What changed in this filing

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Item 1. Business

2021-03-31 compared with 2020-03-30 · 76 added, 74 removed, 279 unchanged (35% of the section changed)

Milestone Scientific is a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical, dental, cosmetic and veterinary applications.

Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets.

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It has specific medical applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures and intra-articular joint injections.

In 2020 the Company received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) related to its new CompuPulse System, which combines the benefits of our CompuWave technology with a manual syringe.

The new CompuPulse System allows one to identify a pulsatile pressure waveform in a variety of applications, thereby improving the reliability and safety of a drug delivery procedure.

Importantly, not all procedures require the sophistication of our CompuFlo system, which precisely controls the administration and flow rate of medication as it is being administered.

This new technology provides an efficient and low-cost alternative for procedures where a manual syringe may suffice, while still providing the ability to verify needle and subsequent catheter placement.

In 1997, Milestone Scientific released its first commercial product, the first computer-controlled local anesthesia delivery (C-CLAD) system, into the North American marketplace.

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We believe that we and our technology solutions are widely recognized by key opinion leaders (i.e., academics, anesthesiologists and practicing dentists whose opinions are widely respected), industry experts and medical and dental practitioners as a leader in the emerging, computer-controlled injection industry.

Milestone Scientific remains focused on advancing efforts to achieve the following five primary objectives:

Milestone Scientific remains focused on advancing efforts to achieve the following six primary objectives:

Establishing Milestone’s DPS Dynamic Pressure Sensing Technology platform as the standard-of-care in painless and precise drug delivery, providing for the first time objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications;

Safety of a drug delivery procedure.

Following obtaining successful FDA clearance of our first medical device in June 2017, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company;

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territories, Canada and in 60 other countries with FDA, CE, and other clearances.

Since receiving FDA clearance in 2017, our epidural devices have had minimal sales.

In 2020 our epidural devices, which received FDA clearance in 2017, have had minimal sales.

DPS Dynamic Pressure Sensing Technology;

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Pain and tissue damage often result from uncontrolled flow rates and pressure created during the administration of drug solutions into human tissue.

While several technologies have can control the flow rate, we believe our patented DPS Dynamic Pressure Sensing technology and CompuFlo Systems provide the ability to accurately and precisely control the pressure of the injection as well.

While several technologies have can control the flow rate, we believe our patented DPS Dynamic Pressure Sensing technology and CompuFlo Systems provide the control of pressure during the injection as well accurately and precisely delivery the drug.

We believe our DPS Dynamic Pressure Sensing technology and CompuFlo Systems provides the following benefits:

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provides a digital record of the time and volume of anesthetic or medicament injected;

minimizes tissue damage because the flow rate and pressure of the injection are controlled;

minimizes tissue damage do to the flow rate and pressure of the injection being controlled;

provides an integrated injection database of algorithms that have been defined which allow for the measurement of the exit pressure, containing the critical components of specific drugs, parameters of needles, tubing and syringes and all other pertinent components for the safe and efficacious delivery of medications;

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In November 2019, the Company and 3B Scientific, the world's leading supplier of didactic material for medical education, signed a global agreement expanding distribution of the CompuFlo® Epidural Trainer (CompuFlo Trainer).

The expanded agreement allows 3B Scientific to capitalize on momentum from strong interest in the CompuFlo Trainer at its unveiling at Euroanesthesia 2019 and the Association of Women's Health, Obstetric and Neonatal Nurses meeting, and gives more anesthesia instructors the ultimate solution to accelerate the epidural procedure's learning curve and trainee success.

The expanded agreement allows 3B Scientific to capitalize on momentum and gives more anesthesia instructors the ultimate solution to accelerate the epidural procedure's learning curve and trainee success.

The CompuFlo Trainer is an instructional instrument that uses Dynamic Pressure Sensing technology and objective intelligence to improve epidural placement by trainees.

The instrument links trainee tactile feel with visual and audible confirmation of real-time pressure changes to verify the epidural space has been reached.

In January 2020, the Company received a Notice of Allowance for a key patent from the U.S.

Patent and Trademark Office on its CompuWave technology, which is being integrated into the CompuFlo® Epidural System.

The Company is constantly evolving and innovating the technology.

