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Kineta® is a nationally-recognized biotechnology company focused on developing leading edge therapeutics in three large high need therapeutic areas: autoimmune disease, viral disease and chronic pain. Our company is focused on the development of novel drug candidates each the outcome of years of scientific exploration and supported by an extensive body of peer-reviewed NIH-supported research.

Xalud Therapeutics is developing novel, non-opioid therapies for the treatment of neuropathic pain and osteoarthritis. Our lead product, XT-101, has shown exceptional efficacy in the leading rodent models of pain and in canine patients with neuropathic pain and osteoarthritis. XT-101 has an excellent safety profile -- it does not cause sedation, dizziness, numbness, addiction or tolerance.  7 and 28 day GLP toxicology studies have been completed with excellent results.  Xalud intends to file an IND for a Phase I/IIa trial in mid-2015 and, pending funding, initiate clinical trials thereafter.

Xalud's approach to treating pain is fundamentally different than conventional approaches. XT-101 causes the body to produce the natural anti-inflammatory IL-10.  In neuropathic pain, the use of this broad spectrum anti-inflammatory reduces inflammation around the spinal cord and reduces aberant pain signaling.  In gold-standard rodent models, a single injection of XT-101 completely eliminates neuropathic pain for 12 weeks.  We have also tested XT-101 in canine patients with severe osteoarthritis that has been resistant to standard treatments.  In these patients, XT-101 has provided long lasting pain relief resulting in dramatically increased mobility and activity levels and increased joint flexibility.

To date, Xalud's efforts have been supported by over $6 million of grant funding from the NIH, the DOD, and disease foundations.  We seek to raise $6 to $10 Million to fund our initial clinical trial or trials.  These will be placebo controlled Phase I/IIa trials in actual patients.  Because XT-101 has an extended duration, we expect that these trials will provide the safety, efficacy and biomarker data necessary to support a robust Phase II program.

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

Brio Device, LLC is a medical device company and spin-out of the University of Michigan Medical Innovation Center based in Ann Arbor, MI. Brio develops airway management devices and intubation instruments.

PROBLEM: High Intubation Failure  

There are 20M+ intubations performed in the US every year. Depending on setting and skill of the clinician, failure rates range from 2% - 40% resulting in approximately 2,000,000 intubation failures every year. Intubation, the procedure to insert a plastic tube into the trachea, requires significant expertise and experience to do well.  With current products in the market, the tube often is inserted multiple times before it is properly placed, resulting in damage to the patient such as broken teeth, torn vocal cords, or insertion into the stomach leading to aspiration and pneumonia.  Three main factors affect intubation success rates: the user’s experience level, having directional control of the tube during insertion, and continuous visualization appreciated in bronchoscopes.  Clinicians need a single go-to device which is appropriate for use both in routine intubation and difficult airway cases offering guidance, maneuverability and visualization necessary to be successful. Failed intubation is the most common preventable cause of trauma-related deaths.  Approximately 180,000 deaths per year list complications associated with failed intubation.

SOLUTION: Brio’s Articulating & Video Stylets  

Brio is introducing a suite of products intended to improve intubation success rates for planned and emergent intubations, minimizing reliance on clinician skill for success.  The products range from disposable mechanical devices to devices with imbedded software providing anatomic image recognition guidance for the clinician. The devices have three critical elements to assist users in locating the trachea and maneuvering the endotracheal tube. 

1. Articulating tip with thumb-controlled steering

2. Continuous visualization

3. Visual guidance software 

BUSINESS MODEL

Brio’s core competencies are R&D, product development, sales and marketing of medical devices.  Projections are built on three revenue streams: two disposable stylets (one with and one without a camera) and a reusable video display.   Brio has an agreement with a manufacturing partner to facilitate design history files, regulatory compliance, manufacturing and customer service.

FUNDING  & MILESTONES

Brio has received $815,000 funding, including $690K in non-dilutive grants and $125k in convertible notes.  The Company has received Small Business Investigational Research (SBIR) Grants from the NIH.