utah medical products, inc. (utmd)

by:Keyuan     2020-05-28
Washington, DC Securities and Exchange CommissionC. 20549FORM 10-
Annual Report submitted under Section 13 or 15 (d)
In the Securities Trading Act of 1934 as of fiscal 31, 2018 Commission File No. : 001-
12575 Utah Medical Products Co. , Ltd. (
The exact name of the registrant specified in the articles of association)Utah87-0342734(
State or other jurisdiction of company or organization)(I. R. S.
Employee Identification Number)
7043 S 300 W, midwell Utah84047 (
Main executive office address)(Zip Code)
The registrant\'s telephone number, including the area code: Telephone (801)566-
1200 securities registered under article 12 (b)
Title of the act: each class name of each exchange registered for common stock, $.
01 face value Nasdaq Global Market preferred stock purchase rights securities registered under section 12th (g)of the Act:(Title of Class)
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Non-Voting Ordinary Shares held
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The registrant\'s affiliates are $376,542,268.
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As of March 1, 2019, 3,722,610 ordinary shares had been issued.
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The company\'s final proxy statement on the annual meeting of shareholders is incorporated into Part 3 of this form by reference, items 10, 11, 12, 13 and 14-K.
Forming 10 k pagepart IItem 1 business sitem 1ARisk FactorsItem 1 bunresoved employee review 2 properties 3 legal procedure 4 common stock for registrant retained IIItem 5 related shareholder matters and issuer purchase stock securities 6 Selected financial data item 7 Management Discussion and Analysis of financial status and operational results differences with accountants on accounting and financial disclosure items 9 accounting and procedures 9 accounting information section 10 directors, executive and corporate governance project 11 executive compensation project 12 guarantee ownership of certain beneficial owners and management and related shareholders 13 certain relationships and related transactions, and director Independence Program 14 major accounting fees and services Financial statements program signature IITEM 1-except for each-
Share Amount and record.
Utah Medical Products Co. , Ltd. (
\"UTMD\" or \"Company \")
Engaged in the production of high-quality, cost-effective medical equipment, which is mainly proprietary, disposable and for hospital use.
Success depends on 1)
Recognize the needs of clinicians and patients, 2)
Quickly design or obtain economic solutions agreed by pre-marketing regulators, 3)
Reliably produce products that meet these clinical needs and then 4)
Sales through a)
UTMD\'s own direct access to the market, the company has a high reputation in the market and has a large number of sales and support resources (orb)
Relationships with other medical companies that have the resources to effectively distribute and support the company\'s products.
UTMD\'s success in delivering reliable solutions comes from its ability to integrate multiple engineering and technical disciplines such as electronics, software, mechanical packaging, instrument and meter, plastic processing and materials.
The resulting differentiated devices have significant incremental improvements in patient safety, clinical outcomes, and/or total cost compared to previously existing clinical tools.
The experience of UTMD is that in the case of saving laboratory equipment, an increase in the cost-effectiveness of clinical surgery has also led to an improvement in overall health care, including a reduction in the risk of complications.
UTMD sells a variety of medical equipment used in the field of intensive care, especially in the neonatal intensive care unit (NICU)
Labor and childbirth (L&D)
The women\'s health center of the hospital, as well as products sold to the outpatient and doctor\'s offices.
The opportunity to apply the solution to recognized needs comes from an excellent core of hands-on clinicians who introduce ideas to the company and key employees who are proficient in clinical application and development engineering.
At home, except for FILSHIE®UTMD\'s medical equipment is sold directly to the clinical end-user facility or its designated inventory dealer.
In addition, some equipment of UTMD is sold through professional distributors, National Hospital distribution companies and other medical device manufacturers. Outside the U. S. (OUS)
Products are sold directly to end users in Canada and the UK (UK)
Through independent medical product distributors in other medical device companies and many other countries, France, Ireland and Australia.
UTMD has representation in major developed countries and many less developed countries around the world through more than 270 dealers, of which 129 purchased at least $5,000 of UTMD medical devices in 2018.
Founded in 1978, UTMD is a company in Utah.
UTMD sold shares to the public for $1,750 on 1982 (
Before offering a fee of $321).
Since 1992, UTMD has returned $117,474 to public shareholders in the form of share repurchase, and has returned an additional $54,688 in cash dividends.
Utah Medical Products Co. , Ltd. , a wholly-
Founded in 1995, it is a manufacturing subsidiary located in Ireland, aiming to better serve the customers of UTMD.
In 1997, UTMD acquired Columbia Medical. (CMI)
A company specializing in silicone injection molding, vacuum assembly and marketing
Obstetric assisted delivery system.
In 1998, UTMDacquired acquired the newborn product line of Gesco International, a subsidiary of Bard Access Systems and C. R. Bard, Inc.
In 2004, UTMD acquired Abcorp.
Is the supplier of fetal monitoring tape.
In 2011, UTMD purchased all ordinary shares of emcare Holdings Ltd (Femcare)
The United Kingdom and its subsidiaries.
The addition of Femcare provides a variety and expansion of product and distribution channels.
The sales of products or product derivatives acquired in the above four acquisitions accounted for 62% of UTMD\'s combined 2018 sales.
In 2016, UTMD established Utah Medical Products Co. , Ltd. , Canada (
Canadian dba female care)
As a sales and distribution business directly serving medical facilities in Canada.
In the early 2019 S, UTMD acquired the remaining four.
Exclusive American 75-year life for women careS.
Distribution Agreement of CooperSurgical FILSHIE editing system company.
UTMD of the company headquarters in South 7043 300 West Meade Vail Sir 84047 u. S. A.
The company\'s office phone number is 01 (801)566‑1200.
The Irish business is located in aslon commercial and Science Park, westmas County, Ireland.
The Irish phone number is 353 (90)647-3932.
The UK operating company is located at 32 Premier Way of SO51 9DQ Romney, Hampshire, UK.
The British phone is 44 (179)452-5100.
The Australian business is located at unit 2154, Unit 12, No. 5, shantylands Road, new state Castle, Australia.
The Australian telephone number is 9045 4110.
Canada business is located at 6355 Kennedy Road, 15 Mississauga Sharjah, L5T 2L5, Canada.
