What changed in this filing

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Item 1. Business

2024-09-30 compared with 2023-09-28 · 199 added, 220 removed, 84 unchanged (83% of the section changed)

We have been a developer and

manufacturer of advanced optical instruments since 1982.

Our proprietary medical instrumentation line, unique custom design and manufacturing

capabilities, and expert engineering and development has generated traditional proprietary endoscopes and endocouplers as well as other

custom imaging and illumination products for our customers’ use in minimally invasive surgical procedures.

We design and manufacture

3D endoscopes and very small Microprecision lenses, assemblies and complete medical devices to meet the surgical community’s continuing

demand for smaller, disposable, and more enhanced imaging systems for minimally invasive surgery.

Effective June 1, 2019 we acquired

the operating assets of Ross Optical Industries, Inc.

We have been a developer and manufacturer of advanced

optical instruments since 1982.

Our proprietary medical instrumentation line, unique custom design and manufacturing capabilities, and

expert engineering and development has generated traditional proprietary endoscopes and endocouplers as well as other custom imaging and

illumination products for our customers’ use in minimally invasive surgical procedures.

We design and manufacture 3D endoscopes

and very small Microprecision lenses, assemblies and complete medical devices to meet the surgical community’s continuing demand

for smaller, disposable, and more enhanced imaging systems for minimally invasive surgery.

Effective June 1, 2019, we acquired the operating

assets of Ross Optical Industries, Inc.

of El Paso, Texas.

As Ross Optical Industries we also operate as a supplier of

custom optical components and assemblies for military and defense, medical and various other industrial applications.

All products sold

by us under the Ross Optical name include a custom or catalog optic, which is sourced through our extensive domestic and worldwide network

of optical fabrication suppliers.

Most systems make use of optical lenses, prisms, mirrors and windows and range from individual optical

components to complex mechano-optical assemblies.

Products often include thin film optical coatings that are applied using our in-house

coating department.

Effective October 1, 2021 we

acquired the operating assets of Lighthouse Imaging, LLC of Windham, Maine.

Our Lighthouse Imaging division supplements our operations

as a manufacturer of advanced optical imaging systems and accessories and has provided further expertise in electrical engineering and

development of end-to-end medical visualization devices.

Product development competencies at Lighthouse Imaging include Systems, Optical,

Mechanical, Electrical and Process Development Engineering.

Our product development team has extensive experience developing visualization

systems that are used in a variety of clinical applications.

As Ross Optical Industries we also operate as a supplier of custom optical

components and assemblies for military and defense, medical and various other industrial applications.

All products sold by us under the

Ross Optical name include a custom or catalog optic, which is sourced through our extensive domestic and worldwide network of optical

fabrication suppliers.

Most systems make use of optical lenses, prisms, mirrors and windows and range from individual optical components

to complex mechano-optical assemblies.

Products often include thin film optical coatings applied using our in-house coating department.

Effective October 1, 2021, we acquired the operating

assets of Lighthouse Imaging, LLC of Windham, Maine.

Our Lighthouse Imaging division supplements our operations as a manufacturer of advanced

optical imaging systems and accessories and has provided further expertise in electrical engineering and development of end-to-end medical

visualization devices.

Product development competencies at Lighthouse Imaging include Systems, Optical, Mechanical, Electrical and Process

Development Engineering.

Our product development team has extensive experience developing visualization systems that are used in a variety

of clinical applications.

Lighthouse Imaging is an industry leader in chip-on-tip visualization systems.

During the fiscal year ended

June 30, 2022, approximately 34% our business was from engineering services primarily relating to the design of medical device optical

assemblies, 41% from the sale of both internally manufactured and purchased optical components, and 25% from the manufacture of optical

assemblies and sub-assemblies primarily for medical device instrument applications.

During the fiscal year ended June 30, 2024, approximately

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of both internally manufactured and purchased optical components, and 12% from the manufacture of optical assemblies and sub-assemblies.

primarily for medical device instrument.

