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We are Driving Economic & Clinical Value
We are Driving Economic & Clinical Value
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Improved Patient Outcomes
Improved Patient Outcomes
Faster healing and reduced infection risk lead to better quality of life and higher patient satisfaction.
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Reduced Readmissions
Reduced Readmissions
Effective wound management helps lower costly and disruptive hospital readmissions.
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Operational Efficiency
Operational Efficiency
Streamlined protocols free up valuable nursing time, allowing focus on other critical patient needs.
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Enhanced Reputation
Enhanced Reputation
Superior outcomes and patient satisfaction boost hospital quality scores and community standing.
How we will generate revenue with our partners:
How we will generate revenue with our partners:
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ClearikonFLEX™ Value to Hospitals
ClearikonFLEX™ Value to Hospitals
Sell ClearikonFLEX™ directly to hospital systems through value-based procurement, emphasizing reduced dressing changes, improved inspection, and lower clinician time—backed by cost modeling and CMS-aligned reimbursement.
Small Adoption, Big Savings
Small Adoption, Big Savings
Every patient bandaged with ClearikonFLEX™ saves hospitals $685 per month.
That’s 1 in 3 patients.
That’s 1 in 3 patients.
$685 saved per patient, per month.
$685 saved per patient, per month.
Hospital Savings Example
*Per the American Hospital Association (AHA), there are 6,093 hospitals in the U.S. totaling 913,136 staffed beds. This averages to about 150 beds per hospital treating about 5,655 unique patients per month. Of these about 1,500 to 2,000 need bandaging. We forecast a conservative yet steady adoption rate from 2026- 2030.
References and where the numbers come from:
References and where the numbers come from:
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ClearikonFLEX™ Value to Home Health Care
ClearikonFLEX™ Value to Home Health Care
Partner with home health agencies and medical product suppliers to distribute ClearikonFLEX™ as a reimbursable product, enabling remote wound monitoring and fewer nurse visits.
ClearikonFLEX™ vs. Traditional Bandaging - side by side
ClearikonFLEX™ vs. Traditional Bandaging - side by side
Half the home health visits. Simple to teach, less painful to change, better compliance with provider orders.
ClearikonFLEX reduces the burden on patients and providers by extending bandage wear, simplifying care, and enabling telehealth monitoring. The result: fewer visits, less pain, and better outcomes.
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ClearikonFLEX™ for Combat Casualty Care
ClearikonFLEX™ for Combat Casualty Care
It is our intention to secure federal contracts and SBIR/STTR funding to deploy ClearikonFLEX™ in field kits and VA systems, highlighting dual-use adaptability, inspection-friendly design, and battlefield efficiency.
Wound infections in a prolonged care environment pose a substantial threat to the operational effectiveness of deployed forces. Clearikon™ will apply for research funding to study combat wound infection mitigation and control in austere environments.
The proposed research will test whether the combination of 1) a topical treatment of a wound to Hypochlorous Acid (ClearSpray™), 2) our newly created bandage ClearikonFLEX™, with 3) the addition of smart sensors, ClearikonSYNC™, can achieve these results.
Clearikon™ will submit a proposal to the Department of Defense Health Agency Funding Opportunity (#HT942523SBAA1) for basic and applied research to support this scientific study.
Regulatory Strategy
Regulatory Strategy
ClearikonFLEX™ meets the requirements of a class I device and is exempt from the 510(k) requirement.
ClearikonFLEX™ meets the requirements of a class I device and is exempt from the 510(k) requirement.
Regulatory Assessment by MRC Global Regulatory Advisors - May 6, 2025
Regulatory Assessment by MRC Global Regulatory Advisors - May 6, 2025
ClearikonFLEX™ meets the requirements of a class I device per the U.S. Code of Federal Regulations under 21 CFR 878.5240 the general product code KGX, which are exempt from premarket notification requirements. Although 510(k) exempt, this device is still subject to general controls, including good manufacturing practices (21 CFR 820) and general labeling requirements (21 CFR 801). Clear Care Products, Inc will comply with the FDA Establishment Registration and Medical Device Listing. Although 510(k) exempt, this device will be manufactured under general controls, including good manufacturing practices (21 CFR 820) and general labeling requirements (21 CFR 801).
ClearikonFLEX™ meets the requirements of a class I device per the U.S. Code of Federal Regulations under 21 CFR 878.5240 the general product code KGX, which are exempt from premarket notification requirements. Although 510(k) exempt, this device is still subject to general controls, including good manufacturing practices (21 CFR 820) and general labeling requirements (21 CFR 801). Clear Care Products, Inc will comply with the FDA Establishment Registration and Medical Device Listing. Although 510(k) exempt, this device will be manufactured under general controls, including good manufacturing practices (21 CFR 820) and general labeling requirements (21 CFR 801).