This patent represents a significant achievement for the Company since it extends the IP protection around the CompuFlo instrument for another 20 years and provides not only additional confirmation of placement, but also verification during the procedure that the catheter has not been displaced.

In February 2020, the Company announced an abstract entitled "Confirmation of epidural catheter location by epidural pressure waveform recordings by the CompuFlo® Epidural Instrument (CompuFlo)," has been accepted for presentation at the prestigious Euroanaesthesia 2020 Congress which was to take place May 30 - June 1, 2020 in Barcelona, Spain.

Euroanaesthesia is Europe’s largest annual event showcasing the latest news and innovations in the field of anesthesia, perioperative medicine, intensive care, emergency medicine and pain treatment.

This international event gathers upwards of six thousand delegates from around the world.

The abstract will be presented during scientific poster sessions highlighting how CompuWave technology integrated with the CompuFlo Epidural System combines both objective in-line pressure measurements and the detection of a pulsatile pressure waveform in a single system.

However due to the continual spread of COVID-19, the Company’s presented at the prestigious Euroanaesthesia 2020 Congress virtual trade in Barcelona August 2020.

Moreover, also in February 2020, the Company introduced the new pre-assembled disposable kit for the CompuFlo® Epidural System that has received CE Mark approval in Europe through the Company’s supplier.

The Board of Directors of the Company believes that this CE Mark approval overcomes an important hurdle to commercialization in Europe.

Based on market feedback, it was evident that anesthesiologists using the epidural instrument preferred to have the disposable kit pre-assembled before packaging to save valuable minutes in the operatory.

On April 21, 2020, Milestone Scientific announced that it had validated and integrated the new CathCheck™ feature into the CompuFlo® Epidural System.

Using CathCheck™, physicians and nurses can monitor the placement of a catheter to determine the presence or absence of a pulsatile waveform (heartbeat) providing new information that can be used to determine if the catheter is in place or has become dislodged from the epidural space.

On May 13, 2020, the Company announced a study was published in the Open Journal of Anesthesiology validating the efficacy of the CompuFlo® CathCheck™ System to confirm the correct placement and positioning of an epidural catheter for use during and after an epidural procedure.

This is another validation that the CathCheck™ feature will help to significantly reduce time and cost for the institution by providing a more reliable way to re-check the catheter throughout the day to ensure that the catheter has not been displaced.

On October 13, 2020, Milestone Medical announced a Group Purchasing Agreement with Premier, an USA leading healthcare improvement company, utilizing an alliance of approximately 4,100 U.S.

hospitals and 200,000 other providers to transform healthcare.

The Agreement, which was effective November 1, 2020, allows Premier members, at their discretion, to utilize pricing and terms pre-negotiated by Premier for the CompuFlo® Epidural System and CathCheck™.

The Agreement expires on February 28, 2022.

CompuFlo Intra-Articular Computer Controlled Injection System

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Identification of the tissue, in which the needle tip is imbedded, is believed to be highly important in intra-articular injections and numerous organs, subcutaneous and intramuscular injections.

The intra-articular device has not obtained regulatory clearance in the US.

We believe our intra-articular injection device is particularly efficacious for arthritis patients who are obliged to endure multiple painful injections annually for a lifetime.

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however, we did not complete this process in 2019 due to a lack of funding.

We cannot provide assurances of when funds will be available to complete this process, and if funding becomes available, if ever, that we will receive FDA clearance for our intra-articular device.

We believe that the touch screen and other platform improvements embodied by our cosmetic device will form the basis for our next generation of devices.

The 2020 -2021 COVID - 19 Pandemic has substantially reduced access to many medical facilities for further research projects and as such, the Company has curtailed any further regulatory effort on this device.

We cannot provide assurances that we will receive FDA clearance for our intra-articular device.

Cosmetic Botulinum Injection Device

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Leveraging our experience in minimizing the pain of dental anesthetic injections, we established a joint venture in 2014 to develop and commercialize a device for the pain free injection of botulinum toxin.

The joint venture entity, Milestone Advanced Cosmetic Systems, Inc., is owned 50% by us and 50% by Milestone China Company Limited (“Milestone China”), a company organized under the laws of Hong Kong and owned 40% by Milestone Scientific.