We expect sales revenue increases to result from assembly and manufacturing orders received

from our customers for the products we assist them in designing using our unique optical product design and manufacturing capabilities.

Much of the technology we have developed for making smaller medical devices can also be used in defense and aerospace systems where smaller

size and weight can be beneficial.

We incorporated in Massachusetts

in December 1982 and have been publicly-owned since November 1990 and have no subsidiaries.

Our websites are www.poci.com,

www.rossoptical.com, and www.lighthouseoptics.com.

Information contained on our websites does not constitute part of this report.

During the fiscal year ended June 30, 2023, approximately 32% our business was from engineering services primarily relating to the design

of medical device optical assemblies, 50% from the sale of both internally manufactured and purchased optical components, and 18% from

the manufacture of optical assemblies and sub-assemblies primarily for medical device instrument applications.

We generally expect revenue

increases over time as the engineering design phase is completed and products transition to the commercial phase, leveraging our unique

manufacturing capabilities.

Much of the technology we have developed for making smaller medical devices is also used in defense and aerospace

systems where smaller size and weight is crucial.

We incorporated in Massachusetts in December 1982,

have been publicly held since November 1990, and have no subsidiaries.

Principal Products and Services

Our Current Core Business:

we have manufactured medical products such as endoscopes and endocouplers.

We have developed and sold endoscopes incorporating various

optical technologies, for use in a variety of minimally invasive surgical and diagnostic procedures.

Today, we produce endoscopes for

various applications, which are CE marked and therefore certified for sale throughout the European Economic Area.

Since 1985, we have

developed, manufactured and sold a proprietary product line of endocouplers.

We also design and manufacture custom optical medical devices

to satisfy our customers’ specific requirements.

In addition to medical devices, we also manufacture and sell components and assemblies

specially designed for industrial and military use.

The acquisition of the assets of Ross Optical

Industries expanded our optics components and assemblies business.

All products supplied by Ross Optical include a custom or catalog

optic, which is sourced through Ross Optical’s extensive domestic and worldwide network of optical fabrication suppliers.

systems make use of optical lenses, prisms, mirrors and windows and range from individual optical components to complex mechano-optical

Products often include thin film optical coatings that are applied by the Ross Optical division in-house coating department.

We have been manufacturing medical products such as

endoscopes and endocouplers since our formation in 1982.

In 1985 we introduced a proprietary product line of endocouplers.

We also design

and manufacture custom optical medical devices to satisfy our customers’ specific requirements, incorporating various optical technologies,

servicing a variety of minimally invasive surgical and diagnostic procedures, using both reusable and single-use medical devices.

to medical devices, we also manufacture and sell components and assemblies specially designed for defense/aerospace and industrial uses.

The acquisition of the assets of Ross Optical Industries

in 2019 expanded our optics components and assemblies business.

All products supplied by Ross Optical include a custom or catalog optic,

sourced through Ross Opticals’ extensive domestic and worldwide network of optical fabrication suppliers.

Most systems make use

of optical lenses, prisms, mirrors, and windows and range from individual optical components to complex mechano-optical assemblies.

often include thin film optical coatings that are applied by the Ross Optical division’s in-house coating department.

The acquisition of the assets of Lighthouse Imaging

LLC expanded our electrical engineering and development of end-to-end medical visualization devices.

Product development competencies

at Lighthouse Imaging include systems, optical, mechanical, electrical and process development engineering.

The Lighthouse product development

team has extensive experience developing visualization systems that are used in a variety of clinical applications representing a vertical

integration of our established product development capabilities we believe will provide our customers with value-added product development

service and product offerings.

LLC in 2021 expanded our electrical engineering capabilities in the development of end-to-end medical visualization devices.

Product development

competencies acquired include systems, optical, mechanical, electrical and process development engineering.

The acquisition represented

a vertical integration of our established product development capabilities with a team with extensive experience developing visualization

systems that we believe provides our customers with single-source value-added development services and product offerings.

