Executive Summary

Introduction

The challenges of infection prevention in the healthcare industry are increasing due to the growing incidence of hospital acquired infections (HAI). As the number one quality and safety issue for healthcare facilities, HAIs affect nearly 5% of all patients and cause nearly 100,000 deaths annually[1]. This results in a loss of life greater than the annual death toll from diabetes and prostate cancer combined. The U.S. healthcare industry incurs over $35B per year in non-reimbursable costs due to HAIs1. Current prevention strategies range from harsh biocidal wipes and sprays to expensive capital equipment; however, HAI’s remain problematic1.

Sterifre Medical, Inc. is commercializing a range of services based on innovative technology that address the growing demand for rapid, automated, point-of-care infection prevention in healthcare facilities. Portable medical equipment has been shown to harbor pathogenic organisms including MRSA and other MDRO’s.[2] By replacing and/or complementing existing products in this market, Sterifre will be able to offer an automated, environmentally friendly and compliant approach to infection prevention.

[1] Elder, M. Healthcare Infection Control Market. Kalorama Market Int. Report. May 2014.

[2] Pyrek, K. Mobile Technology Disinfection: Contaminated Devices Pose Threat to Patients. Infection Control Today. February 2017.

Company History

Sterifre was established in 2016 when former Cornell University researcher, Czeslaw Golkowski, Ph.D., partnered with healthcare industry veteran, Richard Shea, to commercialize this innovative disinfection technology. With over thirty-five years of experience leading companies from start-up to successful commercialization, Mr. Shea recruited an experienced management team to achieve the milestones related to product development, testing, regulatory approvals and commercialization of the company’s first product. Mr. Shea most recently served as the CEO of Olympus Respiratory America (formerly Spiration Inc.), a leader in minimally invasive treatments for patients with severe COPD. He was a founding executive of Stericycle Inc. (SRCL), a global leader in infection prevention products and services. He also serves as the Board Chair for Providence St. Joseph Health and Services Northwest Region and is the Board Chairman emeritus of the University of Washington Bothell.

Aura: A Rapid, Automated, Point-of-Care Disinfection System for Healthcare Facilities

Sterifre’s first service offering, AURA, provides point-of-care, intermediate level disinfection with a fixed monthly budget. AURA utilizes the company’s patented technology, offering rapid, efficacious and automated point-of-care disinfection for a range of items commonly used by healthcare providers such as stethoscopes, hand-held electronics, bedside diagnostic equipment and communication devices. The broad material compatibility of AURA offers an alternative to harsh chemical wipes that can damage equipment, and the unit’s single button operation enables a higher level of compliance with infection prevention policies and practices. AURA will achieve clinically significant levels of disinfection, without adding to the environmental burden that the billions of wipes discarded by healthcare facilities create each year.

AURA is designed for use in multiple point-of-care locations and can be wall mounted or conveniently located on a countertop, cart, etc. The product’s use will replace and, or complement existing infection control products (wipes, sprays, liquid soaks and other manual processes). Using AURA will enable hospitals to:

  • Ensure compliance with infection prevention protocols,
  • Automate existing manual processes to increase nursing satisfaction and improve workflow
  • Reduce the incidence of equipment damage from harsh chemicals during disinfection,
  • Reduce the environmental impact of discarding chemically treated wipes- the only byproduct of the AURA process is clean air,
  • Protect staff from health risks associated with occupational exposure to disinfectants.

AURA will be regulated by the U.S. Environmental Protection Agency (EPA) for use as an automated disinfection system with bactericidal, viricidal, and tuberculocidal claims, including dangerous spore forming organisms such as C. difficile and dangerous fungal organisms like C. auris. This allows customers to use AURA’s subscription service for intermediate level disinfection of reusable non-critical medical devices, as well as general use and employee personal items at the point-of-care throughout healthcare facilities.