The joint venture entity, Milestone Advanced Cosmetic Systems, Inc., was originally owned 50% by us and 50% by Milestone China Company Limited (“Milestone China”), a company organized under the laws of Hong Kong and owned 40% by Milestone Scientific.

Milestone China contributed $900,000 of cash to the joint venture, and we have provided a royalty-free license to utilize our technology to the joint venture to develop a botulinum toxin injection device.

In May 2020, Milestone Scientific finalized an agreement for the purchase of Milestone China’s 50% interest in Advanced Cosmetic Systems Inc., for the forgiveness of $900,000 in accounts receivable owed by Milestone China to Milestone Scientific (and previously fully reserved for), resulting in a noncash transaction.

Milestone China will have the option to repurchase the 50% interest in Advanced Cosmetic Systems within one year from the sale date for $900,000 in cash.

As a result of the purchase Milestone Scientific will own 100% of Advanced Cosmetic Systems Inc.

at the expiration of the option period.

In November 2017, we announced plans for the commercial launch of our proprietary cosmetic injection device using our DPS Dynamic Pressure Sensing technology platform and our CompuFlo Cosmetic System for delivery of botulinum toxin.

Our proprietary cosmetic injection device features improved needle placement with a comfortable stylus grip, precise dosing, the same technology platform that has made dental and epidural injections painless, and a new, intuitive touch-screen interface.

Although the Company received positive outcomes of multi-state human factor studies with targeted customers, the Company does not have the necessary capital to move forward with the commercial launch of our cosmetic device and applying for marketing clearance in Europe (CE clearance), and United States (FDA clearance).

Although the Company’s instrument has progressed beyond the development stage, additional capital is necessary to fund the regulatory process and, if approved the commercialization of the device.

To this end, the Company is currently in the process of pursuing additional capital, to pursue such regulatory process.

However, the Company can provide no assurance that additional capital will be available on acceptable terms, or at all.

We believe that the touch screen and other platform improvements embodied by our cosmetic device will form the basis for our next generation of devices.

Veterinary Nerve Block Anesthesia Device

The effectiveness of our veterinary nerve block anesthesia device (existing medical device) for such use was confirmed by a pilot study and final report completed by Cornell University, College of Veterinary Medicine.

Additional studies with other universities are in process with respect to horses and small animals.

We are exploring commercialization opportunities.

Although the Company received positive outcomes of multi-state human factor studies with targeted customers, the Company did not have the necessary capital to move forward with the commercial launch of our cosmetic device and applying for marketing clearance in Europe (CE clearance), and United States (FDA clearance).

The Wand STA System

In 2006, we received FDA clearance for our Wand/STA System and disposable handpiece, the first system utilizing CompuFlo’s DPS Dynamic Pressure Sensing Technology, for use in the dental market.

The Wand/STA System and handpiece continue to provide all of the benefits of the CompuDent System, allowing dentists to provide virtually painless injections for all dental procedures, including routine fillings, as well as more sophisticated implants, root canals and crowns, while better facilitating single tooth anesthesia (now generally performed with a high-pressure spring-loaded gun-like device), but also incorporates the "pressure feedback" elements of Milestone Scientific's patented CompuFlo ’s DPS Dynamic Pressure Sensing, thereby allowing dentists to administer injections accurately and painlessly into the periodontal ligament space, effectively anesthetizing a single tooth.

The Wand/STA System and handpiece continue to provide all of the benefits of the CompuDent System, allowing dentists to provide virtually painless injections for all dental procedures, including routine fillings, as well as more sophisticated implants, root canals and crowns, while better facilitating single tooth anesthesia (now generally performed with a high-pressure spring-loaded gun-like device), but also incorporates the "pressure feedback" elements of Milestone Scientific's patented CompuFlo ’s DPS Dynamic Pressure Sensing Technology, thereby allowing dentists to administer injections accurately and painlessly into the periodontal ligament space, effectively anesthetizing a single tooth.

Injections made by the Wand/STA System eliminate collateral numbness of the tongue, lips and facial muscles and often hasten the onset of anesthesia by eliminating the need for mandibular blocks.

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Additionally, the Wand/STA System was named one of Dentistry Today’s “Top 100 Products” for the third consecutive year in 2010.

