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Sira-9 targets a specific pathway of the stress response due to oligomer toxicity. Siragen has identified targets within this pathway that prevents the synapse loss induced by synaptic dysfunction and synaptotoxicity. Siragen has also identified another target, which alleviates age-associated phenotypes and extends the life span of neurons by reducing inflammation. These small molecules are specific and can be easily delivered as a pro-drug.

$5M

Siragen’s development programs are focused on 1) target identification 2) target validation 3) hit to lead identification and optimization 4) in vivo studies and 5) begin clinical trials on identified compounds. The Company aims to develop its pipeline of novel molecules to clinical proof of concept and partner with industry leaders for late stage development and commercialization

Private

•  expanding IP portfolio

• Target identified and validated for drug discovery in Alzheimer’s disease • Successful assay development for hits • Lead candidate Sira-9 currently in development for Alzheimer’s disease

The team consists of CEO and Founder: Michel Levesque, MD, entrepreneur and neuroscientist, CSO and Co-Founder: Mohamedi Kagalwala, neurochemist and neurobiologist. Scientific advisory board consists of prominent scientist Dr. Eliezer Masliah (neuropathologist and neurodegenerative disorders expert, UCSD), Dr. Kalpana Merchant (Ex CSO, Translation Science at Eli Lilly Pharmaceuticals) and Dr. Anthony Means (pharmacologist, Baylor College of Medicine)

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.