−Removed: We have been a developer and manufacturer
−Removed: of advanced optical instruments since 1982.
−Removed: Our medical instrumentation line includes traditional endoscopes and endocouplers as
−Removed: well as other custom imaging and illumination products for use in minimally invasive surgical procedures.
−Removed: Much of our recent development
−Removed: efforts have been targeted at the development of next generation endoscopes.
−Removed: For over fifteen years, we have funded internal research
−Removed: and development programs to develop next generation capabilities for designing and manufacturing 3D endoscopes and very small Microprecision™
−Removed: lenses, anticipating future requirements as the surgical community continues to demand smaller and more enhanced imaging systems
−Removed: for minimally invasive surgery.
−Removed: Our unique proprietary technology in these areas, combined with recent developments in the areas
−Removed: of 3D displays and millimeter sized CMOS image sensors, has allowed us to begin commercialization of these technologies.
−Removed: that new products based on these technologies provide enhanced imaging for existing surgical procedures which help to enable development
−Removed: of many new medical device products and related medical procedures.
−Removed: The COVID-19 world-wide pandemic and the
−Removed: domestic and international impact of policy decisions being made in major countries around the world has had, and is expected to
−Removed: continue to have, an adverse impact on various aspects of our business.
−Removed: While we and many of our medical device and defense contracting
−Removed: customers continue to operate as essential businesses, we have taken various actions to augment our operating and human resource
−Removed: policies and procedures to guard against the potential health hazards of COVID-19.
−Removed: These augmented procedures can have a negative
−Removed: impact on our operational efficiencies.
−Removed: Given the uncertainty surrounding the continuation of economic slow-downs domestically
−Removed: and abroad, we cannot predict with certainty at this time what the future impact of COVID-19 and resulting business and economic
−Removed: policies in the US and abroad will be on our up-coming financial operating results.
−Removed: Effective June 1, 2019 we acquired the
−Removed: operating assets of Ross Optical Industries, Inc.
−Removed: of El Paso, Texas, which we began operating as a division of our Company beginning
−Removed: on that date.
−Removed: The accompanying financial statements include the results of operations of the Ross Optical division for the month
−Removed: of June 2019 and the entire fiscal year ended June 30, 2020 and the assets and liabilities of the division as of June 30, 2020
−Removed: The acquisition of the assets of Ross Optical Industries effective June 1, 2019 expands our optics components and assemblies
−Removed: All products supplied by Ross Optical include a custom or catalog optic, which is sourced through Ross Optical’s
−Removed: extensive domestic and worldwide network of optical fabrication companies.
−Removed: Most systems make use of optical lenses, prisms, mirrors
−Removed: and windows and range from individual optical components to complex mechano-optical assemblies.
−Removed: Products often include thin film
−Removed: optical coatings that are applied using the in-house coating department.
−Removed: Approximately 73% of Ross Optical revenues are from customers
−Removed: in the United States, 7% from Western Europe and 8% from Canada during the fiscal year ended June 30, 2020.
−Removed: Ross Optical’s
−Removed: sales are mostly resale of specialized optical components with the remainder being assemblies.
−Removed: Ross Optical does not perform revenue
−Removed: generating engineering services or internal research and development.
−Removed: The majority of Ross Optical sales are for industrial applications
−Removed: with the remainder split between military and medical device products.
−Removed: Approximately 8% of our non-Ross Optical
−Removed: division revenue in fiscal year 2020 was from the design, manufacture and resale of optical products for military and defense and
−Removed: 2% for other industrial, non-medical products and approximately 32-34% of our revenues in each of the fiscal years 2019 and 2020
−Removed: were derived from engineering and design services we performed for our customers to incorporate our technologies and capabilities
−Removed: into their medical device products.
−Removed: Approximately 64-79% of our total revenues in fiscal years 2019 and 2020 were derived from
−Removed: the assembly and manufacture of endoscopic medical devises, sub-assemblies and optical components ordered by our customers and
−Removed: usually developed from the engineering and design services we perform for them.
−Removed: We expect sales revenue increases to come from
−Removed: the orders from our customers to manufacture the products we help them engineer and design.
−Removed: By combining the unique capabilities of
−Removed: our company with the Ross Optical division we are experiencing opportunities for expanded sales of each division products and services
−Removed: throughout the combined customer base.
+Added: We have been a developer and manufacturer of advanced
+Added: optical instruments since 1982.
+Added: Our medical instrumentation line includes traditional endoscopes and endocouplers as well as other custom
+Added: imaging and illumination products for use in minimally invasive surgical procedures.
+Added: Our core efforts are targeted at the development
+Added: of next generation endoscopes.
+Added: Through internal research and development and working in partnership with our customers, we continuously
+Added: develop next generation capabilities for designing and manufacturing 3D endoscopes and very small Microprecision™
+Added: lenses, anticipating
+Added: future requirements as the surgical community continues to demand smaller and more enhanced imaging systems for minimally invasive surgery.
+Added: Our unique proprietary technology in these areas, combined with recent developments in the areas of 3D displays and millimeter sized CMOS
+Added: image sensors, has allowed us to begin commercialization of these technologies.
+Added: The products we design and build based on these technologies
+Added: are providing enhanced imaging for existing surgical procedures and oftentimes represent critical imaging products, components and technology
+Added: which enable the development of new medical device products and related medical procedures.
