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 

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 

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 

Ayal Ronen United States

FreeMind is a consultancy firm that specializes in raising funds from government agencies and other non-dilutive sources through grants and contracts.

FreeMind is the largest consulting group of its kind whose goal is to assist its clients in maximizing their potential to secure funding from non-dilutive sources. Established in 1999, FreeMind's proven long-term strategic approach has garnered its clients, academics and Industry alike, over $1.5 Billion to date. Our expertise in applying for grants and contracts extends throughout every government mechanism open to funding the life sciences including all NIH Institutes, DoD, BARDA, etc., as well as private foundations. FreeMind's knowledgeable and experienced team of Analysts and Project Managers are dedicated to guiding its clients' non-dilutive funding efforts from identification of the most suitable opportunity through to submission and subsequent award. Our team of experts will assist in making non-dilutive funding a key tool in a long-term financial strategy.

Year Founded
1999
FreeMind Group

Chad Ronholdt 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.

Subwave Sensing
President and CEO 

Kurt Rote United States

Western Oncolytics is developing a novel immunotherapy to treat a wide range of solid tumors.  Our therapy is an oncolytic vector with multiple therapeutic transgenes that both stimulate the immune system and remove local tumor immune inhibition.  The vector is engineered to avoid the immune system itself, thus overcoming a major drawback in competing designs.  It is the only therapy in the world with these leading attributes.  Western Oncolytics' therapy works in combination with other treatments, e.g. checkpoint inhibitors, and is capable of systemic (intravenous) delivery. 

Our team comprises the leading scientists, clinicians, and regulatory experts within our field, including entrepreneurs who successfully exited companies with earlier technologies.  In comparison animal testing measuring tumor growth and survival, our therapy performed far better than earlier, clinically-proven oncolytic therapies.

Western Oncolytics is currently raising investment to complete preclinical development and a planned clinical trial. 

Year Founded
2013
Biotech Phase of Development
Technology Overview
Immunotherapy, Oncolyics for Cancer
Supporting Metrics or Evidence
Comparative Live Animal Data
Current Investors
Private
IP Status
PCT Application
Recent Milestones
Seed Funding Round Completed
Management Team Highlights
Experienced Regulatory, Scientific, Medical and Development Experts within our Field
Western Oncolytics, Ltd.
CEO 
BIO

Graduated from Duke in three years while studying Biomedical Engineering and working part-time. Hands-on lab experience using viral vectors to deliver genes to cells. MBA from IMD, a one year program in Lausanne, Switzerland. International network and experience including strategy, business development, project management, product development and start-ups.

Dr Yash Sabharwal United States

Xeris is a clinical-stage pharmaceutical company developing patient-friendly injectable drugs for various indications with an initial focus on diabetes. The current paradigm for many injectable drugs is to design formulations for delivery in water-based systems.  However, the presence of water is problematic because it actively degrades many molecules often preventing drug products from being packaged for use as a “ready-to-use” solution.  Xeris' patented and patent-pending XeriSol™ and XeriJect™ formulation technologies are transformative in their elimination of water. By replacing water with non-water, bio-compatible carriers already used in other FDA-approved drugs, Xeris solves a number of problems adding significant value to existing injectable drugs and to new drugs in development.  This technology is already being validated with the development of a non-aqueous glucagon formulation that has shown 24 months of room-temperature stability in solution and very positive safety and efficacy in a Phase 2 clinical study. While this product and other glucagon products are being developed and $20M has been raised to support this development, Xeris is seeking to spinoff its earlier stage non-glucagon assets and obtain funding (both equity and non-dilutive) to support these projects.  More specifically, these projects include the development of a non-aqueous, auto-injectable diazepam to replace the current diazepam rectal gel for treatment of epileptic seizures and a non-aqueous, intradermal auto-injectable epinephrine to replace the current, antiquated EpiPen.  