Other Devices

At earlier stages of development are our products using CompuFlo ’s DPS Dynamic Pressure Sensing technology for less painful injections for use in rhinoplasty, colorectal surgery, podiatry and other disciplines.

Other Possible P roducts

Using CompuFlo ’s DPS Dynamic Pressure Sensing Technology for less painful injections for use in rhinoplasty, colorectal surgery, podiatry, and other disciplines are under review.

In the self-injectable market, there are many injectable drugs routinely self-administered in a home or office setting using spring loaded automatic injection devices by people who suffer from long term chronic conditions such as multiple sclerosis, rheumatoid arthritis, and other diseases of the auto immune system.

We believe CompuFlo ’s DPS Dynamic Pressure Sensing technology, using pressure sensing capabilities, can serve as a painless subcutaneous injection method for these self-administered drugs.

We believe CompuFlo ’s DPS Dynamic Pressure Sensing Technology, using pressure sensing capabilities, can serve as a less painless subcutaneous injection method for these self-administered drugs.

However, there can be no assurance that we will be able to successfully develop any such products, or that if developed, that we will be able to obtain FDA approval to market any such products, or even if we do obtain such FDA approval, that any such products will generate any revenue for us or be a commercial success.

Distribution and Marketing Arrangements

Our dental devices are sold in the United States, US territories, Canada and in 60 other countries abroad.

Our dental devices are certified to sell in the United States, US territories, Canada and in 60 other countries abroad.

In June 2017, we received FDA regulatory clearance to sell our first medical device, the CompuFlo Epidural Computer Controlled Anesthesia System in the United States.

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Dental Market

In the spring of 2009, Milestone Scientific signed a distribution and marketing agreement with China National Medicines Corporation, dba Sinopharm.

In early October 2012, the State Food and Drug Administration (“CFDA”) of the People’s Republic of China approved the Wand/STA System.

However, the CFDA’s approval of the Wand STA handpieces was not received until May 2014 and the distribution of these handpieces in China began in the fourth quarter of 2014.

The distribution and marketing agreement with Sinopharm were terminated in September 2014.

Proximate to that time, we entered into a new agreement with Milestone China to be our distributor for the Wand/STA System and handpieces in China.

Milestone Scientific then owned forty (40%) percent of Milestone China (the “Milestone China Shares”).

In June 2017, Milestone Scientific sold its Milestone China Shares to an unaffiliated United States domiciled purchaser for a promissory note secured by a pledge of the Milestone China Shares, and received a 10-year option to repurchase the Milestone China Shares at the same price as the purchase price paid for the Milestone China Shares within the first two years and at fair market value for the remainder of the 10-year term.

In April 2018, such promissory note being in default, Milestone Scientific entered into a Release, Assignment and Termination Agreement (the “Termination Agreement”) with the issuer of the promissory note, pursuant to which Milestone Scientific repaid the $250,000 payment made by the issuer, the issuer returned the Milestone China Shares to Milestone Scientific and Milestone Scientific cancelled the promissory note.

In November 2012, Milestone Scientific signed an exclusive distributor and marketing agreement with a well-known U.S.

domestic manufacturer and distributor, for the sale and distribution of the Wand/STA System and handpieces in the United States and Canada.

The marketing initiative included participation in United States and Canadian dental shows, as well as pediatric dental shows;

an active advertising initiative targeting major dental publications;

and direct mailing campaigns to over 150,000 dentists across the United States and Canada.

This exclusive distributor and marketing agreement were converted to a non-exclusive agreement as of December 31, 2016.

Beginning January 1, 2016, Milestone Scientific entered into a non-exclusive distribution agreement with Henry Schein, Inc.

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Under this arrangement we have a semi-dedicated independent sales force visiting dentists.

To date, Henry Schein has endeavored to accomplish the goals set forth in the exclusive distribution agreement for The Wand/ STA device and handpieces, including training of its exclusive products sale’s specialists.

Specifically, up to 35 exclusive product sales specialists have now been fully trained as experts in the features, advantages and benefits of The Wand/ STA device and handpieces and all are currently in the field selling the device.

Henry Schein also increased the number of exclusive product specialist in late 2019 and has agreed to possibly increase the customer service representatives to support dentists across North America through its exclusive product sales customer call center as business volume increases.