Microprecision™ Lenses and Micro Medical

While the size of endoscopes has gradually decreased over time, the widespread use of very small endoscopes, with diameters

of one millimeter or smaller, has been limited, in part, we believe, by the inability of traditional lens fabrication methods to support

these smaller sizes with good image quality and acceptable manufacturing costs.

While the size of endoscopes has gradually decreased over time, we believe the widespread use of very small endoscopes, with

diameters of one millimeter or smaller, has been limited due in part to the limitations of traditional lens fabrication methods to combine

smaller sizes with acceptable image quality at reasonable manufacturing costs.

We believe our Microprecision™ optics technology

provides a solution to this problem.

Combined with recent advances by other companies in complementary metal-oxide-semiconductor, or

CMOS, image sensor fabrication techniques, our Microprecision™ lenses and proprietary manufacturing techniques enable the manufacture

of micro medical cameras at low prices and with sizes on the order of one millimeter or less, characteristics that make them well suited

to medical applications.

We believe the technology developed to support the design, fabrication and manufacturing of Microprecision™

lenses and associated assemblies can also be used to satisfy the needs of defense and aerospace systems that require small size and weight.

We are currently engaged in development projects

to design and produce even smaller CMOS based camera modules together with customized illumination using various technologies to match

the needs of the medical device endoscopes.

We are also currently designing disposable versions of our camera modules and assemblies

designed for single-use and reduced risk of contamination from repeated use.

We believe these on-going improvements are significant to

the continued evolution and acceptance of our Microprecision™ technology platform.

provides a solution to this challenge.

Combined with recent advances by our supply chain partners in complementary metal-oxide-semiconductor,

or CMOS, image sensor fabrication techniques, our Microprecision™ lenses and proprietary manufacturing techniques enable the manufacture

of micro medical cameras at previously unobtainable prices with sizes on the order of one millimeter or less, characteristics that make

them perfectly suited for medical applications.

We believe the technology developed to support the design, fabrication and manufacturing

of Microprecision™ lenses and associated assemblies can also be used to satisfy the needs of defense and aerospace systems that

require small size and weight.

We are currently engaged in development projects to

design and produce even smaller CMOS based camera modules together with customized illumination using various technologies to match the

needs of the medical device endoscopes.

We have now completed and are currently designing, disposable versions of our camera modules and

assemblies designed for single use, reducing the risk of contamination from repeated use.

We believe these on-going improvements are significant

to the continued evolution and acceptance of our Microprecision™ technology platform.

3D Endoscopes:

Our 3D endoscopes provide

next generation optical imaging for minimally invasive surgical procedures that utilize hand-held rigid endoscopes by using the brain’s

Our 3D endoscopes provide next

generation optical imaging for minimally invasive surgical procedures that utilize hand-held rigid endoscopes by using the brain’s

natural ability to perceive depth, which is the third dimension, by viewing one’s environment through two eyes.

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resources than we have, may seek to produce products or services that compete directly with ours.

While our resources are substantially more limited

than those of some of our competitors, we believe that we can compete successfully in this market based on product quality, price, delivery

and innovation tailored to our customers’ specifications.

Our success will depend, in part, on our ability to maintain a technological

advantage over our competitors and to effectively incorporate that technology into our custom designs.

To this end, we intend to continue

to aggressively support and augment our internal engineering, research and development resources and to aggressively pursue patent protection

for existing and new technology.

We believe that our unique technical capabilities in the areas of Microprecision™ optics, micro

medical cameras and illumination, as well as 3D endoscopes, currently represent competitive advantages for us in the minimally invasive

surgical device market.

We recently augmented and extended these capabilities with the acquisition of Lighthouse Imaging which brings

to the Company extensive experience with design and manufacture of minimally invasive optical imaging surgical devices, particularly

those utilizing CMOS sensor and associated electronics technologies.