Innovative Disinfection Technology with a Unique Competitive Advantage

Sterifre’s core technology is a patented disinfection process, using a novel combination of hydrogen peroxide (H2O2) micro-spray and plasma generated ozone (O3) operating at room temperature and atmospheric pressure. Published test results for this process have demonstrated pathogen kill for even the most robust organisms. AURA offers broad material compatibility with a range of sensitive materials commonly used in healthcare facilities, including plastics, metals, glass and electronics[1],[2]. This process is in stark contrast to existing disinfection technologies which employ harsh chemicals, heat, or are pressurized, ultimately limiting material compatibility and the ability to operate at the point-of-care. AURA uses two hospital disinfectants typically found in Central Services Departments but enables their use at the point-of-care. There is no residual disinfectant left on devices. Additionally, AURA can reduce the ~20 million disinfectant wipes that are discarded per day and prevent the occupational health hazards associated with disinfectant exposure.[3]

AURA is a “plug & play” device that does not require special electrical, plumbing or ventilation connections. AURA can be placed in any facility location, without complex installation or specialized training. AURA will be the market leader for low cost, broad compatibility, environmentally friendly, automated services for infection prevention.

[1] Plimpton, S. R., et al., Remote Delivery of Hydroxyl Radicals via Secondary Chemistry of Non-thermal Plasma Effluent. Biotechnology & Bioengineering, 110: 1936–1944. doi: 10.1002/bit.24853 (2013)

[2] Morrison, K., et al., Rapid Sterilization of Cell Phones. Plasma Medicine, 5(1): 57-70 (2015)

[3] Dumas, O., Varraso R., Boggs K., et al. “Association of Occupational Exposure to Disinfectants with Incidence of Chronic Obstructive Pulmonary Disease Among US Female Nurses,” JAMA Network Open 2, no. 10 (2019), doi: 10.1001/jamanetworkopen.2019.13563. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2753247

Future Commercial Opportunities

The technology allows for scalability of products from the current wall mounted/countertop-sized unit to other sizes to meet specific applications, market segments, and various environments of use.

Leadership Bios

Richard Shea, Chief Executive Officer:

Richard Shea is the Chief Executive Officer of Sterifre Medical Inc., an early stage medical products and service company which focuses on the infection control and prevention market. Mr. Shea brings over thirty-five years of domestic and international executive experience in the healthcare industry including, assignments in research, product development, sales, marketing, distribution, manufacturing, joint ventures and acquisitions.

Earlier in his career, Mr. Shea held executive management positions with Johnson & Johnson (JNJ) and Abbott Laboratories (ABT). His professional portfolio expanded with several successful early-stage companies including healthcare service provider, Stericycle (SRCL), where he was one of the original executives. Mr. Shea led Stericycle’s marketing and distribution strategy, a key highlight of the company’s initial public offering and worldwide industry leadership position.

Mr. Shea became the first CEO of Spiration, Inc. (Olympus Respiratory America), a privately held, venture-backed company that developed implantable medical devices for treatment of Chronic Obstructive Pulmonary Disease (COPD) and other lung disease conditions. Mr. Shea secured funding from several corporate strategic partners, ultimately leading to the acquisition of Spiration by Olympus Corporation (Tokyo, Japan) in July 2010. He continued to serve as President, CEO, and Chairman of the Board of Directors at Olympus Respiratory America until retiring in July of 2013.

In 2016, Mr. Shea partnered with the founder and inventor of Sterifre’s patented technology to establish Sterifre Medical, Inc. as a market leader and innovator in the infection control and prevention field. Sterifre’s products are based on advanced technology that addresses the growing demand for rapid, point-of-care infection control in healthcare facilities.

Mr. Shea serves as Board Chair of Providence Health and Services, Northwest Washington Northwest Service Area, and he is a former Advisory Board Member (past Chairman) for the University of Washington, Bothell. Mr. Shea holds a Bachelor of Science in Marketing from Nichols College.

Mike Goonewardene, Chief Commercial Officer and Vice President:

Mike Goonewardene has extensive general management experience and has led market entry, international development, high growth sales, marketing and clinical teams in the healthcare sector. Most recently, Mike served as Vice President of Global Sales for Simulab Corporation. Simulab develops novel asynchronous learning products in the medical simulation/clinical skills development space. Mike led the Simulab team in unprecedented growth by reorganizing the company’s sales function, establishing strategic medical society relationships, and developing novel targeted asynchronous learning products.