In December 2020, the Exclusive Distribution Arrangement with Henry Schein was replaced with a non-exclusive distribution arrangement.

Under the non-exclusive arrangement, Henry Schein will purchase dental instruments and handpieces in the United States and Canada.

Beginning in January 2021, the Company began a process of signing non-exclusive dental distribution arrangements with dental distributors in specific geographical locations in the United States and Canada.

To date there are eight (8) new non-exclusive dental distributors engaged in the USA and Canada.

The goal is to add an additional non-exclusive distributor in three main cities in the USA.

The goal of changing our marketing plan from a sole exclusive distributor in the USA and Canada, to a large number of non-exclusive distributors is to increase placement of our Wand/STA instrument and thus the expansion of our dental disposables.

On the global front, we have granted exclusive marketing and distribution rights for the Wand/STA Instrument to select dental suppliers in various international regions in Asia, Africa, South America, and Europe.

They include FM Produkty Dla Stomatologii in Poland and Unident AB in the countries of Denmark, Sweden, Norway, and Iceland.

Additionally, the Company is in the process of evaluating current international distributors and adding new distributors, globally as required based on the economics of the region.

In first quarter 2020, Milestone China and certain marketing affiliates entered into a plan to merge (the Transaction) into an affiliated manufacturing company, Anhui Maishida Medical Technology, Co.

Anhui will be the surviving entity after the merger and will have complete responsibility for sales, marketing, and distribution for the Company’s dental products in China.

However, as of the filing date of this Quarterly Report, due to the COVID-19 Pandemic, the regulatory documentation for the planned merger has been placed in suspense since applicable government offices are still closed in China and Hong Kong.

After completion of the Transaction, Milestone Scientific is expected to have an approximate 28.4% direct ownership in Anhui.

Milestone China and certain marketing affiliates are expected to be dissolved upon completion of the merger and upon the required regulatory filings in China and Hong Kong.

Medical Market

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Milestone Scientific did not complete this process in 2019, due to a lack of funding.

We cannot provide assurances of when funds will be available, and if funding becomes available, if ever, that we will receive FDA clearance for our intra-articular device.

In October 2018, Milestone Medical signed a Distributor Agreement in the U.S.

This agreement provides that this Distributor will purchase and hold an inventory of the CompuFlo Epidural System and disposables for sale.

At this time there have been no minimum purchase established with the Distributor.

This Distributor purchased five CompuFlo Epidural Systems and disposables after executing the Agreement.

In 2020 raised gross proceeds approximately $19.7 million (in two capital raises) and is in the process of evaluating the use of these funds to improve existing devices, develop new instruments, including the continued regulatory process for the intra-articular instrument.

We cannot provide assurances that funds will be allocated, to fund the FDA clearance process for our intra-articular device.

In April 2019, Milestone Scientific entered an Agreement with American 3B Scientific, a leading supplier of didactic material for education, for the development and sale of a CompuFlo® Epidural Training Instrument.

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We have entered into a limited number of distributor arrangements in Europe and the Middle East for our CompuFlo Epidural System.

Our distribution strategy is initially aimed at having KOL's use and accept the device and initiates their own studies.

In September 2019, the Company appointed a new President, Brent Johnston.

Johnston will also be responsible for the growth of the Medical segment.

He is evaluating the business and marketing operations of our medical segment to make the changes required to increase market penetration and sales of the epidural device, principally in the United States and other countries.

In February 2020, the Company hired two Territory Sales managers to initiate the marker penetration and and sales process in the United States.

Veterinary Market

We are exploring various commercialization opportunities

Our distribution strategy is initially aimed at having key opinion leaders (KOLs)

use and accept the device and initiates their own studies.

On October 13, 2020, Milestone Medical announced a Group Purchasing Agreement with Premier, an USA leading healthcare improvement company, utilizing an alliance of approximately 4,100 U.S.

hospitals and 200,000 other providers to transform healthcare.

The Agreement expires on February 28, 2022.

Patents and Intellectual Property

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Pursuant to these informal arrangements, our third-party manufacturers manufacture the Wand/STA System under specific purchase orders without minimum purchase commitments, and at prices to be agreed upon in each such purchase order.

Our agreement with the principal manufacturer of handpieces, a related party, includes pricing terms.