+Added: The COVID-19 world-wide pandemic and the domestic
+Added: and international impact of policy decisions being made in major countries around the world has had, and may continue to have, an adverse
+Added: impact on various aspects of our business.
+Added: We have taken various actions to augment our operating and human resource policies and procedures
+Added: to guard against the potential health hazards of COVID-19.
+Added: Some of those augmented procedures can have a negative impact on our operational
+Added: efficiencies.
+Added: Given the uncertainty surrounding the continuation of economic slow-downs domestically and abroad, we cannot predict with
+Added: 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
+Added: our up-coming financial operating results.
+Added: Effective June 1, 2019 we acquired the operating
+Added: assets of Ross Optical Industries, Inc.
+Added: of El Paso, Texas, which we began operating as a division of our Company beginning on that date.
+Added: The accompanying financial statements include the results of operations of the Ross Optical division for fiscal years ended June 30, 2021
+Added: and 2020, and the assets and liabilities of the division as of June 30, 2021 and 2020.
+Added: The Ross Optical division expands our optics components
+Added: and assemblies’
+Added: business to include custom and catalog optics, which are sourced through Ross Optical’s extensive domestic
+Added: and worldwide network of optical fabrication companies.
+Added: Most systems make use of optical lenses, prisms, mirrors and windows and range
+Added: from individual optical components to complex mechano-optical assemblies.
+Added: Products often include thin film optical coatings that are applied
+Added: using the in-house coating department.
+Added: Over 70% of the Ross Optical division sales are in the United States, with the majority being specialized
+Added: optical components for industrial applications and the remainder being assemblies.
+Added: The balance of sales is split between military and
+Added: medical device products.
+Added: Approximately 54% of our total revenues in fiscal
+Added: year 2021 were derived from optical components we design, manufacture and assemble as well as custom components we source, qualify and
+Added: resell to our customers.
+Added: Approximately 26% of our revenues in fiscal year 2021 were derived from optical engineering and design services,
+Added: and the remaining 20% from the assembly and manufacture of endoscopic medical devises, sub-assemblies and optical components ordered by
+Added: our customers and typically developed from the engineering and design services we perform for them.
+Added: During fiscal year 2021, approximately
+Added: 60% of our revenues were medical products related, 33% industrial, and 7% related to military and defense.
+Added: The allocation of sales revenues
+Added: between service offerings and industries was similar in fiscal year 2020 to those allocations in fiscal year 2021 described above.
+Added: expect sales revenue increases to result from assembly and manufacturing orders received from our customers for the products we assist
+Added: them in designing using our unique optical product design and manufacturing capabilities.
+Added: By combining the unique capabilities of our company
+Added: with the Ross Optical division we are experiencing opportunities for expanded sales of each division products and services throughout
+Added: the combined customer base.
Additionally, Ross’
−Removed: expanded worldwide vendor relationships are benefiting our traditional
−Removed: efforts to source materials at competitive prices for our development projects and manufacturing activities.
+Added: expanded worldwide vendor relationships are benefiting our traditional efforts to
+Added: source materials at competitive prices for our development projects and manufacturing activities.
We incorporated in Massachusetts in December 1982
and have been publicly-owned since November 1990.
−Removed: References to our Company contained herein include our two wholly-owned
−Removed: subsidiaries, Precise Medical, Inc.
−Removed: and Wood’s Precision Optics Corporation, Limited, except where the context otherwise
−Removed: Effective June 1, 2019 we acquired the operating assets of Ross Optical Industries, Inc.
−Removed: of El Paso, Texas, which we
−Removed: began operating as a division of our Company beginning on that date.
−Removed: The accompanying financial statements include the results
−Removed: of operations of the Ross division for the fiscal year ended June 30, 2020 and the month of June 2019 and its assets and liabilities
−Removed: as of June 30, 2020 and 2019.
+Added: References to our Company contained herein include our two wholly-owned subsidiaries,
+Added: Precise Medical, Inc.
+Added: and Wood’s Precision Optics Corporation, Limited, except where the context otherwise requires.
+Added: June 1, 2019 we acquired the operating assets of Ross Optical Industries, Inc.
+Added: of El Paso, Texas, which we began operating as a division
+Added: of our Company beginning on that date.
+Added: The accompanying financial statements include the results of operations of the Ross division for
+Added: the fiscal years ended June 30, 2021 and 2020 and its assets and liabilities as of June 30, 2021 and 2020.
Our websites are www.poci.com and www.rossoptical.com.
3 unchanged sentences
we have manufactured medical products such as endoscopes and endocouplers.
−Removed: We have developed and sold endoscopes incorporating
−Removed: various optical technologies including our proprietary Lenslock™
−Removed: technology, for use in a variety of minimally invasive surgical
−Removed: and diagnostic procedures.
−Removed: Today, we produce endoscopes for various applications, which are CE marked and therefore certified for
−Removed: sale throughout the European Economic Area.
−Removed: Since 1985, we have developed, manufactured and sold a proprietary product line of
−Removed: endocouplers.
−Removed: We also design and manufacture custom optical medical devices to satisfy our customers’
+Added: We have developed and sold endoscopes incorporating various
+Added: optical technologies including our proprietary Lenslock™
+Added: technology, for use in a variety of minimally invasive surgical and diagnostic
+Added: Today, we produce endoscopes for various applications, which are CE marked and therefore certified for sale throughout the
+Added: European Economic Area.
