What changed in this filing

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Item 1. Business

2026-03-27 compared with 2025-03-26 · 147 added, 136 removed, 387 unchanged (42% of the section changed)

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a) UTMD's own direct channels into markets where the Company enjoys an established reputation and has a critical mass of sales and support resources, or

b) relationship with other companies that have the resources to effectively distribute and support the Company's products.

b) relationships with other companies that have the resources to effectively distribute and support the Company's devices.

UTMD's success in providing reliable solutions comes from its proven ability to integrate a number of engineering and technical disciplines in electronics, software, mechanical assembly and packaging, instrumentation, plastics processing and materials.

The resulting differentiated devices represent significant incremental improvements in patient safety, clinical outcomes and/or total cost over preexisting clinical tools.

The resulting differentiated devices represent significant incremental improvements in patient safety, clinical outcomes and/or total cost over preexisting clinical approaches.

UTMD's experience is that, in the case of labor-saving devices, the improvement in cost-effectiveness of clinical procedures also leads to an improvement in overall healthcare including lower risk of complications.

UTMD markets a broad range of medical devices used in critical care areas, especially the neonatal intensive care unit (NICU), the labor and delivery (L&D) department and the women’s health center in hospitals, as well as medical devices sold to outpatient clinics and physician's offices.

The opportunity to apply solutions to recognized needs results from an excellent core of practicing clinicians who introduce ideas to the Company, and key employees who are both clinical applications savvy and development engineering adept.

Domestically, UTMD’s medical devices are sold directly to clinician end-user facilities or a designated stocking distributor for a medical facility.

The opportunity to apply solutions to recognized needs results from a core of practicing clinicians who introduce ideas to the Company, together with key employees who are both clinical applications savvy and development engineering adept.

Domestically, UTMD’s medical devices are sold directly to clinical end-user facilities or designated stocking distributors for medical facilities.

In addition, UTMD manufactures components and finished devices on a subcontract basis for other companies in the medical device business as well as other businesses.

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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 approximately 200 distributors, 104 of which purchased at least five thousand dollars in UTMD medical devices during 2024.

UTMD has representation globally in the major developed countries as well as many underdeveloped countries through approximately 200 OUS distributors, 108 of which purchased at least five thousand dollars in UTMD medical devices during 2025.

UTMD was formed as a Utah corporation in 1978.

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distribution agreement for the Filshie Clip System from CooperSurgical Inc.

In late 2020, UTMD’s AUS subsidiary incorporated a NZ subsidiary in order to distribute devices directly to medical facilities in NZ.

In late 2020, UTMD’s AUS subsidiary incorporated a New Zealand (NZ) subsidiary in order to distribute devices directly to medical

facilities in NZ.

In 2021, due to BREXIT, Utah Medical Products Ltd in Ireland began distributing devices directly to medical facilities in France in lieu of the UK.

As of the end of 2025, all of UTMD’s owned manufacturing and distribution facilities described above remain operational.

UTMD's corporate headquarters are located at 7043 South 300 West, Midvale, Utah 84047 USA.

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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Fetal Monitoring Accessories.

Electronic Fetal Monitoring (EFM) is the standard of care in labor and delivery throughout the modern world.

Electronic Fetal Monitoring (EFM) is a standard of care in labor and delivery throughout the modern world.

While not all pregnancies are high risk, fetal emergencies can occur suddenly in seemingly normal labors.

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Accurate determination of contraction strength increases the safety of labor augmentation (e.g., oxytocin dose) and reduces the need for Cesarean section for desultory labor.

Infusion of fluid through an intrauterine catheter may cushion the umbilical cord and improve oxygenation of the fetus.

Infusion of fluid through an intrauterine catheter (amnioinfusion) may cushion the umbilical cord and improve oxygenation of the fetus.

To assist the physician in controlling the effectiveness of administration of oxytocin and monitoring effects of amnioinfusion, contraction intensities, uterine resting tones and peak contraction pressures are closely monitored through the use of an invasive intrauterine pressure catheter system.

In addition, to help identify the possible onset of fetal hypoxia, correlation of the changes in fetal heart rate (FHR) relative to the frequency and duration of contractions are often electronically monitored.

UTMD’s intrauterine pressure (IUP) catheters provide for clinician choices from a traditional fluid-filled system to INTRAN® PLUS, for over thirty years the most widely accepted transducer-tipped system.

UTMD’s intrauterine pressure (IUP) catheters provide for clinician choices with several versions of INTRAN® PLUS, for over thirty years the most widely accepted transducer-tipped system.

UTMD’s IUP catheters include:

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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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hospital births, the procedures are generally regarded as safer long term for the mother, and at least as safe for the fetus, as abdominal (Cesarean) delivery in comparable clinical situations.