Milestone Scientific has been supplied by the manufacturer of the Wand/STA System and its predecessor, the CompuDent System , since the commencement of production in 1998, and by the manufacturer of its handpieces since 2003.

The manufacturer of our handpieces is in the People’s Republic of China and the manufacturer of the Wand/STA System is in the United States.

Our agreement with the principal manufacturer of dental handpieces, a related party, includes pricing terms.

The manufacturer of our dental handpieces is in the People’s Republic of China and the manufacturer of the Wand/STA System is in the United States.

Refer to Item 1A.

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Termination of the manufacturing relationship with any of these third-party manufacturers could significantly and adversely affect our ability to produce and sell the products.

Though other alternate sources of supply for handpieces exist, Milestone Scientific would need to establish relationships with new suppliers, and with respect to the Wand/STA System recover its existing tools or have new tools produced and “burn in” and other manufacturing and quality control software re-produced.

Though other alternate sources of supply for dental handpieces exist, Milestone Scientific would need to establish relationships with new suppliers, and with respect to the Wand/STA System recover its existing tools or have new tools produced and “burn in” and other manufacturing and quality control software re-produced.

Establishing new manufacturing relationships could involve significant expense and delay.

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Injection speed increases during the injection, but the operator cannot control when the injection speed increases.

Another computer-controlled injection instrument is called the Comfort Control Syringe or CCS.

In the early 1990's, Dr.

Mark Smith, a dentist from Ontario, Canada, invented a device that he incorporated into his practice as a local anesthetic delivery method.

After perfecting the system, he assigned the rights of this device to Dentsply.

In this system, many of the functions of the computer can be controlled directly from the syringe during the injection process.

The base unit allows the dentist to program one of five different injections by pressing a single button.

The five buttons marked on the base unit are block, infiltration, PDL, intraosseous and palatal.

Each of these injections has a specific corresponding rate of local anesthetic delivery associated with it.

The CCS enables a wide range of injection speeds controlled by the operator and the ability to control the computer directly from the syringe, but, since the CCS computer can be controlled by hand, the syringe must contain a certain amount of electronic equipment and this adds bulk to its circumference.

The circumference of the CCS syringe is 112mm compared to 36mm for a traditional syringe, and 17mm for the Wand/STA System.

In addition, because of the electronics in the syringe, the operator will feel a slight amount of vibration in the syringe while the injection occurs.

This will not affect the anesthesia, but it certainly is a feeling that is different from the traditional syringe or the Wand/STA System, which both have no such vibration.

This instrument is no longer being marketed.

The Calajet instrument, manufactured in Europe, has been very slow to grow market acceptance.

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This classification is based on the controls necessary to reasonably ensure the safety and effectiveness of the medical devices.

Class I devices are those devices whose safety and effectiveness can reasonably be ensured through general controls, such as adequate labeling, pre-market notification, and adherence to the FDA’s

Quality System Regulation (“QSR”), also referred to as “Good Manufacturing Practices” (“GMP”) regulations.

Class I devices are those devices whose safety and effectiveness can reasonably be ensured through general controls, such as adequate labeling, pre-market notification, and adherence to the FDA’s Quality System Regulation (“QSR”), also referred to as “Good Manufacturing Practices” (“GMP”) regulations.

Some Class I devices are further exempted from some of the general controls.

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In March 2018, Milestone Scientific obtained regulatory approval to market the CompuFlo Epidural System in Canada.

Human Capital

As of December 31, 2020, the Company had a total 19 full-time employees including three executive officers of Milestone Scientific.

Milestone Scientific also has a consultant who serves as a Director of Clinical Affairs and a business development consultant.

Milestone Scientific also has a consultant who serves as a Director of Clinical Affairs.

None of our employees are subject to a collective bargaining agreement and we believe our employee relations are good.

The Company currently does not have any official training programs or performance evaluations for its employees.

Corporate Information

We were organized in August 1989 under the laws of the State of Delaware.

Our principal executive office is located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068, effective January 20, 2020.

Prior to January 20, 2020 our principal executive office was located at 220 South Orange Avenue, Livingston, New Jersey 07039.

Our principal executive office is located at 425 Eagle Rock Avenue, Roseland, New Jersey 07068.

Our telephone number is (973) 535-2717.

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