COMPANY PROFILE: Renerva, LLC

CED Life Science Conference 2018 - presenting at the Coulter Investment Forum

https://www.renerva.com/
Sub-sector: Medical Device
Year Founded: 2017

COMPANY PROFILE
Renerva is committed to developing solutions for peripheral nerve injury. Renerva initiated operations in July 2017, but was incubated and derisked for 2 years within the University of Pittsburgh using about $0.9M in nondilutive. Renerva's first product, the Peripheral Nerve Matrix (PNM), is an injectable gel device that accelerates and improves the functional recovery of injured peripheral nerves. PNM will provide surgeons treating peripheral nerve injuries (PNIs) the effectiveness, broad applicability, and ease of use that current neurosurgical solutions lack. PNM is protected by multiple issued U.S. patents, it will be classified in the U.S. as a Class II medical device (i.e., 510(k)) and will be reimbursed by existing codes. Revenue traction in the U.S. is expected by the beginning of 2020, and positive cash flow by early 2021. Mature revenue potential in the U.S. approaches $200M/yr (15% of 2022 U.S. market). A fully outsourced manufacturing supply chain is in already place and we will use contracted regional distributors as sales channels. Renerva has a talented management team and has created a deep network of business, regulatory, and technical consultants, as well as clinical and scientific advisory boards including world-renowned experts and key opinion leaders.

FOUNDERS/MANAGEMENT TEAM
Lorenzo Soletti, President & CEO
Bryan Brown, CTO 
Paul Gardner, CMO
Chris Flaherty, Exec. Vice President for IP

KEY MILESTONES TO DATE

  • 2014-2017: Technical validation: Completed 8 small and large animal studies showing greater than 90% improvement in structural nerve repair and more than 40% improvement in nerve function over standard of care controls
  • Mar-May 2017: Completed nationwide customer discovery showing need validation and initial product-market fit interviewing one-on-one more than 150 stakeholders including 100 surgeons performing nerve repair procedures.
  • Jul 2017: Formal company operations started.
  • Jul 2017: License with Pitt of 3 issued patents and one in prosecution.
  • Jul 2017: Submitted pre-510(k) application to the CDRH at the FDA
  • Sep 2017: Trademark ‘Renerva’ issued
  • Sep 2017: First peer-reviewed paper published on PNM
  • Oct-Nov 2017: Completed early market outsourced supply chain development
  • Jul-Dec 2017: Quality management system in place
  • Dec 2017: PNM Design Freeze

CONTACT
Lorenzo Soletti, PhD, MBA, President and CEO
lsoletti@renerva.com
Pittsburgh, PA

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