UTMD’s bell-shaped soft silicone TENDER TOUCH® cups enjoy a significantly lower reported complication rate compared to other vacuum cup designs, as evidenced by the FDA Medical Device Reporting System (MAUDE) which publicly lists serious injuries reported by hospitals using specific brand names of products.

UTMD’s bell-shaped soft silicone TENDER TOUCH® cups yield fewer complications compared to other vacuum cup designs, as evidenced by the FDA Medical Device Reporting System (MAUDE) which publicly lists serious injuries reported by hospitals using specific brand names of products.

Neonatal Intensive Care :

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Disposa-Hood, in contrast to an incubator, allows for excellent access to and visualization of the underdeveloped infant.

Because it is a disposable product, it also prevents potential cross-contamination that might occur with an incubator.

Less invasive than nasal cannulae, DISPOSA-HOOD avoids potential damage to fragile premature neonatal nasal/ orotracheal tissues, as well as facial tissues as cannulae are often secured with tape.

Because it is a disposable product, Disposa-Hood also prevents potential cross-contamination that might occur with an incubator.

Less invasive than nasal cannulae, Disposa-Hood avoids potential damage to fragile premature neonatal nasal/

orotracheal tissues, as well as facial tissues as cannulae are often secured with tape.

A nasal cannula by itself cannot provide a NTE.

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The system features excellent visualization of clearing volume, and one-handed use.

UTMD continues its customization of Deltran kits for specific hospital applications.

UTMD continued its customization of Deltran accessories for specific hospital applications by introducing ABC TinyDraw™ in 2025, a patented closed blood microsampling device for the tiniest patients.

ABC TinyDraw is designed to reduce the risk of alteration to cerebral blood flow.

In 1998, UTMD acquired the neonatal product line of Gesco International.

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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.

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.

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®, Lubrizol Advanced Materials, Inc.) 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.

In addition, Gesco provides a convenient catheterization procedure tray of instruments and supplies necessary to place UVC catheters, as well as perform other similar procedures.

The primary distinction of GESCO products is that they were developed with the special needs of the neonate in mind, not just cut-down or smaller versions of adult devices.

The primary distinction of Gesco devices is that they were developed with the special needs of the neonate in mind, not just cut-down or smaller versions of adult devices.

For example, in the case of invasive catheters, the introducer, the soft rounded distal tip, mode of securing to the patient after insertion to avoid migration, luer-locking hub with minimal dead space, number of lumens, catheter radiopaque striping for visualization, variations in catheter lengths and diameters and special packaging are all features specially designed for neonates.

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Gesco developed and marketed initial versions of all of these neonatal products.

In order to keep pace with the trend of caring for smaller babies, UTMD has added smaller diameter versions of its URI-CATH® and NUTRI-CATH® products.

At the request of customers who prefer a stiffer catheter for insertion, UTMD added a Tecoflex polyurethane oral-connection only Nutri-Cath series.

PICC-NATE® is a percutaneous intraepithelial central venous catheter family of devices specifically designed to minimize trauma to the critically ill neonate.

In order to keep pace with the trend of caring for smaller babies, UTMD has added smaller diameter versions of its Uri-Cath™ and Nutri-Cath® devices.

At the request of practitioners who prefer a stiffer catheter for insertion, UTMD added a Tecoflex polyurethane oral-connection-only Nutri-Cath series.

PICC-Nate® is a peripherally-inserted central catheter family of devices specifically designed to minimize trauma to the critically ill neonate.

The product line was designed with the input of experienced neonatal medical practitioners for use as a long-term indwelling catheter system for single-use, therapeutic central venous infusion of drug solutions, blood products or other fluids and for blood sampling.

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UTMD replaced all DEHP plasticizer PVC materials in its Gesco product line that may come in contact with neonatal patients, addressing another safety concern related specifically to the possible maldevelopment of male neonates.

Other GESCO specialty products include a disposable peritoneal dialysis (PD) set that is a pre-assembled, sterile, closed system, called DIALY-NATE®.

Other Gesco specialty devices include a disposable peritoneal dialysis (PD) set that is a pre-assembled, sterile, closed system, called Dialy-Nate®.

PD is an ideal method to aid compromised renal function in a neonate because critically-ill pediatric patients may not have sufficient blood volume to support hemodialysis.

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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.

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.

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

Hemo-Nate has also proven to be a popular device for veterinarian use.

UTMD expects to continue to enhance and expand its neonatal product line, seeking to reinforce a reputation as having the most reliable and developmentally-friendly specialty devices available for the NICU.

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The loop is available in varying sizes and includes a Safe-T-Gauge® that can be positioned so the physician can accurately monitor and control the amount of tissue being excised.

Excising too much tissue can compromise fertility and result in premature birth.

Excising too little tissue can result in failure to remove the precancerous tissue.

UTMD continues to augment its specialty electrodes.

Excising too much tissue can compromise fertility and result in premature childbirth.

Excising too little tissue can result in failure to adequately remove precancerous tissue.