+Added: Since 1985, we have developed, manufactured and sold a proprietary product line of endocouplers.
+Added: We also design
+Added: and manufacture custom optical medical devices to satisfy our customers’
specific requirements.
−Removed: In addition to medical devices, we also manufacture and sell components and assemblies specially designed for industrial and military
+Added: In addition to medical devices,
+Added: we also manufacture and sell components and assemblies specially designed for industrial and military use.
The acquisition of the assets of Ross Optical
−Removed: Industries effective June 1, 2019 expands our optics components and assemblies business.
−Removed: All products supplied by Ross Optical
−Removed: include a custom or catalog optic, which is sourced through Ross Optical’s extensive domestic and worldwide network of optical
−Removed: fabrication companies.
−Removed: Most systems make use of optical lenses, prisms, mirrors and windows and range from individual optical components
−Removed: to complex mechano-optical assemblies.
−Removed: Products often include thin film optical coatings that are applied by the Ross Optical division
−Removed: in-house coating department.
+Added: Industries effective June 1, 2019 expanded our optics components and assemblies business.
+Added: All products supplied by Ross Optical include
+Added: a custom or catalog optic, which is sourced through Ross Optical’s extensive domestic and worldwide network of optical fabrication
+Added: Most systems make use of optical lenses, prisms, mirrors and windows and range from individual optical components to complex
+Added: mechano-optical assemblies.
+Added: Products often include thin film optical coatings that are applied by the Ross Optical division in-house coating
Microprecision™
−Removed: Lenses and Micro
−Removed: Medical Cameras:
−Removed: While the size of endoscopes has gradually decreased over time, the widespread use of very small endoscopes,
−Removed: with diameters of one millimeter or smaller, has been limited, in part, we believe, by the inability of traditional lens fabrication
−Removed: methods to support these smaller sizes with good image quality and acceptable manufacturing costs.
+Added: Lenses and Micro Medical
+Added: While the size of endoscopes has gradually decreased over time, the widespread use of very small endoscopes, with diameters
+Added: of one millimeter or smaller, has been limited, in part, we believe, by the inability of traditional lens fabrication methods to support
+Added: these smaller sizes with good image quality and acceptable manufacturing costs.
We believe our Microprecision™
−Removed: optics technology provides a solution to this problem.
−Removed: Combined with recent advances by other companies in complementary metal-oxide-semiconductor,
−Removed: or CMOS, image sensor fabrication techniques, our Microprecision™
−Removed: lenses and proprietary manufacturing techniques enable
−Removed: the manufacture of micro medical cameras at low prices and with sizes on the order of one millimeter or less, characteristics that
−Removed: make them well suited to medical applications.
−Removed: We are currently engaged in development
−Removed: projects with numerous customers to design and produce even smaller CMOS based camera modules together with customized illumination
−Removed: using various technologies to match the needs of the medical device endoscopes.
−Removed: We are also currently designing disposable versions
−Removed: of our camera modules and assemblies designed for single-use and reduced risk of contamination from repeated use.
−Removed: We believe these
−Removed: on-going improvements are significant to the continued evolution and acceptance of our Microprecision™
+Added: optics technology
+Added: provides a solution to this problem.
+Added: Combined with recent advances by other companies in complementary metal-oxide-semiconductor, or CMOS,
+Added: image sensor fabrication techniques, our Microprecision™
+Added: lenses and proprietary manufacturing techniques enable the manufacture
+Added: of micro medical cameras at low prices and with sizes on the order of one millimeter or less, characteristics that make them well suited
+Added: to medical applications.
+Added: We are currently engaged in development projects
+Added: with numerous customers to design and produce even smaller CMOS based camera modules together with customized illumination using various
+Added: technologies to match the needs of the medical device endoscopes.
+Added: We are also currently designing disposable versions of our camera modules
+Added: and assemblies designed for single-use and reduced risk of contamination from repeated use.
+Added: We believe these on-going improvements are
+Added: significant to the continued evolution and acceptance of our Microprecision™
technology platform.
−Removed: We have been engaged by various customers
−Removed: for an increasing amount of development work relating to the design of endoscopes and camera assemblies that utilize our Microprecision™
−Removed: We previously received two production orders exceeding $1M each from two customers for their custom designed products,
−Removed: and follow-on orders for equal or larger amounts from each of these two customers.
−Removed: We also believe we will receive additional productions
−Removed: orders from other customers currently in our engineering and design pipeline.
+Added: We have been engaged by various customers for
+Added: an increasing amount of development work relating to the design of endoscopes and camera assemblies that utilize our Microprecision™
+Added: We previously received production orders each exceeding $1M and follow-on orders from multiple customers for their custom
+Added: designed products fulfillment of which is ongoing.
+Added: We believe we will receive additional production orders from other customers currently
+Added: in our engineering and design pipeline.
3D Endoscopes:
−Removed: Our 3D endoscopes
−Removed: provide next generation optical imaging for minimally invasive surgical procedures that utilize hand-held rigid endoscopes by using
−Removed: the brain’s natural ability to perceive depth, which is the third dimension, by viewing one’s environment through two
−Removed: Utilizing our proprietary technology to provide independent images to right and left eyes, surgeons can view the operative
−Removed: field with 3D perception.
