Renerva, LLC, is a rapidly-growing and innovative medical device company with a focus to develop and commercialize implantable technologies to improve the outcome of peripheral nerve repair procedures.
Renerva’s Lorenzo Soletti says the company is building a stellar team and nourishing a culture of high performance and team cohesiveness with the focused mission of helping patients affected by peripheral nerve injury by advancing nerve recovery and restoring the hope of achieving a good quality of life.
TEQ wanted to learn more and had a few questions for Soletti.
TEQ: So, give us the elevator pitch for Renerva.
Lorenzo Soletti: Traumatic peripheral nerve injuries such as those caused by deep cuts and other accidents often lead to permanent disability and have a major impact on the quality of life and productivity of those affected. Despite the existence of dedicated surgical procedures and products, the prognosis for these patients is very poor.
This is a sizable existing market with reimbursement codes in place for some of the competitive products; however, this market is undeveloped due to a poor performance of such existing technologies resulting in limited adoption.
Renerva’s peripheral nerve matrix or PNM, is an injectable gel derived from porcine nerve tissue. PNM showed a 90% improvement in structural repair and more than a 40% improvement in functional recovery compared to controls, none of the existing products has shown any impact on functionality. Several physicians agree that these margins could make a tremendous positive impact in patients, and one of those even called it “The Neosporin™ of Nerve Repair,” hinting at the broad potential use and acceptance for the PNM across the many types of nerve injuries.
PNM will be classified as a medical device and will follow the short, inexpensive and predicable 510(k)/De Novo 510(k) pre-market notification path in the U.S., which will allow us to start human trials by the end of 2018 and regulatory clearance in 2020. PNM is a paradigm shift as it is the only product for peripheral nerve repair that can actively speed up and improve the functional recovery following traumatic nerve injury and that can be used in a broad variety of applications.
The global market for traumatic peripheral nerve injury is $3.5B, growing at 11% per year. The U.S. has the largest share with $1.1 billion spent annually in products for peripheral nerve repair. Our initial target market will be the segment consisting of transection injuries in the upper limbs operated by plastic surgeons, which is a $150 million annual revenue market in the U.S.
We are four co-founders (Bryan Brown (Pitt), Jonathan Cheetham (Cornell), Paul Gardner (UPMC/Pitt), and myself supporting complementary functional areas, including business strategy, technology development, scientific and clinical development, and we have a vast supporting network of industry and clinical consultants and advisors.
We have a quality management system in place, we received a favorable written response to our 510(k) pre-submission made in July 2017; we completed the development of our supply chain; and plan on completing design verification by July 2018. We are seeking $1.5 million to complete these activities and obtain IDE approval by the end of the year.
TEQ: Tell us more about peripheral nerve damage. How many people does it impact and how can it impact people?
Soletti: Nerve injuries are associated with loss of function, chronic pain, or both. Surgeons performing nerve repair often give their patients very poor prognoses. Nerve regeneration typically requires three to 18 months to complete, and terminal functional recovery is often less than 50%. Lack of functional recovery for peripheral nerves often lead to permanent disabilities. Each year in the U.S. alone, surgeons perform around 550,000 procedures to repair, graft or transfer peripheral nerves affected by traumatic or iatrogenic nerve injury, with a cost of $1.1B and an economic burden on society of $150 billion per year.
TEQ: Where did Renerva license the technology and what has it been like taking it to market?
Soletti: We license three issued U.S. patents, one in prosecution, and extensive know-how from Pitt and Cornell University. We started Renerva’s operations in July 2017. We have been moving very rapidly so far, we strongly believe that our technology will make a great positive impact in patients and, despite the relentless efforts and sacrifices made by all our people, we feel so motivated and empowered by the confidence in our technology, by our mission to impact patients, and by the great team spirit and culture that we developed.
TEQ: Give us more insight on being part of the life sciences industry in Pittsburgh.
Soletti: We are a proud Pittsburgh company, we want to succeed to help patients around the globe recover better and faster from peripheral nerve injury and damage, but we also want to succeed to add to the great momentum that this great city has been experiencing in the past 20 years. We want Renerva to be another Pittsburgh success and consolidate its position as critical hub for the life sciences industry!