BioFuse Series A Equity Funding
BioFuse Tissue Management System 400-N
BioFuse Medical Technologies, Inc. is a privately held medical device technology company engaged in the research, development and commercialization of an innovative, automated surgical tissue management system. The SurgiFuse system holds an FDA 510(k) clearance for tissue sealing. The Company expects to build upon its portfolio of intellectual property and existing FDA clearances with true soft tissue welding capabilities. The technology platform has the potential to improve patient outcomes in vessel and duct sealing as well as a broad variety of surgical procedures.
Used in Europe, not yet FDA approved/cleared. Not for sale in the USA.
|Form of Security||Equity Offering|
- Effective and Proven technology
- Large and Growing markets
- Experienced Medical Device Management team with a history of product commercialization and M&A successes
- Clear path to profitability with high margin recurring revenue model
- Company holds FDA 510(k) clearance for initial application of duct and vessel sealing
- Product roadmap includes tissue welding applications for colorectal anastomosis and pulmonary resections
- Large medical device companies and physicians are seeking safer and newer technologies as an alternative to sutures, staples and meshes - which to the body are considered 'foreign body' objects
- Target Investors: aggressive accredited health care/technology investors seeking equity participation in an early stage medical technology company for a minimum investment of $25,000.
BioFuse Medical Technologies, Inc.
Experienced Board and Management team with a history of successful medical device development, product commercialization and exits. ( Including Olympus | Medtronic | Wright Medical | Gyrus | ACMI | Microsoft)
Led by President, Gary Henley
-President, CEO and Director, United Orthopedic Group
-President, CEO and Director, Wright Medical Group
-President of Americas Division, Orthofix, Inc.
-President, Smith & Nephew Endoscopy Video
Gary has a history of building and managing successful, large-scale medical device companies including over 25 successful M&A transactions.
Chief Medical Advisor - Dr. John Monson, M.D.
-Executive Director of Colorectal Surgery at AdventHealth, Orlando
-Former Chair of U.K.'s National Training program
-Advanced fellowship training at Mayo Clinic in surgical oncology, vacular surgery and colon and rectal surgery.
-Presented more than 1000 lectures around the world, authored 400+ original published papers, four books and more than 250 book chapters.
Advisory Board Chair - Frank D'Amelio
-Over 30+ years of relevant medical device experience with over 250 devices through the FDA
-Prior CEO of Epica International
-President, Live Tissue Connect, Inc.
-Executive VP, CTO of Gyrus Corporation
-Chief Manufacturing Officer, ACMI
Chief Technical Advisor- Albert Juergens
-Extensive Background in medical device and product development
-Holds 7 patents including 2 in electrosurgical generators
-Designed and cleared 3 RF generators through the FDA
-Technical Expertise includes electrical hardware, software and firmware to comply with governmental regulatory requirements
VP of Business Development - Michael Adler
-Accomplished Medical/Surgical device sales management and business develpment
-Track record of startup development, strategic planning and Key Opinion Leader (KOL) introduction
-Former positions with Olympus and Medtronic
|Current Shares Outstanding||17,440,690|
|Value Per Share||$0.86|
|Anticipated Equity Offering||$2,000,000|
|Post Money Valuation||$17,000,000|
|Number New Shares||2,325,425|
|Total Shares Outstanding||19,766,115|
Series A Common Stock Offering of $2,000,000
Seed Round of $1.7mm completed in 2017 @ $0.34/share
Over $12.6mm invested through BioFuse and prior entity, Live Tissue Connect, Inc.
Fund product development of BioFuse 2nd generation tissue management system.
Build the Company’s new product pipeline through additional advanced R&D and clinical studies.
Apply for regulatory approvals, US and international patents.
Hire senior management, operational and sales and marketing personnel.
Purchase of inventory, products, services and/or technologies.
General corporate purposes, including working capital, offering expenses, operating expenses & future capital expenditures.
Demand for “advanced, innovative” devices that vastly improve outcomes
Increase demand to replace or monitor staples under recall , i.e. Ethicon 2019
March 2019, FDA indicated 41,000 “adverse event reports” for staplers, 2011-18
Continued focus on MIS to reduce hospital stays & costs
Surgeons want new technologies to eliminate scars & lower infection rates
Market Watch, 2019, Mordor Intelligence 2017, Researchgate.net, Future Business Insight 2018, Kake -2020
MEDTECH DIVE, Oct 31, 2019
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