The Canadian phone is 01 (905)795-1102.
A more complete product description can be easily obtained, including the part number and picture of the UTMD equipment. utahmed. comand www. femcare-nikomed. co. uk.
Delivery/Obstetrics: fetal monitoring attachment.
Electronic monitoring of the fetus (EFM)
It is the standard of labor and childbirth in the modern world.
While not all pregnancies are at high risk, fetal emergencies can occur suddenly in seemingly normal labor.
The use of EFM can protect the nursing staff and almost eliminate fetal death at birth.
Accurate determination of contraction intensity increases the safety of manual increase and reduces the need for caesarean section for irregular delivery.
Infusion of liquid through the intrauterine catheter can buffer the umbilical cord and improve the oxygen metabolism of the fetus.
Assist the doctor to control the effect of using oxytocin and monitor the effect of amniotic fluid infusion and contraction intensity, and closely monitor the uterine static tension and peak contraction pressure by using the invasive intrauterine pressure catheter system.
In addition, in order to help determine the possible start of fetal hypoxia, the correlation of fetal heart rate changes (FHR)
Electronic monitoring is usually performed relative to the frequency and duration of contractions.
Intrauterine pressure of UTMD (IUP)
Catheter provides clinical selection from traditional fluids
Filling System INTRAN®In addition, in their twenties
The most widely accepted sensor in five yearstipped system.
In addition, auxiliary toco belts and chart paper are provided by UTMD to provide a package of fetalmonitoring supplies.
The IUP catheter for UTMD includes: ● other custom liquids for IUP-075 and UTMD
The filled clear catheter kit utilizes the saline filled catheter placed in the uterine cavity and is connected to a separate external reusable or disposable sensor.
This product is packaged with a double-chamber catheter, which is a traditional intrauterine monitoring mode before the introduction of intran.
The intra-uterine pressure change is transmitted to the external pressure sensor through the fluid column.
● Inlan, launched in 1987, is the first one-time intrauterine pressure catheter to place pressure sensors in the source of internal pressure in the uterine cavity.
This design eliminates the complex settings of the fluid filling system and provides a more accurate pressure waveform.
Intran I stopped using in 1995 and turned to support the more popular INTRAN PLUS.
● Intran PLUS was launched in 1991.
The intran plus catheter combines the sensor tip concept of intran I with a sophisticated tip design, a zeroing switch or a button, allowing clinicians to reset the reference of the display, as well as a dedicated amniotic cavity, it provides the water environment of the sheep, which may contribute to the diagnosis and intervention of certain fetal diseases.
In 1996, a viewport enhancement was added to intran plus, allowing doctors to observe amniotic fluid in a closed system.
In 1997, UTMD introduced several changes in tip size, zero switch/button position, and amniotic fluid visualization to allow user preferences.
UTMD, as described above, sells Force meter belts, ducts and accessories, but does not sell capital equipment for processing electrical signals-electronic displays.
In addition to the products currently available, UTMD continues to examine the feasibility of tools to enhance fetal monitoring techniques. Vacuum-
Auxiliary delivery system (VAD).
UTMD\'s VAD system includes the Maritime Commission®Soft silicone Bell
Shaped delivery Cup and reusable hand
Held vacuum pump is the safest product in vacuum
Assist with surgery.
The soft silicone cup of UTMD is a bell-
Shape cup design that should be preferred for fetal Wells-
At the low or exit fetal station with pillow performance, this represents more than 90% of VAD cases.
Vaginal delivery using tweezers or vacuum
The assisted delivery system provides a more invasive C- for knowledgeable doctors-
Intervention.
Although the risk associated with vaginal delivery may currently represent 3-4% of all U. S.
In hospital delivery, these procedures are generally considered safer for each other, at least as safe for the fetus as the abdomen (Cesarean)
Delivery in a similar clinical condition. UTMD’s bell-
Soft silicone touch®The reported complication rate of the cup is lower compared to other vacuum cup designs, as evidenced by the FDA medical device reporting system (MAUDE)
It publicly lists the serious injuries reported by hospitals using specific brand products.
2 Other manual and delivery tools. AROM-
Baby crib™It is a finger cuff with a patented prong design that can break the maternal membrane without the pain and anxiety of the patient. MUC-
X is a suction device that is used immediately after birth to clear the respiratory tract of the newborn and reduce potential infection.
Warning Line®Is a product that combines multiple steps, puts the cord of theneonate near the umbilical cord, cuts the cord without splashing blood, takes a clean cord blood sample and helps clear the placenta
CORDGUARD\'s sharpless closure system reduces the risk of exposure to potentially infected blood, thus reducing the high cost of exposure treatment under the OSHA and CDC guidelines.
In addition, CORDGUARD helps to get safe and clean newborn blood. BT-
Kass®It is a patented uterine airbag filling catheter used to control severe postpartum bleeding.
Its benefits include ease of rapid deployment and the ability to monitor further bleeding after filling.
Abcorp toco belts and belts latex for fetalmonitor supplied by external tocodynamometer-
Free form of multiple configurations.
In 2014, UTMD extends the product line to include Bari-Belt™And Barry.
Band™, A series of abdominal straps designed for baristas and bands to accommodate patients of all shapes and sizes.
In 2015, UTMD was licensed by the FDA to Mark ETA\'s new mechanical cervical ripening device, vx-
Mature™The catheter, designed to mechanically improve the sensitivity of the cervix of pregnant women in the middle of pregnancy, medically induced labor in these patients. The CVX-
Mature using two adjacent tapered silicone balloons, similar to the shape of the hourglass.
This design is designed to allow clinicians to gently apply internal pressure to the cervical canal as well as to the internal and external OS, reducing the time required for induction and the total time required for successful vaginal delivery.
Neonatal intensive care unit
Hood™The DISPOSA-
The hood is the infant breathing Hood used in the NICU to give oxygen to the newborn and rinse carbon dioxide (carbon dioxide)
While maintaining a neutral thermal environment (NTE)
It is essential for proper physiological response. The DISPOSA-
The cover, placed on the head of the baby, includes a circular diffuser connection specially designed to disperse the incoming gas along the inner surface of the cover, rather than letting them blow directly to the baby\'s head.