The competitive advantage of our Ross Optical

division is its ability to provide difficult-to-find optics, and, increasingly, to provide a broader range of services based on its ability

to source optics worldwide, augmented by its ability to provide thin-film coatings and assembly.

While our resources are more limited than those of

some of our competitors, we believe that we compete successfully in this market through product quality, price, delivery and innovation

tailored to our customers’ specifications.

Our success will depend, in part, on our ability to maintain a technological advantage

over our competitors and to effectively incorporate that technology into our custom designs.

To this end, we intend to continue to aggressively

support and augment our internal engineering, research and development resources and to aggressively pursue patent protection for existing

and new technology.

We believe that our unique technical capabilities in the areas of Microprecision™ optics, micro medical cameras

and illumination, as well as 3D endoscopes, currently represent competitive advantages for us in the minimally invasive surgical device

The competitive advantage of our Ross Optical division

is its ability to provide difficult-to-find optics, and, increasingly, to provide a broader range of services based on its ability to

source optics worldwide, augmented by its ability to provide thin-film coatings and assembly.

Market Opportunities

Microprecision™ Lenses and Micro Medical

While other approaches exist for the manufacture of camera lenses, we design custom camera module assemblies with the combined

objectives of low cost, small size, range of optical specifications and high image quality required by our customer’s precise medical

device specifications.

By enabling the production of millimeter sized and smaller cameras with low manufacturing costs, we believe our

Microprecision™ technology opens the possibility to replace existing re-sterilizable endoscopes with a single-use alternative.

Also, the small size of our Microprecision™ lenses and micro medical cameras combined with our proprietary illumination techniques

can provide visualization for existing procedures that are currently performed blind or with sub-optimal imaging, and we believe can

facilitate the development of new surgical procedures that are currently impractical without sub-millimeter visualization instrumentation.

We design custom camera module assemblies with the combined objectives of low cost, small size, range of optical specifications

and high image quality required by our customer’s precise medical device specifications.

By enabling the production of millimeter

sized and smaller cameras with low manufacturing costs, we believe our Microprecision™ technology opens the possibility to replace

existing re-sterilizable endoscopes with a single-use alternative.

The small size of our Microprecision™ lenses and micro medical

cameras combined with our proprietary illumination techniques can provide visualization for existing procedures that are currently performed

blind or with sub-optimal imaging, and we believe can facilitate the development of new surgical procedures that are currently impractical

without sub-millimeter visualization instrumentation.

3D Endoscopes and Robotic Surgery Systems :

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is high enough to support the cost of a high-quality custom 3D display.

Competition amongst medical device companies, many of which are

our customers for other products, in the area of 3D robotic surgery systems is increasing, and various companies are now pursuing less

expensive, procedure specific robotic systems.

We believe our experience and expertise in 3D endoscopes for medical applications could

be a benefit to various companies in this area that could provide us with new product development and manufacturing opportunities.

Competition amongst medical device companies in 3D robotic surgery

systems has increased.

Various companies are now pursuing less expensive, procedure specific robotic systems.

We believe our experience

and expertise in 3D endoscopes for medical applications will benefit companies in this area.

Sales and Marketing

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referrals, attendance at trade shows and a presence in online professional association websites, we have expanded our on-going pipeline

of projects to significant medical device companies and to well-funded emerging medical device companies, and to a number of major defense

/ aerospace companies..

We expect our customer pipeline to continue to expand as development projects transition to production orders

and new customer projects enter the development phase.

of projects to established medical device companies as well as to emerging medical device companies, and to a growing number of major

defense / aerospace companies.

We expect our revenues and customer base to continue to expand as development projects transition to production

orders and new customer projects enter the development phase.

International Business

Our medical products have received the CE mark

certification, which permits sales into the European Economic Area and which benefits our customers as they market their products manufactured

by us or containing our sub-assemblies into markets outside the United States.

We acquire various optical components from overseas as

necessary to meet the needs of custom device designs.

We acquire various optical components from overseas

as necessary to meet the needs of custom device designs.