Year Founded
2005
Biotech Subsector
Biotech Phase of Development
Technology Overview
Non-aqueous (no water) injectable formulations
Supporting Metrics or Evidence
Stability data, preclinical data, clinical data, FDA interactions
Current Investors
Large family offices and high net worth investors from the pharma industry
IP Status
3 issued patents and 14 additional applications pending
Dr Yash Sabharwal
Xeris Pharmaceuticals, Inc.
LinkedIn logo Chief Operating Officer 

Philip Sanger United States

TEXO Ventures is a healthcare venture capital firm that was founded in 29 and is based in Austin Texas. The firm operates as a hybrid of angel and venture capital. The recent fund closed at $15.4 million in 212. The firm focuses on making equity investments in the Medical Technology and Healthcare IT spaces at near commercialization or early commercialization stage. The firm typically invests ranging from $3 million to $5 million into a company. The firm plans to make 2-3 investments over the next 6-9 month. TEXO Ventures is open to consider companies across the US. The firm primarily focuses on healthcare which includes Health IT Technology  enabled Health Services Chronic Disease Management Managed Care and Benefit Design. Although medical devices and functional diagnostics are considered for investment purposes Texo Ventures must see a clear regulatory pathway and obvious synergies with healthcare reform within a company. The firm's current investment portfolio includes companies in the area of medical technology. Within this field they are in areas such as diagnostic and therapeutic radiation devices electro mechanical medical devices re-usable instruments biomaterials and non-active implantable.

Texo Ventures
Managing Partner 

Matthew Scholz United States

Immusoft’s mission is to develop a breakthrough platform for delivering targeted medicines — programming a patient’s own cells to become miniature drug factories.

Our technology instructs a patient's cells to constantly secrete gene-encoded medicines (biologics). It will enable new treatments by solving current delivery limitations and production challenges. We are initially targeting orphaned diseases. 

Immusoft’s platform can program cells to continually produce and secrete therapeutic proteins and rare antibodies that have been impossible to elicit with a vaccine. This approach makes possible treatments that are otherwise impractical due to short halflife, injection site reactions, production challenges or a small market size. It offers many of the benefits of traditional approaches and modern gene therapies with less risk and greater control.

Immusoft has received grants from the National Institutes of Health and Peter Thiel's Breakout Labs as well as support from private investors, including the former head of preclinical development at Seattle Genetics. We have an exclusive license option on our core technology from Caltech and have filed two additional patents covering our extensive modifications to the technology.

ISP technology could replace a lifetime of infusions with a patient’s own drug-producing cells.

Website:
www.immusoft.com
Year Founded
2009
Biotech Phase of Development
Technology Overview
Turning patients' cells into drug factories
Alliance & Collaborations
Fred Hutchinson Cancer Research Center, Discovery Genomics, Inc, University of Minnesota, The Ragon Institute, University of California San Francisco
Supporting Metrics or Evidence
Late-stage preclinical
Current Financing Needs
$3 to >$20M
Current Timeline
Preparing IND for clinical trial
Current Investors
Breakout Labs, Founders Fund Science, several angels
IP Status
multiple patents filed worldwide
Recent Milestones
GMP scale-up in preparation for clinical trial; engaging the FDA for Investigator-initiated IND; use of Sleeping Beauty Transposon non-viral vector
Management Team Highlights
Matthew Scholz (Founder and CEO) – Seasoned startup executive; founded and exited Point B Telematics. Eric Herbig, Ph.D., M.B.A. (CSO) – 15+ years of research experience and significant commercialization and management expertise. Zach Hall (Dir. of Operations) – Co-founder and operations director at two previous biomedical startups. Mei Xu, Ph.D. (Dir. of Research) – Molecular biologist with extensive research experience.
Immusoft Corporation
CEO 

Frank Sciavolino United States

Year Founded
2011
Biotech Subsector
Biotech Phase of Development
Technology Overview

Thetis has discovered and is in the early stages of developing several compounds in the omega-3 arena that are quite differentiated from existing agents based on its proprietary HEALER Technology. 