Prior to Simulab, Mike was Vice President & General Manager, International, at Stericycle Inc. (SRCL). Stericycle is the world leader in compliance and infection control management services. Mike navigated multiple country/market entries for Stericycle, advanced infection control and compliance product development to better address specific market requirements and held P&L responsibility for Stericycle operations in Asia Pacific and Canada. During his tenure in this position, he also successfully completed and integrated 24 acquisitions in support of the core business strategy. Prior to his international responsibilities, Mike was Corporate Vice President and headed the national launch of Stericycle’s BioSystems initiative, an FDA-regulated sharps safety service which has become the industry standard. Under Mike’s leadership BioSystems grew to serve infection preventionists in over 3000 US hospitals.

Mike’s professional experience also includes several early-stage company successes: Chief Operating Officer, Clear Medical Inc., a high-level disinfection medical device reprocessing service company (acquired by Johnson & Johnson) and Senior Vice President of Development at SpectraSite Broadcast Group (acquired by American Tower). Mike led Stericycle's Southwest business from the company's inception through its rapid growth leading to its initial public offering. Prior to his Stericycle experience, Mike was Vice President Sales Healthcare, Marriott Corporation.

Mike currently serves on the Board of Directors of Trinity Guardion, LLC, an early stage company developing textile-based products focused on reducing hospital acquired infections.

He holds an MBA from Pepperdine University and a BS in Marketing from Indiana University. Mike was also an Infantry Company Commander, U.S. Army Reserve.

Craig Eudy, Chief Financial Officer and Vice President Finance:

Craig Eudy, CFO and Vice President, Finance of Sterifre Medical, is a seasoned financial executive with experience across a range of industries including life sciences, hi-tech manufacturing and public accounting (Big 4 CPA registered status). He has extensive background in public companies and multinationals with additional experience dealing with private equity and venture backed companies.

Mr. Eudy’s professional portfolio encompasses P&L management, FP&A, strategic partnerships, SEC reporting (S-1, S-3, 10K, 10Q, 8K, Proxy), and multinational operations, SOX/Internal controls, 401(k) administration, and stock options (10b5-1 plans. As Executive Director, Finance, reporting to the CEO at Spiration, Inc., he was a key member of executive leadership, having full responsibility for FP&A, accounting and IT, managing multiple electronic system implementations, and responsibility for 401k administration.

Prior positions which helped lay the foundation for Mr. Eudy’s skills set include Vice President, Finance, for Sonus Pharmaceuticals, a pre-commercial (public) company developing cancer drug, Chief Accounting Officer with InfrastruX Group, a privately held utility conglomerate. His position as Manager, Financial Report with ATL Ultrasound (acquired by Phillips Ultrasound) included leading the analysis and accounting team for the purchase price allocation related to the Royal Philips Electronics acquisition ($800 million transaction). As Senior Accountant with Ernst and Young, Mr. Eudy developed expertise in multiple industries including manufacturing, banking and education.

Mr. Eudy holds a Master of Science in Accountancy degree, and Bachelor of Business Administration degree Western Michigan University. He earned his CPA license in September, 1992.

Gen Minor, Vice President, Quality and Regulatory Affairs:

Gen Minor, Vice President, Quality and Regulatory Affairs of Sterifre Medical, has more than 27 years of experience in quality management systems, regulatory compliance, and regulatory affairs at various US FDA Class II and Class III medical device companies that include manufacturers of pulmonary, orthopedic, cardiovascular, and oncology products and systems. Ms. Minor’s career spans across small and mid-size start-up companies to large global businesses where she worked in close collaboration with teams consisting of manufacturing, engineering and product development, research, clinical affairs, and sales and marketing.

Prior to joining Sterifre Medical, Ms. Minor was Director of Quality Systems reporting to the CEO at Spiration, Inc., a subsidiary of Olympus America, overseeing the quality management system, quality engineering, document control, inspection, and internal audit functions. She led the development and execution of quality policies, quality objectives, and strategic quality plans for the company and successfully established an ISO 13485 certified quality management system. Her role with regulatory affairs included preparation of the initial application of Spiration’s flagship pulmonary device that led to CE mark approval, followed by additional applications and subsequent approvals for product family expansions. She also supported FDA submissions and product registration efforts. Designated as quality management representative, she was the company’s Lead during external quality audits and inspections by the FDA, the notified body, and Olympus Corporation.