We believe that the availability of specialized components and cost savings from

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Research and Development

We believe that our future success depends, to

a large degree, on our ability to continue to conceive and develop new optical products and technologies to enhance the performance characteristics

We believe that our future success depends, to a large

degree, on our ability to continue to conceive and develop new optical products and technologies to enhance the performance characteristics

and methods of manufacture of existing and new products.

Although development work on behalf of customers is almost entirely performed

under revenue generating contracts and customer purchase orders, research and development expenses are incurred on our own proprietary

products and technology, such as Microprecision™ optics, micro medical cameras and 3D endoscopes.

Accordingly, we treat engineering

expenses not consumed in customer contracted development and our investment of funds and resources in internal product and intellectual

property development as research and development expense in the accompanying statement of operations.

Although development work on behalf of customers is performed under revenue generating

contracts and customer purchase orders, research and development expenses are incurred on our own proprietary products and technology,

such as Microprecision™ optics, micro medical cameras and 3D endoscopes.

Accordingly, we treat engineering expenses not consumed

in customer contracted development and our investment of funds and resources in internal product and intellectual property development

as research and development expense in the accompanying statement of operations.

Raw Materials and Principal Suppliers

A key raw material component for our products

is precision grade optical glass, which we obtain from a few suppliers, principally SCHOTT North America, Inc.

A key raw material component for our products is precision

grade optical glass, which we obtain from a few suppliers, principally SCHOTT North America, Inc.

and Ohara Corporation.

We obtain CMOS sensors used in the development

of endoscope products for our customers from various suppliers such as OmniVision Technologies, Inc.

We believe that while the number

of sources of supply is limited for the CMOS sensors with the specifications used in medical device endoscopes we develop;

the manufacturing

capacities of those suppliers is adequate to meet our demand in the next twelve months.

obtain CMOS sensors used in the development of endoscope products for our customers from various suppliers such as OmniVision Technologies,

We believe that while the number of sources of supply is limited for the CMOS sensors with the specifications used in medical device

endoscopes we develop;

the manufacturing capacities of those suppliers is adequate to meet our demand in the next twelve months.

Patents and Trademarks

We rely, in part, upon patents, trade secrets

and proprietary knowledge as well as personnel policies and employee confidentiality agreements concerning inventions and other creative

efforts to develop and maintain our competitive position.

We plan to file for patents, copyrights and trademarks in the United States

and in other appropriate countries to protect our intellectual property rights to the greatest extent practicable.

We currently hold

rights to various United States patents, and have patent applications pending, including applications for our new generation of micro

medical cameras.

Our current patent portfolio includes patents, rights to patents and patent applications that cover various aspects

of our technology in the following areas:

Microprecision™

lenses and micro medical cameras;

We rely, in part, upon patents, trade secrets and

proprietary knowledge as well as personnel policies and employee confidentiality agreements concerning inventions and other creative efforts

to develop and maintain our competitive position.

We plan to file for patents, copyrights and trademarks in the United States and in other

appropriate countries to protect our intellectual property rights to the greatest extent practicable.

We currently hold rights to various

United States patents, and have patent applications pending, including applications for our new generation of micro medical cameras.

current patent portfolio includes patents, rights to patents and patent applications that cover various aspects of our technology in the

following areas:

Medical devices;

3-D endoscopes;

Microprecision™ lenses and micro medical cameras;

Defense products.

The patents contained in our current patent portfolio

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We intend to continue to innovate and

extend our technological capabilities in the areas of 3-D endoscopy Microprecision™ optics, micro medical cameras, and related

illumination techniques, and to aggressively pursue patent protection for such developments.

As of June 30, 2023, we had 85 employees, 84

of which were full-time employees.

There were 43 employees in manufacturing, 20 in engineering/research and development, 8 in sales and

marketing, and 14 in finance and administration.

extend our technological capabilities in the areas of 3-D endoscopy Microprecision™ optics, micro medical cameras, and related illumination

techniques, and to aggressively pursue patent protection for such developments.