About MRC Global: Delivers comprehensive solutions for regulatory, quality, clinical, transactional and physician leadership/key opinion leader (KOL) advisory services to the life sciences community - medical device, pharmaceutical, biological and tissue companies.
Specific professional services include: global regulatory assessment, planning and strategy; pre-submission, 510(k), Investigational Device Exemption (IDE), Pre-Market Approval (PMA), de novo preparation and submission to FDA; European technical file and design dossier preparation; FDA, Notified Body, and ISO 13485 audit preparation and participation; Tissues auditing, licensing and registration; supplier and internal audits, valuation services (company or device), royalty arrangements, co-branding FMV and innovative processes to document KOL status and payment rate sheet development, to name a few.
Reimbursement Strategy
Reimbursement Strategy
Coding & Coverage Findings 08.26.2025
Coding & Coverage Findings 08.26.2025
Our certified coders reviewed the ClearikonFLEX™ system and determined there are no appropriate options among the existing CPT and HCPCS codes
Our certified coders reviewed the ClearikonFLEX™ system and determined there are no appropriate options among the existing CPT and HCPCS codes
In off-the-record discussions with contacts on the National HCPCS Panel, we were told the odds of securing a distinct HCPCS code for the bandage system is “very good”
In off-the-record discussions with contacts on the National HCPCS Panel, we were told the odds of securing a distinct HCPCS code for the bandage system is “very good”
About RRS: After a career working reimbursement issues with Amersham (now GEHC) Ms. Ossias founded RRS in 2005. RRS Canada opened in 2010.
RRS supports various clients including Accuray, Alliance Health, Aspect Imaging, Aurora Imaging Technologies, Bayer Healthcare Pharmaceuticals, Biogen, Bio Marin, Bracco, CMC Contrast AB, Cambridge Heart, Covidien, Digirad, Esaote, EUSA Pharma, Fuji Medical, GammaMedica, Guerbet, Jazz Pharmaceuticals, Lundbeck, Merck, NeoProbe, Nuubo, Oxford Pharmascience UK, PETNET, Philips, Planmed OY, Quest Medical, RepliGen, Siemens, Slate Pharma, Sprout Pharma,Terason, Tesaro Bio, TEVA, United Pharmacy Partners, Zevacor.
They have affiliates in the European Union and United Kingdom to assist entering and being successful in those markets.
Barriers to Entry
Barriers to Entry
Intellectual Property
Four issued and pending patents covering human and veterinary products.
Experienced Team
Commercialized multiple medical device and veterinary products with exits.
Proven Contract Manufacturer
FDA approved contract manufacturing and sterile packaging for major medical device companies.
Exit Strategy
Exit Strategy
SWOT Analysis
SWOT Analysis
- Unique Access & Reduced Disruption: Peelable transparent flap allows frequent inspection/treatment without full bandage removal, minimizing pain, stress, and skin trauma.
- Long-Term Efficiency: Potential for significant time and cost savings by reducing full bandage changes, treatment times and accelerating healing.
-Nuanced Exudate Management: The Bandage is dressing agnostic allowing optimal dressings and drains to be installed and changed as often as needed without a complete bandage change.
-Continuous Visual Monitoring: Transparent flap enables instant wound observation, aiding timely intervention.
- Potential for Enhanced Compliance: Less pain and less frequent changes may improve patient adherence.
- High Initial Cost: The more expensive advanced unit cost compared to common or new versions of traditional dressings (e.g., films, basic foams).
- Limited Brand Recognition: Early entrant in the human wound care market compared to major competitors.
- Application Learning Curve: Unique design may require some limited user education for optimal use.
- Market Acceptance - Initial resistance to change in nursing and patient care.
- Massive Human Wound Care Market: Significant potential for chronic wounds (diabetic, pressure, venous ulcers) where its core benefits are highly valuable.
- Strategic Partnerships: Collaborations with major healthcare distributors, Group Purchasing Organizations (GPO), and wound care specialists.
- Product Line Expansion: Development of diverse sizes, absorbency levels, integrated features (e.g., antimicrobials)and sensors to monitor wounds via apps.
- Value-Based Marketing: Emphasize long-term cost-effectiveness, reduced nursing time, and improved patient outcomes to justify initial price.
- Telemedicine Synergy: Transparency supports remote wound assessment.
- Dual Market Opportunity: Products are positioned to offer solutions to address needs for both the Human Health and Animal Health.
- Cost Sensitivity: High initial price may be a significant barrier in a price-conscious healthcare market, especially against much cheaper alternatives (e.g., gauze, basic films).
- Competitor Innovation: Existing large players may develop similar "access" features or introduce other disruptive technologies (e.g., advanced smart dressings).
- Regulatory Hurdles: Rigorous and costly FDA approval processes for human use.
- Entrenched Brand Loyalty: Major brands have deep roots and established trust with clinicians and procurement.
- Disruptive Topical Treatments: Highly effective topical solutions that reduce the need for complex dressings.
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