The design allows for more accurate FIO2 (
Fraction of oxygen)
Control, minimize the convection heat loss of the head, eliminate co2 by ventilation to provide the best flow rate, and allow humidifying. DISPOSA-
Compared to the incubator, Hood can access and visualize the underdeveloped baby well.
Because it is a one-time product, it can also prevent potential cross-contamination that can occur in the incubator.
Less invasive than nasal catheter
The Hood avoids the potential damage to the nasal/oral trachea tissue and facial tissue of fragile premature infants, as the catheter is usually fixed with adhesive tape.
The nasal catheter itself cannot provide NTE.
Deltland®The DELTRAN blood pressure monitoring system of PLUSUTMD has been specifically adapted to the use of icu.
Streamline eliminates the needles used for blood sampling, avoids the loss of blood volume in scarce newborns, and provides a closed system to reduce the risk of infection.
The system has excellent clearingvolume visualization and one-handed use.
UTMD continues to customize the Deltran suite for specific hospital applications.
GESCO®In the third quarter of 1998, UTMD acquired Gesco International\'s newborn product line.
Known for its best biocompatible silicone catheter, GESCO has gained an early and unique reputation for its focus on tiny, critically ill special development needsill babies.
A catheter called an umbilical cord (UVCs)
It is specially designed for entering the inferior vena cava through the cord blood tube immediately after the birth of the baby to inject important drugs and liquids.
Due to the small size of the newborn and insufficient vascular development, there is no better way to contact the vital organs.
These ducts are also called umbilical artery ducts (UACs)
When placed in a umbilical artery, blood pressure is measured by blood analysis or metabolic processes are monitored.
When developing its navel
Kass™Gesco\'s product line takes the lead in using a soft, bio-compatible silicone catheter that helps reduce the number of inserts required and other complications associated with invasive applications.
UTMD has expanded the UVC product line, including flat heads made of proprietary thermosensitive polyurethane (Tecoflex®)
This provides many flexibility and biocompatibility advantages after silicone insertion, and many clinicians prefer the rigidity of polyurethane.
In addition, GESCO provides a convenient conduit program tray for placing UVC tubes as well as instruments and supplies required to perform other similar procedures.
3 The main difference between GESCO products is that they are developed according to the special needs of newborns, not just cutting
Down or smaller versions of adult devices.
For example, in the case of invasive catheter, the importer, the soft rounded distal tip, is fixed to the patient\'s mode after insertion to avoid migration, luer-
The smallest locking wheel hub with dead angle, the number of lumens, opaque stripes of catheter rays for visualization, variations in catheter length and diameter, and special packaging are all features designed for newborns.
UTMD continues to modify the product functionality to incorporate the preferences of current neonatal physicians.
The soft, biocompatible silicone catheter concept has important advantages in other applications, including central venous catheter inserted around (PICC lines)
The drainage catheter of the intestinal nutrition tube, urinary drainage tube and chest.
GESCO developed and sold the initial version of all these newborn products.
In order to keep up with the trend of taking care of small babies, UTMD has added a smaller version of URIKass®And Jade GirlCATH® products.
At the request of a customer who prefers to insert a harder catheter, UTMD added Tecoflexpolyurethane oral-
Connecting Jade only
2009 Cath series.
In 2000, UTMD obtained the FDA\'s pre-market license to approve a series of PICC Property insurance products specifically designed to minimize the trauma of critically ill newborns, called PICC Property Insurance-NATE®. The PICC-
NATE product line is designed based on input from experienced neonatal medical practitioners for long term
Disposable catheter system
Therapeutic central venous infusion and blood sampling for drug solutions, blood products or other liquids.
Soft and sturdy silicone PICC-
Nate has two diameter sizes and two hub configurations.
At the beginning of 2003, UTMD added the Tecoflexpolyurethane version, which provides many flexibility and biocompatibility advantages of the silicone after insertion, and many clinicians prefer the rigidity of polyurethane.
In 2006, UTMD developed a unique type of gut feeding
Only extension set named NUTRI-
Music®This addresses important safety risks in the NICU-accidental connection to the IV line, and accidental disconnection of the system components that span the distribution container through the infusion catheter.
October 2007, UTMD in its NUTRI-CATH/NUTRI-
LOK family of intestinal feeding devices.
In 2008, UTMD expanded NUTRI-
GI system with special extension device for GI tube and continuous connection to fluid pump.
In 2009, UTMD added a kangaroo bag for larger feed along with other nutrientsMusic accessories.
In 2011, UTMD added changes to the adapter and extension set used with NUTRI-CATH.
Recognizing the important need to prevent eating by mistake or medication by mistake, the FDA issued the final guide on February 2015, \"mitigating the safety considerations of the risk of small hole connector connection errors for intestinal applications.
\"This guide includes ISO 80369-compliant-
3 Standard connectors.
This new standard was released to create a universal connection that is not compatible with luer connections or any other type of small hole medical connector.
In 2016, UTMD launched a family of alternative intestinal feeding devices containing ENFit™ISO 80369-
3 compatible connectors.
These purple connectors replace the current Nutri-
Lok connectors on conduit and extension devices.
UTMD also distributes ENFit oral syringes.
On 2006, UTMD completed the replacement of all DEHP plasticizer PVC materials in its Gescoproduct line that may be in contact with neonatal patients, addressing another safety related to possible dysplasia in male newborns
Other special products of GESCO include one-time peritoneal dialysis (PD)
Set of apre
Assembly, aseptic, closed system called DIALY-NATE®.
PD is an ideal way to help with impaired renal function in newborns
Sick pediatric patients may not have enough blood volume to support hemodialysis. DIALY-
NATE is provided in the form of allowing the timely implementation of PD.
In 2008, UTMD added a dial-up
NATE version that can be used with various fluid heating systems.
In 2010, UTMD introduced a fork system that allows for a larger manual pdapplication.
Additional custom configurations have been added since 2013 to meet specific clinical preferences.