+Added: Our 3D endoscopes provide
+Added: next generation optical imaging for minimally invasive surgical procedures that utilize hand-held rigid endoscopes by using the brain’s
+Added: natural ability to perceive depth, which is the third dimension, by viewing one’s environment through two eyes.
+Added: Utilizing our proprietary
+Added: technology to provide independent images to right and left eyes, surgeons can view the operative field with 3D perception.
Competition and Markets
−Removed: We sell our products in a highly competitive
−Removed: market and we compete for business with both foreign and domestic manufacturers.
−Removed: Many of our current competitors are larger than
−Removed: us and have substantially greater resources than we do.
−Removed: In addition, there is an ongoing risk that other domestic or foreign companies
−Removed: who do not currently service or manufacture products for our target markets, some with greater experience in the optics industry
−Removed: and greater financial resources than we have, may seek to produce products or services that compete directly with ours.
−Removed: While our resources are substantially more
−Removed: limited than those of some of our competitors, we believe that we can compete successfully in this market on the basis of product
−Removed: quality, price, delivery and innovation.
−Removed: Our success will depend, in part, on our ability to maintain a technological advantage
−Removed: over our competitors.
−Removed: To this end, we intend to continue to aggressively support and augment our internal engineering, research
−Removed: and development resources and to aggressively pursue patent protection for existing and new technology.
−Removed: We believe that our unique
−Removed: technical capabilities in the areas of Microprecision™
−Removed: optics, micro medical cameras and illumination, as well as 3D endoscopes
−Removed: currently represent competitive advantages for us in the minimally invasive surgical device market.
+Added: We sell our products in highly competitive markets
+Added: and we compete for business with both foreign and domestic manufacturers.
+Added: Many of our current competitors are larger than us and have
+Added: substantially greater resources than we do.
+Added: In addition, there is an ongoing risk that other domestic or foreign companies who do not
+Added: currently service or manufacture products for our target markets, some with greater experience in the optics industry and greater financial
+Added: resources than we have, may seek to produce products or services that compete directly with ours.
+Added: While our resources are substantially more limited
+Added: than those of some of our competitors, we believe that we can compete successfully in this market on the basis of product quality, price,
+Added: delivery and innovation tailored to our customers’
+Added: specifications.
+Added: Our success will depend, in part, on our ability to maintain
+Added: a technological advantage over our competitors and to effectively incorporate that technology into our custom designs.
+Added: To this end, we
+Added: intend to continue to aggressively support and augment our internal engineering, research and development resources and to aggressively
+Added: pursue patent protection for existing and new technology.
+Added: We believe that our unique technical capabilities in the areas of Microprecision™
+Added: optics, micro medical cameras and illumination, as well as 3D endoscopes currently represent competitive advantages for us in the minimally
+Added: invasive surgical device market.
The competitive advantage of our Ross Optical
−Removed: division is its ability to provide difficult-to-find optics, and, increasingly, to provide a broader range of services based on
−Removed: its ability to source optics worldwide and augmented by its ability to provide thin-film coatings and assembly.
+Added: division is its ability to provide difficult-to-find optics, and, increasingly, to provide a broader range of services based on its ability
+Added: to source optics worldwide and augmented by its ability to provide thin-film coatings and assembly.
Market Opportunities
Microprecision™
−Removed: Lenses and Micro
−Removed: Medical Cameras:
−Removed: While other approaches exist for the manufacture of camera lenses, we design custom camera module assemblies
−Removed: with the combined objectives of low cost, small size, range of optical specifications and high image quality desired by our customer’s
+Added: Lenses and Micro Medical
+Added: While other approaches exist for the manufacture of camera lenses, we design custom camera module assemblies with the combined
+Added: objectives of low cost, small size, range of optical specifications and high image quality required by our customer’s precise medical
device specifications.
−Removed: By enabling the production of millimeter sized and smaller cameras with low manufacturing costs, we believe
−Removed: our Microprecision™
+Added: By enabling the production of millimeter sized and smaller cameras with low manufacturing costs, we believe our
+Added: Microprecision™
technology opens the possibility to replace existing re-sterilizable endoscopes with a single-use alternative.
−Removed: Also, the small size of our Microprecision™
−Removed: lenses and micro medical cameras combined with our proprietary illumination techniques
−Removed: can provide visualization for existing procedures that are currently performed blind or with sub-optimal imaging, and we believe
−Removed: can facilitate the development of new surgical procedures that are currently impractical without sub-millimeter visualization instrumentation.
+Added: the small size of our Microprecision™
+Added: lenses and micro medical cameras combined with our proprietary illumination techniques can
+Added: provide visualization for existing procedures that are currently performed blind or with sub-optimal imaging, and we believe can facilitate
+Added: the development of new surgical procedures that are currently impractical without sub-millimeter visualization instrumentation.
3D Endoscopes and Robotic Surgery Systems :
−Removed: 3D endoscopes have been used for many years as part of robotic surgery systems partly because the market price of robotic surgery
−Removed: systems is high enough to support the cost of a high-quality custom 3D display.
−Removed: Competition amongst medical device companies, many
−Removed: of which are our customers for other products, in the area of 3D robotic surgery systems is increasing, and various companies are
−Removed: now pursuing less expensive, procedure specific robotic systems.
−Removed: We believe our experience and expertise in 3D endoscopes for medical
−Removed: applications could be a benefit to various companies in this area that could provide us with new product development and manufacturing
−Removed: opportunities.
