What changed in this filing

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Item 1. Business

2023-09-28 compared with 2022-09-27 · 188 added, 216 removed, 116 unchanged (78% of the section changed)

We have been a developer and manufacturer of advanced

optical instruments since 1982.

Our medical instrumentation line includes traditional endoscopes and endocouplers as well as other custom

imaging and illumination products for use in minimally invasive surgical procedures.

Our core efforts are targeted at the development

of next generation endoscopes.

Through internal research and development and working in partnership with our customers, we continuously

develop next generation capabilities for designing and manufacturing 3D endoscopes and very small Microprecision™ lenses, anticipating

future requirements as the surgical community continues to demand smaller and more enhanced imaging systems for minimally invasive surgery.

The COVID-19 world-wide pandemic and the domestic

and international impact of policy decisions being made in major countries around the world has had, and is expected to continue to have,

an adverse impact on various aspects of our business.

While we and many of our medical device and defense contracting customers continue

to operate as essential businesses, we have taken various actions to augment our operating and human resource policies and procedures

to guard against the potential health hazards of COVID-19.

These augmented procedures can have a negative impact on our operational efficiencies.

Given the uncertainty surrounding the continuation of economic slow-downs domestically and abroad, we cannot predict with certainty at

this time what the future impact of COVID-19 and resulting business and economic policies in the US and abroad will be on our up-coming

financial operating results.

As Ross Optical Industries of El Paso, Texas 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 companies.

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.

Over 70% of the Ross Optical division sales are in the United States, with the

majority being specialized optical components for industrial applications and the remainder being assemblies.

The balance of sales is

split between military and medical device products.

On October 4, 2021, we closed on an asset purchase

agreement with an effective date of October 1, 2021 with Lighthouse Imaging, LLC and Anania & Associates Investment Company, LLC for

substantially all of the assets of Lighthouse Imaging, LLC, a Maine limited liability company operating a medical optics and digital imaging

As Lighthouse Imaging of Windham, Maine we also operate as a manufacturer of advanced optical imaging systems and accessories.

We have a strong 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.

Approximately 34% our business during the fiscal

year ended June 30, 2022 is 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.

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 electrical 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.

We are registered to the ISO 9001:2015 and ISO

13485:2016 Quality Standards and comply with the FDA Good Manufacturing Practices and the European Union Medical Device Directive for

CE marking of our medical products.

We incorporated in Massachusetts in December 1982

and have been publicly-owned since November 1990.

References to our Company contained herein include our two wholly-owned subsidiaries,

Precise Medical, Inc.

and Wood’s Precision Optics Corporation, Limited, except where the context otherwise requires.

Our websites are www.poci.com, www.rossoptical.com, and www.lighthouseoptics.com.

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.

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, 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.

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.

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We have developed and sold endoscopes incorporating various

optical technologies including our proprietary Lenslock™ technology, for use in a variety of minimally invasive surgical and diagnostic

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.

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 effective June 1, 2019 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

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 by the Ross Optical division in-house coating

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.

The acquisition of the assets of Lighthouse Imaging

LLC effective October 1, 2021 expanded our electrical engineering and development of end-to-end medical visualization devices.

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

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 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.

Microprecision™ Lenses and Micro Medical

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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

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

with numerous customers 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.

We have been engaged by various customers for

an increasing amount of development work relating to the design of endoscopes and camera assemblies that utilize our Microprecision™

We previously received production orders each exceeding $1M and follow-on orders from multiple customers for their custom

designed products fulfillment of which is ongoing.

We believe we will receive additional production orders from other customers currently

in our engineering and design pipeline.

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.

3D Endoscopes:

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While our resources are substantially more limited

than those of some of our competitors, we believe that we can compete successfully in this market on the basis of 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

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.

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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 and augmented by its ability to provide thin-film coatings and assembly.

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

Market Opportunities

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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.

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.

3D Endoscopes and Robotic Surgery Systems :

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to broaden awareness of the benefits of our new technology platforms and our successful application of these new technologies to medical

device projects requiring surgery-grade visualization, as well as defense and other industrial applications, from sub-millimeter sized

devices and 3D endoscopy, including single-use products and assemblies.

We market directly to established medical device companies primarily

in the United States that we believe could benefit from our advanced endoscopy visualization systems.

Through this direct marketing, 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 technology 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.

Our Ross Optical

and Lighthouse divisions market through existing customers and trade shows, in addition to proactive online marketing strategies executed

primarily through their websites.