UTMD continues to

augment its specialty electrodes.

For example, the Company markets a unique conization electrode for deep endocervical disease called C-LETZ®, designed by UTMD to limit the removal of healthy tissue that might compromise adequate cervical function.

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UTMD also will continue to provide other components to augment the use of its market-leading specialty electrodes with other manufacturers’ electrosurgical generators.

The FINESSE+ electrosurgical generator design includes dispersive pad contact monitoring for patient safety, specialized circuitry for computer-controlled output that provides a precise tissue specimen for histopathology, an efficient output stage resulting in minimal heat generation and long electronic component life, an electronic components design which reduces the number of required components and allows a long service life, and an easy change internal filter for integral smoke evacuation, a unique feature of FINESSE.

The FINESSE+ electrosurgical generator design includes dispersive pad contact monitoring for patient safety, specialized circuitry for computer-controlled output that provides a precise tissue specimen for histopathology, an efficient output stage resulting in minimal heat generation and long electronic component life, an electronic components design which reduces the number of required components, allowing a long service life, and an easy change internal filter for integral smoke evacuation, a unique feature of FINESSE.

FILTRESSE™ Evacuator;

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EPITOME® and OPTIMICRO™ Electrosurgical Devices

After finding the general surgical market lacked a precision electrosurgical blade, UTMD developed EPITOME, an electrosurgical scalpel which delivers precise performance in surgical incision and excision with hemostasis while minimizing thermal side effects.

After learning that the general surgical market lacked a precision electrosurgical blade, UTMD developed Epitome, an electrosurgical scalpel which delivers precise performance in surgical incision and excision with hemostasis while minimizing thermal side effects.

Where rapid yet precise dissection of dense or fatty tissue is necessary, such as in mammaplasty or abdominoplasty, UTMD believes that Epitome has no close substitute.

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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UTMD introduced a product line of ultra-fine tipped microdissection needles, called OptiMicro™ Needles, to complement the Epitome Scalpel.

Whereas the Epitome Scalpel has been particularly effective for large scale surgeries that entail a great amount of tissue cutting, the OptiMicro electrosurgical needles are particularly useful in small-scale plastic and reconstructive surgery applications where extreme precision and ideal cosmetic results are expected.

Whereas the Epitome has been particularly effective for large scale surgeries that entail a great amount of tissue cutting, the OptiMicro electrosurgical needles are particularly useful in small-scale plastic and reconstructive surgery applications where extreme precision and ideal cosmetic results are expected.

UTMD added extended length OptiMicro needle versions useful in certain head and neck procedures.

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Dollar denominated sales.

The Filshie clip is a female surgical contraception device used for tubal ligation, i.e., placed on the fallopian tubes, generally laparoscopically in between pregnancies (interval sterilization), but also postpartum (following childbirth) during C-Sections.

The Filshie clip, implanted in over six million women worldwide during the last 40 years, has empirically been proven to be the safest and most effective tubal occlusive device, is as easy or easier to achieve occlusion as any of the alternative surgical techniques, and has a substantially higher probability of reversibility when compared to all of the other approaches for women who later decide that they would like to get pregnant.

The Filshie clip is a surgical female permanent contraception device used in tubal ligation, i.e., placed on the fallopian tubes, generally laparoscopically in between pregnancies (interval sterilization) or postpartum (following childbirth) during C-Sections.

The Filshie clip, implanted in six and a half million women worldwide during the last 43 years, has empirically been proven to be the safest and most effective tubal occlusive device, is as easy or easier to achieve occlusion as any of the alternative surgical techniques, and has a substantially higher probability of reversibility when compared to all of the other approaches for women who later decide that they would like to get pregnant.

Femcare has obtained numerous regulatory approvals for the Filshie Clip System, which throughout 2025 was sold OUS directly by UTMD and its subsidiaries to medical facilities in Canada, Ireland, France, the UK, Australia and New Zealand, and through specialty distributors in other countries.

In February 2019, UTMD purchased the remaining exclusive U.S.

distribution rights of CooperSurgical Inc.

(CSI), allowing the Company to directly distribute the Filshie Clip System to medical facilities in the U.S.

Since February 2019, UTMD has been Femcare’s exclusive Filshie device distributor to medical facilities in the U.S.

There have been several tubal ligation methods with varying degrees of effectiveness, safety and opportunity to be reversed.

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During this procedure a small loop of the fallopian tube is tied with a suture and the top section removed by cutting.

A traditional method for interval sterilization is with the use of bipolar cautery (electrocautery).

A traditional method for interval sterilization was with the use of bipolar cautery (electrocautery).

With this method, an electrical current flows between the tips of forceps when applied to the fallopian tube.

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Bipolar cautery has a higher rate of ectopic pregnancy, a life-threatening complication, compared to other tubal occlusion methods.