4 Other Special NICU equipment includes a silicone oral protection device for the Prevention of breath tube (called PALA-NATE®; a pre-
Assembled closed urinary drainage system called URI
Kass®, Which reduces the risk of infection and precious care time, and provides a waist sampling kit with special features
Beveledneedle, which takes a sample of spinal fluid, is called spinal cord-NATE®.
HEMO, GESCO\'s first patented product-
Nate®, Is a disposable filter designed to remove microaggregates from stored blood before entering the newborn
The blood vessels are developed and the total blood volume is small.
In 2001, UTMD introduced a new filter and an improved blood bag spike for HEMO-
Nate, a version with no requirements.
UTMD hopes to continue to improve and expand its newborn product line to enhance its reputation as the most reliable and promising product
The NICU offers friendly professional products.
Department of Gynecology/Urology/electrical surgery®LeTV system (
Ring resection of transformation area)
For the removal of cervical epithelial tumor (CIN)
Other lower genital lesions related to human HPV (HPV)infections.
Electric Knife surgery for stopping bleeding has become the standard care for HPV cervical infection treatment, replacement of cold knife, laser and freezing treatment procedures, because it is economical, safe, effective and easy to operate, there are fewer potential side effects and few doctor training.
A major incentive to perform a theLETZ operation is that it can use local anesthesia in the doctor\'s office, thus eliminating the time and cost of access to a hospital or surgery center.
Compared with laser, the most important thing is clinical (Tissue ablation)
Frozen treatment (
Frozen tissue)
, LETZ provides fine tissue specimens for pathological evaluation.
UTMD\'s LETZ system includes disposable electrodes®Electrical surgical generators and various other components.
The disposable loop electrode used to remove tissue samples is a pencil-like tube with a fine tungsten wire loop.
The circuit is available in a variety of sizes and includes safety meters®This allows doctors to accurately monitor and control the number of tissue removed.
Too much tissue removal can affect fertility and lead to premature birth.
UTMD continues to expand its professional electrodes.
For example, the company has introduced a patented cone-cut electrode called C- con Tube disease
LeTV®, Designed to limit the removal of healthy tissue margins that may impair sufficient cervical function.
UTMD will also continue to provide other components to expand the use of its market
Leading professional electrodes with electrical surgical generators from other manufacturers.
More than 20 years after listing, in 2012, UTMD completed a major redesign and was certified by the latest EN 60601 international safety standard for FINESSE electro-surgical generators.
Sophisticated design includes decentralized pad contact monitoring to improve the safety of patients and improve the circuit controlled by the computer
Provide accurate tissue sample output for tissue pathology, more efficient output stage, less heat generated, longer life of electronic components, the update of the electronic components reduces the number of components required and increases the service life, and provides an internal filter that is easy to replace for the overall smoke evacuation, a unique feature of FINESSE.
UTMD obtained the pre-listing license of fda finesse in January 2013.
Excellent generator;
Special circuit, Ball, needle electrode;
FILTRESSE®Evacuation personnel;
Other special electrodes;
Other UTMD supplies and gynecological tools;
Female Care Car and kanulai;
Laparoscopic instruments and accessories for female care.
UTMD is licensed by the FDA to bring its electro-surgical systems and tools to market for general surgical applications such as dermatology, plastic surgery and ENT.
In 2002, UTMD launched the super
Fine pointed Micro Needle called OptiMicro™Needle.
These Electrosurgical needles are small-
Application of scale plastic surgery and reconstruction surgery.
In 2009, UTMD added an extended length OptiMicro needle version useful in certain head and neck surgeries.
FILTRESSE is a position.
A separate surgical smoke filtration system that combines high filtration efficiency, low cost and convenient use in a surgical office environment.
Other electro-surgical tools and accessories include disposable electro-surgical pens, dispersion pads, foot switches, filter packs, speculators, hooks, tweezers, tenacula and hooks.
UTMD has gained a unique reusable four
The Way expander system, which helps to enter the cervix and visualize the cervix, eliminates the need for less effective spots and side tractors.
At 2007, the OptiSpec was developed by UTMD®A patent Super
In the examination, Pap smear and other vaginal surgery that requires direct cervical visualization, bright light allows the cervix to be visualized without the need for a doctor\'s distraction and without the use of a colposcopy.
In 2011, UTMD obtained tube needles and sleeves designed by Femcare for single patients using shielding, flawless, optical flawless, blunt and chest.
In addition, UTMD obtained Femcare\'s laparoscopic instrument series and accessories, which include instruments suitable for all routine laparoscopic procedures requiring anatomy, cutting, grip and coagulationg.
, Monopolar scissors, all kinds of grip pliers, anatomical pliers, L and J hooks, spatula, Veressneedles, suction and rinse pipes, inflatable pipes and connectors, pressure input bags and control valves
5 epitome®EPITOME is an electric surgical knife that minimizes thermal side effects while surgically removing and stopping bleeding, providing precise performance.
If rapid and accurate anatomy of dense tissue is required, such as breast shaping or abdominal shaping, UTMD believes that EPITOME does not have a close alternative.
In addition, an independent study concluded that EPITOME scalpel had significantly improved wound healing compared to other devices.
EPITOME allows for rapid incision without reverse traction, resulting in a limited incidence and reduced postoperative
Better surgical pain and beauty.
EPITOME is useful where minimizing thermal tissue damage is important but needs to control bleeding.
In 1998, a flexible version of EPITOME with smaller active electrodes was introduced.
Designed to significantly reduce the chance of tissue burns due to inadvertent contact with the electrodes, and require smaller, curved surgical knife tips, the miniature of which can be bent has special value, E. G. g.
The thoracic surgeon who harvested the intra-breast artery during coronary artery bypass surgery, as well as the otolaryngology doctor who underwent tonectomy or suspension.
Faith®As part of the acquisition of Femcare in March 2011, Clip SystemUTMD acquired the FILSHIE Clip system.
In 2018, UTMD accounted for 35% of total U. S. Sales. S.
Sales in dollars
FILSHIE clip is a female surgical contraceptive device for tubal ligatione.
, Usually placed on the fallopian tube, but also in the postpartum C-
Segment program.