Through the gradual integration of the sales, marketing and operating resources of the three operations

we have expect to realize both expanded sales opportunities from the coupling of Ross’ worldwide vendor relationships for optical

components with our micro optics engineering services now expanded and strengthened by the addition of the Lighthouse electrical engineering

device projects requiring surgery-grade visualization, as well as defense, aerospace and other industrial applications, from sub-millimeter

sized devices and 3D endoscopy, including single-use products and assemblies.

We market directly to established medical device companies

primarily in the United States that we believe could benefit from our advanced endoscopy visualization systems.

Through this direct marketing,

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.

International Business

Other than the Ross Optical division international

sales described below, we have had negligible direct export sales to date.

However, 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.

In the future, we may establish or use additional production

facilities overseas to produce key components for our business, such as lenses.

From the 1990s through approximately 2014, we maintained

a physical presence in Asia to support business and quality control activities throughout the region as needed.

We continue to acquire

various optical components from overseas to meet the needs of custom device designs.

We believe that the availability of specialized components

and cost savings from various overseas production resources is essential to our ability to deliver complex and unique device designs and

to compete on a price basis in the medical products area particularly and to our profitability generally.

Ross Optical has an expanded network of overseas

suppliers of various types and sizes of optical components and assemblies that enhance our ability to meet the material demands of our

customers’ unique optical and medical device designs.

During fiscal year 2022, 23% of the Ross Optical division sales were

to customers outside of the United States and Canada, with the balance of sales primarily split between Western Europe and Singapore.

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 believe that the availability of specialized components and cost savings from

various overseas production resources is essential to our ability to deliver complex and unique device designs and to compete on a price

basis in the medical products area particularly and to our profitability generally.

We have an expanded network of overseas suppliers

of various types and sizes of optical components and assemblies that enhance our ability to meet the material demands of our customers’

unique optical and medical device designs.

Research and Development

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

For the years ended June 30, 2022

and 2021, research and development expenses were $666,479 and $624,253, respectively.

Raw Materials and Principal Suppliers

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and Ohara Corporation.

We obtain CMOS sensors used in our development

We obtain CMOS sensors used in the development

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

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

We have experienced supply disruptions and customer

delays from certain vendors and customers that we believe were the result of the COVID-19 pandemic and related economic slow-down.

we are not currently experiencing vendor supply issues as a result of COVID-19, we cannot predict with certainty at this time what the

future impact of COVID-19 and resulting business and economic policies in the US and abroad will be on our vendors and principal suppliers.

Patents and Trademarks

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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

Our 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.

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;

The patents contained in our current patent portfolio

have various expiration dates through May 2036.

have various expiration dates through March 2043.

We are not aware of any infringements of these patents.

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defend these patents or effectively limit the development of competitive products and services.

In July 2011, we entered into an asset purchase

agreement with Intuitive Surgical Operations, Inc., in which we assigned to Intuitive Surgical all of the issued and non-expired patents

and pending patent applications that we held at that time, and in return, Intuitive Surgical granted us a royalty-free, worldwide license

to these patents in fields outside of medical robotics.

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, 2022, we had 77 employees, 76 of

which were full-time employees.

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

in finance and administration.

marketing, and 14 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 2022 we sold product and services

to over 377 customers and no customer accounted for 10% or more of our total revenues during the fiscal years ended June 30, 2022, and

Our largest customer account receivable balance

at June 30, 2022, was 8% of total accounts receivable.

At June 30, 2021, our largest customer account receivable balance was 16%

of total accounts receivable.

No other accounts accounted for more than 10% of accounts receivable at June 30, 2022, or 2021.

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.

Two customer accounts receivable balances accounted

for 14.0% and 13.7% of total receivables on June 30, 2023.

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

receivable on June 30, 2022.

Environmental Matters

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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

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.

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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 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.

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 our Ross Optical division imports, exports and manufactures 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 company and as part of exported shipments.

In particular, we maintain a technology control plan, we are ISO

certified and ITAR (International Traffic in Arms Regulations) registered with the U.S.

State Department and we maintain a number of technology

assistance agreements with overseas suppliers that have been approved by the 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

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

company and as part of exported shipments.

In particular, we maintain a technology control plan, we are ISO certified and ITAR (International

Traffic in Arms Regulations) registered with the U.S.

State Department and we maintain a number of technology assistance agreements with

overseas suppliers that have been approved by the U.S.

State Department.

Non-compliance with applicable requirements

can result in U.S.

actions that may result in withdrawal or suspension of approvals, suspension of company imports, exports or production,

or the imposition of fines or various other penalties.

Non-compliance with applicable requirements can result in U.S.

actions that may result in withdrawal or suspension of approvals, suspension of company imports, exports or production, or the imposition

of fines or various other penalties.

Foreign Requirements .

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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.

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.

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.

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.

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