Gerrit Gmel

Provide advice for the Medical Device industry, Biotech, Pharma, and Venture Capital Firms. Consult on Business Strategy, Due Diligence, Product Development, Clinical Strategy and Clinical Trial Design, Data Analysis, and IP. Strong Project Management skills and experience from startup to FDA-approved commercial companies.

Hemideina pursued a novel approach to cochlear implants, with a cross-ear-canal link allowing for a bud-like speech processor with custom electrode arrays fit to each patient's cochlear anatomy.

• Oversaw a team of 6 cross-functional engineers, COO, and CFO.

• Managed all aspects of product development and research.

• Led shareholder engagement and constructed pitch decks and data room content for fundraising. Received term sheet for $3m.

• Founded and spun out CLM from Saluda Medical with Saluda's CEO and Founder, John Parker with an initial seed of A$10m (post-money valuation of A$30m).

• Re-acquired by Saluda Medical (merger) 14 months later at A$100m valuation.

• Hired multidisciplinary team of engineers, clinical field force, and managers (10 members).

• Managed CRO (2 teams of 3 people each) and contract manufacturers in Australia, the US, and the Netherlands.

• Led team in building world's first closed-loop sacral neuromodulation system with a new lead design, manufacturing process (in-house), software, firmware, surgical tools and documentation.

• Created and launched the "CARE Study" in 3 international sites (Australia, Belgium, and the Netherlands) to investigate the safety and performance of the Repose SNS System.

• Designed and launched the "Liberty Trial" to investigate spinal cord stimulation (SCS) for the treatment of Spasticity in children with Cerebral Palsy in one Sydney site.

• Developed and presented operating and financial models to the board to guide the business operation pre- and post-merger.