Although these common methods are relatively easy to perform, their failure rate - defined as the percentage of patients having undergone the procedure who subsequently get pregnant - has been reported to be about 3%.

Although the other surgical methods are relatively easy to perform, their failure rate - defined as the percentage of patients having undergone the procedure who subsequently get pregnant - has been reported to be about 3%.

The Filshie clip, which can be used either postpartum or at times unrelated to the post-partum period (interval sterilization), is at least as easy to use, has much less intraoperative risk, has a reported failure rate an order of magnitude less than bipolar cautery and is more effective and much simpler to perform than the Pomeroy technique.

Apart from bipolar cautery and the Pomeroy technique, other mechanical devices have been used but are no longer manufactured:

the Falope Ring (or Yoon Ring) and the Hulka clip.

Both these older methods had a higher failure rate than the Filshie clip, are associated with more post-operative pain and have generally been abandoned in favor of other sterilization techniques.

In addition, two more recent hysteroscopic sterilization methods, the Adiana and the Essure occlusive devices, also are no longer being sold.

the Falope Ring (or Yoon Ring), the Hulka clip, the Adiana and the Essure.

Both of the first two older methods had a higher failure rate than the Filshie clip, were associated with more post-operative pain and have been abandoned in favor of other sterilization techniques.

The two more recent hysteroscopic sterilization methods, the Adiana and the Essure occlusive devices, also are no longer being sold.

Pain associated normally with any laparoscopic procedure generally resolves within 48 hours, and is not severe, nor does it become chronic unless the result of an infection.

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Given widely available imaging and normal laparoscopic skills, Filshie clips can be removed safely, although removal is very rarely requested by patients or recommended by physicians.

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

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

Separation of the Fallopian tubes confirms that sterilization has been achieved.

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

In some cases where tissue encapsulation is slow, movement of a clip may occur after sterilization has been achieved.

Although the silicone lining of the clip helps prevent clip migration and reduces the risk of tubal regeneration, one clinical journal publication indicated migration occurs 6% of the time.

Marcus Filshie, the inventor of the clip, expressed his opinion in 2002 that more than 25% of patients will experience a migration of one or more clips, typically within the abdominal cavity.

As the silicone and titanium materials in a clip are inert and biocompatible, movement of a clip does not cause a foreign body reaction.

Once detached, the clip typically becomes encompassed in dense adhesive tissue without any symptoms.

Rarely, a low-grade inflammatory response can occur.

Because clips are biologically inert and small, physicians generally have concluded that removing a migrated clip represents more risk to long term well-being than leaving it in the body.

Although the silicone lining of the clip helps prevent clip migration and reduces the risk of tubal regeneration, one clinical journal publication indicated clip migration may occur 6% of the time.

Marcus Filshie, the inventor of the clip, expressed his opinion in 2002 that more than 25% of patients will experience an innocent (asymptomatic) migration of one or more clips, typically within the abdominal cavity.

When migration is asymptomatic, it is not detected unless during a subsequent unrelated imaging or surgical procedure.

In 2019, UTMD retained an independent clinical expert, Dr.

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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 TX.

for 25 years and implanted in millions of women, a clip migration product liability 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.

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

(CSI), resides.

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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.

The initial TX bellwether federal lawsuit was dismissed in March 2025.

As of this report, the original plaintiff law firm and copycat law firm have filed lawsuits in a total of 19 federal or state courts.

As of March 2026, 15 of those 19 courts have dismissed the lawsuits filed in their jurisdictions.

UTMD and its lawyers continue to believe that it has persuasive legal arguments in every case being put before courts, and all cases except the lawsuits filed in CT state court are likely to be dismissed by summary judgment during 2026.

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.

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

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

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(An applicator is a precision instrument which closes the implanted Filshie clip on the Fallopian tube to achieve proper permanent tubal ligation.) Reused applicators require extra handling, cleaning, resterilization and storage, which all have the potential to damage or misalign the delicate mechanism.

Timely periodic servicing and recalibration is needed, but often not sought by hospitals.

In addition, the reuse of a surgical instrument introduces the possibility of infection if not properly cleaned and resterilized between procedures.

Timely periodic servicing and recalibration of a reused instrument is needed, but often not sought by hospitals.

The reuse of a surgical instrument introduces the possibility of infection if not properly cleaned and resterilized between procedures.

The precalibrated, single-use sterile Sterishot applicator eliminates these safety, effectiveness and cost exposures.

After more than ten years since being introduced outside the U.S.

(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., 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.

After being introduced OUS in 2009, the patented Sterishot is used in almost all of the 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., recommending that hospitals use a Sterishot kit for each procedure.

In 2025, UTMD Ltd in Ireland received regulatory approvals for manufacture of clips distributed worldwide except in the EU, replacing Femcare’s former third-party manufacturer in the UK.

The EU regulatory approval is pending, but Femcare retains sufficient inventory from its former UK manufacturer to cover EU demand in the interim.