+Added: 3D endoscopes have been used for many years as part of robotic surgery systems partly because the market price of robotic surgery systems
+Added: is high enough to support the cost of a high-quality custom 3D display.
+Added: Competition amongst medical device companies, many of which are
+Added: our customers for other products, in the area of 3D robotic surgery systems is increasing, and various companies are now pursuing less
+Added: expensive, procedure specific robotic systems.
+Added: We believe our experience and expertise in 3D endoscopes for medical applications could
+Added: be a benefit to various companies in this area that could provide us with new product development and manufacturing opportunities.
Sales and Marketing
−Removed: Current sales and marketing activities
−Removed: are intended to broaden awareness of the benefits of our new technology platforms and our successful application of these new technologies
−Removed: to medical device projects requiring surgery-grade visualization from sub-millimeter sized devices and 3D endoscopy, including
−Removed: single-use products and assemblies.
−Removed: We market directly to established medical device companies primarily in the United States that
−Removed: we believe could benefit from our advanced endoscopy visualization systems.
−Removed: Through this direct marketing, referrals, attendance
−Removed: at trade shows and a presence in online professional association websites, we have expanded our on-going pipeline of projects to
−Removed: significant medical device companies as well as well-funded emerging technology companies.
−Removed: We expect our customer pipeline to continue
−Removed: to expand as development projects transition to production orders and new customer projects enter the development phase.
−Removed: Optical division markets through existing customers and trade shows, in addition to proactive online marketing strategies executed
−Removed: primarily through its website.
−Removed: Through the gradual integration of the sales and marketing resources of the two operations we have
−Removed: begun to realize both expanded sales opportunities of the Ross component products and our micro optics engineering services, as
−Removed: well as benefits from utilizing Ross’
−Removed: worldwide vendor relationships for optical components.
+Added: Current sales and marketing activities are intended
+Added: to broaden awareness of the benefits of our new technology platforms and our successful application of these new technologies to medical
+Added: device projects requiring surgery-grade visualization from sub-millimeter sized devices and 3D endoscopy, including single-use products
+Added: and assemblies.
+Added: We market directly to established medical device companies primarily in the United States that we believe could benefit
+Added: from our advanced endoscopy visualization systems.
+Added: Through this direct marketing, referrals, attendance at trade shows and a presence
+Added: in online professional association websites, we have expanded our on-going pipeline of projects to significant medical device companies
+Added: and to well-funded emerging technology companies.
+Added: We expect our customer pipeline to continue to expand as development projects transition
+Added: to production orders and new customer projects enter the development phase.
+Added: Our Ross Optical division markets through existing customers
+Added: and trade shows, in addition to proactive online marketing strategies executed primarily through its website.
+Added: Through the gradual integration
+Added: of the sales and marketing resources of the two operations we have begun to realize both expanded sales opportunities of the Ross component
+Added: products and our micro optics engineering services, as well as benefits from utilizing Ross’
+Added: worldwide vendor relationships for
+Added: optical components.
International Business
−Removed: We have had negligible direct export sales
−Removed: However, our medical products have received the CE mark certification, which permits sales into the European Economic
−Removed: Area and which benefits our customers as they market their products manufactured by us or containing our sub-assemblies into markets
−Removed: outside the United States.
−Removed: In the future, we may establish or use additional production facilities overseas to produce key components
−Removed: for our business, such as lenses.
−Removed: From the 1990s through approximately 2014, we maintained a physical presence in Asia to support
−Removed: business and quality control activities throughout the region as needed.
−Removed: We continue to acquire various optical components from
−Removed: overseas to meet the needs of custom device designs.
−Removed: We believe that the availability of specialized components and cost savings
−Removed: from various overseas production resources is essential to our ability to deliver complex and unique device designs and to compete
−Removed: on a price basis in the medical products area particularly and to our profitability generally.
+Added: Other than the Ross Optical division international
+Added: sales described below, we have had negligible direct export sales to date.
+Added: However, our medical products have received the CE mark certification,
+Added: which permits sales into the European Economic Area and which benefits our customers as they market their products manufactured by us
+Added: or containing our sub-assemblies into markets outside the United States.
+Added: In the future, we may establish or use additional production
+Added: facilities overseas to produce key components for our business, such as lenses.
+Added: From the 1990s through approximately 2014, we maintained
+Added: a physical presence in Asia to support business and quality control activities throughout the region as needed.
+Added: We continue to acquire
+Added: various optical components from overseas to meet the needs of custom device designs.
+Added: We believe that the availability of specialized components
+Added: and cost savings from various overseas production resources is essential to our ability to deliver complex and unique device designs and
+Added: to compete on a price basis in the medical products area particularly and to our profitability generally.
The addition of Ross Optical adds an expanded
−Removed: network of overseas suppliers of various types and sizes of optical components and assemblies that will enhance our ability to
−Removed: meet the material demands of our customers’
+Added: network of overseas suppliers of various types and sizes of optical components and assemblies that will enhance our ability to meet the
+Added: material demands of our customers’
unique optical and medical device designs.
−Removed: During fiscal year 2020, 27%
−Removed: of the Ross Optical division sales were to customers outside of the United States, with 8%, 7% and 7% of total Ross Optical division
−Removed: sales to Canada, Western Europe and Singapore, respectively.
+Added: During fiscal year 2021, 13% of the Ross Optical
+Added: division sales were to customers outside of the United States and Canada, with the balance of sales primarily split between Western Europe
+Added: and Singapore.