Over the past 37 years, the FILSHIE clip has been implanted in more than 6 million women around the world, and experience has shown that it is the safest and most effective tubal occlusion device, as with any alternative surgical technique, isas is easy or easier to achieve occlusion, and compared to all other methods, this method has a higher reversible probability for women who later decide that they may want to get pregnant.
Femcare has received many regulatory approvals for the FILSHIE Clip system, which was sold directly by UTMD to medical institutions in Canada, Ireland, France, the United Kingdom and Australia in 2018 and through the inclusion of CooperSurgical Inc. professional dealers in many other countries. (CSI)in the U. S.
On February 2019, UTMD obtained exclusive sales rights from CSI and will start selling the FILSHIE clip system directly to medical institutions in the United StatesS.
There are several methods for tubal ligation, with different degrees of effectiveness, safety and opportunity to choose from.
The traditional method of tubal ligation, which is informally called \"tying the fallopian tubes\", is a female sterilization operation in which the fallopian tubes are cut off and sealed, permanently blocked or squeezed off.
If sterilization is performed after delivery, Pomeroy technique is usually used.
During this process, a small ring of the fallopian tube is stitched and the top is removed by cutting.
The traditional method of interval sterilization is to use a bipolar knife (electrocautery).
In this way, when applied to the fallopian tube, the current flows between the clamp tips.
This current then \"burns\" part of the fallopian tube shutdown.
Bipolar thermotherapy has a higher incidence of ectopic pregnancy, which is a life
There are threatening complications compared to other methods of tubal blockage.
Although these common methods are relatively easy to operate, it is reported that the failure rate of these methods is about 3%, which is defined as the percentage of patients who have experienced subsequent pregnancy.
FILSHIE clips that can be used at any interval (
Between menstruation)or post-partum (
Postpartum)
, At least equally easy to use, and an order of magnitude lower than the failure rate of bipolar knife and Pomeroy technology.
In addition to the double-polar burning and Pomeroy technology, there are Falope rings for other mechanical equipment (orYoon Ring)
And the Hulka clip.
The failure rate of both old methods is higher than that of FILSHIE clips, with more post-
Pain in surgery, which is usually abandoned, is switched to other sterilization techniques.
Sterilization with the Falope ring also reduces the chance of a successful reversal.
In recent years, hysteroscopy Sterilizer has been introduced as an alternative to laparoscopic tubal ligation.
These devices are Adiana of Hologic Inc and ESSURE of Concept Inc. (
Acquired by Bayer in 2013).
Both of these devices are no longer sold by nerve implants;
Adiana stopped operating on 2012, and ESSURE stopped operating on 2017.
Before Bayer stopped releasing ESSURE, the device had received a lot of negative publicity about unwanted side effects, especially from patients via social media.
Unfortunately, because both filshie clips and ESSURE are devices implanted through surgery, designed to achieve sterilization through tubal blockage, some readers of the media mistakenly concluded, the negative effects of ESSURE also apply to FILSHIE clips.
UTMD wants to explain to shareholders why this association is incorrect.
In particular, in thousands of implanted ESSURE devices, thousands of women complain about the possibility of self-immune reactions, allergic reactions to nickel, and/or severe chronic pain.
These symptoms do not apply at all to FILSHIE clips because the ESSURE device and FILSHIE clips are very different in design and use.
ESSURE has a metal coil with a tip that can be perforated, with nickel composition, hysteroscopy (
There are some difficulties and risks of unwanted physical injury)
Within the fallopian tubes, over time, this causes scar tissue to grow around the fallopian tubes and clog the fallopian tubes.
The FILSHIE clip is clipped to the tube, under laparoscopic or in C-
In part, in addition to the normal risk of laparoscopic surgery, patients have little chance of injury.
There is no nickel in the FILSHIE clip.
However, there is indeed a small amount of nickel in medical grade silicone and titanium, which is globally recognized as the most suitable biological material for human implantation.
A toxicology study by a well-known microbial biology company confirmed that the amount of nickel found in the FILSHIE clip was significantly lower than the amount of nickel in normal drinking water and food.
Plastic surgery implants, for example, are usually made of a large amount of titanium.
In millions of times of use, several patients complained about suspected allergic reactions to the FILSHIE clip (
Including patients who are allergic to copper, there is no copper in the FILSHIE clip)
But there is no such report in the clinician or in the clinical literature.
Pain usually associated with any laparoscopic surgery is usually relieved within 48 hours and will not be severe or become chronic unless the infection causes it.
Sterile FILSHIE clips are provided to the surgeon in a validated sterile package.
However, pain is the most common (but rare)
FILSHIE complaints.
Among women who reported implant fragments with chronic pain, several other gynecological symptoms that were not related to FILSHIE fragments were also present.
For a person experiencing pain, the obvious way she is associated with the implanted device is to remove it.
ESSURE requires very professional surgical techniques that are difficult to remove if not impossible.
In contrast, given the widely available imaging and normal laparoscopic techniques at present, FILSHIE clips can be removed safely, despite the need for removal. A well-
Known and clinically reported potential side effects of FILSHIE clip tubal ligation of isclip migration.
After clamping the fallopian tube for tissue necrosis under clamping, it is finally separated into two permanently closed stubs.
The abdominal tissue usually encapsulates the implanted clip when in contact with the farnoba tube.
In the case of slow encapsulation of certain tissues, the migration of the clip occurs after sterilization.
Although the silicone lining of the clip helps prevent clip migration and reduces the risk of fallopian tube regeneration, a clinical journal showed that migration took place at 6%. Dr.
FILSHIE, the inventor of the clip, expressed his view in 2002 that more than 25% of patients will experience the migration of one or more clips, usually in the abdominal cavity.
Once separated, the clip is usually surrounded by dense sticky tissue, without any symptoms, and rarely causes any complications.
However, a low-level inflammatory response can occur.
Since the clips are biologically inert and relatively small, doctors often conclude that removing the migrated clips is more risky for long-term health
Instead of leaving it in the body
Utmd recently hired the clinical experts he in 2010 published the natural 20-
Annual review of all reported FILSHIE clip migration events in the UK literature, in order to independently review all reported complaints contained in the us fda maude website and Australian tga daen website in the last decade.
