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BioTherapeutics Inc. (BTI) is a pre-clinical stage company developing novel small-molecule drugs to treat inflammation associated with autoimmune related disorders and type 2 diabetes (T2D). We have identified an orally-active, first-in-class top lead compound that targets a unique and novel MoA: the LANCL2 pathway. Our top lead compound has demonstrated extremely positive efficacy in mouse models of both IBD and T2D and our preliminary toxicology data has confirmed that is safe at a very high dose and as a multiple dose for 14 days.

We just closed a very well funded seed round (NIH, CIT Gap Funds, other investments) and we are now looking to raise from $3 to $5M to generate IND enabling data and start human trials.

Boehringer Ingelheim was founded in 1885 and is based in Ingelheim am Rhein Germany. The firm invests by means of in-licensing and acquisitions and is primarily focused on respiratory diseases cardiovascular diseases metabolic diseases oncology diseases of the central nervous system and immunology. Boehringer Ingelheim also invests in veterinary medicine.

Brace Pharmaceuticals is based in Rockville, MD, and is a strategic investment company formed by Brazil-based pharma company EMS S/A. Brace investment structure varies depending on a company’s development stage; for early-stage opportunities Brace typically makes equity investments and may syndicate with other investors, whereas for clinical-stage opportunities Brace is more likely to form strategic partnerships that involve rights to an asset. Brace is open to considering therapeutic opportunities globally, but only if the company is pursuing the US market.

Brace Pharmaceuticals invests in therapeutics; about 80% of the firm’s investments are in clinical-stage assets, with a preference for companies with some human proof-of-concept data; the remaining 20% of investments are made in preclinical opportunities. Drug-device combinations will also be considered, but Brace does not invest in diagnostics. The firm will invest in both small and large molecules, and has a strong preference for investing in orphan drugs and other niche disease areas. It is preferred that indications have validated clinical endpoints and can be studied using small trials. Indications that require large clinical trials, including as cardiovascular diseases and primary care indications (such as influenza) will not be considered.

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.