PATHFINDER PLUS™

PATHFINDER PLUS is a proprietary endoscopic irrigation device that allows a uro/gyn surgeon to precisely irrigate, clearing the visual field, with the same hand that controls the endoscope, eliminating the need for a separate assistant to irrigate without visualization.

Pathfinder Plus is a proprietary endoscopic irrigation device that allows a uro/gyn surgeon to precisely irrigate, clearing the visual field, with the same hand that controls an endoscope, eliminating the need for a separate assistant to irrigate without visualization.

An example of a procedure where Pathfinder has found particular success is ureteroscopic stone ablation.

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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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LIBERTY® System

LIBERTY is a device for the conservative treatment and effective control of urinary incontinence in women.

The Liberty System is a device for the conservative treatment and effective control of urinary incontinence in women.

UTMD believes that Liberty is the easiest-to-use, most cost-effective incontinence treatment available that yields a therapeutic effect, not just a cover-up.

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In pressure monitoring, a transducer is used to convert physiological (mechanical) pressure into an electrical signal that is displayed on electronic monitoring equipment.

UTMD developed and is now distributing its disposable transducer as a stand-alone product, and as a component in sterile blood pressure monitoring kits through direct representatives and other medical companies in the U.S., as well as independent distributors and other medical device companies OUS.

The Company believes that the DELTRAN DPT which it designed over thirty years ago and currently manufactures, remains the standard in terms of accuracy, reliability and ease of use.

UTMD developed and is distributing its disposable transducer as a stand-alone product, and as a component in sterile blood pressure monitoring kits through direct representatives and other medical companies in the U.S., as well as independent distributors and other medical device companies OUS.

The Company believes that the Deltran DPT which it designed over thirty-five years ago and currently manufactures, remains the standard in terms of accuracy, reliability and ease of use.

Introduced in 1998, the DELTRAN PLUS provides a closed system for blood sampling, without the use of needles, reducing the risk of an unwanted infection for both the patient and the practitioner.

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BioPharm HP-PRT™

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.

Over 17 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.

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In addition, UTMD sells plastic molded parts on a subcontract basis to a number of medical and non-medical device companies.

In addition, partly as a result of its excellent quality system and ISO13485 certification, UTMD performs subcontract assembly, testing and packaging of components that are proprietary to other medical device firms.

Partly as a result of its excellent quality system and ISO13485 certification, UTMD performs subcontract assembly, testing and packaging of components that are proprietary to other medical device firms.

UTMD believes that this practice helps better utilize its investment in fixed plant and equipment, and spreads overhead costs resulting in better gross profit margins on finished device sales.

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UTMD’s marketing focus is with clinicians who take responsibility for obtaining optimal patient care outcomes, primarily through clinical meetings, trade shows and the internet.

In competitive bidding processes, UTMD must work primarily with administrators who are responsible for hospital purchasing decisions.

In competitive bidding processes, UTMD must work with administrators who are responsible for hospital purchasing decisions.

UTMD competes primarily on the basis of improved patient safety and reliable device performance in the hands of a trained clinician.

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In recent years, access to U.S.

hospital clinicians has become increasingly restricted and the involvement of clinicians in medical device purchasing decisions, which is critical to the Company’s success, has declined.

hospital clinicians has become increasingly restricted and the involvement of clinicians in medical device purchasing decisions, which is critical to UTMD’s success, has declined.

To the degree that U.S.

hospitals become less focused on patient safety and clinical outcomes and more on out-of-pocket unit price, UTMD’s competitive position weakens.

hospitals become less focused on patient safety and clinical outcomes and more on out-of-pocket unit price or bureaucratic rules, UTMD’s competitive position weakens.

In 2025, UTMD sold components and finished devices to 134 other companies in the U.S.

For over 40 years, the Company has utilized its manufacturing capabilities and engineering know-how to produce high quality components and finished devices for other companies.

companies which wish to distribute their products outside the U.S., UTMD’s maintenance of certification to current ISO 13485 medical device quality standards is an important benefit.

companies which wish to distribute their products OUS, UTMD’s maintenance of certification to current ISO 13485 medical device quality standards is an important benefit.

UTMD’s website, which lists its capabilities, is often the basis for contacts for new OEM work.

Although there are other manufacturers in the U.S.

with similar manufacturing capabilities, UTMD’s primary competition comes from Mexico, East Europe, India and China device component manufacturers which have much lower wage rate structures.

To the extent that the U.S.

Dollar (USD) gains strength in any period of time against foreign currencies, UTMD’s ability to be cost-competitive with foreign manufacturers is diminished.

with similar manufacturing capabilities, UTMD’s primary competition for U.S.

OEM work comes from Mexico, East Europe, India and China device component manufacturers which have much lower wage rate structures.

Foreign currency fluctuations and reciprocal tariffs implemented in 2025 also can have an impact on UTMD’s ability to be cost-competitive with foreign manufacturers.

