1,885 as of January 1, 2025 compared to $3,650 as of January 1, 2024 and $5,605 as of January 1, 2023.

The decline in the beginning of 2024 backlog was due to lower orders from UTMD’s largest OEM customer.

The decline in the beginning backlogs was due to diminishing orders from UTMD’s largest OEM customer.

SEASONAL ASPECTS

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UTMD is self-insured for product liability risk, and reserves funds against its current performance on an ongoing basis to provide for its costs of defense should any lawsuits be filed.

UTMD was named as a defendant on six product liability lawsuits over the time span of the last twenty-nine years, excluding the Filshie Clip System acquired twelve years ago.

UTMD was named as a defendant on six product liability lawsuits over the time span of the last thirty years, excluding the Filshie Clip System acquired fourteen years ago.

Four of the six lawsuits involved a patient injury related to operative vaginal deliveries where a UTMD VAD birthing cup or hand pump was used.

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The case was settled in 2012 without any UTMD involvement or liability.

The Company’s average cost of defense of the six lawsuits was $15/year, well below the deductible level of product liability insurance policies and hundreds of thousands of dollars less than product liability insurance premiums.

The Company’s average cost of defense of the six lawsuits was $15/year, well below the deductible level of product liability insurance policies and hundreds of thousands of dollars less than

product liability insurance premiums.

The best defense the Company believes that it has is the consistent conformance to specifications of its proven safe and effective products.

1 unchanged sentence

The average annual cost of those Filshie Clip System lawsuits since 2011 up to late 2021 was $7 per year (less than $25 per lawsuit to achieve resolution).

However, in late 2021, Femcare was added as a defendant in a clip migration lawsuit in Texas, which expanded to thirteen other states with a total of eighteen lawsuits as plaintiffs’ lawyers have sought to solicit and recruit claimants in other states.

Five lawsuits in three states have been dismissed as of January 31, 2024.

Unfortunately, social media is being used by aggressive attorneys to solicit plaintiffs using statements that have not been proven to be true.

Nevertheless, the filing of new lawsuits died down considerably in 2023.

However, in late 2021, Femcare and UTMD were added as defendants in a clip migration lawsuit in Texas, which expanded to fourteen other states with a total of nineteen lawsuits as plaintiffs’ lawyers have sought to solicit and recruit claimants in other states.

Ten lawsuits have been dismissed completely as of March 25, 2025, including the bellwether Texas lawsuit.

Unfortunately, social media is being used by aggressive attorneys to solicit plaintiffs using representations that are not true.

The filing of new lawsuits died down considerably in 2024.

There is no basis for a claim of either a poor device design, which was approved as safe and effective by the U.S.

FDA, and has remained FDA approved since 1996 during more than two decades of use, or no evidence to-date of any defective clips implanted in the patients who have filed complaints, or no lack of proper disclosure of side effects to physicians who are learned intermediaries.

FDA, which approval has been continuously maintained since 1996, nor any evidence to-date of any defective clips implanted in the patients who have filed complaints.

The basis for claims appears to be an allegation that Femcare failed to properly inform of potential side effects.

The contents of “Instructions For Use”, which contain warnings and precautions and accompany shipments of clips, have been and remain approved by the FDA.

There have been dozens of clinical articles over decades of time describing case studies and use of Filshie Clips.

Therefore, there has been no lack of proper disclosure of side effects to physicians who are learned intermediaries.

Filshie Clips have been prescribed by knowledgeable U.S.

1 unchanged sentence

and worldwide.

Although the cost of defense has been unusually high compared to UTMD’s historical average, and will continue to increase should cases go to trial, the Company believes that the costs can be absorbed without a material impact on UTMD’s overall consolidated financial performance.

Other than the Filshie clip claims, there have been no product liability lawsuits for any UTMD device during the last twelve years.

Except for the six non-Filshie Clip System lawsuits described above, there have been no other product liability claims filed over the last 30 years after distribution and use of over 20 million UTMD critical care and surgical finished devices.

Although the cost of defense has been exceptionally high compared to UTMD’s historical average cost of product liability defense, and would possibly increase should cases go to trial, the Company believes that the costs can be absorbed without a material impact on UTMD’s overall consolidated financial performance.

Other than the Filshie Clip claims, there have been no product liability lawsuits for any UTMD device during the last thirteen years.

With the exception of the six non-Filshie Clip System lawsuits described above, there have been no product liability claims filed over the last 31 years after distribution and use of over 20 million UTMD critical care and surgical finished devices excluding the Filshie Clip System.

Since 1993, during which time over one hundred million finished devices and OEM components were manufactured and distributed by UTMD and its subsidiaries, there have been no adverse judgments resulting from a claim of defect in UTMD’s or its subsidiaries’ designs or manufacture of products, or a fault in informational materials.

Although it hasn’t happened in the past 46 years, a product liability lawsuit could result in a significant damages award against the Company.

In the current tort system, particularly in the U.S., meritless product liability cases do get filed where aggressive attorneys calculate that a company will find it cheaper to settle for what they consider a nominal amount in lieu of potentially substantial defense costs of discovery and going to court.

FORWARD LOOKING INFORMATION

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business