As of June 30, 2024, we had 84 employees, 83 of which

were full-time employees.

There were 41 employees in manufacturing, 22 in engineering/research and development, 9 in sales and marketing,

and 12 in finance and administration.

We are not a party to any collective bargaining agreements.

We believe our relations

with our employees are very good.

During fiscal year ended June 30, 2023 we sold

product and services to 361 customers and one customer accounted for 11.4% of our total revenues for that year.

The loss of this customer

would not have a material impact on our business.

For the fiscal year ended June 30, 2022, we sold products and services to 377 customers

and no customer accounted for more than 10% of our total revenues for that year.

We believe our relations with our employees

are very good.

During the fiscal year ended June 30, 2024, we sold

product and services to 325 customers with one product development customer accounting for 19.1% of total revenues and with one optical

components customer accounting for 13.8% of our total revenues.

The loss of these customers would have a material impact on our business.

For the fiscal year ended June 30, 2023, we sold products and services to 361 customers and one customer accounted for 11.4% of our total

revenues for that year.

Two customer accounts receivable balances accounted

for 15.4% and 12.1% of total receivables on June 30, 2024.

No customer accounts receivable balance accounted for more than 10% of accounts

receivable on June 30, 2022.

Two customer accounts receivable balances accounted for 14.0% and 13.7% of

total receivables on June 30, 2023.

Environmental Matters

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of the environment.

From time to time, we use a small amount of hazardous materials in our operations.

We believe that we currently comply

with all applicable environmental laws and regulations and intend to do our best efforts to remain in compliance.

Such compliance does

not entail significant expense to us.

We believe that we currently comply with all applicable environmental laws and regulations.

We use limited amounts

of hazardous materials in our operations, and as such, compliance does not entail significant expense to us.

Government Regulations

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devices are regulated in the United States by the Food and Drug Administration, or FDA, and, in some cases, by certain state agencies.

The FDA regulates the research, design, testing, manufacture, safety, effectiveness, labeling, promotion and distribution of medical

devices in the United States.

The FDA regulates the research, design, testing, manufacture, safety, effectiveness, labeling, promotion and distribution of medical devices

in the United States.

Generally, medical devices require clearance or approval prior to commercial distribution.

Additionally,

certain material changes to, and changes in, intended uses of, medical devices are also subject to FDA review and clearance or approval.

Non-compliance with applicable requirements can result in failure of the FDA to grant pre-market clearance or approval, withdrawal or

suspension of approval, suspension of production, or the imposition of various other penalties.

We previously notified the FDA of our intent

to market our endoscopes, image couplers, beamsplitters, adapters and video ophthalmoscopes, and the FDA has determined that we may market

such devices, subject to the general control provisions of the Food, Drug and Cosmetic Act.

We obtained this FDA permission without the

need to undergo a lengthy and expensive approval process due to the FDA’s determination that such devices met the regulatory standard

Additionally, certain

material changes to, and changes in, intended uses of, medical devices are also subject to FDA review and clearance or approval.

Non-compliance

with applicable requirements can result in failure of the FDA to grant pre-market clearance or approval, withdrawal or suspension of approval,

suspension of production, or the imposition of various other penalties.

We previously notified the FDA of our intent to market

our endoscopes, image couplers, beamsplitters, adapters and video ophthalmoscopes, and the FDA has determined that we may market such

devices, subject to the general control provisions of the Food, Drug and Cosmetic Act.

We obtained this FDA permission without the need

to undergo a lengthy and expensive approval process due to the FDA’s determination that such devices met the regulatory standard

of being substantially equivalent to existing FDA-approved devices.

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devices that may require the FDA’s permission to market such products.

We may also develop additional products or seek to sell

some of our current or future medical products in a manner that requires us or our customers to obtain the permission of the FDA to market

such products, as well as the regulatory approval or license of other federal, state and local agencies or similar agencies in other

The FDA has authority to conduct detailed inspections of manufacturing plants in order to assure that “good manufacturing

practices” are being followed in the manufacture of medical devices including medical devices or components of medical devices

manufactured for other medical device companies, to require periodic reporting of product defects to the FDA, and to prohibit the sale

of devices which do not comply with law.