2) Outside the U.S.

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In USD terms, 72% of 2025 OUS sales were invoiced in foreign currencies.

In addition, foreign subsidiary expenses are in the native currency of the respective country.

Therefore, changes in foreign currency exchange (FX) rates can have a significant impact on UTMD’s USD-reported financial results.

(In addition, foreign subsidiary expenses are in the native currency of the respective country.) Therefore, changes in foreign currency exchange (FX) rates can have a significant impact on UTMD’s USD-reported financial results.

Prior to 2011, with only a few exceptions, UTMD’s OUS sales were to other medical device companies and distributors, not to clinical end-user facilities.

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 2025, UTMD distributed directly to OUS medical facilities in Canada, the UK, France, Ireland, Australia and New Zealand.

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An important success factor in the medical device industry is access to medical practitioners.

In the U.S., the hospital supplier environment has consolidated as a result of group purchasing organizations (GPOs), or their equivalents.

In the U.S., the hospital supplier environment has consolidated as a result of group purchasing organizations (GPOs), or their administrative equivalents.

It is UTMD’s assessment that U.S.

hospitals are not saving costs under GPO contracts when it comes to specialty medical devices that can reduce complications, utilization rates, clinician time and unwanted side effects, because administrators are focused primarily on out-of-pocket costs and miss the broader total cost of care issues.

The longer-term overall cost of care in the U.S.

will continue to increase, with quality of care lower, as innovative suppliers are excluded from participating in the marketplace as a result of unnecessary regulatory and other purely administrative burdens.

The length of time and number of administrative steps required in evaluating new products for use in hospitals has grown substantially.

The length of time and number of administrative steps required in evaluating new products for use in hospitals has also grown.

As a potential negative factor to future performance, as UTMD introduces new products it believes are safer and more effective, it may find itself excluded from certain customers because of the existence of long-term supply agreements for existing products.

UTMD may also be unable to establish viable relationships with other medical device companies that do have access to users but lack an interest in the Company’s approach or demand too great a financial or administrative burden.

UTMD may also be unable to establish viable relationships with other medical device companies that do have access to users but lack an interest in the Company’s solutions, or demand too great a financial or administrative burden.

hospital customers request it, UTMD provides its devices through national distribution companies, also known as Med/Surg distributors.

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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.

UTMD’s previously largest OEM customer, PendoTECH, to which sales peaked at $11.6 million in 2022, representing 22% of UTMD’s total consolidated sales in that year, were just 1% ($0.4 million) of total sales in 2025.

UTMD stopped accepting PendoTECH orders in 2025, and did not supply any sensors to PendoTECH after 1H 2025.

For comparison after the 2022 peak, the PendoTECH sales decline was 17% ($8.6 million) of total sales in 2023 and 7% ($2.7 million) of total consolidated sales in 2024.

OUS, the Company and its subsidiaries distribute directly to end-user facilities in Canada, the UK, France, Ireland, NZ and AUS, and in 2025 sold to 197 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 75% of UTMD’s indirect OUS sales in the years of 2023 - 2025.

For more than a decade, UTMD’s independent distributor of Deltran blood pressure monitoring kits in China was its largest OUS distributor, representing 14% of total OUS sales in 2024 and 18% of OUS sales in 2023.

In 3Q 2025, this distributor surprisingly canceled the remaining portion of its presumably “non-changeable” annual order, ending up with 2025 sales of $2.1 million (13% of total OUS sales) including a $0.4 million cancellation fee, which remains unpaid, and was written off to UTMD’s bad debt reserve in 3Q 2025.

NEW PRODUCT DEVELOPMENT

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1) improvements, enhancements and extensions of current product lines in response to clinical needs or clinician requests, 2) introduction of new or augmented devices that represent a significant improvement in safety, effectiveness and/or total cost of care, and 3) acquisitions of products or technology from others.

Manufacturing process development is an equally important aspect that cannot be separated from the successful design and development of devices.

Manufacturing process development is an equally important function that cannot be separated from a successful design in development of marketable devices.

Because of UTMD’s reputation as a focused product developer, its financial strength and its established clinician user base, it enjoys a substantial inflow of new product development ideas.

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Only a small percentage of ideas survive feasibility screening.

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

For internal 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 between 1% and 2% of sales in 2025.

Internal product development expenses are expected to remain approximately 2% of sales in 2026.

EMPLOYEES AND OTHERS

At December 31, 2024, the Company worldwide had 155 full-time employees, 12 part-time employees, 6 regular consultants, 20 independent sales representatives and 9 outside directors of UTMD and its subsidiaries.

At December 31, 2025, the Company worldwide had 140 full-time employees, 12 part-time employees, 7 regular consultants, 15 independent sales representatives and 9 outside (non-employee) directors of UTMD or its subsidiaries.