Research and Development
−Removed: We believe that our future success depends,
−Removed: to a large degree, on our ability to continue to conceive and develop new optical products and technologies to enhance the performance
−Removed: characteristics and methods of manufacture of existing and new products.
−Removed: Although development work on behalf of customers is almost
−Removed: entirely performed under revenue generating contracts and customer purchase orders, research and development expenses are incurred
−Removed: on our own proprietary products and technology, such as Microprecision™
+Added: We believe that our future success depends, to
+Added: a large degree, on our ability to continue to conceive and develop new optical products and technologies to enhance the performance characteristics
+Added: and methods of manufacture of existing and new products.
+Added: Although development work on behalf of customers is almost entirely performed
+Added: under revenue generating contracts and customer purchase orders, research and development expenses are incurred on our own proprietary
+Added: products and technology, such as Microprecision™
optics, micro medical cameras and 3D endoscopes.
−Removed: Accordingly, we treat engineering expenses not consumed in customer contracted development and our investment of funds and resources
−Removed: in internal product and intellectual property development as research and development expense in the accompanying statement of
−Removed: For the years ended June 30, 2020 and 2019, research and development expenses were $886,129 and $505,300, respectively.
+Added: Accordingly, we treat engineering
+Added: expenses not consumed in customer contracted development and our investment of funds and resources in internal product and intellectual
+Added: property development as research and development expense in the accompanying statement of operations.
+Added: For the years ended June 30, 2021
+Added: and 2020, research and development expenses were $624,253 and $886,129, respectively.
Raw Materials and Principal Suppliers
4 unchanged sentences
of endoscope products for our customers from various suppliers such as OmniVision Technologies, Inc.
−Removed: We believe that while the
−Removed: number of sources of supply is limited for the CMOS sensors with the specifications used in medical device endoscopes we develop,
−Removed: the manufacturing capacities of those suppliers is adequate to meet our demand in the next twelve months.
−Removed: Likewise, a limited number
−Removed: of suppliers provide CMOS electronic cabling services for the smallest sensors, such as FujiKura, Ltd.
−Removed: and High Speed Interconnects.
−Removed: However, we believe our demand for these services is relatively small compared to these companies’
−Removed: and others’
−Removed: for CMOS sensor electronic cabling services.
−Removed: We have experienced supply disruptions
−Removed: and customer delays from certain vendors and customers that we believe were the result of the COVID-19 pandemic and related economic
−Removed: Although we are not currently experiencing vendor supply issues as a result of COVID-19, we cannot predict with certainty
−Removed: 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
−Removed: vendors and principal suppliers.
+Added: We believe that while the number
+Added: of sources of supply is limited for the CMOS sensors with the specifications used in medical device endoscopes we develop;
+Added: the manufacturing
+Added: capacities of those suppliers is adequate to meet our demand in the next twelve months.
+Added: We have experienced supply disruptions and customer
+Added: delays from certain vendors and customers that we believe were the result of the COVID-19 pandemic and related economic slow-down.
+Added: we are not currently experiencing vendor supply issues as a result of COVID-19, we cannot predict with certainty at this time what the
+Added: 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
We rely, in part, upon patents, trade secrets
−Removed: and proprietary knowledge as well as personnel policies and employee confidentiality agreements concerning inventions and other
−Removed: creative efforts to develop and maintain our competitive position.
−Removed: We plan to file for patents, copyrights and trademarks in the
−Removed: United States and in other appropriate countries to protect our intellectual property rights to the greatest extent practicable.
−Removed: We currently hold rights to various United States patents, and have patent applications pending, including applications for our
−Removed: new generation of micro medical cameras and 3D endoscopes.
−Removed: Our current patent portfolio includes patents, rights to patents and
−Removed: patent applications that cover various aspects of our technology in the following areas:
+Added: and proprietary knowledge as well as personnel policies and employee confidentiality agreements concerning inventions and other creative
+Added: efforts to develop and maintain our competitive position.
+Added: We plan to file for patents, copyrights and trademarks in the United States
+Added: and in other appropriate countries to protect our intellectual property rights to the greatest extent practicable.
+Added: We currently hold rights
+Added: to various United States patents, and have patent applications pending, including applications for our new generation of micro medical
+Added: Our current patent portfolio includes patents, rights to patents and patent applications that cover various aspects of our technology
+Added: in the following areas:
Medical devices;
2 unchanged sentences
lenses and micro medical cameras;
−Removed: Military products.
−Removed: The patents contained in our current patent
−Removed: portfolio have various expiration dates through May 2036.
+Added: Defense products.
+Added: The patents contained in our current patent portfolio
+Added: have various expiration dates through May 2036.
We are not aware of any infringements of these patents.
−Removed: While we believe
−Removed: that our pending applications relate to patentable devices or concepts, these patents may not ultimately be issued and we may not
−Removed: be able to successfully defend these patents or effectively limit the development of competitive products and services.
−Removed: In July 2011, we entered into an asset
−Removed: purchase agreement with Intuitive Surgical Operations, Inc., in which we received $2.5 million in connection with the sale of certain
−Removed: intellectual property.
−Removed: Pursuant to the agreement, we agreed to assign to Intuitive Surgical all of the issued and non-expired patents
−Removed: and pending patent applications that we held on the date of the agreement, and in return, Intuitive Surgical agreed to grant to
−Removed: us a royalty-free, worldwide license to these patents in fields outside of medical robotics.