Before Spiration, Ms. Minor managed the regulatory compliance group at Spinal Dynamics where she made significant contributions to the company’s growth, clinical and outside US market success, and subsequent $270M merger with Medtronic, Inc. She was a quality engineer at InControl, Inc. (acquired by Guidant), Ventritex, Inc. (acquired by St. Jude Medical), and Varian Medical Systems responsible for vendor management, final test, inspection, manufacturing support, and quality records.

In addition, Ms. Minor has a broad range of experience and extensive working knowledge of other quality- related areas including risk management, corrective and preventive action systems, complaint handling, product recall, employee training, product labeling, ethylene oxide sterilization validation, and contract manufacturing management.

Ms. Minor holds a Master of Science degree in Quality Assurance and a Bachelor of Science in Industrial Technology, both from San Jose State University.

Press Releases

Press Release #1

Media Contact:
Aaron Blank for Sterifre
(206) 343-1543, ablank@feareygroup.com

Sterifre Medical Announces the Successful Completion of its Series B Financing

Kirkland, Wash. – July 29, 2019Sterifre Medical, Inc., today announced that it has officially raised $8 million in a Series B private equity round of financing. Sterifre had previously raised $12 million in a 2017 Series A offering, bringing total capital financing to $20 million to date. The company is commercializing a suite of products based on an innovative disinfection and sterilization technology to address the acute need for rapid, point-of-care device disinfection in healthcare facilities.

“Proceeds from the Series B financing will fund our initial commercialization in the U.S. Acute Care Market beginning early next year,” said Richard Shea, CEO of Sterifre. “We appreciate the ongoing support of our investment partners. This financing will enable the company to play a unique role in increasing staff and patient safety.”

Preventing healthcare-acquired infections is a key challenge for hospital staff. Handheld portable medical equipment can harbor pathogenic communicable organisms such as MRSA (Methicillin-resistant Staphylococcus aureus), Pseudomonas, Influenza, Staphylococcus Aureus, Clostridioides Difficile and other harmful bacteria, viruses and spores. According to the U.S. Center for Disease Control and Prevention, about one in 31 hospital patients has at least one healthcare-associated infection, and more than one in 17 (98,000 patients) dies from them. In addition, the U.S. healthcare system spends billions each year battling these infections.

Sterifre’s patented technology, called Aura™, is a compact one-touch system that treats multiple organisms on hard-surface items used in doctors’ offices and hospitals. A fully automated medical device disinfection system, it replaces manual processes that are frequently deployed incorrectly, damaging to equipment and ineffective.

A New Solution for Challenging Environments

The Instructions for Use published with point of care medical devices prescribe specific chemical disinfectants chosen for compatibility with each device’s surface materials. “Selecting the proper wipe-based chemical for a specific device in the fast-paced healthcare setting is challenging for any provider,” Shea explained. “Often the proper chemistry-based solution is not readily available at the point of use and a substitute is chosen strictly out of the need to complete the disinfection task.”

By adding the Aura system to Instructions for Use, Shea said, “medical device manufacturers help customers protect their equipment investment, automate the manual disinfection process and reduce environmental impact.”

Preventing Materials Issues Following Disinfectant Usage

Materials such as plastics compounds, glues and the coatings of display screens are susceptible to corrosion, cracking, fogging and general material destruction over repeated exposure to many commonly used chemical disinfectants. Yet, the various manual ‘wipes’ and sprays typically used to deliver these chemistries can be both very abrasive and corrosive.

“Multiple studies have shown that the use of improper disinfectants results in Environmental Stress Cracking and premature device failure,” Shea noted. “These harmful effects can be virtually eliminated by using Sterifre’s Aura ™ point of care system to disinfect these devices – while still achieving the appropriate EPA regulated pathogen kill.”

A New Approach to Rapid Disinfection

Aura enables the safe and effective use of Hydrogen Peroxide, the widely recognized microbicide, via a novel approach that does not damage the items being processed. This extends equipment’s useful life, delivers standardized disinfection without exposing users to chemicals and reduces the cost of infection control.

The company is actively pursuing registration with the EPA for common problematic pathogenic organisms found in the healthcare setting. Sterifre believes Aura will be the first technology of its kind to achieve full EPA approval.

