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Our flexible sensor can assess mechanical deformation of orthopaedic implants via a painless and wireless radio frequency emission, which is captured and analyzed using our handheld reader. Upon analysis of these radio emissions, Subwave Sensing will be the first MedTech company to provide real-time, post-operative clinical feedback on implant performance as well as patient healing patterns.

• Designed and manufactured working prototypes (sensor and handheld reader)

• Successfully completed a statistically significant large animal (ovine) fracture model with favorable results for our primary indication (trauma)

• Successfully completed a proof-of-princiapal study in a large animal (ovine) fracture model with favorable results in our secondary indication (spine) 

• Successfully completed a proof-of-principal study in a large animal (ovine) cadaveric model using a second generation flexible sensor (trauma and spine)

• Completed ASTM biocompatibility evaluations confiming that our implant materials do NOT ilicit an immune response

• Received a regulatory opinion from a top tier Washington D.C. regulatory law firm (Hogan and Lovells)

2015 = $1.3M

2016 = $2.4M

Subwave Sensing is requesting an initial investment of $700,000 for the first half of 2015 to accelerate the scale-up of our prototypes and creation of data/cloud infrastructure as well as file additional patent applications and solidify a reimbursement strategy. A second investment of $600k will support formal product (sensor and antenna) design control and web app development as well as begin initial validation studies.

After successfull completion of our 2015 miletsone events, another investment of $2.4M will be required to go to market. This money will be used for large-scale manufacturing, regulatory and FDA filings, product validation, additional large animal market validation studies, quality control/assurance activities as well as setting up distribution/sales networks.

Subwave Sensing plans to be on the market in two years and revenue positive by year three.

The founders have boot-strapped the design and development of the technology with National Institutes of Health (NIH) grants and personal funds.

Subwave Sensing filed a PCT application in 2008 on our core technology and have recieved a notice of allowance in China and Korea. We anticipate a notice of allowance in the United States within six months.

We have filed an additional patent application last year expanding the breadth of our IP footprint and have several other applications awaiting filing.

Subwave has a full-release and freedom to operate from Colorado State University, where the technology was originally developed.

• Subwave Sensing was selected as a finalist in the 2014 Digital Health Investor Challenge (PRIME Healthcare Collaborative http://primehealthco.com/) in September 2014.  

• Subwave Sensing has two formal quotes from premier software developers for the creation of a Subwave software app, cloud service and user interface.

• Subwave Sensing has started discussions with a premier medical device contract manufacturer for the completion of medical device compliant prototypes as well as the set-up and maintenance of our corporate quality system and regulatory strategy.

• Subwave Sensing is actively seeking experts to fulfill advisory and Board level roles on our Board of Directors.

The Subwave Sensing management team has over forty years of experience within the orthopaedic and electrical engineering disciplines, in both academic and commercial settings. Our team is keenly aware of the obstacles and regulatory requirements to commercialize intelligent orthopaedic medical device products in the United States as well as abroad. We have the expertise, commitment and passion to commercialize high quality products that disrupt the traditional understanding of how medical information is used and delivered in the evolving mobile health environment.

Founders:

• Chad J. Ronholdt, B.Sc., MBA. President and CEO:

  • Charismatic and passionate executive with eighteen years of product development, validation and quality expertise with a successful track record of commercializing orthopaedic devices.

• Christian Puttlitz, PhD. Founder and Scientific Advisory Board Member:

  • Key opinion leader within the orthopaedic biomechanical testing discipline and tenured professor of Mechanical Engineering at Colorado State University.

• Hilmi Volkan Demir, PhD. Founder and Scientific Advisory Board Member:

  • BioMEMS key opinion leader and tenured professor of Electrical Engineering at Nanyang Technological University in Singapore.

Our Services Include:

• Concept Development
• Development Engineering
• Design-for-Manufacturing
• Industrial Design
• Project Rescue
• Design Control per IOS 13485
• Finite Element Analysis (FEA)
• Design Verification Testing
• Test Method Development
• Transfer to Manufacturing

Our In-House Capabilities and Expertise Include:

• Stereolithography (SLA) Prototyping
• CNC Machining / Fabrication
• Prototype Mold Fabrication
• Prototype Injection Molding of Devices for Testing, Trials and Studies
• Liquid Injection Molded (LIM) Silicone Prototype Molding
• Product Reliability Testing
• Plastics Assembly Expertise: Ultrasonic and Laser Welding, Heat Sealing, Pressure Sensitive Adhesives, Swaging, Snap Fits, Press Fits, Interlocks.
• Speed: Prototype Molds in as little as 1 week and Modifications in as little as 1 Day
• Material Selection Expertise, Research and Testing to Ensure All Product Requirements Are Met.