Rajesh Ranganathan

NINDS
Director Office of Translational Research 

Kristian Ranta

Website:
www.mendor.com
Mendor
CEO Co-Founder 

Rich rborncamp@xmission.com United States

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.  

Year Founded
2011
Main Sector
Indication
Medtech Phase of Development
Technology Overview

Brio suite of devices for intubation. The products are used to insert endotracheal tubes and are designed for first-attempt intubation success.

Key Features

  • Software algorithm recognizes anatomical landmarks and displays labels on video screen
  • Software displays optimal position of sytlet tip with a white “x” as the stylet advances through the airway
  • Visualization of the tip
  • Tip articulation

 

Benefits

  • Software enhanced visualization
  • Visually confirm success
  • Reduces time to intubate
  • Reduces tissue trauma

Alliance & Collaborations
Brio has its primary office and lab space within the medical device incubator and business accelerator facilities of MC3, Inc. The Company is considered a “Member” of MC3’s Medical Device Business Accelerator. Address: MC3, Inc. 3550 West Liberty, Suite 3, Ann Arbor, Michigan 48103. Manufacturing Partner Brio has an agreement with Summit Medical Products, Inc. based in Sandy, UT. The contract provides Brio with a team of experienced professionals from engineering, manufacturing, regulatory affairs, marketing and sales. Summit is engaged in the business of and possesses expertise with respect to, among other things, the manufacturing, assembling, processing, packaging, approvals and regulatory processes, and sales of medical devices. The strategic partnership Brio has with Summit is to assist in product design and development, process validation, risk management procedures, manufacturing, verification and validation, and quality assurance for the intubation device.
Supporting Metrics or Evidence

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.

Current Financing Needs

Current Financing Round: $1.5M ... Anticipated total paid-in-capital: $4.0M

Current Timeline

Completing design for manufacturing and pilot manufacturing. First generation product, FDA Class I exempt, enters the market in Q2 2015. Follow-on products to enter the market starting Q3 2016.

Current Investors

Convertible Notes: State of Michigan University Commercialization Fund, MC3, Inc., and Summit Medical

IP Status

PCT/US12/36290 submitted May, 2012. National Phase Patent Application Ser. No. 14/115,196 - Filed: Nov. 1, 2013.

Recent Milestones

Prototypes tested by groups of clinicians ranging from Residents to experienced specialists in simulation mannequins. First generation product being converted from 3D prototype to design for manufacturing and pilot manufacturing.

Management Team Highlights

Hannah Hensel, CEO, holds an MBA from the University of Michigan Ross School of Business and has 20+ years business leadership experience. A unique start-up experience for her took place as Sponsorship Sales & Marketing Manager for the 2002 Olympic Winter Games where she reported to Mitt Romney; the organization went from $0 to $1.5B in seven years. Product development for Brio is led by Laura McCormick, PhD in biomedical engineering, Douglas Mullen, PhD in nanotechnology/materials science and Sabina Siddiqui, MD. Brio's Commercialization Officer, Rich Borncamp, is the newest member of the team. He has spent his career launching new medical devices, establishing go-to-market plans nationally and internationally, and negotiating agreements with Group Purchasing Organizations.

Brio Device, LLC
Commercialization Officer 

Ken Reali

Baxano Surgical Inc.
President and CEO 

Christian Renaudin

MedForce is the business accelerator arm of Almond Tree Capital and is based in Davis CA. The program makes seed and venture round investments in the form of equity or convertible loans. Investments may range up to $5 with the potential for follow-on investments. While Medforce?s investments are not restricted by region MedForce prefers to support companies based in Northern California or with ties to the region. The fund plans to invest in 2-4 companies in the next 6-9 months.
MedForce
Partner 

Lisa Rhoads United States

Easton Capital Investment Group is a venture capital firm based in New York. Easton Capital invests broadly in the life science sector, and considers investment opportunities globally. The firm is likely to make 4-6 allocations in the next 6 months. Allocations typically vary from $250,000 to $5 million, in the form of equity or convertible debt. Allocations are typically made at the venture stage of development, but may be made in seed rounds if a company already has proof of their product's efficacy.

Investor Type
Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Easton Capital
Managing Director 

John Ricci

US Angel Investors
Founder 

Alexandra Richardson United States

Clayton Biotechnologies commercializes technologies that are developed and owned by the Clayton Foundation for Research and its supporting entities through research programs at leading research hospitals and institutions in the US and Switzerland.

We have several projects in various stages of development from discovery to advanced pre-clinical that are available for licensing, collaboration, and the creation of new start-up ventures.

Clayton Biotechnologies has a significant portfolio of technologies to offer for licensing and collaboration. 

 

Some of our featured technologies:

- Urocortins and analogues for Diabetes

- Fc engineering of aglycosylated antibodies

- Granzyme B - a potent payload for antibody drug conjugates (ADC)

- Alk4-Fc, a Cripto antagonist for Cancer

- TEAD gene and peptide therapies for ocular neovascular disease

- Stem cell therapy program for Parkinson's Disease

- Vaccines and Diagnostics for Ehrlichioses

- Biomarker for personalized breast cancer therapy

- YESS - engineering of proteases

- OCT Image Guided Smart Laser Knife Diagnosis and Therapy in Small Spaces

 

To date, 9 products based on Clayton Foundation discoveries have been have been successfully commercialized through the creation of start-up companies and out-licensing

Clayton Biotechnologies
Head of Business Development 

Jayson Rieger

PBM Capital is a hybrid family office and operating company based in Charlottesville Virginia with an additional office in New York City. The firm is funded and led by the successful life science entrepreneur Paul Manning who started and sold several companies in his career. The firm can make investments ranging from approximately $5 to $1 million into companies and due to its funding structure has no requirements for holding period or capital structure. The firm makes investments in the forms of equity controlling interest in-licensing MBO/LBO growth capital and is also willing to co-invest. The firm is looking for companies located around the globe and makes around 5-15 investments in a given year.
PBM Capital Group
SVP of Business Development & Portfolio Management