We design and manufacture components for the

defense industry, and import, export and manufacture optical products for the defense industry, some of which is controlled by U.S.

We may also develop additional products or seek to sell some

of our current or future medical products in a manner that requires us or our customers to obtain the permission of the FDA to market

such products, as well as the regulatory approval or license of other federal, state and local agencies or similar agencies in other countries.

The FDA has authority to conduct detailed inspections of manufacturing plants in order to assure that “good manufacturing practices”

are being followed in the manufacture of medical devices including medical devices or components of medical devices manufactured for other

medical device companies, to require periodic reporting of product defects to the FDA, and to prohibit the sale of devices which do not

comply with law.

We design and manufacture components for the defense

industry, and import, export and manufacture optical products for the defense industry, some of which is controlled by U.S.

Generally, these regulations require strict control over technical data in documented form and as embodied in products, both within our

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Foreign Requirements.

Sales of medical

device products outside the United States are subject to foreign regulatory requirements that may vary from country to country.

to comply with foreign regulatory requirements would jeopardize our ability to market and sell our products in foreign jurisdictions.

The regulatory environment in the European Union member countries of the European Economic Area for medical device products differs from

that in the United States.

Medical devices sold in the European Economic Area must bear the Conformité Européenne, or CE

Devices are classified by manufacturers according to the risks they represent, with a classification of Class III representing

the highest risk devices and Class I representing the lowest risk devices.

Once a device has been classified, the manufacturer can

follow one of a series of conformity assessment routes, typically through a registered quality system, and demonstrate compliance to

a “European Notified Body.” The CE mark may then be applied to the device.

Maintenance of the system is ensured through annual

on-site audits by the notified body and a post-market surveillance system requiring the manufacturer to submit serious complaints to

the appropriate governmental authority.

All of our medical products are manufactured in conformity with the CE mark requirements.

All our medical products

are manufactured in conformity with ISO 13485:2016, using a comprehensive Quality Management System (QMS) that helps meet both international

and EU regulatory standards.

ISO 13485 is an internationally recognized standard that emphasizes risk management throughout the product

lifecycle, from design to post-market surveillance, and aligns with the European Union Medical Device Regulation (“EU MDR”)

focus on ensuring the safety and performance of medical devices.

ISO 13485 provides a solid foundation for meeting the QMS requirements

of the EU MDR.

It ensures that manufacturers maintain detailed documentation and traceability of their devices, which is required for

compliance with the EU MDR’s requirements.

Conformity with ISO 13485 conveys our commitment to maintaining a robust QMS specifically

for medical device manufacturing, and consistent quality and regulatory compliance, which is essential helping our customers achieve compliance

with the EU MDR and other international regulatory standards.

Our failure to comply with ISO 13485 or other applicable regulatory requirements

would jeopardize our ability to sell our products to certain customers who place their product on the EU and other international markets.

Available Information

Our website is www.poci.com.

We make available on our website, free of charge, copies of our annual reports on Form 10-K, quarterly reports on Form 10-Q,

current reports on Form 8-K and amendments to those reports, as soon as reasonably practicable after we electronically file or furnish

such materials to the U.S.

We make available on

our website, free of charge, copies of our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K

and amendments to those reports, as soon as reasonably practicable after we electronically file or furnish such materials to the U.S.

Securities and Exchange Commission (SEC).

Our website and the information contained therein or connected thereto

are not intended to be incorporated into this report.

The SEC maintains an Internet

site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the

SEC at http://www.sec.gov.

RISK FACTORS.

Smaller reporting companies are not required to provide the information

required by this item.

Our website and the information contained therein or connected thereto are not intended to be

incorporated into this report.

The SEC maintains an Internet site that contains reports,

proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov.

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