The Company utilizes independent consultants and directors, some of which were prior employees.

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

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.

At the end of 2025, the average tenure with the Company of all 130 full-time employees in Utah and Ireland was 17 years.

for clinicians and patients.

The Company's continued success will depend to a large extent upon its ability to retain skilled and experienced employees and consultants.

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There can be no assurance, however, that patents will be issued with respect to any pending applications, that marketable products will result from the patents or that issued patents can be successfully defended in a patent infringement situation.

The Company also owns thirty-one registered trademarks which have achieved significant brand recognition.

The Company also owns thirty-three registered trademarks, many of which have achieved significant brand recognition.

The Company believes that its trademarks and tradenames, many of which have become well known in the global medical community through decades of successful use of the associated medical devices, likely have and will continue to have substantially more intangible value than its patents.

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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 2024, royalties

included in cost of goods sold were $159.

During 2025, royalties included in cost of goods sold were $164.

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

During 2025 the Company received $20 in royalty income compared to $15 in 2024 and $20 in 2023.

GOVERNMENT REGULATION

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The Filshie Clip System is a Class III device which has more stringent regulatory controls.

The Company is in compliance with all applicable U.S.

The Company has been in compliance with all applicable U.S.

regulatory standards including CFR Part 820, the FDA Quality System Regulation (QSR) effective in 1997, also known as cGMPs (current good manufacturing practices).

In 1994, UTMD received certification of its quality system under the ISO9001/EN46001 standards (“ISO” stands for “International Organization of Standardization”) which it maintained until December 2003.

FDA QSR has been amended effective February 2, 2026, and rebranded as the Quality Management System Regulation (QMSR).

This change incorporates ISO13485:2016 by reference to align FDA regulations with internationals standards, replacing most of the previous 21 CFR 820 requirements.

Previously in 1994, UTMD received certification of its quality system under the ISO9001/EN46001 standards (“ISO” stands for “International Organization of Standardization”) which it maintained until December 2003.

In October 2003, UTMD’s Utah facility was certified under the more stringent ISO13485 standard for medical devices.

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Currently, UTMD’s facilities in the UK, Ireland and Utah are all certified under the most recent ISO13485:2016 standard.

In 2020, UTMD’s manufacturing facilities in Ireland and UK were audited and certified by a recognized authorized auditing organization under the MDSAP.

In 2020, UTMD’s manufacturing facilities in Ireland and UK were audited and certified by a recognized authorized auditing organization under the Medical Device Single Audit Program (MDSAP).

In 2024, UTMD’s manufacturing facility in Ireland was inspected by the FDA in conjunction with manufacturing Filshie clips in Ireland.

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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).

Since 2019, UTMD’s manufacturing facilities in Utah, Ireland and UK have been annually audited and certified by a recognized authorized auditing organization under the MDSAP.

The MDSAP allows a recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities of Australia, Brazil, Canada, USA and Japan.

In other words, the FDA accepts MDSAP audit reports as a substitute for routine periodic FDA QSR inspections.

In other words, the FDA accepts MDSAP audit reports as a substitute for previous routine periodic FDA QSR inspections.

UTMD and Femcare remain on a continuous periodic audit schedule by its independent notified body and authorized MDSAP auditing organization in order to stay current with international regulatory standards, and retain certifications.

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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

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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and 3) from a manufacturing point of view, reduced dependence on one manufacturing site and increased capacity for meeting customer needs.

Total 2024 trade USD revenues from customers OUS were $17,458 (43% of total consolidated USD sales) compared to $22,020 (44% of total consolidated USD sales) in 2023 and $20,310 (39% of sales) in 2022.

OUS trade sales (U.S.

exports) from the U.S.

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

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

Total 2025 trade USD revenues from customers OUS were $15,758 (41% of total consolidated revenues) compared to $17,458 (43% of total consolidated USD sales) in 2024 and $22,020 (44% of total consolidated USD sales) in 2023.

UTMD believes that tariffs assessed by the U.S.

government in 2025 triggered “reciprocal tariffs” in countries OUS that made UTMD’s devices more expensive and reduced OUS sales.

OUS trade sales from the U.S.

to OUS customers (U.S.

exports) were $4,010 in 2025 compared to $3,995 in 2024 and $4,516 in 2023.

exports represented 25% of total OUS sales in 2025 compared to 23% of total OUS sales in 2024, and 21% of total OUS trade sales in 2023.

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.

Also as an intercompany sale, UTMD imports proprietary Filshie devices for distribution in the U.S.

from its Ireland manufacturing subsidiary, which are now subject to a 15% tariff that is simply a separate U.S.

government excise tax on UTMD.

As a result, in 2026 UTMD will shift OUS orders for other devices previously manufactured and exported from the U.S.

to Ireland in order to help offset the difference by lowering U.S.

income taxes.

Stockholders might note that this is the exact opposite effect that the U.S.

government intended by imposing tariffs.