  • TP-252 is an ionic derivative of eicosapentaenoic acid that delivers EPA with remarkable bioavailability in animal models. Unlike anything known in the omega-3 arena, TP-252 is a solid, stable, free-flowing drug substance that is suitable for tablet formulations and for potential use in fixed dose combination products with statins.
  • TP-113 (bis-metformin glutamate DHA) is a novel oral agent for treatment of T2DM as a 2nd generation metformin product with substantial differentiating pharmacological attributes and intellectual property protection. Its PPP targets significant HbA1c reduction as its primary clinical endpoint with enhanced pharmacological benefits that include insulin resistance resolution, multiple mechanistic effects on hepatic gluconeogenesis that could translate into lower metformin dosing requirements, and reduced serum triglyceride (TG) levels.
  • TP-352, an ionic derivative of docosahexaenoic acid that delivers DHA with remarkable bioavailability in animal models, has prospects for treatment of NASH based on the anti-fibrotic, metabolic and TG lowering effects of DHA.
  • TP-110 (bis-metformin glutamate EPA) has prospects as a first in class agent for treatment of PCOS based on the clinically established effects of its active moeties for ovulation restoration, reduced insulin resistance and enhanced anti-androgenic effects.  
Alliance & Collaborations
Marette Laboratory
Supporting Metrics or Evidence

HEALER Technology applied to already approved APIs with established safety records.

Current Financing Needs

$25 million to fund TP-113 through Phase IIa

Current Timeline

INDs can be opened on lead candidates within 12 months due to non-clinical safety efficiencies based on prototype candidate already vetted by FDA

Current Investors

Connecticut Innovations and Angel Investors

IP Status

Issued patents (US8765811, US8993124, US8901107) and non-provisional patent applications under petition to make special 

Recent Milestones
  • TP-113 preclinical studies in mice showing PDX formation
  • IND allowance establishing non-clinical safety of Thetis compounds
  • Extensive rodent pharmacokinetic studies demonstrating unique PK properties
  • Pre-formulation feasibility studies completed on lead candidates
  • Issued composition of matter patents on metformin compounds (TP-113/110)
Management Team Highlights

Frank Sciavolino, PhD, Chief Scientific Officer

  • former Pfizer R&D executive (Zithromax) and in-licensing (Celebrex)
  • PhD, Organic Chemistry, University of Michigan
  • Over 30 issued patents

Gary Mathias, MBA, Chief Financial Officer

  • Over 25 years as healthcare investment banking and entrepreneur
  • Former SVP, GE Equity, Healthcare
  • MBA, Yale University; BA Economics, Harvard College

Alexander Fleming, MD, Senior Clinical & Regulatory Officer

  • Former supervisory physician, DMEP, FDA
  • Expert in metabolic disease
  • MD, Board Certified, Endocrinology, Emory University

Andre Marette, PhD, Lead Investigator and Scientific Advisor

  • Professor of Medicine, Institute for Heart & Lung Research, Laval University
  • Pfizer Research Chair, Pathogenesis of Insulin Resistance and CVD
  • Recent publication on PDX effect on insulin resistance (Nat. Med. 5/11/2014)

Michael Van Zandt, PhD, Director, Discovery Chemistry

  • Former Director, Institute for Pharmaceutical Discovery (1996-2012)
  • PhD, Organic Chemistry, Wayne State University

Robert Lipper, PhD, Technical Consultant, Formulation

  • VP, Biopharmaceutics, BMS (1984-2008)
  • PhD, Pharmaceutical Chemistry, University of Michigan

Mehar Manku, PhD, Scientific Advisory

  • former Chief Scientific Officer, Amarin Corp.
  • Executive editor, PLEFAs
  • Inventory on 61 patents in polyunsaturated fatty acids
Thetis Pharmaceutcals
CSO