−Removed: We intend to continue to innovate and extend
−Removed: our technological capabilities in the areas of 3-D endoscopy Microprecision™
+Added: While we believe that our pending
+Added: applications relate to patentable devices or concepts, these patents may not ultimately be issued and we may not be able to successfully
+Added: defend these patents or effectively limit the development of competitive products and services.
+Added: In July 2011, we entered into an asset purchase
+Added: agreement with Intuitive Surgical Operations, Inc., in which we assigned to Intuitive Surgical all of the issued and non-expired patents
+Added: and pending patent applications that we held at that time, and in return, Intuitive Surgical granted us a royalty-free, worldwide license
+Added: to these patents in fields outside of medical robotics.
+Added: We intend to continue to innovate and extend our
+Added: 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.
−Removed: As of June 30, 2020, we had 60 employees,
−Removed: 58 of which were full-time employees.
−Removed: There were 38 employees in manufacturing, 9 in engineering/research and development, 6 in
−Removed: sales, and 7 in finance and administration.
+Added: As of June 30, 2021, we had 52 employees, 50 of
+Added: which were full-time employees.
+Added: There were 28 employees in manufacturing, 9 in engineering/research and development, 6 in sales, and 9
+Added: in finance and administration.
We are not a party to any collective bargaining agreements.
−Removed: We believe our relations
−Removed: with our employees are very good.
−Removed: Revenues from our largest customers, as
−Removed: a percentage of total revenues, for fiscal years 2020 and 2019 were as follows:
−Removed: During fiscal year 2020 we sold product
−Removed: and services to 643 customers in addition to those represented in the table above, and no other customer accounted for more than
−Removed: 10% of our revenues in fiscal years 2020 and 2019.
+Added: We believe our relations with our employees
+Added: are very good.
+Added: During fiscal year 2021 we sold product and services
+Added: to over 326 customers and no customer accounted for 10% or more of our total revenues during the fiscal years ended June 30, 2021, and
+Added: Our largest customer account receivable balance
+Added: at June 30, 2021, was 16% of total accounts receivable.
At June 30, 2020, our largest customer account receivable balance was 14%
of total accounts receivable.
−Removed: At June 30, 2019, our largest customer account receivable balance was 12% of total accounts
No other accounts accounted for more than 10% of accounts receivable at June 30, 2021, or 2020.
Environmental Matters
−Removed: Our operations are subject to a variety
−Removed: of federal, state and local laws and regulations relating to the discharge of materials into the environment or otherwise relative
−Removed: to the protection of the environment.
+Added: Our operations are subject to a variety of federal,
+Added: state and local laws and regulations relating to the discharge of materials into the environment or otherwise relative to the protection
+Added: of the environment.
From time to time, we use a small amount of hazardous materials in our operations.
−Removed: that we currently comply with all applicable environmental laws and regulations and intend to do our best efforts to remain in
+Added: We believe that we currently comply
+Added: with all applicable environmental laws and regulations and intend to do our best efforts to remain in compliance.
Government Regulations
Domestic Regulation .
−Removed: develop, manufacture and sell several medical products, the marketing of which is subject to governmental regulation in the United
−Removed: Medical devices are regulated in the United States by the Food and Drug Administration, or FDA, and, in some cases, by
−Removed: certain state agencies.
−Removed: The FDA regulates the research, design, testing, manufacture, safety, effectiveness, labeling, promotion
−Removed: and distribution of medical devices in the United States.
−Removed: Generally, medical devices require clearance or approval prior to commercial
−Removed: distribution.
−Removed: Additionally, certain material changes to, and changes in, intended uses of, medical devices are also subject to
−Removed: FDA review and clearance or approval.
−Removed: Non-compliance with applicable requirements can result in failure of the FDA to grant pre-market
−Removed: clearance or approval, withdrawal or suspension of approval, suspension of production, or the imposition of various other penalties.
−Removed: We previously notified the FDA of our intent
−Removed: to market our endoscopes, image couplers, beamsplitters, adapters and video ophthalmoscopes, and the FDA has determined that we
−Removed: may market such devices, subject to the general control provisions of the Food, Drug and Cosmetic Act.
−Removed: We obtained this FDA permission
−Removed: without the need to undergo a lengthy and expensive approval process due to the FDA’s determination that such devices met
−Removed: the regulatory standard of being substantially equivalent to existing FDA-approved devices.
−Removed: In the future, we plan to market additional
−Removed: medical devices that may require the FDA’s permission to market such products.
−Removed: We may also develop additional products or
−Removed: 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
−Removed: market such products, as well as the regulatory approval or license of other federal, state and local agencies or similar agencies
−Removed: in other countries.
−Removed: The FDA has authority to conduct detailed inspections of manufacturing plants in order to assure that “good
−Removed: manufacturing practices”
−Removed: are being followed in the manufacture of medical devices including medical devices or components
−Removed: of medical devices manufactured for other medical device companies, to require periodic reporting of product defects to the FDA,
−Removed: and to prohibit the sale of devices which do not comply with law.
−Removed: We design and manufacture components for
−Removed: the defense industry, and our Ross Optical division imports, exports and manufactures optical products for the defense industry,
−Removed: some of which is controlled by U.S.
