Subsequent Events

12 Months Ended

Dec. 31, 2016

Subsequent Events [Abstract]

Subsequent Events

Note 10—Subsequent Events

We have evaluated events that occurred subsequent to December 31, 2016 and through the date the consolidated financial statements were issued.

FDA Approval of Phase 3 Clinical Trial for GenerxTM

On February 3, 2017, Angionetics received notice that the FDA has granted Fast Track designation for the Phase 3 clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents).  Under the FDA Modernization Act of 1997, designation as a Fast Track product means that FDA will take actions, as appropriate, to expedite the development and review of a biologics license application (BLA) for product approval. The FDA’s Fast Track process is designed to facilitate clinical and commercial development and expedite the review of new drugs and biologics that are intended to treat serious conditions that demonstrate the potential to address an unmet medical need.

Notice of Allowance on Patent Application Covering Excellagen®

On June 7, 2017, the Company’s wholly-owned subsidiary, Activation Therapeutics, received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application (U.S. Application No. 13/648,255) entitled “Flowable Formulations for Tissue Repair and Regeneration.” The patent application includes claims covering methods to utilize formulations encompassing Excellagen [2.6%] as a topically applied flowable fibrillar collagen matrix for wound repair by promoting localized release of platelet derived growth factors and providing an in situ microstructural scaffold for cell migration.