In his written report of February 2019, he generally stated that \"there is no serious clinical or life
Threat complications directly or indirectly related to FILSHIE fragments or their migration.
In conclusion, shareholders of UTMD should believe that FILSHIE clips is a very safe and effective method of tubal blockage. The U. S.
FDA released a FILSHIE clip for marketing in the USS.
In 1996, after a prospective clinical trial involving 5,454 women implanted with FILSHIE clips, PMAsubmission.
On 2016, the FDA approved the use of Femcare\'s Sterishot disposable applicator to apply FILSHIE clips.
The applicator is a precision instrument that is used to close the FILSHIE clip implanted on the fallopian tube to achieve the correct permanent tubal ligation.
The reusable applicator requires additional processing, cleaning, re-sterilization and storage, and these operations may damage or misplace delicate mechanisms.
Regular maintenance and re-calibration are required in a timely manner.
In addition, repeated use of surgical instruments is possible if there is no proper cleaning and re-disinfection between the two operations.
Pre-calibrated single
The use of sterile Sterishot eliminates these safety, effectiveness, and cost risks.
It has been more than eight years since being introduced to the United States. S. (OUS)
, Patented Sterishot is used in most FILSHIE clip ligation procedures, but is not sold effectively by CSI.
Starting in February 2019, UTMD began direct marketing of the FILSHIE editing system in the United States. S.
Preferably in the form of a Sterishot kit.
Pathfinder PLUS 7™Pathfinder PLUS is a proprietary endoscopic Flushing device that allows uro/gyn surgeons to rinse directly with the same hand that controls the endoscope, clearing the field of view, there is no need for a separate assistant to do irrigation without visualization.
One of the successful surgical examples found by Pathfinder is the ablation of stones under the urethroscope.
Additional super professional organizationa-
Cath introducer is a female care device designed for simple and safe superconductive entry of bladder drainage ducts.
Superior pubic duct insertion is generally good
It is considered to be a drainage method with fewer complications than urinary tract intubation.
In 2013, UTMD launched the ultra-professional organization program suite with additional featuresa-
Now, UTMD distributes Cath introducer directly to end users in the United States. S.
Under the trade name of \"above\"Foley”.
Freedom®SystemLIBERTY is a device for conservative treatment and effective control of urine control in women.
UTMD believes that freedom is the simplest. to-
The use of the most cost-effective treatment of urinary incontinence can not only provide cover, but also produce therapeutic effectsup.
LIBERTY consists of a battery-powered electrical stimulation device and a vaginal electrode probe.
This physiotherapy technique can be performed in the privacy of the home, including passively strengthening the muscles around the urethra.
Pulse, low pressure, and high frequency current are mainly applied to the muscle tissue of the genital nerve, resulting in muscle contraction in the pelvic region, resulting in better muscle tension.
Since electrical stimulation does not have known adverse side effects, LIBERTY provides an effective, lower-cost, and lower-risk alternative treatment for women with mild to moderate incontinence, such as surgery and medication.
Tube cavity™In collaboration with the Mayo Clinic, UTMD developed an advanced endometrial tissue sampling spoon in the doctor\'s office.
The sampling procedure is mainly to exclude pre-menopausal women with abnormal uterine bleeding or pre-cancerous changes in women with post-menopausal bleeding.
The device is part of a class of catheter and is designed for non-expansion of the cervix and non-general anesthesia.
This device is related to its small size and its inherent weakness is that it may not have removed enough endometrial tissue for accurate histological evaluation compared to more invasive D & C hospital procedures.
The tip of the EndoCurette is specifically designed to obtain a more thorough tissue sample than the other catheter used, without the need to expand and without increasing patient discomfort. TVUS/HSG-
Kass™To further evaluate persistent abnormalities or dysfunctional uterine bleeding and other suspected uterine abnormalities, or as the next step after sampling with the ure tube for the endometrium tissue, gynecologists can use ultrasound imaging of the vaginal uterus.
TVUS/HSG for UTMD-
Cath was designed and released for the 2007 market with the aim of providing effective cervical occlusion, allowing uterine expansion to differentiate the anterior and posterior endometrium, as well as other irregularities, along with minimal visual obstruction of the uterus near the internal OS.
Also, TVUS/HSG-
Cath can be used for radiation examination of uterine fallopian tube angiography to evaluate the smoothness of fallopian tubes.
A related device obtained in 2011 was Femcare\'s Spackman-type uterine sleeve, which was designed to operate the daughter Palace and the injection body to test the smoothness of the fallopian tube.
Luming®Luming®Is a gynecological tool developed by UTMD for reliable and safe manipulation of the uterus during laparoscopic surgery.
LUMIN combines the strength, range of motion and versatility of high-end reusable instruments with the low cost and cleanliness of cheap, poorly functional disposable instruments on the current market, at the same time reduce the number of tools needed to move and fix the uterus.
8 Blood Pressure Monitoring: DELTRAN®Disposable pressure sensor (DPT)
In pressure monitoring, the sensor is used (mechanical)
The pressure of the electrical signal displayed on the electronic monitoring device.
UTMD develops and is distributing its disposable sensors as a stand-alone product and as part of a sterile blood pressure monitoring kit through directpresentatives and other medical companies in the United StatesS.
As well as independent distributors and other medical device companies.
The Company believes that the deltran dpt designed and currently produced more than 30 years ago remains the standard in terms of accuracy, reliability and ease of use.
Launched in 1998, deltran plus provides a closed blood sampling system that reduces the risk of uninfected patients and doctors without using needles.
In 2009, UTMD, together with other NICU equipment, continued to configure the newborn Deltran custom kit to meet the special needs of keeping limited blood volume and protecting the newborn from infection.
Pressure Monitoring Accessories, components and other molded parts.
Components included in the blood pressure monitoring kit configuration include flushing equipment, Cocks, fluid management devices, bottle caps, pressure tubes, interface cables and organizers.
The company sells similar components designed for other medical device company applications that combine UTMD\'s technology and design. DELTA-
CAL™Is a calibration device used to check the normal operation of the arterial pressure system.
