- FDA application to expand HemoStyp's market reach: Earlier this year United Health Products filed a 510K Class II Application with the FDA (Food and Drug Administration) to allow for expanded usage of HemoStyp® into general surgeries and internal and external procedures. If the FDA approves this application, the company will be able to enter the estimated $15 billion surgical market. United Health Products has received initial comments from the FDA and has responded. United Health Products awaits any additional comments that the FDA may have before approval.
- International markets: United Health Products has forged a number of alliances with major health products distributors covering Australia and Asia. Further, the company has submitted an application to have its flagship HemoStyp® product approved for use in South Korea. Additional strategic partnerships with distributors in South Africa and in additional Asian countries are expected in 2017.
- Expanded Manufacturing Capabilities: The Company has conducted a number of Quality Control audits at prospective contract manufacturers of its patented HemoStyp® products, following which it has decided to double the number of facilities which will be permitted to manufacture HemoStyp® for domestic and international distribution. Backup production capabilities enable the company to continue shipping products should one facility suffer from a supply disruption.
For further information contact Investor Relations: Philippe Niemetz, 212-344-6464 PAN Consultants Ltd. email@example.com