For sales by OUS geographic area, please see note 9 to the Consolidated Financial Statements.

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Backlog shippable in less than 90 days was $731 as of January 1, 2026 compared to $1,885 as of January 1, 2025 and $3,650 as of January 1, 2024.

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

The decline in the beginning backlogs was due to diminishing orders from UTMD’s largest OEM customer, PendoTECH, and the lack of a new 2026 annual order from UTMD’s China distributor of Deltran BPM kits.

SEASONAL ASPECTS

The Company's business is generally not affected by seasonal factors, but it is affected by uneven purchasing patterns of OEM customers and independent distributors.

The Company's business is generally not affected by seasonal factors, but it is affected by uneven purchasing patterns of OEM customers and independent OUS distributors.

PRODUCT LIABILITY RISK MANAGEMENT

The risk of product liability lawsuits is a negative factor in the medical device industry because devices are frequently used in inherently risky situations to help clinicians achieve a more positive outcome than what might otherwise be the case, and even the use of the safest medical devices may still result in injury.

Even the use of the safest medical devices may still result in injury.

In any lawsuit against a company where an individual plaintiff claims to have suffered permanent physical injury, a possibility of a large award for damages exists whether or not a causal relationship exists.

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 thirty years, excluding the Filshie Clip System acquired fourteen years ago.

UTMD is self-insured for product liability risk, and reserves funds against its current performance as applicable to provide for its costs of defense.

Excluding the Filshie Clip System, UTMD’s costs for product liability have been de minimis over the last 30 years, despite many millions of its devices used in critical care situations.

More specifically, 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 fifteen 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 lawsuit was settled in 2010 for an immaterial amount to avoid the diversion of management time and substantial costs of litigation, even though UTMD was confident that the case was without merit.

In a sixth, UTMD was brought into the lawsuit by a defendant physician, speculating a design deficiency in a Finesse electrosurgical generator (ESU) which had been in use for eighteen years before the injury event, and used successfully by the same physician in multiple procedures after the event.

In a sixth, UTMD was brought into the lawsuit by a defendant physician, speculating a design deficiency in a Finesse electrosurgical generator which had been in use for eighteen years before the injury event, and used successfully by the same physician in multiple procedures after the event.

The injured patient did not allege any fault by UTMD.

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.

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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 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.

However, in late 2021, Femcare and UTMD were added as defendants in a clip migration federal court lawsuit in Texas, which subsequently expanded to eighteen other federal or state courts across the country as plaintiffs’ lawyers sought to solicit and recruit claimants in other states.

As of March 2026, fifteen of the nineteen courts have dismissed all the lawsuits brought before them, including in the bellwether TX federal court.

Three other court cases are currently pending decisions on summary judgment motions, which UTMD expects in 2026.

The remaining lawsuits are filed in CT state court.

Unfortunately, social media has been used by aggressive attorneys to solicit plaintiffs using misrepresentations about the safety and effectiveness of Filshie clips.

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

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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.

physicians for decades, and implanted in millions of patients in the U.S.

Filshie Clips have been prescribed by knowledgeable physicians for decades, and implanted in millions of patients in the U.S.

and worldwide.

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.

Although the cost of defense has been unusually high compared to UTMD’s historical average cost of product liability defense, and would increase should any case 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 lawsuits, there have been no product liability lawsuits for any other UTMD device during the last fourteen years.

In summary, with the exception of the Filshie Clip System and six non-Filshie Clip System lawsuits described above, there have been no product liability claims filed over the last 33 years after distribution and use of over 21 million UTMD critical care and surgical finished devices.

Stated another way, 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.

However, although it hasn’t happened since UTMD’s inception in 1978, 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 trial.

Settlement is simply not feasible for a small specialized company that relies on its reputation for safety and effectiveness of its devices, and simply would open the door to other claimants seeking extortionist settlements.

FORWARD LOOKING INFORMATION

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When used in this document, the words “anticipate,” “believe,” “project,” “estimate,” “expect,” “intend” and similar expressions, as they relate to the Company or its management, are intended to identify forward-looking statements.

Such statements reflect the current view of the Company respecting future events and are subject to certain risks, uncertainties and assumptions, including the risks and uncertainties stated throughout the document.

Such statements reflect the current view of the Company respecting past and future events and are subject to certain risks, uncertainties and assumptions, including the risks and uncertainties stated throughout the document.

Although the Company has attempted to identify important factors that could cause the actual results to differ materially, there may be other factors that cause the forward statement not to come true as anticipated, believed, projected, expected, or intended.

Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may differ materially from those described herein as anticipated, believed, projected, estimated, expected or intended.

Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and the Company assumes no obligation to update or disclose revisions to those estimates.

Financial estimates are subject to change and are not intended to be relied upon as predictions of

future operating results, and the Company assumes no obligation to update or disclose revisions to those estimates.

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