−Removed: Generally, these regulations require strict control over technical data in documented
−Removed: form and as embodied in products, both within our company and as part of exported shipments.
−Removed: In particular, we maintain a technology
−Removed: control plan, we are ISO certified and ITAR (International Traffic in Arms Regulations) registered with the U.S.
+Added: We currently develop,
+Added: manufacture and sell several medical products, the marketing of which is subject to governmental regulation in the United States.
+Added: devices are regulated in the United States by the Food and Drug Administration, or FDA, and, in some cases, by certain state agencies.
+Added: The FDA regulates the research, design, testing, manufacture, safety, effectiveness, labeling, promotion and distribution of medical devices
+Added: in the United States.
+Added: Generally, medical devices require clearance or approval prior to commercial distribution.
+Added: Additionally, certain
+Added: material changes to, and changes in, intended uses of, medical devices are also subject to FDA review and clearance or approval.
+Added: Non-compliance
+Added: with applicable requirements can result in failure of the FDA to grant pre-market clearance or approval, withdrawal or suspension of approval,
+Added: suspension of production, or the imposition of various other penalties.
+Added: We previously notified the FDA of our intent to
+Added: market our endoscopes, image couplers, beamsplitters, adapters and video ophthalmoscopes, and the FDA has determined that we may market
+Added: such devices, subject to the general control provisions of the Food, Drug and Cosmetic Act.
+Added: We obtained this FDA permission without the
+Added: need to undergo a lengthy and expensive approval process due to the FDA’s determination that such devices met the regulatory standard
+Added: of being substantially equivalent to existing FDA-approved devices.
+Added: In the future, we plan to market additional medical
+Added: devices that may require the FDA’s permission to market such products.
+Added: We may also develop additional products or seek to sell some
+Added: 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
+Added: well as the regulatory approval or license of other federal, state and local agencies or similar agencies in other countries.
+Added: has authority to conduct detailed inspections of manufacturing plants in order to assure that “good manufacturing practices”
+Added: are being followed in the manufacture of medical devices including medical devices or components of medical devices manufactured for other
+Added: medical device companies, to require periodic reporting of product defects to the FDA, and to prohibit the sale of devices which do not
+Added: comply with law.
+Added: We design and manufacture components for the defense
+Added: industry, and our Ross Optical division imports, exports and manufactures optical products for the defense industry, some of which is
+Added: controlled by U.S.
+Added: Generally, these regulations require strict control over technical data in documented form and as embodied
+Added: in products, both within our company and as part of exported shipments.
+Added: In particular, we maintain a technology control plan, we are ISO
+Added: certified and ITAR (International Traffic in Arms Regulations) registered with the U.S.
+Added: State Department and we maintain a number of technology
+Added: assistance agreements with overseas suppliers that have been approved by the U.S.
State Department.
−Removed: and we maintain a number of technology assistance agreements with overseas suppliers that have been approved by the U.S.
−Removed: Non-compliance with applicable requirements can result in U.S.
−Removed: actions that may result in withdrawal or suspension
−Removed: of approvals, suspension of company imports, exports or production, or the imposition of fines or various other penalties.
+Added: Non-compliance with applicable requirements
+Added: can result in U.S.
+Added: actions that may result in withdrawal or suspension of approvals, suspension of company imports, exports or production,
+Added: or the imposition of fines or various other penalties.
Foreign Requirements .
1 unchanged sentence
device products outside the United States are subject to foreign regulatory requirements that may vary from country to country.
−Removed: Our failure to comply with foreign regulatory requirements would jeopardize our ability to market and sell our products in foreign
−Removed: jurisdictions.
−Removed: The regulatory environment in the European Union member countries of the European Economic Area for medical device
−Removed: products differs from that in the United States.
+Added: to comply with foreign regulatory requirements would jeopardize our ability to market and sell our products in foreign jurisdictions.
+Added: The regulatory environment in the European Union member countries of the European Economic Area for medical device products differs from
+Added: that in the United States.
Medical devices sold in the European Economic Area must bear the Conformité
−Removed: Européenne, or CE mark.
−Removed: Devices are classified by manufacturers according to the risks they represent, with a classification
−Removed: of Class III representing the highest risk devices and Class I representing the lowest risk devices.
−Removed: Once a device has been
−Removed: classified, the manufacturer can follow one of a series of conformity assessment routes, typically through a registered quality
−Removed: system, and demonstrate compliance to a “European Notified Body.”
+Added: Européenne, or CE
+Added: Devices are classified by manufacturers according to the risks they represent, with a classification of Class III representing the
+Added: highest risk devices and Class I representing the lowest risk devices.
+Added: Once a device has been classified, the manufacturer can follow
+Added: one of a series of conformity assessment routes, typically through a registered quality system, and demonstrate compliance to a “European
+Added: Notified Body.”
The CE mark may then be applied to the device.
−Removed: of the system is ensured through annual on-site audits by the notified body and a post-market surveillance system requiring the
−Removed: manufacturer to submit serious complaints to the appropriate governmental authority.
−Removed: All of our medical products are manufactured
−Removed: in conformity with the CE mark requirements.
+Added: Maintenance of the system is ensured through annual on-site audits
+Added: by the notified body and a post-market surveillance system requiring the manufacturer to submit serious complaints to the appropriate
+Added: governmental authority.
+Added: All of our medical products are manufactured in conformity with the CE mark requirements.
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.