Subwave Sensing United States

Subwave Sensing is poised to be the future of fracture care by giving the traditional orthopaedic hardware market an infusion of intelligence that will improve patient outcomes, decrease treatment costs and fundamentally change how fracture care is treated in the United States.

Year Founded
2012
Main Sector
Medtech Phase of Development
Technology Overview

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.

Alliance & Collaborations
DePuy/Synthes (a division of Johnson and Johnson)
Supporting Metrics or Evidence
  • 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)
Current Financing Needs

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.

Current Timeline

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

Current Investors

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

IP Status

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.

Recent Milestones
  • 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.
Management Team Highlights

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.

Chad Ronholdt
President and CEO 

Susavion Biosciences Inc.

Website:
www.susavion.com
Laura Eggink
President 
Ken Hoober
CSO 
David McCaleb
Consultant 

Symbient Product Development United States

Rapid Development of Injection Molded Medical Devices
From Concept Through Transfer-to-Manufacturing

Symbient specializes in engineering research and development, prototyping and design-for-manufacturing of innovative medical devices that use injection molded components. Our highly experienced team consists of mechanical and biomedical engineers, industrial designers, machinists and molding technicians. They leverage our in-house rapid prototyping, and prototype tooling fabrication and injection molding to create proven, manufacturable designs with unmatched speed, efficiency and precision. These designs make up our deep portfolio of over 300 successful devices that have collectively generated hundreds of millions of dollars. They include FDA Class I, II and III devices, developed under our ISO 13485 certified quality management system.

 

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.

 

Our Portfolio Includes:

  • Diagnostics / Molecular Diagnostics
  • Sample collection / preparation
  • Life Sciences / Microfluidics
  • OTC Consumer products
  • Respiratory
  • Surgical devices and clinical tools
  • Drug Delivery

 

Year Founded
2004
Unique Capabilities

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.
Lisa Coyne
Business Development Manager 
Luke Helm
Director of Business Development 

Syncona Partners United Kingdom

Syncona Partners, founded in 2012, is an evergreen investment firm based in London, UK. The firm is an independent subsidiary of the Wellcome Trust who invested the initial £200m capitalization. The firm is mandated to invest in companies with the potential to make major breakthroughs in healthcare. The investment size will usually range from £1M – £20M per company. The firm seeks to create sustainable, profitable businesses, to support them with capital over the long term, for the benefit of patients, and to hold an ownership position to create value for the Wellcome Trust. The firm is actively screening new investment opportunities.

Year Founded
2012
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Chris Hollowood
Partner 

SynDevRx Inc. United States

SynDevRx develops new and effective treatments for metabolic-related diseases including pre-diabetes, diabetes, obesity, dyslipidemia and fatty liver disease as well as treatments for cancer.  Our treatments are best-in-class MetAP2 inhibitors of the fumagillin drug class.  SynDevRx lead compound, SDX-7320, is a polymer conjugate of a novel fumagillol derivative which releases the pharmacologically active drug in vivo.  Our approach improves both the efficacy and safety of low molecular weight drugs while reducing systemic drug exposure compared to the small molecule drug alone.

Website:
www.syndevrx.com
Year Founded
2007
Biotech Subsector
Biotech Phase of Development
James Shanahan
VP Business Development 

SYNthesis medchem

Adam Galan
VP Medicinal Chemistry 

Tangen Biosciences United States

Tangen Biosciences is an early stage diagnostic instrument company that has developed a group of novel technologies that together enable rapid, portable, lab-free, and very low cost molecular diagnostics at the point of care.   

The Tangen platform will amplify and detect specific nucleic acid sequences obtained from a variety of source samples, including clinical specimens such as blood, tissue and sputum, as well as environmental samples obtained from water, soil or food, for example.  The first application of the Tangen platform is the detection and diagnosis of Tuberculosis using DNA extracted from sputum samples, using the Tangen Sputum Processing assay kit

Year Founded
2012
Biotech Subsector
Indication
Biotech Phase of Development
Current Financing Needs

Additional $0.5-1M to close seed round

John Nobile
President and CEO 
John Davidson
CSO 

Tech Coast Angels

Founded in 1997, Tech Coast Angels is the largest angel investor group in the United States. Its members provide funding and guidance to more early-stage high-growth companies in Southern California than any other investment group. TCA members invest in companies in a wide range of industries including life sciences, biotech and health IT. TCA has more than 325 members including its venture capital affiliates in five networks in Los Angeles Orange County San Diego Westlake/Santa Barbara and the Inland Empire. The organization will finance on an opportunistic basis as long as substantial disruptive market opportunities exists. The firm has historically invested in Biotech Therapeutics & Diagnostics, Biotechnology R&D Services, Biotechnology Other, Medical Technology companies with sub sectors of Anti-Infectives, Bioinformatics, CRO (Contract Research Organization), Diagnostic Instrumentation, Diagnostic Services, Drug Delivery, Food, Industrial Biotechnology, Small Molecules, Small Molecule Therapeutics, Wound Care and indications including Diseases of the Nervous System, Infectious and Parasitic Diseases, Neoplasms/Cancer/Oncology, Respiratory.

Websites:
www.greenwingsbiomedical.com
techcoastangels.com

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Richard Koffler
Member 

Teijin Pharma Ltd. United States

Teijin Pharma Ltd. has unique profiles managing pharmaceutical and home healthcare products and also strong value chaines from basic research to sales, maintenance and follow up to patients in both business divisions.

We are actively dedicating to look for opportunities to collaborate with the US companies including startups, instituites and investors to introduce products/technologies into JP market with some amounts of investments for the best collaborations.

We are focusing on areas of respiratory, cardiovascular, orthopedics, rehab and neurological diseases.

Mr Aki Maeda
Mr Aki Maeda
Manager of Business Development 

Telormedix SA Switzerland

Telormedix is a Swiss biotech company focused on small molecules binding to TLR7 for the development in oncology and infectious diseases.
Johanna Holldack
CEO