In addition, UTMD sells plastic molded parts to many medical and non-medical institutions under the subcontract
Medical device company
In addition, UTMD, with its excellent quality system and iso13135 certification, subcontracted assembly, testing and packaging of proprietary components from other medical device companies.
UTMD believes that this approach helps to make better use of its investment in fixed plants and equipment and to diversify indirect costs, thereby increasing the gross profit margin for the sale of finished equipment.
Marketing and competitor utmd divides its sales into \"domestic\" U. S. S.
Sales and \"outside of the United StatesS.
\"Sales, which is sales of finished equipment and components to entities outside the United StatesS. 1)Domestic sales.
Domestic sales for terminals
Users of finished equipment, marketing work is complex and decentralized.
UTMD\'s marketing focus is on clinicians who are primarily responsible for obtaining the best patient care results through clinical conferences, trade shows and the Internet.
In the competitive bidding process, UTMD mainly cooperates with the administrators responsible for hospital procurement decisions.
The competition for UTMD is mainly based on the improved safety of patients and reliable equipment performance of trained clinicians.
Many UTMD devices are strong brands because they
Considered clinically different by clinicians, it has been in use for decades.
The finished equipment that UTMD provides extensively includes dozens of special equipment types.
Although there may be only a few competitors of each type, in general, UTMD has dozens of US competitorsS.
Medical device competitors
Of each device type in UTMD, at least two competitors have a huge market share.
In general, due to the differences in design and reliability of UTMD, the competitor\'s equipment represents a replacement, not an equivalent device.
The company\'s main marketing challenge is to keep customers focused on these differences and their important clinical benefits.
In recent years, UTMD has entered the US market. S.
Hospital clinicians are increasingly restricted and their participation in medical device purchase decisions that are critical to the company\'s success has declined.
To the extent of the United StatesS.
Instead of focusing on patient safety and clinical outcomes, hospitals focus more on outpatientof-
The competitive position of UTMD has been weakened.
In 2018, UTMD sold components and finished equipment to 152 other companies in the United States. S. (OEMsales).
Over 40 years, the company has used its manufacturing capabilities and engineering knowledge
How to produce high quality components and finished equipment for other companies. For U. S.
Companies looking to sell products outside the United StatesS.
UTMD maintaining the certification of the current ISO 13485 medical device quality standards is an important benefit.
UTMD sites that list their capabilities are often the basis for new OEM work contacts.
Although there are other manufacturers in the United States. S.
With similar manufacturing capabilities, UTMD\'s main competitors come from manufacturers of equipment components in Eastern Europe, India and China with much lower wage structures.
To some extent, the United StatesS. Dollar (USD)
In any period of time, the exchange rate of UTMD against foreign currency will rise, the cost capability of UTMD-
Competition with foreign manufacturers has weakened. 92)Outside the U. S. (OUS)sales.
OUS sales in 2018 accounted for 50% of total sales in the US dollar, compared with 51% in 2017.
Since UTMD\'s subsidiaries distribute equipment directly to medical institution OUS, the OUS sale of 2 out of 3 is invoiced in foreign currency.
In addition, the expenses of foreign subsidiaries are calculated in the national currency.
Therefore, changes in foreign currency exchange (FX)
Interest rates could have a significant impact on the US dollar for UTMD
Report financial results.
Until 2011, with a few exceptions, UTMD was sold to other medical equipment companies and distributors, not clinical end-user institutions.
After the acquisition of Femcare in 2011, UTMD began the transition to direct marketing for end users in countries where FILSHIE\'s editing system has received significant acceptance.
This also increases distribution opportunities for other UTMD equipment that previously had no significant third-party dealer interest.
In 2018, UTMD was distributed directly to medical institutions in Canada, the UK, France, Ireland and Australia.
In addition, the company\'s equipment is also sold in other countries through more than 270 independent regional distributors.
The information provided by UTMD\'s website often results in unsolicited contact from OUS entities.
An important success factor in the medical device industry is access for medical practitioners. In the U. S.
Organization of hospital supplier Environmental CorpsGPOs)
Or their equivalent.
According to the evaluation of UTMD, the United StatesS.
In terms of professional medical equipment, the hospital currently does not save costs based on GPOcontracts, which can reduce complications, utilization, clinician time and unwanted side effectsof-
The broader issue of medical expenses is ignored.
Long-term overall cost of care in the United StatesS.
Due to unnecessary regulation and other purely administrative burdens, innovative suppliers are excluded from the market and the quality of care will continue to improve.
The amount of time and administrative steps required to evaluate new products used in hospitals has increased significantly.
As UTMD launches new products that it considers safer and more effective, as a potential negative factor in future performance, it may be excluded from certain customers due to the existence of a long-term supply agreement for existing products.
UTMD may also not be able to establish a viable relationship with other medical device companies that do have access to users but lack interest in the company\'s approach or require a financial or administrative burden. When U. S.
Hospital customers require UTMD to provide its equipment through the national distribution company (also known as Med/Surg distributors.
Sales to Med/Surg distributors in 2018 accounted for 14% of the total domestic direct sales (
Does not include FILSHIE clip system sales to CSI). In the U. S.
Canada, Ireland, France, the UK and Australia, UTMD sells its products with the support of its directly hired customer service and sales team, independent consultants and selective independent manufacturer representative.
Direct sales reps focus on customer training and support for UTMD device applications that may be important.
Direct sales personnel include \"external\" reps operating remotely in a specific geographic area and \"internal\" reps operating primarily through the company\'s office telephone.
The direct representative was trained to understand the medical procedures being performed within the UTMD clinical focus.
By using one of it-on-
In a contact with doctors and other clinicians directly involved in patient care, the direct sales department will position UTMD as a market leader in obtaining specific solutions to clinical problems.
In addition to direct representation, UTMD also uses third-party consulting clinical experts to expand its client training programs.
In addition, UTMD sells parts and finished equipment to other companies for use in its product line.
This OEM distribution channel only maximizes the manufacturing capabilities required for UTMD\'s main business and does not compete or dilute with UTMD\'s direct distribution and marketing programs.
The company distributes directly to end-user agencies in Canada, the UK, France, Ireland and Australia and sells to more than 270 regional distributors and OEMs (
Other medical device manufacturers and/or distributors)
In hundreds of countries.