Aura is a game-changer for infection control,” concluded Shea, the former CEO of Olympus Respiratory America, a leader in novel treatments for patients with severe COPD; and one of the founding executives of Stericycle Inc. (SRCL), a worldwide leader in infection control related products and services.

# # #

About Sterifre

Sterifre Medical, Inc., is a privately held medical technology company located in Kirkland, Wash., focused on commercializing innovative, cost effective, environmentally friendly approaches to protect patients and caregivers from the pathogenic organisms that contribute to complications associated with hospital acquired infections that result in more than 100,000 annual deaths. Find the company online at www.sterifre.com.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding Sterifre products, technological capabilities, product registration, and future business aspirations. All such statements are based upon current Sterifre expectations and involve a number of business and technical risks and uncertainties that could cause actual results to differ materially from anticipated results described, implied or projected in any forward-looking statement, including, without limitation, regulatory approvals, unexpected changes in technologies, uncertainties inherent in product development and commercialization, intellectual property protection, and the ability of our products to gain market acceptance.

SOURCES:

https://www.cdc.gov/hai/data/index.html

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6245375/

https://health.gov/hcq/prevent-hai.asp

https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf

Press Release #2

Media Contact:
Aaron Blank for Sterifre
(206) 343-1543, ablank@feareygroup.com

Sterifre Medical Announces Michael Goonewardene as Chief Commercial Officer

Kirkland, Wash. August 13, 2019 – Sterifre Medical, Inc., has appointed Mike Goonewardene as its chief commercial officer. Based in Kirkland, Wash., he will lead business development, sales, marketing, clinical support and customer service for the company. Sterifre is commercializing a suite of products based on innovative, patented, disinfection technology that addresses the growing demand for rapid, point-of-care infection control in healthcare facilities.

Goonewardene comes to Sterifre following executive roles with leading healthcare companies in the compliance, safety and infection-control market. He was one of the original employees at Stericycle Inc. (NASDAQ: SRCL) with responsibility for developing and implementing the startup business plan that led to its growth to $3.5 billion. He went on to serve as corporate vice president for BioSystems, a Stericycle company, building the team that implemented adoption of a unique sharps safety product/service at more than 3,000 U.S. hospitals. After the IPO, Goonewardene was the company’s vice president and general manager of the international business, successfully leading global product development and international expansion. He completed 24 international acquisitions and created business entities in multiple countries. Goonewardene previously served as chief operating officer at ClearMedical, a medical device company focused on the high-level disinfection of single-use medical devices to support economical, FDA-approved reprocessing. The business was successfully sold to Johnson & Johnson.

Additionally, Goonewardene serves on the board of directors of Trinity Guardion, a novel infection control company developing a patented barrier technology that targets the reduction of C. diff. and other healthcare-acquired infections associated with patient beds. He recently completed 15 years of board service for the Western States Healthcare Materials Management Association.

A graduate of Indiana University and the U.S. Army Infantry School, Goonewardene holds an MBA from the Graziadio Business School at Pepperdine University.

# # #

About Sterifre

Sterifre Medical, Inc., is a privately held medical technology company located in Kirkland, Wash., focused on commercializing innovative, cost effective, environmentally friendly approaches to protect patients and caregivers from the pathogenic organisms that contribute to complications associated with hospital acquired infections that result in more than 100,000 annual deaths. Find the company online at www.sterifre.com.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding Sterifre products, technological capabilities, product registration, and future business aspirations. All such statements are based upon current Sterifre expectations and involve a number of business and technical risks and uncertainties that could cause actual results to differ materially from anticipated results described, implied or projected in any forward-looking statement, including, without limitation, regulatory approvals, unexpected changes in technologies, uncertainties inherent in product development and commercialization, intellectual property protection, and the ability of our products to gain market acceptance.

Press Coverage

GeekWire: Medical device startup Sterifre nabs $8M to launch sterilization technology

Medical Device and Diagnostic Industry: Disinfecting Devices at the point-of-care:

Contact Information

H. Michael Goonewardene

Chief Commercial Officer

Sterifre Medical, Inc.

4020 Lake Washington Blvd. N.E., Suite 300

Kirkland, Washington 98033

mgoonewardene@sterifre.com

(817) 239-2817