Challenge
Nerve injury has significant health, social, and cost implications. Permanent disability despite surgical intervention includes constant pain (56%), adverse impact on daily life (71%), dexterity (97%), cold sensation (79 %), and reduced function(91%). 20-30% of nerve gap patients experience poor recovery of sensation, and the cost implications are estimated to be EUR 51,238 per person (2005).
Opportunity
Autographing, the current gold standard, is time-consuming with long surgical preparation time, and also faces the difficulties of harvesting donor site deficit, a finite resource, and risk of donor site morbidity and second surgical procedure. There are synthetic solutions in the market, however, Polynerve is the only one designed with an internal lumen microgrooving design to enhance the directional growth of the nerves.
Solution
Polynerve is designed specifically to promote nerve regeneration and is absorbable with no long-term side effects, it can eliminate second surgical harvesting site morbidity and potential neuroma formation and also can improve patients’ recovery due to reduced complications and less surgical intervention. For surgeons, no special training is required, and Polynerve provides a range of sizes to accommodate various needs. Simplified surgical procedure minimizing time in theatre by up to a third.
Status
The first in-man clinical trial is done, the next step is to assess the gap in documentation to see what is needed to amend in order to submit to FDA, and to have a clear pathway for Eu and UK CE. Building the Quality system, raising non-dilutive funds, submitting for a substantial clinical trial, and retrospective use of available uncontrolled information into the quality system are also top priorities, the team and the inventors are available for brainstorming.
Meet the team
Gina Melchner
NLC Venture Partner
Gina joined NLC in February 2020. As a Venture Partner, she works with a portfolio of Biotech and Medtech ventures. Gina also leads NLC’s Medtech Domain, ensuring we build impactful new Medtech ventures year after year. Gina holds a master’s in biotechnology from ETH Zurich and worked in management consulting as well as venture capital before joining NLC.