In 2016, 10% of UTMD\'s independent OUS distributors accounted for 79% of UTMD\'s indirect sales2018.
New product development is a key factor in UTMD\'s market identity.
Development takes several interrelated forms: 1)
Improve, enhance and expand the current product line according to clinical needs or the requirements of clinicians, 2)
Introduction of new or enhanced equipment with significant improvements in safety, effectiveness and/or total cost of care, 3)
Acquire products or technologies from others.
Manufacturing process development is also an important aspect, which is inseparable from the successful design and development of equipment.
Thanks to UTMD\'s reputation as a dedicated product developer, its financial strength and established clinician user base, it has gained an influx of new product development concepts.
In the Opportunity survey, internal development, joint development, product acquisition and licensing arrangements are all viable options.
Only a small number of ideas have passed the feasibility screening.
For internal development purposes, the project is assigned to a project manager who brings together a cross-domain, cross-domain
Function development team.
The team\'s goal is to have clinically acceptable, manufactured and regulated
Products released before a specific date are ready to go public.
Depending on the level of resources required, UTMD is working on several projects at any given time.
Only projects signed by fewassigned can successfully obtain products that meet all the company\'s standards.
In particular, this includes a highly reliable, easy-to-use, low-cost product
Effective, safe, useful and different from competition.
Regulatory level 3-once aproduct has been developed, tooled, fully tested and applied-
Unobservable inputs of assets or liabilities, which are valued on the basis of management estimates of assumptions that market participants will use when pricing assets or liabilities.
The table below provides financial assets measured at fair value for the past two years as of December 31: Level 1, Level 2 and Level 3 total 201820172018201720182017equities $-$80--$-$80Total$-$80--$-
None of the company\'s financial instruments at $80 are current assets and liabilities that can be traded at any time for trading purposes.
For details of the investment, see note 4 above.
The company estimates that as of December 31, 2018, the fair value of all financial instruments does not differ materially from the aggregate face value of the financial instruments recorded in the consolidated balance sheet.
Note 6-Property and equipment includes the following: $1,653 for land, 1,339 for construction and improvement, 75215,350,003 for furniture, equipment and tools 15,696 building-December 31-in-
Accumulated depreciation of 54932,398 (21,190)(20,777)
Property and equipment, Utah Medical Products Limited, net $10,359
Notes to Consolidated financial statements as at December 31, 2018, 2017 and 2016-Property and equipment (continued)
The Company\'s consolidated balance sheet includes its assets in manufacturing and management facilities in Utah, Canada, the UK, Australia and Ireland.
Property and equipment by geographical area are as follows: December 31, 2018S.
And British and canadaaustraliairelandtotalland $621 $639 $393 $1,653 building improvements6 3483,2054 19913,752 furniture, equipment and tooling14 1047651,13416 003Construction-in-progress141--
141total 21,2144, 6095, accumulated depreciation of 72631,549 (17,475)(531)(3,184)(21,190)
Equipment properties net $3,739 $4,078 $2,542 $10,359 December 31, 2017 U. S.
$926 & England & Canada-
$413 $1,339 buildings and improvements s6, 5834,3614, 40615,350 buildings-14515,696 furniture, equipment and tools 14, 1244271-in-progress103-
Accumulated depreciation (96432,398)17,270)(346)(3,161)(20,777)
Property and equipment, net $4,373 $4,445 $2,803 $11,621
Term debit note 8-commitment and emergency leasing company have a lease agreement for land adjacent to the facilities in Utah for a period of 40 years, starting from 1991 months.
In September 1, 2001 and after every five rental years, the basic rent has been and will be adjusted according to the published changes in the price index.
The company also leased a car for an employee in Ireland, and before late207, the company leased its UK factory.
Under these operating lease agreements, for the year ended December 31, 2018, the rental fees charged to the operation were approximately $59, $160 and $175, respectively, at 2017 and 2016.
As of December 31, 2018, the future minimum lease payment under its lease obligations is as follows: Year as of December 31: amount2020612021612022345after344
Notes to Consolidated financial statements as at December 31, 2018, 2017 and 2016-commitments and contingency expenses (continued)
On December 31, 2018, the company signed a final agreement with CSI to purchase the remaining 4 CSI vehicles.
Exclusive America for 75 yearsS.
The issuance rights of the Femcare FILSHIE editing system are $21 million, and CSI resale stocks are about $2 million.
The deadline is February 1, 2019.
In addition, the company is obliged to purchase raw materials for the manufacturing business.
The company has the right, among other things, to make changes to the quantity of purchases, the delivery schedule and the acceptance of orders.
The company is a product of its own ability
Product liability risk insurance.
\"Product Liability\" is an insurance industry term used for legal defense and for damages that may be caused by the use of company products in procedures that cause injuries to patients.
The Company reserves for product liability litigation and damages consistent with the previous long termSemester experience.
Actual product liability litigation costs and damages for the last three reporting years are not important, which is consistent with the company\'s overall history.
The company bears the cost and trouble of clinical training-
Shoot on it
Operating expenses.
Warranty terms the warranty terms published by the company are: \"UTMD guarantees that its products meet all published product specifications effective on the date of shipment in all material respects, and there are no defects in materials and processes in 30 years (30)
Number of days supplied, or 20 daysfour (24)
The equipment is several months from the date of shipment.
During the warranty period, UTMD shall, at its sole discretion, replace any defective product reasonably satisfied with UTMD free of charge or refund the purchase price.
\"UTMD maintains the warranty reserve to provide estimated costs that may occur.
Adjust the amount of the reserve as needed to reflect its actual experience.
Based on its analysis of historical warranty claims and its estimation that it is irrelevant to existing warranty obligations, no warranty reservation was made on December 31, 2018 -august 31, 2017.
The litigation company has been involved in the litigation, which is the expected consequence of the company\'s operation and normal business process.
At present, there are no lawsuits or threat lawsuits that companies believe the results may be critical to their financial results.
The company applies its accounting policy, and notes 9-Income tax deferred tax assets for legal costs that can be easily estimated (liabilities)
Including the following temporary differences: 20182017 inventory write-
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