We may be small, but we are no startup.
Mike Hooven, backed by an experienced team of executives and Board members, founded Enable Injections in Cincinnati, Ohio. As CEO of Enable Injections, Mike utilized his prior experience in founding the following successful medical device companies:
- Enable Medical Corporation was founded in 1994. Its acquisition in 2005 returned over 33x to initial investors.
- AtriCure (ATRC) was founded in 2000 and completed an IPO in August 2005. AtriCure is currently the leading company in the world in the surgical treatment of Atrial Fibrillation. In 2019, Atricure has a market capitalization of over $500 million.
Enable Injections engineering and design efforts are established in Franklin, Ohio.
The Enable Injections team moves into a new space, renovated as a pharmaceutical-grade device facility in northern Cincinnati.
Enable Injections closes $30M Series A Financing.
Enable Injections closes $40M Series B Financing.
The Enable Injections team is a fully-integrated combination product company comprised of top talent from around the world.
- Research & Development: The Enable design team consists of top medical device design engineers. Two of our engineers have over 100 issued and pending US patents in a wide variety of medical devices. Our lead design engineer was awarded the Johnson and Johnson Chairman’s Medal.
- Product Development and Manufacturing: Our development members have had direct responsibility for developing and introducing over 200 medical devices to the marketplace, representing over $10 billion in sales.
- Human Factors: Our Human Factors group has conducted comprehensive programs to shape the design and development of the Enable enFuse.
- Program Management: Our Program Management team has direct experience in the development and marketing of some of the most recent and innovative products on the market today.
- Regulatory: Enable has on-staff top expertise in combination products, and has completed more than 10 interactions with the US FDA and Notified Body authorities on the development of the enFuse device.
- Strategic Alliance and Marketing: Enable’s team has strategic alliance management experience of more than 30 years in the pharmaceutical industry, and deep marketing experience combining technical backgrounds and pharmaceutical backgrounds.
- Finance: The Enable Finance team has implemented SAP enterprise management system at Enable in anticipation of scaling to commercial needs.
- Operations: Enable’s leadership and operations includes a team of highly skilled operators supporting clinical manufacturing on-site.
- Quality: Enable’s Quality System is ISO 13485:2016 certified, and Enable’s Quality team sits on the ISO 11608 Working Group Committee.
- Human Resources: Human Resources team has more than 35 years successfully leading organizations in the healthcare industry.